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Tilburg University

Organ donation, policy and legislation

Coppen, R.

Publication date:2010

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Citation for published version (APA):Coppen, R. (2010). Organ donation, policy and legislation: With special reference to the Dutch organ DonationAct. Labor Grafimedia BV.

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Organ Donation, policy and legislation

With special reference to the Dutch Organ Donation Act Remco Coppen

Cover design: Richard van Kruysdijk Cover photo: Louis Janssen Donor form: www.donorregister.nl Word processing: Herma van den Brink Printing: LABOR Grafimedia BV, Utrecht ISBN 97894‐6122‐0202 http://www.nivel.nl [email protected] Phone: +31‐30‐2729700 Fax: +31‐30‐2729729 ©2010 NIVEL, PO Box 1568, 3500 BN UTRECHT All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior written permission of NIVEL. Exceptions are allowed in respect of any fair dealing for the purpose of research, private study or review.

Organ Donation, policy and legislation

With special reference to the Dutch Organ Donation Act

PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Universiteit van Tilburg

op gezag van de rector magnificus, prof.dr. Ph. Eijlander, in het openbaar te verdedigen ten overstaan van een door het college

voor promoties aangewezen commissie in de aula van de Universiteit op vrijdag 3 september 2010 om 10.15 uur

door

Remco Coppen geboren op 20 december 1976 te Rotterdam

Promotores: Prof.dr.ir. R.D. Friele Prof.mr.dr. J.K.M. Gevers Prof.dr. J. van der Zee This thesis was conducted at NIVEL, Netherlands Institute for Health Services Research, Utrecht, The Netherlands. The studies described in this book were carried out with financial support from ZonMw (the Netherlands organisation for health research and development), the Ministry of Health, Welfare and Sports, the Ministry of Education, Culture and Science, and the Kidney Foundation.

Contents Chapter 1 General introduction 7 Part I Chapter 2 The potential of legislation on organ donation to 33 increase the supply of donor organs Part II Chapter 3 The impact of donor policies in Europe: a steady 53 increase, but not everywhere Chapter 4 Donor education campaigns since the introduction 71

of the Dutch Organ Donation Act: increased cohesion between campaigns has paid off

Chapter 5 Explaining differences between hospitals in numbers 87 of organ donors Part III Chapter 6 Opting‐out systems: no guarantee for higher donation 101 rates Chapter 7 Imagining the impact of different consent systems 113

on organ donation: the decisions of next of kin Chapter 8 General discussion and conclusions 127 References 153 Samenvatting (Summary in Dutch) 179 Dankwoord 197 Curriculum Vitae 203 List of publications 207

5

6

1

General introduction

7

8


1.1 Introduction In the second half of the twentieth century it became medically possible to transplant organs from one person into another. Over the years transplantation medicine has undergone enormous development. Currently, the transplantation of organs is a regular medical procedure for people with failing organs. However, organ transplantation requires the availability of donor organs from other (mostly deceased) persons. Since the 1980’s there is a shortage of donor organs in the Netherlands (Gezondheidsraad, 2003). The number of people waiting for an organ has increased, while the number of available post mortem donor organs has remained fairly stable. This shortage resulted in waiting lists for patients to receive an organ, with increasing waiting times building up to several years (Gezondheidsraad, 1987). The problem of organ shortage is not unique to the Netherlands; all developed countries have a severe shortage of donor organs (Council of Europe, 2008). Nowadays, with a population of 16 million, there are 1288 people waiting for a donor organ in the Netherlands (Nederlandse Transplantatie Stichting, 2010),1 while there are around 200 post mortem donors2 each year (Nederlandse Transplantatie Stichting, 2009). It is, therefore, important to maximise the number of post mortem donor organs. In doing so one should take account of fundamental principles pertaining to the right to physical integrity, equitable access to and equal availability of care, and the non‐commerciality principle. The shortage of donor organs in the Netherlands persists. This leads to a lot of pressure on the Dutch government to take measures directed at increasing the supply of donor organs. This thesis focuses on the Dutch policy to increase the supply of post mortem donor organs, with special reference to the Organ Donation Act’s

1 The number of people waiting for an organ on 31 December 2009. 2 In this thesis donation rates are the “number of post mortem organ donors of whom at least one solid organ had been successfully transplanted per year”. Some countries (e.g. France and Sweden) use a deviating definition for their number of effectuated donors: “the number of post mortem organ donors of whom at least one solid organ had been recovered for the purpose of organ transplantation per year”.

9

Chapter 1

objective in this matter. The impact of the Act, and the effects of the additional policy measures will be assessed. In this chapter we will first explain some relevant aspects of organ donation and transplantation (section 1.2). Next, we will focus on the reasons for introducing legislation on organ donation in the Netherlands (section 1.3), the Dutch Organ Donation Act and additional policy measures (section 1.4), and the development of organ donation post mortem since the enactment of a legal system in the Netherlands (section 1.5). In section 1.6 we will examine the Dutch shortage of donor organs in an international context. Furthermore, this chapter contains the research questions of this thesis and elaborates on the strategy for studying the impact of the legal system on the shortage of donor organs (section 1.7). The final section (1.8) provides an overview of the structure of this book. 1.2 Organ donation and transplantation Organ donation is the removal of tissues of the human body from a person who has recently died (post mortem organ donation), or from a living donor, for the purpose of transplantation into another person with a failing organ. For a medically successful transplantation it is necessary to take account of (1) high quality standards for donor organs and (2) the fact that the human body experiences an implanted donor organ as foreign and will reject such organs. Donor organs have to meet high quality standards because an organ of low quality may cause the death of the recipient. The quality of an organ is influenced by age, sepsis, malignancies (with some exceptions for brain tumours), and active viral infections (e.g. HIV, herpes) (Nederlandse Transplantatie Stichting, 2006). Because of these factors, only a limited number of deceased people are eligible for post mortem organ donation. In the Netherlands, approximately 80% of post mortem donors died from a cerebral vascular accident (CVA – 59% in 2008) or (traffic) accident (21% in 2008) (Nederlandse Transplantatie Stichting, 2009). These rates are consistent with other Western European countries (Coppen, Marquet, & Friele, 2003). To suppress the body’s reaction of rejecting donor organs it is important to find the best medical match between the donor and recipient. For this

10


reason, the allocation of donor organs requires at least blood group matching; kidneys are also allocated by tissue matching (also called Human Leukocyte Antigen matching or HLA‐matching). Nevertheless, a transplant patient has to take immunosuppressive drugs to suppress the rejection of the donor organ for the rest of his or her life (Frohn, Fricke, Puchta J.C., & Kirchner, 2001). The world’s first cadaveric donor kidney transplant ever was performed in 1963 in Belgium.3 In the Netherlands, the first transplantation of a kidney took place in 1966 (Akveld, 1987; Polak, 1980). Since then, transplantation medicine has undergone enormous development. Over the years, transplant techniques improved and rejection symptoms became more manageable by means of (combinations of) drugs and better HLA‐matching (Kootstra, 1988; Cohen et al., 2005) (see Box 1.1 for a historical overview of milestones in transplantation). Transplantation of organs has evolved from being a medical procedure with an experimental character to a regular medical treatment for several diseases. The development of transplantation medicine contributes to the quality of life of many people (Kontodimopoulos & Niakas, 2008), and transplantation is often the only therapy for certain patients to live a relatively ‘normal’ life, without severe disabilities.

3 http://www.eurotransplant.nl/?id=timeline (25‐01‐2010).

11

Chapter 1

Box 1.1 A historical overview: milestones in transplantation Year

First transplantation worldwide of †

First transplantation in the Netherlands of *

1963

Kidney (Belgium)

1966

Kidney (Leiden)

1966

Pancreas/kidney/ (USA)

1967

Heart (South Africa)

1967

Liver (USA)

1979

Liver (Groningen)

1981

Heart/lung (USA)

1984

Pancreas (Leiden/Maastricht)

1984

Heart (Rotterdam)

1987

Intestine (USA)

1990

Lung (Groningen)

2001 Intestine (Groningen) Source: †: http://www.eurotransplant.nl/?id=timeline (26‐11‐2009) *: http://www.donorvoorlichting.nl/index.cfm?act=structuur.tonen&pagina=124 (26‐11‐2009)

Nowadays, organs which can be donated post mortem include lungs, liver, pancreas, intestines, heart, and kidneys (see Box 1.2 for information on heart beating and non‐heart‐beating donors). Some organs (kidneys and liver parts) can also be procured during life (living organ donation) (Gezondheidsraad, 2003). As surgery on a healthy body may have serious consequences for a person (Hou, 2000), in general post mortem donation is

12


preferred to living donation. Nevertheless, the number of living donations has increased over the years (Nederlandse Transplantatie Stichting, 2009). Box 1.2 Post mortem donation: heart‐beating vs. non‐heart‐beating donors For post mortem organ donation it is important that organs can be preserved from the moment the donor is declared dead until the moment that the organs are actually transplanted. The preservation of most organs, therefore, requires a supply of oxygenated blood, and the presence of blood circulation is necessary (Gezondheidsraad, 2003). This is only possible when the donor is declared brain dead and is mechanically ventilated (Op de Coul, 1998). Such donors are called heart‐beating donors. Even if blood circulation is absent, the donation of some organs (kidney, liver, lungs and pancreas) is still possible. After death by cardiac arrest the blood circulation stops and organs are no longer supplied with oxygenated blood. It is then important to artificially perfuse these organs (Kievit, Nederstigt, & Kootstra, 1998). Such donors are called non‐heart‐beating donors. 1.3 Issues in organ donation in the Netherlands The development of transplantation during the ‘eighties and early ‘nineties confronted the Dutch government with two main issues. A first issue was that from a legal point of view the procurement of a donor organ is a potential infringement of someone’s basic right to the integrity of his/her body. A second issue in organ donation was the scarcity of donor organs. Organ donation and physical integrity of the donor The right to physical integrity of one’s body is laid down in art. 11 of the Dutch Constitution and reads: “Everyone shall have the right to inviolability of his person, without prejudice to restrictions laid down by or pursuant to Act of Parliament”. Art. 11 also applies after one’s death. Removing organs from one’s body is a violation of the right to physical integrity. This right is not

13

Chapter 1

only relevant in the Dutch context, but it is a generally recognized principle. To prevent an infringement of the right to physical integrity, consent for organ donation is necessary. Also in an international context there is general agreement on the necessity to obtain consent for the removal of organs from a corpse. This is for instance reflected in legal documents such as the additional protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin, which stipulates in art. 17 that “Organs or tissues shall not be removed from the body of a deceased person unless consent or authorisation required by law has been obtained. The removal shall not be carried out if the deceased person had objected to it”. There are several ways to obtain consent for post mortem organ donation. In general, there are two defaults: systems of explicit consent (opting in) or systems of presumed consent (opting out). In explicit consent systems the donor himself has to authorise organ removal after his death (in the form of an advance directive or donor card, or by filling in a form in order to record consent in a national registry). For organ removal in presumed consent systems it is sufficient that the deceased person has not objected to it during his life; consent is presumed (Gevers, Janssen, & Friele, 2004). According to the Explanatory Report on the Additional Protocol (nos. 101‐102) countries are free to enact systems based on presumed consent or systems based on explicit consent. The Dutch Constitution only permits a deviation from the right to physical integrity when this deviation is allowed by an Act of parliament. Accordingly, the Dutch government took steps to enact a consent system through legislation. The scarcity of donor organs During the nineteen eighties it became clear that transplantable organs were scarce and that the demand for organs was higher than their supply (Akveld, 1988); the number of people on the waiting list for an organ transplant in 1988 was approximately 5 times higher than the annual number of effectuated post mortem organ donors. Because knowledge about HLA‐matching, surgical techniques and immunosuppressive drugs had improved over the years more patients could be treated for their diseases by means of the transplantation of an organ (Kootstra, 1998). At the same time, the number of procured donor organs had been more or less stable for years.

14


This led to a persistent shortage of donor organs and consequently to a considerable waiting time to receive an organ (Gezondheidsraad, 1987). In 1991 the Dutch government considered that there were two underlying causes for this shortage of donor organs: (1) there seemed to be a lack of trust among the population in organ donation, and (2) there seemed to be inefficiencies in the organisation of the process of organ donation in hospitals.4Although approximately 76% of the population supported organ donation (Tijmstra, Slooff, Heyink, & Pruim, 1989), only a limited segment actually gave consent to the removal of one’s own organ or the organs of a close relative (Akveld, 1987). In 1987 approximately 10‐15% of the Dutch population gave consent to organ donation by signing a donor codicil (a written declaration of will). The Dutch government assumed that the limited willingness to consent was caused by a lack of trust among the Dutch population in organ donation procedures. This was considered to be a major reason for the scarcity of organs. The organisation of the process of organ donation in hospitals was considered to be another cause of the shortage of donor organs. There was a limited capacity in hospitals to remove organs, and the medical staff were insufficiently aware of the relevance of organ donation. They were poorly trained in donor recognition and had limited competence in asking for consent from next of kin of deceased potential donors. The government assumed that these inefficiencies in the organisation were to blame for the loss of a considerable number of organs. The government felt responsible for the organ shortage and considered that the shortage could be solved by increasing public trust in donation procedures and providing legal certainty with the enactment of a legal system for organ donation. Additionally, the incorporation of several organisational provisions (e.g. the hospital donor protocol, in which a hospital describes the procedures in the case of a potential organ donation) into a statutory regime for organ donation was intended to increase the

4 House of Representatives II, 1991/92, 22 358, nr. 3, p.2‐3 (Explanatory Memorandum).

15

Chapter 1

efficiency of the donation procedure and to address the importance of increasing the efficiency of organ donation procedures in hospitals. When drafting the legislation on organ donation, the government was aware of the fact that enacting legislation alone would not be enough to solve the problem.5 Additional policy measures were needed to resolve the lack of trust issues and the inefficiencies in the organisation of the donation process. The government considered that the population should be informed about the possibility to donate organs and about the legal safeguards concerning organ donation to increase trust in the procedures.6 Furthermore, the government concluded that additional policy measures should focus on increasing the efficiency of the organisation of the organ procurement process. 7 1.4 The policy on organ donation in the Netherlands Because of these issues, the Netherlands enacted the Dutch Organ Donation Act in 1998, which provides for a consent system based on explicit consent, and it implemented additional policy measures. The Dutch Organ Donation Act is considered to be part of Public Law (Engberts et al., 2006). Public law regulates matters of public interest (Haan, Drupsteen, & Fernhout, 2001); the government supervises compliance with its provisions (Wijk, Konijnenbelt, & Male, 1997). If the Act should be infringed, there are legal instruments (sanctions) designed to enforce compliance (Engberts et al., 2006). Furthermore, the Dutch Organ Donation Act constitutes a closed legal system, which means that organs can only be donated under the conditions provided by the Act. In this system it is, for example, not possible to donate organs only on condition that they go to a non‐smoker.

5 House of Representatives II, 1991/92, 22 358, nr. 3, p.4, 25‐27 (Explanatory Memorandum). 6 House of Representatives II, 1991/92, 22 358, nr. 3, p.4 (Explanatory Memorandum). 7 House of Representatives II, 1991/92, 22 358, nr. 3, p.4, 25‐27 (Explanatory Memorandum).

16


The preamble to the Act states that “Whereas we have considered that, partly in view of the provisions of Article 11 of the Constitution, it is desirable, given the need to protect the legal interests of the parties involved, to regulate the donation of organs for use in the special medical treatment of others, this with a view to increasing the availability of organs, securing the equitable distribution of suitable donated organs and preventing trade in organs”. Accordingly, the Act has to safeguard the rights of donors and other directly involved persons (safeguarding function of the Act – objective 1, 3, 4) and has to increase the supply of donor organs (instrumental function of the Act – objective 2) (see Box 1.3). Box 1.3 The objectives of the Dutch Organ Donation Act 1 to codify the law and to provide legal certainty, also with regard to the consent system 2 to increase the supply of donor organs and tissues 3 to ensure the fair allocation of donor organs and tissues 4 to prevent commercialisation and organ trade In conclusion, the Dutch policy on organ donation contains three elements: - Safeguarding the rights of donors and other persons through legislation - Increasing the supply of organs through legislation (instrumental

function of the Act) - Increasing the supply of organs by implementing additional policy

measures The next three sections will examine these elements separately in more depth. 1.4.1 The safeguarding function of the Dutch Organ Donation Act The safeguarding function is an important aspect of legislation in general and especially of the Dutch Organ Donation Act. In a society the interests of people and governments vary and may conflict with each other. To prevent such conflicts and to acknowledge different interests legislation defines what

17

Chapter 1

people may expect from each other and their governments. The safeguarding function of legislation refers to its role to ensure that rights will be respected in accordance with what citizens may expect on the basis of the law in force and in line with the fundamental principles underlying that law. When drafting legislation it is important to take into account universal basic (legal) principles. For example, in our society we agreed that violence to a person’s body is not allowed. This is reflected in the right to physical integrity. Other principles are for instance, the principle of non‐discrimination, the principle of the freedom of speech, or the principle of nulla poena sine lege (Latin: ʺno penalty without a lawʺ). Since the second World War such fundamental principles have increasingly been incorporated into international human rights documents (Malanczuk, 1997). There is a traditional distinction between individual freedoms and social rights in the sense of rights that give access to basic social goods (e.g. the right to health care) (Leenen, 2000). Individual freedoms are inalienable and legally enforceable rights protecting the individual (Malanczuk, 1997). The enforcement of social rights is less stringent, as the scope of these rights is limited to national resources and there is room for national interpretation; countries have some freedom in how they codify these principles in their national legislation. However, social rights (e.g. the right to health care) have become more important over the years. Two basic principles that are relevant for health care are the right to physical integrity and the right to equitable access to health care. Draft legislation in health care can be tested against these international principles. As citizens may refer to these principles, countries have to ensure that their legislation is in accordance with them, and that legislation safeguards the interests enshrined in them. Hence, the safeguarding function of legislation contributes to certainty on what people may expect in terms of their rights and duties, given these basic principles. One of the most important interests to be protected in organ donation is the physical integrity of the donor. It is not permitted to retrieve an organ if the donor made an objection to organ donation. Consent systems for post mortem organ donation contain different mechanisms (based on opting‐in or opting‐out) to guarantee that organs will not be retrieved against a person’s wishes (the first objective of the Act). The Dutch government had to

18


carefully weigh up their decision to opt for the consent mechanism. According to the Dutch Organ Donation Act citizens have the options of registering (1) explicit consent, (2) refusal, or (3) that next of kin or (4) a specified person may decide upon the donation of organs after they have died.8 The Dutch consent system is considered to be an explicit consent system because retrieval of organs post mortem is not allowed without explicit consent, if not from the donor him/herself (while still alive) then at least from his/her relatives after he/she died. When drafting the Act, the government considered that the donation of organs greatly depends on the trust people have in the donation system. Another important issue is equitable access to and equal availability of care (Hendriks, 2005), which derives from (1) the more fundamental principle that all individuals in the Netherlands shall be treated equally in equal circumstances (art. 1 of the Dutch Constitution) and (2) the right to public health care9 (art. 22 of the Dutch Constitution). As a consequence, waiting lists for patients to receive a donor organ on a hospital level are not allowed; there are only national waiting lists for donor organs. All patients waiting for an organ are listed and organs are allocated according to the waiting list information (medical criteria and waiting time). To guarantee a fair allocation of organs, and thus equitable access to and equal availability of care (the third objective of the Act), this allocation is based on medical criteria and waiting time. In addition, the non‐commerciality principle plays a prominent role in organ donation in the Netherlands. This principle is based on the fundamental concept of human dignity, in particular the idea that the human body has an intrinsic value and cannot be dealt with as a mere object. Furthermore, it

8 Staatsblad (Bulletin of Acts, Orders and Decrees) 1998, nr. 41. 9 The Committee on Economic, Social and Cultural Rights (CESCR) explains in its General Comment No. 14 (Document E/C.12/2000/) that the right to health cannot be interpreted as “a state of complete physical, mental and social well‐being”. According to the Committee the right to health “embraces a wide range of socio‐ economic factors that promote conditions in which people can lead a healthy life, and extends to the underlying determinants of health, such as food and nutrition, housing, access to safe and potable water and adequate sanitation, safe and healthy working conditions, and a healthy environment”(Hendriks, 2009).

19

Chapter 1

was considered that a commercial market for organs that are scarce may lead to organ removal on improper grounds or people donating organs out of financial need. A commercial market might not only raise questions about the origin of organs and on their quality, but also about a fair allocation of organs, thereby putting pressure on the system as a whole and endangering the trust of people in the entire organ donation system. Therefore, it is important to prevent commercialisation in organ donation and organ trade (the fourth objective of the Act) (Caplan, Domínguez‐Gil, Matesanz, & Prior, 2009). 1.4.2 The instrumental function of the Dutch Organ Donation Act The instrumental function of the Act originates from the government’s policy to address the organ shortage and to reduce the gap between the donation rates and the number of people waiting for an organ. From this point of view the Act is part of the national policy and is used as an instrument to increase the supply of donor organs (the second objective of the Act). An important provision of the Act, designed to increase the supply of donor organs is its consent system. The mechanism behind this consent system is rather complex. The government assumed that people find it important that they can be sure that organs will only be procured if the donor, or his/her relatives, explicitly consented to organ donation (maximum physical integrity). The choice of an explicit consent system was based on the assumption that the supply of donor organs (the Act’s instrumental function) would benefit from providing legal certainty through explicit consent registration. Additionally, legal certainty would also benefit from safeguarding an equitable allocation of organs and the prohibition of organ trade. Thus, the safeguarding function of the Act (providing legal certainty) was considered to be a necessary condition to increase consent rates and to boost the national supply of donor organs. Other provisions of the Act supporting its instrumental function include the obligation for hospitals to implement a donor protocol and a donation committee. These provisions form an important legal basis for further implementation of additional policy measures.

20


1.4.3 Additional policy measures The additional policy measures on organ donation are predominantly aimed at the organ donation process in hospitals and donor education. Organ donation in hospitals With the enforcement of the Dutch Organ Donation Act, the Dutch government founded the Dutch Transplant Foundation (NTS). The objective of this foundation is to support organ‐ and tissue donation in the Netherlands. Accordingly, the NTS performs the following tasks (Nederlandse Transplantatie Stichting, 2001; Nederlandse Transplantatie Stichting, 2009): - Supervising the acquisition, classification and transportation of organs

from donors and their allocation to suitable recipients, in its capacity as an organ centre, as stated in Section 24 of the Act;

- Establishing a national database with data on donations and transplantations;

- Implementing activities to optimise donor procurement in hospitals. - Several tasks that result from the implementation of the Act, such as

enabling consultation of the Donor register and acting as an information source for medical questions.

To optimise organ procurement and to increase the efficiency of the donation process it is essential to counteract bottlenecks in organ donation procedures in hospitals. Consequently, in its plan for donor procurement the NTS proposed to implement structural adjustments to the donation procedure in hospitals. For example, special teams were set up to retrieve the organs of a donor and to overcome the limited capacity to remove organs (Smit, Berg, & Zeggelt, 2001; Smit & Mathijssen, 2002). Also, special donation officers were introduced in Dutch hospitals to increase the awareness of organ donation among medical professionals and to improve their competence in requesting consent from next of kin of deceased potential donors (Akveld, Cleophas, & Ras, 2002). Furthermore, by implementing several applications and databases to compile unambiguous information on donation procedures in hospitals, the NTS aims to increase insight into (bottlenecks for) organ donation procurement (Nederlandse Transplantatie Stichting, 2009).

21

Chapter 1

The NTS has delegated its responsibility for the allocation of organs in the Netherlands to the cross border allocation system of the Eurotransplant International Foundation. Eurotransplant was founded in 196710 from an informal academic network which focused on the allocation of kidneys. Eurotransplant was formed by small, mostly neighbouring countries (Austria, Belgium, Luxemburg and the Netherlands) and Germany. Later, Croatia and Slovenia joined Eurotransplant. By participating in cross border organ allocation schemes countries increase their donor pool and ensure optimum allocation of the donor organs. When an organ is procured but cannot be allocated in one country, it is offered to another country that has an eligible recipient. This prevents the loss of procured but not transplanted organs. The exchange of organs between the Eurotransplant countries is more or less balanced. Donor education Donor education in the Netherlands is conducted through a specialised centre. Initially, the SDV Donor Information Foundation (Stichting Donorvoorlichting) took care of donor education in the Netherlands. This foundation was set up in 1976 and represented several vested‐interest parties (the Dutch Kidney Foundation, the Dutch Heart Foundation, the Dutch Red Cross, Dutch Burns Foundation, Cornea Foundation Netherlands, the Dutch Stomach, Liver and Intestines Foundation, the Dutch Diabetes Funds, the Netherlands Asthma Foundation, the Royal Netherlands Society for the Advancement of Medicine) (Stichting Donorvoorlichting, 2001). The SDV Donor Information Foundation contributed to the introduction of the donor‐codicil and public debate on organ donation. The SDV Donor Information Foundation was also involved in drafting the Dutch Organ Donation Act. In 2003 the SDV Donor Information Foundation merged with the Netherlands Institute for Health Promotion and Disease Prevention NIGZ and continued its activities as NIGZ‐Donor Education. The aims of NIGZ‐Donor Education are (NIGZ‐donorvoorlichting, 2004):

10 http://www.eurotransplant.nl/?id=about (11‐06‐2009).

22


- to increase the number of (positive) registrations in the Donor Register - to increase the awareness of the role of next of kin - to maintain positive attitudes towards organ donation and support the

aims of organ donation policy. NIGZ‐Donor Education has two main functions: 1) to respond to questions about organ donation, 2) to set up and carry out organ donor campaigns (NIGZ‐donorvoorlichting, 2007). Besides campaigns which focus on the population in general, there are also campaigns which target special groups. Examples of such groups are: eighteen‐year‐olds, next of kin of deceased donors, and various religious groups. Since 1 January 2010 NIGZ‐Donor Education is embedded in NTS‐Donor Education. 1.5 Developments since the enactment of the Dutch Organ Donation Act Despite the introduction of the Organ Donation Act and the additional policy measures, the shortage of organs remained. Figure 1.1 shows that the demand for organs is still higher than supply. Because of improved techniques, more patients are eligible for an organ transplant and more patients are put on the waiting list. At the same time, the number of donor organs has been more or less stable during these years. This causes a persistent shortage of donor organs, leading to a considerable waiting time.

23

Chapter 1

Figure 1.1 The gap between the supply of donor organs and the demand for donor organs

0

200

400

600

800

1000

1200

1400

1600

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

Year

Number of people on thewaiting listNumber of post mortal organdonations

Introduction of the Dutch Organ Donation Act

Source: Dutch Transplantation Foundation: Annual Reports 1998‐2008 1.6 Organ donation in an international context The scarcity of donor organs is not unique to the Netherlands. Other countries likewise experience a shortage of donor organs (Barber, Falvey, Hamilton, Collett, & Rudge, 2006; Jansen, Leiden, Sieber‐Rasch, Hoitsma, & Haase‐Kromwijk, 2007; Roels, Gachet, & Cohen, 2004; Wesslau et al., 2007; Wight & Cohen, 1997). To put the Dutch shortage of donor organs into perspective, this section discusses similarities and differences between a number of surrounding countries for which information was available. These are countries which have all developed health care systems11 that enables them to perform transplantation of post mortem donor organs as a

11 http://stats.oecd.org/index.aspx (01‐02‐2010).

24


regular medical treatment for several diseases. That transplantation of post mortem donor organs is accepted as a regular treatment is reflected by positive attitudes to organ donation. Several studies point out that more than three quarters of the Dutch population is positively disposed towards organ donation (Zijdenbosch & Lutterveld, 1997; Zijdenbosch & Kamphuis, 1998; Ipso Facto, 2000; Verzijden & Schothorst, 2003; Cox, 2005; Lems, 2005). This is in accordance with the public attitude in other countries, such as Sweden (Sanner, 1998) and Spain (Fernández Luca, Miranda, & Matesanz, 1996). Furthermore, these countries share a similar historical background; they are all Western European. Figure 1.2 provides international figures on organ donation rates and the number of people waiting for an organ. Because this thesis focuses on post mortem organ donation we classified the countries based on their donation rates (post mortem). This figure illustrates the gap between the supply and the demand for donor organs, which dates back to the nineteen eighties (Gezondheidsraad, 1987). As transplantation developed and more diseases could be treated by means of organ transplantation, more people were put on a waiting list in these countries. In the meantime, the supply of donor organs proved to be insufficient to treat all patients waiting for an organ. Since then, the size of the waiting list for organ transplantation of these countries by far exceeds the annual organ donation rates. People even die while waiting for an organ (Council of Europe, 2008; Defever, 1990; Smith, 2009).

