HEALTH AND WELLBEING | eHealth 28 PARLIAMENTMAGAZINE 2 May 2011 Compatible health We must all work together to ensure Europe makes the best use of innovation in healthcare, writes John Dalli A ll EU countries face the common challenges of providing safe and high quality healthcare to their citizens while making their health systems more efficient and sustainable. This is particularly press- ing with current budgetary constraints, an ageing population and a shrinking health workforce. To help health systems adapt to these challenges, it is clear that we need more efficient models of healthcare. This means putting a greater focus on finding and deploying innovative solutions. Europe needs innovation in health not just to be modern and at the cutting edge, but to provide better health- care to more people in a sustainable, cost-effective way. So what are key challenges faced by Europe’s health systems? Firstly, there is the ageing population. Between 2010 and 2030, the number of Europeans aged 65 and over will rise by nearly 40 per cent. Secondly, we suffer from an “Europe needs innovation in health not just to be modern and at the cutting edge, but to provide better healthcare to more people in a sustainable, cost-effective way”
Transcript
HealtH and wellbeing | eHealth
28 PARLIAMENTMAGAZINE 2 May 2011
Compatible healthWe must all work together to ensure Europe makes the best use of innovation in healthcare, writes John dalli
All EU countries face the common challenges of providing safe and high quality healthcare to their citizens while making their health systems more efficient and sustainable. This is particularly press-ing with current budgetary constraints, an ageing population and a shrinking health workforce. To
help health systems adapt to these challenges, it is clear that we need more efficient models of healthcare. This means putting a greater focus on finding and deploying innovative solutions. Europe needs innovation in health not just to be modern and at the cutting edge, but to provide better health-care to more people in a sustainable, cost-effective way.
So what are key challenges faced by Europe’s health systems? Firstly, there is the ageing population. Between 2010 and 2030, the number of Europeans aged 65 and over will rise by nearly 40 per cent. Secondly, we suffer from an
“Europe needs innovation in health not just to be modern and at the cutting edge, but to provide better healthcare to more people in a sustainable, cost-effective way”
2 May 2011 PARLIAMENTMAGAZINE 29
PoliCyfocus
John Dalli is European commissioner for health and consumer policy
increasing shortage of healthcare workers. Our own estimates point to a shortfall in supply of around one million doctors and nurses throughout the EU by 2020. This figure rises to two million if you count lower skilled health workers. Current economic constraints and cuts in public spending only serve to intensify these challenges.
How do we deliver more healthcare, to more people, with fewer health professionals and limited resources? I believe that the answer very much lies in smart innovation. This involves innovative products and processes of providing care. In other words, working better with the resources we have. It also involves looking at how we can use new and emerg-ing health technologies, such as personalised medicines, innovative medical devices and eHealth. Innovation has the potential to improve the quality of, and access to, healthcare. It can also serve to increase the efficiency of health systems and make them more patient-centred. The EU has an important role to play in encouraging member states to work together, share knowledge and pool information.
An exciting area in pharmaceuticals is personalised medi-cine. Medicines which are tailored to the right patient groups, as opposed to the standard “one size fits all” variety, are cur-rently being researched and developed. It is true that these medicines can be expensive. But they offer the perspective of treating just patients in whom the medicines are effective, but not those where they don’t work or even have side effects.
Another fast developing area of innovation in healthcare is eHealth. Technologies such as telemedicine (including tele-assistance) can help alleviate some of the burdens on health systems across the EU, and that’s what e-Health is about. Another example is telemonitoring, which could reduce the costs of treating chronic diseases, for example. It could also help doctors and nurses in managing their workload by monitoring patients’ conditions remotely, thereby reducing hospital admissions. But aside from the gains in efficiency and cost-effectiveness, it is simply more comfortable for patients to be treated at home. I also believe that patients feel empow-ered when they are involved in their healthcare.
The potential for eHealth is clearly there. But it still cannot work prop-erly across EU borders because of the lack of interoperability or compat-ibility between health systems across Europe. The European commission is playing its part in bridging these gaps in eHealth. For example, the recently adopted directive on patients’ rights in cross-border healthcare supports future cooperation on eHealth by
foreseeing the establishment of a voluntary network for cooperation among member states.
While innovative medicines, tools, devices and processes are exciting, we need to focus public spending on those health technologies which deliver the highest value for patients and the society. This is where health technology assessment (HTA) can help, by assessing whether new technologies trigger effi-ciency gains that help secure the quality and sustainability of health systems. HTA has proven to be a valuable tool for decision-makers when considering taking up new health technologies. Member states have much to gain from greater cooperation on HTA, that is why the commission is fostering and supporting cooperation in HTA at EU level.
I believe in a Europe that explores innovation to respond to the needs, expectations and concerns of patients and policymakers alike. Responsible, cost-effective innovation in health-care has the potential to provide safe and high quality health care for all Europeans and contribute to the efficiency and sustainability of health systems. A continuous dialogue between all member states is indispensable. Only by working together can we make the best use of innovation in healthcare for the benefit of the patient.
“How do we deliver more healthcare, to more people, with fewer health professionals and limited resources?”
HealtH and wellbeing | eHealth
30 PARLIAMENTMAGAZINE 2 May 2011
Patient powerThe EU should make the most of the benefits presented by eHealth systems, which range from improved patient care to economic efficiency, says Françoise grossetête
The possibilities of eHealth are endless. We have the means to make our lives more comfortable and dras-tically reduce the costs for our healthcare systems. eHealth leads to a better follow-up of patients and, by developing a patient-centred process, makes patients more involved in their own health: this is a
strong factor of wellbeing.As rapporteur on the cross-border healthcare directive, I am
directly involved in this topic, eHealth being an integral part of cross-border healthcare. Both contribute to the sustainability of our health systems and are deeply interlocked. By coordi-nating these fields in the best possible way, we can provide better patient care and save money, by drastically improving the continuity of care.
