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WHO/EMP/MPC/2010.1

Country pharmaceutical situations

Fact Book on WHO Level 1 indicators 2007

Country pharmaceutical situations Fact Book on WHO Level 1 indicators 2007

© World Health Organization 2009

All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 3264; fax: +41 22 791 4857; email: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; email: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. The World Health Organization does not warrant that the information contained in this publication is complete and correct and shall not be liable for any damages incurred as a result of its use.

This document has been produced with the financial assistance of the European Union and the Department for International Development (DFID), UK. The views expressed herein are those of the authors and can therefore in no way be taken to reflect the official opinion of the European Union and the Department for International Development (DFID), UK.

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Contents

Abbreviations ........................................................................................................................xiii Preface ..................................................................................................................................... xv Acknowledgements .............................................................................................................xvii Summary: Background and key findings........................................................................xvii

1. Introduction......................................................................................................................1

1.1 Background..............................................................................................................1 1.2 Indicators to measure the country pharmaceutical situation...........................1 1.3 About this Fact Book ..............................................................................................2 1.4 Methods....................................................................................................................4 1.5 How to read the data..............................................................................................6

2. National medicine policy.............................................................................................11

2.1 Why is this important?.........................................................................................11 2.2 What is the current situation? .............................................................................11 2.3 Summary................................................................................................................17

3. Regulatory system .........................................................................................................19

3.1 Medicines Regulatory Authority........................................................................19 3.1.1 Why is this important? ...............................................................................19 3.1.2 What is the current situation? ...................................................................19

3.2 Marketing authorization......................................................................................21 3.2.1 Why is this important? ...............................................................................21 3.2.2 What is the current situation? ...................................................................21

3.3 Licensing ................................................................................................................25 3.3.1 Why is this important? ...............................................................................25 3.3.2 What is the current situation? ...................................................................25

3.4 Regulatory inspection ..........................................................................................26 3.4.1 Why is this important? ...............................................................................26 3.4.2 What is the current situation? ...................................................................26

3.5 Controlled substances .........................................................................................28 3.5.1 Why is this important? ...............................................................................28 3.5.2 What is the current situation? ...................................................................28

3.6 Quality control ......................................................................................................29 3.6.1 Why is this important? ...............................................................................29 3.6.2 What is the current situation? ...................................................................29

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3.7 Pharmacovigilance ...............................................................................................31 3.7.1 Why is this important? ...............................................................................31 3.7.2 What is the current situation? ...................................................................32

3.8 Counterfeit medicines ..........................................................................................34 3.8.1 Why is this important? ...............................................................................34 3.8.2 What is the current situation? ...................................................................34

3.9 Summary................................................................................................................35 4. Medicines supply system.............................................................................................37


5. Medicine financing .......................................................................................................43


6. Production and trade.....................................................................................................57


7. Essential medicines and rational use.........................................................................65

7.1 Essential medicines list, treatment guidelines, formularies ...........................65 7.1.1 Why is this important? ...............................................................................65 7.1.2 What is the current situation? ...................................................................66

7.2 Education and information about rational use.................................................71 7.2.1 Why is this important? ...............................................................................71 7.2.2 What is the current situation? ...................................................................71

7.3 Key policies and regulations to promote rational use.....................................78 7.3.1 Why is this important? ...............................................................................78 7.3.2 What is the current situation? ...................................................................79

7.4 Summary................................................................................................................88 8. Achievements and methodological limitations.......................................................89

8.1 Achievements ........................................................................................................89 8.2 Limitations of the questionnaire and recommendations

for improvement ...................................................................................................89 References.................................................................................................................................91

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Annexes Annex I: Level I questionnaire 2007 ...................................................................................93 Annex II: List of key indicators ..........................................................................................107 Annex III: List of countries responding to 2007 level I questionnaire

(by income level and WHO region) .................................................................109 Annex IV: Level I country data 2007* Annex V: Level I country data 2003* Annex VI: Metadata on key indicators* * Available on CD-ROM. Requests should be addressed to:

Department of Essential Medicines and Pharmaceutical Policies World Health Organization, 1211 Geneva 27, Switzerland. Fax: +41 22 791 4167, E-mail: [email protected]

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List of Tables Table 1.1 Number of countries submitting a questionnaire in 2007 by income level

and WHO region Table 2.1 Status of national medicine policies (NMPs) in 2007 Table 2.2 Countries reporting recent indicator assessments Table 3.1 Provision for Medicines Regulatory Authority (MRA) Table 3.2 Legislation and regulation on registration of medicines Table 3.3 Legal provisions for licensing Table 3.4 Legal provisions for inspections Table 3.5 Control of narcotics Table 3.6 Quality management systems and sample testing Table 3.7 Monitoring of adverse drug reactions (ADRs) Table 3.8 Counterfeit medicines Table 4.1 Public sector procurement and distribution Table 4.2 Essential medicines list (EMLs), procurement and tender process Table 5.1 Types of free medicines and patients receiving free medicines Table 5.2 Free provision of medicines and types of fees in public health facilities Table 5.3 Total public expenditure for medicines Table 5.4 Countries with per capita public expenditure on medicines lower than

US$ 2 Table 5.5 Health insurance and medicines coverage Table 5.6 Monitoring, information and guidelines on medicine prices and donations Table 5.7 Policies on medicines pricing covering different sectors Table 6.1 Country production capability Table 6.2 Patents and TRIPS flexibilities Table 7.1.1 Essential medicines lists (EMLs) Table 7.1.2 Standard treatment guidelines (STGs) for major conditions and formulary

manuals Table 7.2.1 Basic training on concepts of rational use of medicines available to health

workers Table 7.2.2 Education and information on medicines for health workers and

consumers Table 7.3.1 Staff prescribing medicines at primary care level in the public sector Table 7.3.2 Legislation on prescription of generic medicine in the public and private

sectors Table 7.3.3 Drug and Therapeutics Committees Table 7.3.4 Antimicrobial resistance (AMR) and over-the-counter (OTC) sales Table 7.3.5 Legislation and regulation of medicines promotion and advertising

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List of Figures

Figure 1.1 WHO strategy for monitoring country pharmaceutical situations

Figure 1.2 Model Table I

Figure 1.3 Model Table II

Figure 1.4 Model Graph

Figure 2.1 Countries in 2007 with an official national medicine policy (NMP) document updated within the past 5 years by WHO region

Figure 2.2 Countries with an official NMP document updated within the past 5 years in 2003 and 2007 by income level

Figure 2.3 Countries in 2007 with NMP implementation plan updated within the last 5 years by WHO region

Figure 2.4 Countries with NMP implementation plan updated within the past 5 years in 2003 and 2007 by income level

Figure 2.5 Countries reporting in 2007 to have carried out a national assessment study covering the overall pharmaceutical situation in the previous 5 years by WHO region

Figure 2.6 Countries reporting in 2003 and 2007 to have ever carried out a national assessment study of the overall pharmaceutical situation

Figure 3.1.1 Existence of Medicines Regulatory Authority (MRA) in 2007 by WHO region

Figure 3.1.2 Existence of Medicines Regulatory Authority (MRA) in 2003 and 2007 by income level

Figure 3.2.1 Countries with computerized system for registered products in 2007 by WHO region

Figure 3.2.2 Countries with computerized system for registered products in 2003 and 2007 by income level

Figure 3.2.3 Countries using INN for registration of medicines in 2007 by WHO region

Figure 3.2.4 Countries using INN for registration of medicines in 2003 and 2007 by income level

Figure 3.2.5 Countries using the WHO Certification Scheme in 2007 by WHO region

Figure 3.4.1 Legal provision to inspect premises in 2007 by WHO region

Figure 3.6.1 Quality management system in 2007 by WHO region

Figure 3.7.1 Countries monitoring ADRs in 2007 by WHO region

Figure 3.7.2 Countries monitoring ADRs in 2003 and 2007 by income level

Figure 3.8.1 Countries with mechanisms to detect and combat counterfeit medicines in 2007 by WHO region

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Figure 4.1 Countries limiting public sector procurement to EML in 2007 by WHO region

Figure 4.2 Countries limiting public sector procurement to EML in 2003 and 2007 by income level

Figure 4.3 Countries using the WHO Prequalification Scheme in 2007 by WHO region

Figure 5.1.1 HIV/AIDS-related medicines free at primary health care facilities in 2007 by WHO region

Figure 5.1.2 HIV/AIDS-related medicines free at public primary care facilities in 2003 and 2007 by income level

Figure 5.1.3 Countries providing free medicines to pregnant women at public primary health care facilities in 2007 by WHO region

Figure 5.1.4 Countries providing free medicines to pregnant women in 2003 and 2007 by income level

Figure 5.5.1 Countries with medicines covered by public health insurance in 2007 by WHO region

Figure 5.5.2 Countries with medicines covered by public health insurance in 2003 and 2007 by income level

Figure 5.6.1 Countries with medicines pricing policy in the public sector in 2007 by WHO region

Figure 5.6.2 Countries with medicines pricing policy in the public sector in 2003 and 2007 by income level

Figure 5.7.1 Countries monitoring prices in the public and private sectors in 2007 by WHO region

Figure 6.2.1 Countries with provision for parallel importing in 2007 by WHO region

Figure 6.2.2 Countries with provision for parallel importing in 2003/2007 by income level

Figure 6.2.3 Countries with provision for compulsory licensing in 2007 by WHO region

Figure 6.2.4 Countries with provision for compulsory licensing in 2003/2007 by income level

Figure 7.1.1 Countries with National Essential Medicines List in 2007 by WHO region

Figure 7.1.2 Countries with Essential Medicines List in 2003 and 2007 by income level

Figure 7.1.3 Countries with National Standard Treatment Guidelines in 2007 by WHO region

Figure 7.1.4 Countries with National STGs in 2003 and 2007 by income level

Figure 7.2.1 Countries with EML and STGs concepts in basic doctor curricula in 2007 by WHO region

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Figures 7.2.2(a) Countries with (a) EML and (b) STGs in basic doctor curricula in 2003 and 7.2.2(b) and 2007 by income level

Figure 7.2.3 Countries with obligatory continuing education for doctors in 2007 by WHO region

Figure 7.2.4 Countries with obligatory continuing education for doctors in 2003 and 2007 by income level

Figure 7.2.5 Countries with information centres for prescribers in 2007 by WHO region

Figure 7.2.6 Countries with information centres for prescribers in 2003 and 2007 by income level

Figure 7.2.7 Countries reporting public education campaigns on the use of antibiotics in 2007 by WHO region

Figure 7.2.8 Countries reporting public education campaigns on the use of antibiotics in 2003 and 2007 by income level

Figure 7.3.1 Countries permitting generic substitution in the public and private sectors in 2007 by WHO region

Figures 7.3.2(a) Countries with generic substitution allowed in the (a) public and (b) and 7.3.2(b) private sectors in 2003 and 2007 by income level

Figure 7.3.3 Countries with DTCs in at least half of general hospitals and regions/provinces in 2007 by WHO region

Figures 7.3.4(a) Countries with DTCs in at least half of (a) general hospitals and (b) and 7.3.4(b) regions/provinces in 2003 and 2007 by income level

Figure 7.3.5 Countries with a strategy to contain AMR in 2007 by WHO region

Figure 7.3.6 Countries with a strategy to contain AMR in 2003 and 2007 by income level

Figure 7.3.7 Countries with legal provisions on promotion and/or advertisement of medicines in 2007 by WHO region

Figure 7.3.8 Countries with legislation on promotion in 2003 and 2007 by income level

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Abbreviations

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Abbreviations

ADR Adverse drug reaction

AFRO* WHO Regional Office for Africa

AMR Antimicrobial resistance

AMRO* WHO Regional Office for the Americas

DTC Drug and therapeutics committee

EML Essential medicines list

EMP Essential Medicines and Pharmaceutical Policies Department

EMRO* WHO Regional Office for the Eastern Mediterranean

EURO* WHO Regional Office for Europe

HIV/AIDS Human immunodeficiency virus/Acquired immunodeficiency syndrome

INN International Nonproprietary Name

MoH Ministry of Health

MRA Medicines Regulatory Authority

NGO Nongovernmental organization

NHP National health plan

NMP National medicine policy

OTC Over-the-counter

PSP Public sector procurement

RDU Rational drug use

SEARO* WHO Regional Office for South-East Asia

STG Standard treatment guideline

TRIPS Trade-Related Aspects of Intellectual Property Rights

WHO World Health Organization

WPRO* WHO Regional Office for the Western Pacific

WTO World Trade Organization

* WHO regional office country groupings were used for regional data summary and analysis.

Country pharmaceutical situations. Fact Book on WHO Level 1 indicators 2007

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Preface

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Preface

In 1975, the Twentieth World Health Assembly passed resolution WHA28.66 which mandated the World Health Organization (WHO) to assist Member States in formulating national medicine policies and to help countries implement pharmaceutical strategies for the selection of essential drugs, appropriate procurement of quality drugs, and training in various elements of pharmaceutical programmes. The resolution marked the beginning of the evolution of essential drugs programmes in countries towards the development of national drug policies. A decade later, the conference of experts held in Nairobi in 1985 requested WHO to provide information on the pharmaceutical situation at the global and national levels.1

These events provided the impetus for the development of systems and tools to collect and publish data on a regular basis. In 1988 The World Drug Situation was published. This was updated in 2004 with the publication of The World Medicines Situation. Meanwhile, indicators and tools for assessing the pharmaceutical situation have also been developed and improved.

Between 2000 and 2007, WHO’s work on medicines was guided by the WHO medicines strategies for 2000-2003 and 2004-2007. The WHO Medicines Strategy 2004-07, approved by the World Health Assembly in resolution WHA 54.11, highlighted the challenges in medicines access and use in the 21st century. Both strategies emphasized the use of indicators to measure achievement and assess the medicines situation in countries, and to ascertain the impact of the WHO Medicines Strategy in achieving pharmaceutical objectives in countries.

WHO has continued to gather data and information on the pharmaceutical situation of Member States, using indicator-based tools to monitor the progress of pharmaceutical work in countries. These tools include the Level I monitoring indicators on structures and processes in national pharmaceutical systems, which were used to gather the data in this Fact Book.

The 2007 Fact Book is an update of the previous publication on the Level I survey undertaken in 2003.2 The 2007 survey results presented here are part of the WHO commitment to encourage Member States to regularly monitor their own pharmaceutical sector and assess whether they have a sufficiently enabling environment to ensure that people have access to the essential medicines they need; that the medicines are safe, effective and of good quality; and that the medicines are prescribed and used rationally. As in the 2003 Fact Book this document aims to summarize and provide a picture of the pharmaceutical situation in countries that have provided data through their ministries of health. Global information is presented by level of income and in some cases by WHO region.

The document includes a section on methods, including how the questionnaire was developed, how country data were obtained, and how data editing and


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quality checks were carried out. It also includes a review of the lessons learned – not only to help inform future similar surveys but also to highlight the limitations of the current survey process and information collected.

Additional information is presented in Annexes I-III, including the Level I questionnaire for 2007 and a list of key indicators. The actual data submitted by countries and the calculated indicators are provided on a CD-ROM (Annexes IV-V). These data are made available to encourage further analysis by region or economic level of development. Metadata for the 34 key indicators are also provided on the CD-ROM (Annex VI).

It is hoped that the information provided in this Fact Book will provide a useful tool for policy-makers, planners, researchers and others who need such data and information. We also hope that the data and information presented here can be used to inform the work of policy-makers at global and regional levels in identifying gaps, establishing priorities and setting targets. The Fact Book may also be helpful to international agencies and donors by supplying information that can be used as baseline data and possibly to assess the potential impact of activities. The data can also be used by professional groups and nongovernmental organizations (NGOs) in advocacy and information campaigns.

We would appreciate any comments and corrections to the data and information presented, to enable us to further improve the process of data-gathering and information sharing. Contact:


Acknowledgements

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Acknowledgements

The development of indicators for monitoring country pharmaceutical situations and the publication of this Fact Book are initiatives of the WHO Essential Medicines and Pharmaceutical Policies Department (EMP). This publication is an update of the 2003 Fact Book which was produced with the WHO Boston Collaborating Center on Pharmaceutical Policy, Harvard Medical School and Pilgrim Health.

Hans V. Hogerzeil provided leadership and management support in the development of this Fact Book. Precious Matsoso and German Velázquez provided leadership support during data collection, in collaboration with WHO regional and country offices.

Edelisa D. Carandang and Gilles Forte coordinated and supervised the overall process of indicator data collection and the development and editing of the Fact Book. Richard Laing supervised the report writing, editing and finalization of this document. Kathleen Holloway supervised the analysis and interpretation of findings, wrote sections of the text and undertook technical editing of the document. Anne Paschke and Enrico Cinnella drafted the 2007 Fact Book.

The Questionnaire on Structures and Processes of Country Pharmaceutical Situations 2007 was developed and revised during the WHO Expert Meeting on Pharmaceutical Indicators, Monitoring and Assessment held in July 2006 in Geneva. The meeting was attended by experts in various areas of pharmaceuticals from member countries, civil society groups, international organizations and WHO staff from countries, regions and HQ who extensively discussed the questionnaire in group and plenary sessions. During the meeting the following comprised the working group on level I indicators: Helene Moller, Patrick Mubangizi, Vera Lucia Luiza, Kathleen Holloway, Guitelle Baghdadi-Sabeti, Helen Tata, Alain Prat and Ogori Taylor. Diane Whitney assisted in the development, revision and finalization of the 2007 Level I questionnaire.

The collection of Level I data was coordinated by the WHO Regional Pharmaceutical Advisers and Technical Officers: Jean-Marie Trapsida (AFRO); Jorge Bermudez, Nelly Marin and Christophe Rerat (AMRO); Zafar Mirza and Mohammed Bin Shahna (EMRO); Kees de Joncheere, Trine Lyager Thomsen and Nina Sautenkova (EURO); Krisantha Weerasuriya (SEARO); and Budiono Santoso and Vanchinsuren Lkhagvadorj (WPRO). WHO country offices coordinated with respective national officials in 156 countries the collection and completion of the 2007 Level I questionnaires.

The following reviewed the document and gave comments: James Fitzgerald, Adriana Ivama and Nelly Marin.

Pierrick Gonet developed the program for the questionnaire. José Barros and Jorg Hetzke organized the data extraction and management of the database with assistance from Trine Lyager Thomsen and Anne Paschke. Trine Lyager Thomsen and Anne Paschke cleaned and analysed the Level I data set. Claude Da Re did the layout and supervised the printing of the report.


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Summary: Background and key findings

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WHO pharmaceutical indicators

The 2001 World Health Assembly (WHA) resolution on the WHO medicines strategy (WHA 54.11) identified the four main objectives of WHO’s medicines strategy, namely, to frame and implement policy; to ensure access; to ensure quality, safety and efficacy; and to promote the rational use of medicines. To monitor the progress of efforts to improve the global medicines situation, WHO has developed a system of indicators that measure key aspects of a country’s pharmaceutical situation. One set of these tools is the Level I indicators, which measure the existence and performance of key national pharmaceutical structures and processes. These indicators assess progress in improving the pharmaceutical situation over time and enable comparison between the situation in countries by level of income.

This Fact Book gives the results of the assessment of Level I indicators conducted in 2007. Indicator data are grouped into six component topics. Comparisons are provided by income levels and by WHO Regions. The key points to note for each topic are introduced at the beginning of each section. Data and information are presented in tables and graphs for the current situation – result of 2007 Level I survey – and for some indicators, comparison of Level I indicators for 2003 and 2007 surveys are also shown to see whether there has been any progress.

The key findings are summarized below.