25

Chapter 1

Figure 1.2 International data on organ donors and waiting lists in 2007

34,3

28,2

25,3

22,3

20,5

16,9

16 14,5

13,2

10,7

117,

5

107,

5

121,

9

138,

8 172,

5

79,7

143,

7

48,7

165,

2

118,

8

0

20

40

60

80

100

120

140

160

Spain*

Belgium

*

France*

Austria

*Ita

ly*

Netherlan

ds†

German

y†

Sweden

*

United King

dom*

Switzerl

and†

Donation rates (per million inhabitants) Numbers waiting (per million inhabitants)

* Countries with a presumed consent system † Countries with an explicit consent system Source: Council of Europe, 2008 Although each country has a shortage of donor organs, there are differences in donation rates and in the number of people waiting for an organ transplant. For example, in 2007 Spain had 34.3 organ donors per million inhabitants (PMI) and Switzerland had 10.7 donors PMI (Figure 1.2), while the size of their waiting lists was equal. In that same year, 165.2 patients PMI were waiting for an organ transplant in the U.K. and (only) 48.7 patients PMI were waiting in Sweden. Fritsche et al. (2000) found significant practice variations in the evaluation of renal transplant candidates in Europe. This may explain the large differences between countries in the numbers of people waiting for an organ. Whether differences between countries in the organisation of the health care system also contribute to these differences is unknown. Can the differences in post mortem donor rates be explained by differences in national organ procurement policies? For instance, countries differ in the

26


way they have organised their consent systems. Some countries have enacted presumed consent systems, while others have enacted explicit consent systems. Figure 1.2 demonstrates that most of the presumed consent countries have higher donation rates than explicit consent countries. But there are other differences between countries. Firstly, countries differ in their quality standards for donors, which may have an effect on donation rates. For example, countries use different criteria when it comes to the maximum age of donors. To achieve a more efficient use of kidneys from elderly donors and to offer transplantation to elderly patients some countries use organs from donors older than 65 years for transplantation of recipients older than 65, whereas other countries have excluded this option (Chang, Mahanty, Ascher, & Roberts, 2003; Cohen et al., 2005). Secondly, there are large differences in the use of non‐heart‐beating donors between countries (Gezondheidsraad, 2003). In 2008, 41% of the total amount of post mortem organ donations in the Netherlands consisted of non‐heart‐beating donations (Nederlandse Transplantatie Stichting, 2009). In the meantime, the increase in non‐heart‐beating donations has been offset by a decrease in heart‐beating donors (Friele et al., 2004). Also other countries are performing more and more non‐heart‐beating donations. In 2008, 5.7% of Spanish, 13.4% of Belgian, 2.4% of French, 3% of Austrian, and 23,5% of British donors were non‐heart‐beating donors (Council of Europe, 2008). In other countries, non‐heart‐beating donations are not performed.12 Apart from legal restrictions no proper explanation for the differences between countries can be given. And, thirdly, there are differences between countries other than their donor procurement policies, which are difficult to influence, but may have an effect on procurement rates. These are, for example, cultural differences between countries, such as the influence of the family on organ donation (Fleischhauer et al., 2000), or the religious majority in a country (Gimbel, Strosberg, Lehrman, Gefenas, & Taft, 2003). Apart from that, for the organ supply, the availability of possible donors is vital. Approximately 80% of all deceased organ donors died from either a CVA or a (traffic) accident (Coppen et al., 2003). This suggests that differences in traffic safety (Baxter,

12 In Germany, non‐heart‐beating donation is even prohibited by law (Cohen et al., 2005).

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Chapter 1

2001) and CVA‐treatment (Kompanje.E.J.O., 2002; Kompanje.E.J.O., 2003) may be relevant confounders for differences in procurement rates between countries. 1.7 Research questions Although the Dutch Government introduced the Dutch Organ Donation Act, including an explicit consent system, and several additional policy measures, the gap between the organ supply and the demand for donor organs has remained. This has led to ongoing debate about the ability of Dutch law and policy to increase the donor organ supply. Several people took the position that the consent system as laid down in the law was an obstacle to procuring sufficient donor organs (Wezel, Keizer, & Cohen, 2001; Hessing, 2002). These people refer to presumed consent countries, which reported higher donation rates. They expected that replacing the explicit consent system by a presumed consent system would reduce the gap between donor supply and demand (Koene, 2002; Buijsen, 2003). The aim of this thesis is to study the effects of the Dutch Organ Donation Act’s objective to increase the supply of donor organs, with a special focus on the Act’s consent system, and the effects of the additional policy measures. The following research question will be addressed: “What is the impact of legislation on organ donation and additional policy measures on the supply of post mortem donor organs, with special reference to the Netherlands?” From a methodological point of view, studying the impact of an Act and its additional policy measures on effects in society, such as the impact on the supply of donor organs, is complicated. Many factors influence the availability of donor organs, and the impact of policy measures is somewhat indirect. To answer the main research question it is, therefore, necessary to use a strategy that addresses these difficulties. In this thesis we have adopted a strategy that approaches the research question from different perspectives in three consecutive parts. Consistency of the results of the

28


consecutive parts contributes to the reliability of the answer to the research question. The first part of the thesis contains an analysis of the proposals to change the Dutch Organ Donation Act in order to increase the supply of donor organs. The provisions of the Dutch Organ Donation Act, and the scope to increase the supply of organ donors without compromising the other objectives of the Dutch Organ Donation Act will be studied. The main emphasis of this thesis, however, will be on the empirical analysis in part 2 and part 3. Part 2 will give insight into the impact of the Dutch Organ Donation Act and its additional policy measures on the supply of donor organs. In this part both the impact of the implementation of the Dutch Organ Donation Act’s consent system as well as the impact of additional policy measures will be assessed. Part 3 will give insight into the impact which can be expected from changing or adjusting the current consent system. Countries with different consent systems will be compared on their procurement efficiency. Because next of kin play an important role in obtaining consent for an organ donation procedure, part 3 will also focus on next of kin decisions for different imaginary consent systems. This approach leads to three research questions, which will be answered in the consecutive parts: Q1 To what extent is it possible to adapt the Dutch Organ Donation Act

with a view to increasing the supply of donor organs? Q2 What is the impact of the implementation of the Dutch Organ Donation

Act and its additional policy measures? Q3 Will changing or adjusting the current consent system influence the

donor organ supply?

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Chapter 1

1.8 Structure of the thesis Part 1: The Dutch Organ Donation Act and the scope to adapt the Act The Act aims at safeguarding the rights of individuals and important legal principles13, but also at increasing the supply of donor organs (see Box 1.3). The first part of this thesis (chapter 2) focuses on the Dutch Organ Donation Act itself and the legal instruments designed to increase the supply of donor organs. Chapter 2 describes the objectives of organ donation legislation in general, and the provisions of the Dutch Organ Donation Act to increase the donor organ supply in particular. This chapter also pays attention to proposals which were made to amend the Act with a view to increasing the supply of donor organs. We will analyse whether proposed legal instruments are in accordance with the right to physical integrity, equitable access to and equal availability of care, as well as the non‐commerciality principle. Moreover, we will assess whether it is likely that these instruments will lead to an increased supply of donor organs. Part 2: The impact of the Act and additional policy measures In this part of the thesis we look back on the impact of the Act and 10 years of policy making. In chapter 3 longitudinal data is used to assess the general impact of donor policies on donor procurement in 10 Western European countries during the course of a decade. Special attention is given to the question whether differences in donor rates between countries can be explained by differences in legal systems or whether differences between countries can be explained otherwise. To assess the true impact of the Act and additional policy measures confounding factors will be considered and the data will be adjusted for the impact of these confounding factors. This part of the thesis will also take into account of the fact that policies need time to have an effect. Therefore, we will describe the impact of policies over a longer period of time. A bottleneck in the donation process is the high refusal rate. For this reason, the government has developed a strategy to increase the consent rate for

13 E.g. the right to physical integrity, equitable access to and equal availability of care, and the non‐commerciality principle.

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organ donation and to improve the efficiency of the process of organ donation. One element of this strategy is to provide donor education to the Dutch population. This is designed on the one hand, to point out the possibility of becoming an organ donor, and on the other hand to increase the number of registrations. The fourth chapter focuses on the combined impact of several policy measures in the field of donor education in the Netherlands over time. We will assess the impact of the additional policy measures on donor education by using trends in donor registration and donor procurement. Another part of the strategy to increase the consent rates is to optimize the organ donation process in hospitals. There are differences between hospitals with regard to the implementation of policy measures and their numbers of organ donors. These differences lead us to infer that some hospitals are more efficient in donor procurement than others. In chapter 5 these differences are studied and the scope for hospitals to increase their supply of donor organs is assessed. Part 3: Possible impact of changing the consent system The third part of this thesis focuses on what may be expected from changing the current consent system. The consent system is an important instrument of the Act. Many people expect that presumed consent systems lead to higher donation rates than explicit consent systems. The Netherlands implemented a system which is based on explicit consent because it was expected that the safeguarding power of the explicit consent system would contribute to increasing the supply of donor organs. Since the introduction of the Act there has been a lot of debate about changing to a presumed consent system in order to solve the shortage of donor organs. This part refers to the expected effects of a system change. Because other countries have implemented various consent systems, their results may shed some light on the possible effects of changing the current Dutch system (chapter 6). As next of kin seem to play an important role in providing consent for an organ donation procedure, chapter 7 models several imaginary consent systems, which were proposed to an internet panel. This chapter reveals whether the degree to which consent is explicit or presumed influences next of kin in their decisions and how this may have an effect on the supply of donor organs.

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Chapter 1

Chapter 8 is the final chapter of this thesis and summarizes the answers to the research questions, based on the findings of the previous chapters. In this chapter we also reflect on our findings and their relevance for donor procurement in the Netherlands. Finally, pointers are given for future research and policy making.

32

2 The potential of legislation on organ donation to increase the supply of donor organs A shortened version of this chapter has been accepted for publication as: Coppen, R., Friele, R.D., Zee, J. van der, Gevers, J.K.M. The potential of legislation on organ donation to increase the supply of donor organs, Health Policy.

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Abstract Each Western European country has legislation on organ donation. Whereas most have a presumed consent system, the 1998 Dutch Organ Donation Act, provides for an explicit consent system. The persistent shortage of organs has given rise to a national debate on the Act’s effectiveness. The question is asked, to what extent is it possible to adapt the Act, taking account of fundamental principles such as the right to physical integrity, equitable access to and equal availability of care, and the non‐commerciality principle, with a view to increasing the organ supply? In 2008 the Dutch Taskforce on Organ Donation presented several proposals to amend the Act and to increase the supply of organs. Several of these proposals could constitute an infringement of fundamental principles of the Act. Moreover, evidence for their impact on the organ supply is lacking. Changing the consent system is possible, as this would not incur legal objections. There are diverging views regarding the impact of consent systems on the organ supply. We conclude that the scope for changing the Act and its impact on organ procurement is at best limited. Relying on legislation alone will possibly not bring much relief, whereas additional policy measures may be more successful.

34

The potential of legislation to increase the organ supply

2.1 Introduction During the past decades, Western European countries have developed and implemented legislation on organ donation. Such legislation has various objectives: protecting the rights of the donor and other directly involved individuals, supporting the supply of donor organs by encouraging the donation and efficient use of donor organs. It seeks to prevent organ trafficking and financial gain from organ donation, to guarantee a transparent and fair allocation of organs, and to provide legal certainty. These objectives are based on a number of fundamental (legal) principles that take into account the interests of and provide legal certainty to patients, their next of kin, and medical staff. For example, the interests of a patient on a waiting list may conflict with the interests of a potential donor, when there is a shortage of donor organs and the potential donor has made objections to organ donation during life. Principles such as the right to physical integrity, the prohibition of trade in human tissues (non‐commerciality principle) and equitable access to and equal availability of care are laid down in international human rights documents, e.g. the Convention on Human Rights and Biomedicine. On the one hand these principles leave room for interpretation, and countries are, at least to some extent, free as to how they incorporate them into their national legislation. On the other hand citizens may seek to derive rights from these principles and countries should ensure that their legislation is in accordance with these principles. When developing legislation on organ donation, governments, therefore, have to take into account these diverging interests and guarantee adherence to international legal documents, such as the Convention on Human Rights and Biomedicine. The Netherlands, for example, enacted the Dutch Organ Donation Act in 1998. However, the persistent shortage of transplantable donor organs has given rise to heated political debate on this Act and has become a dominant issue in policy making for organ donation in the Netherlands. Members of parliament and interest groups, such as the Kidney Foundation and the Heart Foundation, have stated that because the implementation of the Act did not lead to an increase in organ donation rates, the Act failed to achieve its instrumental objective to increase the supply of donor organs. This debate

35

Chapter 2

has resulted in several proposals to amend the Act regarding the legal position of the (potential) donor (particularly in relation to presumed or explicit consent), the criteria for the allocation of donor organs and the provision of incentives for donation. Likewise in other countries, such as the United Kingdom and the United States, the legal system for organ donation has recently been the subject of debate (Yadav, 2008; UK Organ Donation Taskforce, 2008a; Childress & Liverman, 2006; DuBois, 2009). The question is to what extent legislation on organ donation can be amended with a view to increasing the supply of donor organs, taking into account fundamental principles such as physical integrity, equitable access to and equal availability of care, and the non‐commerciality principle. In answering that question we consider the Dutch Organ Donation Act and the proposals to amend the Act in this study. We first describe the underlying assumptions of the Dutch legal system regarding organ donation (section 2.2) and its most important provisions in relation to a number of fundamental principles in health care and organ donation (physical integrity, equitable access to care, non‐commerciality) and the objectives of the Act in particular (section 2.3). The proposals to amend the Act, made by The Dutch Taskforce on Organ Donation in June 2008 with a view to increasing the number of organs, are presented in section 2.4. In section 2.5 we discuss these proposals and assess the options for amending the Act taking into account the legal consequences as well as the possible impact on the supply of donor organs. In our final remarks we will address the question cited earlier, on the basis of our findings in the Dutch case. 2.2 Background: The Dutch Organ Donation Act The Dutch Organ Donation Act (the Act) regulates the donation of organs and tissues for the medical treatment of other individuals (Ministerie van Volksgezondheid, Welzijn en Sport, 2000). The Act covers post mortem donation and living donation. In this paper we focus on post mortem donation. The enactment of the legislation was preceded by public debate for more than 20 years. After all, the technical success of organ transplantation had given rise to several topical issues (Charro et al., 1993; Defever, 1990; Roscam

36


Abbing, 1990). At first, the debate focused on the rights of the donor and on how to obtain consent. Because of a possible infringement of physical integrity, consent to organ removal was considered to be a necessary pre‐condition At the end of the 1980’s the organ procurement rates had declined, while the waiting lists for organ transplantation increased because of the growing possibilities for organ transplantation (Roscam Abbing, 1990; Kokkedee, 1992b). According to the Act’s Explanatory Memorandum (1998), the following factors were considered to have caused this decline: - A decrease in the confidence of the general public in organ donation procedures:

Some people feared that their organs would be taken prior to death, which addressed the need for a brain‐death protocol (Gezondheidsraad, 1987). Others were afraid that their organs would be donated without their consent (Caplan et al., 1991; Gezondheidsraad, 1987; Kokkedee, 1992a). In addition, it was not clear how organs were allocated and whether financial motives played a part in the allocation scheme.

- Lack of knowledge about the opportunity to donate: Despite the increased attention by the press towards issues related to transplantation during the ’eighties only a part of the population was acquainted with the opportunity to donate organs after death (Gezondheidsraad, 1987; Thiel et al., 1993).

- Legal uncertainty about procedures and consent: For both the general public and the medical professions the legal implications of consent or refusal by relatives of the deceased were unclear (Akveld, 1988; Vroom‐Kastelein, 1986). The limits of physicians’ authority to prepare and remove organs had not been defined. Not only were the medical staff of some hospitals insufficiently informed about the formal procedures of an organ donation, there was also a lack of knowledge needed to recognize potential donors (Kokkedee, 1992a; Leeuwen et al., 1990).

The Dutch government concluded in the Act’s Explanatory Memorandum that the implementation of legislation and the creation of legal certainty and trust in organ donation procedures were necessary to help overcome these problems. The government considered safeguarding the rights of (potential) donors (i.e. providing legal certainty, but also ensuring compliance with fundamental principles such as protection of the physical integrity of the

37

Chapter 2

body, justice in the allocation of scarce organs, and the principle of non‐commerciality) as a necessary condition for increasing the supply of donor organs. The legislator assumed that trust in the system was an essential condition for increasing the willingness to donate and would boost the supply of donor organs. These functions are reflected in the preamble to the Act: “Whereas We have considered that, partly in view of the provisions of Section 111 of the Constitution, it is desirable, given the need to protect the legal interests of the parties involved, to regulate the donation of organs for use in the special medical treatment of others, this with a view to increasing the availability of organs, securing the equitable distribution of suitable donated organs and preventing trade in organs…” (Ministerie van Volksgezondheid, Welzijn en Sport, 2000). Hence, the Act has been accorded the following objectives: 1) to codify the law and to provide legal certainty, also with regard to the consent system 2) to increase the supply of donor organs and tissues 3) to ensure the fair allocation of donor organs and tissues 4) to prevent commercialisation and organ trade. These objectives are in line with more general and international legal principles such as protection of physical integrity, justice in allocation, and the principle of non‐commerciality; they are further elaborated in the Act’s provisions. 2.3 The provisions of the Dutch Organ Donation Act 2.3.1 Provisions to codify the law and to provide legal certainty The primary reason why legislation was adopted was to safeguard the rights of (potential) donors, e.g. the fundamental right to protection of physical integrity (art. 1.3 of the Declaration on the Promotion of patients’ rights, art. 1 of The Convention on Human Rights and Biomedicine). An important element of legislation on organ donation is the consent system. In an explicit consent system the donor himself has to authorize organ removal after his

1 This article states the fundamental right that “…everyone shall have the right to

inviolability of his person, without prejudice to restrictions laid down by or pursuant to Act of Parliament”.

38


death. In the Netherlands, if the deceased’s will is not known, the next of kin are consulted. By contrast, a strict presumed consent system does not require obtaining consent – either from the deceased, or from the next of kin; it is sufficient to verify that the deceased did not object during his lifetime to becoming a donor (Gevers et al., 2004). Although the international standards for organ donation support both explicit and presumed consent systems, most European countries have implemented a presumed consent system. However, the Netherlands chose to implement an explicit consent system. According to the Dutch government an explicit consent system is more in line with the assumption that becoming a donor should not be the choice of government but of the individual (or his/her next of kin). Also, it was not expected that a presumed consent system would lead to more organ donations than an explicit consent system. Moreover, the government considered that offering citizens the opportunity to register their wishes according to one of the four options, set out below, would increase their trust in organ procurement. Consequently, this increase in trust was expected to contribute to an increase in the supply of donor organs. The Dutch system is regarded as an explicit consent system because consent, either from the donor or from his next of kin, is necessary for donation;2 the removal of organs only takes place after consent. This is laid down in Section 9(1) and in Section 11(1) of the Act, which reads: ”Adults and minors aged twelve years or more who are capable of reasonably assessing their interests in such matters may consent to the removal of their organs or certain specified organs after their death, or may record their objection to such removal” and “If a person of a kind referred to in Section 9 is not known to have made a statement of will regarding removal of their organs, consent for removal may be given following his death by a cohabiting spouse or other life partner…” Consent for post mortem donation can be given prior to death by means of a document such as a donor card, by registering consent in the National Donor Register or by means of a last will. It is also possible to register one’s

2 In presumed consent systems people who did not register their refusal to organ donation during life are presumed to have given consent. In such a case explicit consent is not required, either from the deceased or from the next of kin.

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Chapter 2

refusal, to register a wish to leave the decision to relatives or to some other, specified individual, or to register consent to be a donor of all but certain organs and/or tissues. Other countries likewise provide for registration of consent as well as refusal (Gevers et al., 2004). Besides the implementation of the consent system, the Act contains other provisions for safeguarding the rights of (potential) donors. For example, the Act obliges doctors to determine brain death using the national brain death protocol (Gezondheidsraad, 2006) (Section 15); physicians have to follow certain procedures for preparatory activities and the preservation of organs (Section 22); and the physician who is involved in the determination of the death of the donor is not allowed to be involved in the removal or implementation of the donor’s organs (Section 14: “Before an organ may be removed, death must be confirmed by a physician who is not to be involved in its removal or implantation…”). 2.3.2 Provisions to increase the supply of donor organs and tissues The objective to increase the supply of donor organs and tissues is related to basic social rights, in particular the right to health care (Section 22 of the Dutch Constitution reads: “The authorities shall take steps to promote the health of the population”). For patients whose organs are failing, transplantation is often the only available treatment. The explicit consent system was considered to be the most important provision for creating trust in the procurement system and for increasing the supply of donor organs. Apart from the consent system two other provisions with this same function were enacted: - Protocol in hospitals (to ensure that medical professionals in hospitals

put effort into the procurement of post mortem organs; Section 23 reads: “The hospital management shall be responsible for ensuring that a protocol covering the donation of organs for implantation is drawn up and adhered to”);

- Legal basis for preparatory activities and preservation of organs (Section 22 reads: “If it is established that a person has given consent for the removal of an organ after his death, preparatory tests may be conducted and preparatory action taken, insofar as such tests and action are not detrimental to the person’s medical treatment and cannot for technical reasons relating to implantation of the organ be postponed until after the person’s death”). If no statement of will

40


can be traced, and if the deceased has not left the decision to relatives or to some other, specified individual, “… such action as is necessary may be taken to preserve the organ in a suitable condition for implantation until the procedure for obtaining consent pursuant to this Act is complete”.

2.3.3 Provisions to ensure the fair allocation of donor organs and tissues The right to health care also presupposes equitable access to and equal availability of care (Roscam Abbing, 1990).3 The third objective of the Act refers to this legal principle; the Act contains provisions for the allocation of organs. The allocation of organs takes place on both national and international level and is only based on medical criteria and waiting time on the national transplant waiting list. This is laid down in Section 18(3), which reads: “When allocating organs, no factors shall be taken into account other than the blood and tissue compatibility of the donor and recipient, the medical urgency of the recipient’s condition, other circumstances relating to the condition of the organ and, if the foregoing alone do not provide adequate grounds for the selection of a recipient, the length of time that the possible recipients have been waiting”. Which medical criteria are relevant varies between organ types and is established on a national level by medical professionals. In the Netherlands, the Dutch Transplant Foundation (NTS) documents the relevant (medical) characteristics of patients who are on the national organ donation waiting list. The NTS shares this information with the Eurotransplant International Foundation (Eurotransplant). Eurotransplant is responsible for the mediation and allocation of organ donation procedures in Austria, Belgium, Croatia, Germany, Luxemburg, the Netherlands and Slovenia.4 The NTS is responsible for the allocation of organs in the Netherlands.5 The allocation of organs is based on medical criteria; the

3 See also art. 5.5 of the Declaration on the Promotion of patients’ rights, art. 3 of The Convention on Human Rights and Biomedicine, and art.3 of the Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin. 4 http://www.eurotransplant.nl/?id=about (11‐06‐2009). 5 http://www.transplantatiestichting.nl/?id=orgaantransplantatie#aanmeldingspro cedure (11‐06‐2009).

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Chapter 2

medical match between the donor organ and the recipient is crucial (e.g. blood type, organ size). When an organ becomes available for transplantation, all relevant (medical) information about the donor is gathered by the NTS and transferred to Eurotransplant. Special computer software selects the patient most suitable to receive the organ of a specific donor. 2.3.4 Provisions to prevent commercialisation and organ trade The fourth objective of the Act reflects the more general concept of human dignity and the non‐commerciality principle in health care.6 To protect human dignity and prevent organ trade and commercialisation, the legislator stipulated that the donation of organs may only take place on a voluntary basis; remuneration of donors (or their family) is not allowed, nor are other parties in the process allowed to make profit out of the donation of organs. Certain payments are not to be treated as financial gain such as expenses that may be incurred during or as a result of the donation of organs. This is laid down in Section 2: “Consent given for the removal of an organ, given in return for payment amounting to more than the costs (including loss of income) incurred by the donor as a direct result of the removal of the organ, shall be invalid”. Furthermore, any trade in organs and tissues in order to make financial profit is prohibited. Only a not‐for‐profit organ centre (Section 24‐25) which is licensed by the minister is allowed to allocate organs. 2.4 The proposals to increase the supply of donor organs At the time of the enactment of the Dutch Organ Donation Act the government chose to be neutral in its communication about organ donation; it had no objections to organ donation, nor was it explicitly in favour of organ donation. The choice of being an organ donor had to be made by the citizens themselves. However, after the introduction of the Act in 1998,

6 See also art. 21 of The Convention on Human Rights and Biomedicine, and art. 21 of the Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin.

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national donation rates dropped from 216 post mortem donors in 1997 (13.8 donors per million inhabitants (PMI)) to its all time low of 165 donors in 1999 (10.4 donors PMI) (Nederlandse Transplantatie Stichting, 2000; Nederlandse Transplantatie Stichting, 2007). At the same time the transplant waiting lists were still increasing and the shortage of donor organs had become a serious issue in both the political and the public arenas. In reaction, the government implemented additional policy measures to support the objective of the Act to increase the supply of donor organs (its instrumental function); i.e. measures to increase the efficiency of the organ procurement process in hospitals and measures to inform the public on the positive aspects of organ donation. In 2008, ten years after the introduction of the Act, 201 organ donors were procured (12.3 donors PMI) (Nederlandse Transplantatie Stichting, 2009). Several political parties and interest groups, such as the Dutch Kidney foundation and the Dutch Heart Foundation, held the opinion that the introduction of the Act and the implementation of the additional measures had apparently failed to have a positive impact on organ donation rates. The Dutch Kidney foundation therefore proposed the setting up of a master plan for organ donation. The Dutch Taskforce on Organ Donation took up this initiative and presented several proposals to amend the Act in order to increase the numbers of organ donors by June 2008 (Coördinatiegroep Orgaandonatie, 2008). These proposals were aimed at adjusting the consent system, introducing non‐medical criteria to the allocation system, and introducing financial incentives. 2.4.1 Changing or adjusting the consent system The low consent rate for organ donation, either from potential donors themselves or next of kin, was regarded as one of the main bottlenecks behind the chronic shortage of transplantable donor organs (Ploeg et al., 2003). Therefore, it was proposed to change or adjust the consent system. Presumed consent Irrespective of the consent system, most people do not register their wishes (whether consent or refusal), consequently the pool of potential donors in a presumed consent system far exceeds the pool of potential donors in an explicit consent system (Gäbel, 2006; Johnson & Goldstein, 2004). For this

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Chapter 2

reason several Dutch interest groups and political parties suggested changing the current consent system, based on explicit consent, to a system based on presumed consent. However, changing to a presumed consent system was rejected by the Dutch House of Representatives.7 Some political parties feared that switching to a presumed consent system would lead to a decline in legal certainty and in the public’s trust in the procurement system. They feared that this would harm organ procurement. Automatic consent To avoid a decline in legal certainty by losing the current consent registrations while retaining the possible advantages of a presumed consent system, a broad coalition of interest groups has suggested changing the position of unregistered individuals by introducing, what they call, “automatic consent registration”. This would mean that all citizens not yet registered in the national registry, will receive a letter to inform them that if they do not explicitly refuse to be a donor they will automatically be registered as willing to donate in the national registry. To verify whether an individual really wants to be registered, this individual will receive a letter confirming his automatic registration. On the whole, it was considered that automatic consent registration would seem to combine the advantages of presumed consent systems with the advantages of explicit consent systems. It still safeguards the rights of individual donors and their families and provides sufficient legal certainty; the advantage of explicit consent registrations. At the same time, this system might increase the donor pool; the advantage of introducing the default rule of presumed consent. It was considered that an increase of the donor pool could have a positive impact on the organ donation rates. Automatic consent registration was considered the best way to guarantee the registration of each Dutch citizen in the Dutch Donor Register. One could also have opted for a mandated choice system (Chouhan & Draper, 2003; Spital, 1996). However, a mandated choice system was not seriously considered, because of difficulties with the implementation of such a system in the Netherlands.

7 Acts of Parliament II, 2001/02, 83, p.5014‐5015.

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2.4.2 Introducing non‐medical criteria to the allocation system to increase the donor organ supply

To increase the number of transplantable donor organs the introduction of non‐medical criteria to the allocation system has also been proposed. Reciprocity In the Netherlands there is a considerable difference between the number of people that say they are willing to donate their organs after death (69%) (European Commission, 2007) and the number of those who actually register their consent (23%) (Nederlandse Transplantatie Stichting, 2009). Besides that, most people want to receive an organ when they need one. To make use of the willingness of people to donate their organs, to stimulate registration and to point out that that those who want to receive an organ should normally be willing to donate an organ, Den Hartogh proposes the addition of reciprocity as a non‐medical criterion to the allocation system (Hartogh, 2003). He proposes that those who register as donors should be given priority if they are ever on a transplant waiting list. His underlying presumption is that creating incentives for becoming a donor would convince citizens to register their consent in the national register. Living donor list exchange In the case of kidneys, one of the alternatives to the transplantation of a deceased individual’s organ is to transplant a living individual’s organ. For a successful living donation the medical match with the recipient is crucial. Sometimes, there is no medical match between the living donor and the intended recipient and there is no possibility for a cross‐over transplantation (the exchange of an organ with another donor‐recipient couple who experience the same problem) (Kranenburg et al., 2004). According to the living donor list‐exchange principle this patient (A) can pass on the organ, which was intended for him, to someone on the waiting list for a post mortem organ (patient B). Patient B no longer needs to be on the waiting list for a post mortem organ and therefore patient (A) gets extra priority in the allocation system to receive a post mortem organ. Hence, the living donor list exchange introduces a new, non‐medical, allocation criterion to increase the possibilities for transplantation. The underlying idea of this proposal is

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to stimulate living donation, even when there is no medical match between the acquainted living donor and the intended recipient. 2.4.3 Introducing financial incentives to register as a donor or to donate

organs The transplantation of a kidney saves lives and is considered to be more cost effective than dialysis (Council of Europe, 1999). Organ donors, therefore, reduce the financial burden of patients with organ failure. It has therefore been suggested that it is reasonable that citizens who show their intention to reduce this financial burden may also financially profit from this reduction. During the past years several examples of financial incentives to convince citizens to actually become a living or a post mortem donor, or to register as a donor have been proposed. Discount on health insurance by donor registration It is assumed that more registered organ donors will lead to more organ donations, thereby reducing the financial burden of patients with organ failure. It would be fair to return the money saved to the people who made this saving possible, the registered donors. Therefore, it has been proposed to give citizens who are registered as donors in the national register a discount on their health insurance. Reimbursement of funeral costs Another proposal was to reimburse the funeral costs for deceased individuals from whom an organ has been procured. It was proposed that the family should receive a part of the costs saved by the donation of the organ, to finance the funeral of their beloved and to reward them for not refusing organ donation. Rewarding living donors Because post mortem donor organs are scarce, living donation has become an important alternative treatment for patients with organ failure. To encourage people to donate an organ during their life it has been proposed, not only to pay the expenses for living donation but also to financially reward living donors.