Françoise Grossetête is a member of parliament’s environment, public health and food safety committee and rapporteur on the cross-border healthcare directive
Article 14 of the cross-border healthcare directive deals with eHealth and creates a European eHealth network, the possibilities of which are very diverse. In cross-border health-care, eHealth also allows for better research and innovation. The added value of cooperation and data sharing between European and national authorities is extraordinary. More use of technologies means less duplication of work and studies, with centres of excellence that can now be Europe-wide. It is proof that EU-wide studies provide a much more interesting view on diseases and drug trials.
Of course, the usefulness of eHealth in rural areas needs no explanation. It provides us with better means to fight against health inequalities.
Moreover, in the context of an ageing population, European health and consumer policy commissioner John Dalli announced that eHealth would have a part to play in the new “healthy ageing” partnership, an initiative I warmly welcome. The senior members of our society can also directly benefit from these advances.
My only regret, in this field, is what I see as a final lack of ambition, despite the will of commissioner Dalli and the European parliament to create a strong text. The European parliament has always been conscious of the fascinating possibilities offered by eHealth. During the drafting of the directive, MEPs tried to make EU-wide eHealth cooperation compulsory. Unfortunately, the commission and parliament’s position was then weakened in the negotiations with the council. There is now a clear competence in eHealth, but not nearly as strong as we would have wished it to be: we were only able to obtain cooperation on a voluntary basis.
The directive merely provides a framework for new health technologies. The creation of a European eHealth network is a positive thing, but we must go further. There is currently a lack of sufficient interoperability between the EU’s different healthcare systems and their IT systems. We need to agree on terminology, record-sharing and data protection, as well as the use of more user-friendly systems.
We must make sure we apply sufficient standards to eHealth, in terms of safety and quality. For instance, data privacy is an issue which must be addressed. This strong need for more interoperability concerns both member states and other willing stakeholders. Public-private partnerships to help develop this European network must be encouraged. Collaboration with firms in order to build innovative programmes may change the lives of EU citizens.
In my view, member states therefore need to be much more ambitious. For their own reasons, they decided that they didn’t want, for now, to go any further on this issue. Let’s hope they will change their minds in the near future, as this field carries real potential. The world is moving forward and innovating, Europe must not fall behind its partners.
2 May 2011 PARLIAMENTMAGAZINE 31
eQuality in eHealthHealthcare in Europe must adapt if it is to meet the challenges of an ageing population and shrinking budgets, writes John Bowis
There is no doubt that healthcare systems throughout Europe are being forced to change. An ageing popu-lation, combined with tighter government budgets and fewer healthcare professionals, inevitably means that the delivery of healthcare, and the systems which provide it, must adapt.
Through the newly adopted patients rights in cross-border healthcare directive, my former colleagues in the European parliament aimed to facilitate modifications to European health systems by looking at healthcare from the perspec-tive of the patient. Though the legislation could have given further rights to patients, it did, for the first time, authorise cooperation amongst member states in issue areas previously seen as outside the scope of the EU institutions – namely eHealth and health technology assessment (HTA). eHealth especially, is seen as a solution for patients to expand self-care management, lessening hospital visits and overnight stays for those with chronic illnesses. The legislative basis for enhanced collaboration in eHealth in the cross-border health directive will allow the European commission to foster new avenues to increase the uptake of eHealth technologies to combat the dif-ficulties faced by health systems throughout the EU. However, many barriers still exist which prevent the broad uptake of new eHealth solutions.
In my current role as honorary president of health first Europe (HFE) – the organisation of patients, healthcare professionals, experts and industry – we released in February this year our publication “eQuality in eHealth: Stakeholders’ reflections on addressing eHealth challenges at the European level”, in which we put forward recommendations on how to increase the use of eHealth technologies. With contributions from ECR deputy Milan Cabrnoch and public health and risk assessment director for DG health Andrzej Jan Rhys, among others, HFE concluded that the European institutions, in
John Bowis is a former MEP and honorary president of Health First Europe
partnership with stakeholders, need to consider the following when determining eHealth policy:
Patient needs, including access and quality of care, should remain at the centre of eHealth poli-cies. Encouraging patient trust in eHealth solutions is essential and efforts to raise awareness of solutions, sharing information and defining proper architecture for data protection, should be supported. Healthcare providers including nurses, doctors, hospitals and other carers must be involved and considered in the provision of eHealth solutions. Reimbursement and funding systems in member states and local health systems must be adapted to encourage innovation and not hinder it. All member states should have an eHealth road map to increase the uptake of eHealth. The EU should allocate funds for eHealth proportionate to the current and projected trends in health, such as ageing population.
These recommendations provide the basis for what we at Health First Europe believe to be the areas in which amending current structures could reduce the barriers for patient access to eHealth solutions. However, we also understand that there are more incremental steps to be taken to ensure that patients, healthcare professionals and industry stakeholders all realise the potential of eHealth. That is why I shall be unveiling HFE’s key tenets on eHealth for the Hungarian presidency during eHealth week in Budapest (10-13 May 2011). I hope that health stakeholders, including the European institutions, will consider our recommendations as they further develop policy to meet the needs of European patients and healthcare systems. eHealth is an opportunity for us all, as patients and policymakers, and should not be wasted.