National medicine policy

In 1975, the World Health Assembly in resolution WHA 28.66 requested WHO to develop means to assist Member States in formulating national drug policies. For those countries which have formulated and implemented a national medicine policy (NMP), it has provided a common framework, a commitment to a goal and a guide for action in country pharmaceutical systems.3,4

As of 2007, almost all low-income countries, most middle-income and many high-income countries report having an NMP document, but only half of high-income and one quarter of low-income countries had updated it in the previous five years. About three quarters of all countries have an implementation plan and NMP integrated within their national health plans. However, while most high-income countries had updated their implementation plans within the previous five years, less than half of low-income countries had done so.

Only a few countries reported that they had assessed their pharmaceutical situation with indicators within the previous five years.


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Regulatory system

A legislative framework is required to implement and enforce pharmaceutical policies both in the public and private sectors. Almost all countries report the presence of a regulatory authority.

Marketing authorization

The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce as part of the marketing authorization process is most frequently used by low-income countries. A computerized system for medicines registration is existent in only about half of the low but in almost all middle- and high-income countries. Most countries used the International Nonproprietary Name (INN) in registration of medicines.

Licensing and regulatory inspection

Most countries across all income levels have legal provisions covering the licensing and premises inspection of medicine manufacturers and importers.

Quality control, adverse drug reactions (ADRs) and counterfeit medicines

Quality control is important to ensure that patients receive medicines that are of assured quality, safe and effective. Medicines regulatory authorities (MRAs) should have access to a quality control laboratory to test whether samples of medicines meet the required quality criteria.

Almost all high-income countries report having a quality management system in place and monitor adverse drug reactions (ADRs), while for low-income countries only 50% monitor ADRs and less than 70% have a quality management system in place. However, there has been an increase in the number of ADR monitoring systems in low-income countries in 2007 compared to 2003. Nearly all high-income countries report having laws and regulations related to counterfeit medicines, while only about two thirds of low- and middle-income countries report having such laws and regulations.

Medicines supply system

A well-coordinated medicines supply system aims to ensure that funds available for medicines purchases are used effectively and efficiently. Many countries adopt a mixed medicines supply system incorporating public, private and NGO procurement, storage and distribution services.3


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While the public sector is responsible for procurement and distribution, in many countries these functions are also undertaken by the private and NGO sectors. In most low-income countries public sector procurement is generally pooled at national level and ministries of health are the main public sector procurement agencies. Low-income countries report most frequently using national competitive tender whereas direct negotiations and purchasing is the method most commonly used in high-income countries. Seventy-five per cent of low-income countries and 90% of middle- and high-income countries limit their public sector procurement to their national essential medicines list (EML). Fifty per cent of the middle-income, 70% of low-income countries and 35% of high-income countries report using the WHO Prequalification Scheme.

Medicine financing

WHO is committed to helping countries develop strategies to promote fair financing mechanisms to improve the affordability and availability of essential medicines in the private and public sectors.3 Key strategies to improve access to affordable medicines include increased public funding to improve medicines supply, especially in the public sector, the provision of medicines benefits through social health insurance and prepayment schemes, and the use of pricing regulation and policies.3

Pricing policies for medicines are most common in high-income countries. Almost all countries across all income groups report providing at least some medicines free of charge. The number of countries providing HIV/AIDS-related medicines for free at public primary care facilities has increased significantly since 2003. Similarly, an increasing number of countries provide medicines free of charge to pregnant women.

More than half of low- and middle-income countries have public health insurance that covers at least some medicines in the public sector, while virtually all high-income countries have public health insurance that covers some or all medicines. One third of low-income countries have no public health insurance that covers medicines.

It is very important for countries to avoid creating perverse financial incentives that encourage overuse of medicines, such as occurs when prescribers sell medicines. Fifty per cent of low-income countries, compared to 10% of high-income countries, use revenue from the sale of medicines to pay prescriber salaries. In the public sector, prescribers dispense medicines in two thirds of low-income and in one third of high-income countries, while in the private sector they dispense in three quarters of low-income and in more than half of high-income countries.

Production and trade

Intellectual property rights have an important impact on the affordability and availability of medicines and thereby on public health.3 The World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual


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Property Rights (TRIPS) requires WTO Members to implement and enforce minimum standards of intellectual property rights. However, the 2001 Doha Declaration on the TRIPS Agreement and Public Health confirmed that TRIPS-compliant mechanisms and flexibilities can be used to enable access to lower-priced medicines.

Over 80% of middle-income and almost all high-income countries have patent protection for pharmaceutical products, compared to only about fifty per cent of low-income countries. The situation is similar for countries reporting to have modified their national legislation to implement TRIPS.

Only one third of low-income and half of the middle-income countries report having parallel importation provisions in their national legislation compared with 60% of high-income countries. Compulsory licensing is the provision most frequently used across all income level groups.

Local production of medicines is undertaken in order to improve access to high-quality, low-cost medicines. A key challenge is to determine whether the criteria for successful local production are met, to ensure that investment in local production is not at the expense of the cost or quality of medicines.

The production capability of countries increases with income level. Most low-income countries report having the capability to formulate from starting materials and repackaging of finished dosage forms but only a few report having the capability to carry out research and development of active substances and production of pharmaceutical starting materials.

Rational use of medicines

Essential medicines lists and standard treatment guidelines

Many factors influence the use of medicines and countries need to implement a range of different strategies to improve rational use. Such strategies can include developing and implementing the use of standard treatment guidelines (STGs) for common conditions, and the use of essential medicines lists (EMLs) to guide procurement and training.

Almost all low- and most middle-income countries have a national EML, and most have updated their EML within the past five years. The number of medicines included on national EMLs tends to increase with increasing country income level. Likewise, the use of the EML in public or private sector health insurance reimbursement increases with country income level. Overall, use of the EML for insurance reimbursement occurs in less than half of countries in the public sector and in less than one fifth of countries in the private sector.

Most countries reported that they have national STGs for major conditions but less than half had updated them in the previous five years. The number of countries that report having a national STG appears to have increased between 2003 and 2007.

More than half of low-income countries and more than two thirds of middle- and high-income countries reported having a national formulary.


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Education and information about rational use

The Level I survey revealed that most health professionals are widely exposed to concepts of EMLs, STGs, problem-based pharmacotherapy and rational prescribing during basic training, more so in high- than in low-income countries. However, paramedical staff are exposed to such concepts in only one third of countries.

Mandatory continuing education for doctors occurs in 70% of high-income countries but in only 50% of low- and middle- income countries.

Independent national medicines information centres for prescribers/dispensers and consumers exist in three quarters of high-income countries but in only about one third of low-income countries. However, the proportion of low- and middle-income countries with a medicines information centre for prescribers/dispensers has increased slightly since 2003.

Only about half of all countries have carried out a public education campaign on antibiotic use, with more of these in high- than in low-income countries.

Key policies and regulations to promote rational use

Selecting the optimal medicine for an individual from a broad range of choices requires expertise and considerable skill by the health professionals involved. Prescribers also have an influence over the choice between prescribing a branded medicine or the generally cheaper generic product. Cost-effective generic prescribing can have a beneficial effect both on a country’s public health expenditure and on out-of-pocket spending on medicines for people who are sick.

In countries of all income levels, prescribing is mostly done by doctors, but low-income countries also report a similar frequency for prescribing by nurses/midwives. About a quarter of low-income countries report that prescribing in the public sector is sometimes done by staff with less than one month’s training.

About three quarters of countries report that generic substitution is permitted in pharmacies in both the public and private sectors. Generic substitution in the private sector is generally less common than in the public sector, except for the European Region, where generic substitution is equally permitted in public and private pharmacies. In the private sector generic substitution has increased throughout all WHO regions in 2007 as compared to 2003.

A mandated multidisciplinary national body can coordinate national policies to promote rational use of medicines, and Drug and Therapeutics Committees (DTCs) have a role to play in ensuring the safe and effective use of medicines in the facilities or areas under their jurisdiction. Two thirds of high-income but less than a quarter of low-income countries have a national body to coordinate policies to promote rational use of medicines. DTCs are more common in high-income countries and in referral hospitals. Less than half of low-income countries have DTCs in half or more of their general hospitals or regions.


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Irrational use of antibiotics contributes to increased antimicrobial resistance (AMR), rendering essential antibiotics ineffective and requiring the use of newer, more expensive antibiotics for the treatment of bacterial illnesses. High-income countries are much more likely to have a national strategy to contain AMR, a national task force to implement the strategy, and a national reference laboratory to conduct surveillance. Only a quarter of low-income countries report having an AMR containment strategy, which mirrors the situation in 2003.

Due to lack of regulation and enforcement of prescription-only status, over-the-counter (OTC) sales of antibiotics remain an issue of global health concern. Almost all low- and most middle-income countries report that OTC sales of antibiotics occur at least occasionally and/or frequently.

Nearly all low- and middle-income countries and all high-income countries report having legal provisions to regulate the promotion and advertisement of medicines.

Achievements and limitations

The 2007 Level 1 survey provides an updated overview of the pharmaceutical situation with regard to the existence of policy in countries. However, it is not known how well these policies are implemented or even whether they are actually enforced. Although improved from 2003, analysis of the most recent Level 1 survey data has identified several limitations in the current survey instrument and in data collection and management. Future surveys will address these limitations.

Introduction

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Level I Core structure

& process indicators

Level II Core outcome/impact indicators

(facility & household survey)

Level III

Indicator tools for specific components of the pharmaceutical sector ● Pricing ● Traditional medicine ● HIV/AIDS ● Assessing regulation ● Impact of TRIPS

Systematic Survey

Questionnaire (Health Officials)

1. Introduction

1.1 Background

The 2001 World Health Assembly resolution on the WHO medicines strategy (WHA 54.11) identified the four main objectives of this strategy, namely: to frame and implement policy; to ensure access; to ensure quality, safety and efficacy; and to promote rational use of medicines. The WHO Medicines Strategy 2004–2007 presented the strategies developed to help staff at WHO headquarters and in the regions and countries to work towards realizing this vision.3 The 2007 Level 1 indicator survey was done as part of the 2004-7 strategy to assess the pharmaceutical situation globally.

1.2 Indicators to measure the country pharmaceutical situation

Monitoring the progress of efforts to improve the global medicines situation is a crucial part of the strategy. WHO has developed a three-tiered monitoring strategy to assess progress, compare situations between countries, and reassess and prioritize efforts based on the results. Figure 1 illustrates the three levels of the monitoring strategy. The WHO operational package for monitoring and assessing the country pharmaceutical situation (i.e. Level I and Level II indicators) provides a practical indicator-based tool that can be regularly implemented without the need to invest substantial amounts of human or financial resources.5 The core indicators can be easily collected using standardized methodologies, small samples of data and simple survey techniques.

Figure 1.1: WHO strategy for monitoring country pharmaceutical situations


2

Level I indicators assess the structures and processes related to medicines in a country. They can be used to characterize the achievements and weaknesses of individual pharmaceutical systems and to illustrate common sectoral strategies and approaches. They also enable rapid assessment of the implementation of various components of a country's pharmaceutical system. Every four years, health officials from WHO Member States are invited to complete a standardized questionnaire reporting on the status of national medicine policies and their components, including: legislation and regulations; quality control of medicines; essential medicines lists; supply systems; financing; access to medicines; production; rational use; and protection of intellectual property rights (see Annex I for the Level I questionnaire).

As figure 1.1 shows, level II and level III indicators (not presented in this report) describe other types of data that are relevant to assess countries' pharmaceutical situations. Level II indicators measure the degree of attainment or outcome of the strategic pharmaceutical objectives. The description of each indicator, including calculations, is contained in the manual WHO Operational Package for Monitoring and Assessing Country Pharmaceutical Situations.5 Level III indicators assess in more depth specific components of the pharmaceutical sector, health system, or national medicine policy. Examples are indicators for investigating the use of medicines in health facilities; medicines price surveys; or indicators to monitor the impact of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

1.3 About this Fact Book

The present Fact Book details the results of the 2007 assessment of Level I indicators submitted by 156 countries. Table 1.1 shows the response rate of countries by income level and region. (See Annex III for the list of countries responding in 2007, including labelling by World Bank income level and WHO Region). The current situation is based on the 2007 Level I survey and is presented by income level with a global summary. Most of the data for Level I indicators have been gathered through the countries’ ministries of health.

Introduction

3

Table 1.1: Number of countries submitting a questionnaire in 2007 by income level and WHO region

As with the previous Fact Book2 this document does not attempt to analyse or address pharmaceutical policy issues, nor does it cover all key pharmaceutical components. The aim is to update the 2003 data and information with the latest available information on the pharmaceutical situation in various countries. It is hoped that this information can be used as reference material by those who are interested in working on pharmaceutical sector issues at country, regional and global levels.

The Fact Book summarizes data for the Level I structure and process indicators according to six topics:

• National medicine policy (NMP);

• Regulatory system;

• Medicines supply system;

• Medicines financing;

• Production and trade;

• Rational use.

The importance of each of these topics is explained briefly and summarized data on the situation in 2007 are displayed. Where comparable data for 2003 are available, progress made between 2003 and 2007 is also shown.

Indicator data were summarized across countries classified as low-, middle-, or high-income, following the World Bank categorization of countries based on

# Countries returning

questionnaire in

2007

# Countries receiving

questionnaire in

2007

Response rate

(%)

Income level total 156 192 81%

Low-income 48 53 91%

Middle-income 73 95 77%

High-income 35 44 80%

WHO Regions total 156 192 81 %

AFRO 42 44 95 %

AMRO 31 36 86%

EMRO 16 21 76%

EURO 36 52 69%

SEARO 6 11 55%

WPRO 25 28 89%


4

2007 gross national income per capita (GNI). The criteria were: low-income, US$905 or less; middle-income, US$906-11,115; and high-income, US$11,116 or more.6 Annex III lists the countries submitting the Level I questionnaire in 2007 that were included in each income category.

1.4 Methods

Questionnaire development

The Level I questionnaire on structure and processes of the pharmaceutical situation in countries is a refined version of the 2003 questionnaire. The questionnaire was extensively reviewed during an expert meeting in July 2006.7 The questionnaire was then finalized in consultation with members of the Essential Medicines and Pharmaceutical Policies (EMP) department and regional pharmaceutical advisers. For each section of the questionnaire people with expertise in the relevant topic area were consulted.

An additional feature of the 2007 questionnaire was the development of definitions for specific terms. These definitions and explanations could be accessed by clicking on a box next to the relevant question in the electronic questionnaire file. Country responses to the 2003 survey were also provided in the new questionnaire. A program that generated individual questionnaires for each country was also developed, providing each country with its own questionnaire to be completed. Upon submission, questionnaires were imported into a database designed to manage the data.

Gathering data

In July 2007, CDs with specific country questionnaires were prepared and sent in individual envelopes to 192 countries through the regional advisers, who in turn sent the envelopes to WHO representatives in each country. In most cases the regional advisers also opted to send the questionnaires by email. Most of the follow-up with countries was done by WHO HQ staff.

Countries were asked to submit the completed files electronically if possible. Some countries submitted hard copies through regional advisers or by regular mail. Instructions were provided on how to work on each of the country files such as enabling the macros. In case country staff encountered problems they were encouraged to contact HQ for help. Most countries returned the questionnaire either directly to WHO HQ or via the Country Office to the responsible Regional Office.

An introduction was included in the questionnaire, underscoring the objective of the activity and including some recommendations on how to best gather the information and data. It was recommended that a coordinator or official from the ministry of health should be identified to supervise the completion of questionnaire. The coordinator was expected to identify responsible people, government agencies or groups who would provide responses to different pharmaceutical sections/areas in the questionnaire. The names of those who provided information were recorded at the end of the questionnaire.

Introduction

5

Data quality

All completed questionnaires were then centrally collected at WHO HQ, where they were quality checked and processed. As part of the data processing, data editing was done to improve the quality and thereby the reliability of the data. Any data that appeared to be erroneous (for example, typos, figures entered in a different currency and inconsistent responses) were not included in the database if the data issues could not be resolved. The current database allows response parameters to be set for each question. When the questionnaires were uploaded into the database, any answers falling outside the set parameters were verified and then manually accepted in the database.

Problems were noted during data processing owing to the electronic features of the questionnaires and the high volume of information collected from 156 countries. A generally identified problem was the limitation of the knowledge of respondents and hence the accuracy and validity of some responses. Attempts were made to validate the data and reflect them as accurately as possible in this report.

Most data quality checking was done on the integrated data sheet generated from the database and included:

• Checking for inconsistencies in the questionnaire responses through identifying structural mistakes (for example, if countries answered follow-up questions while not giving any responses to the root question). Inconsistent answers to prerequisite questions were also verified and corrected.

• Going back to respondents in countries via email for clarification of various responses, although the response rate to these requests for clarifications was rather low. Nevertheless data submitted are considered to be data officially provided by the countries,

• Cross-checking and triangulation with data from other sources, such as public health expenditures on pharmaceuticals. Criteria were set to exclude outlying figures.

Data analysis

The data were exported into Microsoft Excel 2003. Pivot tables were used to calculate the percentage of countries stating that various documents, policies or institutions exist. Results (for 2007) are presented by income level of country and for some indicators by region. For some indicators collected in both 2003 and 2007 a comparison is also presented to see if there has been any change.

In general, only aggregate data for questions to which the majority of countries responded with a yes/no, other categorical or numerical response (as requested) are reported. Countries that reported "don't know" and those with missing data are excluded. For certain questions where the year of an existing document or policy was requested and where the response rate for the year was very low, non-response was taken to indicate that the document or policy was more than five years old. Further detail on analysis is included in section 1.5 below.


6

1.5 How to read the data

Data are presented by country income category and for some indicators by WHO region. Firstly, all the major indicators for a certain area of policy are presented by country income level and on a global scale in a table format, followed by a box showing the key findings. Secondly, data for key indicators (shaded in the tables) are presented graphically by WHO region for 2007 data and then a comparison between 2003 and 2007 is shown by income level. These graphs are followed by a box showing key findings with regard to policies by region and changes between 2003 and 2007.

As there can sometimes be strong variations between the response rates to questions, both the numerator (countries that responded positively to questions about the presence of documents, policies or institutions) and denominator (countries that responded to questions, whether positively or negatively, about the presence of documents, policies or institutions) are displayed on the left for each income category (see figure 1.2 for model table I). This allows the reader to interpret results for her/himself. The percentage is indicated on the right for each income category. Countries that reported “don’t know” and those with missing data were excluded from analyses, unless specifically stated otherwise.

Figure 1.2: Model Table I

Country income level Low (48) Middle (73) High (35) Global (156)

ye s / resp. countries

% yes

yes / resp. countries

% yes


% yes


% yes

NMP implementation plan 32 / 45 71% 40/64 63% 22/28 79% 94 / 137 69%

For indicators where more than 30% of countries did not respond to a certain question (within an income category and/or on a global scale), they were labelled with one asterisk (*) in order to make readers aware that a cautious interpretation of the results is necessary (See figure 1.3 for model table II).

Number of countries reporting to have policy in place (Yes)

Policy indicator countries reporting to have policy as percentage of all middle-income countries responding

sum of countries answering ’Yes‘ of all income levels

sum of all countries responding to question

Total number of low-income countries that returned the 2007 level I questionnaire

Total number of low-income countries providing an answer to this question

Introduction

7

For dates of documents or policies, the lack of data was so great that it was assumed that the countries which had not indicated a date had not recently updated the policy or document in question. These cases have been indicated in the concerned tables with three asterisks (***).

Most multiple choice questions with various answer categories were converted into binomial data (yes/no). Such questions were labelled with two asterisks (**) and a legend was provided below the table explaining which categories were included as "yes" and which as "no" responses.