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2.5 Discussion: proposals to amend the Act In this section we will evaluate these proposals by assessing their intrinsic adherence to basic principles in health care and organ donation and the available evidence that the proposals will indeed increase the supply of donor organs and reduce waiting time for patients. More specifically, in our analysis we take into account the principle of equitable access to and equal availability of care, the prohibition of trade in human tissues (non‐commerciality principle), and the principle of physical integrity, which are laid down in international documents such as the Declaration on the Promotion of patients’ rights in Europe, the Convention on Human Rights and Biomedicine and its Additional Protocol on Transplantation of Organs and Tissues of Human Origin. For the introduction of non‐medical criteria in the allocation system, Section 18(3) of the Dutch Organ Donation Act would have to be changed. This raises the question whether such a change may possibly constitute an infringement of the Declaration on the Promotion of patients’ rights in Europe (art. 5.5) and the Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin (art. 3). Both documents address the importance of equitable access to health care and stipulate that choices in health care should only be based on medical criteria. Does introducing reciprocity and the availability of a living donor as non‐medical criteria detract from the fundamental principle that each patient should have the same opportunity to receive an organ? In the Netherlands, the right of equal access of patients to health facilities is embedded in the right to health and the equality principle laid down in the Constitution (Hendriks, 2001). The equitable distribution of health services, safeguarded by the right of equal access, is one of the main principles of the Dutch health care system. To our view, compromising this principle by introducing non‐medical criteria may detract from the equal opportunity of patients to receive an organ, which may lead to a decrease in trust in the organ procurement system. A second question is whether there is sufficient evidence that introducing non‐medical criteria will increase the supply of donor organs. Ravelingien & Krom (2005) state that, on the contrary, introducing reciprocity to the

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allocation system could have some undesirable effects. They argue that the more donors there are, the more people on a waiting list have priority, and the less advantage an individual gains by registering. They do not expect the supply of donor organs to increase. Apart from that, they state that the emphasis on personal responsibility within the practice of medicine is a new and still controversial matter of debate (Ravelingien & Krom, 2005). As some people are better equipped to exercise their own responsibility than others (others being mostly the least advantaged), introducing reciprocity into the allocation system may create longer waiting times for certain patient groups. In the case of another example, the living donor list‐exchange, Den Hartogh (2010) argues that although it is expected that the living donor list‐exchange should increase the donor organ supply, it will tend to extend the waiting time for patients with rare blood groups or HLA‐types who are not able to use the living donor list‐exchange program. He therefore, argues that the living donor list exchange program disadvantages the least advantaged. In conclusion, changing the Act in this respect may detract from the principle of equitable access to and equal availability of care. In both of our examples the equal opportunity for patient groups to receive an organ is at stake. Moreover, there is no clear evidence that the introduction will have an effect on the supply of donor organs. Introducing these criteria may even lead to some undesirable effects on the waiting times for (some) patients. Apart from that, Verzijden & Schothorst (2003) report that introducing reciprocity into the allocation of organs is not supported by the Dutch population. Introducing non‐medical criteria into the allocation system may, therefore, lead to reduced trust in the system. The introduction of financial incentives for donating an organ, e.g. reimbursing funeral costs or rewarding living donors, means that the non‐commerciality principle of the Act would be abandoned and Section 2 of the Act would have to be changed. Would such a change still be in line with international legal documents? The Convention on Human Rights and Biomedicine states in article 21 that “the human body and its parts shall not, as such, give rise to financial gain”. In addition, art. 21 of its Additional Protocol on Transplantation of Organs and Tissues of Human Origin states that “the human body and its parts shall not, as such, give rise to financial gain or comparable advantage”. These sections safeguard the principle that consent to the

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removal of organs may not be based on improper grounds or arise from financial need. By introducing financial incentives for donating organs, people with financial problems may feel compelled to donate organs in order to solve their monetary problems. Moreover, such an introduction could instigate trafficking in human beings for the purpose of the removal of organs. Safeguarding the non‐commerciality principle is important for people’s confidence in the organ procurement system. Recently, this importance was addressed once more by a joint study of the Council of Europe and the United Nations (Caplan et al., 2009). In addition, it is not clear that financial incentives would lead to more organ donors; there are a lot of contradictory findings in this respect (Rodrigue et al., 2006; Mayrhofer‐Reinhartshuber et al., 2006; Arnold et al., 2002; Oz et al., 2003; Schweda & Schiktanz, 2009; Jasper et al., 1999). And again, the Dutch population do not support an organ procurement system with financial incentives (Raaij & Taels, 2008). Van Raaij & Taels (2008) report that introducing financial incentives would raise questions about the real intentions of donors: Did the donor act because of financial problems? Was the donation really made on a voluntary basis? Are there differences in quality between organs of donors with a financial incentive and organs of donors without a financial incentive? This leads us to conclude that introducing financial incentives to donate organs will possibly meet with legal objections. Changing the Act as proposed may conflict with the non‐commerciality principle, may diminish faith in the system, and there is no evidence available that this introduction will increase the donor organ supply. Dutch health insurers are allowed to give a maximum of 10% discount on health insurance for collective contracts via employers, associations and member organizations. At the end of 2008 some health insurers did introduce a discount on health insurance for people who register in the national donor register; a variation on the discount on health insurance by donor registration. To receive this discount, it is not relevant which choice the insured has registered; those insured who register as non‐donors are equally rewarded with a discount. In this case, it is not the human body and its parts, as such, but registering in the National Register that gives rise to financial gain. The introduction of this discount led to a political debate. Because the discount is only linked to registration, regardless of consent,

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refusal or leaving the decision to another individual, and is therefore achievable for anyone, the Dutch Minister of Health considered this discount to be in line with the Dutch Organ Donation Act8 and did not prohibit the discount. As Section 2 of the Act as well as art. 21 of the Convention and art. 21 of its Additional Protocol seem to focus on financial gain by selling organs, whereas rewarding registration alone does not appear to be based on improper grounds or to arise from financial need, this measure does not seem to be in conflict with the non‐commerciality principle. However, it remains unknown whether the measure has led to an increase of consent registrations or has had an effect on the supply of donor organs. For the introduction of a system of automatic consent registration, Section 11(1) and 9(1) of the Act would have to be changed. Again, would such a change still be in line with international legal documents? The Additional Protocol (article 17) stipulates that “Organs or tissues shall not be removed from the body of a deceased person unless consent or authorisation required by law has been obtained. The removal shall not be carried out if the deceased person had objected to it”. According to the explanatory report of the Additional Protocol (no. 101‐102), countries are free to implement a presumed or explicit consent system. As a matter of fact, many countries have implemented a consent system based on presumed consent (Gevers et al., 2004), which to some extent corresponds with a system of automatic consent registration. The introduction of automatic consent registration does not lead to an infringement of relevant fundamental principles in health care and organ donation. Nonetheless, it remains unknown whether changing to another consent system will influence a sense of legal certainty regarding the protection of physical integrity and might jeopardise public trust in the procurement system (Murphy et al., 2009). Another important question is whether changing to another system will increase the supply of donor organs. There is, however, no clear answer to this question. In theory, there seem to be considerable differences in the efficiency of donor procurement between consent systems. But, there is a lot of debate as to whether in practice the efficiency of a presumed consent

8 House of Representatives II, 2008/09, 28 140, nr. 66 / Acts of Parliament II, 2008/09, 1210, p.2535‐2537.

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system prevails over the efficiency of an explicit consent system (Abadie & Gay, 2006; Coppen et al., 2005; Coppen et al., 2008; Gäbel, 2006; Gimbel et al., 2003; Johnson & Goldstein, 2003; Matesanz, 1998; Matesanz, 2004; Mossialos et al., 2008; Wright, 2007). Gevers et al. report that because next of kin play an important role in obtaining consent for organ donation in each country, in reality consent systems are more similar than suggested by the explicit/presumed consent distinction (Gevers et al., 2004; Janssen & Gevers, 2005; Matesanz, 2004). Therefore we conclude that although the introduction of the latter system is possible from the point of view of fundamental principles in health care and organ donation, there is no evidence base to support the notion that changing the consent system will increase the supply of donor organs and reduce waiting time for patients. 2.6 Conclusions The Dutch Organ Donation Act was originally designed to provide both legal certainty and trust in the procurement and distribution of organs. It was considered that more trust would increase the supply of donor organs. However, the implementation of the Dutch Organ Donation Act did not solve the shortage of donor organs. Many considered the fact that explicit consent was a necessary pre‐condition for organ donation to be a barrier for increasing the supply of donor organs in the Netherlands. Although the safeguarding function (i.e. providing legal certainty and ensuring compliance with fundamental principles) of the Act was basically in line with its instrumental function to increase the supply of donor organs, an area of tension became visible between both functions. This led to a reconsideration of the legislation in order to increase the supply of donor organs. In order to boost the supply of donor organs, various proposals were made to amend the Act. These proposals were aimed at introducing non‐medical criteria to the allocation system, introducing financial incentives to donate organs, and adjusting the consent system. We found several of the proposals to be at variance with the fundamental principles protected by the Dutch Organ Donation Act. The introduction of non‐medical criteria to the

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allocation system may detract from the principle of equitable access to and equal availability of care. The introduction of financial incentives to donate organs would possibly conflict with the non‐commerciality principle. Human organs are not a marketable commodity. Infringement of these principles may harm the trust of people in the procurement and distribution system of organ donation. The current opinion that in organ donation such infringements should be avoided is consistent among Western countries (Caplan et al., 2009). Apart from this, for most of the proposals evidence is lacking that they will lead to more donor organs. In fact, adverse effects may even be expected. There is one exception to this finding. Many people consider that changing the consent system from explicit consent to presumed consent or automatic consent registration may help to increase the number of donations. Changing to another consent system will not incur legal objections, since it still leaves room for people to express their wishes and provides a guarantee for their right to physical integrity. The international literature provides diverging views regarding the impact of introducing a presumed consent system on increasing the supply of donor organs (Abadie et al., 2006; Gäbel, 2006; Gimbel et al., 2003; Johnson et al., 2003; Matesanz, 1998; Matesanz, 2004; Mossialos et al., 2008; Wright, 2007). However, international comparative research linking procurement rates to consent systems, while controlling for differences in mortality rates, suggests the impact of such a change to be limited (Coppen et al., 2005; Coppen et al., 2008; Gevers et al., 2004; Janssen et al., 2005; Matesanz, 1998). This implies that the scope for changing the Dutch Organ Donation Act in order to increase the supply of donor organs is at best limited. More in general, it seems that relying on legal measures only to increase the number of donations will not bring much relief. Other ways, such as additional policy measures aimed at the procurement process in hospitals and at a sustained and comprehensive donor education policy, may be more successful in achieving this.

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3 The impact of donor policies in Europe: a steady increase, but not everywhere This chapter has been published as: Coppen, R., Friele, R. D., Gevers, J. K. M., Blok, G. A., & Zee, J. v. d. (2008). The impact of donor policies in Europe: a steady increase, but not everywhere. BMC Health Services Research, 8, 235‐244.

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Abstract Background Transplantable organs are scarce everywhere. Therefore, countries have developed policies to support the efficient use of potential donors. Nevertheless, the shortage of organs remains. Were these policies in vain? The aim of this study is to assess the impact of donor policies on donor procurement in 10 Western European countries from 1995 to 2005. Method To assess the impact of the donor policies we studied the conversion of potential donors into effectuated donors. 80% of the donors died from CVAs or a (traffic) accident. We considered these mortality rates to be a good proxy for potential donors. Here we call the conversion of potential donors into actual donors ‘the donor efficiency rate by proxy’. Results The mortality rates for CVA and (traffic) accidents have decreased in the countries under study. At the same time, in most countries the donor efficiency rates have steadily increased. The variance in donor efficiency rates between countries has also increased from 1995 to 2005. Four countries introduced a new consent system or changed their existing system, without (visible) long‐term effects. Conclusion The overall increase in donor efficiency means that the efforts to improve donor policies have paid off. However, substantial differences between countries were found. The success of donor policies in terms of the number of absolute donors is blurred by the success of policies on traffic safety and CVA treatment. It remains unclear which specific policy measures are responsible for the increase in donor efficiency rates. This increase is not related to having a presumed consent system. Furthermore, an analysis of countries that introduced a new consent system or changed their system showed no effect on donor efficiency.

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The impact of donor policies in Europe

3.1 Background Transplantable organs are scarce throughout the world. The discrepancy between the number of people listed on a national organ transplant waiting list and the number of post mortem organ donations per year results in long waiting times for patients to receive an organ (Langone & Helderman, 2003; Matas & Sutherland, 2005). In other words, the supply of organs that can be used for a transplant does not meet the need. The urgency of this problem was once again addressed by the EU Health Commissioner Markos Kyprianou in 2007.1To deal with the scarcity of organs, countries have developed national organ donation policies. In most countries these donor policies consist of a legislative system which regulates consent for donation (Gevers et al., 2004) and additional policy measures. Basically, there are two kinds of legislative systems: explicit consent and presumed consent. In an explicit consent system, the donor has to authorize organ removal after his death in the form of an advance directive or a codicil, or by registration in a national registry. If the deceased’s wishes are unknown, next of kin are asked to consent. A presumed consent system does not require to obtain consent, either from the donor or from the next of kin; it is sufficient to verify that the deceased has not objected during his lifetime to becoming a donor (Gevers et al., 2004). In all countries, the group of non‐registered residents is larger than the group of registered residents. Thus, presumed consent countries have larger pools of donor‐consent than explicit consent countries, which might automatically result in greater numbers of donors in the former. Several authors have argued that differences in organ donation rates between consent systems prove that a presumed consent system leads to a more effective procurement of donors (Gimbel et al., 2003; Kittur et al., 1991; Roels & De Meester, 1996). Other policy measures are directed at optimizing the process of donor procurement. Examples of such measures are hospital programs like Donor Action (Roels & Wight, 2001; Roels et al., 2002) and EDHEP (Blok, 2003), or informing the public about the relevant aspects of organ donation (Netten, 2000; Gäbel & Rehnqvist, 1997). To optimize the process of donor

1 http://europa.eu/rapid/pressReleasesAction.do?reference=IP/07/719&format HTML &aged=0&language=EN (30‐05‐2007).

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procurement, Spain developed an organizational model (‘the Spanish model’) with policy measures on national, regional, and hospital level to address the importance of organ donation and to effectively convert potential donors into actual donors (Matesanz & Miranda, 2002; Matesanz, 2003; Matesanz, 2004). In many countries these efforts have intensified over time. However, the shortage of organ donors remains. According to several studies (Roels et al., 1991; Randhawa, 1998; Langone et al., 2003; Kittur et al., 1991) the number of organ donations per million inhabitants (PMI) has increased only in some countries, whereas in most countries it has been stable or even decreased. Were these policy measures in vain? An international comparison of the performance of countries with regard to donor procurement over the years may provide some insight into the impact of policy measures in general. To assess the impact of donor policies and to compare the performance of the different countries, a valid and reliable measure is needed. In many studies the national donation rates PMI are used. Several studies have demonstrated that using the number of donors PMI does not produce a valid comparison (Abadie & Gay, 2006; Barber et al., 2006; Barnieh et al., 2006; Baxter, 2001; Cohen, 2004; Cuende et al., 2007; Hauptman & OʹConnor, 1997; Langone et al., 2003; Luskin & Delmonico, 2003; Ojo et al., 1999; Ojo et al., 2005; Roels et al., 2004; Roels et al., 2007; Stogis et al., 2002). There are significant differences in the number of potential donors between countries, e.g. in the numbers of people dying from a CVA or (traffic) accident. Therefore, a measure which expresses the conversion of potential donors into effectuated donors PMI produces a more valid comparison than only the number of effectuated donors as a whole. The aim of this study is to assess the impact of the donor policies in 10 Western European countries on donor procurement from 1995 until 2005. This study is part of the national evaluation of the Dutch Organ Donation Act (Friele et al., 2007).

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3.2 Method Population To assess the impact of the donor policies we studied the conversion of potential donors into effectuated donors in 10 Western European countries. The number of confounding factors between countries was restricted by analysing only countries which share a more or less similar historical background and have more or less the same status of health systems. The number of potential donors per country An exact measure for establishing a country’s number of potential donors could be found by analysing all hospital medical records of deceased persons and identifying all potential donors(Wesslau et al., 2007; Sheehy et al., 2003; Friele et al., 2006). Such data are not available for all countries. In most countries approximately 80% of donors die of a Cerebral Vascular Accident (CVA) or a traffic accident. A high correlation (Spearman’s ρ=0.81 (P<0.01)) has been found between these mortality rates and donation rates (Coppen et al., 2005). In a study on differences between Dutch hospitals, Friele et al. also found this high correlation (Friele et al., 2006). We therefore considered the national mortality rates for these causes of death to be a good proxy for the number of potential donors per country. Another issue in establishing a country’s number of potential donors is the selection of age groups. The number of people dying from a CVA increases with age, especially after the age of 65. Several countries implement senior donor programs (Cohen et al., 2005; Chang et al., 2003). However, except for Spain (Cuende et al., 2007), the number of effectuated donations from donors older than 65 years is relatively small. The increase in mortality rates of CVA among people older than 65 does not lead to a matching increase in number of donors. The number of people dying from a CVA who are older than 65 years therefore seems to be of little relevance for a national proxy of the number of potential donors. In addition, a strong correlation is found between the mortality rates for CVA and traffic (accidents) among people younger than 65 and donation rates (Coppen et al., 2005). We therefore chose to restrict the proxy for the number of potential donors to the age groups below 65 years.

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The data for CVA and (traffic) accident mortality rates were derived from the WHO’s Health for All Database (HFA‐DB).2 The age‐standardized mortality rates in this international and uniform database are based on the International Statistical Classification of Diseases and Related Health Problems ‐ 10th Revision (ICD‐10). For some countries the mortality rates for certain years were missing in the WHO’s HFA‐DB. Because the mortality rates in all countries show a steady decrease we decided it was safe to estimate the missing mortality rates. The trend lines, which are based on estimated mortality rates, are shown in the graphs by a dotted line. The national organ donation rates Different countries use different definitions for their national organ donation rates. To counteract these variations in national definitions we collected new data on the national number of donors based on one uniform definition. We asked the national transplant centres to send us their ‘numbers of post mortal organ donors of whom at least one solid organ had been successfully transplanted per year’. This definition was preferred because it accounts for differences between countries in the quality of procured organs and it has a better coverage of the data in the period 1995 to 2005. Because France and Sweden could not provide their data according to this definition for the entire period (1995‐2005), they were asked for their ‘numbers of post mortal organ donors of whom at least one solid organ had been recovered for the purpose of organ transplantation (Council of Europe, 1999)’. From the countries that could provide the rates according to both ways of measuring organ donation rates we learned that the difference between both rates is no more than 5% overall. As we use the same definition within countries, the use of different definitions between countries does not affect the national trends for organ donation. Therefore, we found it acceptable to use the rates for France and Sweden, although they were obtained by using a deviating definition. The rates per million inhabitants were calculated using the population size of the mid‐year population given by the WHO HFA‐DB.

2 www.euro.who.int/hfadb (2007)

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Analysis In this study we assess the conversion of potential donors into actual donors by the donor efficiency rate by proxy. The donor efficiency rate by proxy is calculated by using the following definition: (national donation rates PMI / national mortality rates relevant for organ donation PMI) * 100. To determine significantly increasing or decreasing trends, the slopes of the donor efficiency trends of three time frames (1995‐2005, 1995‐1999, and 2000‐2005) were calculated using a standard regression analysis. Consent systems As several authors report a positive impact of consent systems on donor procurement (Gimbel et al., 2003; Kittur et al., 1991; Roels et al., 1996), we assessed the impact of consent systems on the donor efficiency rate. The information on the national consent systems is based on a legal analysis by Gevers et al. (2004). Box 3.1 shows information about the national consent systems and the changes which occurred in some countries during the period under review. Box 3.1 Consent systems in 10 European countries (1995‐2005)

Consent systems (according to national legislation effective in 2005)

Presumed consent Spain, Austria, Italy, France, Belgium, Sweden, the United Kingdom1

Explicit consent Germany, the Netherlands, Switzerland

1 According to the British Human Tissue Act of 1961 and the Human Organ Transplants Act of 1989 it is necessary to have consent of the donor to use his organs (explicit consent). However, when his will is not known it is (according to these Acts) sufficient to determine that the potential donor did not register an objection against organ donation. Consequently, the UK had a presumed consent system during the period under review (Gevers et al., 2004; Janssen & Gevers, 2005). By implementing the Human Tissue Act 2004 the UK introduced a formal explicit consent system in September 2006.

‐ Box 3.1 To be continued ‐

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‐ Box 3.1 Continued ‐

Countries in which the legislative systems changed between 1995 en 2005

Sweden On July 1 1996, Sweden changed from an explicit consent system to a presumed consent system. This change was accompanied by an information campaign to the Swedish public. All 4.2 million homes were informed about the system change and were neutrally motivated to take a stance in one or more of three ways: by telling next of kin, by signing a donor card, or by notifying the National Donor Register, established in 1996 (Gäbel et al., 1997).

Germany On December 1 1997, the German Transplantation Act, in which an explicit consent system was laid down, came into force (Gevers et al., 2004). The passing of this Act was accompanied by a long and critical public debate, and several reports on organ donation in all media (Weber et al., 1999).

The Netherlands In January 1998 the Netherlands laid down its explicit consent system in the Dutch Organ Donation Act. Along with the Organ Donation Act, a national donor registry (containing consents, refusals, or wishes that next of kin or specific person may decide) was implemented (Gevers et al., 2004) and the Dutch Transplant Foundation was established. To accompany the introduction of the Organ Donation Act, the Dutch government supported neutral and soft‐sell public campaigns (Netten, 2000). Since 2000 the Dutch government has focused more on public recruitment campaigns and on supporting the process of organ donation in hospitals (Minister van Volksgezondheid, Welzijn en Sport, 2000; Friele et al., 2006).

Italy Italy enacted its new transplantation law in 1999, introducing a presumed consent system. The introduction of this new legislation was accompanied by the founding of a national transplantation centre in 2000 and improved organization of the donation process (Venettoni et al., 2004).

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3.3 Results: The organ donation rates and the national donor efficiency rates by proxy Figure 3.1 shows that there are differences between countries in the mortality rates relevant for donation. These rates have decreased during the last decade and have moved slightly towards each other. Figure 3.1 National mortality rates relevant for organ donation per million inhabitants in 10 European countries (1995‐2005)

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Figure 3.2 shows the organ donation rates PMI in the 10 European countries. There are large differences between the national organ donation rates PMI. As often mentioned in other studies, Spain has by far the highest rate per million inhabitants, followed by Austria and Belgium. These countries have twice as many organ donors PMI as for example Germany, the Netherlands, Sweden, Switzerland and the United Kingdom. Figure 3.2 Organ donation rates per million inhabitants in 10 European countries (1995‐2005)

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The impact of donor policies, taking into account differences in relevant mortality between countries, is demonstrated by the donor efficiency rates by proxy in Figure 3.3. This figure shows that some countries have obvious trends in their donor efficiency rates. For Spain, Italy, France, Austria, and Germany the donor efficiency rates steadily increased from 1995 to 2005, whereas Switzerland, the Netherlands, Belgium, Sweden, and the United Kingdom have more fluctuating donor efficiency rates. Since the donor efficiency rates increased in some countries more than in others, the variance of donor efficiency rates between countries was larger in 2005 than in 1995. Figure 3.3 The donor efficiency rates by proxy in 10 European countries (1995‐2005)

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Table 3.1 shows the slopes of the donor efficiency trends for three time frames (1995‐1999, 2000‐2005 & 1995‐2005). Table 3.1 Slopes of the donor efficiency trends in 10 European Countries (1995‐2005) 1995‐2005

slope (ranking) 1995‐1999 slope (ranking)

2000‐2005 slope (ranking)

Spain 0.682 (1)* 1.288 (1) 0.715 (1)*

Italy 0.512 (2)* 0.416 (3) * 0.577 (4)*

France 0.477 (3)* 0.144 (8) 0.620 (3)*

Austria 0.460 (4)* 0.413 (4) 0.632 (2)*

Germany (E) 0.279 (5)* 0.239 (7)* 0.463 (6)*

Belgium 0.262 (6)* 0.354 (5) 0.116 (9)

Switzerland (E) 0.198 (7)* 0.428 (2)* 0.436 (7)*

The Netherlands (E) 0.145 (8) ‐0.402 (10)* 0.517 (5)*

Sweden 0.081 (9) 0.295 (6) 0.306 (8)*

The United Kingdom ‐0.001 (10) ‐0.162 (9)* 0.078 (10)

Mean donor efficiency 0.354* 0.269* 0.632*

*=significant increase/decrease (E) indicates that this country has an explicit consent system During the 1995‐2005 period, most countries (Spain, Italy, France, Austria, Germany, Belgium and Switzerland) showed a significantly rising trend. In the same period the Netherlands, Sweden and the United Kingdom had no significant increase in their donor efficiency rates. We even see that during 1995‐1999 the Netherlands as well as the United Kingdom had a significant decrease in their donor efficiency rates. The decreasing trend in the Netherlands recovered after 2000, showing a significantly rising trend instead. Likewise, the Swedish donor efficiency significantly increased in this period. In addition to Figure 3.3, Table 3.1 reveals that, on balance, the

64


mean donor efficiency trend significantly increased during all three time frames. On average, we did not find obvious differences between countries with a presumed consent system and countries with an explicit consent system (Figure 3.3), nor did we find systematic differences between the slopes of the donor efficiency rates by proxy of presumed and explicit consent countries (Table 3.1). 3.4 Discussion The positive impact of donor policies on donor procurement We found a decrease in relevant mortality rates (Figure 3.1), which is likely to be due to the success of policies on CVA treatment and traffic safety. The strong correlation between the mortality rates for CVA and (traffic) accidents and donation rates (Coppen et al., 2005; Frezza et al., 1999) means that policy measures on traffic safety and CVA treatment also have an impact on donor procurement (Baxter & Smerdon, 2000). For the procurement of donors the decrease in relevant mortality rates implies that it has become more difficult to find potential donors and that more effective strategies are necessary to prevent a decrease in organ donation rates. After adjusting the organ donation rates for the changes in relevant mortality rates, most of the ten countries under review now demonstrate an increased efficiency in their donor procurement, implying a positive impact of donor policies in these countries. Not all countries show a steady increase in donor efficiency. The variance in donor efficiency rates by proxy increased from 1995 to 2005 (see Figure 3.3). Apparently, the policies of some countries had more impact on donor procurement than others. The low impact of the donor policy in the United Kingdom has recently been addressed in an editorial by Smith & Murphy (2008). In this publication they report that the British Organ Donation Taskforce has recommended the implementation of a new framework for organ donation in the United Kingdom.

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Presumed consent versus informed consent In our study we found no evidence that presumed consent systems perform better than explicit consent systems; we did not find obvious differences between consent systems (Figure 3.3), nor did we find that donor efficiency rates by proxy of presumed consent countries increased in a more accelerated way than those of explicit consent countries (Table 3.1). From 1995 until 2005 some countries introduced a new formal consent system or changed their existing one (see Box 3.1). These events often go together with mass media campaigns and changes in the organization of donor procurement. The causality between these events and their impact on donor procurement is difficult to prove. However, insight into these events may shed some light on our findings. We see that with regard to the system changes in Germany and Italy there are no differences between the trends before and after the introduction of the (new) consent system. In both countries the donor efficiency trend was already increasing before the implementation of the new consent system and continued to increase in the same way after the introduction (see Figure 3.3). For Sweden and the Netherlands we do see differences between the donor efficiency trends before and after the introduction of their new consent system. The change to the Swedish system in 1996 led to a temporary increase in donor efficiency rate by proxy. In 1998 the Swedish donor efficiency reached the same level as before the introduction of their presumed consent system. Prior to the implementation of the Dutch explicit consent system in 1998 the donor efficiency trend was already decreasing, and one year after the introduction it reached its all‐time low. Since 2001, the Dutch donor efficiency by proxy has increased. For the Netherlands we know that this probably has to do with the introduction of a range of new policy measures (Friele et al., 2007). On the whole, none of the legal changes led to a significant change in the trend of a country’s donor efficiency rate by proxy. It seems more likely that the changes in the donor efficiency trends in Sweden and the Netherlands were due to the impact of public awareness regarding organ donation. Our findings to the effect that having a presumed consent system does not guarantee higher donation rates and that changing the consent system does

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not have a significant impact on the trends of the donor efficiency rates by proxy are in concordance with the findings of other studies. In a legal analysis of consent systems Gevers et al. point out that in reality the different systems are much more similar than suggested by the explicit/presumed distinction (Gevers et al., 2004). They furthermore conclude that in particular the predominant role of relatives, in case no decision of the deceased has been recorded (as is most frequent in both presumed‐ as well as explicit consent countries), reduces the potential of the presumed consent system. Several studies report the same finding that also in presumed consent practice the next of kin are consulted (Miranda et al., 1999; Matesanz, 1998; Matesanz, 2003; Cohen & Wight, 1999; Cameron & Forsythe, 2001). Our findings do not correspond with the findings of studies using national donation rates PMI to assess the impact of consent systems (Gimbel et al., 2003; Johnson & Goldstein, 2003; Kittur et al., 1991). Abadie et al. conclude that, after controlling for other determinants for organ donation, presumed consent has a positive and sizeable effect on organ donation rates (Abadie et al., 2006). However, to control for differences in potential donors between countries they use mortality rates for all ages. By using CVA mortality rates of high age categories, it remains to be seen whether their method does not overestimate the contribution of CVA mortality rates to the donor potential. Limitations A limitation of this study is that we cannot attribute the differences in donor efficiency rates by proxy between countries to specific policy measures. Nonetheless, according to our results, policies in general do have a positive impact on donor procurement. It is difficult to determine which specific policy elements are responsible for this success. There is no structured overview of specific donor policy measures per country, or of status of implementation regarding these measures per year. An exception to this general picture is the Spanish model, the effect of which has been described many times (Matesanz et al., 2002; Matesanz, 2003). Another limitation of this study is that the numbers of potential donors are based on national mortality rates. Although the WHO puts a lot of effort into optimizing the reliability of the data, differences between countries in how they measure the mortality rates may occur. As a reaction to an editorial by

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Roels et al. (2007), Matesanz et al. (2007) conclude in their letter to the Editor that because of these possible differences, the number of donors PMI is the most realistic and simple way to make comparisons. However, neglecting huge differences in mortality rates between countries does not seem to be an option which leads to a valid international comparison. Neglecting differences in the number of, for example, traffic accidents will blur a valid comparison between countries regarding the impact of their donor policy. Besides, for the comparison between years within one country as well, we should take account of differences in the number of potential donors each year. 3.5 Conclusion This international comparative study shows that implementing policies for organ donation and putting effort into the procurement of donors does seem to have a positive impact on donor procurement in most countries. The success of donor policies is, however, blurred by the success of policies on traffic safety and CVA treatment and is therefore not revealed by the actual donation rates PMI. Our results also demonstrate that in some countries donor policy had greater impact than in others. A gap is emerging between successful and less successful countries in this respect. Because there is insufficient information about which specific policy measures are implemented per country per year, it is not possible to determine which measures cause a significant increase in the donor efficiency rates by proxy. The differences between countries and between years cannot be explained by differences in consent system between countries. Factors other than the consent system seem to be responsible for the differences between countries regarding the impact of their donor policy. These are for instance differences between countries regarding the measures they undertake to optimize the process of donor procurement (in hospitals), to increase the donor pool (by using older donors or non heart beating donors) or to inform the public about the relevant aspects of organ donation.