“Many barriers still exist which prevent the broad uptake of new eHealth solutions”
Policyfocus
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On the frontlineeHealth developments can produce many positive outcomes and it is Europe’s nurses who will be utilising this technology, writes Paul de Raeve
Nurses are champions in using eHealth technology frontline. By applying eHealth, nurses reengi-neer the health systems in the EU and Europe, especially when it comes to the elderly, chronic diseases and continuity of care. The EU needs a paradigm shift towards personalised care where
synergies between health and social care are urgently needed. Through the developments already in play, several positive out-comes arise with a widespread use of eHealth services: increase of patient independence, improvements in the delivery of care, reduce of repeated hospitalisations rates and the emergency department attendance. Therefore, the European federation of nurses (EFN) recommends extending tele-Health services from monitoring focus to self-care focus by integrating care amongst all health service providers.
Interoperability is not the only challenge as the ‘usability’ of these technologies by health professionals, patients and citizens are needed to achieve a paradigm shift. Some concrete examples: Norway has developed an internet program to support fami-lies in charge of a relative with Alzheimer’s; nurses can bring information and knowledge directly to the family. Scotland has evolved an initiative to support the self-management of long
term conditions through the use of tele-Health tools, at community level and at home, enabling patients to stay in their homes longer with a good quality of life. In the same direction, but in Portugal through the use of an ICT program, professionals are pro-viding healthcare and psychological support at home keeping the patient in a familiar environment and avoid-ing hospitalisations. In Northern Ireland, a new service of chronic illness case management is a reality where nurses receive extra education and technical support to manage multiple chronic conditions. These examples emphasise the importance of engaging nurses to show the developments at local level, how they use the technologies and ICT tools and what their needs are.
For that reason, EFN is part of the governance of the active and healthy ageing innovation partnership in which eHealth initiatives, led by nurses, can show huge potential for alterna-tive healthcare delivery in a more cost-effective scenario. EFN believes that through this partnership it will be possible to address real concerns in everyday life for European citizens, spreading good examples of innovative management of chronic conditions and contributing to self-management and allowing the elderly to live more independently. As well, it will reinforce promotion and prevention activities and long-term strategies, instead of promoting direct and indirect medical care solutions. If this shift is not taking place, nothing will change.
Finally, considering that the 92 per cent of the nursing work-force are women, a gender approach should orient the activities and developments when designing eHealth tools for a successful implementation. If we want eHealth to lead to new jobs, new skills and economic growth, eHealth needs to be more gender sensitive in which primarily the industry, policymakers, and professional associations should advocate gender sensitivity. If the design is not made by women, women will not use it and, consequently, neither will the health system.
“The EU needs a paradigm shift towards personalised care where synergies between health and social care are urgently needed”
Paul de Raeve is secretary general of the European federation of nurses
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Policyfocus
Reaching potentialInnovation in medical technology is vital for sustainable healthcare systems, writes John Wilkinson
In a first major step in increasing its footprint on the European research and innovation agenda, medical technology and its specific research and innovation chal-lenges and opportunities were presented at the recent Brussels multi-stakeholder conference “Innovation in healthcare: from research to market” organised by the
European commission.This conference is quickly becoming the European reference
point for ‘Innovation in healthcare’. Organised jointly by the European commission’s DGs research and innovation, enterprise and industry and health and consumers, the event was addressed by no less than three EU commissioners and gathered over 500 international policymakers, research institutes, venture capitalists and entrepreneurs who heard the latest EU and global policy and thinking in healthcare research, innovation and funding.
The European commission invited our chairman Guy Lebeau, also a representative of a small medical technology firm and me to take an active role in the programme. Speaking on behalf of the medical technology industry at the opening keynote session, Lebeau emphasised the power of medical technology to rapidly innovate and bring the necessary changes needed to help build new models of healthcare delivery. I addressed the conference on ‘a multifaceted approach to responsible innovation in healthcare’ where I spoke about opportunities to reorganise healthcare deliv-ery by aiming for new holistic care models and how the medical technology industry can support them.
These views were echoed by senior policy makers and politi-cians at the event which can only be positive pointers to a bright future for medical technology. Health commissioner, John Dalli, and the Hungarian minister of state for health, Miklós Szócska, both signalled where society really needs to innovate. Dalli emphasised that innovation is the only way to have modern healthcare delivery and that this modern healthcare will mainly be technology enabled. Szócska spoke about the need to invest in the health systems of the future and the technology changes needed to help effect change in health systems.
Small and medium sized enterprises (SMEs) also received a special focus. Swedish medical technology association Swedish Medtech together with Eucomed were delighted that the European commission invited Torbjörn Kronander, mammog-raphy entrepreneur and CEO of Swedish SME Sectra, to talk about the specific challenges facing SMEs. Kronander echoed
John Wilkinson is the chief executive of Eucomed – the European Medical Technology Industry Association
the pressing needs of European SMEs as laid out in Eucomed’s recent survey into small medical technology businesses. He par-ticularly expressed the difficulties that Europe’s complex web of reimbursement systems played in getting his technologies into the hands of health professionals and patients. He found, com-pared to the EU system, the US FDA system is a real barrier to innovation, adding delays and unnecessary bureaucracy with no patient or product improvement. EU commission vice president, Antonio Tajani, stated that we have to innovate to realise the full potential for Europe and its citizens.
Eloquently introducing her closing address in Gaelic, her native tongue, research and innovation commissioner Máire Geoghegan Quinn pledged increased funding to SMEs, sur-passing the previous 15 per cent of the €6bn allocated to health research in the seventh framework programme. She encouraged engagement in the commission’s active and healthy ageing project as a multiplier not only to gain an extra two years of active life but also to achieve economic growth and jobs. A particular emphasis was given to measures aimed at freeing up access to finance and the urgent need for a single EU patent system. The need to innovate and modify health systems and services was stated as key.