Figure 1.3: Model Table II

Country income level

Low (48) Middle (73) High (35) Global (156)


%

yes yes / resp. countries

%


%


%

yes

Public sector procurement limited to EML*

25/34 74% 37/41* 90% 12/13* 92% 74/88* 84%

Fees are used to pay salaries** 22/44 50% 12/61 20% 3/31 10% 37/136 27%

* Note: More than 30% of countries did not provide an answer to this question ** Yes = Always + Frequently + Occasionally

When countries were asked to provide numerical data (for example, on the annual budget for medicines and number of samples collected), medians, 25th and 75th percentiles of the responses are shown. The median is the middle value of a series of numbers: that is, half of the responding countries reported a value lower than the median, and half reported a value higher than the median. Similarly, the 25th and 75th percentiles are values below which a quarter or three quarters, respectively, of responding counties report their own value. Because medians and percentiles are less sensitive to extreme values than means (averages), they are the best summaries of indicator data which may be highly skewed due to extreme outlying values.

Key indicators

A range of key indicators has been identified, which are primarily based on the WHO Medicines Strategy 2004-20073 and are highlighted in grey in the data tables (see model table II). All 34 indicators are provided as a list in Annex II and are further defined by metadata, which are provided on the data spreadsheet in Annex VI (available in CD-ROM). For most key indicators the

Key indicator highlighted in grey


8

table is followed by a graph displaying the data in the indicator by WHO Region (note: in the graphs AFRO is labelled as Africa; AMRO - America; EMRO – Eastern Mediterranean; EURO – Europe; SEARO – South-East Asia; WPRO – Western Pacific). For a complete list of countries responding in each region see Annex III.

Where available, the 2007 data for these indicators were compared with the 2003 data and displayed in a graph by income level. Although all countries responding from both years were included, samples were too small to present the comparison of 2003 and 2007 by WHO region. For this reason, the comparison by income level was chosen as the best option. It should however be born in mind that the income level of some countries has changed since 2003.

The following model graph (figure 1.4) illustrates how comparison of 2003 and 2007 data has been displayed.

Figure 1.4: Model Graph to show how 2003 and 2007 data have been displayed in the Fact Book

Limitations of the data and interpretation

It should be remembered when reading this Fact Book that the Level 1 indicators themselves and the methodology used to collect them have limitations. Thus the findings give only a general indication of the pharmaceutical situation in countries. The principal limitation was that there were large amounts of missing data for some questions, probably as a result of the questions being unclear or due to lack of knowledge of the respondents.

It is possible that the findings presented in this Fact Book may provide an over-optimistic scenario with regard to the pharmaceutical situation in countries. There are two reasons for this. Firstly, the data reflect the policies officially in

Number of countries reporting to have policy in place (Yes)

Total number of high-income countries providing an answer to this question in 2007

Note: if the response rate to question in one year significantly differs than in the other year, percentages might indicate a decrease, while total numbers suggest an increase or vice-versa.

Introduction

9

existence but many of these policies may not be fully enforced. Secondly, many countries not responding to certain questions were excluded from the analysis except where indicated in the relevant tables. However, such non-response is more likely to be associated with the non-existence rather than the existence of the policies concerned. As a result, their exclusion from the analysis is likely to bias the results to show a more optimistic picture. For example, if 50% of countries did not respond to a specific question on policy existence because the policy did not exist, and these non-responders were included in the analysis, then the proportion of countries with a policy in existence would be 20% lower than presented in the tables or graphics. The non-response rate was so high with regard to the provision of dates, particularly older dates, for certain policies or documents that exclusion of these countries would have reduced the sample size too greatly to leave meaningful results. In these cases of non-response it was assumed that an absence of date meant that the document concerned was more than five years old.

When comparing policy existence between 2003 and 2007, the sample sizes were too small to limit the comparison to countries responding to the particular question in both years, i.e. comparison was made using the complete sample of countries for each year. This meant that different countries were included in the samples and any comparisons should be interpreted with caution, particularly where the response rate was quite small and different in the two periods.

Annexes

Annexes should be consulted for the content of Level I questions, key indicators and country data provided, encouraging readers to do further regional analysis using the data provided. This Fact Book's annexes are:

Annex I: Level I questionnaire 2007

Annex II: List of key indicators

Annex III: List of countries responding to 2007 level I questionnaire (by income level and WHO region)

Annex IV: Level I country data 2007

Annex V: Level I country data 2003

Annex VI: Metadata on key indicators

Annexes I, II and III are at the end of this document. Annexes IV-VI are available on CD-ROM. Requests should be addressed to:



10


11

2. National medicine policy

2.1 Why is this important?

A comprehensive and common framework is needed to develop policies which can address interdependent problems in the pharmaceutical system and involve all stakeholders at the same time. Therefore WHO strongly recommends that countries should formulate and implement a national medicine policy (NMP) as a “commitment to a goal and a guide for action”.3,4 An NMP defines a framework for setting and monitoring medium- to long-term objectives in the public and private pharmaceutical sectors and should encompass objectives to ensure:

• Access: equitable availability and affordability of essential medicines;

• Quality: all medicines are safe, efficacious and of high quality;

• Rational use: promotion of therapeutically sound and cost-effective use of medicines by health professionals and consumers.

By attaining these objectives, countries can reduce levels of morbidity and mortality; reduce public health expenditure; and help prevent catastrophic expenditure on medicines by people who are sick.

The functions and strategies of each component of the NMP should be brought together in an implementation plan. It is recommended that an NMP implementation plan cover a period of 3–5 years. Incorporation of the NMP into the national health system and strategies is necessary to ensure that the NMP goals and objectives are articulated in the broader national health plans and that resources can be used efficiently.

NMPs require regular review to evaluate whether objectives have been achieved and to track progress over time. Based on these reviews policies can be refined, priorities established, and new evolving health needs integrated into the current NMP. This should occur in the context of monitoring conducted as part of policy implementation and in response to changes in health policy and the broader environment which have an impact on the pharmaceutical sector. Standardized indicators of the pharmaceutical situation allow countries to monitor and evaluate the impact of implementing an NMP.

2.2 What is the current situation?

Table 2.1 and figures 2.1 and 2.2 illustrate how many countries, in various income-level groups and by regional grouping, have an NMP and implementation plan, and whether these have been recently updated. Table 2.2 shows the number of countries reporting a recent indicator assessment study to review their pharmaceutical situation.


12

Table 2.1.: Status of national medicine policies (NMPs) in 2007




% yes


% yes


% yes


% yes

NMP official (or draft) document 45/48 94% 61/73 84% 26/35 74% 132/156 85%

Official document Updated < 5 years*** 11/48 23% 32/73 44% 19/35 54% 62/156 40%

NMP implementation plan 32/45 71% 40/64 63% 22/28 79% 94/137 69%

Updated < 5 years*** 20/44 45% 31/64 48% 2128 75% 72/136 53%

NMP integrated in NHP 37/47 79% 44/60 73% 19/27 70% 100/134 75%

*** Since over 20% of countries with an NMP document / NMP implementation plan did not

provide dates and very few indeed provided dates earlier than 5 years previously, it was assumed that those countries not providing dates had not updated their NMP document / NMP implementation plan in the last 5 years.

The majority of countries have an NMP document but only a minority appear to have been updated in the last five years.

NMP documents are less common with rising income level but updated implementation plans are more common with rising income level.

Most countries have an implementation plan and the NMP integrated within their National Health Plan (NHP).

Twice as many low-income countries have updated their NMP implementation plan within the past five years as have updated their NMP document.


13

Figure 2.1: Countries in 2007 with an official national medicine policy (NMP) document updated within the past 5 years by WHO Region

9/42 8/315/16

28/36 4/6

8/25

0%

20%

40%

60%

80%

100%

Afri

ca

Am

eric

a

East

ern

Med

iterra

nean

Euro

pe

Sout

h-E

ast

Asia

Wes

tern

Paci

fic

Figure 2.2: Countries with an official national medicine policy (NMP) document updated within the past 5 years in 2003** and 2007 by income level

8/17

15/61

15/55

19/35

32/73

11/48

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

20072003

** In 2003, some countries reported having updated their NMP but also that it was a draft document. If these countries also reported having an implementation plan or having integrated the NMP into the health plan, then it was assumed the draft had official status.

In four Regions (Africa, Eastern Mediterranean, Americas and Western Pacific) less than one third of countries have an updated NMP document.

Europe is the only WHO Region in which most countries have updated their NMP document within the last five years.

The existence of updated NMP documents (official or draft) appears to have increased between 2003 and 2007 in middle- and high-income countries but not in low-income countries.


14

Figure 2.3: Countries in 2007 with NMP implementation plan updated

within the past 5 years by WHO region

10/193/6

28/35

6/1310/2415/39

0%

20%

40%

60%

80%

100%

Afri

ca

Amer

ica

Eas

tern

Med

iterr

anea

n

Eur

ope

Sout

h-Ea

stA

sia

Wes

tern

Pac

ific

Figure 2.4: Countries with NMP implementation plan updated

within the past 5 years in 2003 and 2007 by income level

19/54

19/46

6/12

20/44

31/64

21/28

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

20072003

In five regions (Africa, Eastern Mediterranean, Americas, Western. Pacific and South-East Asia) half or less of countries have an updated NMP implementation plan.

Europe is the only WHO Region in which most countries have updated their NMP implementation plan within the last five years.

The existence of an updated NMP implementation plan appears to have increased slightly between 2003 and 2007 in all countries but mainly in high-income countries.


15

Table 2.2: Countries reporting recent indicator assessments




%


%


%


%

yes

National assessment study carried out 37/46 80% 46/71 65% 26/32 81% 109/149 73%

Areas assessed in the last 5 years (2003-2007)

Overall pharmaceutical situation

14/38 37% 24/50* 48% 18/26 69% 56/114 49%

Rational use (prescription audit)* 12/31* 39% 22/48* 46% 17/24* 71% 51/103* 50%

Access 16/32* 50% 26/50* 52% 18/25 72% 60/107* 56%

* Note: More than 30% of countries did not provide an answer to this question.

About half of the countries report having assessed their pharmaceutical situation, access and rational use in the last five years.

The likelihood of a country having undertaken a pharmaceutical assessment or a prescription audit of medicines use increases with income level.

The data suggest that less than half of the countries undertake such assessments regularly since only about one third of the countries were able to indicate the year of the last assessment.


16

32/47

27/41

6/8

36/38

25/26

38/50

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

20072003

5/16

0/3

25/32

4/108/2114/32

0%

20%

40%

60%

80%

100%

Africa

America

Easter

n Medit

erranea

n

Europe

South-

East A

sia

Western

Pacific

Figure 2.5: Countries reporting in 2007 to have carried out a national assessment study covering the overall pharmaceutical situation in the previous 5 years by WHO region

Figure 2.6: Countries reporting in 2003 and 2007 to have ever carried out a national assessment study of the overall pharmaceutical situation


17

In 2007 in all regions except the European Region, less than half of countries have carried out a national assessment of the overall pharmaceutical situation in the past five years.

The proportion of countries that have ever undertaken a national assessment of the pharmaceutical situation increased between 2003 and 2007 in countries of all income levels, but it is not known whether this increase occurred in the previous five years since these data are unavailable for 2003.

2.3 Summary

In 1975, the World Health Assembly in resolution WHA28.66 requested WHO to develop means to assist Member States in formulating national drug policies. For those countries which have formulated and implemented an NMP, it provides a common framework, a commitment to a goal and a guide for action in the country pharmaceutical system.3,4

This chapter reviews the status of NMPs in countries. As of 2007, almost all low-income countries, most middle-income and many high-income countries report having an NMP document, but only half of high-income and one quarter of low-income countries had updated it in the previous five years. About three quarters of all countries have an implementation plan and NMP integrated within their national health plans. However, while most high-income countries had updated their implementation plans within the previous five years, less than half of low-income countries had done so.

Only a few countries reported that they had assessed their pharmaceutical situation with indicators within the previous five years.


18

Regulatory system

19

3. Regulatory system

Access to high quality medicines can only be ensured if a strong medicines regulatory system is in place. The regulatory system should be responsible for establishing controls and stringent rules for the processes and people involved in the production, dispensing and sale of medications. Without stringent regulation in place to control the safety and efficacy of medicines, an increasing number of ineffective, poor quality, and harmful medicines will circulate in national and global markets. These medicines may fail to have the needed therapeutic effect, which in turn can lead to a worsening of the disease, an increase in the spread of infectious diseases and the development of antimicrobial resistance (AMR).

Only a well developed legislative framework with a designated body responsible for implementing and enforcing regulatory policies and laws can create a legal basis for the control of activities in the public and private pharmaceutical sector.8 This framework should also include administrative measures and sanctions in response to violations.

The following subsections present data on the areas that should be covered by a regulatory system.

3.1 Medicines Regulatory Authority

3.1.1 Why is this important?

Medicines regulatory authorities (MRAs) are essential to ensure strong regulation of the manufacture, trade and use of medicines in order to protect public health. An MRA establishes a legal framework to guarantee independent testing and assessment of the quality, efficacy and safety of medicines. It should also ensure the integrity of the interactions between patients and dispensers, once a prescription has been issued. To ensure this, the MRA should be overseeing several mutually reinforcing activities such as licensing, control and monitoring.9

3.1.2 What is the current situation?

The tables and figures in the following section present data on the existence, funding and capacity of MRAs.


20

Table 3.1: Provisions for Medicines Regulatory Authority (MRA) Country income level Low (48) Middle (73) High (35) Global (156)


% yes


% yes


% yes


% yes

Legal provisions for establishing MRA 41/46 89% 62/70 89% 33/35 94% 136/151 90%

Existing formal medicines MRA 40/45 89% 60/71 85% 34/35 97% 134/151 89%

Legal provision requiring transparency 30/45 67% 46/65 71% 31/32 97% 107/142 75%

RA involved in harmonization initiative 36/44 82% 59/71 83% 34/34 100% 129/149 87%

Publicly accessible MRA web site 16/48 33% 45/73 62% 27/33 82% 88/154 57%

Sources of funding for MRA

Government budget 35/40 88% 60/67 90% 32/33 97% 127/140 91%

Medicines registration fees 27/37 73% 35/48* 73% 26/32 81% 88/117 75%

Other* 17/24 71% 16/35 46% 9/18 50% 42/77* 55%


The majority of countries report having legal provision for the establishment of an MRA.

The main source of funding for MRAs is the government budget, but fees from registration of medicines are also often used.

Figure 3.1.1 Existence of Medicines Regulatory Authority (MRA) in 2007 by WHO region

Regulatory system

21

Figure 3.1.2 Existence of Medicines Regulatory Authority (MRA) in 2003 and 2007 by income level

Almost all countries across WHO regions reported the existence of an

MRA.

3.2 Marketing authorization


A marketing authorization is the licence for a product which is to be put on the market. Before granting market authorization, a country needs to have in place a regulatory system and facilities to test the quality, safety and efficacy of these products.10 The use of the International Nonproprietary Name (INN) simplifies the procurement, prescription and distribution of medicines, both within and across country borders, lowering the risk of mistakes due to confusing names of medicines.11


Table 3.2 shows data on marketing authorization and product registration in countries by income level. In figure 3.2.1 all countries reporting to have a computerized medicines registration system are displayed by WHO regions.


22

Table 3.2 Legislation and regulation on registration of medicines



% yes


% yes


% yes


% yes

Provision for marketing authorization 42/48 88% 59/70 84% 33/35 94% 134/153 88%

Marketing authorization list publicly available 28/47 60% 48/71 68% 29/35 83% 105/153 69%

Computerized medicines registration system

25/46 54% 51/70 73% 31/34 91% 107/150 71%

WHO Certification scheme part of marketing authorization

34/47 72% 38/65 58% 10/23* 43% 82/135 61%

INN used in registration of medicines 37/43 86% 55/69 80% 33/35 94% 125/147 85%

Official registration committee 39/46 85% 49/69 71% 29/33 88% 117/148 79%

Median Median Median Median

[25th , 75th percentile] [25th , 75th percentile] [25th , 75th percentile] [25th , 75th percentile]

2814 5895 7940 5500

[1711 , 5250] [3172 , 12000] [5,446 , 13,475] [2700 , 9500]Total no. of products receiving marketing authorization*

n=33 n=50 n=22 n=105*


Most countries report the existence of a comprehensive market authorization framework.

A computerized system for registered products is common in most high- and many middle-income countries but present in only half of the low-income countries.

The WHO Certification Scheme is more often used in low-income countries than in high-income ones.

Most countries use the INN in registration of medicines. High-income countries have more products market-authorized than

low-income countries.

Regulatory system

23

24/40

20/29

14/16 34/36

1/5

14/24

0%

20%

40%

60%

80%

100%

Africa

America

Easter

n Med

iterra

nean

Europe

South-

East A

sia

Wester

n Pac

ific

Figure 3.2.1: Countries with a computerized system for registered products

in 2007 by WHO region

Figure 3.2.2 Countries with a computerized system for registered products in 2003 and 2007 by income level

The number of countries with a computerized registration system appears to have increased in middle- and high-income countries.


24

Figure 3.2.3

Countries using INN for registration of medicines in 2007 by WHO region

Figure 3.2.4 Countries using INN for registration of medicines in 2003 and 2007 by income level

The INN is used for registration in all countries in the European Region and by at least two thirds of countries in other regions.

The proportion of countries by income level using the INN system appears relatively unchanged between 2003 and 2007.

Regulatory system

25

Figure 3.2.5 Countries using the WHO Certification Scheme in 2007 by WHO region

Countries in the African and Eastern Mediterranean Regions most frequently report the use of the WHO Certification Scheme for marketing approval.

3.3 Licensing


A licensing system is crucial in order to ensure the quality of medicines. But it is not only the marketed product which needs a proof of quality. In addition, all stakeholders involved in selling and distributing the product should be required to obtain a licence granting them permission to sell and distribute. For that purpose their premises and procedures need to be evaluated so as to guarantee their eligibility for distribution and to make sure that they are meeting the required standards.


Table 3.3 shows the number of countries which have legal provisions for licensing of manufacturers, wholesalers and importers/exporters of medicines.


26

Table 3.3: Legal provisions for licensing




%


%


%


%

yes

Legal provisions for licensing of:

Manufacturers 43/48 90% 64/69 93% 35/35 100% 142/152 93%

Importers/wholesalers 43/48 90% 64/70 91% 34/35 97% 141/153 92%

Importers or exporters of medicines 44/48 92% 64/71 90% 30/31 97% 138/150 92%

Over 90% of the countries have legal provisions for licensing manufacturers, wholesalers and importers/exporters of medicines.

3.4 Regulatory inspection


A regulatory inspection is a tool that can be used to survey the quality and reliability of products and sales personnel, including after they have been granted market authorization or a licence respectively. Only continuous checks can assure lasting quality over time.


Table 3.4 shows how many countries have legal provision for the inspection of premises and collection of samples. The table also gives information on which types of facilities are checked for compliance with applicable requirements and whether countries provide for written national guidelines for such inspections.

Regulatory system

27

Table 3.4: Legal provisions for inspections




%


%


%


%

yes

Legal provision to inspect premises 39/47 83% 66/70 94% 33/34 97% 138/151 91%

Inspections of the following facilities:

Manufacturers 36/46 78% 55/68 81% 34/35 97% 125/149 84%

Wholesalers/ distributors 37/45 82% 57/68 84% 31/35 89% 125/148 84%

Importers/ exporters 36/44 82% 53/64 83% 30/33 91% 119/141 84%

Retail distributors/ pharmacies 39/46 85% 60/68 88% 31/34 91% 130/148 88%

Written guidelines for inspections of the following facilities:

Manufacturers 22/32* 69% 41/54 76% 30/31 97% 93/117 79%

Wholesalers/ distributors 23/33* 70% 39/54 72% 29/31 94% 91/118 77%

Importers/ exporters 19/31* 61% 39/53 74% 26/29 90% 84/113 74%

Retail distributors/ pharmacies 23/33* 70% 47/57 82% 27/30 90% 97/120 81%


Almost all countries report legal provisions to inspect premises, including those of manufacturers, wholesalers, importers/exporters and retail distributors.

The provision of written guidelines for inspection of facilities increases with country income level.