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Whereas the shortage of donor organs persists, it is important to find pointers for the improvement of donor procurement. Because little is known about which specific policy measures are successful for each country, an organization like the European Commission, for instance, should support initiatives that achieve international comparable data on national policy measures among EU‐members. In 2007 the European Commission organized two meetings to discuss organ donation and transplantation at EU level.3 In addition, this study points out the necessity of adjusting such data for fundamental differences between countries (e.g. relevant mortality rates) which influence the organ donation rates. This can be encouraged by using a simple, yet effective method such as discussed in this study. Applying such a method will make it possible for policymakers to make evidence based decisions when implementing organ donation policy measures. Nonetheless, policymakers should be aware of the fact that post mortem organ donation alone will not solve the long waiting times for patients in need of an organ. Therefore, other methods of donor procurement, such as encouraging living donation and the development of an artificial kidney, should be considered.

3 http://ec.europa.eu/health/ph_threats/human_substance/events_organs_en.htm (01‐07‐2008).

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4 Donor education campaigns since the introduction of the Dutch Organ Donation Act: increased cohesion between campaigns has paid off This chapter has been accepted for publication as: Coppen, R., Friele, R.D., Gevers, J.K.M., Zee, J. van der. Donor education campaigns since the introduction of the Dutch Organ Donation Act: increased cohesion between campaigns has paid off, Transplant International.

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Summary Governments utilise special policy measures to increase and maintain positive attitudes among their citizens towards consent registration and organ donation. Little has been published on these national strategies. Some studies report on the impact of single policy measures shortly after their implementation, while the assessment of the impact of a national strategy on organ donation over a long period of time has been lacking. The aim of this paper is to assess the impact of the Dutch donor education strategy (1998‐2008) on the availability of donor organs, by trying to disentangle the impact of education from other factors. In this study we have devised a research strategy to assess the impact of policy measures at national level, while providing information about Dutch initiatives to increase registration and procurement rates, and demonstrating and explaining these increases. The increased resources and improved strategies employed to educate the public in relation to organ donation have paid off, but the impact decreases over time. The question remains whether the effects of these policy measures will further level off over time and what levels of increase in donor registration rates and efficiency of donor procurement are realistic targets to achieve.

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4.1 Introduction All Western European countries are faced with a large shortage of donor organs (Barber et al., 2006; Jansen et al., 2007; Roels et al., 2003; Roels et al., 2004; Wesslau et al., 2007; Wight & Cohen, 1997). As donor organs are scarce and patients are dying while waiting for an organ, the loss of potential donors (deceased people who are medically suitable) should be reduced to a minimum. An important issue which causes a loss of potential donors is obtaining consent for organ donation (Frutos et al., 2005; Siminoff et al., 1995; Stein et al., 1995). To support the procedure of obtaining consent, countries employ either presumed or explicit consent systems. Regardless of the consent system, it has been established that in each country next of kin play an important role in the removal of a deceased’s organs (Chouhan & Draper, 2003; Gevers et al., 2004; Janssen & Gevers, 2005; Neades, 2009). Therefore, governments implement policy measures in the field of public education to encourage citizens to take a stand on organ donation and they develop strategies to increase and maintain positive attitudes towards organ donation. Similar to the UK, in the Netherlands there is an ongoing debate on the organ shortage (UK Organ Donation Taskforce, 2008a; Yadav, 2008). In the UK, the Organ Donation Taskforce embarked in 2006 on a process of identifying obstacles to organ donation. The Taskforce identified the lack of a structured and systematic approach to organ donation in the past and emphasised the importance of additional policy measures (UK Organ Donation Taskforce, 2008b); these findings are in line with other studies (Coppen et al., 2008; Wright, 2007; Matesanz & Miranda, 2002). One of the recommendations of the Taskforce includes the identification and implementation of the most effective methods through which organ donation can be promoted to the general public. In the Netherlands in 1998, the Dutch Organ Donation Act was introduced, heralding increased government effort regarding policy measures to support organ donation. An important aim of the Dutch strategy is to increase and maintain positive attitudes among citizens towards organ donation. This strategy has been implemented by the Dutch Ministry of Health, the Dutch

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Donor Register, and NIGZ Donor Education. Additionally, charities, such as the Dutch Kidney Foundation and the Dutch Heart Foundation, support this strategy. One of the key aims of such charity organisations is to improve patient care. Almost ten years after the introduction of the Organ Donation Act questions were raised as to the impact of this strategy on increasing and maintaining positive attitudes among citizens towards organ donation. In spite of the importance of effective policy measures, little has been published on these measures and their impact. It is difficult to gain insight into the strategies of governments and the additional policy measures implemented by governments over a period of several years (Coppen et al., 2008). Additionally, assessing the impact of national strategies for organ donation is a difficult issue. The evaluation of national strategies for organ donation cannot be the subject of an experimental research approach, since many factors influence the availability of donor organs and the effects of campaigns are rather indirect and difficult to quantify. For example, while an education campaign may not lead directly to more donors, it might influence the attitude of citizens and might in turn induce them to register their consent. In the Netherlands, consent rates for potential donors that registered consent are much higher than consent rates for unregistered potential donors (92% vs. 30% (Friele et al., 2004)). The aim of this study was to assess the impact of the Dutch donor education strategy on the availability of donor organs, by trying to disentangle the impact of education from other factors. Additionally, we sought to provide feedback on the impact of the Dutch donor education strategy together with proposing a strategy for analysing the impact of such policy measures over time.

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4.2 Method Assessing the policy strategy To gain insight into the donor education strategy we assessed the contents of the national policy on donor education (1998‐2007). The overview of policy measures carried out in this period was obtained by analysing policy documents of the Ministry of Health and the annual reports of both the Donor Register, and NIGZ Donor Education. Assessing direct effects and indirect effects When studying the effects of donor education, we distinguished between direct and indirect effects. Direct effects are directly attributable to individual policy measures, such as the range of a campaign and its effects on attitudes and/or registration. To establish the direct effects we studied the specific evaluation reports of these policy measures. The indirect effects of the successive donor education campaigns are reflected by the development of the annual rates of the Donor Register (secondary effects) and the development of donor procurement itself (final effects). The developments in registration and procurement give insight into the overall impact of the Dutch policy. Assessing donor procurement National organ donation rates depend largely on a country’s mortality rates for Cerebral Vascular Accidents (CVA) and (traffic) accidents (<65 years). Relevant mortality rates are a good proxy for donor potential (Coppen et al., 2005; Coppen et al., 2008; Roels et al., 2007); exact data on ICU death which is relevant for organ donation is not available in the Netherlands. These mortality rates differ over time, which contributes to differences in donation rates between periods, and may obscure one’s understanding of the impact of donor education strategy throughout the years. Therefore, we have adjusted the organ donation rates for differences in relevant mortality rates between years. In this study we call this adjustment ‘the donor efficiency rates by proxy’. The donor efficiency rates by proxy were calculated by using the following definition: (National donation rates (per million inhabitants (PMI)) / relevant national mortality rates (PMI) for organ donation * 100 (Coppen et al., 2005).

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4.3 The Dutch strategy on donor education The Dutch strategy to increase and maintain positive attitudes towards organ donation among the public consists of policy measures in the field of public education, within the framework of a legal consent system. 4.3.1 The Dutch legal system of consent registration A key element of the Dutch Organ Donation Act is the consent system, which is based on explicit consent registration and is implemented in the Donor Register. This Register contains roughly three options: (1) consent to organ removal or to removal of specific organs, (2) objection to organ removal, or (3) leave the decision to next of kin or to a specific person (Gevers et al., 2004). The aim of the Donor Register is to provide clear information on the individual’s wishes to those involved in the donation process (next of kin, medical staff). When a deceased is a suitable organ donor, but consent is not registered, his/her next of kin are asked for consent. Therefore the Dutch consent system is characterised as an explicit consent system. At the time, the government assumed that the introduction of the Act and the introduction of a new consent system, combined with public education, would increase the number of transplantable organs. 4.3.2 Additional policy measures in the field of public education Donor education in the Netherlands is an ongoing activity. However, since the introduction of the Organ Donation Act (1998) there have been three important periods. First period: Introduction of the Organ Donation Act in 1998 When the Organ Donation Act came into force, over twelve million registration forms were sent to all citizens of eighteen years and older. This mailing was accompanied by a two tier public information campaign. This two tier approach was based on a study by Cleiren & Zoelen (Cleiren & Zoelen, 1999). The first tier was an information campaign (Box 4.1) conducted on behalf of the government. In this campaign, the government did not take a stand on organ donation, but simply informed people about the possibility of registering an individual’s wishes in the donor register. The aim of this campaign was to obtain as many registrations as possible. As

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a pilot study showed that a large part of the respondents (76%) said that it would return a registration form and would register in the National Register, the government expected a registration rate of 35%‐50% to be feasible. The aim of the second tier (Box 4.1) was to obtain as many registrations as possible, with the emphasis on registered consents. This tier was supported by several stakeholders (patients, The Dutch Transplantation Foundation, and charities such as the Kidney Foundation and the Heart Foundation); it was more focused on convincing people to register their consent than the first tier. Both tiers of the campaign were carried out at the same time. Additionally, the Foundation for Donor Information (later merged with NIGZ Donor Education) was funded to provide a call centre, respond to mail/email questions, and provide extensive information material, including material for migrants, organise lectures and an exhibition, and host a website. Box 4.1 Tools used for the two tier public information campaign in

1998 First tier

Second tier

• mail pack (including a donor form) • TV and radio commercials • billboard posters • advertisements in national daily newspapers

• a campaign brochure • explanatory leaflets (on request) • an internet site

• TV and cinema commercials • A national TV show

To add to these initiatives, since 1998, the government has organised an annual campaign aimed at eighteen‐year‐olds sending them registration forms with the request to register their wish and return the form to the Donor Register (Reubsaet et al., 2001; Smits et al., 2005).

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Direct effects of the introduction of the Act Zijdenbosch & Kamphuis report in 1998 that, regarding the tools of the two tier campaign, 67% of their respondents (n=828) remembered receiving the mail pack, 61% remember seeing the TV commercial, and 34% remembered seeing an advertisement in a newspaper. At the end of 1998 36% of adult citizens (almost 4.5 million people) had returned their registration form to the Donor Register (Netten, 2000). Of these 4.5 million people 55% registered their consent for organ donation, 35% recorded their refusal, and 10% registered that next of kin or a specified person should decide. The overall registration rates correspond to the response rate of the annual campaigns targeting eighteen‐year‐olds, which have varied from 33% (2000) to 40% (2005). Second period: The organ donation plan of action in 2000 One year after the Organ Donation Act came into force, donation rates dropped dramatically. In response, the government (2000) announced additional policy measures to support organ donation. These policy measures included the “organ donation plan of action”, which marked a strategy change focussing more on specific initiatives. The plan contained measures (1) to support public education regarding organ donation, (2) to increase the efficiency of the procurement of organs in hospitals, and (3) to find new pools of organ donors. As a part of the “organ donation plan of action” the government decided that the public campaigns (radio & TV commercials, newspaper advertisements and the activities aimed at eighteen‐year‐olds) should focus more on convincing people to register consent, rather than on registration in general (= consent and refusal). It was decided that the intensity of mass media interventions for organ donation should also be stepped up, and a multi‐channel strategy was proposed. To inform religious groups about the opinions of their religion on organ donation, NIGZ Donor Education has engaged with key persons from these groups since the implementation of the plan of action. Although no religion formally forbids organ donation, and only some orthodox Jews may have religious objections to opting in (Bruzzone, 2008), it seemed that the attitudes of the members of some religious groups (both Christians as well as Muslims) were not conducive to organ donation. In 2006 a final statement

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was drafted by key persons of the Muslim community with the message that Islam is not considered to be a barrier for a Muslim to donate organs (NIGZ‐donorvoorlichting, 2007). For churches as well as mosques information packages are available to inform their communities on the religious perspectives on organ donation. Furthermore, several interventions, which were believed to increase registration rates and to have an impact on organ donation, were studied on their possible effects when implemented on a national level. These included a study on the cost effectiveness of a mail shot to all non‐registered residents (Het Expertise Centrum, 2002), a pilot study on the effectiveness of handing out or mailing registration forms to those applying for a passport, identity card or driver’s licence (Perenboom & Davidse, 2006), and an analysis of reasons for non‐registration among non‐registered residents (Cox & Vroom, 2002). The outcomes of these pilot studies suggested that national implementation of these interventions would increase the number of registrations, and they were subsequently implemented during the next period. Direct effects of the plan of action in 2000 In the second period no direct effects were reported. The measures proposed in the plan of action were piloted during the second period, but were implemented and evaluated during the third period. Third period: The capitalisation of donor education on an extensive public debate in 2004‐2007 In early 2004 an extensive public debate on organ donation took place in the media. This debate was initiated by NIGZ when it proposed an alternative consent system combining the advantages of both explicit consent and presumed consent. Until then, the country had been divided into proponents of either the existing explicit consent system, or changing to a presumed consent system. The alternative system would be based on the existing explicit consent system, but if after several personal reminders to register, people still did not register either consent or refusal, they would be automatically registered as a donor. Hence, the alternative system combines what the NIGZ sees as the best of both systems; explicit consent registration and a large donor pool.

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Many stakeholders (e.g. The Kidney Foundation, the Heart Foundation, the Dutch Transplant Foundation) supported the proposed alternative system and undertook strenuous efforts to promote this new system by using the media and by lobbying. The public debate on changing the consent system reached a crescendo in early 2005 when it seemed that the alternative consent system would be adopted by parliament. Despite these efforts the proposal was eventually rejected. After the rejection of the alternative consent system, a sustained, comprehensive multi‐channel campaign to promote donor registration and organ donation was initiated in 2005 by the government. This campaign capitalised on the existing public debate. The Kidney Foundation continued a campaign entitled “Are you informed?”. The aim of this campaign was to get people to talk to their next of kin and inform each other about their wish to become a donor or not. Meanwhile, in an initiative which originated from the plan of action, the government (supported by the Kidney Foundation and the Heart Foundation) sent out a mail shot to 6 million households. In addition, the Dutch commercial television network SBS6 broadcast a big charity show. The aim of these activities was to increase the number of registrations and to inform people about the shortage of donor organs. Further to these initiatives, in spring 2007 two major events took place. Firstly, the NIGZ sent out registration forms to individuals in the age group that were thought to be most likely to register as a donor (45‐49 years). In the second half of 2007 this campaign was repeated for the 50‐54 year age group. Secondly, in addition to the campaign initiated by the government, on 1 June 2007 the independent television network BNN, founded by a kidney patient, broadcast the controversial Big Donor Show. During the show several patients waiting for a kidney presented themselves and were interviewed. At the end of the show a supposedly ‘terminal patient’ chose one of these patients to donate a kidney to. This show received a lot of national and international media attention. The intensive debate generated by the broadcast highlighted the shortage of donor organs once again. It has to be noted that this event was an initiative by a private party and was not supported as such by the Dutch government.

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Direct effects of the multi‐channel campaign The direct effects of the activities performed in 2005 (the campaign by the Kidney Foundation, the mail shots to 6 million households and the big TV charity show by SBS6 with 300.000 viewers) were evaluated by Cox (2005), using a sample of 672 non‐registered citizens. The results of this study indicated that nearly all respondents (94%) remembered one or more of the campaigns. More than half of the respondents (57%) said that as a result of the campaigns they talked to their next of kin about organ donation. For the first mail shot to the 45‐49 year age group in spring 2007, 733,008 registration forms were sent out and 83,930 registration forms returned (response rate 11.5%), of which 47% were consent registrations for organ donation. The controversial Big Donor Show was broadcast in that same period and had 1.2 million viewers. Around the 15th of July 2007 (one month after the show), 12,000 new registrations, mostly consent registrations, were received by the Donor Register. The second mail shot to the 50‐54 year age group took place later that year. For this second batch 663,232 forms were sent out and 86,111 returned (response rate 13 %), of which 40% were consent registrations.1 In 2008 23,900 registration forms were returned by people who received their form when they applied for a passport, identity card or driver’s licence (65% consents, 25% refusals). 13,774 were new registrations. 4.4 Identifying the overall effects of the Dutch strategy 4.4.1 Secondary effects (indirect): Impact on registration rates Figure 4.1 shows the registration rates of the Donor Register (1998‐2007). Initially, the number of registrations after the Organ Donation Act came into force was in line with expectations (36% of the adult population, corresponding with an expected rate of 35‐50% (Cleiren et al., 1999)).

1 http://www.donorregister.nl/ (08‐09‐2009).

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Figure 4.1 The number of registrations in the Dutch Donor Register (1998‐ 2008)

0

1.000.000

2.000.000

3.000.000

4.000.000

5.000.000

6.000.000

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

Totalregistrations

Registeredconsents

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Registerednext of kindecide

1 2 3

1 Introduction of the Act in 1998 2 Plan of Action on organ donation in 2000 3 Capitalisation of donor education on the massive public debate

Source: http://www.donorregister.nl/organisatie/cijfers/registraties/keuze.aspx (06‐04‐2008) Figure 4.1 shows an increase in registrations from the introduction of the Organ Donation Act in 1998 until 2001. In 2002 the number of registrations declined. In 2005, the year marked by the Kidney Foundation campaign, the mail shots to 6 million household and the big TV charity show by SBS6, the number of registrations increased by 286,079 (6%). 77% of this increase consisted of registered consents (NIGZ‐donorvoorlichting, 2007). Since that year we see a steady rise in the number of registrations. For the most part this increase is due to a larger number of registered consents. In 2007, when the age‐group mailings and the Big Donor Show took place, the number of registrations in the Donor Register increased by 142,082 (2.8%). 72% of this increase was attributable to a rise in the number of registered consents

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(NIGZ‐donorvoorlichting, 2007). By the end of 2008 5.3 million people had registered, of which 3 million consents and 1.6 million refusals (Figure 4.1). 4.4.2 Final effects (indirect): Impact on organ procurement Figure 4.2 shows that shortly after the Organ Donation Act came into effect, donor procurement (shown by the donor efficiency rate by proxy) dropped considerably. After 2000 the procurement of donors showed an increase. This increase seemed to level off in 2005. In 2007 we see a further rise in donor procurement. However, taking into account the rate in 2008, this increase appears to be an incidental fluctuation. Figure 4.2 Donor procurement in the Netherlands shown by the donor rates adjusted for differences in relevant mortality rates between years (1997‐2008)

0,0

2,0

4,0

6,0

8,0

10,0

12,0

14,0

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2001

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1 2 31 Introduction

of the Act in 1998

2 Plan of Action on organ donation in 2000

3 Capitalisation of donor education on the massive public debate

There is a strong correlation between donor efficiency rates and total registration rates [Pearson correlation = 0.74 (P < 0.01)], and consent registration rates [Pearson correlation = 0.80 (P < 0.01)].

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4.5 Discussion From separate interventions to cohesive multi‐channel campaigns At the time of the enactment of the Organ Donation Act, donor education in the Netherlands consisted of a number of separate measures with little cohesion between them. As a result of persisting low donor rates following the implementation of the Act, the government reshaped its strategy for donor education into a more cohesive multi‐channel approach, focussing more on convincing people to register consent. The positive development of (consent) registrations and organ procurement suggests that the increased efforts in the area of continuous public education on organ donation and the shift to a strategy with cohesive multi‐channel campaigns have paid off. Other studies support this view, identifying an interaction between donor education campaigns (Morgan & Miller, 2002). Nonetheless, the response to the mailing of registration forms in 2005 was much smaller than the response just after the introduction of the Act. Apparently, most of the people who could easily be convinced were already registered by then. The mailings to age groups, of whom it is known that they are willing to donate, were relatively more successful. It is unknown whether and how other groups can be convinced to register. It has to be noted that the effects of measures aimed at religious groups on registration rates are unknown. This raises the question how to further increase the number of registrations and what number of registrations is a realistic target. The diffuse correlation between donor education campaigns and donor procurement The effects of multi‐channel education campaigns on donor procurement are rarely reported; the correlation between the effects of education campaigns and donor procurement seems to be rather unclear. In this study we found a strong positive correlation between donor procurement rates and (consent) registration rates. As other studies have shown that registered consent has a positive influence on the consent rates of next of kin (Martínez et al., 2001; Farsides, 2000; Sque & Payne, 1996), this confirms the importance of policy measures aimed at enlarging the donor register and increasing the number of explicit consent registrations within the framework of an explicit consent registration system.

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When interpreting donor procurement rates it is important to keep in mind that they can fluctuate between years. The fluctuation in 2007 is often attributed to the non‐government Big Donor Show of television network BNN. The monthly donation rates of that year (Nederlandse Transplantatie Stichting, 2008), however, already showed a steady increase months before the Big Donor Show was broadcast in June. As there were no changes to the legal or organisational system this raises the question whether there was already a sense of urgency regarding this issue in the Netherlands, and whether the Big Donor Show was simply an expression of that sense of urgency. This fluctuation could of course be just coincidental. For the time being, we do not have an explanation for this fluctuation, but in terms of the number of extra donors (20 extra donors – 10% of the total number of organ donors) the fluctuation was relevant. The fluctuation in 2007 indicates that the procurement rates of consecutive years should be taken into account when assessing the impact of policies on organ donation on a national level. High rates of registered refusals? Since the enactment of the Donor Register 35% of the registered people refuse organ donation. Compared to other countries, this rate of registered refusals seems high (Gäbel, 2006). However, unlike the Netherlands the governments of presumed consent countries do not have policy measures to encourage people to register. It is therefore difficult to compare the Dutch refusal rates with the refusal rates of countries with a presumed consent country. Strengths and limitations Our strategy to describe and explain the impact of policy measures over time seems to be effective. The increases in (consent) registration rates and procurement rates could well be explained by the change to the government’s policy on donor education and implemented policy measures. A key limitation of the assessment of the impact of donor education on procurement rates is that other policy measures also have an effect on organ procurement. The plan of action on organ donation not only contained measures aimed at public education, but also measures designed to increase the donor pool (Haase‐Kromwijk et al., 2006) and optimise the procurement process in hospitals (Friele et al., 2006). Furthermore, not all measures have

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been evaluated in the Netherlands; there is limited data available on their effects. For example, for individual measures, data on the effects on consent rates, the distinction between areas (rural and metropolitan) or ethnic groups, or the influence of costs on effects is lacking. Moreover, this study only highlights the Dutch situation. Other countries show trends in their donor procurement efficiency (Coppen et al., 2008). For many countries it remains unknown what causes these trends. Studying these trends using a similar method might reveal which policy measures are responsible for decreases and increases in donor registration and donor procurement. 4.6 Conclusions This study gives insight into both the strategy of the Dutch government to increase and maintain positive public attitudes towards organ donation and the impact of this strategy on organ procurement. Evidently, it is important that governments explicitly support organ donation. For countries with an explicit consent system, it seems to be important to maximise the number of consent registrations, because of a high correlation with donor procurement rates [Pearson correlation= 0.80 (P < 0.01)]. Over time, a lot of effort was put into donor education. The message of the campaigns focussed more on convincing people to register consent, and multi‐channel campaigns gained more cohesion. This change in the strategy of Dutch donor policy has paid off. Our study shows that trends in donor registration and donor procurement can be linked to the strenuous efforts made in the implementation of campaigns. But we also found some fluctuation in donor procurement between years which cannot be explained by the implementation of policy measures or changes in the organisational or legal system. Apparently, unknown mechanisms also have an impact on donor procurement. Finally, despite increased efforts, the impact of mass media campaigns on registration rates decreases over time. The question remains whether the effects of policy measures will further level off and what donor registration rates and efficiency of donor procurement are realistic targets.

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5 Explaining differences between hospitals in number of organ donors This chapter has been published as: Friele R.D., Coppen R., Marquet R.L., Gevers J.K.M. (2006). Explaining Differences Between Hospitals in Number of Organ Donors. American Journal of Transplantation, 6, 539‐543.

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Abstract The shortage of donor organs calls for a careful examination of all improvement options. In this study, 80 Dutch hospitals were compared. They provided 868 donors in a 5‐year period, constituting 91% of all donors in that period in The Netherlands. Multilevel regression analysis was used to explain the differences between hospitals. Potential explanatory variables were hospital‐specific mortality statistics, donor policy and structural hospital characteristics. Of all donors, 81% came from one quarter of the hospitals, mainly larger hospitals. A strong relationship was found between the number of donors and hospitalspecific mortality statistics. Hospitals with a neurosurgery department had additional donors. Seven hospitals systematically underperformed over a period of 5 years. If these hospitals were to increase their donor efficiency to their expected value, it would lead to an increase of 10% in the number of donors. Most donors are found in large hospitals, implying that resources to improve donor‐recruitment should be channelled to larger hospitals. This study presents an efficient strategy toward a benchmark for hospitals of their organ donation rates. Some larger hospitals performed less well than others. This suggests that there is still room for improvement. There is no evidence for large undiscovered and unused pools of donor organs.

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Explaining differences between hospitals

5.1 Introduction In many countries the demand for donor organs greatly exceeds the supply; there is a considerable shortage of donor organs. Many attempts have been made to increase the number of donor organs. This also applies to the Netherlands, where in 2003 a total of 1411 people were on the waiting list for organ transplantation, with only 202 deceased donors in that year (Nederlandse Transplantatie Stichting, 2004). The shortage of donor organs has led to various activities: a campaign among the general public for registration as a consenting donor in the national register (mid‐2004 37% of the adult Dutch population had actively registered in the national register, 55% of them consenting to organ donation); introducing support plans for Dutch hospitals and allowing for non‐heart‐beating organ donation (in 2002 one‐third of all deceased donors were derived from a non‐heart‐beating procedure) (Nederlandse Transplantatie Stichting, 2004; Gezondheidsraad, 2003). These activities did not lead to a significant increase in the number of deceased organ donations. Subsequently, a debate followed concerning the consent system for deceased organ donation, as laid down in the Dutch Organ Donation Act of 1998. In the Netherlands, organ donation is allowed only when explicit consent is given, either by a potential donor or relatives. It has been suggested that changing the consent system to a system of presumed consent might increase the number of donors. However, the comparison of donor rates in European countries with an informed consent system to countries with a presumed consent system, while correcting for differences in relevant mortality, shows more than reasonable doubt regarding this assumption (Gevers et al., 2004; Coppen et al., 2005). Since a system change will not solve the shortage of deceased donors, all potential alternatives should be considered. In this article, we will focus on the role of the hospital. Hospitals play a vital role in the process of organ procurement: potential donors have to be identified, relatives consulted and organs have to be removed. Several initiatives have been employed to help hospitals increase the number of donors. About 50 out of 102 Dutch hospitals with an intensive care unit have a donation officer. Their role is to increase the awareness of the issue of organ donation among hospital staff, so that potential donors are

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not overlooked and doctors feel supported in their communication with relatives. Also, a donation protocol was developed. Its use is mandatory by law. Specialized teams take on the responsibility of organ removal, so that this does not burden the human resources of busy hospitals. In the year 2002, 1131 possible donors out of 23 953 deaths were identified by doctors in 57 hospitals that provide almost all deceased donors. Of these 264 were reported as donor. Eventually, the number of effective deceased donors was 233. Consent rate for cases not included in the national register was 29% (Friele et al., 2004). For the United States, Sheehy et al. (2003) showed that potential donors are mainly to be found in larger hospitals: hospitals with 150 or more beds accounted for 80% of all donors. The presence of a neurosurgical service and an emergency department were both correlated to the number of potential donors. The presence of a transplantation program was not related to the number of potential donors, but only to a higher recovery of organs from potential donors. In an earlier study, Christiansen et al. (1998) also found that larger hospitals had higher numbers of potential donors than smaller hospitals, just like trauma centers and hospitals with a medical school affiliation. Several authors reported differences in conversion rates from the number of potential donors to the number of effective donors between different organ procurement organizations (OPOs) or hospitals. This suggests a potential for improvement in organizations or hospitals with the lowest conversion rates (Sheehy et al., 2003; Christiansen et al., 1998; Senouci et al., 2004; Evans et al., 1992; Stogis et al., 2002). In this study, we aim at explaining differences in the number of donors between hospitals. Systematic unexplained differences may point to room for improvement among the hospitals that ‘underperform’ as compared to their peers. Explanatory factors will be structural aspects, such as the donor‐potential, type of hospital, number of beds and the degree of implementing a donor policy. This study was part of the national evaluation of the Dutch Organ Donation Act (Friele et al., 2004).