Eucomed is already looking forward to working with the commission again on planning next year’s conference especially, as recognised during the conference as innovation in medical technology is vital if we are to bring efficient, sustainable and equitable healthcare systems.
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it supportInformation technology is key to modernisinh healthcare, argues Miklós Szócska
Modernised, responsive, effective, efficient and sustainable healthcare systems. That is what national governments would constitute a priority in the EU in the 21st century. Information technology is essential to mod-ernising healthcare, while innovation is crucial
to developing new solutions and promoting transformation towards new care models.
The upcoming ministerial eHealth conference in Budapest will highlight that eHealth can contribute to better investment in the health systems of the future. Smart solutions are bring-ing new aspects into health policy decision-making while safe and high quality healthcare can be better supported through IT applications. The Hungarian government recognised the need to design new models of care responding to the emerging chal-lenges and to develop future long term strategies with special focus on health sector investment.
The effective use of EU structural funds can substantially contribute to health systems innovation promoting health sector development. Our national pilot projects proved to demonstrate a comprehensive and complex eHealth portfolio of the country. These strategic projects have been co-financed by the European Union.
Information technology is not for the future, it is our present. The national health strategy document, the Semmelweis plan promotes evidence-based policy decision-making, a process that has been built on genuine needs and sound data. Information technology plays an active and key role in defining, analysing and optimising the existing processes to increase efficiency in the healthcare systems. IT solutions also support the management of professional human resources. The growing shortage within the health workforce partly due to professional mobility is an EU-wide challenge not only for the countries of losing their professionals but also for theose receiving them. The issues of demographic changes and the increasing number of patients with chronic diseases will call for urgent steps. IT applications can help to better address the problems of a shortage of professionals.
Hungary has great potential for eHealth through its national registration and information systems which have not been appro-priately used until now for capacity planning. Why not benefit
from them? In these times of social and economic challenges policymakers need real solutions and actions. Today needs-based capacity planning is a strong approach in the Hungarian health policy where IT support tools and methods are key contributors for decision makers in achieving their objectives and goals.
I am proud to share with you that Hungary has been developing a unique national capacity analysing and planning application which will display the information of organised data set on a digital map. The pilot tool “monitor and capacity map” (called by the nickname “Kateter and Monika”) collects and analyses major data sources of different governmental entities. The aim is to create functional and regional level integrated, pro-gressive patient pathways. This solution will enable health policy decision-makers to take evidence-based measures with a view to increasing healthcare system efficiency and improving care quality. We agree that speeding up the development and spread of eHealth systems will bring the necessary support.
The Hungarian EU presidency welcomes the European efforts and initiatives on a closer cooperation in the field of R&D to contribute to address demographic and social chal-lenges at EU level. We share the view that EU should encourage more innovation in the provision of IT healthcare solutions and that sustainable health systems will promote better Europe competitiveness. The Hungarian pavilion at eHealth week 2011 will show our pilot decision-support IT applications already in use in the Hungarian healthcare system and demonstrate our large scale eHealth projects in development phase in the field of chronic diseases.
Miklós Szócska is Hungarian minister of state for health
“In these times of social and economic challenges policymakers need real solutions and actions”
Why is it key for sanofi-aventis to conduct clinical trials in Europe?
Clinical Trials are considered as a life science research activity in human beings and are conducted under strict conditions laid down in Directive 2001/20 EC. The assessment of the data collected via clinical trials is the cornerstone of the evaluation of a new medical product made by the health authorities, before they grant the marketing authorization. These studies can also be conducted after the launch of the product to assess potential new indications. These studies are playing a key role in the EU healthcare system by contributing to the development and sharing of the EU medical knowledge. Clinical trials also contribute to the translation of basic science in clinical progress, fuelling innovative thinking in the clinical scientists’ teams and ultimately translate basic science in clinical progress and recognition of EU leading and reference role in Medical Research and Innovation. Moreover the conduct of clinical trials in Europe makes the conclusions and the results of clinical research more relevant for the European population, because tailored on European patients therapeutics needs.
What is sanofi-aventis assessment of the implementation of 2001 clinical trials directive? Have the Directive’s objectives been reached?
Overall, sanofi-aventis considers that one of the key objectives of the Clinical Trials Directive 2001/20/EC “Protection of the health and safety of clinical participants” has been achieved, and represents a fully acquired value. The clinical trials Directive 2001/20/EC also introduced a first level of harmonisation among Member States procedures for clinical trials approval. However different national implementations of these procedures have created a substantial lack of homogeneity
in terms of administrative requirements, leading to bottlenecks that hamper the EU competiveness. The very complex set of heterogeneous national procedures requires a quite sophisticated and costly administrative deployment which, in our opinion, is one of the leading causes for the decrease of clinical trials in Europe. At present the impact of administrative burden for implementing Clinical Trials in the EU is substantial enough to discourage and prevent the active involvement of numerous clinical entities, including centres of Medical Excellence and to meaningfully reduce the number of Members States hosting these programmes.
What improvement can we expect from a review of this directive?
The above situation hampers de facto scientific knowledge sharing and medical innovation, and most importantly, it excludes a relevant proportion of otherwise eligible European Patients from accessing clinical trials. The lack of common interpretation of the European legislation should timely and effectively be addressed at a time where more clinical trials covering the life cycle of a new medicine will be required by the new pharmacovigilance legislation. To curb the negative impact of the current Directive, strong efforts on the harmonised implementation of the regulatory administrative process needs to be envisaged. We are notably convinced that an optional centralised community pathway for the technico-scientific evaluation of clinical trials is today opportune and fully justified. This will in the end stimulate sharing of knowledge and enhance clinical science state of the art for the greatest number of Clinical Centres across the EU and will effectively allow more patients to participate in this research for the benefit of the community.