28

Figure 3.4.1: Legal provisions to inspect premises in 2007 by WHO Region

Almost all countries throughout all regions report legal provisions to inspect premises.

3.5 Controlled substances


The illicit production of and traffic in narcotics and psychotropic substances pose a serious threat to public health and control regulations are necessary. In accordance with its mandate, WHO provides advice and guidance on the scheduling of substances under the three relevant conventions: the Single Convention on Narcotic Drugs, 1961, (as amended by the 1972 Protocol); the Convention on Psychotropic Substances, 1971; and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988.12,13 If overly restrictive, however, regulations can hamper access to controlled medicines for therapeutic use. There is increasing acknowledgement that a balance must be struck between medical and regulatory requirements to improve legitimate medical access to all medications controlled under the drug conventions.


Table 3.5 shows that nearly all countries have legal provision for the control of narcotics and are signatory to the various conventions.

Regulatory system

29

Table 3.5: Control of narcotics




% yes


% yes


% yes


% yes

Legal provisions for control of narcotics 43/47 91% 72/72 100% 35/35 100% 150/154 97%

Signatory to int. conventions on control of narcotics 47/47 100% 70/70 100% 35/35 100% 152/152 100%

All responding countries report being signatories to the international

convention on control of narcotics.

3.6 Quality control


Quality control is important to ensure that patients receive medicines that are safe and effective. WHO recommends that each national MRA should have access to a quality control laboratory to test whether medicines samples meet required quality criteria. WHO provides guidelines on establishing testing facilities.14,15

The intake of medicines of low quality results mainly in low bioavailability and medicine under-dosage. This can lead to a lack of the needed therapeutic effect and promote the development of AMR, a major threat to public health.

But quality control includes not only testing whether medicinal products contain the right ingredients in the correct amount, but also ensuring that they are properly stored and have not passed the expiry date. The latter controls are intended to ensure that, at the final distribution point, patients are getting high quality and efficacious drugs. Countries with tropical climates can experience difficulty in maintaining good storage conditions for medicines. The quality of medicines can be degraded by conditions such as: high temperature and high humidity; storage on the floor; lack of systematic arrangement of stock; presence of dust and pests; inadequate protection from direct sunlight; and lack of provision of temperature monitoring charts and facilities to monitor room temperature.


Table 3.6 provides information on the medicines quality management systems in countries. Figure 3.6.1 shows the number of countries with a quality management system in place in the six WHO regions.


30

Table 3.6: Quality management systems and sample testing



% yes


% yes


% yes


% yes

Quality management system in place 32/47 68% 48/70 69% 23/24* 96% 103/141 73%

Samples tested for

Medicines registration 31/45 69% 45/70 64% 15/24* 63% 91/139 65%

Post-marketing surveillance 34/47 72% 51/68 75% 19/23* 83% 104/138 75%

Samples tested in

Government quality control laboratory 34/43 79% 49/58 84% 21/23* 91% 104/124 84%

Local academic institutions* 11/30* 37% 18/39* 46% 4/21* 19% 33/90* 37%

Private laboratory* 6/29* 21% 9/36* 25% 6/20* 30% 21/85* 25%

Mini laboratories (regional)* 11/27 41% 6/35* 17% 2/20* 10% 19/82* 23%

Quality control laboratory in another country* 23/39 59% 23/45* 51% 11/20* 55% 57/104* 55%

Quality control procedures for imported medicines 35/47 74% 62/72 86% 33/34 97% 130/153 85%

Legal procedures to recall/ dispose of defective products

34/47 72% 57/71 80% 33/34 97% 124/152 82%

* Note: More than 30% of countries did not provide an answer to this question

* Note: More than 30% of countries did not provide an answer to this question

The majority of countries report having a quality management system in place testing medicines for both registration and post-marketing surveillance.

The government quality control laboratory is the most commonly used laboratory for testing.

Median Median Median Median [25th , 75th percentile] [25th , 75th percentile] [25th , 75th percentile] [25th , 75th percentile]

817 812 288 5500

[111, 2884] [334, 2362] [150, 663] [2700, 9500] Number of samples tested*

n=30 n=41 n=17 n=88

*

31 45 6 30

[6, 125] [15, 93] [3, 30] [5, 89] Number of samples that failed*

n=28 n=38 n=17 n=83*

Regulatory system

31

Figure 3.6.1: Quality management system in 2007 by WHO region

At least two thirds of countries throughout all WHO regions report having a quality management system in place.

The proportion of countries with a quality management system is greatest in the European Region and least in the African Region.

3.7 Pharmacovigilance


Adverse drug reactions (ADRs are a common, though often preventable cause of illness, disability and even death. The system of pharmacovigilance is understood to be a tool to detect, assess, understand and prevent ADRs. Every country should have a pharmacovigilance system in place to safeguard public health.9,16

After initial testing during the clinical trials process, mainly for short-term safety and efficacy, pharmacovigilance provides the surveillance and long-term monitoring of medicines for potential side-effects during the period of clinical use. These side-effects might only occur when the medicines are used for the first time by a considerable number of people belonging to a specific population group, or when given in combination with other medications, which may entail negative interactions.


32


Table 3.7 provides data on the monitoring of ADRs in countries by income level. Figure 3.7.1 shows the number of countries monitoring ADRs in the different WHO regions.

Table 3.7: Monitoring of adverse drug reactions (ADRs)




%


%


%


%

yes

Monitoring of ADR 24/48 50% 46/72 64% 34/35 97% 104/155 67%

Local level* 15/23* 65% 30/42* 71% 24/32 75% 69/97* 71%

Regional level* 18/25* 72% 26/40* 65% 22/30 73% 66/95* 69%

Central level* 21/25* 84% 43/46* 93% 32/33 97% 96/104* 92%

International reporting of ADRs 14/42 33% 34/68 50% 28/33 85% 76/143 53%


Only half of the low-income countries monitor ADRs and only one third report ADRs internationally, whereas most high-income countries both monitor ADRs and report them internationally.

Regulatory system

33

Figure 3.7.1: Countries monitoring ADRs in 2007 by WHO region

Figure 3.7.2: Countries monitoring ADRs in 2003 and 2007 by income level

ADRs are monitored in most countries in the European and South-East Asian Regions but by less than 60% of countries in the African, Americas and Western Pacific Regions.

There has been some increase in the number of countries monitoring ADRs among low-income and high-income countries.


34

3.8 Counterfeit medicines


Counterfeit medicines, whether branded or generic, are deliberately or fraudulently mislabelled with respect to identity or source and may have fake packaging. These products may contain the wrong ingredients, an inappropriate dosage or lack active substances and therefore pose a major threat to health. As counterfeit drugs are trafficked across borders, all countries should assume their responsibility to contribute to global efforts to combat illicit trade of these potentially life-threatening products by taking measures to detect and combat counterfeit medicines at national level.17


Table 3.8 shows the number of countries with laws, regulations, programmes or procedures to detect and combat counterfeit medicines.

Table 3.8: Counterfeit medicines




%


%


%


%

yes

Laws or regulations for counterfeit

medicines 28/47 60% 46/70 66% 32/34 94% 106/151 70%

Detect counterfeit medicines by reports from

National authorities 28/37 76% 56/64 88% 32/33 97% 116/134 87%

Specific/ ad hoc studies 20/30* 67% 49/55 89% 26/31 84% 95/116 82%

From the pharmaceutical sector 29/36 81% 62/68 91% 32/32 100% 123/136 90%

Civil society/NGOs 15/30* 50% 50/57 88% 28/31 90% 93/118 79%


More than 90% of high-come countries as compared to only 60% of low-income countries report having laws, regulations, programmes or procedures for detecting and combating counterfeit medicines.

All countries report using all sources to detect and combat counterfeit medicines (e.g. national authorities and specific / ad hoc studies). However, civil society, NGO and ad hoc studies are used less often in low-income than in high-income countries.

Regulatory system

35

Figure 3.8.1

Countries with mechanisms to detect and combat counterfeit medicines in 2007 by WHO region

The proportion of countries with mechanisms to detect and combat counterfeit medicines is greatest (nearly 100%) in the European Region and least (less than 50%) in the African Region.

3.9 Summary

This chapter describes the existence of medicines regulations and legislation in countries. A legislative framework is required to implement and enforce pharmaceutical policies both in the public and private sectors. Almost all countries report the presence of a regulatory authority.

The WHO Certification Scheme as part of the marketing authorization process is most frequently used by low-income countries. A computerized system for medicines registration exists in only about half of the low- but in almost all middle- and high-income countries. Most countries use the INN in registration of medicines.

Most countries across all income levels have legal provisions for licensing and premises inspection of manufacturers and importers of medicines.

Quality control is important to ensure that patients receive medicines that are of assured quality, safe and effective. MRAs should have access to a quality control laboratory to test whether samples of medicines meet the required quality criteria.


36

Almost all high-income countries report having a quality management system in place and monitor ADRs, while for low-income countries only 50% monitor ADRs and less than 70% have a quality management system in place. However, there has been an increase in the number of countries with an ADR monitoring system in low-income countries in 2007 compared to 2003. Nearly all high-income countries report having laws and regulations related to counterfeit medicines while only about two thirds of low- and middle-income countries report having such laws and regulations.


37

4. Medicines supply system


A well-coordinated medicines supply system helps to ensure that funds available for medicines purchases are used effectively and efficiently. Failures in the supply system can lead to life-threatening medicines shortages and waste of scarce resources. The 2004-2007 WHO Medicines Strategy aimed to support the development of an efficient mixed medicines supply system of public, private and NGO procurement, storage, and distribution services.3

Individual facility-based purchasing may be intended to improve the efficiency of medicines management by locating decisions about medicines purchasing closer to the point of use, thus maximizing responsiveness to local needs. However, medicines purchasing by individual health institutions often lacks transparency, and may not benefit from the economies of scale due to bulk purchasing and centralized tender and procurement. In higher-income countries, better infrastructure and a more competitive market among private medicine wholesalers can mitigate the possible inefficiencies of individual purchasing.


Table 4.1 provides data on public sector procurement and distribution and table 4.2 illustrates the use of the Essential Medicines List (EML) and tender processes in procurement.


38

Table 4.1: Public sector procurement and distribution




%


%


%


%

yes

PSP pooled at national level 38/44 86% 59/72 82% 24/32 75% 121/148 82%

Responsible for Public Sector Procurement

Ministry of health 42/45 93% 66/69 96% 14/24* 58% 122/138 88%

NGO* 12/32 38% 10/39 26% 2/20 10% 24/91* 26%

Private institution* 14/35 40% 8/40* 20% 4/20* 20% 26/95* 27%

Individual health institution* 17/32 53% 25/48 52% 11/21 52% 53/101* 52%

Responsible for Public Sector Distribution

Ministry of health* 27/28 96% 41/51 80% 8/20 40% 76/99* 77%

NGO* 8/22 36% 10/29 34% 1/18 6% 19/69* 28%

Private institution* 13/25 52% 13/34 38% 4/17 24% 30/76* 39%

Individual health institution* 10/23 43% 18/35 51% 10/18 56% 38/76* 50%


Ministries of health are the main public sector procurement agencies, followed by individual health institutions, although private institutions and NGOs also play an important role in low-income countries.

Ministries of health are the main distribution agencies in low-income countries but these countries also involve NGOs and private organizations in distribution of medicines.

Ministries of health play a much larger role in procurement and distribution of medicines in low-income countries than in high-income ones.


39

Table 4.2: Essential medicines lists (EML), procurement and tender process




% yes


% yes


% yes


% yes

Public sector procurement limited to EML* 25/34 74% 37/41* 90% 12/13* 92% 74/88* 84%

provisions for medicines outside EML 34/47 72% 41/71 58% 13/30 43% 88/148 59%

participation in pooled procurement scheme 2/43 5% 12/64 19% 5/24 21% 19/131 15%

Tender board overseeing public sector procurement 38/46 83% 58/69 84% 16/23 70% 112/138 81%

separation of procurement office/tender committee 30/38 79% 49/56 88% 14/16* 88% 93/110 85%

Use of WHO Prequalification system 29/43 67% 32/62 52% 7/20* 35% 68/125 54%

Type of tender

National competitive tender 30/36 83% 49/59 83% 12/18* 67% 91/113 81%

International competitive tender 36/42 86% 43/61 70% 13/18* 72% 92/121 76%

Negotiation/ direct 34/37 92% 47/57 82% 14/17* 82% 95/111 86%


In the majority of countries public sector procurement is limited to the EML.

While provision for purchasing medicines outside the EML appears to be higher in low-income than in high-income countries, EMLs in high-income countries contain many more medicines (see table 7.1.1).

In the majority of countries, an independent tender board committee oversees public sector procurement.

The WHO Prequalification Scheme is used most often in low-income countries and to a much lesser extent in high-income countries.


40

11/143/3

17/208/811/12

24/31

0%

20%

40%

60%

80%

100%

Afric

a

Am

eric

a

Eas

tern

Med

iterr

anea

n

Eur

ope

Sou

th-E

ast

Asi

a

Wes

tern

Pac

ific

Figure 4.1: Countries limiting public sector procurement to EML in 2007 by WHO region

Figure 4.2

Countries limiting public sector procurement to EML in 2003 and 2007 by income level

Most responding countries across all regions limit public sector

procurement to their national EML. An increasing number of high- and middle-countries have limited their

public sector procurement to the EML in 2007 as compared to 2003.


41

Figure 4.3: Countries using the WHO Prequalification Scheme in 2007 by WHO region

The WHO Prequalification Scheme is used by most countries in the African Region and by at least one third of countries in other WHO regions.

4.3 Summary

This chapter describes the medicines supply systems that exist in countries. A well-coordinated medicines supply system aims to ensure that funds available for medicines purchases are used effectively and efficiently. Many countries employ a mixed medicines supply system incorporating public, private and NGO procurement, storage and distribution services. While the public sector is responsible for procurement and distribution, in many countries these functions are also undertaken by the private and NGO sectors.

In most low-income countries public sector procurement is generally pooled at national level and ministries of health are the main public sector procurement agencies. Low-income countries report most frequently using national competitive tender whereas direct negotiations and purchasing is the method most commonly used in high-income countries. Seventy-five per cent of low-income countries and 90% of middle- and high-income countries limit their public sector procurement to their national EML. Fifty per cent of the middle-income, 70% of low-income countries and 35% of high-income countries, report using the WHO Prequalification Scheme.


42

Medicines financing

43

5. Medicines financing


In developing countries, medicine expenditures account for 25%-65% of total public and private health expenditures, and for 60%-90% of out-of-pocket household expenditures on health.19 Households are more likely to incur catastrophic expenditures (greater that 40% of income, after subsistence needs are met) when health services require payments (including for medicines), households are poor, and when there is no prepayment or health insurance scheme.19

WHO is committed to providing guidance to countries on the development of strategies to promote fair financing mechanisms to improve medicines supply, especially in the public sector, and to improve the affordability of essential medicines in both the private and public sectors.3 Increased public funding is important to achieve high public health impact and equitable access in most countries. Another strategy is the provision of medicines benefits through social health insurance and prepayment schemes.3

Access to specific treatments for high priority conditions has life-saving implications for individuals and major public health benefits for the community. While user fees have some advantages if managed properly, they tend also to disproportionately burden the poor. Fees from medicines sales can create perverse incentives to prescribe inappropriately and should be discouraged unless a strict medicines use audit is in place.20

A medicines pricing policy is another important strategy since the price of medicines is one of the most important obstacles to access. Pricing regulation and policies can provide a good basis for equitable access, provided they are effectively enabled. Medicine prices can be inflated in current market environments. In recent years WHO has put efforts into developing a standardized methodology for surveying medicine prices and has conducted numerous pricing surveys in WHO regions.21


Table 5.1 shows which medicines are provided free of charge in countries of the three income groups and which patients are most likely to receive free medicines. Table 5.2 illustrates what types of fees are charged in public health facilities and whether they are used to pay for prescriber salaries. Table 5.3 shows countries’ total and per capita public expenditure on medicines. Tables 5.4a and 5.4b show the percentage of countries where per capita public expenditure on medicines is lower than US$2. Table 5.5 illustrates the situation of health insurance and the degree of medicines coverage by health insurance in countries. Information on monitoring of and guidelines on medicine prices and donations is provided in table 5.6. Finally table 5.7 provides data on pricing policies in different sectors.


44

Table 5.1: Types of free medicines and patients receiving free medicines



% yes


% yes


% yes


% yes

National policy including some medicines free of charge

43/46 93% 71/71 100% 33/33 100% 147/150 98%

Types of free medicines

All medicines 13/37 35% 36/61 59% 11/20* 55% 60/118 51%

Malaria medicines* 19/32* 59% 39/54 72% 8/17* 47% 66/103* 64%

Tuberculosis medicines 38/38 100% 56/61 92% 17/18* 94% 111/117 95%

Sexually transmitted infections medicines* 17/34 50% 39/55 71% 11/18* 61% 67/107* 63%

HIV/ AIDS-related medicines 35/38 92% 54/58 93% 15/18* 83% 104/114 91%

At least one vaccine 38/39 97% 57/57 100% 18/18* 100% 113/114 99%

Patients who receive free medicines

Patients who cannot afford medicines 32/40 80% 47/62 76% 15/20* 75% 94/122 77%

Children under 5 years of age 28/38 74% 46/61 75% 10/19* 53% 84/118 71%

Older children* 14/33 42% 34/56 61% 10/19* 53% 58/108* 54%

Pregnant women 25/35 71% 42/60 70% 11/20* 55% 78/115 68%

Elderly people 18/33 55% 39/57 68% 10/19* 53% 67/109 61%


The majority of countries provide some medicines free of charge, these most often being TB and HIV/ AIDS-related medicines.

Medicines for malaria and sexually transmitted infections are more likely to be available free of charge in middle-income countries than in low- or high-income ones.

In most countries patients who cannot afford medicines are the main recipients of free medicines.

The proportion of countries providing free medicines to children under five years and pregnant women appears to be greater in low- and middle-income than in high-income countries.

About 60% of countries provided free medicines for the elderly, more so in middle-income countries than in low- or high-income countries.

Medicines financing

45

Figure 5.1.1: HIV/AIDS-related medicines provided free at primary health care facilities in 2007 by WHO region

Figure 5.1.2: HIV/AIDS-related medicines provided free at public primary care facilities

in 2003 and 2007 by income level

Most countries in all regions provide free medicines for HIV/AIDS at primary health care facilities.

Free medicines for HIV/AIDS at primary health care facilities are considerably more common in 2007 than they were in 2003.

The most significant increase is to be found in the low-income group of countries, in which more than twice as many countries provide HIV/AIDS medicines for free in 2007 compared to 2003.


46

Figure 5.1.3. Countries providing free medicines to pregnant women at public primary health care facilities in 2007 by WHO region

Figure 5.1.4 Countries providing free medicines to pregnant women in 2003 and 2007 by income level

Pregnant women are most likely to receive free medicines in primary care facilities in the Americas Region and least likely in the European Region.

An increasing number of high- and low-income countries provide medicines free of charge to pregnant women.

Medicines financing

47

Table 5.2: Free provision of medicines and types of fees in public health facilities




%


%


%


%

yes

Types of fees charged

Registration/ consultation fees 43/43 100% 64/64 100% 23/23* 100% 130/130 100%

Dispensing fees 13/38 34% 11/61 18% 8/23* 35% 32/122 26%

Flat fees for medicines 9/32* 28% 14/63 22% 8/23* 35% 31/118 26%

Flat rate co-payments for medicines 7/29* 24% 10/60 17% 4/23* 17% 21/112 19%

Percentage co-payments for medicines

6/29* 21% 18/60 30% 10/22* 45% 34/111 31%

Fees are used to pay salaries** 22/44 50% 12/61 20% 3/31 10% 37/136 27%

Prescribers dispensing medicines - Public Sector**

28/43 65% 28/69 41% 8/24 33% 64/136 47%

Prescribers dispensing medicines - Private Sector**

29/37 78% 37/62 60% 12/23* 52% 78/122 64%

* Note: More than 30% of countries did not provide an answer to this question. ** Yes = Always + Frequently + Occasionally

All countries appear to charge registration/consultation fees in primary health care facilities.