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5.2 Methods Population The boards of directors of 102 hospitals with an intensive care unit were approached for this study. From 86 boards, consent was obtained for the use of hospital specific mortality figures. They also provided the name of an intensive care unit doctor involved in organ donation. They were contacted by telephone. It was ascertained that they did indeed work in an intensive care unit and that they considered themselves as a key person involved in the process of organ donation in their hospital. They were invited to participate in this study: 85 of the contacts consented to participate. Subsequently, they were sent a questionnaire assessing the degree of implementation of the donor policy in the year 2002. In total, 80 questionnaires were returned (78% out of 102 hospitals), 76 by medical doctors, 2 by registered nurses, 1 by a transplant coordinator and 1 by a ‘donation officer.’ The data of 80 hospitals were analyzed. Outcome Measure The number of effective donors (donors whose organs have not only been presented for transplantation, but have actually been transplanted) for each hospital was obtained from the annual report of the Dutch transplant foundation (Nederlandse Transplantatie Stichting, 2004). The number of donors for 5 consecutive years (1998–2002) was taken in order to test the stability of outcomes through those years. Explanatory Variables Structural factors were defined as factors that determine the conditions of a hospital for organ donation; for instance, the number of relevant deaths or the availability of an intensive care unit. Those conditions are not amenable to intervention by hospitals. Hospitals with a similar structural position may be expected to do equally well in the number of effective donors. The number of relevant deaths was based on the routine coding of new hospital patients according to the ICD‐9 DE, the Dutch language version of the ICD‐9 CM. In the Netherlands, more than 85% of all deceased organ donors died from either a cerebral vascular accident (CVA), a (traffic‐) accident or suicide. Furthermore, organ donation is limited to donors under 75 years of

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age (Nederlandse Transplantatie Stichting, 2004). We therefore used the mortality figures for these categories, restricted to the age group of under 75 years for each hospital. Mortality data for 5 consecutive years were used. For our analyses we distinguished two categories: CVA and accidents/suicides. In earlier studies, other relevant structural hospital characteristics were identified: number of hospital beds, presence of a neurosurgical service, trauma center, transplant center or academic educational center (Sheehy et al., 2003; Christiansen et al., 1998) and having a donation officer (Senouci et al., 2004). These variables were added to the variables in this study. Because of the stability of these characteristics, we restricted these data to the 2002 situation. The degree of implementation of a donor policy was assessed using a questionnaire. Implementation was characterized by three steps: (1) having a donor policy on paper (2), putting a donor policy into practice and (3) sustaining a donor policy, with two questions for each step (see Table 5.1). All questions were combined into one variable. Scale analyses showed satisfactory reliability of 0.71, implying that all items refer to one underlying concept: the implementation of a donor policy. Respondents were asked to describe the situation in 2002, thus resulting in one measure for implementation of a donor policy ranging from 0 to 6. Table 5.1 The implementation of a donor policy (n=80 hospitals) Number of hospitals A policy on paper We have a donor protocol 65 We have a registration form 73 A policy in practice We have a donation committee 73 One person feels extra responsible for

organ donation 71

Sustaining a policy We give regular instructions to new

personnel on donor policy 61

We have regular meetings monitoring our donor efficacy

56

We have all six 41

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Analysis First, descriptive statistics were used. Subsequently, to predict the number of organ donations in Dutch hospitals from structural factors and donation policy, multiple regression analysis was used within a multilevel model. Two types of explanatory variables should be distinguished. The mortality figures are yearly figures: each hospital provides mortality figures for 5 years. The remaining structural characteristics are restricted to 1 year. Also the implementation of a donor policy and the presence of a donation officer is restricted to a one‐time assessment. The dependent variable was the number of donors in each individual hospital, for each of the 5 years in our assessment. A multilevel model was used to tackle these differences, by allowing for an analysis of 5‐year data nested within hospitals (Leyland & Groenewegen, 2003). This analysis enabled us to locate the sources of variance: either between hospitals or between years. Most variance, 86%,was located between hospitals, whereas only 14% of the variance was located within hospitals between years. This means that large differences exist between hospitals and far smaller differences between years within one hospital. A hospital with many donors in 1 year is very likely to have many donors in the following year as well. A regression analysis was used to explain the differences between the hospitals. The focus of the analysis is not only on the explanatory power of this model but also on the unexplained variance. These analyses were repeated on the split half of the hospitals with the highest mortality rates. These hospitals are of special interest, since the larger hospitals are reported to be of most relevance for organ donation (Sheehy et al., 2003). In this subset, 85% of all variance was located between hospitals and only 15% within hospitals between years. 5.3 Results Number of Donors The participating 80 hospitals provided 868 effective donors in the period 1998–2002 (mean 2.2 per year, maximum 29 per year), accounting for 91% of the total number of donors in that period in the Netherlands (Nederlandse Transplantatie Stichting, 2004). The distribution is skewed: the top 25% of

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the hospitals provide 81% of all donors. In these hospitals the average number of beds was 797 with a minimum of 429. Structural factors In the participating hospitals, 14,804 patients died with a diagnosis of accident, suicide or CVA in the period 1998–2002; in the age category 20–75 years (CVA n = 11,016 (mean 28 deaths per hospital per year), (accidents/suicide: n = 3,788 (mean 10 deaths per hospital per year)). The mean number of beds in the hospitals was 536 (ranging from 140 to 1,368). Nineteen hospitals had a neurosurgery department, 7 had a transplant center, 10 had a trauma center and 8 had an academic training center. These hospital characteristics were highly related: all transplant centers were academic training centers and all but one were trauma centers. Implementation of donor policy The degree of implementation of donor policy is shown in Table 5.1. Most frequently cited—by 73% of all hospitals— are the donor registration form and the donation committee. About half of all hospitals (41) said they had a fully implemented donor policy. Larger hospitals more often report a fully implemented donor policy than smaller hospitals. In 44 of the hospitals donation officers were present. The relationship between structural factors, donor policy and the number of donors In the regression analysis mortality rates were entered first. These explained 80.5% of the variance between hospitals (not in table). Entering the remaining structural factors increased the explanatory power by 0.7% to 81.2% (not in table). Only one of these variables contributed significantly to the model: having a neurosurgery department (Table 5.2). Entering the implementation of a donor policy and the donation officer did not change the explanatory power of the model. Table 2 shows the full model. It shows that 17 out of 100 dead (0.17) from accidents or suicides became donors, whereas 4.9 out of 100 (0.049) dead from a CVA became a donor. The presence of a neurosurgery department adds 1.84 donors per hospital.

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Table 5.2 Regression analyses presenting only the significant independent variables explaining the number of donors in hospitals in the Netherlands (1998‐2002) N=80 hospitals N=40 hospitals

with highest mortality Explanatory variables

b 95% CI b 95% CI

Constant

2.15 0.95‐3.35 2.41 0.33‐4.49

Implementation of donor policy

0.04 ‐0.26‐0.34 ‐0.10 ‐1.26‐1.07

Having a donation officer

0.15 ‐0.90‐1.20 0.46 ‐2.04‐2.96

Number of beds

0.00 0.00 0.00 0.00‐0.01

With a neurosurgery department (yes=1,n=0)

1.84 0.62‐3.05 2.21 0.09‐4.34

Trauma center (yes=1,n=0)

0.25 ‐1.32‐1.82 0.17 ‐1.92‐2.26

Academic educational center (yes=1,n=0)

1.18 ‐2.26‐4.62 0.99 ‐3.59‐5.57

Transplant center (yes=1,n=0)

‐1.43 ‐4.76‐1.91 ‐1.20 ‐5.62‐3.23

Number of dead diagnosed as accident or suicide

0.17 0.13‐0.21 0.16 0.10‐0.21

Number of dead diagnosed as CVA

0.05 0.03‐0.07 0.02 ‐0.01‐0.05

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These analyses were repeated on the split half of the hospitals with the highest mortality rates. In these hospitals the number of dead diagnosed as accident/suicide explained 70.7% of the variance between hospitals (not in table). Table 5.2 shows that the number of dead from a CVA no longer adds significantly to the model. The variance in the number of deaths from accidents and suicides explains 70.7% of the variance between hospitals. Entering the remaining structural factors increased the explanatory power by 1.1% to 71.8% (not in table). In these hospitals the presence of a neurosurgery department provides an extra of 2.2 donors each year. The implementation of donor policy and the donation officer again failed to reach significance. Figure 5.1 Scatterplot of the yearly number of relevant death by number of donors in 80 Dutch hospitals in the period 1998‐2002 *

0

5

10

15

20

25

30

35

0 25 50 75 100

Number of relevant

num

ber o

f don

ors

125 150 175

Deaths

* Each dot represents one hospital in one year, thus hospitals appear 5 times

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Figure 5.1 demonstrates the strong linear correlation between total relevant mortality (CVA, accidents and suicide) and the number of donors (0.80; p < 0.001). However, the differences between hospitals remain. In particular, the right‐hand side of the graph shows hospitals with mortality figures in the same range (e.g. between 100 and 150) but with a far wider range of number of donors, namely between 6 and 28. In the subset of 40 hospitals with higher mortality rates, we found 7 hospitals that performed systematically worse than average: every year their number of donors was below the expected value based on the regression analysis, taking into account the mortality figures and neurosurgery. The mean difference was –2.8 donors per hospital per year. On the other hand, there were six hospitals that always scored above their expected value, with a mean difference of +3.3 donors per hospital per year. 5.4 Discussion In this study, we aimed at explaining the differences in the number of organ donors between hospitals and at identifying hospitals with potential to improve. The strongest predictor of the number of donors is mortality—from accidents, suicide and CVA. The number of traumatic deaths is correlated to more donors as compared to deaths from a CVA, as was also found by Frezza et al. (1999). In addition to this, the presence of a neurosurgical department increases the number of donors. The degree of donor policy implementation nor having a donation officer did add to this explanation. Finally, we found seven hospitals that performed systematically worse than average over a 5‐year period. One quarter of the hospitals accounted for 81% of all donors, confirming earlier findings (Sheehy et al., 2003) that the highest proportion of donors is to be found in the larger hospitals. However, in our study the larger hospitals had at least 429 beds as compared to 150 in the Sheehy et al. (2003) study. Nevertheless, we agree that extra efforts to increase the number of donors should focus on relatively larger hospitals, without neglecting the smaller hospitals; additional resources should be spent where most donors are.

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Several studies have focused on the issue of defining a reliable denominator for comparing hospitals or OPOs for their donor efficiency. Ojo et al. (2005) state that population size is not a good indicator for donor potential, because of the apparent differences between populations. They suggest using ‘notifiable’ deaths instead. Notifiable deaths are defined in terms of age (70 years or below), place of death (in hospital) and relevant ICD codes. ICD‐9 codes of inhospital deaths have been used to identify the donor pool and to compare the performance of OPOs (Beard et al., 2004; Christiansen et al., 1998). Stogis et al. (2002) calculated an expected number of donors based on the link between national donation rates and deaths in 24 population‐subgroups. A more labor intensive approach was used by Sheehy et al. (2003), who extracted exact data from the death records of individual hospitals to identify actual potential donors. This methodology provides precise data for each hospital, but also is very labor intensive (Evans et al., 1992; Stogis et al., 2002). In our study, we used routinely registered mortality figures per hospital as a predictor for the number of donors in each hospital. They serve as a better denominator than population size. We found a strong relationship between mortality figures and the number of donors (R2 = 0.80). This correlation exceeded the correlation between the expected number of donors and the real number of donors as found by Stogis et al. (2002), suggesting hospital‐specific mortality figures to be a more precise predictor for the number of donors than the expected number of donors as calculated by Stogis et al. (2002). The use of hospital specific mortality figures will offer certain advantages to chart review. First, the use of such data is less time‐consuming than chart reviews, as was also noted by Tuppin & Pessione (2003). Second, such data are routinely collected with a standardized procedure and therefore less prone to influence for strategic reasons or coding errors. The difficulty in standardizing chart reviews nationally was mentioned earlier by Stogis et al. (2002). It is also less likely that hospitals will be lost for analysis because of nonresponse. Third, the use of mortality data enables hospital comparison over a period of more years. Differences between years explained 15% of the variance in the number of donors. These differences could not be attributed to the differences in mortality. This means that a benchmark of hospitals based on 1 year can lead to misclassifications. Stogis et al. also demonstrated that random variation may cause some misclassification (Stogis et al., 2002).

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Even if these advantages are not fully convincing, the use of mortality figures can introduce a vital element of efficiency by using the donor/mortality ratio as a preselection for chart review. The more time‐consuming and costly method of chart review could subsequently be administered to those hospitals that seem to underperform based on their donor/mortality ratio. This would reduce the burden dramatically. All in all, we think that the use of mortality figures for assessing the performance of hospitals on donor recruitment should not be discarded with the argument that these figures can never be the gold standard. Either as a screening instrument, but also on their own, mortality figures can serve as a cost effective and reliable instrument for assessing the potential number of donors in individual hospitals. Stogis et al. report formal hindrances to accessing OPOs specific information (Stogis et al., 2002). We were in a fortunate situation to be able to get hospital‐specific data on both mortality figures combined with diagnoses and donation figures. However, we restricted our analysis to only three relevant diagnoses, covering at least 85% of all causes of death for donors in the Netherlands (Nederlandse Transplantatie Stichting, 2004). Others included many more diagnoses (Stogis et al., 2002; Ojo et al., 2005). Another limitation of our study is that ICD‐code is based on the diagnoses given to a patient when entering the hospital. This is not necessarily in all cases the cause of death. From this point of view our analyses may seem crude. Nonetheless, these data, whether crude or not, proved to be a strong predictor for the number of donors in each hospital. The ultimate goal of this study was to identify hospitals with improvement potential. This is important, since many other strategies have already been employed and we seem to be running out of options as far as cadaveric organ donation is concerned (Beard et al., 2004; Gäbel, 2003; McAlister et al., 2003). Not much gain is to be expected from a general measure aiming at improving the implementation of a donor policy. As our data show, more than half of the hospitals state that they implemented their donor policy fully. We also found a strong relationship between mortality and number of donors. This implies that hospitals with many potential donors also use this potential: no large undiscovered and unused pools of donor organs were found. In spite of this we found some hospitals that appear to underperform.

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For 5 consecutive years these hospitals provided less donors than might be expected from their mortality figures and the availability of a department with neurosurgery. These differences are not spectacular, but can amount to several donors per hospital per year. It would require a more in‐depth analysis in these seven hospitals on the relevance of inhibiting or promoting factors for organ donation. If these hospitals could improve their performance toward their expected value, this would mean an increase of 20 donors, which is an increase of 10% in the annual number of donors in the Netherlands: a worthwhile quest.

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6 Opting‐out systems: no guarantee for higher donation rates This chapter has been published as: Coppen, R., Friele, R. D., Marquet, R. L., & Gevers, J. K. M. (2005). Opting‐out systems: no guarantee for higher donation rates. Transplant International, 18, 1275‐1279.

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Summary There are considerable differences in the number of organ donations between countries. It is assumed that opting‐out systems have a significantly positive impact on the national organ donation rate. The aim of our study was to establish whether different consent systems explain the difference in organ donation rates between countries when taking into account the difference in relevant mortality rates. For this study, we compared data on donation and relevant mortality rates for 10 different countries as well as information on the existing consent systems. This international comparative study shows that there is a strong correlation between mortality rates and donation rates (Spearman’s ρ = 0.81 (P < 0.01). International comparative legal research has shown that the differences between decision systems are marginal. When the national organ donation rates are corrected for mortality rates, these findings are confirmed: the donor efficiency rate shows that opting‐out systems do not automatically guarantee higher donation rates than opting‐in systems.

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Opting‐out systems: no guarantee for higher donation rates

6.1 Introduction There are considerable differences in the number of organ donations when countries are compared. And while the need for donor organs in every country is increasing, the numbers of organ donations have remained steady during the last years or have even decreased (Gäbel, 2003a; Gimbel et al., 2003; Poinard et al., 2004). Because some countries have organ donation rates that are almost twice as high as in others, studies have been conducted to explain this discrepancy and to find a solution to reduce the differences (Matesanz, 2003; Pugliese et al., 2003). Because organ donation is a process with several stages, there are different ways to increase the post mortem organ donation rates (Roscam Abbing, 1990; Sheehy et al., 2003). Examples of initiatives to increase the organ donation rates are: the Spanish model for organ donation, the use of the non‐heart‐beating donor pool, and the European Donor Hospital Education Programme. An important and much‐discussed cause of loss of donors is the absence of consent for post mortem organ donation (Taub et al., 2003). Basically, two kinds of consent systems can be distinguished: systems of explicit consent and systems of presumed consent. In the former, the donor himself has to authorize organ removal after his death in the form of an advance directive or donor codicil, or by filling in a form to record consent in a national registry. In the presumed consent system, explicit consent is not required: it is sufficient that the deceased person did not object during life (according to national law) and therefore consent is presumed. The absence of explicit consent is by‐passed by presuming the consent of the potential donor. Because of its reliance on explicit consent, the first kind of system is also known as an opting‐in system, while presumed consent systems are characterized as opting‐out systems (Gevers et al., 2004). According to Gevers et al., countries may differ in their laws concerning consent systems, but in practice differences turn out to be much smaller because of the role of the next of kin. In theory, if an opting‐out system is strictly applied it should result in more donations. This is based on the assumption that the group of people who make an objection to organ donation under an opting‐out system is smaller than the group of people who do not register consent under an opting‐in

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system (Roels & De Meester, 1996). As shown in Table 6.1, high‐rate countries have an opting‐out system. Table 6.1 Organ donation rates in 10 European countries in 2002 Per million inhabitants* Consent system (Friele et al., 2004Spain

33.7 Opting‐out

Austria

24.3 Opting‐out

Belgium

21.9 Opting‐out

France

20.0 Opting‐out

Italy

18.1 Opting‐out

Germany

12.4 Opting‐in

The Netherlands

13.6 Opting‐in

UK

13.1 Opting‐out

Sweden

11.0 Opting‐out

Switzerland 10.4 Opting‐in * The rates shown comply with the definition of the Council of Europe: An organ donor is effectuated if ‘at least one solid organ has been retrieved for the purpose of organ transplantation’. This seems to endorse the opinion that opting‐out systems have a significantly positive impact on the national organ donation rate, an opinion already expressed by many authors (Dorozynski, 1998; Gimbel et al., 2003; Kennedy et al., 1998; Kittur et al., 1991; Langone & Helderman, 2003; Roels et al., 1996). However, there is good reason to doubt that this is indeed the case (Sheehy et al., 2003). Like other countries, the Netherlands has made various efforts to increase the number of organ donations. These include, among other initiatives, a campaign among the general public for registration as a consenting donor in the national register, introducing support plans for Dutch hospitals and

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allowing non‐heart‐beating organ donation. Until now, these measures did not result in a significant increase in national organ donation rates. As several studies state that opting‐out systems have a positive impact on the number of donor organs (Kennedy et al., 1998; Kittur et al., 1991; Randhawa, 1998), the question has been raised in the Netherlands whether the consent system for post mortem organ removal (laid down in the Organ Donation Act of 1998) should be changed. To answer that question, an extensive study has been carried out, including a survey of attitudes in the Dutch population on organ donation, an analysis of the practice of organ retrieval in Dutch hospitals, as well as an international comparative analysis of the consent systems in 10 European countries (Friele et al., 2004). In order to ascertain whether consent systems influence the output of the organ donation process (the organ donation rates), the input (mortality rate) also has to be taken into account. Only persons who have died meeting specific medical conditions are initially suitable as an organ donor. This mortality rate which is relevant for organ donation is the first step of the process of organ donation. Therefore, the Dutch study included an international comparison of relevant mortality and donation rates in 10 European countries in order to identify the relative importance of the consent systems as a factor influencing the availability of organs. The aim of our study was to establish whether different consent systems explain the difference in organ donation rates between countries when taking into account the difference in relevant mortality rates. 6.2 Material and methods For this study, we used data on donation rates and relevant mortality rates for 10 different countries (Table 6.2) as well as information on the existing consent systems in these countries. To restrict the number of confounding factors, we chose to compare only countries which share the same historical background and have more or less the same status of health care systems. The national organ donation rates were derived from the national organ transplant centers and meet the definition used by the Council of Europe: an organ donor is effectuated if ‘at least one solid organ has been retrieved for the purpose of organ transplantation’. We focused on the period 2000–2002,

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in which no major fluctuations in organ donation rates were observed. To correct for random fluctuations between years, we used three‐year‐means (Table 6.2). Table 6.2 Three year mean organ donation and mortality rates for 10 European countries Three year mean organ

donation rates* (per million inhabitants)

Three year mean mortality rates† for organ donation (per million inhabitants)

Spain

33.8 309

Austria

23.5 298

Belgium

23.0 343

France

18.3 330

Italy

16.8 246

UK

13.2 243

The Netherlands (I)

13.0 187

Germany (I)

12.6 240

Switzerland (I)

12.5 195

Sweden 11.3 240 * The rates shown comply with the definition of the Council of Europe: ‘if at least one solid organ has been retrieved for the purpose of organ transplantation’. † Mortality rates for CVA and (traffic) accidents 0–65 years. I indicates that this country has an opting‐in system. This study focuses on the first factor of relevance in the donor procurement process, which is the number of people who die in a mortality category specific to organ donation. These relevant mortality rates of 10 European countries were derived from the World Health Organization’s Health For All Database.

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According to the annual reports of each national transplant center, approximately 80% of the deceased who become organ donors died of a cerebral vascular accident (CVA) or (traffic) accident. That is why these mortality categories play an important role in the effectuation of a potential organ donor and we have therefore focused on these categories. The WHO’s Health for All Database was considered the best suitable source for obtaining mortality rates for international comparison, because it is a uniform database which contains the mortality rates per category per country. The mortality rates are based on the international Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD‐10). The database only provides the mortality rates in two groups: 0–65 years or all ages. As approximately 80% of the effectuated donors have died of a CVA or (traffic) accident and are not older than 65, this study presents the mortality rates [CVA + (traffic) accident] for this group only. To avoid extremes, an average mortality rate over the three most recent available years with complete data is used (Table 6.2). For most countries, this was the period 1999–2001, with the exception of Belgium (1995–1997). The correlation between mortality rates and donation rates was calculated using the Spearman’s test. To test the relationship between the different systems and the rates for mortality, donation, and donor efficiency, a t‐test was performed. The information about the consent systems of the 10 European countries used in this study is derived from the international comparative analysis of these consent systems by Gevers et al. (2004). 6.3 Results The relationship between the average donation rate and the relevant mortality for organ donation is shown in Figure 6.1. There is a strong correlation between the donation rates and the mortality rates which are relevant for organ donation [Spearman’s ρ = 0.81 (P < 0.01)]. Countries with low donation rates usually have low mortality rates relevant for organ donation, while countries with high donation rates have high relevant mortality rates.

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Figure 6.1 Relevant mortality rate and average donation rate per million inhabitants.

Spain

AustriaBelgium

France

rmany (I)ngdom

300 350

nation

Italy

Netherlands (I)

Switzerland (I) GeSweden

United Ki

0

5

10

15

20

25

30

35

40

0 50 100 150 200 250

Mean mortality rates for organ do (per million inhabitants)

Mea

n or

gan

dona

tion

rate

s(p

er m

illio

n in

habi

tant

s)

(I) indicates that this country has an opting‐in system To determine the influence of other factors on the difference in the donation rates, these rates should be corrected for the differences in mortality rates. Only after this correction is it possible to ascertain any influence of factors other than mortality. The donor efficiency rate reflects the number of organ donors as a percentage of the mortality for organ donation. Figure 6.2 shows that countries with an opting‐in system vary in their donor efficiency rate. This variability is also found in the countries with an opting‐out system, which indicates that there is no correlation between consent systems and organ donation rates. This finding is confirmed by the t‐test. According to the results of this test, there is no relation between the different systems and the efficiency rates. In other words, when donation rates are controlled for differences in relevant mortality there is no significant influence of the systems on these rates.

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Figure 6.2 The donor efficiency rate

4,7 5,3 5,4 5,56,4 6,7

0,0

2,0

4,0

6,0

8,0

10,0

12,0

Sweden

German

y (I)

United King

dom

France

Switzerl

and (

I)

Belgium It

N

6,8 7,07,9

10,9

aly

etherlan

ds (I)

Austria

Spain

(I) indicates that this country has an opting‐in system 6.4 Discussion Our analysis indicates that the apparent relationship between consent systems and organ donation rates disappears after controlling for difference in relevant mortality. Gevers et al. (2004) have shown that countries may differ in their laws concerning consent systems, but in practice differences turn out to be much smaller. In their analysis of the national transplantation laws, and interviews with several contacts in these countries, they have shown that relatives always seem to play a certain role in the opting‐out systems and that in practice these systems do not always work strictly as such. In practice, there seems to be a need on behalf of the doctor concerned to involve the next of kin if an explicit intention by the deceased is lacking (Gevers et al., 2004; Miranda, Naya, & Cuende, 1999). Even if it is legally admissible not to involve relatives for an organ donation, there is no country that does not give them a role in the organ donation process. In Belgium, France, Italy and Sweden relatives can voice an objection. In Austria,

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Germany, the Netherlands, Switzerland, Spain, and the UK relatives are asked to give their consent. Obviously the opting‐out systems in practice in Austria, Spain and the UK are less strict than one would expect according to the law. This observation may explain the lack of difference between consent systems in organ donation rates as shown in Figure 6.2 of this study. To conduct an international comparison of national organ procurement systems, a number of difficulties must be confronted. A dramatic data reduction is necessary to study the impact of consent systems on organ procurement rates. Even disregarding aspects that are unique to a country’s procurement system such as cultural differences and the influence of state’s support in higher procurement performance regarding organization, educational and economical aspects, one needs to identify the relevant mortality rates. Unfortunately, at this moment there is no reliable and comparable data on cultural, organizational, educational, and economical data available. Moreover, it will be very difficult to obtain such data which can be compared on an international level. Therefore, we did not specify our analysis to the different initiatives taking place in some countries, such as the Spanish model for organ donation, or the use of non‐heart‐beating donations. Another issue for international comparative studies is the need for the use of the same terminology for different steps in the organ donation process (Di Ciaccio et al., 2003). It is therefore essential to verify whether the numbers which are used for an international comparison meet the same definition. This has been accomplished here by requesting the national transplant centers to provide us with the organ donation rates which met the same definition. To increase the donor pool in the Netherlands, the use of non‐heart‐beating donations was one of the initiatives introduced during the 1990s. In 2003, 39% of the total amount of post mortem organ donations consisted of non‐heart‐beating donations (Nederlandse Transplantatie Stichting, 2004). Other countries which also perform non‐heart‐beating donations and publish their non‐heart‐beating results are Spain and the UK. However, non‐heart‐beating donations in those countries only account for <5% of the total amount of post mortem organ donations. The decision to widen the donor pool to include non‐heart‐beating donations was based on an assumed increase of usable organ donors in non‐

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heart‐beating mortality categories. However, so far this initiative has not resulted in a change in the mortality pattern for organ donation (Coppen et al., 2004). It seems that the initiative did not increase the donor pool, but took over a part of the heart‐beating donations. Therefore, we included these cases of non‐heart‐beating donation in our donation rates. However, it should be noted that without the share of non‐heart‐beating organ donations in the Netherlands the efficiency rate shown in Figure 6.2 would have been much lower. Although non‐heart‐beating has become a very important category of organ donors in the Netherlands, the use of this category does not change the final results of this study. 6.5 Conclusion This international comparative study shows that there is a strong correlation between relevant mortality rates and organ donation rates [Spearman’s ρ = 0.81 (P < 0.01)]. International comparative legal research has shown that the differences between decision systems are marginal. When the national organ donation rates are corrected for the mortality rates, the findings of the legal research are confirmed: the donor efficiency rate shows that opting‐out systems do not automatically guarantee higher organ donation rates than opting‐in systems.

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Imagining the impact of different consent systems on organ donation: the decisions of next of kin This chapter has been accepted for publication as: Remco Coppen, Roland D. Friele, Sjef K.M. Gevers, Jouke van der Zee. Imagining the Impact of Different Consent Systems on Organ Donation: The Decisions of Next of Kin, Death Studies.

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Abstract Next of kin play an important role in organ donation. The aim of this study was to assess the extent to which explicitness of consent to organ donation by the deceased impacts the likelihood that next of kin will agree to organ donation of the deceased by using hypothetical cases. Results indicate that that people say they are more willing to agree to donate organs of those who explicitly consented to donate than those whose permission to donate is presumed. The degree of explicitness for the consent to donate by the deceased appears to influence the next of kin’s decision about whether to agree to donation. This variation might explain the absence of differences in efficiency between various types of consent systems.

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7.1 Introduction The need for organs suitable for transplantation is acute. For example, in the Netherlands in 2006, there were 1,441 people on a waiting list for transplantation. However in that same year, donations by only 200 post mortem organ donors were procured (Dutch Transplantation Foundation, 2007). Other countries experience the same problem (Council of Europe, 2008). The shortage of procured post mortem organs is forcing countries to develop policies to optimize efficiency in retrieving post mortem organs from potential donors. An important issue in the donation process that causes a loss of donors is obtaining consent for an organ donation procedure (Frutos et al., 2005; Klenow & Youngs, 1995; Siminoff et al., 1995; Stein et al., 1995). There is general agreement that the procurement of organs post mortem is only allowed if the deceased or his or her next of kin consented to organ donation. In general, there are two legal systems for obtaining consent: explicit consent and presumed consent (Gevers et al., 2004). In an explicit consent system the donor himself or herself has to authorize organ removal after his or her death in the form of an advance directive or donor codicil, or by filling in a form to record consent in a national registry. If the deceased’s wish is not known, the next of kin are consulted. On the other hand, under a strict presumed consent system, it is not required to obtain consent ‐ either from the deceased or from the next of kin; it is sufficient to verify that the deceased did not object during his or her lifetime to becoming a donor (Gevers et al., 2004). Irrespective of the consent system, most people do not register their wishes (whether consent or refusal) (Gäbel, 2003b, 2006). The consequence of this is that the pool of consenting donors in a presumed consent system far exceeds the pool of consenting donors in an explicit consent system (Johnson & Goldstein, 2003). This would suggest a more efficient procurement (i.e., larger numbers) of organ donors in presumed consent countries. However, several studies show that there is no substantial difference in the efficiency of procurement between both consent systems (Cameron & Forsythe, 2001; Matesanz, 1998). When differences in the organ donation rates between countries are adjusted for differences in the numbers

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of potential donors based on relevant mortality rates, presumed consent systems do not guarantee higher efficiency of donor procurement (Coppen et al., 2008; Coppen et al., 2005). A possible explanation for this surprising finding may lie in the role of next of kin. Gevers and colleagues (2004) concluded that in Western European countries, regardless of the legal consent system, next of kin play an important role in obtaining consent. In an explicit consent system, next of kin are consulted when the deceased’s wishes are unregistered; further, even when the deceased is an explicit donor, next of kin play a role in the procurement process (Friele et al., 2004). In addition, in presumed consent systems too, next of kin are given a voice when the wishes of the deceased are unknown – even though consent is presumed (Childress & Liverman, 2006; Chouhan & Draper, 2003; Galea & Pegg, 2003; Gevers et al., 2004; Janssen & Gevers, 2005; Matesanz, 1998; Prottas, 1985). Therefore, in Western European countries next of kin are always consulted during the organ procurement process, regardless of the legal conditions of the donor (i.e., explicit donor, presumed donor, or non‐registered). Next of kin are not consulted only when the deceased made an objection against donation because the deceased will not be a donor in that case. Because next of kin play a role in whether organs are donated, a large donor pool filled with presumed consents will result a much smaller pool of donors if next of kin withhold their approval. On the other hand, countries with a small donor pool filled with explicit consents may suffer far less from this phenomenon if next of kin follow the explicit wishes of the deceased. Because of a lack of impact of the current donor legislation, a number of interest groups (e.g. several political parties, patient organizations, and the Netherlands Institute for Health Promotion and Disease Prevention) joined together and looked for ways to ameliorate the performance of the Dutch Organ Donation Act. In order to create a large donor pool filled with registered consents, they have proposed to combine what they see as the best of both systems: a system with automatic consent registration in the national Donor Registry.