Clinical Trials: Increasing the European attractiveness
3 questions to Jean-Pierre Lehner, MDSenior Vice President - Chief Medical Officer of sanofi-aventis
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SUSTAINABLE COMPETENCE IN ADVANCING HEALTHCARE COCIR
The benefi ts of eHealth are widely recognized, but the European eHealth market remains fragmented and limited. Signifi cant barriers, such as the lack of business models and common infrastructure, are still hindering its deployment.
For years, COCIR has built strong competencies in eHealth and has raised awareness of this technology as one of the most effi cient ways to achieve integrated care. The evidence in favour of combining healthcare and ICT technology is compelling, as it leads to better access to healthcare, reduces inequalities and ensures better quality of products and services while driving cost-effi cient ways to achieve more sustainable healthcare systems in Europe and beyond.
Increasingly, eHealth is brought into policy discussions and is in the driving seat in several strategic European initiatives: the Digital Agenda, the Active and Healthy Ageing Innovation Partnership, the eHealth Governance Initiative, the eHealth Action Plan and as a key element in the cooperation agreement signed by Europe and the US at the end of 2010.
eHealth will be showcased at the Hungarian Presidency’s eHealth Week in Budapest on 10-12 May. We expect that this event, which brings together two major events in the sector in Europe - the ‘Interministerial eHealth Conference’ and the ‘World of Health IT Conference & Exhibition’ - will be very special.
COCIR has mobilised recognised industry experts and key opinion leaders to deliver a compelling vision for the future of eHealth in Europe through various sessions including on cross-border healthcare, management of chronic diseases as well as activities at regional level. A dedicated COCIR session on 12 May will focus on how to speed up the deployment of eHealth.
Based on the considerable knowledge and competences developed by COCIR members, COCIR is the leading trade association in the fi eld of eHealth. In 2007, we published our Ten Recommendations on eHealth which are still relevant today. In 2010, we published a Telemedicine Toolkit.
The new COCIR eHealth Toolkit, to be published shortly, sets out three priority areas for accelerating the deployment of eHealth, giving
for the fi rst time facts and fi gures on the hospital IT market in Europe, supported by a glossary of terms which proposes common terminology, including new elements such as cloud computing.
Based on its success in 2010, COCIR will also launch an updated version of its Telemedicine Toolkit. The 2011 edition contains new
evidence on the benefi ts of telehealth for patients and highlights the potential of mHealth alongside telemedicine solutions to improve the management of chronic diseases.
COCIR estimates that the global eHealth market is €55 billion of which Europe represents one third. All agree that this market is set for explosive growth. We hope that the COCIR Toolkits will help us unlock it.
COCIR estimates that the global eHealth market is €55 billion of which Europe represents one third. All agree that this market is set for explosive growth.
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driving seat in several strategic European initiatives: the Digital Agenda, the Active and Healthy Ageing Innovation Partnership, the eHealth Governance Initiative, the eHealth Action Plan and as a key element in the cooperation agreement signed by Europe and the US at the end of 2010.
on trialEurope’s clinical trials processes need more harmonisation, clear ethical limits and more public support, says Peter liese
We still cannot treat most life-threatening and debilitating diseases, and even with ones we can treat, we still have to accept a lot of side effects. That is why research into new pharmaceuticals is as urgent as ever. After computer models, cell culture and animal
testing, new drugs still need to be tested on human beings. That is why clinical trials are an unavoidable and necessary
step in this development. The 2001 directive on clinical trials was an important first step for a common European approach. Parliament and council set ethical criteria and measures to safeguard the participants’ safety. We also took a first step towards harmonisation. This was only a first step because at that time the member states were not ready to go for a real European approach. Now it is time to take the next step and it is very good that the European commission intends to present a revision of the directive next year.
We need to come to a more European approach because clinical trials are still very difficult, especially those that are mul-tinational. But especially in paediatric treatment and treatment for rare diseases, a single member state cannot make the neces-sary efforts alone. The regulation must be based more on the actual risk of the clinical trial. This would also be beneficial for the non-commercial so called “investigator driven” clinical trials.
Pharmaceutical companies need to earn money. That is why we cannot expect them to invest in trials that prove that the amount of drugs can be reduced or that other methods are better for the patient.
These trials are important, that is why the public needs to support it. We have successfully made clini-cal trials a priority in the seventh framework programme. We should put even more emphasis in the next research framework programme, especially in the areas of paediatric and rare diseases, which the member states cannot tackle alone.
Peter Liese is a member of parliament’s environment, public health and food safety committee
“We need to come to a more European approach because clinical trials are still very difficult, especially those that are multinational”
Standardising the regulatory regime?
Revision of the clinical trials directive was built into the European commission's 2008 communication on “safe, innovative and accessible medicines: a renewed vision for the pharmaceutical sector”, where the EU executive announced that an assessment would be made of the application of the clinical trials directive.
According to the commission, the assessment would consider, in particular, various options for improving the functioning of the directive with a view to making legisla-tive proposals, if appropriate, while taking the global dimension of clinical trials into account.
Following a public consultation in January 2010, the commission has scheduled adoption of a legislative proposal for next year (2012).
On 9 February 2011, a public consultation on a concept paper on the revision of the directive was launched. The concept paper presents a preliminary appraisal of which option appears to be the most suitable one to address some of the key concerns of the directive.