While 50% of low-income countries use medicines revenue to pay prescriber salaries, only 20% of middle-income and 10% of high-income countries do so.

The likelihood of prescribers dispensing medicines in the public sector increases with decreasing country income level, occurring in two thirds of low-income but only one third of high-income countries.

The likelihood of prescribers dispensing medicines in the private sector is much greater than in the public sector, occurring in more than three quarters of low-income and about half of high-income countries.


48

Table 5.3: Total public expenditure for medicines

* Note: More than 30% of countries did not provide an answer to this question. ** Data can be compared with more recent information reported in the OECD publication,

Pharmaceutical Pricing Policies in a Global Market, Figure. 1.12, p.68. Table 5.4: Countries with per capita public expenditure on medicines lower than US$ 2 a)

Country income level Low Middle High TOTAL


% yes


% yes


% yes


% yes

20/31 65% 5/56 9% 0/18 0% 25/105 24%

b)

Region Responding countries Countries with pub. exp. < US$ 2 % AFRO 28 17 61% AMRO 22 1 5% EMRO 9 2 22% EURO 21 4 19%

SEARO 3 0 0% WPRO 22 1 5%

Total public or government expenditure on medicines is markedly higher in high-income countries than in middle- and low-income countries.

In about 60% of low-income countries and of countries in the African Region public expenditure on medicines is less than US$ 2 per capita.




[25th, 75th percentile] [25th, 75th percentile] [25th, 75th percentile] [25th, 75th percentile]

$5.9 M $43.4 M $1.7 BN $35.2 M

[$1.4 M, $27.0 M] [$3.2 M, $375.0 M] [$135.0 M, $ 5.0 BN] [$3.0 M, $350.0 M] Total public expenditure (TPE) US$**

n=31* n=56 n=18* n=105*

$0,80 $13,50 $179,60 $8,60

[$0,30, $2,50] [$5,20, $37.60] [$82,40, $437,40] [$ 2,10, $45,30] Total public expenditure (TPE) on medicines per

capita in US$ n=31* n=56 n=18* n=105*

Medicines financing

49

Table 5.5: Health insurance and medicines coverage




%


%


%


%

yes

Health insured population - public sector

All 1/38 3% 18/65 28% 22/31 71% 41/134 31%

Some 25/38 66% 37/65 57% 7/31 23% 69/134 51%

None 12/38 32% 10/65 15% 2/31 6% 24/134 18%

Health insured population - private sector

All 1/33 3% 8/59 14% 19/31 61% 28/123 23%

Some 28/33 85% 49/59 83% 12/31 39% 89/123 72%

None 4/33 12% 2/59 3% 0/31 0% 6/123 5%

Medicines covered by health insurance - public sector

All 1/41 2% 10/62 16% 15/33 45% 26/136 19%

Some 25/41 61% 38/62 61% 13/33 39% 76/136 56%

None 15/41 37% 14/62 23% 5/33 15% 34/136 25%

Medicines covered by health insurance - private sector

All 2/34 6% 6/55 11% 14/29 48% 22/118 19%

Some 27/34 79% 42/55 76% 14/29 48% 83/118 70%

None 5/34 15% 7/55 13% 1/29 3% 13/118 11%

Less than 5% of low-income countries have public health insurance coverage of all the population, while more than 70% of high-income countries have public health insurance of all the population.

More than one third of low-income countries do not have any public health insurance that covers medicines.

The likelihood of public or private health insurance covering the cost of medicines increases with country income-level.

Private health insurance coverage is more likely to provide medicines benefits across all country income levels.


50

17/44

34/46

17/44

26/41

48/62

28/33

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

20072003

Figure 5.5.1

Countries with medicines covered by public health insurance in 2007 by WHO region

Figure 5.5.2 Countries with medicines covered by public health insurance in 2003 and 2007 by income level

Public health insurance systems are mostly likely to cover medicines in the European and Americas Regions and least likely to cover them in the African and South-East Asian Regions.

The number of countries in which medicines are covered by public health insurance appears to have increased in low-income countries.

Medicines financing

51

Table 5.6: Monitoring, information and guidelines on medicine prices and donations




% yes


% yes


% yes


% yes

Policy covering medicine prices

Public sector 26/46 57% 43/70 61% 27/31 87% 96/147 65%

Private sector 17/41 41% 38/62 61% 26/31 84% 81/134 60%

NGO 6/35 17% 16/49 33% 20/25 80% 42/109 39%

Policies covering medicines - public sector*

Maximum wholesale mark-up 19/30 63% 25/43 58% 20/26 77% 64/99* 65%

Maximum retail mark-up* 18/28 64% 29/45 64% 21/27 78% 68/100* 68%

Duty on raw pharmaceutical materials* 15/29 52% 15/43 35% 2/11 18% 32/83* 39%

Duty on finished pharmaceutical materials* 19/32 59% 19/43 44% 3/12 25% 41/87* 47%

Policies covering medicines - private sector*

Maximum wholesale mark-up* 14/23 61% 30/38 79% 22/27 81% 66/88* 75%




Policies covering medicines – NGO*

Maximum wholesale mark-up* 3/17 18% 15/29 52% 15/18 83% 33/64* 52%





Policies covering medicine prices in the public, private and NGO sectors are more common in high-income countries than in low- and middle-income countries.

Duty on pharmaceuticals in all three sectors decreases with country income level.

Wholesale and retail mark-ups increase with country income level in the NGO and private sectors but not in the public sector.


52

Figure 5.6.1 Countries with medicine pricing policy in the public sector in 2007 by WHO region

Figure 5.6.2

Countries with medicine pricing policy in the public sector in 2003 and 2007 by income level

Policies covering medicine prices in the public sector are more common in the European and South-East Asian Regions than in the Americas and African Regions.

Pricing policies in the public sector have increased significantly in high-income countries between 2003 and 2007 but have remained essentially the same in low- and middle-income countries.

Medicines financing

53

Table 5.7: Policies on medicine pricing covering different sectors




%


%


%


%

yes

Monitoring, information and guidelines on medicine prices and donations - public sector

Monitoring system for prices 18/45 40% 40/69 58% 24/31 77% 82/145 57%

Regulations on accessibility of medicine price information

14/45 31% 28/67 42% 23/32 72% 65/144 45%

Guidelines on medicine donations 33/44 75% 47/67 70% 14/19* 74% 94/130 72%

Monitoring, information and guidelines on medicine prices and donations - private sector



9/37 24% 23/55 42% 23/32 72% 55/124 44%

Guidelines on medicine donations* 25/36 69% 27/48* 56% 8/15* 53% 60/99* 61%

Monitoring, information and guidelines on medicine prices and donations - NGOs



4/34 12% 15/49 31% 19/29 66% 38/112 34%

Guidelines on medicine donations* 26/34 76% 28/44 64% 7/14* 50% 61/92 66%


Retail price monitoring systems in the public, private and NGO sectors exist more commonly in high-income countries than in low- and middle-income countries.

Official written guidelines on medicine donations are more common in low-income countries.


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7/21

4/6

31/34

14/3020/41 6/13

4/16

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26/338/12

11/2816/34

0%20%40%60%80%

100%

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Europe

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Pacific

PublicPrivate

Figure 5.7.1 Countries monitoring prices in the public and private sectors in 2007 by WHO region

Countries in the European Region are most likely to have a system for monitoring medicine retail prices.

5.3 Summary

This chapter describes the medicine financing and pricing policies that exist in countries. WHO is committed to helping countries develop strategies to promote fair financing mechanisms to improve the affordability and availability of essential medicines in the private and public sectors.3 Key strategies to improve access to affordable medicines include increased public funding to improve medicines supply, especially in the public sector, the provision of medicines benefits through social health insurance and prepayment schemes, and the use of pricing regulation and policies.3 Pricing policies for medicines are most common in high-income countries. Almost all countries across all income groups report providing at least some medicines free of charge. The number of countries providing HIV/AIDS-related medicines for free at public primary health care facilities has increased significantly since 2003. Similarly, an increasing number of countries provide medicines free of charge to pregnant women.

More than half of low- and middle-income countries have public health insurance that covers at least some medicines in the public sector, while virtually all high-income countries have public health insurance that covers some or all medicines. One third of low-income countries have no public health insurance that covers medicines.

Medicines financing

55

It is very important for countries to avoid creating perverse financial incentives that encourage overuse of medicines, such as occurs when prescribers sell medicines. Fifty per cent of low-income countries, compared to 10% of high-income countries, use revenue from the sale of medicines to pay prescriber salaries. In the public sector, prescribers dispense medicines in two thirds of low-income and in one third of high-income countries and in the private sector they dispense in three quarters of low-income and in more than half of high-income countries.


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57

6. Production and trade


Intellectual property rights have a significant impact on the affordability and availability of medicines and thereby on public health. The World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires WTO Members to provide minimum standards of intellectual property protection, including patent protection. Patent protection grants exclusive rights to the patent holder for the use, manufacture and sale of a medicine. During the term of the patent, the patent holder has a monopoly on the medicine, which prevents generic competition as a means of reducing prices. However, TRIPS-compliant mechanisms can be used to provide access to lower-priced medicines22 for low-income groups in developing countries who cannot pay the same prices for newer medicines as those affordable in wealthier countries.

It is crucial that countries assess the impact of the TRIPS Agreement and other international, regional and bilateral trade agreements and consider adapting national legislation to incorporate all flexibilities available in the TRIPS Agreement (see below) to safeguard access to essential medicines for all.3 WHO supports Member States in the use of TRIPS flexibilities to enhance the affordability and availability of medicines. These safeguards also include setting criteria for the patentability of pharmaceuticals which adequately reflect public health concerns; legislative provisions for compulsory licensing; government use authorization; parallel import; exceptions to exclusive patent rights: and other measures that promote generic competition and extension of the transition period.

There are variations in the manner in which governments have incorporated the provisions for such flexibilities into national laws.23 As a result, there are limitations in the completeness of the information on TRIPS flexibilities as presented in the tables below. For example, although provisions for parallel import may exist in some countries, there may be limitations which restrict its use – as, for example, when the explicit consent of the patent holder is required before parallel importation can take place. In such cases, the so-called flexibility is lost. Another factor is the existence of essentially two kinds of parallel importation regimes: international exhaustion and regional exhaustion. When the international exhaustion regime is incorporated into the national law, parallel import of a product will be permitted into the country from anywhere else, whereas regional exhaustion (as for the whole of the European Union) allows products to be imported only from within a particular regional grouping. There may therefore be differences in the parallel import provisions that will be important in determining whether or not the flexibilities are maintained.

Such variations also exist in countries in terms of their provisions for compulsory licensing. Whilst compulsory licensing provisions exist within most national laws, the provisions may differ, for example, in terms of the various grounds on which a compulsory licence may be granted. It was agreed


58

in the Doha Declaration concerning the TRIPS Agreement and Public Health that WTO Members were free to determine the grounds on which compulsory licences may be granted. However, this flexibility may not have yet been properly incorporated in the appropriate national laws.

Article 65 of the TRIPS Agreement established three separate and different transition periods. The first transition period ended in 1995, when developed country WTO Members were required to implement the TRIPS Agreement and developing country Members had to implement the basic TRIPS provisions of most-favoured nation and national treatment. The second transition period ended on 1 January 2000, when developing countries and centrally-planned economies were required to implement the TRIPS Agreement. The third transition period expired on 1 January 2005, at which time those countries which had delayed product patent protection for certain types of products and technology (such as pharmaceuticals) were required to provide such protection.

This chapter provides information about national policies on medicines-related intellectual property rights. Some information is also included below on local production of medicines aimed at improving access to high-quality, low-cost medicines. A key challenge is to determine whether the criteria for successful local production are being met, so that investment in local production is not at the expense of the cost or quality of medicines.


Table 6.1 shows how many countries have medicines production capability. Table 6.2 provides data on patents and TRIPS flexibilities.

Table 6.1: Country production capability




%


%


%


%

yes

Medicines production capability

R&D of new active substances 7/44 16% 17/64 27% 12/21* 57% 36/129 28%

Production of pharmaceutical starting materials

7/45 16% 21/68 31% 12/21* 57% 40/134 30%

Formulation from starting materials 34/45 76% 57/71 80% 19/21* 90% 110/137 80%

Repackaging of finished dosage forms 38/46 83% 54/69 78% 17/21* 81% 109/136 80%



59

Research and development are confined mostly to high-income countries.

Production in most countries consists of repackaging finished dosage forms and formulation from starting materials.

Table 6.2: Patents and TRIPS flexibilities




%


%


%


%

yes

Patents granted by national office 22/38 58% 53/64 83% 32/34 94% 107/136 79%

National legislation modified to implement TRIPS

17/31 55% 41/54 76% 25/29 86% 83/114 73%

TRIPS Article 65* 12/27 44% 18/43 42% 6/25 24% 36/95* 38%

TRIPS Article 66* 14/25 56% 7/30 23% 3/19 16% 24/74 32%

Doha Declaration (Article 7)* 16/26 62% 16/41 39% 3/23 13% 35/90* 39%

TRIPS flexibilities incorporated into national legislation

Yes 18/33 55% 35/56 63% 12/18 67% 65/107* 61% Compulsory licensing*

CBD** 6/33 18% 12/56 21% 3/18 17% 21/107* 20%

Yes 13/29 45% 23/48 48% 8/17 47% 44/94* 47% Government use*

CBD** 6/29 21% 12/48 25% 3/17 18% 21/94* 22%

Yes 12/33 36% 26/54 48% 11/20 55% 49/107* 46% Parallel importing provisions* CBD** 8/33 24% 11/54 20% 2/20 10% 21/107* 20%

Yes 6/26 23% 26/48 54% 10/16 63% 42/90* 47% The Bolar exception*

CBD** 7/26 27% 8/48 17% 2/16 13% 17/90* 19%

* Note: More than 30% of countries did not provide an answer to this question. ** CBD = Currently being discussed


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7/192/5

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In more than 50% of low-income countries and in more than 90% of high-income countries, patents on pharmaceutical products are granted by the national patent office.

More than 2/3 of the WHO Member States which are also WTO Members have modified their national legislation to implement the TRIPS Agreement, this being more common in high-income countries than in low- and middle-income countries.

Of the four listed TRIPS flexibilities, the "compulsory licensing provision" is the most common flexibility incorporated into national legislation.

High-income countries have more TRIPS flexibilities incorporated into national legislation than low- and middle-income countries.

Figure 6.2.1: Countries with provision for parallel importing in 2007 by WHO region


61

19/31 13/26

6/914/17

3/5 10/19

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Figure 6.2.2: Countries with provision for parallel importing in 2003/2007 by income level

Countries in the European Region are most likely to include provisions for parallel importing in their legislation.

As of 2007, an increased number of middle-income countries had incorporated parallel importing into their legislation.

Figure 6.2.3: Countries with provision for compulsory licensing in 2007 by WHO region


62

Figure 6.2.4 Countries with provision for compulsory licensing in 2003/2007 by income level

Compulsory licensing provisions were used by more countries in 2007 than in 2003.

Countries in the European Region are most likely to include provisions for compulsory licensing in their legislation.

6.3 Summary

This chapter looks at national policies and issues regarding medicines-related intellectual property rights. Intellectual property rights have a significant impact on the affordability and availability of medicines and thereby on public health.3 The WTO Agreement on TRIPS requires WTO Members to implement and enforce minimum standards of intellectual property rights. However, the 2001 Doha Declaration on the TRIPS Agreement and Public Health confirmed that TRIPS-compliant mechanisms and flexibilities can be used to enable access to lower-priced medicines.

Over 80% of middle-income and almost all high-income countries have patent protection for pharmaceutical products, compared to only about 50% of low-income countries. The situation is similar for countries reporting to have modified their national legislation to implement TRIPS.


63

Only one third of low-income and half of the middle-income countries report having parallel importation provisions in their legislation compared with 60% of high-income countries. Compulsory licensing is the provision most frequently used across all income level groups.

Local production of medicines is aimed at improving access to high-quality, low-cost medicines. A key challenge is to determine whether the criteria for successful local production are met, to ensure that investment in local production is not at the expense of the cost or quality of medicines.

The production capability of countries increases with income level. Most low-income countries report having the capability to formulate from starting materials and repackaging of finished dosage forms but only a few report having the capability for the research and development of active substances and the production of pharmaceutical starting materials.


64

Essential medicines and rational use

65

7. Essential medicines and rational use

Rational use of medicines means that “patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community”.1 Overuse, underuse and misuse of medicines may lead to unnecessary suffering and death, and waste of scarce resources. Examples of irrational use of medicines include:

• use of antibiotics for non-bacterial illnesses, thus contributing to increased antimicrobial resistance (AMR);

• non-adherence to recommended dosing regimens, thereby preventing desired therapeutic outcomes from being achieved and potentially increasing the spread of AMR;

• use of expensive and frequently unsafe injections when less expensive oral formulations would be more appropriate, contributing to increased incidence of hepatitis B and C and HIV.

Many factors influence the use of medicines and therefore countries need to implement a range of different strategies to improve rational use. Some policies, strategies and interventions found to be of value include: creating a mandated multi-disciplinary national body to coordinate policies on medicines use; standard treatment guidelines (STGs) for common conditions; using essential medicines lists (EMLs) to guide procurement and training; establishing Drug and Therapeutics Committees (DTCs) to coordinate medicines management in hospitals; implementing problem-based pharmacotherapy training in undergraduate curricula; mandating continuing in-service medical education as a licensure requirement; establishing effective supervision in health systems; using audit and feedback to inform clinicians and facilities about their practice; developing independent sources of information about medicines for providers and consumers; avoiding perverse financial incentives to overuse medicines; establishing and enforcing a sound regulatory framework; and guaranteeing sufficient government expenditure to ensure availability of medicines and retain well-trained staff.24,25

7.1 Essential medicines list, treatment guidelines, formularies


The essential medicines concept is the basis for rational use of medicines.6 Ideally, countries develop and routinely update EMLs and medicines formularies that meet the needs of the population according to a number of criteria, including disease patterns, patient characteristics, treatment recommendations formulated in standard treatment guidelines, and level of care provided. Using an EML makes medicines management easier in all


66

respects: procurement, storage, and distribution are easier with fewer items, and prescribing and dispensing are more straightforward for health professionals if they have to know about fewer medicines. A national EML should be based on national STGs and should follow a careful selection process.26

Together an EML and STG help to ensure rational drug use. STGs should be developed for each level of care, based on prevalent clinical conditions and the skills of prescribers practising at that level. These consist of systematically developed statements to help prescribers make decisions about appropriate treatments for specific clinical conditions, providing a benchmark for satisfactory diagnosis and treatment. Adherence to the recommendations in the STG should be reinforced by prescription audit and feedback.

A formulary can be an important source of evidence-based information about medicines but it is important that it is consistent with the STGs and EML if all three strategies are to achieve the maximum overall effect.


Table 7.1.1 and figures 7.1.1 and 7.1.2 provide data on countries with a national EML. Table 7.1.2 and figures 7.1.3 and 7.1.4 give information on countries with STGs and a medicines formulary.