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To obtain an automatic consent registration, these interest groups have proposed that all citizens not yet registered in the national registry should be sent a letter to inform them that if they do not explicitly refuse to be a donor they will automatically be registered as a donor in the national registry. To verify whether a person really wants to be registered, the individual will receive a follow‐up letter which confirms his or her registration (Friele & de Jong, 2007; Friele & Kerssens, 2004). Because of the role that next of kin play, it is important for professionals and policy makers to know whether the different legal conditions of donors influence next of kin in their decision to agree to an organ donation procedure and to get insight into how this mechanism works. Hence, the aim of this study was to assess the extent to which explicitness of consent to organ donation by the deceased impacts on the likelihood that next of kin will agree to the procurement of the deceased’s organs. It is assumed that next of kin of explicit donors are more willing to agree than next of kin of presumed donors so we tested this assumption. 7.2 Method Sample This study was conducted via the Dutch Health Care Consumer Panel (DHCP), a panel on consumers’ experiences and opinions regarding health services. The DHCP is representative of the general Dutch population in terms of age and sex. To ensure that the panel continues to represent a cross‐section of the population, every two years one third of the consumer panel is renewed. This also prevents panel members from developing specific knowledge or awareness of certain health care issues or “questionnaire‐fatigue” (van der Schee et al., 2006). Materials The questionnaire consisted of four hypothetical cases that were presented to all respondents. Each hypothetical case described a situation in which a close family member had been declared brain dead by a physician. The cases varied with respect to the degree with which consent was made explicit:

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- Case 1: The deceased is registered as a donor in an explicit consent system

- Case 2: The deceased is not registered as a donor in an explicit consent system

- Case 3: the deceased is presumed to be a donor in a presumed consent system

- Case 4: the deceased is automatically registered as a donor in an alternative system proposed in the Netherlands

Cases 1 and 2 occur in explicit consent systems. Case 3 occurs in presumed consent systems. Case 4 is derived from the system with automatic consent registration proposed by a number of interest groups in the Netherlands. For each case two questions were asked: (a) Taking into account the cited (legal) conditions, would you as next of kin of the deceased agree to an organ donation procedure? and (b) Taking into account the cited legal conditions, would you approve a situation in which you are not consulted at all? The respondents only had the option of answering both questions with “Yes,” “No,” or “I don’t know.” The respondents were not given the opportunity to explain their answers. Data Analysis The questionnaire was first sent to 669 members of the DHCP in 2004 (response rate 98%). To confirm the sustainability of the results, we repeated the study in a renewed DHCP in 2007. The response rate in 2007 was 80% (1,376 questionnaires were sent out and 1,094 were returned). The number of questionnaires sent out in 2004 was much smaller than in 2007 because the DHCP was smaller at that time. Because the sex, consent registration, and age distribution of the respondents differed slightly from the Dutch population, we controlled the data for these factors in both years. For both years a weight factor (% of the Dutch population/% respondents) was used to make the DHCP comparable with the Dutch population. A total of 20 weight factors were used for the combination of sex (male, female), consent registration (registered with consent, not registered), and age (0‐34; 35‐44; 45‐54; 55‐64; 65 and older).

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7.3 Results First, this section gives insight into the reported willingness of next of kin to donate within different hypothetical legal scenarios. Our results reveal similarities and/or differences between the different legal scenarios. And second, this section gives insight into their preferred position within these different systems for organ donation and addresses whether the respondents will approve a situation in which next of kin are not consulted at all. We report 95% confidence intervals (CIs) and used them to determine significant differences between cases. When the 95% CIs of the results do not overlap each other there is a statistically difference between these cases. Willingness to Donate within Different Legal Scenarios Figure 7.1 shows that respondents, in their role as next of kin, say they are most often willing to agree to donate the organs of a deceased relative when he or she is registered as a donor and an explicit consent system is in place (case 1 – 73%; 95% CI 70.3‐75.6). Where registration is absent, the respondents say they are more likely to agree to donate when a presumed consent system (case 3 – 48%; 95% CI 45.3‐51.3) is in force than when an explicit consent system is in force (case 2 – 30%; 95% CI 27.7‐33.1). The results also indicate that the respondents make a distinction between presumed donors (case 3) and automatically registered potential donors (case 4 – 61%; 95% CI 58.5‐64.4). Figure 7.1 also shows that the respondents are more likely to refuse to donate the organs of a deceased relative when there is no registration (cases 2 & 3). The absence of registration in an explicit consent system (case 2 – 41%; 95% CI 37.7‐43.6) leads to a significantly higher refusal rate than the absence of registration in a presumed consent system (case 3 – 34%; 95% CI 31.6‐37.2 ).

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Figure 7.1 Four hypothetical cases and the decisions the sample would make if they (as next of kin) were asked to consent to the organ donation procedure of a potential donor

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Figure 7.2 Percentage of next of kin in the sample who would not approve a situation in which they are not consulted

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Case Legal conditions 1 The deceased is registered as a donor (explicit consent system) 2 The deceased is not registered as a donor (explicit consent system) 3 The deceased is (by law) presumed to be a donor (presumed consent system) 4 The deceased is automatically registered as a donor (alternative system) 7.4 Discussion The aim of our study was to assess the extent to which explicitness of consent to organ donation by the deceased impacts on the likelihood that next of kin will agree to the procurement of the deceased’s organs. This section reviews the findings that (a) explicit consent is more likely to result in agreement to organ donation and (b) most next of kin want to be involved in the decision about organ donation and discusses the study’s limitations. Explicit Consent is Most Likely to Result in Agreement to Organ Donation There are considerable differences in how people say that they think they

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will react as next of kin to the question of whether to agree with the procurement of the organs of a close family member. They report that their reaction will depend on the applicable legal conditions. According to our results, the likelihood that next of kin will agree to organ donation increases when the consent of the deceased is explicit. When the deceased is an explicit donor, the next of kin report being more likely to actually donate an organ than when consent is presumed. Thus, we conclude that in a presumed consent system, the pool of consenting donors is large, but the likelihood that next of kin will agree with donation is lower; however, in an explicit consent system the pool of consenting donors is small, but the likelihood that next of kin will agree is larger. This might explain the absence of a clear difference in the efficiency of donor procurement between presumed consent countries and explicit consent countries. It is noteworthy that an explicit consent system can only accomplish the above effect when a significant part of the population is registered or carries a donor card. For example, in the Netherlands, approximately 40% of the population is registered in the Donor Register. This register contains three types of registration: registered consent (57%), registered refusal (30%), and registered next of kin (or a specified person) may decide upon the organ donation (13%) (Dutch Transplantation Foundation, 2008). To our knowledge no other country has a register with such high registration rates (Gäbel, 2003b). These results parallel previous findings. New results in this study are that the respondents, in their role as next of kin, distinguish between explicit donors, presumed donors, automatic donors, and non‐registered persons when agreeing to the procurement of organs of a deceased person. In hospital‐based studies that analyzed differences between next of kin who agreed with the procurement of organs of a deceased person and next of kin who refused, it was also found that when the next of kin were convinced that it was the deceased’s wish to donate his or her organs, they were more likely to agree (Farsides, 2000; Flodén et al., 2006; Frutos et al., 2005; Martínez et al., 2001; Rosel et al., 1999; Siminoff et al., 1995; Siminoff et al., 2001; Siminoff et al., 2001; Sque et al., 2005). Furthermore, the analysis of organ donation procedures in 57 Dutch hospitals supports these findings. In that study 1,131 deceased persons were identified as potential donors. When

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consent of the donors was registered, 92% of the next of kin agreed with an organ donation procedure (Friele et al., 2004). Most Next of Kin Want to be Involved in the Decision about Organ Donation Another relevant observation in this study is that about two‐thirds of the Dutch respondents report that they would not approve a consent system in which they (as next of kin) are not consulted. The study also indicates that the more the respondents are convinced that organ donation is exactly what the potential donor wanted, the less importance they attach to being involved in the decision‐making process. It seems that the respondents experience more confidence in donating organs when consent is made more explicit. Most respondents reported that next of kin should have a say in whether a donation procedure is performed, regardless of the presence of explicit, presumed, or automatic registration. Siminoff and Mercer (2001) reported a similar finding and argued that people are distrustful of strangers making decisions about a deceased’s body. They noted that people “are clearly more comfortable to know that family members have a final say” (Siminoff & Mercer, 2001, p. 385). These results show that people, in their imagined role as next of kin, also want to take up this role and have a final say. Limitations of this Study The main limitation of this survey is that it sheds light on what people believe they would do in hypothetical circumstances. When people are actually confronted with the question of donating the organs of a deceased relative, they tend to be more cautious (Dyer, 2007; Klassen & Klassen, 1996; Siminoff et al., 1995). In the case of organ donation, a cautious decision is a refusal. Secondly, people were asked to provide their answers in only three categories: “Yes,” “No,” or “I don’t know.” In reality, when consulting next of kin, questions may be asked, uncertainties addressed, and feelings exchanged (Simpkin et al., 2009). All of these factors will contribute to the final decision. The impact of this process cannot be accounted for in this study. Another limitation of this study is that it only sheds light on the Dutch

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situation (our current system is an explicit consent system). Because there are no valid, reliable data on refusal rates at international level, it is difficult to study next of kin decisions between countries with different consent systems. It would be relevant to test whether our results can also be replicated in other countries. For now, it is important to see that, according to our results, families distinguish between presumed and explicit donors. 7.5 Conclusion This research shows that the degree to which consent is made explicit by the legislative consent system seems to affect the willingness of the Dutch population in its role as next of kin to agree with an organ donation procedure. Respondents said they are more likely to agree with the procurement of the organs of an explicit donor than of a presumed donor. Taking into account that it is more likely that the organs of an explicit donor are procured than those of a presumed donor, this might explain the absence of clear differences in the efficiency of donor procurement between presumed and explicit consent systems. Moreover, respondents made it clear that they would not approve a consent system in which they are not consulted. Apparently, the belief that they have the possibility to agree or disagree with an organ donation procedure is comforting, contributes to their sense of justice. Moreover, having the possibility to agree or disagree with an organ donation seems to support next of kin in their responsibility for taking care of the deceased’s body. This may explain why in most countries, regardless of consent system, next of kin play an important role (Chouhan et al., 2003) and is in line with the finding of Gevers et al. (2004, p. 184) “that in reality the different systems are much more similar than suggested by the explicit/presumed consent distinction” (see also Childress et al., 2006; Galea et al., 2003; Janssen et al., 2005; Matesanz, 1998; Prottas, 1985). Thus, next of kin do matter when a decision regarding organ donation is made. This study shows that is it important that people inform their relatives about the wish to become an organ donor and to confirm that wish either by registering in a national register or by document (e.g., donor card, driver’s license) (Alleman et al., 1996; Childress et al., 2006; Farsides, 2000;

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Simpkin et al., 2009). When searching for non‐legal strategies to increase the consent rate regarding organ donation, governments or organ procurement organizations could implement this suggestion into a communication package aimed at the general population: let your next of kin know that you want to be a donor and confirm that wish.

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General discussion and conclusions

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8.1 Introduction In this thesis we have focused on the Dutch policy to increase the supply of post mortem donor organs, with special reference to the Organ Donation Act’s objective in this matter. Central to this is a social issue, besides the policy issues. The social issue relates to the lengthy waiting periods for patients to receive an organ. In the Netherlands approximately 1,300 people are waiting for an organ, while there are only some 200 post mortem organ donors on a yearly basis. This means there is a considerable discrepancy between the demand for donor organs and the supply of organs, resulting in waiting lists, and consequently long waiting times for patients to receive an organ; patients even die while waiting (Defever, 1990; Council of Europe, 2008; Smith, 2009). In order to reduce the gap between the supply of and demand for donor organs, and to shorten the waiting list the Dutch government has implemented a policy to increase the supply of organs. In 1998 the Dutch Organ Donation Act came into force, introducing a consent system based on explicit consent and followed by the implementation of several additional policy measures. However, in the past decade the post mortem donation rates have not increased and the gap remains. This has raised a policy issue, as was demonstrated by the ongoing debate about the ability of the Dutch policy on organ donation to increase the donor organ supply. The debate has focused on the consent system. Because countries with a presumed consent system have higher donation rates, it has been suggested that the Netherlands should change the consent system and introduce a system based on presumed consent. But will changing the consent system indeed increase the supply of donor organs? After all, changing the consent system is a radical step, and other factors may influence the outcomes of such a change. Thus further analysis is called for. Therefore, the main research question was: “What is the impact of legislation on organ donation and additional policy measures on the supply of post mortem donor organs, with special reference to the Netherlands?” We assumed that the supply of donor organs depends largely on the impact of legislation, additional policy measures, and on external factors, such as

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the number of deceased people eligible for organ donation (e.g. deaths from traffic accidents and Cerebral Vascular Accidents (CVA)). Furthermore, legislation and policy measures are often intertwined and their effects may be indirect. This makes it difficult to answer the main research question and therefore this thesis has adopted a three‐pronged approach. By achieving consistency in the results of the three separate parts, we hoped to contribute to the reliability of the answer to the research question. First, we have explored the possibilities of adapting the Dutch Organ Donation Act, with a view to increasing the organ supply. Second, we have assessed the impact of the implementation of the Act and its additional policy measures on the supply of donor organs. And third, we have explored whether a (hypothetical) change to the consent system might lead to an increased donor organ supply. The results of these analyses are described in section 8.2.1, section 8.2.2, and section 8.2.3 respectively. Based on these findings we will discuss the impact of organ donation legislation and additional policy measures on the supply of donor organs (section 8.3), followed by the conclusion of this thesis (section 8.4). Furthermore, the strengths and limitations of our analyses are discussed (section 8.5). And finally, we will dwell in greater depth on pointers for future research (section 8.6) and the relevance and implications for the policy on organ donation (section 8.7). 8.2 Results of preceding analyses This section will summarise the main results of the preceding analyses and will answer the three research questions. 8.2.1 To what extent is it possible to adapt the Dutch Organ Donation Act with a view to increasing the supply of donor organs? (Q1) The Dutch Organ Donation Act has four objectives: (1) to provide legal certainty and to codify the law, (2) to increase the supply of donor organs and tissues, (3) to ensure the fair allocation of donor organs and tissues, and(4) to prevent commercialisation and organ trade.

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The basic idea behind these objectives was that providing legal certainty and trust would change people’s behaviour, leading to increased consent rates, and thus resulting in an increase in the national supply of donor organs. The Act’s main provision to provide legal certainty and trust and to increase the supply of donor organs consists in its consent system based on explicit consent. Other important provisions contributing to the Act’s objectives are the allocation system, provisions for organ donation procedures in hospitals and prohibitions regarding the commercial use of organs. Because the shortage of donor organs persisted even after the introduction of the Act, several proposals to amend the Act were made with a view to increasing the supply of donor‐organs and were discussed in a public debate. These proposals concerned adjusting the consent system, introducing non‐medical criteria to the allocation system, and introducing financial incentives. Chapter 2 focuses on compliance of the proposals with the principles of physical integrity, non‐commerciality and equitable access to care, as laid down in the Declaration on the Promotion of patients’ rights in Europe, the Convention on Human Rights and Biomedicine and its Additional Protocol on Transplantation of Organs and Tissues of Human Origin, and the potential of the proposals to increase the supply of donor organs and reduce waiting time for patients. General conclusion of part 1 In this part of the thesis we found that the scope for changing the Dutch Organ Donation Act, with a view to increasing the supply of donor organs, is limited. Introducing non‐medical criteria, such as reciprocity1 or the living donor list exchange2 into the allocation system may infringe on the right of equal access to health care facilities. Introducing financial incentives for organ donation may be at variance with the principle of non‐commerciality in organ donation. These potential infringements may harm the trust that people have in the procurement system. Moreover, there is no evidence that the proposed changes will increase the donor organ supply; they may even have a counterproductive effect on the supply of donor organs. 1 E.g. those who register as donors should be given priority if they are ever on a transplant waiting list. 2 E.g. priority on the waiting list for a post mortem donor organ by offering an organ from a living donor to another person waiting for an organ.

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The principles of physical integrity and equitable access to care do not stand in the way of changing the consent system. Such a change might be considered when it is thought likely that it will increase the number of donor organs. It remains however to be seen whether changing the consent system will have that effect. 8.2.2 What is the impact of the implementation of the Dutch Organ Donation Act and its additional policy measures? (Q2) To assess the impact of consent systems and additional policy measures on organ procurement, the second part of the thesis focused on the empirical evidence. We assessed the impact of 1) the organ donor policies in ten Western European countries, 2) the policy measures on donor education in the Netherlands, and 3) the implementation of policy measures in Dutch hospitals. The impact of organ donor policies in ten Western‐European countries A comparison of the impact of policies in ten Western‐European countries shows an overall increase in donor efficiency from 1995 to 2005 (chapter 3). Over time, these countries became more efficient in procuring donors, when adjusted for mortality rates relevant for organ donation (e.g. CVA and (traffic) accidents). This means that the efforts to improve donor policies have paid off. The impact of these efforts is partially abated by the success of other policy measures, for instance those directed at reducing the number of traffic accidents. Nonetheless, substantial differences remain between countries in the efficiency of post mortem donor procurement. The results of chapter 3 indicate that increased donor efficiency is not related to having a presumed consent system. We did not find consistent differences between consent systems, nor did we find that the donor procurement rates of presumed consent countries (adjusted for relevant mortality) increased more rapidly than those of explicit consent countries (Figure 8.1). Particularly relevant to our analysis are the reports of countries that introduced a new consent system or changed their system (Figure 8.2). These countries show no consistent effect on their efficiency in donor procurement. Germany enacted an explicit consent system in 1997 and the Netherlands enacted its explicit consent system in 1998. In Germany we see that the

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efficiency of donor procurement was already increasing; there are no differences between the trends before and after the enactment of the consent system. In the Netherlands, however, we see that the efficiency of donor procurement was already declining, and one year after the enactment, the efficiency in donor procurement reached an all‐time low. From 2001 on, the efficiency in donor procurement increased. There are also countries which switched to a presumed consent system between 1995 and 2005. Sweden changed from an explicit consent system to a presumed consent system in 1996. This change led to a temporary increase in the efficiency of donor procurement. Italy changed from explicit consent to presumed consent in 1999. For Italy we see, as in the case of Germany, that the efficiency of donor procurement was already increasing and that there are no differences between the trends before and after changing the consent system. For most countries, the national policies on organ donation are “black boxes”; it is difficult to gain insight into the strategies of governments and the additional policy measures implemented over a period of several years. It remains unclear which specific policy measures are responsible for increased donor efficiency rates. To gain insight into this black box and to explain the trend of donor procurement in the Netherlands, we tried to disentangle the Dutch strategy and the additional policy measures from the impact on the supply of donor organs. To increase the consent rates for organ donation, the government developed a strategy with additional policy measures that focused on providing donor education to the public (chapter 4) and on increasing the efficiency of the process of organ donation in hospitals (chapter 5).

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Figure 8.1 The efficiency of post mortem donor procurement in 10 European countries*

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Figure 8.2 The efficiency of donor procurement in 4 European countries that introduced a new consent system or changed their system*

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1995‐2005 The impact of the policy measures on donor education The introduction of the Dutch Organ Donation Act (1998) was accompanied by several rather fragmented donor education campaigns which merely informed people about organ donation and registration (chapter 4). One year after the enactment of the Act, the national donation rates dropped from 216 post mortem donors in 1997 (13.8 donors per million inhabitants (PMI) to an all‐time low of 165 donors in 1999 (10.4 donors PMI) (Nederlandse Transplantatie Stichting, 2000; Nederlandse Transplantatie Stichting, 2007). Because of these disappointing donor rates the government initiated a plan of action for organ donation in 2000. This initiative proposed cohesive sustained and comprehensive multi‐channel campaigns with a

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focus on persuading people to register consent. In 2004, an extensive public debate about the donor organ shortage and the Dutch consent system took place. In anticipation of this public debate, a sustained and comprehensive multi‐channel campaign was conducted, which included mass media interventions and several mail shots of donor registration forms. By assessing the effects of the policy measures in the field of donor education, chapter 4 shows that this change in strategy led to an increase in registrations. It seems that putting effort into donor education had paid off. The positive correlation between (consent) registrations and donor procurement underlines the importance of maximising the number of consent registrations in an explicit consent system. We also found some noteworthy fluctuation in the efficiency of donor procurement in 2007. This fluctuation cannot be explained by the implementation of policy measures or changes in the organisational or legal system. When interpreting donor procurement rates it is important to bear in mind that they can fluctuate between years. Despite intensified efforts to carry out donor education campaigns, the effects of campaigns seem to level off over time. Because it is unknown how much room there is for an improvement in donation and registration rates, it is unclear what effects may be expected from future policy measures. The impact of the implementation of policy measures in hospitals Donation rates vary among Dutch hospitals. When comparing 80 hospitals (chapter 5), most of the variation in numbers of organ donors can be explained by the hospital‐specific mortality statistics. It was found that 81% of all donors came from one quarter of the hospitals, mainly larger hospitals. This strong correlation between mortality and number of donors implies that hospitals with many potential donors also utilise this potential; there are no large undiscovered and unused pools of donor organs. There are many smaller hospitals with relatively low mortality rates for organ donation, that have small numbers of donors, whereas the (larger) hospitals with high mortality rates for organ donation have more donors. We also found that some larger hospitals performed less well on organ procurement than others. Seven hospitals systematically underperformed over a period of 5 years.

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These findings suggest that, despite the absence of large undiscovered and unused pools of donor organs, there still seems to be room for improvement in certain hospitals. We found that the degree of policy implementation or the presence of a donation officer within a hospital do not significantly increase donation rates in hospitals. Hospitals with a neurosurgery department had extra donors. A more in‐depth analysis may provide clues as to how donor procurement in underperforming hospitals can be improved. General conclusion of part 2 One year after the introduction of the Act, the efficiency of donor procurement dropped (Figure 8.2). Apparently, the impact of legislation on the supply of organ donation was insufficient and subsequently additional policy measures were implemented. In general, these additional policy measures led to a steady increase in the efficiency of donor procurement (chapters 3 and 4). According to the findings of chapters 3, 4, and 5 it is expected that improvements in the efficiency of donor procurement will only be modest. Notwithstanding that, each additional donor is an important contribution to shortening the waiting list for donor organs. 8.2.3 Will changing or adjusting the current consent system influence the donor organ supply? (Q3) The impact of consent systems in ten Western European countries The first part of our analysis concludes that theoretically there is room to change the consent system. This last part of our analysis focuses on what effects can be expected from changing the consent system. The higher donation rates of countries with presumed consent systems seem to prove the assumption that countries with large pools of presumed donors are more effective than countries with much smaller pools of explicit donors. However, we found that differences in donation rates between countries can be explained by differences in mortality rates, e.g. causes of death that are relevant for organ donation such as CVA or (traffic) accidents. When adjusting the donation rates for these differences in mortality rates the difference between presumed consent and explicit consent countries disappears (chapter 6).

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Imagining the impact of consent systems on organ donation The pool of possible donors in presumed consent systems is much larger than the donor pool in explicit consent systems. However, there are no clear differences in the efficiency of donor procurement between presumed and explicit consent countries (chapters 3 and 6). How can the absence of differences be explained? Formally, next of kin are only consulted in an explicit consent system when the potential donor is not registered. Next of kin need not be consulted when a potential donor is not registered in a presumed consent system. Nonetheless, several studies have found that in practice next of kin are always consulted (Childress & Liverman, 2006; Chouhan & Draper, 2003; Galea & Pegg, 2003; Gevers, Janssen, & Friele, 2004; Janssen & Gevers, 2005; Matesanz, 1998; Prottas, 1985). The predominant role of next of kin, where no decision by the deceased has been recorded (as is most frequent in both presumed as well as explicit consent countries), reduces the potential of the presumed consent system. Because next of kin play such an important role in both systems, a large donor pool filled with presumed consents will result in a much smaller pool of donors if next of kin withhold their approval. On the other hand, countries with a small donor pool filled with explicit consents may suffer far less from this phenomenon if next of kin follow the explicit wishes of the deceased. We found that people say they are more likely to agree to donate organs of explicit than of presumed donors (chapter 7). The degree to which deceased made their consent explicit, influences next of kin in their decisions. Thus, in a presumed consent system, the pool of (presumed) consenting donors is large, but the likelihood that next of kin will agree with donation is lower; in an explicit consent system the pool of (explicit) consenting donors is small, but the likelihood that next of kin will agree is larger. This variation might explain the absence of differences in efficiency between consent systems. Furthermore, a noteworthy observation in this study is that about two‐thirds of the Dutch respondents report that they would not approve a consent system in which they (as next of kin) are not consulted. The respondents, in their imagined role as next of kin, indicate that the more they are convinced that organ donation is exactly what the potential donor wanted, the less importance they attach to being involved in the decision‐making process. It seems that the respondents experience more confidence in donating organs

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when consent is made more explicit. General conclusion of part 3 Differences in organ donation rates between consent systems disappear when these rates are adjusted for an important confounder; i.e. differences in relevant mortality rates between countries. The absence of influence by the formal consent system can be explained by the role of next of kin in donation procedures. Other studies demonstrated that in general next of kin are consulted. This study adds to this finding that next of kin seem to differentiate between presumed and explicit donors. As people say they are more likely to agree to donate organs of explicit than of presumed donors, it is unlikely that changing the system will increase the supply of donor organs. This leads to the conclusion that the impact of consent systems on the supply of donor organs is only limited and that introducing a presumed consent system in the Netherlands will not guarantee higher donation rates. 8.3 Discussion What do the conclusions of the three different parts of this thesis mean for the main research question? What is the impact of organ donation legislation and additional policy measures on the supply of donor organs? And how can we explain our results? 8.3.1 The impact of explicit consent systems on the supply of donor organs Opting for the current explicit consent system is for a large part based on the basic idea that safeguarding the right to physical integrity by law is important and essential for people’s trust in organ procurement. In the Netherlands, creating trust in organ procurement was considered to be a necessary condition for increasing the supply of donor organs. According to this view, the impact of the consent system on the supply of donor organs depends on the impact on the people’s trust in organ procurement. However, the correlation between the introduction of the Act’s consent system and its impact on the supply of donor organs is rather indirect and there is no empirical evidence that there is a relationship between creating

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trust in organ procurement through legislation on organ donation and increasing the supply of donor organs. 8.3.2 The impact of presumed consent systems on the supply of donor organs Countries with presumed consent systems have higher donation rates than countries with explicit consent systems. It is tempting to ascribe these higher donation rates to the larger pool of possible donors in presumed consent systems (based on raw statistics). As the introduction of the Dutch organ Donation Act in 1998 did not increase the donation rates in the Netherlands, it was proposed to enact a presumed consent system or a system with automatic donor registration. Although countries with presumed consent systems have higher donation rates than countries with explicit consent systems, we cannot confirm that these higher rates are the result of having a presumed consent system. This thesis demonstrates that the differences in donation rates between presumed consent countries and explicit consent countries are explained by their differences in mortality rates that are relevant for organ donation. When adjusting the donation rates for these differences the potential of presumed consent countries for higher donation rates disappears. We found that in explicit as well as presumed consent systems next of kin play a role in obtaining consent for organ donation. Involving next of kin in the procurement procedure is standard practice in each Western European country. Apparently, the medical staff do not comply with the rule that the absence of a refusal implies consent. As a result, presumed consent and explicit consent systems are more similar than assumed by their distinction (Gevers et al., 2004) and, therefore produce similar results. 8.3.3 The impact of legislation in general Although the Dutch Organ Donation Act did not lead to an increased donor organ supply, enacting legislation on organ donation was considered important to create legal certainty and trust in organ donation procedures (the first objective of the Act). To support the further objective of the Act ‐ increasing the supply of donor organs ‐ additional policy measures were needed. It seems that in this case, legislation alone was not sufficiently effective in increasing the number of donor organs. This observation raises a

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broader question regarding the potential of legislation as an instrument for change. The complex relationship between legislation and change has also been highlighted by others. One of the elements in the complex relationship between legislation and change is time. The first evaluation in 2001 of the Dutch Act on Medical Examinations, three years after its enactment, reported a limited impact. In 2007 the second evaluation reports that the Act is indeed rather effective (Klein Haarhuis & Niemeijer, 2008). Sometimes it takes a considerable length of time for legislation to have impact. One of the reasons may be that it may take time for its target population to become familiar with the Act, and to change their behaviour accordingly (Klein Haarhuis et al., 2008). But time is not the sole factor influencing the relationship between legislation and change. In another example in health care regulation on the position of the patient, it appears that the relationship between a legal provision and its intended impact is somewhat indirect. Friele discusses the position of the patient by focussing on the impact of informed consent (laid down by the Medical Treatment Agreement Act), the freedom of choice (laid down by the Health Insurance Act), and medical complaints (laid down by the Health Care Complaints Act). He concludes that although these Acts are supported by both medical professionals as well as patients, in reality their impact on the position of the patient is (still?) limited (Friele, 2009). It seems that the limited impact of legal instruments on the position of the patient can be explained by the complexity of the legal provisions. Furthermore, in the case of the Medical Treatment Agreement Act it is not easy to enforce compliance with its provisions in practice and the provisions do not always meet the real demands of patients (Friele, 2009). This limited impact of legislation is not only seen within the health care sector. According to an overview of 58 Dutch law evaluations only 11 evaluations concluded that the objectives of the evaluated Act were predominantly met. Six evaluations even concluded that the objectives of the evaluated Act were hardly met. The remaining 41 evaluations concluded that only some of the objectives were met (Klein Haarhuis et al., 2008). The enactment of legislation only will usually not be enough to have an impact, and time and law enforcement are necessary.