Source: European commission
While innovation is the backbone of the EU 2020 Agenda, this high-level
political objective can only be achieved if it is reflected in concrete pieces of legislation that influence the day-to-day business of innovative sectors, such as the pharmaceutical industry. In this sense, the upcoming revision of the Clinical Trials Directive can be seen as a chance to improve a legislative piece that is central for pharmaceutical research and thus patients’ access to innovative medicines. The current regulatory framework for clinical trials, applicable since 2004, has been criticized by regulators and stakeholders alike. In addition to the strain it puts on resources, it has resulted in limited alignment between Member States regarding the scientific assessment and authorization of clinical trial applications. As a result, it has been a disappointment for many stakeholders. Diverging practices of national authorities and ethical committees in the different Member States add to the complexity of the system. Delays, especially in the area of multinational trials, are the rule rather than the exception. These delays may also have a negative impact on the innovative potential of companies in their need to quickly start early phase clinical trials.
Fit for InnovationA Future-Proof Framework for Clinical TrialsMichael Doherty, Stephane André, Pharma Development Regulatory Affairs, F. Hoffmann-La Roche Ltd., Switzerland
Maintaining the current system puts opportunities at stake. It hinders innovation for multinational clinical trials in the EU. While patients’ safety must be guaranteed through a well documented risk-benefit and ethical assessment, many of the current burdens are primarily bureaucratic in nature and thus delay patients’ access to new therapeutic options. Ultimately, this endangers the EU’s attractiveness for pharmaceutical research.
To restore this attractiveness, a minimum of changes should be included in a revised Clinical Trials Directive including:
1 It should be possible to submit all documents required for multinational clinical trials to one single EU portal. All communication with national authorities should be coordinated by this portal. At least core documentation should be required in English only.
2 The requirements for risk-benefit documentation and assessment should be fully harmonized in the EU, preventing Member States from adding their own rules.
3 A central, up-to-date overview of requirements that fall under national competences (e.g. insurance and ethical committees) should be established to allow for sufficient predictability. Better exchange and voluntary cooperation between ethical committees should be encouraged.
4 The application assessment should be linked with preceding scientific discussions (scientific advice, paediatric investigation plan) so as to make processes easier to predict.
5 “Centers of Excellence” for defined areas (e.g. cancer, CNS, paediatrics, ageing population) should be further promoted within the EU. The basis could be a network of experts able to take leading roles in the assessment of clinical trial applications.
Efficient, timely and high-quality assessments would be a required outcome.
6 Sponsors should be motivated to apply innovative standards in protocol design, trial methodology and trial management through incentives such as expedited reviews and – specifically for academic sponsors - through fee waivers.
7 For multinational clinical trials, applicants should receive only one consolidated list of questions within a defined timeframe. This should apply to the initial submission and any subsequent amendments.
8 Sequential assessments of different studies within a clinical trial program for a new medicine should be streamlined on the basis of a risk-assessment and thus lead to fast-track authorizations.
“Perhaps the biggest challenge for the EU and its Member States is to adopt a much more strategic approach to innovation. An approach whereby innovation is the overarching policy objective, where we take a medium- to longer-term perspective, where all policy instruments, measures and funding are designed to contribute to innovation, where EU and national/ regional policies are closely aligned and mutually reinforcing, and last but not least, where the highest political level sets a strategic agenda, regularly monitors progress and tackles delays.”
1
9 The timeframe laid down by the legislation must be respected (currently 60 days for assessment and authorization). As mentioned above, incentives for a faster process should be put into place.
10 Flexibility is needed to quickly expand an authorized clinical trial to centers in additional Member States in the interest of patients, who may wish to participate in a given clinical trial.
How could a revised Clinical Trials Directive fulfill these requirements?
The Commission proposes to solve the identified shortcomings of the current framework by introducing a “coordinated assessment procedure” (CAP), modeled after the procedure for decentralized marketing authorizations, where a “Reporting Member
State” leads the scientific assessment and receives input from other concerned Member States. While this would be an improvement to current practice, it does not fully address the risk of diverging administrative practices and delays.
This risk could be addressed by a centralized assessment and authorization procedure established at the European Medicines Agency (EMA) leading to an authorization in all Member States. Unlike ethical questions, scientific aspects are not a national issue. Good science doesn’t stop at country borders and could thus be assessed by one committee instead of several. This would ensure full harmonization.
The concrete workings of such a committee should be looked at in more detail so as to make it efficient and keep costs low. For instance, it could be a virtual network of experts located in national authorities, video and telephone conferences could in many cases replace expensive travelling, and Member States should have the possibility to delegate their votes to others.
Furthermore, the Parliament should promote an enhanced cooperation mechanism for ethics committees, in order to support a better exchange between them.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS.
Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.
In 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D. In 2010 alone, Roche sponsored more than 300 multi-national clinical trials.
For more information:
www.roche.com and specifically on Roche conducted trials www.roche-trials.com.
The Parliament should not hesitate to call for a dialogue of all involved stakeholders – from industry to payers, patient and healthcare professional organizations, academia, European and national authorities. If legislators understand the needs for a future legislative framework, they can take this chance and make the European clinical trials system “fit for innovation.”
Footnote1 Europe 2020 Flagship Initiative Innovation Union (SEC (2010) 1161)
ADVERTORIAL
KEY ISSUES FOR EUROPEAN CLINICAL RESEARCH
The Clinical Trials Directive was adopted in April 2001. It started being applied in 2004 when Member States finished transposing it into national law.