67

Table 7.1.1: Essential medicines lists (EMLs)




%


%


%


%

yes

Existence of national EML 48/48 100% 63/73 86% 23/34 68% 134/155 86%

update of EML within last 5 years*** 39/48 81% 54/73 74% 14/34 41% 107/155 69%

Use of EML in different sectors

Public sector procurement 44/46 96% 59/65 91% 22/22* 100% 125/133 94%

Public insurance reimbursement * 14/40 35% 20/50* 40% 13/18* 72% 47/108* 44%

Private insurance reimbursement * 4/35 11% 6/49* 12% 2/8* 25% 12/92* 13%

Committee for EML drugs selection 38/44 86% 59/67 88% 19/19* 100% 116/130 89%


[25th , 75th percentile] [25th , 75th percentile] [25th , 75th percentile] [25th , 75th percentile]

355 441 1706 397

[272, 384] [350, 601] [1143, 3272] [334, 580] Number of medicines in EML

n=34 n=52 n=8* n=94*

* Note: More than 30% of countries did not provide an answer to this question *** Since many countries with a national EML did not provide dates and very few indeed

provided dates of earlier than 5 years previously, it was assumed that those countries not providing dates had not updated their EML in the last 5 years

All low-income countries and most middle-income countries have a national EML.

EMLs are commonly used in public sector procurement across all countries and in public health insurance reimbursement in high-income countries.

EMLs are not commonly used for private health insurance reimbursement.


68

21/256/627/3613/1525/3142/42

0%

20%

40%

60%

80%

100%

Afri

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Am

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a

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Med

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Eur

ope

Sou

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Asi

a

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Pac

ific

55/56

52/60

6/18

48/48

63/73

23/34

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

20072003

Figure 7.1.1: Countries with national essential medicines list in 2007 by WHO region

Figure 7.1.2: Countries with Essential Medicines List in 2003 and 2007 by income level

The number of countries with a national EML has increased significantly in high-income countries between 2003 and 2007.

The European Region appears to have the lowest proportion of countries with a national EML.


69

Table 7.1.2: Standard treatment guidelines (STGs) for major conditions and formulary manuals




% yes


% yes


% yes


% yes

National STG* 42/47 89% 52/69 75% 24/30 80% 118/146 81%

update of STG within last 5 years*** 29/47 62% 29/69 42% 7/30 23% 65/146 45%

Hospital STG 25/38 66% 36/60 60% 24/29 83% 85/127 67%

Primary health care STG 28/39 72% 46/63 73% 25/28 89% 99/130 76%

STGs for key paediatric illnesses 31/45 69% 40/62 65% 25/29 86% 96/136 71%

Medicines formulary manual 26/46 57% 49/71 69% 23/33 70% 98/150 65%

update of formulary within last 5 years*** 17/46 37% 32/71 45% 12/33 36% 61/150 41%

Covering only EML medicines * 16/26* 62% 27/45* 60% 14/23* 61% 57/94* 61%

* Note: More than 30% of countries did not provide an answer to this question *** Since many countries with STGs and formularies did not provide dates and very few indeed

provided dates of earlier than 5 years previously, it was assumed that those countries not providing dates had not updated their STGs and formularies in the last 5 years

Most countries have national STGs. Only about two thirds of low-income countries and one quarter of high-

income countries appear to have guidelines that have been updated within the last five years.

Low-income countries tend to have STGs at the national level more often than at the hospital and primary care level, while high-income countries tend to have hospital and PHC guidelines rather than national ones.

The majority of high-income countries have paediatric STG but only about two thirds of middle- and low-income countries have STG for key paediatric illnesses.

Medicines formulary manuals exist in more than 50% of the low-income countries and in about 70% of the middle- and high-income countries.

Less than half of all countries appear to have formularies that have been updated within the last five years.


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35/52

31/53

7/13

42/47

52/69

24/30

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

20072003

Figure 7.1.3: Countries with national standard treatment guidelines in 2007 by WHO region

Figure 7.1.4

Countries with national standard treatment guidelines in 2003 and 2007 by income level

The number of countries with national STGs has increased significantly between 2003 and 2007 in countries across all income levels.

The proportion of countries with national STGs appears to be less in the South-East Asian, Eastern Mediterranean and Western Pacific Regions.


71

7.2 Education and information about rational use


Rational medicines use depends on the knowledge, attitudes, and behaviours of prescribers and patients. Rational pharmacotherapy training, linked to STG and an EML, can help establish good prescribing habits and should be part of the basic curricula of medical, nursing and pharmacy students. In-service education allows health workers to keep up-to-date with changes in pharmacotherapy, to become familiar with policies, and to share experiences and learn from peer discussion. In some countries, continuing education is a licensure requirement for health professionals. Continuing education is more likely to be effective if it is problem-based, face-to-face, targeted, and involves professional societies, universities and the ministry of health.24

Patient demand and popular media are important drivers of medicines use. Without sufficient knowledge about the risks and benefits of using medicines, consumers can have unrealistic expectations. Countries should consider a range of strategies to better inform consumers about appropriate medicine use.

Frequently, pharmaceutical company advertising is the only source of easily available medicines information. Advertising directly to consumers should be regulated to limit exposure to unbalanced or inaccurate information about medicines. Unbiased consumer information on medicines use is much needed in the form of public education campaigns or through independent information centres. Targeted public education should take into account the cultural beliefs and social factors that influence medicines use.

Health facilities where medicines are dispensed should also provide adequate information through verbal information and adequate labelling. Both prescription and non-prescription medicines should have labels that are accurate, legible and easily understood.


Table 7.2.1 and figures 7.2.1 and 7.2.2 show which countries include rational use concepts such as EML and STG in the basic curricula of health workers. Table 7.2.2 and figures 7.2.3, 7.2.4, 7.2.5 and 7.2.6 provide data on which countries provide non-commercially funded continuing education programmes and a medicines information centre for health workers, and on whether public education campaigns on medicines use have been carried out.


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Table 7.2.1: Basic training on concepts of rational use of medicines available to health workers Country income level



% yes


% yes


% yes


% yes

EML concepts

Doctors 29/44 66% 39/57 68% 10/16 63% 78/117 67%

Nurses 31/43 72% 37/61 61% 7/14 50% 75/118 64%

Paramedical staff* 14/35 40% 18/46 39% 4/12 33% 36/93 39%

Pharmacists 34/44 77% 40/59 68% 11/17 65% 85/120 71%

STG concepts

Doctors 25/42 60% 36/54 67% 14/16* 88% 75/112 67%

Nurses* 25/42 60% 30/54 56% 10/12* 83% 65/108 60%

Paramedical staff* 11/33* 33% 15/45* 33% 4/9* 44% 30/87 34%

Pharmacists* 26/41 63% 27/52 52% 11/15* 73% 64/108 59%

Pharmacotherapy training

Doctors* 22/38 58% 40/49* 82% 16/16* 100% 78/103* 76%

Nurses* 19/38 50% 25/46* 54% 11/13* 85% 55/97* 57%

Paramedical staff* 8/30* 27% 10/42* 24% 3/9* 33% 21/81* 26%

Pharmacists* 20/39 51% 30/51 59% 14/16* 88% 64/106* 60%

Rational prescribing concepts

Doctors 25/39 64% 41/54 76% 17/17* 100% 83/110 75%

Nurses* 22/40 55% 29/50* 58% 11/15* 73% 62/105* 59%

Paramedical staff* 11/33* 33% 15/47* 32% 3/9* 33% 29/89* 33%

Pharmacists 22/40 55% 33/53 62% 15/16* 94% 70/109 64% * Note: More than 30% of countries did not provide an answer to this question.

EML concepts are taught to medical students in two thirds of countries and to paramedical staff in only about one third of countries irrespective of income status; nurses are much more likely to be trained in the EML concepts in low-income countries compared to high-income ones.

STGs, pharmacotherapy and rational prescribing concepts are more likely to be included in the curricula of all cadres of staff in high-income countries compared to low-income ones.

Only about one third of low-income countries train their paramedical staff in EML concepts, STG, pharmacotherapy and prescribing concepts, even though these staff regularly prescribe medicines.


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a) EML

33/49

25/37

5/8

29/44

39/57

10/16

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

2007

2003

b) STGs

28/45

23/34

6/7

25/42

36/54

14/16

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

2007

2003

Figure 7.2.1

Countries with EML and STGs concepts in basic doctor curricula in 2007 by WHO region

5/5 15/2012/207/1115/2524/36

15/194/517/215/1113/2221/34

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EMLSTGs

Figures 7.2.2a and 7.2.2b:

Countries with (a) EML and (b) STGs in basic doctor curricula in 2003 and 2007 by income level

There is no difference between 2003 and 2007 in the percentage of countries including EML and STG concepts in the basic medical school curricula.

Between 20% and 50% of countries in all regions appear not to train their medical undergraduates in the use of STG.


74

Table 7.2.2: Education and information on medicines for health workers and consumers


Low (48) Middle (73) High (35)* Global (156)


%


%


%


%

yes

Obligatory continuing education

Doctors 23/45 51% 36/67 54% 14/20* 70% 73/132 55%

Nurses/midwives/ paramedical staff 23/43 53% 28/63 44% 13/20* 65% 64/126 51%

Pharmacists 25/45 56% 36/70 51% 12/21* 57% 73/136 54%

Medicines Information Centre

Prescribers 17/47 36% 37/71 52% 18/24* 75% 72/142 51%

Dispensers 16/45 36% 37/71 52% 18/24* 75% 71/140 51%

Consumers 15/45 33% 35/70 50% 15/22* 68% 65/137 47%

Education campaigns in the last 2 years

Use of antibiotics 20/45 44% 36/69 52% 13/21* 62% 69/135 51%

Use of injections 19/43 44% 19/65 29% 5/18* 28% 43/126 34%

Other rational medicine use topics 28/47 60% 39/70 56% 16/22* 73% 83/139 60%


The likelihood of doctors receiving continuing medical education increases with country income.

Medicines Information Centres for prescribers exist in about half or more of high- and middle-income countries but only in about one third of low-income countries.

Only about half of the countries had recently carried out a public education campaign on the use of antibiotics and only one third had done so on the use of injections.


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21/4010/27 7/14

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20/53

28/52

7/9

23/45

36/67

14/20

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

2007

2003

Figure 7.2.3 Countries with obligatory continuing education for doctors in 2007 by WHO region

Figure 7.2.4 Countries with obligatory continuing education for doctors in 2003 and 2007 by income level

The number of low-income countries with obligatory continuing education programmes for doctors has increased slightly between 2003 and 2007.

Continuing medical education for doctors is obligatory in 60%-75% of countries in the European and South-East Asian Regions but in less than 50% of countries in the Americas, African, and Eastern Mediterranean Regions.


76

14/42 16/30 6/15 19/25 5/6 12/24

0%

20%

40%

60%

80%

100%

Africa America EasternMediterranean

Europe South-EastAsia

WesternPacific

Figure 7.2.5: Countries with information centres for prescribers in 2007 by WHO Region

Figure 7.2.6 Countries with information centres for prescribers in 2003 and 2007 by income level

Information centres for prescribers have increased significantly in high-income countries, but only slightly in low- and middle-income ones.

Less than half of countries in the African, Americas, Eastern Mediterranean and Western Pacific Regions have information centres for prescribers.

6/13

28/62

18/56

18/24

37/71

17/47

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

2007

2003


77

20/54

26/53

9/14

20/45

13/21

36/69

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

20072003

20/245/6

13/228/15

10/2913/39

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60%

80%

100%

Africa

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Figure 7.2.7: Countries reporting public education campaigns on the use of antibiotics in 2007 by WHO region

Figure 7.2.8: Countries reporting public education campaigns on the use of antibiotics

in 2003 and 2007 by income level

The proportion of countries undertaking public education campaigns about antibiotic use is greatest in the South-East Asian and Western Pacific Regions and least in the African and Americas Regions.

Only about half of countries had undertaken any public education campaigns on antibiotics and the likelihood of them doing so increases with income level.

The proportion of low-income countries undertaking public education campaigns between 2003 and 2007 appears to have increased slightly in low- and middle income countries but not in high-income countries.


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7.3 Key policies and regulations to promote rational use


Selecting the optimal medicine for an individual from a broad range of choices requires expertise and considerable skill by the health professionals involved. Prescribing contraindicated medications or the wrong dosage can have a major impact on the patient's health and even threaten their life. Prescribing medicines unnecessarily or ones which are overly expensive can cause serious financial hardship for people in the many countries where patients have to pay for their medicines out-of-pocket.

A key factor to consider in promoting rational use of medicines is the level of qualification of the health personnel doing the prescribing, particularly of prescription-only medicines. In some countries prescribing is often done not by doctors but by other cadres of staff who may not have received sufficient training. In addition there are many health system factors that influence how health professionals prescribe and dispense medicines and how consumers use them. National policies can play an important role in changing behaviours with regard to the use of medicines.

Prescribers can often decide whether to prescribe a branded medicine or the generally cheaper generic product. Cost-effective generic prescribing can have a beneficial impact both on public health expenditure and on individual expenditure for those who have to pay for their medicines. Establishing measures to promote and ensure generic prescribing can save money which can be invested in other public health sectors.

A mandated multidisciplinary national body can coordinate national policy to promote rational use of medicines and DTCs have a role to play in ensuring the safe and effective use of medicines in health facilities or areas under their jurisdiction. 24,27 The DTC must have clear objectives, a firm mandate, the support of senior hospital staff, transparency, wide representation, technical competence, a multidisciplinary approach, and sufficient resources to implement its decision.

Over-the-counter (OTC) sale of antibiotics - which may be due to lack of enforcement of regulations or lack of information on the part of consumers about the potential risks of antibiotic misuse – remains an issue of global health concern. Irrational use of antibiotics contributes to increased AMR - rendering essential antibiotics ineffective and requiring the use of newer, more expensive antibiotics to treat bacterial illnesses. Strategies are needed to monitor and contain AMR and prevent the avoidable sickness and deaths caused by inappropriate use of antibiotics.

Finally, given the known impact of advertising and promotion of medicines on both prescribing behaviour and patient demand, it is essential to regulate and monitor medicines promotion to ensure that it remains ethical. All promotional claims should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation, and in good taste.28 WHO has published a set of ethical criteria for the promotion of medicines that countries can use as a basis for developing their own national measures.29 The main purpose of promotion and advertisement of medicines is to encourage health workers and consumers to use a particular product.


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This section covers a number of policies and issues that impact on the quality of prescribing:

• Which health personnel are prescribing prescription-only medicines at the primary care level

• Policies on the use of generic medicines

• The use of DTCs and national bodies to promote rational use of medicines

• Antibiotic policies and OTC sales of medicines

• Medicines promotion

Other policies that impact on medicines use, such as financial incentives, are covered elsewhere in this document but will be referred to in the concluding section.

Who is prescribing?

Table 7.3.1 shows data on the cadre of staff who are prescribing at the primary care level.

Table 7.3.1: Staff prescribing medicines at primary care level in the public sector




% yes


% yes


% yes


% yes

Prescription of medicines by

Doctors 45/46 98% 72/73 99% 32/32 100% 149/151 99%

Nurses/midwives/paramedical staff 41/46 89% 43/72 60% 21/32 66% 105/150 70%

Pharmacists/ pharmacy aides / assistants 16/43 37% 11/68 16% 1/33 3% 28/144 19%

Personnel with < 1 month's training 9/40 23% 6/64 9% 0/21* 0% 15/125 12%

* Note: More than 30% of countries did not provide an answer to this question. ** Yes=Always + Frequently + Occasionally

Prescription of medicines is most often done by a doctor but in most low-income countries nurses/midwives also frequently prescribe.

Prescription of medicines by pharmacists and pharmacy assistants increases with decreasing country income level.

In nearly a quarter of low-income countries prescribing is sometimes done at public primary care facilities by staff with less than one month's training.


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Generic policies

Table 7.3.2 provides information about generic prescribing in the public and private sectors. Figure 7.3.1 and 7.3.2 (a) and (b) illustrate how many countries permit generic substitution in the private and public sector.

Table 7.3.2: Legislation on prescription of generic medicine in the public and private sectors




%


%


%


%

yes

Legal provisions for licensing and practice of

Prescribers 42/45 93% 70/71 99% 35/35 100% 147/151 97%

Pharmacy 44/47 94% 70/71 99% 35/35 100% 149/153 97%

Prescribing generics obligatory in

Public sector 30/48 63% 45/73 62% 6/34 18% 81/155 52%

Private sector 10/46 22% 19/67 28% 1/34 3% 30/147 20%

Permitting generic substitution in *

Public pharmacies 41/48 85% 58/67 87% 17/22* 77% 116/137 85%

Private pharmacies 36/48 75% 46/61 75% 18/25 72% 100/134 75%

Incentives for dispensing of generics

Public pharmacies 22/46 48% 18/68 26% 14/21* 67% 54/135 40%

Private pharmacies 13/44 30% 17/63 27% 11/21* 52% 41/128 32%


Almost two thirds of the low- and middle-income countries have legislation requiring obligatory prescribing of generic products in the public sector.

Requirements for obligatory generic prescribing in the private sector are unusual in all countries.

Generic substitution is commonly permitted in the public and private sectors of all countries.

Incentives for dispensing generic medicines are less common in middle-income countries compared to low-income countries, but occur in more than half of high-income countries.


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a)

45/56

52/62

12/16

41/48

58/67

17/22

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

2007

2003

b)

40/56

35/56

10/17

36/48

46/61

18/25

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

2007

2003

24/25

4/615/1911/15

27/3035/42

18/23

2/5

19/23

6/14

21/2734/42

0%

20%

40%

60%

80%

100%

Africa

America

Easter

n Medit

erranea

n

Europe

South-

East A

sia

Western

Pacific

Public SectorPrivate Sector

Figure 7.3.1 Countries permitting generic substitution in the public and private sectors in 2007 by WHO region

Figures 7.3.2 (a) and 7.3.2 (b). Countries with generic substitution allowed in the (a) public and (b) private sectors in 2003 and 2007 by income level

Generic substitution is permitted more often in the public than in the private sector in all regions except the European Region.

Generic substitution is least common in the South-East Asian and Eastern Mediterranean Regions.

Generic substitution has slightly increased between 2003 and 2007 both in the public and private sectors.


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National body to promote rational use of medicines and Drug and Therapeutic Committees (DTCs)

Table 7.3.3 and figures 7.3.3 and 7.3.4 (a) and (b) show how many countries have DTCs and a body to promote rational medicines use.

Table 7.3.3: Drug and Therapeutics Committees




%


%


%

yes

yes / resp.

countries

%

yes

Body designated to promote Rational Drug Use 10/45 22% 29/70 41% 15/24* 63% 54/139 39%

Requirement for drugs and therapeutic committees 21/44 48% 42/71 59% 12/21* 57% 75/136 55%

Availability of Drug and Therapeutics Committees in half or more facilities **

Referral hospitals 17/42 40% 40/64 63% 13/15* 87% 70/121 58%

General hospitals 17/41 41% 42/66 64% 13/17* 76% 72/124 58%

Regions/provinces 14/41 34% 29/60 48% 9/15* 60% 52/116 45%

* Note: More than 30% of countries did not provide an answer to this question. ** Yes=All + Most + Half of hospitals / regions

The likelihood of countries having a national body designated to monitor and promote rational use of medicines increases with income level, two thirds of high-income countries having such bodies compared to less than a quarter of low-income countries.

DTCs are generally more common in high-income countries and in referral hospitals.

Less than half of low-income countries have DTCs in half or more of their referral hospitals, general hospitals or regions or provinces.


83

a) General Hospitals

19/49

25/45

10/11

17/41

42/66

13/17

0% 20% 40% 60% 80% 100%

Lowincome

Middleincome

Highincome

2007

2003

b) Regions/Provinces

17/47

13/41

6/8

14/41

29/60

9/15

0% 20% 40% 60% 80%

Lowincome

Middleincome

Highincome

2007

2003

17/21

3/515/21

8/1416/28

13/35

11/18

3/4

12/21

4/13

11/2511/35

0%

20%

40%

60%

80%

100%

Africa

America

Easter

n Med

iterra

nean

Europe

South-

East A

sia

Wes

tern P

acific

GeneralHospitals

Regions/Provinces

Figure 7.3.3: Countries with DTCs in at least half of general hospitals

and regions/provinces in 2007 by WHO region

Figures 7.3.4(a) and 7.3.4(b): Countries with DTCs in at least half of (a) general hospitals and (b) regions/provinces in 2003 and 2007 by income level

DTCs are most common in countries in the Western Pacific, South-East Asian and European Regions and least common in the African Region.