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8.3.4 The impact of additional policy measures Although legal systems alone seem to have only limited impact on the supply of donor organs, we did find that additional policy measures do have an impact. One year after the enactment of the Act the efficiency of donor procurement reached its all‐time low (Figure 8.3) and the Dutch government developed a strategy to increase the efficiency of donor procurement by implementing additional policy measures. From 2000 on we see that the efficiency of donor procurement in the Netherlands increased slightly. This increase seems to demonstrate that implementing these measures has paid off (see Figure 8.3). Figure 8.3 Donor procurement in the Netherlands shown by the donor rates adjusted for differences in relevant mortality rates between years (1997‐2008)

1. Introduction of the Act in 1998 2. Plan of Action on organ donation in 2000 3. Capitalisation of donor education on the massive public debate 4. Trendline

0,0

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8,0

10,0

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1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

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8.4 Conclusion Although it is difficult to assess the impact of legislation alone on the supply of donor organs, it seems that this impact is only limited. The enactment of the Dutch consent system, based on explicit consent, did not lead to an increase in the supply of post mortem donor organs. Additional policy measures were needed to realise this increase. However, it is important to acknowledge that the Act forms an important legal basis for the

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implementation of the additional policy measures and determines their scope. The Organ Donation Act provides legal certainty to potential donors, their next of kin, patients waiting for an organ, and medical staff. Public trust in organ donation procedures is still considered to be an important condition for policy measures designed to increase procurement rates. To support the impact of legislation on organ donation and to optimally use the room for improvement of organ procurement, the implementation of additional policy measures is essential. We found that additional policy measures have an impact on the supply of donor organs, or at least support the instrumental function of legislation on organ donation. Since the introduction of the Dutch Organ Donation Act and the implementation of additional policy measures the donor rates (adjusted for differences in relevant mortality rates between years) have increased gradually. Finally, we found no indications that introducing a presumed consent system in the Netherlands would lead to higher donation rates. Changing to another consent system will possibly not increase the organ supply in the Netherlands. 8.5 Strengths and limitations of this study Assessing the impact of the legal system and additional policy measures on the supply of donor organs was challenging, and some difficulties had to be dealt with. A first (methodological) difficulty is that national strategies, such as the implementation of the Dutch Organ Donation Act, cannot be the subject of an experimental design. It is unthinkable to divide a country’s population into an experimental group and a control group. This would cause (legal) inequality; the chance of receiving an organ would be larger for one of the groups. Furthermore, when evaluating the impact of legislation pre‐ and post‐measurements are often missing because the enactment of legislation is often an offshoot of existing governmental policies. A second difficulty is that the effects of legislation are blurred by external factors. These factors may cause differences in organ donation rates between years, regions or hospitals within a country, or between countries. Examples of such factors are the number of potential donors of a hospital or a country, hospital based factors (e.g. size, operating room capacity), or cultural

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differences between countries. Hence, the impact of an Act and additional policy measures is rather diffuse (Klein Haarhuis et al., 2008). A third difficulty is that an Act and its additional policy measures are often intertwined. Several provisions of the Act and the additional policy measures aim to reach the same effect. An Act is part of a legal system. The impact of an Act cannot be seen apart from the impact of other pieces of legislation and its place in the legal system as a whole. Besides, the legal system and additional policy measures evolve over time. Moreover, legislation also needs time to have an effect on society. It takes time before its target population is familiar with the Act and is willing and able to use the Act. Attributing effects to an Act or part of it is difficult and should be done with great caution. To overcome these difficulties we addressed the problem from three different angles, (1) an exploration of the possibilities to adapt the Act, (2) an assessment of the impact of the implementation of the Act and its additional policy measures, (3) an exploration of whether a virtual change of the consent system might lead to an increase in the donor organ supply. In doing so we used different techniques including international comparative research, and assessments of the impact of donor legislation and additional policy measures over time. When comparing donation rates between hospitals, countries, and even years, it is important to adjust for differences in relevant mortality rates. The donor rates in our studies (chapters 3, 4, 5, 6) were therefore adjusted for the confounding effects of relevant mortality. Because legislation needs time to have an effect on society it was also important to include time series in some of our studies (chapters 3 and 4). The strengths and limitations of the separate studies of this thesis have been described in the consecutive chapters. The results of the three different parts are consistent and, therefore, we believe they give a reliable answer to our research question. This thesis focuses on the problematic shortage of donor organs and questions regarding the limited ability of the legislation to solve this shortage. A limitation of this thesis is, therefore, that it focuses strongly on only one of the Act’s objectives, i.e. to increase the supply of donor organs, and more specifically on one of its provisions ‐ its explicit consent system. Accordingly, this thesis does not provide a full discussion of the functioning

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of the Act. We did not assess the aspects of the Act regarding the fair allocation of donor organs, nor issues related to the trade in donor organs. Furthermore, we limited ourselves to post mortem donation, whereas living donation is developing at a very fast rate. Finally, we did not pay attention to the symbolic function of legislation, i.e. the potential of legislation on organ donation to express such values as solidarity with patients in need of organ transplantation (see Box 8.1), or to instigate changes in policy making or social behaviour. Box 8.1 The symbolic function of the Dutch Organ Donation Act: expressing solidarity to patients in need of an organ People waiting for an organ depend on the solidarity of others to start a new life. The current consent system delegates the responsibility for showing solidarity with patients waiting for an organ to each individual. Individuals are responsible for their own consent registration. Where does the Dutch population stand on solidarity with people waiting for an organ? On the one hand, 5.4 million people (approximately 40% of the adults in the Netherlands) are registered in the Donor Register and approximately 3 million people have explicitly registered their consent. With such high registration rates the Netherlands has the world’s largest donor registration. On the other hand, approximately 60% did not register, which may suggest that these persons are not committed to organ donation or find it difficult to make a decision on whether or not to be a donor and to formalise this decision. Still, as anyone could need an organ, the commitment, as suggested by the number of registered consents, seems to be rather low. The results of several survey studies, however, indicate that 90% of the Dutch population supports organ donation (Cox, 2005; Ipso Facto, 2000; Verzijden & Schothorst, 2003; Zijdenbosch & Lutterveld, 1997; Zijdenbosch & Kamphuis, 1998). Hence, these findings give a contradictory answer to the question of where the Dutch population stands on solidarity with organ donation. According to Nys, explicit consent systems are the expression of societies comprising isolated, independent individuals who make informed choices on their own, whereas presumed consent systems express the commitment and solidarity of people with organ donation (Nys, 2004). In presumed consent systems the solidarity of people with organ donation is arranged at community level.

‐ Box 8.1 To be continued ‐

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‐ Box 8.1 Continued ‐ Also the alternative system for consent registration (the automatic consent registration), in which people are automatically registered after several personal reminders, regulates solidarity of people at community level. In this alternative system the current explicit consent registrations are maintained. A change to a system with presumed consent aspects, such as the alternative system for consent registration, could be seen as an expression of the commitment and solidarity of healthy people to those waiting for an organ. As a relatively small group of people in desperate need of a donor organ depends on a large group of people who may seem to be reluctant to register their consent and to express their solidarity, this raises questions on how to organise solidarity in organ donation. Some people will say that because of the weak position of the people waiting for an organ, organ donation should be organised on community level rather than on the individual level. It remains unknown whether changing to another consent system will have a positive effect on public trust in the organ procurement system or will harm that trust and may even backfire on the supply of donor organs. Changing to another consent system demands in‐depth study on its possible effects on this topic, including the symbolic function of legislation. 8.6 Directions for future research The importance of adjusting donation rates for differences in relevant mortality rates Although donor procurement is a complex process influenced by several external factors, the impact of consent systems on donor procurement is often assessed by comparing donation rates between countries or years. Failure to adjust donation rates for important confounding factors may result in false conclusions. We found a strong correlation between donation rates and relevant mortality for organ donation (CVA and (traffic) accidents) when comparing 10 Western European countries. Hence, this thesis addresses the importance of adjusting donation rates for differences in relevant mortality rates when comparing the impact of donor policies between countries or years. It remains unknown whether other differences between countries explain discrepancies in organ donation rates and whether our results are also applicable for countries other than these ten.

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Family refusal as an outcome measure when assessing donor education policy An important factor in the loss of potential donors is family refusal. Several policy measures aim at reducing family refusal. For this reason, the impact of these policy measures should be assessed by their effect not only on registration rates and donor procurement rates, but also on refusal rates. Since 2006 the Dutch Transplant Foundation (NTS) publishes national refusal rates. This enables future research to assess trends in refusal rates and may shed more light on the impact of policy measures. Suggestions for the assessment of the impact of legislation Expectations regarding the impact of legislation are high. Improved insight into how legislation impacts on society may contribute to more realistic expectations of legislation and may lead to better quality of legislation (Veerman, 2004; Winter, 1997). In this thesis on the impact of organ donor legislation we encountered some issues that may be relevant not only for the assessment of legislation on organ donation, but also for studying the impact of health legislation in general. Firstly, when evaluating the impact of legislation it is important to also take account of the impact of additional policy measures. We found that the introduction of the Dutch Organ Donation Act alone did not increase the organ supply. Apparently, the Organ Donation Act on its own could not realise a change in this part of health care. Additional policy measures were needed to create an impact. Other evaluations of health law likewise report the importance of taking additional policy measures into account. Winter, for example, concludes that compliance with the Dutch Psychiatric Hospitals Compulsory Admissions Act three years after its introduction was still limited; its provisions were not clear to professionals (Winter, 1997). Professionals had to be educated about the provisions of the Psychiatric Hospitals Compulsory Admissions Act. The impact of the intensified education on compliance with the Act was assessed by its second and third evaluation (Derde evaluatiecommissievan de Wet Bopz, 2007). Furthermore, the relationship between an Act, its additional policy measures, and their impact is rather complex. The effects of legislation are often rather indirect and are often intertwined with the effects of other policy measures. On top of this, national policies tend to be vague and policy objectives may change over time. This makes it even more difficult for a researcher to assess the

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impact of legislation and policy measures (Kroneman & van der Zee, 1997). When studying the impact of legislation it is important to develop a strategy that addresses this interdependence of laws and policy measures. In this study we assessed the impact of additional policy measures over time. Because the introduction of the Act was followed by a phased introduction of additional policy measures we were able to assess the individual phases. Secondly, the evaluation of laws often demands a multidisciplinary research approach. After all, legislation has an impact on different aspects of society. This multidisciplinary research approach should result in combining the findings of various disciplines and formulating an unambiguous conclusion. The approach taken in this thesis is from the perspective of the underlying problem: the donor organ shortage and the impact of legislation and policy measures on this shortage. Our study has focused on the legal aspects (chapter 2), effects on macro‐level (on the national and international level ‐ chapters 3, 4, and 6), effects on meso‐level (organisations ‐ chapter 5), and effects on micro‐level (individuals ‐ chapter 7). As it turned out, this thesis has resulted in an unambiguous conclusion, due to the different approaches of the separate studies. Thirdly, when assessing empirical effects an outcome indicator, a baseline‐measurement and a control group are essential. In our evaluation of the impact of the Dutch Organ Donation Act we were able to use an outcome indicator: donation rates which were adjusted for differences in mortality rates between years. Besides, measuring organ donation rates was already common practice before the enactment of the Dutch Organ Donation Act and pre‐ and baseline‐measurements were available. For that reason it was possible to assess the impact of the introduction of the Act and of its effects over time. This enabled us to ascertain a decline in donation rates in the initial period following enactment. To enable valid evaluations of health law, such data are vital. They may be found in data already collected routinely, as was the case in this study. But there is no guarantee that such data will always be available. To be able to assess the real impact of legislation, data should therefore be gathered in advance, e.g. by pre‐ and baseline‐measurements. Furthermore, assessing the impact of an Act over time raises questions about the lapse of time between the introduction of the legislation and its first evaluation. It also raises questions about the frequency of law evaluations. As discussed earlier, it may take a

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considerable length of time for legislation to have an effect. When interpreting the findings of evaluations of health law it should be established how much impact is realistic to expect, taking the time factor into account. In addition, controls are always difficult to create when evaluating health law. It is unthinkable that an experimental and a control group could be created within one country. As a second best approach we used other countries, and the impact of their donor policies, as a proxy. This strategy proved to be useful to assess the impact of consent systems on donor procurement. It also demonstrated the importance of taking into account confounding factors leading to differences between countries (e.g. differences in relevant mortality rates (such as CVA and (traffic) accidents)). These issues show that there is a large variety in methodological issues. And there will be more issues when assessing the impact of laws (Winter, 1997); each law evaluation requires its own tailored method. At the same time, a common perspective on how to perform law evaluations is needed to be able to compare findings on the impact of legislation. This requires further development of the methodology. 8.7 Relevance and implications for the policy on organ donation Some 1,300 patients are waiting for an organ in the Netherlands, for the larger part kidney patients (approximately 950) (Nederlandse Transplantatie Stichting, 2009), whereas there are only around 200 post mortem organ donors a year. For the people waiting for an organ the availability of donor organs is of major importance. Receiving a donor organ makes a difference between living as a patient and being dependent on dialysis or living as a relatively healthy person. In this thesis (chapter 2) we have found that there is room, taking into account national and international fundamental legal principles, to change to another consent system. Many consider changing from the current explicit consent system to a presumed consent system, or adjusting the current system to automatic consent registration, to be the best option for increasing the donor organ supply. However, we have also found (chapters 3, 6) that

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there is no empirical evidence that such a change will lead to a substantial increase in organ supply. We conclude that it is not likely that the gap between the number of people who need an organ and the number of post mortal donor organs will be reduced by changing to another consent system. The instrumental effects of legislation alone are limited. Nor did we encounter other policy measures that could easily solve the donor organ shortage. Chapter 7 even indicates that changing to a presumed consent system may cause an increase of family refusals. That changing the policy on post mortem organ donation is not a magic bullet to solve the organ shortage is a disappointing message for those waiting for an organ. Recommendations for policies on organ donation Although the instrumental impact of legislation on the supply of donor organs is limited, we did find that the implementation of additional policy measures has an effect on increasing the organ supply. Putting efforts into additional policy measures is therefore important. Still, even the impact of additional policy measures is at best limited in solving the organ shortage. Furthermore, it is important to keep in mind that some policy measures may only have a one‐off effect and that the effects of policy measures level off over time. We observed a one‐off fluctuation in Dutch (adjusted) donation rates in 2007 which cannot be explained by the implementation of policy measures or changes in the organisational or legal system. This indicates that as yet unknown mechanisms have an impact on donor procurement. Regular evaluation of the impact of policy measures on the supply of organs is important to monitor developments and may yield pointers for making adjustments in order to optimise the impact and eventually increase the organ supply. The findings of this thesis indicate that next of kin play an important role in donor procurement. As about two‐thirds of our respondents would not approve a consent system in which they (as next of kin) are not consulted, it seems important to take the role of next of kin into account when drafting policy measures. In the Netherlands, when a deceased person registered consent in the National Donor Register 10% of next of kin still refused consent for the removal of organs. When no registration of consent or refusal is available as many as 68% of next of kin refuse permission for the removal

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of organs (Friele et al., 2004). Furthermore, we found a strong correlation between the number of consent registrations and donor procurement rates. However, there is no systematic insight into the effectiveness of measures regarding donor education and communication (Friele, Gevers, Blok, Coppen, & Smit, 2006). It is unknown what donor rates and efficiency in donor procurement rates are realistic targets. Finally, we also found that there are differences in the efficiency of donor procurement between larger hospitals. These differences cannot be explained by structural factors (such as the degree of policy implementation or the presence of a donation officer). This suggests that for some hospitals there is still room for improvement. To determine which factors may increase donor procurement in the hospitals it is necessary to conduct a more in‐depth analysis of the differences in donor procurement and policy measures in the larger hospitals. This will also give hospitals the opportunity to exchange best practices on donor procurement. This leads to three recommendations for policy making on organ donation. Firstly, the number of consent registrations should be maximised. More consent registrations will lead to fewer family refusals. Secondly, the role of the family should always be taken into account when new policy measures are being drafted. Moreover, it is important to keep developing policy measures which focus on the role of next of kin and monitor their impact on family‐refusal rates. And thirdly, it is important to monitor which larger hospitals still have room for improving their efficiency in the donor procurement process and to assess how this process can be improved. 8.8 Final remarks We are aware that our findings convey a disappointing message to people waiting for an organ. After all, the shortage remains and the gap between the supply of post mortem donor organs and people waiting for an organ is large. The theoretical maximum post mortem donor potential in the Netherlands is 500‐550 (Ploeg et al., 2003; Friele & Kerssens, 2004; Friele & Jong, 2007). Despite various strategies to maximise the number of post mortem donor organs, there are only some 200 organ donors on a yearly basis, while approximately 1,300 people are waiting for an organ. In both

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Dutch as well as international studies we did not discover strategies, which are not yet implemented in the Netherlands, that show large increases in post mortem organ donation. Therefore, it seems unlikely that this gap can be closed by organ donation post mortem. Improvements to the post mortem organ supply will be modest. In the meantime, the government cannot ignore this problem. Waiting lists may increase and people on these waiting lists may not survive lengthy waiting periods. It is likely that some of those in need of an organ will search for alternative ways to find a donor. Adverse consequences, such as organ‐tourism, may thus arise. It is important for countries to put effort in increasing their supply of donor organs (Caplan, Domínguez‐Gil, Matesanz, & Prior, 2009). An effective (but unthinkable) strategy to increase the number of potential donors and consequently the supply of donor organs would be to become less strict on traffic safety. This is of course not realistic. Another strategy would be to adopt a consent system in which next of kin cannot obstruct the donation of organs, but our findings indicate that such a strategy would also meet with serious objections in the Netherlands. Are there no options at all to increase the supply of donor organs? A large part of the Dutch population has a positive attitude to organ donation, but family refusal rates for organ donation are high. This suggests that improvement and refinement of donor communication and education may increase the supply. Notwithstanding that, the consent procedure takes place under emotional and stressful conditions. We also see some other developments. First of all, the number of living donations has increased over the years. In 2008, the number of kidney transplants from a living donor (411 kidneys) for the first time exceeded the number of kidney transplants from a post mortem donor (352 kidneys) in the Netherlands (Nederlandse Transplantatie Stichting, 2009). Apparently, living donation is considered to be an alternative source for some organs. Secondly, in the long run, the development of artificial organs may provide an alternative source for donor organs. For the immediate future, however, there is no magic bullet to solve the organ shortage problem.

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178

Samenvatting (Summary in Dutch)

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Er is een groot tekort aan donororganen. Per jaar heeft Nederland ongeveer 200‐220 orgaandonoren die na hun dood één of meerdere organen afstaan, terwijl er al jaren tussen de 1300 en 1400 mensen op een wachtlijst staan om een orgaan te ontvangen. Deze grote discrepantie tussen het aantal post mortem donoren en het aantal wachtenden zien we niet alleen in Nederland, maar ook in andere landen waar de mogelijkheid tot transplantatie van een orgaan deel uitmaakt van de reguliere geneeskunde. Om het tekort aan organen tegen te gaan zet de overheid beleid in dat gericht is op het vergroten van het aantal post mortem donoren. Zo is in 1998 de Wet op de Orgaandonatie (WOD) ingevoerd. Deze wet heeft vier doelen: 1) het bieden van rechtszekerheid aan betrokkenen 2) het bevorderen van het aanbod van geschikte organen en weefsels 3) een rechtvaardige verdeling hiervan 4) het voorkomen van handel in organen en weefsels. Doelen 1, 3 en 4 richten zich op de waarborgfunctie van de wet. Het tweede doel richt zich op de instrumentele functie van de wet. De waarborgfunctie van wetgeving verwijst naar de borgende rol van wetgeving in het eerbiedigen van rechten overeenkomstig de verwachtingen van burgers op basis van het geldende recht en de fundamentele beginselen die aan dat recht ten grondslag liggen. Hiermee vormt wetgeving een belangrijke basis voor het vertrouwen van burgers in een overheid. De instrumentele functie van wetgeving verwijst naar de rol van wetgeving als instrument om het aanbod van donororganen te vergroten. De overheid veronderstelde dat het scheppen van vertrouwen van de Nederlandse bevolking in procedures voor orgaandonatie door middel van het invoeren van wetgeving tot meer orgaandonaties zou leiden. Met andere woorden de waarborgfunctie zou moeten bijdragen aan de instrumentele functie van de wet. Een belangrijk instrument van de WOD waarin deze gedachte tot uiting komt is het volledige beslissysteem. Dit beslissysteem is gebaseerd op de principes van een toestemmingssysteem. Andere belangrijke instrumenten van de wet ten behoeve van de doelen zijn het allocatiesysteem, bepalingen voor het orgaandonatieproces in het ziekenhuis en het verbod om in organen te handelen.

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De invoering van de wet en het volledige beslissysteem leverde echter niet direct meer post mortem orgaandonoren op. De overheid zette vervolgens aanvullende beleidsmaatregelen in om de doelstelling van de wet om het aanbod van donororganen te vergroten te ondersteunen. Het uitblijven van een stijging van het aantal post mortem orgaandonoren leidde tot een intensieve discussie over het Nederlandse beslissysteem. Landen met een bezwaarsysteem hebben immers meer post mortem orgaandonoren dan landen met een toestemmingsysteem. Er is daarom regelmatig voorgesteld om van beslissysteem te veranderen en zo het tekort op te lossen. Dit lijkt een logisch voorstel. Het essentiële verschil tussen beide systemen is dat in een bezwaarsysteem alleen mensen, die geen orgaandonor willen zijn, zich kunnen laten registreren. In een toestemmingssysteem kunnen juist mensen, die wel orgaandonor willen zijn, zich laten registreren. Als mensen zich in een toestemmingssysteem niet hebben geregistreerd dan kan via nabestaanden alsnog toestemming voor de donatie van organen worden verkregen. In beide systemen is het aantal mensen dat actie onderneemt en zich registreert relatief klein. Landen met een bezwaarsysteem hebben daarom doorgaans een relatief klein aantal geregistreerden die geen orgaandonor willen zijn. Landen met een toestemmingssysteem hebben doorgaans een relatief klein aantal geregistreerden die wel orgaandonor willen zijn. Met andere woorden, het aantal veronderstelde donoren in een bezwaarsysteem is veel groter dan het aantal geregistreerde donoren in een toestemmingssysteem. Het wijzigen van het beslissysteem is echter een ingrijpende procedure en kan verstrekkende gevolgen hebben. Daarom is het noodzakelijk eerst onderzoek te doen naar mogelijke (onverwachte) effecten en gevolgen. De probleemstelling van dit proefschrift luidt daarom: “Wat is de invloed van wetgeving en aanvullend beleid gericht op orgaandonatie op het aanbod van post mortem donororganen, met name in het licht van de Nederlandse situatie?” Er is geen standaard methode voor het uitvoeren van een onderzoek naar de invloed en effecten van wetgeving en aanvullend beleid. Wel is duidelijk dat

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het een vraagstelling betreft die vanuit verschillende invalshoeken kan worden benaderd; invalshoeken die elkaar kunnen versterken. Om de probleemstelling te kunnen beantwoorden hebben we in dit proefschrift vanuit verschillende invalshoeken onderzoek verricht (hoofdstuk 1). Deze verschillende invalshoeken komen aan de orde in de drie afzonderlijke delen van dit proefschrift. Hierbij worden de volgende deelvragen beantwoord: Deel 1 In hoeverre is het mogelijk om de Wet op de Orgaandonatie aan te passen

met het oog op het vergroten van het orgaanaanbod? Deel 2 Welke impact heeft de implementatie van de Wet op de Orgaandonatie en

de aanvullende beleidsmaatregelen gehad? Deel 3 Zal het wijzigen of aanpassen van het huidige beslissysteem invloed hebben

op het aanbod van donororganen? Deel 1: De mogelijkheden om de Wet op de Orgaandonatie aan te passen ter vergroting van het orgaanaanbod Omdat na het van kracht worden van de WOD het tekort aan organen bleef bestaan werden er verschillende voorstellen gedaan om de WOD aan te passen. Hoofdstuk 2 geeft een beschrijving van de voorstellen die gericht zijn op het verhogen van het aantal post mortem orgaandonoren door aanpassing van de wet. In grote lijnen richtten deze voorstellen zich op 1) het aanpassen van het beslissysteem, 2) het introduceren van niet‐medische criteria voor de allocatie van organen en 3) het introduceren van financiële vergoedingen voor het doneren van organen. Hierbij rijst de vraag in hoeverre de WOD aangepast kan worden, rekening houdend met de fundamentele beginselen zoals de lichamelijk integriteit, het non‐commercialiteitsbeginsel en het beginsel van gelijke toegang tot zorg. Daarom wordt in dit hoofdstuk tevens geanalyseerd of deze voorstellen een mogelijke oplossing kunnen zijn voor het tekort aan donororganen.

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De bevindingen uit dit deel van het proefschrift leiden tot de conclusie dat de ruimte om de Wet op de Orgaandonatie aan te passen, met het oog op het vergroten van het orgaanaanbod, beperkt is. Het introduceren van niet‐medische criteria in het allocatiesysteem, zoals wederkerigheid of de “living donor list exchange”, is mogelijk in strijd met het beginsel dat patiënten gelijke toegang tot zorg moeten hebben. De introductie van financiële vergoedingen voor orgaandonatie is mogelijk in strijd met het beginsel dat, in het licht van de menselijke waardigheid, organen geen handelswaar zijn. De mogelijke inbreuken op deze beginsels kunnen het vertrouwen van de bevolking in het Nederlandse systeem voor donorwerving schaden. Daarnaast ontbreekt het wetenschappelijke bewijs dat deze voorstellen het orgaanaanbod zullen vergroten; het is zelfs mogelijk dat de invoering van de voorstellen tot een boemerang effect leidt waarbij het orgaanaanbod afneemt. Hier staat tegenover dat er wel ruimte is om een wijziging in het beslissysteem aan te brengen. De beginselen van lichamelijke integriteit en gelijke toegang tot zorg staan een dergelijke wijziging niet in de weg. Het aanbrengen van een wijziging in het beslissysteem is echter alleen relevant als het aannemelijk is dat het tot een stijging van het aantal post mortem orgaandonoren zal leiden. Of dit daadwerkelijk het geval is wordt bekeken in de volgende delen van dit proefschrift. Deel 2: De impact van de implementatie van de Wet op de Orgaandonatie en de aanvullende beleidsmaatregelen Het tweede deel van het proefschrift richt zich op de empirische effecten van het beslissysteem en de aanvullende beleidsmaatregelen. In dit deel van het proefschrift wordt de impact hiervan op het orgaanaanbod bestudeerd door 1) de effecten van orgaandonatiebeleid in 10 West‐Europese landen te vergelijken, 2) het effect van het voorlichtingsbeleid in Nederland in kaart te brengen en 3) de effectiviteit van beleidsmaatregelen in ziekenhuizen te bekijken.

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De effectiviteit van orgaandonatiebeleid in 10 West‐Europese landen In hoofdstuk 3 worden 10 West‐Europese landen vergeleken op de effectiviteit van hun orgaandonatiebeleid tussen 1995‐2005. Uit deze vergelijking komt naar voren dat deze landen over een periode van tien jaar efficiënter zijn geworden in het werven van post mortem orgaandonoren. Bij de vergelijking tussen landen hebben we rekening gehouden met de verschillen in mortaliteitscijfers tussen landen, die relevant zijn voor orgaandonatie (zoals de sterftecijfers voor CVA en (verkeers‐)ongevallen van mensen jonger dan 65 jaar). Dat de efficiency in het werven van donoren is toegenomen betekent dat de inspanningen van het orgaandonatiebeleid zijn vruchten heeft afgeworpen. Maar er zijn ook grote verschillen tussen landen in de efficiency waarmee ze post mortem donoren werven. Het ene land is efficiënter dan het andere land. De impact van de inspanningen op het terrein van het verhogen van het aantal post mortem orgaandonoren wordt deels teniet gedaan door het succes van andere beleidsmaatregelen. Door bijvoorbeeld het verkeersveiligheidsbeleid dat zich richt op het verminderen van verkeersdoden zijn er minder overledenen geschikt als orgaandonor. De resultaten uit hoofdstuk 3 wijzen erop dat de stijging van de efficiency in het werven van donoren niet gerelateerd is aan het hebben van een beslissysteem. We hebben geen consistente verschillen tussen landen gevonden die zijn toe te wijzen aan verschillen in beslissysteem. Voor dit onderzoek zijn de landen die een nieuw beslissysteem hebben ingevoerd of hun bestaande beslissysteem hebben gewijzigd nader bestudeerd. Deze landen zijn Duitsland (invoering van een wettelijk toestemmingssysteem in 1997), Nederland (invoering van een wettelijk toestemmingssysteem in 1998), Zweden (wijziging van wettelijk toestemmingssysteem in een bezwaarsysteem in 1996) en Italië (wijziging van wettelijk toestemmingssysteem in een bezwaarsysteem in 1999). De wijzigingen die in deze landen hebben plaatsgevonden laten geen duidelijk effect zien op de donorwerving. In landen waar na de invoering of wijziging van het beslissysteem een stijging in de efficiency van donorwerving is te zien (Duitsland en Italië), was in de jaren voor de invoering of wijziging ook al een stijging van de efficiency van donorwerving te zien. In Zweden is vlak na de overgang naar een bezwaarsysteem een stijging te zien. In Nederland

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is vlak na de introductie van het beslissysteem een daling te zien. Maar in beide landen was dit slechts een tijdelijke stijging, respectievelijk daling. Voor veel landen is de beleidsstrategie om tot een groter orgaanaanbod te komen niet helder beschreven. Het is lastig om inzicht te krijgen in de strategie die overheden in een bepaalde tijdsperiode hebben ingezet. We konden de stijgende efficiency van de donorwerving daarom niet verklaren aan de hand van de verschillende nationale beleidsstrategieën. Om deze zwarte doos voor Nederland inzichtelijk te maken hebben we getracht om de Nederlandse strategie vanaf de introductie van de WOD te ontrafelen. Hierbij hebben we ons gericht op het beleid om Nederlandse burgers voor te lichten over orgaandonatie (hoofdstuk 4) en op het beleid in ziekenhuizen om de efficiency van het donatieproces te vergroten (hoofdstuk 5). De effectiviteit van het Nederlandse voorlichtingsbeleid Rond de introductie van de WOD in 1998 werden tevens voorlichtingscampagnes ingezet om mensen te informeren over orgaandonatie en donorregistratie (hoofdstuk 4). Deze campagnes hadden een neutrale boodschap; ze waren gericht op het informeren van mensen over de mogelijkheid om donor te worden. Er was weinig samenhang tussen de campagnes. Als reactie op het dieptepunt van het aantal post mortem orgaandonoren in 1999 ontwikkelde de overheid een plan van aanpak meer gericht op het werven van donoren. In dat plan van aanpak stelde de regering een samenhangend en uitgebreid voorlichtingsbeleid voor, met een focus op een vergroting van het aantal positieve donorregistraties. In 2004 ontstond er een uitgebreide publieke discussie over het orgaantekort en het Nederlandse beslissysteem. In aansluiting op dit debat voerde de overheid een geïntensiveerd voorlichtingsbeleid uit, waarbij onder andere via verschillende kanalen registratieformulieren werden verspreid. Hoofdstuk 4 laat zien dat de verandering in strategie van donorvoorlichting tot een stijging van het aantal registraties, voor een groot deel positieve registraties, heeft geleid. We vonden vervolgens een positieve correlatie tussen het aantal geregistreerde toestemmingen en de donorwerving. Dit geeft aan dat, wanneer een land een toestemmingssysteem heeft (zoals het Nederlandse systeem), het van belang is om het aantal geregistreerde toestemmingen te bevorderen.