Since then, it has become clear that a number of issues need to be addressed in the current clinical trials legislation, namely:
its • divergent application across Member States;
the • increased administrative burden and costs resulting from additional national regulatory requirements;
the fact that clinical trial legislation •does not sufficiently take into account the increasingly multi-country and international scale of clinical trials (In 2009, in the EU, multinational trials represented 21% of approved trials but included two-thirds of the total of patients involved in clinical trials*).
Furthermore, divergent requirements on clinical trials also create discrepancies in access to innovative treatments amongst citizens of the European Union. To get sound scientific results, it is necessary to maintain the same study protocol in all countries involved. Under the current Clinical Trials Directive, Member States can request certain amendments to be enforced. If these amendments are not compatiblewith the study protocol in other countries,applicants may have to remove the countryfrom the clinical research.
Against this background, there is more and more data to show that innovative clinical research is moving away from Europe.
Evolution of clinical trials in Europe 2007-2010*:
• Numberofapprovedprotocolsdecreased by more than 17% (from 5028 to 4143)
• Numberofclinicaltrialenrolledsubjects decreased by approximately 26% (from 535 481 to 396 784)
TOWARDS AN IMPROVED CLINICAL TRIALS LEGISLATION IN THE EU
ABOUT US
Celgene is a multinational biopharmaceutical company engaged primarily in the discovery, development and commercialization of products for thetreatmentofcancersandotherseriousdiseases.HeadquarteredinNewJersey,USA,Celgeneoperatesin18EUMemberStatesandcurrentlyhas over 30 clinical trial programmes running in the EU. Celgene is working in partnership with many European academic centres. As a company committed to clinical development of innovative medicines, we believe that the revision of the Clinical Trials Directive is necessary and an opportunity to improve the state of European Clinical Research, ultimately to the benefit of patients.
RECOMMENDED AREAS FOR IMPROVEMENT IN THE REVISION OF THE CLINICAL TRIALS DIRECTIVE
In order to improve the clinical trials situation in Europe it is critical that the revised clinical trials legislation adopts a format that is binding to national competent authorities, at least for those aspects which cause serious administrative burden such as:
the • content of the clinical trials application dossier;
the • conditions for safety reporting. The revised legislation should therefore provide for a mechanism whereby the application for the clinical trial is submitted jointly to all Member States concerned through a single submission. As put forward in the Commission’s Concept Paper, a coordinated assessment of the clinical trial application, while keeping ethical assessments within the remit of the Member States, may be a helpful step towards avoiding national divergences.
Finally a better adaptation of regulatory requirements to those trials presenting low risk for patients should also be considered.
It is essential to rapidly find a pragmatic solution, to safeguard a fundamental and competitive role for European Clinical Research and provide optimal and equal access to innovative treatments for all EU patients.
For more information on clinical trials please contact Fabien [email protected]
For any other enquiry please contactLaura Gutié[email protected], +32(0)28949053
*Source “09/02/2011 European Commission Concept Paper on the Revision of the Clinical Trials Directive 2001/20/EC”
2 May 2011 PARLIAMENTMAGAZINE 41
Policyfocus
Fair and balancedThe upcoming review of the clinical trials directive is an opportunity to rationalise the regulatory burden while still protecting patients, argues Philippe Juvin
As a doctor, I believe it is imperative that the European Union addresses the impasse in which European clinical research now finds itself: exces-sive red tape, the steady fall not only in the number of licensing applications but also in the number of individuals participating in clinical trials and the
decline in competitiveness in European clinical research. The fact is that dynamic biomedical research is essential if our labo-ratories are to be competitive, our universities attractive and European patients are to be assured of being able to benefit from the best care and the latest techniques and medicinal products. The complexity of the measures for setting up a clinical trial has become such that investigators now prefer to approach other countries where regulations are more flexible.
It is, therefore, a matter of urgency for there to be a review of the clinical trials directive, which, while undoubtedly strength-ening patient protection, has led to increased administrative costs. The European commission is due to put forward a new draft directive in 2012. Therefore now is the time to open the debate, to agree and put together, as of now, the points of view of each of the players involved. It was with this in mind that, I organised an initial working lunch on last month in Brussels. This exchange of views between the commission, patient associations, pharmaceutical companies and academics proved to be highly informative, making it possible not only to draw up a lengthy list of problems but also to pick out a number of interesting paths to follow.
All participants agreed on one essential point: the need to rationalise the regulatory and administrative procedures employed when conducting clinical trials. One of the key points is the heterogeneous nature of procedures across the various member states. Should we not be envisaging a proce-dure based on mutual recognition, which would mean that the duly authorised opinion of one ethics committee would apply automatically throughout the Union? Could we not at least standardise clinical trial application and assessment proce-dures, in a way that would set an upper limit for harmonisation which would prohibit any one member state from applying more stringent (or more flexible) regulations?
Further issues arise, particularly the need for taking greater account of the case of such specific domains as rare diseases
Philippe Juvin is a medical doctor and member of parliament’s internal market and consumer protection committee and substitute member of the environment, public health and food safety committee
or the extreme ages of life. Furthermore, what really needs to be handled differ-ently are prospective intervention studies and observation studies. Lastly, the parliament and the commission abso-lutely must treat commercially-targeted research sponsored by industry differently from that undertaken within a university context. Faced with all these questions, the parliament has a fundamental role to play: that of launching a constructive upstream debate with all the parties concerned and, at the time of the negotiations with the council and commission, proposing solutions which are fair and balanced, following in the direction of the 2020 Strategy.
The results of the second public consultation will, I hope, make it possible to arrive at solutions in order to stimulate biomedical research in Europe while ensuring a high level of patient protection. The burden of responsibility which we carry is a heavy one: to ensure, at all costs, that the forthcom-ing directive on clinical trials does not prove to be merely “a bandage on a wooden leg”.