Between 2003 and 2007, there has been a slight increase in the number of middle-income countries with DTCs in more than half of their general hospitals and regions, but little change in high- and low-income countries.


84

Antibiotic policies and over-the-counter sales

Table 7.3.4 and figures 7.3.5 and 7.3.6 provide data on AMR containment strategies and frequency of OTC sales of medicines that would normally be regarded as needing a prescription from an authorized clinical practitioner before being dispensed.

Table 7.3.4: Antimicrobial resistance (AMR) and over the counter (OTC) sales




%


%


%


%

yes

Strategy for AMR containment 11/46 24% 30/65 46% 16/22* 73% 57/133 43%

National reference laboratory for surveillance of AMR

24/44 55% 39/71 55% 27/32 84% 90/147 61%

National task force for AMR containment 6/44 14% 17/65 24% 12/21* 57% 35/130 27%

Frequency of OTC sales **

Antibiotics 43/47 91% 59/72 82% 5/22* 23% 107/141 76%

Injections 40/46 87% 45/67 67% 6/22* 27% 91/135 67%

* Note: More than 30% of countries did not provide an answer to this question. ** Yes=Always + Frequently + Occasionally]

The likelihood of having a national strategy to contain AMR increases with income level of country and less than a quarter of low-income countries have a national strategy to contain AMR.

Only about half of low- and middle-income countries have a national reference laboratory for surveillance of AMR.

Only about a quarter of countries have a national task force for AMR containment.

OTC sales of antibiotics and injections decreases with increasing country income level.

Antibiotics are available over the counter in more than 80% of low- and middle-income countries but in only 23% of high-income countries.


85

9/40

12/316/12

18/24

3/5

9/21

0%

20%

40%

60%

80%

100%

Afric

a

Amer

ica

Easte

rn M

edite

rrane

an

Euro

pe

South-Eas

t Asia

Wes

tern P

acific

13/55

18/47

11/14

11/46

30/65

16/22

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

2007

2003

Figure 7.3.5: Countries with a strategy to contain AMR in 2007 by WHO Region

Figure 7.3.6: Countries with a strategy to contain AMR in 2003 and 2007 by income level

A national strategy to contain AMR is most common in the European Region (75% of countries) and least common in the African Region (23% of countries).

The proportion of middle-income countries with a strategy to contain AMR has increased slightly between 2003 and 2007, but this has not been the case in low- and high-income countries.


86

Controlling medicines promotion

Table 7.3.5 and figures 7.3.7 and 7.3.8 show how many countries currently provide regulations for advertisement and promotion of medicines. The table additionally gives information on the types of regulations countries provide and whether NGOs and civil societies are involved in monitoring promotional activities.

Table 7.3.5: Legislation and regulation of medicines promotion and advertising



% yes


% yes


% yes


% yes

Legislation on promotion/advertising 41/48 85% 61/71 86% 35/35 100% 137/154 89%

Responsible agency for regulating promotion/advertising

i) Industry 2/44 5% 4/66 6% 1/35 3% 7/145 5%

ii) Government or national regulatory authority

40/44 90% 51/66 77% 12/35 34% 103/145 71%

iii) Co-regulation 2/44 5% 11/66 17% 22/35 63% 35/145 24%

Regulations of government including*

Pre-approval for advertisement / promotion 26/39 67% 41/52 79% 11/19 58% 78/110 71%

Prohibition of public advertising 36/42 86% 44/51 86% 21/21 100% 101/114 97%

Guidelines on advertising of OTC medicines 20/39 51% 31/47 66% 15/19 79% 66/105 63%

Civil society/NGOs taking active part in monitoring promotional activities

6/42 14% 21/65 32% 11/21 52% 38/128 30%


Most countries report having legislation on medicines promotion and advertising.

The government or national regulatory authority is most often the responsible agency for regulating promotion and advertising in low- and middle-income countries.

In high-income countries, promotion and advertising is most often co-regulated between the government and industry.

More than half of countries require pre-approval for advertisement or other promotional activities and also prohibit public advertising of medicines.

The likelihood of countries having guidelines on the advertising of OTC medicines increases with income level.

Civil society takes an active part in monitoring promotional activities in less than one third of countries across all income levels.


87

35/42 25/30 14/16 36/36 6/6 21/24

0%20%40%60%80%

100%

Africa

America

Eastern

Mediterrane

anEurope

South-East Asia

Western Pacifi

c

47/53

47/53

16/18

41/48

41/48

35/35

0% 20% 40% 60% 80% 100%

Low income

Middle income

High income

20072003

Figure 7.3.7: Countries with legal provisions on promotion and/ or

advertisement of medicines in 2007 by WHO region

Figure 7.3.8: Countries with legislation on promotion in 2003 and 2007 by income level

There has not been any significant change in the number of countries with legislation on promotion/advertising between 2003 and 2007.

Most countries in most regions have legislation on medicines promotion.


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7.4 Summary

This chapter describes the existence in countries of the major policies that are needed to encourage rational use of medicines. While most countries appear to have EMLs and STG, many of them do not appear to have policies to encourage their use. For example, many countries do not use their EMLs in public and private insurance reimbursement and many do not report training their prescribers in the essential medicines concept or in the use of STG. In many countries unqualified personnel undertake much of the prescribing, there is no obligatory continuing medical education, no medicines information centre for prescribers, no public education on medicines use and prescription-only medicines are freely available over the counter. Only a minority of countries, mostly high-income ones, have a national body and DTCs in most hospitals and regions to monitor and supervise the use of medicines.

Data from other chapters show that only a minority of countries regularly undertake prescription audit (chapter 2) and that many prescribers are encouraged to over-prescribe since they gain income from the sales of medicines (chapter 5). In such circumstances, it is not surprising that irrational use of medicines continues to be a problem worldwide.30

However, the situation is likely to be even worse than it appears in the data presented above. There are two reasons for this. Firstly, while these data reflect the policies officially in existence, many of these policies may not be fully enforced. Secondly, many countries did not respond to certain questions and these countries were excluded from the analysis except where indicated in the relevant tables. Where non-response was substantial, this is indicated with a symbol for the question concerned and a footnote to the table. However, non-response is likely to be associated with non-existence of the policies concerned.

Achievements and methodological limitations

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8. Achievements and methodological limitations

8.1 Achievements

This Fact Book summarizes what is known about the pharmaceutical situation in countries, using the most recently collected data on Level I indicators. With 156 out of 192 WHO Member States responding to Level I surveys in 2007, many data on the structure and process of pharmaceutical sectors are available. A few comparisons with 1999 data and more comparisons with 2003 data are now possible as the start of longitudinal monitoring.

The methodology for data collection of the Level I indicators in 2007 was refined, based on the experiences of data collection and analysis in 2003 and on the recommendations of a WHO meeting of experts in July 2006 in Geneva. Thus, in 2007, an electronic submission process was used and much follow-up was undertaken to help countries complete the questionnaire and to clarify unclear answers. Furthermore, the questionnaire had been revised and questions clarified, instructions on how to fill in the questionnaire developed and explanations of the questions provided with the questionnaire. Countries' responses to questions which had been asked in the 2003 survey were included with the 2007 questionnaire.

Using the current indicators and methods, countries are able to perform comprehensive assessments of their pharmaceutical sector, to evaluate their data in the light of existing policies and in comparison to other countries, and to develop strategies for change and improvement.

Analyses of the 2007 Level I data contained in this Fact Book also highlight some of the limitations of the surveys and point to recommendations for future improvements. Limitations fall into two broad categories: limitations of the current questionnaire and data collection instrument, and limitations related to survey administration and data management.

8.2 Limitations of the questionnaire and recommendations for improvement

Although the current Level 1 questionnaire was revised and refined between 2003 and 2007, with subsequent improved data quality, it remains quite long and some skip patterns are still difficult to follow. Furthermore, based on responses received, it would seem that the wording of several questions remains unclear. It is also important to note that the accuracy of the data depends largely on the knowledge of individual respondents who are asked to complete the Level 1 questionnaire on behalf of the ministries of health. Some data asked for in the survey may be difficult to obtain, particularly when


90

estimates are required, e.g. proportion of hospitals with a DTC or whether medicines are covered by insurance - even though choices such as "all", "half", "few", "none" or "all", "some", "none", were offered as options in response to these questions. These characteristics tended to increase the amount of missing data. Changes in the wording of some items between the 2003 and the 2007 surveys, while improving data quality, limited the possibilities for comparing results over time.

Level I surveys are currently completed in the form of electronic questionnaires sent to respondents in the countries being surveyed. One way to increase the reliability of data and reduce the number of missing responses would be to develop an automated web-based data collection method, with built-in controls for admissible answers, an online glossary of terms, and answers to frequently asked questions.

It is unclear to what extent responses to Level I questionnaires would coincide if two respondents were asked to complete the questionnaire. While some questions may be more liable to subjective errors, completion of the survey by more than one individual could be used to test the reliability of data on individual items. In the 2007 survey, some attempt was made to reduce such subjective errors by validating the responses to some questions against data from other sources, e.g. pharmaceutical expenditure. Such validation could be extended to other questions, although many of the questions are designed to obtain information that is not available elsewhere. Furthermore, in the 2007 survey, follow-up was undertaken through the WHO regional and country offices to improve the accuracy of responses. Reliability and validity in future surveys could be further improved by identifying key personnel in the ministries of health to respond to specific questions and by providing improved follow-up and support for respondents.

Another limitation is that Level I indicators only measure the existence of policies or documents and not whether they are enforced. Furthermore, they do not measure access to and use of medicines from the perspective of patients and consumers. Only household surveys can provide population-based information about how pharmaceutical policies affect the well-being of individuals; and only health facility surveys (level II indicators) can provide information about how policies impact on health facilities and service delivery.

The lessons learned from the 2007 survey will be used when planning the next round of Level I surveys.

References

91

References

1. The rational use of drugs: report of the Conference of Experts, Nairobi, 25-29 November, 1985. Geneva, World Health Organization, 1987.

2. Using indicators to measure country pharmaceutical situations. Fact Book on WHO level I and level II monitoring indicators. Geneva, World Health Organization, 2006.

3. WHO medicines strategy 2004-2007. Countries at the core. Geneva, World Health Organization, 2004.

4. How to develop and implement a national drug policy, 2nd ed. Geneva, World Health Organization, 2001.

5. WHO Operational package for assessing, monitoring and evaluating country pharmaceutical situations. Guide for coordinators and data collectors. Geneva, World Health Organization, 2007.

6. The World Bank country classification. Available at: http://www.worldbank.org/data/countryclass/countryclass.html

7. WHO Expert Meeting on Pharmaceutical Indicators, Monitoring and Assessment. 10-12 July 2006, Geneva, Switzerland. Geneva, World Health Organization, 2006.

8. Effective medicines regulation: ensuring safety, efficacy and quality. WHO Policy Perspectives on Medicines, No. 7. Geneva, World Health Organization, 2003.

9. Pharmacovigilance: ensuring the safe use of medicines. WHO Policy Perspectives on Medicines 2004, No. 9. Geneva, World Health Organization, 2004.

10. Marketing authorization of pharmaceutical products with special reference to multi-source (generic) products: a manual for drug regulatory authorities. Geneva, World Health Organization, 1998.

11. Guidelines on the use of international nonproprietary names (INNs) for pharmaceutical substances. Geneva, World Health Organization, 1997.

12. Guidelines for the control of narcotic and psychotropic substances in the context of the international treaties. Geneva, World Health Organization, 1984.

13. Narcotic and psychotropic drugs - achieving balance in national opioids control - guidelines for assessment. Geneva, World Health Organization, 2000.

14. National laboratories for drug quality surveillance and control. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Twenty-ninth report. Geneva, World Health Organization, 1984. Annex 1 (WHO Technical Report Series No.704).


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15. Good laboratory practices in government drug control laboratories. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fifth report. Geneva, World Health Organization, 1999. (WHO Technical Report Series No.885).

16. Safety of medicines - a guide to detecting and reporting adverse drug reactions - why health professionals need to take action. Geneva, World Health Organization, 2002.

17. Counterfeit drugs - guidelines for the development of measures to combat counterfeit drugs. Geneva, World Health Organization, 1999.

18. Global comparative pharmaceutical expenditures with related reference information. Geneva, World Health Organization, 2000.

19. Xu K et al. Household catastrophic health expenditure: a multicountry analysis. Lancet 2003; 362:111-117.

20. Holloway KA, Gautam BR, Reeves BC. The effects of different kinds of user fees on prescribing quality in rural Nepal. Journal of Clinical Epidemiology 2001; 54(10):1065-71.

21. Cameron A et al. Medicine prices, availability and affordability in 36 developing and middle-income countries: a secondary analysis. Lancet 2009; 373:240-249.

22. Globalization, TRIPS and access to pharmaceuticals. WHO Policy Perspectives on Medicines, No. 3. Geneva, World Health Organization, 2001.

23. The use of flexibilities in TRIPS by developing countries: can they promote access to medicines? Geneva, South Centre and World Health Organization, 2005.

24. Promoting rational use of medicines: core components. WHO Policy Perspectives on Medicines, No. 5. Geneva, World Health Organization, 2002.

25. Laing RO, Hogerzeil HV, Ross-Degnan D. Ten recommendations to improve use of medicines in developing countries. Health Policy and Planning 2001; 16(1):13–20.

26. The selection of essential medicines. WHO Policy Perspectives on Medicines, No. 4. Geneva, World Health Organization, 2002.

27. Drug and therapeutics committees - a practical guide. Geneva, World Health Organization, 2003.

28. Drug promotion - what we know, what we have yet to learn. Reviews of materials in the WHO/HAI database on drug promotion. Geneva, World Health Organization and Health Action International, 2005.

29. Ethical criteria for medicinal drug promotion. Geneva, World Health Organization, 1988.

30. Medicines use in developing and transitional countries: fact book summarizing results from studies reported between 1990 and 2006. Geneva, World Health Organization, 2009.

Annex I

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Annex I

Questionnaire on structures and processes of country pharmaceutical situations

Country: Date (dd/mm/yyyy):

Name of coordinator/principal respondent:

E-mail address:

Position: Postal address:

Questions Responses Explanations 1. NATIONAL MEDICINES (DRUGS) POLICY (NMP)

Please consult the health ministry, medicines regulatory authority and/or medicine service in answering the questions in this section.

1.1 Is there a National Medicines Policy (NMP) document?

If no, skip to 1.4.

Yes No Don’t Know

a) If yes, is it an official or draft document?

Official Draft Don’t Know

b) What year was it last updated? Year 1.2 Is there an NMP implementation

plan that sets activities, responsibilities, budget and timeline?

Yes No Don’t Know

a) If yes, when was it last updated? Year 1.3 Is the NMP integrated into or

included in the published/official national health policy/plan?

Yes No Don’t Know

a) If yes, when was the national health policy/plan last updated? Year

1.4 Has a national assessment/indicator study been conducted?

Yes No Don’t Know

a) If yes, which topics have been studied and when was the most recent study covering each topic conducted:

Overall pharmaceutical situation: Yes No DK Year


94

Questions Responses Explanations Rational use/prescription audit: Yes No DK Year

Access (i.e. prices, affordability and/or availability) to

medicines: Yes No DK Year

1.5 Is there a code of conduct that applies to public officials and staff involved in pharmaceutical-related activities or posts, such as persons working in pharmaceutical services, medicines regulation, procurement and supply of medicines and other pharmaceutical divisions of the health ministry?

Yes No Don’t Know

2. REGULATORY SYSTEM Please consult the medicines regulatory authority in answering the questions in this section. Specific information regarding medicines tested for quality control purposes and monitoring of adverse drug reactions may need to be obtained from the quality control laboratory or the responsible agency/department.

Regulatory authority 2.1 Are there legal provisions

establishing the powers and responsibilities of the medicines regulatory authority?

Yes No Don’t Know

2.2 Is there an existing formal medicines regulatory authority?

Yes No Don’t Know

2.3 What are the sources of funding for the medicines regulatory authority:

Regular budget from the government: Yes No Don’t Know Fees from registration of medicines: Yes No Don’t Know

Other: Yes No Don’t Know 2.4 Are there legal provisions

requiring transparency and accountability and promoting a code of conduct in regulatory work?

Yes No Don’t Know -

2.5 Is the medicines regulatory authority involved in regional/international harmonization initiatives?

Yes No Don’t Know

Annex I

95

Questions Responses Explanations 2.6 Is there a medicines regulatory

authority website providing publicly accessible information on any of the following: legislation, regulatory procedures, prescribing information (such as indications, counterindications, side effects, etc.), authorized companies, and/or approved medicines?

Yes No Don’t Know

Marketing authorization 2.7 Are there legal provisions for

marketing authorization? Yes No Don’t Know

2.8 How many medicinal products have been approved to be marketed? (count total number of unique dosage forms and strengths)

Number

2.9 Is a list of all registered products publicly accessible?

Yes No Don’t Know

2.10 Is there a computerized registration system that facilitates retrieval of information on registered products?

Yes No Don’t Know

2.11 Is the WHO Certification Scheme certificate required as part of the marketing authorization process?

Yes No Don’t Know

2.12 Is the INN used in the registration of medicines?

Yes No Don’t Know

2.13 Is there a functional formal committee responsible for assessing applications for registration of pharmaceutical products?

Yes No Don’t Know

Licensing 2.14 Are there legal provisions for

licensing of the following:

Manufacturers: Yes No Don’t Know Wholesalers or distributors: Yes No Don’t Know

Importers or exporters of medicines: Yes No Don’t Know Regulatory inspection 2.15 Are there legal provisions to

inspect premises and collect samples?

Yes No Don’t Know

2.16 Are the following types of facilities inspected to check compliance with applicable requirements and are there written national guidelines/checklists for the inspection:

Facilities inspected Written national guidelines/ checklists


96

Questions Responses Explanations Manufacturers: Yes No DK Yes No DK

Wholesalers/distributors: Yes No DK Yes No DK Importers/exporters: Yes No DK Yes No DK

Retail distributors/pharmacies: Yes No DK Yes No DK Control of narcotics 2.17 Are there legal provisions for the

control of narcotics, psychotropic substances and precursors?

Yes No Don’t Know

2.18 Is your country a signatory to the international convention on the control of narcotics, psychotropic substances and precursors?

Yes No Don’t Know

Quality control 2.19 Is there a quality management

system in place? Yes No Don’t Know

2.20 Are medicine samples tested for the following regulatory purposes:

Medicines registration: Yes No Don’t Know Post-marketing surveillance: Yes No Don’t Know

2.21 In which of the following laboratories are samples tested:

Government quality control laboratory: Yes No Don’t Know

Local academic institutions: Yes No Don’t Know Private laboratory: Yes No Don’t Know

Mini laboratories (district, regional): Yes No Don’t Know

Quality control laboratory in another country: Yes No Don’t Know

2.22 What is the total number of samples quality tested in 2006?

Number

2.23 What is the total number of samples tested in 2006 that failed to meet quality standards?

Number

2.24 Are there regulatory procedures to ensure quality control of imported medicines?

Yes No Don’t Know

2.25 Are there legal procedures for the recall and disposal of defective products?

Yes No Don’t Know

Pharmacovigilance 2.26 Are adverse drug reactions

(ADRs) monitored? Yes No Don’t Know

a) If yes, at which of these health system levels are adverse drug reactions (ADRs) monitored:

Annex I

97

Questions Responses Explanations Local level: Yes No Don’t Know

Regional level: Yes No Don’t Know Central level: Yes No Don’t Know

2.27 Does your country report ADRs to an international network or to the WHO Collaborating Centre for International Drug Monitoring?