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De donatiecijfers, gecorrigeerd voor verschillen in relevante mortaliteit tussen jaren, laten ook een onverwachte piek in 2007 zien. Deze piek kunnen we niet verklaren aan de hand van de implementatie van beleidsmaatregelen of wijzigingen in de organisatorische structuur of het juridische systeem voor orgaandonatie. Bij de interpretatie van donatiecijfers is het daarom van belang om er rekening mee te houden dat ze van jaar tot jaar kunnen fluctueren. Ondanks dat de inspanningen op het gebied van donorvoorlichting vruchten lijken af te werpen, lijken deze inspanningen in de loop van de tijd geleidelijk aan minder effect te hebben. Het is onbekend hoeveel ruimte er nog is om het aantal donaties en registraties te verhogen. Het is daarmee ook onzeker wat er van toekomstige beleidsmaatregelen verwacht mag worden. De effectiviteit van beleidsmaatregelen in ziekenhuizen In hoofdstuk 5 worden 80 ziekenhuizen met elkaar vergeleken. Uit deze vergelijking komt naar voren dat het aantal donaties tussen ziekenhuizen varieert. Het grootste deel van deze variatie wordt verklaard door de verschillen in de voor orgaandonatie relevante mortaliteit tussen ziekenhuizen. 81% van alle orgaandonaties vond plaats in een kwart van de ziekenhuizen. Dit waren met name de grotere ziekenhuizen. Deze sterke correlatie tussen de relevante mortaliteit en donatiecijfers toont aan dat ziekenhuizen met veel potentiële donoren dit potentieel ook gebruiken. Er zijn echter wel enkele grotere ziekenhuizen die relatief minder donoren hebben dan andere grote ziekenhuizen. Dit suggereert dat in deze ziekenhuizen het aantal post mortem orgaandonoren nog kan worden vergroot. De hogere donatiecijfers van sommige ziekenhuizen worden niet verklaard door de aanwezigheid van een donatiefunctionaris of de implementatie van het donatiebeleid. Ziekenhuizen met een afdeling neurochirurgie hadden meer donoren dan ziekenhuizen zonder een dergelijke afdeling. Om inzicht te krijgen in hoe ziekenhuizen met minder donoren hun donatiecijfers kunnen verbeteren is een nadere analyse nodig. Samenvattend, een jaar na de introductie van de WOD bereikte de werving van orgaandonoren een dieptepunt. Het introduceren van alleen wetgeving bleek onvoldoende om het tekort aan orgaandonoren op te lossen. Daarom werd er aanvullend beleid ingevoerd. Over het algemeen zorgde dit

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aanvullende beleid voor een stijging van het aantal post mortem orgaandonoren. De studies uit dit deel van het proefschrift tonen aan dat we van verbeteringen in donorwerving slechts een beperkte toename in het aantal orgaandonoren mogen verwachten. Niettemin is elke orgaandonor belangrijk voor het verkorten van de wachtlijst voor organen. Deel 3: De verwachte invloed van het wijzigen of aanpassen van het huidige beslissysteem op het aanbod van donororganen Uit de conclusie van het eerste deel van dit proefschrift komt naar voren dat het, rekening houdend met fundamentele beginselen, mogelijk is om een ander beslissysteem in Nederland in te voeren. In dit laatste gedeelte van het proefschrift worden de effecten in beeld gebracht die van een dergelijke wijziging verwacht kunnen worden. De effectiviteit van beslissystemen in 10 West‐Europese landen Landen met een bezwaarsysteem hebben meer orgaandonoren dan landen met een toestemmingssysteem. Dit verschil in aantal orgaandonoren tussen landen wordt vaak verklaard door het verschil in het beslissysteem. Landen met een bezwaarsysteem hebben immers een grotere pool met veronderstelde donoren, terwijl landen met een toestemmingssysteem een veel kleinere pool met expliciete donoren hebben. In hoofdstuk 6 wordt de invloed van beslissystemen van tien West‐Europese landen op het aantal post mortem orgaandonoren bestudeerd. Hierbij zijn de donatiecijfers gecorrigeerd voor verschillen in relevante mortaliteitscijfers tussen landen, zoals de sterftecijfers voor CVA en (verkeers)ongevallen voor personen jonger dan 65 jaar. Deze relevante mortaliteitscijfers vormen namelijk het uitgangspunt voor het aantal potentiële orgaandonoren van een land. Verder komt uit deze analyses naar voren dat de verschillen in deze mortaliteitscijfers tussen landen voor een groot deel de verschillen in het aantal orgaandonoren tussen landen verklaart. Na deze correctie vallen de verschillen tussen landen met een bezwaarsysteem en landen met een toestemmingssysteem weg. De

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aanwezigheid van een bezwaarsysteem in een land leidt dus niet automatisch tot een groter aantal post mortem orgaandonoren. De mogelijke invloed van beslissystemen op de toestemming door nabestaanden Maar hoe kan het dan dat het ogenschijnlijk grote verschil tussen beslissystemen geen effect heeft op het aantal orgaandonoren? Hoofdstuk 7 gaat daar verder op in. Formeel gezien worden nabestaanden alleen bij de toestemmingsprocedure betrokken wanneer er in een toestemmingssysteem een toestemming van de potentiële donor ontbreekt. In een bezwaarsysteem spelen nabestaanden formeel gezien helemaal geen rol tijdens de toestemmingsprocedure. In de praktijk worden nabestaanden echter altijd betrokken tijdens deze procedure, in alle landen (Gevers et al., 2004; Friele et al., 2004). Hiermee wordt het theoretische voordeel van een bezwaarsysteem, veel veronderstelde donoren waarvoor formeel geen toestemming hoeft te worden gevraagd, beperkt. In hoofdstuk 7 is aan mensen gevraagd of zij, in hun rol als nabestaande, onder verschillende wettelijke condities toestemming zouden verlenen voor orgaandonatie van een overleden. De respondenten geven aan dat ze eerder geneigd zijn om toestemming te verlenen wanneer de overledene zich in een toestemmingssysteem expliciet als donor heeft laten registeren, dan wanneer de overledene zich in een bezwaarsysteem niet heeft laten registeren (en dus verondersteld donor is). In een bezwaarsysteem is de pool van veronderstelde donoren groot. In een toestemmingssysteem is de pool met geregistreerde donoren een stuk kleiner. Maar de kans dat nabestaanden van een geregistreerde donor toestemming geven is groter dan bij veronderstelde donoren. Dit verklaart wellicht waarom een bezwaarsysteem niet automatisch tot meer post mortem orgaandonoren leidt dan een toestemmingssysteem. Uit hoofdstuk 7 komt tevens naar voren dat de respondenten uit het onderzoek tegen een systeem zijn waarbij nabestaanden geen inbreng hebben. Conclusie Het is lastig om de impact, die wetgeving heeft op het aanbod van donororganen, vast te stellen. Desondanks komt uit de bevindingen van dit proefschrift naar voren dat die impact waarschijnlijk beperkt is. Het van

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kracht worden van het wettelijke Nederlandse beslissysteem leidde aanvankelijk niet tot een stijging van het aantal post mortem orgaandonoren. Uiteindelijk waren er aanvullende beleidsmaatregelen nodig om deze stijging te realiseren. De wet vormt wel een belangrijke juridische basis voor de implementatie voor deze beleidsmaatregelen en hun reikwijdte. De WOD zorgt voor rechtszekerheid bij de potentiële donoren, hun nabestaanden, patiënten op een wachtlijst en de medische staf. Het publieke vertrouwen wordt nog steeds gezien als een belangrijk uitgangspunt voor beleidsmaatregelen om de donorwerving te verbeteren. Om de impact van de WOD te ondersteunen en om de ruimte voor verbetering van de donorwerving te benutten is de implementatie van aanvullend beleid essentieel. Uit dit proefschrift komt naar voren dat de aanvullende beleidsmaatregelen invloed hebben gehad op het aanbod van donororganen en daarmee de instrumentele functie van de wet ondersteunt. Sinds de introductie van de WOD en de aanvullende beleidsmaatregelen is de efficiency van het werven van orgaandonoren verbeterd. Tenslotte hebben we niet vast kunnen stellen dat de introductie van een bezwaarsysteem in Nederland tot meer donororganen zal leiden. Het wijzigen van het beslissysteem zal waarschijnlijk geen aanzienlijke stijging van het aantal post mortem orgaandonoren in Nederland tot gevolg hebben. Overwegingen voor toekomstig onderzoek Dit proefschrift levert twee concrete overwegingen op voor onderzoek naar wetgeving en beleid dat zich richt op orgaandonatie. Daarnaast levert dit proefschrift meer algemene overwegingen voor het vaststellen van de effectiviteit van wetgeving op. De correctie van donatiecijfers voor verschillen in mortaliteit De invloed van beslissystemen op donorwerving wordt vaak vastgesteld aan de hand van de vergelijking van donatiecijfers tussen landen of tussen jaren. Orgaandonatie is echter een complex proces waarop verschillende externe factoren van invloed zijn. Dit proefschrift toont aan dat er een sterke relatie is tussen de donatiecijfers en het uitgangspunt voor orgaandonatie: de voor donatie relevante mortaliteit (CVA en (verkeers)ongevallen).

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Wanneer donatiecijfers tussen landen of jaren met elkaar worden vergeleken is het daarom belangrijk om te corrigeren voor verschillen in relevante mortaliteit. Dit proefschrift geeft geen inzicht in andere verschillen tussen landen die mogelijke verschillen in donatiecijfers verklaren. Daarnaast is niet bekend of de resultaten uit dit proefschrift ook van toepassing zijn op landen die niet in de analyses van dit proefschrift zijn meegenomen. Nabestaandenweigering als uitkomstmaat voor de evaluatie van voorlichtings‐activiteiten De weigering van nabestaanden tijdens de toestemmingsprocedure is een belangrijke oorzaak voor het verlies van potentiële orgaandonoren. Verschillende beleidsmaatregelen richten zich daarom op het reduceren van deze nabestaandenweigeringen. Om de effectiviteit van die beleidsmaatregelen vast te stellen zouden niet alleen de effecten op donatiecijfers in de tijd moeten worden bestudeerd, maar ook de effecten op de weigeringspercentages door nabestaanden in de tijd. Sinds 2006 publiceert de Nederlandse Transplantatiestichting deze weigeringspercentages. Dit maakt het mogelijk om in de toekomst onderzoek te doen naar trends in weigeringspercentages. Algemene overwegingen voor het vaststellen van de effectiviteit van wetgeving De verwachtingen van de effectiviteit van wetgeving zijn hoog. Inzicht in hoe wetgeving invloed heeft op maatschappelijke processen leidt mogelijk tot realistische verwachtingen en de verbetering van de kwaliteit van wetgeving. Dit proefschrift levert mogelijk niet alleen relevante punten voor onderzoek naar de effectiviteit van donatiewetgeving op, maar ook voor onderzoek naar de effectiviteit van wetgeving in het algemeen. Ten eerste is het belangrijk om bij onderzoek naar de effectiviteit van wetgeving ook de effectiviteit van aanvullende beleidsmaatregelen in beschouwing te nemen. Uit dit proefschrift komt naar voren dat het van kracht worden van de WOD alleen niet tot een vergroting van een aanbod van donororganen leidde. Aanvullend beleid bleek nodig. Dat aanvullend beleid belangrijk is om de effectiviteit van wetgeving te ondersteunen en te vergroten is ook uit onderzoek naar andere wetten in de gezondheidszorg

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gebleken. Daarnaast is de relatie tussen wetgeving en aanvullende beleidsmaatregelen complex. Effecten van wetgeving zijn vaak niet direct zichtbaar, effecten van wetgeving en aanvullende beleidsmaatregelen zijn vaak verstrengeld en de doelen van beleid veranderen in de tijd. Bij onderzoek naar de effecten van wetgeving is het noodzakelijk om een strategie bedenken die aandacht besteedt aan de verstrengeling van wetgeving en aanvullende beleidsmaatregelen. Dit proefschrift geeft inzicht in de gefaseerde invoering van aanvullende beleidsmaatregelen. Door een analyse van de effecten van de aanvullende beleidsmaatregelen in de tijd konden we de effectiviteit van de verschillende fasen van de invoering van het aanvullende beleid achterhalen. Ten tweede is voor de evaluatie van wetgeving vaak een multidisciplinaire aanpak nodig. Wetgeving heeft immers invloed op verschillende aspecten van de samenleving. Bij een multidisciplinaire aanpak moeten de resultaten van de verschillende disciplines uiteindelijk samenkomen en leiden tot een eenduidige conclusie. De aanpak voor dit proefschrift is vanuit het probleem, namelijk het tekort aan donororganen en de invloed van wetgeving en aanvullend beleid daarop, beredeneerd. Het proefschrift richt zich op de juridische aspecten (hoofdstuk 2), de effecten op macroniveau (hoofdstukken 3, 4, 6), effecten op mesoniveau (hoofdstuk 5) en microniveau (hoofdstuk 7). Uiteindelijk leidt dit proefschrift, door de verschillende invalshoeken van de studies, tot een eenduidige conclusie. En ten derde is het voor het vaststellen van de empirische effecten van wetgeving essentieel om te beschikken over een uitkomstindicator, een nulmeting en een controlegroep. Voor het vaststellen van de effectiviteit van de WOD beschikten we over een uitkomstindicator: de donatiecijfers gecorrigeerd voor verschillen in relevante mortaliteit tussen jaren. Deze cijfers werden al voor het van kracht worden van de WOD gemeten en daarmee beschikten we over een nulmeting en vervolgmetingen; we konden de effecten van de WOD en het aanvullend beleid in de tijd zichtbaar maken. Voor onderzoek naar de effectiviteit van wetgeving in het algemeen is dit soort data essentieel. Het probleem is echter dat dit soort data niet altijd voor handen is. Daarom is het belangrijk om al voor de invoering van een wet na te gaan hoe de effecten van de wet zichtbaar kunnen worden gemaakt. Er kan dan, indien nodig, alvast gestart worden met de dataverzameling. Daarnaast rijst bij het analyseren van de effecten van een

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wet in de tijd de vraag hoeveel tijd er zou moeten zitten tussen de introductie van de wet en de eerste evaluatie. En hoe vaak moeten evaluaties worden uitgevoerd? Bij de interpretatie van onderzoek naar de effectiviteit van wetgeving is het belangrijk om een realistisch beeld te hebben van wat er van die effectiviteit verwacht mag worden gegeven de tijd dat de wet van kracht is. Het kost immers tijd voordat wetgeving effect heeft. Tenslotte is het bij onderzoek naar de effectiviteit van wetgeving in een land niet mogelijk om met controlegroepen te werken. Als alternatief hebben we in dit proefschrift gebruik gemaakt van informatie uit andere landen. Dit bleek een bruikbare strategie. Deze strategie toonde ook aan dat het belangrijk is om andere factoren die ook van invloed zijn op de uitkomstindicator, zoals structurele verschillen in relevante mortaliteit tussen landen, mee te nemen. Kortom, er zijn verschillende methodologische problemen bij onderzoek naar de effectiviteit van wetgeving. Naast de problemen die we in dit proefschrift tegenkwamen, zijn er nog vele anderen; elke evaluatie van wetgeving vraagt daarom om een op maat gemaakte aanpak. Tegelijkertijd is een algemene visie op het doen van wetsevaluaties belangrijk om vergelijkingen tussen de effectiviteit van wetten mogelijk te maken. Daarom is verdere ontwikkeling van de methodologie van wetsevaluatie nodig. Relevantie en implicaties voor het beleid Uit dit proefschrift komt naar voren dat de invloed van wetgeving op het aantal orgaandonoren beperkt is. Ondanks dat die invloed beperkt is kwam ook naar voren dat de implementatie van aanvullende beleidsmaatregelen een positieve invloed had op het aantal post mortem orgaandonoren. Dit geeft het belang van de aanvullende beleidsmaatregelen aan. Tegelijkertijd moeten we ons ervan bewust zijn dat ook de invloed van het aanvullende beleid beperkt is. Daarnaast moeten we ons ervan bewust zijn dat de effecten van aanvullende beleidsmaatregelen eenmalig kunnen zijn en dat de effectiviteit van aanvullende beleidsmaatregelen in de loop van de tijd is afgenomen. In 2007 zagen we eenmalig fluctuatie in het aanbod van post mortem orgaandonoren. Deze fluctuatie kunnen we niet verklaren. Blijkbaar zijn er

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nog onbekende factoren die het aantal post mortem orgaandonoren beïnvloeden. Om inzicht te krijgen in de effecten van beleidsmaatregelen is het daarom noodzakelijk om niet alleen naar de effecten in één bepaald jaar te kijken, maar naar de effecten over meerdere jaren. Uit dit proefschrift komt ook naar voren dat nabestaanden een belangrijke rol vervullen tijdens de toestemmingsprocedure. Tweederde van de respondenten (hoofdstuk 7) keuren een systeem waarin ze geen rol spelen af. Dit geeft het belang aan om bij het ontwikkelen van aanvullende beleidsmaatregelen aandacht aan nabestaanden te besteden. Registratie van de overledene kan nabestaanden ondersteunen in het verlenen van toestemming. Tenslotte hebben we ook gezien dat er verschillen in de efficiency van donorwerving tussen, met name grote, ziekenhuizen zijn. Dit suggereert dat er voor sommige ziekenhuizen nog ruimte voor verbetering is. De verschillen konden echter niet worden verklaard door structurele factoren (zoals de mate van invoering van een donorprotocol of het hebben van een donatiefunctionaris). Om inzicht te krijgen in waar die ruimte zit is een diepteanalyse nodig. Dit alles leidt tot drie aanbevelingen voor het ontwikkelen van beleid voor orgaandonatie: 1 Het is belangrijk om het aantal positieve registraties te vergroten; meer

positieve registraties leidt tot minder nabestaandenweigeringen; 2 Het is belangrijk om de rol van de nabestaanden mee te nemen tijdens

het ontwikkelen van beleid; 3 In grote ziekenhuizen zou moeten worden gemonitored waar en hoe

verbetering van het orgaandonatieproces mogelijk is. Tot slot De bevindingen uit dit proefschrift bevatten een teleurstellende boodschap voor mensen die op een orgaan wachten. Er blijft een tekort aan organen en de kloof tussen het aanbod van donororganen en de vraag naar donororganen is groot. Het aantal mensen dat jaarlijks overlijdt en medisch

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geschikt is als orgaandonor (het aantal potentiële donoren) ligt rond de 500‐550. Ondanks verschillende strategieën om het onderste uit de kan te halen zijn er jaarlijks niet meer dan 200‐220 orgaandonoren terwijl het aantal wachtenden al jaren rond de 1300 ligt. Zowel in Nederlandse als in internationale onderzoeken hebben we geen strategieën, die nog niet in Nederland zijn toegepast, ontdekt die een grote stijging in het aantal post mortem orgaandonoren laten zien. Het is daarom niet waarschijnlijk dat deze kloof door post mortem donatie kan worden gedicht. Verbeteringen in het aanbod van donororganen zullen slechts bescheiden zijn. Tegelijkertijd kan de overheid dit probleem niet zomaar terzijde schuiven. Wachtlijsten nemen mogelijk toe en de patiënten op deze wachtlijsten overleven de lange wachttijden voor een donororgaan mogelijk niet. Het is daarom aannemelijk dat de patiënten die een donororgaan nodig hebben naar alternatieven gaan zoeken om aan een donor te komen. Hiermee ontstaat er mogelijk het gevaar van ongewenste effecten zoals orgaanhandel. Het is daarom belangrijk dat landen zich inspannen om het aanbod van donororganen te optimaliseren. Een effectieve, maar ondenkbare strategie om het aantal potentiële donoren te doen toenemen, en daarmee het aantal donororganen, is om het verkeersveiligheidsbeleid te versoepelen. Een andere strategie zou zijn om een beslissysteem in te voeren waarin nabestaanden geen inbreng hebben met betrekking tot de toestemming voor orgaandonatie. Onze bevindingen wijzen er echter op dat een dergelijke strategie in Nederland op ernstige bezwaren zal stuiten. Zijn er dan geen mogelijkheden om het aanbod te vergroten? Een overgrote meerderheid van de bevolking staat positief tegenover orgaandonatie, maar tegelijkertijd is het weigeringspercentage van de nabestaanden voor donatie hoog. Hieruit valt af te leiden dat verbetering en verfijning van donorvoorlichting en verbeterde communicatie in het ziekenhuis mogelijk positieve effecten zal hebben. Een kanttekening hierbij is wel dat de toestemmingsprocedure voor orgaandonatie plaatsvindt onder stressvolle en emotionele omstandigheden. Er is nog weinig onderzoek verricht naar de communicatie tijdens de toestemmingsprocedure. Daarnaast zien we ook andere ontwikkelingen. Ten eerste is het aantal donaties bij leven in de afgelopen jaren sterk toegenomen. In 2008 was het

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aantal donaties van een nier bij leven (411) voor het eerst groter dan het aantal donaties van een nier (352) na overlijden. Blijkbaar wordt donatie bij leven als een alternatieve bron voor donororganen steeds reëler. Ten tweede zal op de lange termijn de ontwikkeling van kunstmatige organen mogelijk een alternatieve bron voor donororganen opleveren. Voor de nabije toekomst moeten we ons realiseren dat er geen magische oplossing is om het tekort aan donororganen op te lossen.

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Tijdens mijn studietijd ontstond de wens om mijn opgedane kennis over het juridische domein en het domein van de gezondheidszorg in het werk te combineren. Die uitdaging heb ik bij mijn werkzaamheden bij het NIVEL gekregen en heeft uiteindelijk onder andere tot dit proefschrift geleid. Bij de totstandkoming van dit proefschrift heb ik de hulp en steun gehad van velen. Enkelen van hen wil ik door middel van dit dankwoord extra aandacht geven. Allereerst wil ik mijn promotoren, prof. dr. ir. Friele, prof. dr. van der Zee en prof. mr. dr. Gevers bedanken. Roland, ik prijs mezelf erg gelukkig met de vele ervaringen die ik dankzij jou heb mogen opdoen en de mogelijkheden en begeleiding die je me hebt geboden om dit proefschrift te kunnen schrijven. De onderzoeken die we samen uitvoeren zijn voor mij avonturen met uitdagingen en naderhand een voldaan gevoel. Iedere ochtend stap ik weer met veel plezier op mijn fiets naar mijn werk. Daar ben ik je erg dankbaar voor. Jouke, jij vormt een rode draad door mijn ontwikkeling als onderzoeker. Je vervulde een belangrijke rol bij mijn afstudeeronderzoek voor gezondheidswetenschappen en bood me de mogelijkheid om naast mijn werkzaamheden bij het NIVEL mijn rechtenstudie af te maken. Bij de totstandkoming van dit proefschrift heb je, naast kritische vragen over inhoud van het proefschrift, altijd goed het nog af te leggen traject in de gaten gehouden en er voor gewaakt dat er voortgang bleef. Veel dank daarvoor. Sjef, ik ben er erg dankbaar voor jouw kritische opmerkingen vanuit de juridische invalshoek en dat je elke keer naar Utrecht afreisde voor onze besprekingen. Door jouw betrokkenheid bij dit proefschrift is het mogelijk geweest om de effecten van de WOD zowel in empirisch als juridisch perspectief te bezien. Daarnaast dank ik de leden van de leescommissie voor hun deskundig oordeel: prof.dr. R. Bal, prof.dr. H. Garretsen, prof.dr. H. Nys en dr. H. Winter. Bij mij eerste onderzoek naar beslissystemen voor orgaandonatie heb ik veel geleerd van iemand die al veel ervaring had in het onderzoek en de wereld van orgaandonatie. Beste Richard, dank voor je kritische opmerkingen bij de

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verschillende hoofdstukken uit dit proefschrift en de fijne gesprekken die we hadden over het werk en al het andere dat ons bezighield. Drs. B. Elbertse en mw. B. Neades, PhD wil ik graag bedanken voor hun commentaar op een conceptversie van hoofdstuk 4. Bienke, Daan, Janneke, Joost, Lieke, Marjan, Sanne en Wilco, bedankt voor de laatste controle van de hoofdstukken. Veel van mijn NIVEL collega’s zorgen dagelijks voor een dosis inspiratie en plezier in het doen van onderzoek. Mijn kamergenoten (van het verleden en het heden) hebben mij veel steun gegeven tijdens mijn werkzaamheden. Cindy, Marieke, Wendy, Judith, Perdita, Janneke, Judith, Susanne, Aafke en Lieke, dank voor de goede sfeer die jullie tijdens het werk creëer(d)en. Daarnaast wil ik graag Raymond bedanken voor de ontspannen wandelingen in de pauzes van de afgelopen jaren. Aan de goede sfeer hebben jullie, Sanne en Willemijn, ook in belangrijke mate bijgedragen. Het is me een genoegen om samen met jullie onderzoek te mogen doen. Ook Herma en Doortje dragen steevast bij aan een plezierige werkomgeving door hun ondersteuning tijdens het doen van onderzoek. Daarbij wil ik Herma in het bijzonder bedanken voor haar geweldige hulp bij het drukklaar maken van dit boek. Richard en Louis, dankzij jullie ziet ook de voorkant er erg mooi uit. Bas, broer, dat we bijna dagelijks in de sportschool stonden toen ik weer even in Rotterdam woonde vond ik erg fijn. Die dagelijkse gesprekken met jou, terwijl er een gewicht boven ons hoofd hing, mis ik nu wel. Michel, na het volgen van een gezamenlijke cursus, waarin we tevens onze interesse in verschillende muziekinstrumenten bespraken, besloten we om elkaar op weg te helpen met het schrijven van onze proefschriften. Dat gaf erg veel steun. Ik ben er trots op dat jullie mijn paranimfen zijn. Naast de steun van de mensen van het NIVEL mag ik mij ook gelukkig prijzen met de steun van vele vrienden en familie. Bedankt dat jullie telkens weer geïnteresseerd vroegen hoe het met de vorderingen van het proefschrift stond en dat ik telkens weer mocht vertellen over wat me

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bezighield. In het bijzonder wil ik mijn ouders bedanken. Jullie lieten me al vroeg in het leven zien dat de gezondheidszorg een interessant vakgebied is waar ik graag mijn energie in wilde steken. Lieve Bienke, door jou stap ik iedere avond ook weer met veel plezier op de fiets op weg naar huis. Niet alleen omdat je me thuis de mogelijkheid gaf om vrolijk door te gaan met mijn proefschrift en zelf van die mogelijkheid gebruik maakte om hetzelfde te doen. Maar juist ook vanwege al die andere leuke dingen waar we samen zo van kunnen genieten!

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Curriculum Vitae

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Curriculum Vitae

Remco Coppen was born on December 20, 1976, in Rotterdam, the Netherlands. He graduated from secondary school at the Marnix Gymnasium in 1995 in Rotterdam. He studied Health Sciences and Law at the University of Maastricht. During his studies Remco worked as a student assistant at the Faculty of Health Sciences and the Faculty of Law. Since he obtained his master’s degree in Health Sciences (2002), he has been working as a researcher at the Netherlands Institute for Health Services Research (NIVEL). In 2005 he obtained his master’s degree in Law as well. His research addresses various topics concerning evaluations of health law & policy and quality management in health care. Besides his work as a researcher he was secretary of the NIVEL works council (2005‐2009). Since 2010 he is secretary of the NIVEL quality council. Currently he is involved in the evaluation of the layered supervision of the Dutch Healthcare Inspectorate and in a research on bottlenecks in organ donation procedures in hospitals.

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Curriculum Vitae

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List of publications

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Articles Coppen, R., Friele, R.D., Gevers, J.K.M., Zee, J. van der, Donor education

campaigns since the introduction of the Dutch Organ Donation Act: increased cohesion between campaigns has paid off, Transplant International (accepted for publication).

Coppen, R., Friele, R.D., Zee, J. van der, Gevers, J.K.M., The potential of

legislation on organ donation to increase the supply of donor organs, Health Policy (accepted for publication).

Coppen, R., Friele, R.D., Gevers, J.K.M., Zee, J. van der, Imagining the

Impact of Different Consent Systems on Organ Donation: The Decisions of Next of Kin, Death Studies (accepted for publication).

Coppen R., Friele R.D., Gevers J.K.M., Blok G.A., Zee J. van der, The impact

of donor policies in Europe: a steady increase, but not everywhere. BMC Health Services Research 2008; 8(235):lit.

Friele R.D., Coppen R., Marquet R.L., Gevers J.K.M., Explaining differences

between hospitals in number of organ donors. American Journal of Transplantation 2006; 6(3):239‐243.

Coppen R., Friele R.D., Marquet R.L., Gevers J.K.M., Opting‐out systems no

guarantee for higher donation rates. Transplant International 2005; 18(11):1275‐1279.

Friele R., Coppen R., Marquet R., Nederland is goed in donorpreventie. Medisch Contact 2003; 58(46):1760.

Books, bookchapters, and reports Coppen R., Jong J.D. de, Friele R.D., De WMG en de versterking van de

positie van de consument door keuze‐informatie. In: R.D. Friele (Red.). Evaluatie Wet Marktordening Gezondheidszorg. Den Haag: ZonMW, 2009.

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Ven W.P.M.M. van de, Schut F.T., Hermans H.E.G.M., Jong J.D. de, Maat M.

van der, Coppen R. et al., Evaluatie Zorgverzekeringswet en Wet op de Zorgtoeslag. Den Haag: ZonMw, 2009.

Kruikemeier S., Coppen R., Rademakers J., Friele R.D., Ervaringen van mensen met klachten over de gezondheidszorg. Utrecht: NIVEL, 2009.

Wagner C., Coppen R., Poortvliet M.C., Quality and safety management in hospitals (QSMH): survey manual of the QSMH. Utrecht: NIVEL, 2008.

Friele R.D., Dute J.C.J., Coppen R., Volkers A.C., Tweede evaluatie Wet inzake Bloedvoorziening. Den Haag: ZonMw, 2008.

Coppen R., Friele R.D., The effectiveness of organ donor policies in 10

European countries: a widening gap? In: G. Polak. Course Catalogue Medicine and Health 2009. Wenen, 2008: 140‐142.

Coppen R., Verhaak P.F.M., Indicatoren in de eerstelijns GGZ: een voorstudie naar de informatievoorziening in de eerstelijns GGZ voor zorggebruikers en verzekeraars. Utrecht: NIVEL, 2007.

Coppen R., Wagner C., Friele R., Servicenormen voor de gezondheidszorg: weten waar je aan toe bent. Utrecht: NIVEL, 2007.

Friele R.D., Blok G.A., Gevers J.K.M., Coppen R., Smit M.C., Derde evaluatie Wet op de Orgaandonatie. Den Haag: ZonMw, 2006.

Friele R.D., Coppen R., Een effectieve donormailing: vooral personen tussen de 45 en 49 jaar. www.nivel.nl: NIVEL, 2006.

Coppen R., Sixma H.J., Delnoij D.M.J., Indicatoren voor toezicht op de openbare gezondheidszorg. Utrecht: NIVEL, 2006.

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Friele R.D., Gevers J.K.M., Coppen R., Janssen A.J.G.M., Brouwer W., Marquet R., Tweede evaluatie Wet op de Orgaandonatie. Den Haag: ZonMw, 2004.

Coppen R., Marquet R.L., Friele R.D., Het donorpotentieel: een vergelijking van het donorpotentieel in Nederland en 9 andere West‐Europese landen. Utrecht: NIVEL, 2003.

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