“The complexity of the measures for setting up a clinical trial has become such that investigators now prefer to approach other countries where regulations are more flexible”
HealtH and wellbeing | Clinical trials
42 PARLIAMENTMAGAZINE 2 May 2011
Clinical challengeECRIN works to harmonise European quality standards, writes Jacques demotes-Mainard
Around 5000 clinical trials are done each year in the European Union. Conduct requirements for these trials are provided for in Directive 2001/20/EC of the European parliament and of the council of 4 April 2001 (clinical trials directive). Targeted by the scientific community for its cumbersomeness and
its excess of regulation in certain areas, it will be undergoing a revision next year. The need for an improved, bolder and more harmonised legislation, taking into account the risks associated with the different categories of clinical trials, and improved alignment with the regulatory requirements in other world regions, were key issues broached at a dinner debate on clinical research hosted by MEP Peter Liese and the European clinical research infrastructures network (ECRIN) on 12 April.
ECRIN was created in 2004 to support multinational inde-pendent clinical research in the EU. The network aims to help
Jacques Demotes-Mainard is a coordinator at the European Clinical Research Infrastructure Network (ECRIN)
academics and small or medium-sized enterprises to do the sort of cross-border trials that phar-maceutical companies have been doing for years. Until now it was almost impossible for academic institutes and SMEs to run mul-tinational clinical trials. ECRIN also works to harmonise European quality standards, building nation-al capacity in Eastern European countries and pushing for open access to anonymised trial data.
The dinner brought togeth-er key stakeholders from the political, industrial and academic world. MEPs, European commission officials, European associations, big pharma-ceutical companies, physicians and researchers discussed the challenges faced by the sector. Besides the legislative framework, the participants tackled such issues as the need for infrastructure providing professional support to clinical research, funding for multinational investigator-driven clini-cal trials, and the promotion of transparency.
Access to data was much debated. There has been an expo-nential growth of the amount of handled data in the past ten years, but most of it is still unavailable, as it is stored in private researchers’ or organisations’ computers. Broadened access would have many benefits, amongst which avoiding much duplication in the studies. However, industry representatives pointed out to the risk of loss of competitiveness for compa-nies if the data was made available too soon.
The case was also made for more independent, investigator-driven clinical trials. Indeed, clinical trials are usually meant to show the efficacy of a drug for registration purpose, and not to compare its risk or benefit profile with the available therapies. And healthcare professionals often lack comparisons between treatments, as not enough trials focus on daily clinical issues. Independent trials address these questions, but multinational funding is hard to obtain. Moreover, conductors of trials have to pay a high risk insurance, which should not be necessary in such cases as comparisons between existing drugs, where the associated risk is very low.
Building ECRIN strengthens the capacity of each member state to run clinical trials, as it builds up national infrastructures. This in turn augments the attractiveness of the member states for medical and pharmaceutical research. To achieve a single European area for clinical research, three components are there-fore needed: EU-wide infrastructure, the funding to build it and conduct multinational trials, and a good piece of legislation. ECRIN will work actively to promote its vision for the future European legislative framework on clinical research.
“Building ECRIN strengthens the capacity of each member state to run clinical trials, as it builds up national infrastructures”
• Patients:Enable access to new therapeutic treatments, strengthen their rights, serve as basis for informed patients
• Researchers,EthicsCommitteesandAuthorities,HTA-researchers,FundingOrganizations,PatientsOrganisations:Provide overview of state of the art of science, foster cooperation among researchers, enable an increased accuracy through larger studies, avoid redundant studies, provide complete data basis
• Physicians/MedicalAssociations: Provide search tool for innovative treatments for patients, provide up-to-date view on clinical research and evidence for developing guidelines
Continuous medical development and the rapid increase of knowledge in the field of clinical research require the constant dissemination of information. The evidence from well planned and conducted clinical trials should be the base for decisions in healthcare and for the planning of further medical research. A significant proportion of clinical trials, however, is never published. This publication bias can lead to a distorted assessment of an intervention which negatively affects the treatment of patients.
Publicly available clinical trial registries are crucial for providing information about planned, ongoing and finished clinical trials for patients and their doctors, scientists, health professionals, and the general public.
The 2001 Clinical Trials Directive, the corresponding regulations, guidelines and drafts regulating the opening of EudraCT and the publication of results are an important step towards the transparency urgently needed. Clinical research is global and complex and the need for comprehensive data is neither restricted to drug trials (between 40 and 50% of clinical research involves e.g. surgical methods, other procedures, medicinal products or psychotherapy) nor restricted to one member state.
The last 10 years of clinical trials registries show that voluntary registration does not lead to comprehensive registries! Trial registration should be mandatory for all types of clinical trials, not only drug trials. It is in the interest of DG Sanco and DG Research and Innovation to provide full access to research information affecting public health care. The German Federal Ministry of Education and Research identified this necessity and decided to fund the implementation of a national clinical trials registry (on a voluntary basis, though). The German Clinical Trials Registry (DRKS, www.drks.de) is located at the University Medical Center Freiburg, is online since 2008 and approved by the WHO as a primary registry.
A combined effort of European and national institutions is needed to implement a network of similar clinical trial registries.
Institute of Medical Biometry and Medical Informatics
University Medical Center Freiburg
OpeningtheEuropeanClinicalTrialsDatabase(EudraCT)–afirststepintherightdirection–moreneeded!Dreier G, Jena S, Hasselblatt H, Antes G
Contact information:Dr. Gabriele DreierUniversity Medical Center [email protected]
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