Yes No Don’t Know

2.28 Are there any laws, regulations,

programmes or procedures for detecting and combating counterfeit medicines?

Yes No Don’t Know

2.29 What sources of information are used to detect and combat counterfeit medicines:

Reports from national authorities: Yes No Don’t Know Reports from specific/ad hoc studies: Yes No Don’t Know

Reports from the pharmaceutical sector: Yes No Don’t Know Reports from civil society/NGOs: Yes No Don’t Know

Dispensing and prescribing 2.30 Are there legal provisions for the

following:

Licensing and practice of prescribers: Yes No Don’t Know Licensing and practice of pharmacy: Yes No Don’t Know

2.31 Is prescribing by generic name obligatory in the:

Public sector: Yes No Don’t Know Private sector: Yes No Don’t Know

2.32 Is generic substitution permitted at: Public pharmacies: Yes No Don’t Know

Private pharmacies: Yes No Don’t Know 2.33 Are there incentives to dispense

generic medicines at:

Public pharmacies: Yes No Don’t Know Private pharmacies: Yes No Don’t Know

Promotion and advertising 2.34 Are there provisions in the

medicines legislation/regulations covering promotion and/or advertising of medicines?

Yes No Don’t Know


98

Questions Responses Explanations 2.35 Who is responsible for regulating

promotion and/or advertisement of medicines?

Industry (self-regulation) only Government or national regulatory

authority only Co-regulation Don’t Know

a) If regulated by government, do regulations include any of the following:

Pre-approval for advertisement and/or promotional materials:

Yes No Don’t Know

Prohibition on advertising prescription medicines to the

public: Yes No Don’t Know

Guidelines on advertising of non-prescription medicines:

Yes No Don’t Know

2.36 Are civil society/NGOs included in surveillance of promotion and/or advertisement of medicines?

Yes No Don’t Know

3. MEDICINES SUPPLY SYSTEM Please consult the agency/department responsible for the procurement and supply of medicines in

answering the questions in this section. 3.1 Is public sector procurement

pooled at the national level (i.e. there is centralized procurement for the regions/provinces)?

Yes No Don’t Know

3.2 Who is responsible for public sector medicines procurement and distribution:

Procurement Distribution

Ministry of Health: Yes No DK Yes No DK Nongovernmental organization (NGO): Yes No DK Yes No DK

Private institution contracted by the government:

Yes No DK Yes No DK

Individual health institutions: Yes No DK Yes No DK 3.3 What type of tender process is

used for public sector procurement and what is the percentage of the total cost for each:

Percentage of total cost

National competitive tender: Yes No DK % International competitive tender: Yes No DK %

Negotiation/direct purchasing: Yes No DK %

3.4 Is there a tender board/committee overseeing public sector procurement?

Yes No Don’t Know

Annex I

99

Questions Responses Explanations a) If yes, are the key functions of

the procurement office and those of the tender committee clearly separated?

Yes No Don’t Know

3.5 Does public sector medicines procurement use the WHO Prequalification system?

Yes No Don’t Know

3.6 Is public sector procurement limited to medicines on the Essential Medicines List (EML)?

Yes No Don’t Know

a) If yes, are there provisions for purchasing medicines not on the Essential Medicines List?

Yes No Don’t Know

3.7 Did your country participate in a pooled procurement scheme with at least one other country for at least one of the last two procurement cycles?

Yes No Don’t Know

4. MEDICINES FINANCING Please consult the budget/ finance division of the health ministry and/or the pharmaceutical supply

group in answering the questions in this section. The hospital/health facility service and/or the national social and insurance services may also need to be consulted.

4.1 What is the total public or government expenditure for medicines in US$ for the most recent year for which data are available?

US$ Year

4.2 Is there a national policy to provide at least some medicines free of charge (i.e. patients do not pay out-of-pocket for medicines) at public primary care facilities?

Yes No Don’t Know

a) If yes, which of the following are free at public primary care facilities:

All medicines: Yes No Don’t Know

Malaria medicines: Yes No Don’t Know Tuberculosis medicines: Yes No Don’t Know

Sexually transmitted diseases medicines: Yes No Don’t Know

HIV/AIDS-related medicines: Yes No Don’t Know At least one vaccine: Yes No Don’t Know

b) Which of the following types of patients receive medicines for free:

Patients who cannot afford them: Yes No Don’t Know Children under 5 years of age: Yes No Don’t Know


100

Questions Responses Explanations Older children: Yes No Don’t Know

Pregnant women: Yes No Don’t Know Elderly persons: Yes No Don’t Know

4.3 Which fees are commonly charged in public primary care facilities:

Registration/consultation fees: Yes No Don’t Know Dispensing fees: Yes No Don’t Know

Flat fees for medicines: Yes No Don’t Know - Flat rate co-payments for medicines: Yes No Don’t Know

Percentage co-payments for medicines: Yes No Don’t Know 4.4 Is revenue from fees or the sale of

medicines used to pay the salaries or supplement the income of public health personnel in the same facility?

Always Frequently Occasionally Never DK

Public sector Private sector 4.5 Do prescribers dispense medicines? Always

Frequently Occasionally Never DK


4.6 What proportion of the population has health insurance?

All None

Some DK

All None

Some DK

-

4.7 Are medicines covered by health insurance?

All None

Some DK

All None

Some DK

Public sector Private sector NGO 4.8 Is there a policy covering medicine prices that applies to the public sector, the private sector, or non-governmental organizations?

Yes NoDK

Yes NoDK

Yes No DK

a) If yes, which of the following policies covering medicine prices apply:

Maximum wholesale mark-up: Yes NoDK

Yes NoDK

Yes No DK

Maximum retail mark-up: Yes NoDK

Yes NoDK

Yes No DK

Duty on imported raw pharmaceutical materials:

Yes NoDK

Yes NoDK

Yes No DK

Duty on imported finished pharmaceutical products:

Yes NoDK

Yes NoDK

Yes No DK

4.9 Is a national medicine prices monitoring system for retail/patient prices in place?

Yes NoDK

Yes No DK

Yes No DK

Annex I

101

Questions Responses Explanations 4.10 Are there regulations mandating

retail/patient medicine price information to be made publicly accessible?

Yes No DK

Yes NoDK

Yes No DK

4.11 Are there official written guidelines on medicine donations that provide rules and regulations for donors and provide guidance to the public, private and/or NGO sectors on accepting and handling donated medicines?

Yes NoDK

Yes NoDK

Yes No DK

5. PRODUCTION AND TRADE Please consult the medicines regulatory authority, the patent office and/or the trade ministry in answering the questions in this section.

5.1 What is the medicines production capability in the country:

Research and development of new active substances: Yes No Don’t Know

Production of pharmaceutical starting materials: Yes No Don’t Know

Formulation from pharmaceutical starting materials: Yes No Don’t Know

Repackaging of finished dosage forms: Yes No Don’t Know 5.2 Are patents granted on

pharmaceutical products by the national patent office?

Yes No Don’t Know

5.3 If your country is a member of the World Trade Organization (WTO), has national legislation been modified to implement the TRIPS Agreement?

Yes No Don’t Know Country not a member of WTO

a) If a WTO member, has your country used the following available transitional periods to implement the TRIPS Agreement:

Article 65: Yes No Don’t Know Article 66: Yes No DK Country not an LDC

Doha Declaration (Article 7): Yes No Don’t Know 5.4 Which of the following TRIPS

flexibilities have been incorporated into national legislation as applies to pharmaceuticals: CBD = Currently being discussed

Compulsory licensing provisions: Yes No CBD DK Government use: Yes No CBD DK

Parallel importing provisions: Yes No CBD DK


102

Questions Responses Explanations The Bolar exception: Yes No CBD DK

6. RATIONAL USE OF MEDICINES Please consult the health ministry (hospital division), professional bodies and/or the education

ministry in answering the questions in this section. 6.1 Is there a national Essential

Medicines List (EML)? Yes No Don’t Know

a) If yes, how many unique medicine formulations does the national EML contain?

Number:

b) How many paediatric formulations are included in the:

National EML: Number:

Separate Paediatric EML: Number: No separate paediatric EML

c) When was the national EML last updated? Year:

d) Is the national EML being used in the following:

Public sector procurement: Yes No Don’t Know Public insurance reimbursement: Yes No Don’t Know

Private insurance reimbursement: Yes No Don’t Know e) Is there a committee

responsible for the selection of products on the national EML?

Yes No Don’t Know

National STG

Hospital level STG

Primary care STG

6.2 Are the following types of standard treatment guidelines (STGs) produced by the health ministry for major conditions?

Yes NoDK

Yes NoDK

Yes No DK

a) If yes, when were the STGs last updated? Year Year Year

6.3 Are there standard treatment guidelines for key paediatric illnesses?

Yes No Don’t Know

6.4 Is there a National Medicines Formulary Manual?

Yes No Don’t Know

a) If yes, when was it last published/reviewed? Year:

b) Does it cover only medicines on the national EML? Yes No Don’t Know

6.5 Are the following prescribing issues part of the basic curricula in most health training institutions for:

Essential Medicines List (EML)

Standard Treatment Guidelines (STG)

Problem-based pharmaco-therapy

Rational prescribing

Annex I

103

Questions Responses Explanations Doctors: Yes

No DK

Yes No DK

Yes No DK

Yes No DK

Nurses: Yes No DK

Yes No DK

Yes No DK

Yes No DK

Pharmacists: Yes No DK

Yes No DK

Yes No DK

Yes No DK

Pharmacy assistants: Yes No DK

Yes No DK

Yes No DK

Yes No DK

Paramedical staff: Yes No DK

Yes No DK

Yes No DK

Yes No DK

6.6 Are there obligatory, non-commercially funded continuing education programmes that include use of medicines for:

Doctors: Yes No Don’t Know Nurses/midwives/paramedical staff: Yes No Don’t Know

Pharmacists: Yes No Don’t Know Pharmacy aides/assistants: Yes No Don’t Know

6.7 Is there a public or independently funded, nationally accessible (e.g. by phone) medicines information centre or service that provides information on demand to:

Prescribers: Yes No Don’t Know Dispensers: Yes No Don’t Know Consumers: Yes No Don’t Know

6.8 Have there been any public education campaigns about rational medicines use in the previous two years conducted by the health ministry, a non-governmental organization, or academia on the following topics:

Use of antibiotics: Yes No Don’t Know Use of injections: Yes No Don’t Know

Other rational medicine use topics/issues: Yes No Don’t Know

6.9 How often do the following personnel prescribe prescription-only medicines at the primary health care level in the public sector:


104

Questions Responses Explanations Doctors: Always Frequently Occasionally

Never DK

Nurses/midwives/paramedical staff: Always Frequently Occasionally Never DK

Pharmacists/pharmacy aides/assistants: Always Frequently Occasionally Never DK

Personnel with <1 month formal health training:


6.10 Is there a national programme and/or multidisciplinary body, involving government, civil society and professional bodies, which monitors and promotes the rational use of medicine?

Yes No Don’t Know

6.11 Is there a mandatory requirement to organize/develop drugs and therapeutics committees?

Yes No Don’t Know

6.12 What proportions of hospitals and regions have drug and therapeutics committees:

Referral hospitals: All Most Half Few NoneDK

General hospitals: All Most Half Few NoneDK

Regions/provinces: All Most Half Few NoneDK

6.13 Is there a national strategy to contain antimicrobial resistance?

Yes No Don’t Know

6.14 Is there a national reference laboratory to coordinate epidemiological surveillance of antimicrobial resistance?

Yes No Don’t Know

6.15 Is there a funded national inter-sectoral task force to coordinate the promotion of appropriate use of antimicrobials and prevention of spread of infection?

Yes No Don’t Know

6.16 How frequently are the following types of medicines sold over the counter without any prescription:

Antibiotics: Always Never

Frequently Occasionally DK

Injections: Always Never

Frequently Occasionally DK

Annex I

105

List of respondents

Name Position Address E mail Section(s) completed

Comments about indicators and values

Item number Comment


106

Annex II

107

Annex II

List of key indicators

No. Indicator

NMP

1 Official NMP document updated < 5 years

2 NMP implementation plan updated < 5 years

3 National Assessment Study covering overall pharmaceutical situation carried out in the past 5 years

Regulation

4 Existing formal Medicines Regulatory Authority

5 Computerized medicines registration system

6 WHO Certification Scheme part of Marketing Authorization

7 INN used in registration of medicines

8 Legal provisions to inspect premises

9 Quality management system in place

10 Monitoring of ADR

11 Laws on regulations for counterfeit medicines

Medicines Supply System

12 Public sector procurement limited to EML

13 Use of WHO Prequalification system

Medicines Financing

14 HIV/AIDS-related medicines free at primary health care facilities

15 Free medicines for pregnant women at primary health care facilities

16 Medicines covered by health insurance in the public sector

17 Policy covering medicine prices - Public sector

18 Monitoring system for prices - Public Sector

19 Monitoring System for prices- Private Sector

Production and Trade

20 TRIPS flexibilities incorporated into national legislation - compulsory licensing

21 TRIPS flexibilities incorporated into national legislation - parallel importing


108

Rational Use of Medicines

22 Existence of national EML

23 Existence of National STG

24 EML concepts included in the basic training of doctors

25 STG concepts included in the basic training of doctors

26 Obligatory continuing education for doctors

27 Existence of Medicines Information Centre for Prescribers

28 Education campaign in the use of antibiotics

29 Generic substitution permitted - Public pharmacies

30 Generic substitution permitted - Private pharmacies

31 Availability of DTCs at general hospitals

32 Availability of DTCs in Regions / Provinces

33 Strategy for AMR containment

34 Legislation on promotion / advertising

Annex III

109

Annex III

List of responding countries and income level

No. of countries Country Region Income Level

1 Afghanistan Eastern Mediterranean Low income 2 Antigua and Barbuda Americas High income 3 Argentina Americas Middle income 4 Armenia Europe Middle income 5 Australia Western Pacific High income 6 Austria Europe High income 7 Azerbaijan Europe Middle income 8 Bahamas Americas High income 9 Bahrain (Kingdom of) Eastern Mediterranean High income 10 Barbados Americas High income 11 Belarus Europe Middle income 12 Belgium Europe High income 13 Belize Americas Middle income 14 Benin Africa Low income 15 Bhutan South-East Asia Middle income 16 Bolivia Americas Middle income 17 Botswana Africa Middle income 18 Brazil Americas Middle income 19 Brunei Darussalam Western Pacific High income 20 Bulgaria Europe Middle income 21 Burkina Faso Africa Low income 22 Burundi Africa Low income 23 Cambodia Western Pacific Low income 24 Cameroon Africa Middle income 25 Canada Americas High income


110

26 Cape Verde Africa Middle income 27 Central African Republic Africa Low income 28 Chad Africa Low income 29 Chile Americas Middle income 30 China Western Pacific Middle income 31 Colombia Americas Middle income 32 Comoros Africa Low income 33 Congo Africa Middle income 34 Cook Islands Western Pacific Low income 35 Costa Rica Americas Middle income 36 Côte d'Ivoire Africa Low income 37 Cuba Americas Middle income 38 Cyprus Europe High income 39 Czech Republic Europe High income

40 Democratic People's Republic of Korea South-East Asia Low income

41 Democratic Republic of the Congo Africa Low income

42 Denmark Europe High income 43 Djibouti Eastern Mediterranean Middle income 44 Dominican Republic Americas Middle income 45 Ecuador Americas Middle income 46 Egypt Eastern Mediterranean Middle income 47 El Salvador Americas Middle income 48 Eritrea Africa Low income 49 Estonia Europe High income 50 Ethiopia Africa Low income 51 Fiji Western Pacific Middle income 52 Finland Europe High income 53 France Europe High income 54 Gabon Africa Middle income 55 Gambia Africa Low income 56 Ghana Africa Low income 57 Grenada Americas Middle income 58 Guatemala Americas Middle income 59 Guinea Africa Low income 60 Guinea-Bissau Africa Low income 61 Guyana Americas Middle income 62 Honduras Americas Middle income 63 Hungary Europe Middle income

Annex III

111

64 India South-East Asia Low income 65 Indonesia South-East Asia Middle income 66 Iran (Islamic Republic of) Eastern Mediterranean Middle income 67 Iraq Eastern Mediterranean Middle income 68 Ireland Europe High income 69 Italy Europe High income 70 Jamaica Americas Middle income 71 Japan Western Pacific High income 72 Jordan Eastern Mediterranean Middle income 73 Kenya Africa Low income 74 Kiribati Western Pacific Middle income 75 Kyrgyzstan Europe Middle income

76 Lao People's Democratic Republic Western Pacific Low income

77 Latvia Europe Middle income 78 Liberia Africa Low income 79 Lithuania Europe Middle income 80 Luxembourg Europe High income 81 Madagascar Africa Low income 82 Malawi Africa Low income 83 Malaysia Western Pacific Middle income 84 Maldives South-East Asia Middle income 85 Mali Africa Low income 86 Malta Europe High income 87 Marshall Islands Western Pacific Middle income 88 Mauritania Africa Low income 89 Mauritius Africa Middle income 90 Mexico Americas Middle income 91 Mongolia Western Pacific Low income 92 Morocco Eastern Mediterranean Middle income 93 Mozambique Africa Low income 94 Namibia Africa Middle income 95 Nauru Western Pacific Low income 96 Netherlands Europe High income 97 New Zealand Western Pacific High income 98 Nicaragua Americas Middle income 99 Niger Africa Low income 100 Nigeria Africa Low income 101 Niue Western Pacific Middle income 102 Norway Europe High income


112

103 Oman Eastern Mediterranean Middle income 104 Palau Western Pacific Middle income 105 Panama Americas Middle income 106 Papua New Guinea Western Pacific Low income 107 Paraguay Americas Middle income 108 Peru Americas Middle income 109 Philippines Western Pacific Middle income 110 Poland Europe Middle income 111 Portugal Europe High income 112 Qatar Eastern Mediterranean High income 113 Republic of Korea Western Pacific High income 114 Republic of Moldova Europe Low income 115 Romania Europe Middle income 116 Rwanda Africa Low income 117 Saint Kitts and Nevis Americas Middle income 118 Saint Lucia Americas Middle income

119 Saint Vincent and the Grenadines Americas Middle income

120 Samoa Western Pacific Middle income 121 Sao Tome and Principe Africa Low income 122 Saudi Arabia Eastern Mediterranean High income 123 Senegal Africa Low income 124 Serbia Europe Middle income 125 Seychelles Africa Middle income 126 Sierra Leone Africa Low income 127 Singapore Western Pacific High income 128 Slovakia Europe Middle income 129 Slovenia Europe High income 130 Solomon Islands Western Pacific Low income 131 South Africa Africa Middle income 132 Spain Europe High income 133 Sri Lanka South-East Asia Middle income 134 Sudan Eastern Mediterranean Low income 135 Suriname Americas Middle income 136 Swaziland Africa Middle income 137 Sweden Europe High income 138 Switzerland Europe High income 139 Syrian Arab Republic Eastern Mediterranean Middle income 140 Tajikistan Europe Low income 141 The former Yugoslav Europe Middle income

Annex III

113

Republic of Macedonia 142 Togo Africa Low income 143 Tonga Western Pacific Middle income 144 Trinidad and Tobago Americas High income 145 Tunisia Eastern Mediterranean Middle income 146 Uganda Africa Low income 147 United Arab Emirates Eastern Mediterranean High income 148 United Kingdom Europe High income 149 United Republic of Tanzania Africa Low income 150 Uruguay Americas Middle income 151 Uzbekistan Europe Low income 152 Vanuatu Western Pacific Middle income 153 Viet Nam Western Pacific Low income 154 Yemen Eastern Mediterranean Low income 155 Zambia Africa Low income 156 Zimbabwe Africa Low income

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