Under the Lisbon Treaty, the role of EU institutions in Health Policy is limited to carrying out actions to support, coordinate or supplement Member States' actions." Health Care remains a Member State competency.
In a 2011 Commission Communication, two major problems were recognised within the context of EU health policy. First, the cost of Union health and social security care systems are rising. It is expected that the number of Europeans over 65 years of age is expected to double from 85 million in 2008 to 151 million by 2060. Moreover, chronic conditions, such as cardiovascular disorder diabetes, cancer as well as mental and neurological health disorders, present a huge social and economic cost.
In identifying health, demographic change and well-being for all European citizens as a major societal goal, the EU looks to raise the quality of the health care system across the Union that is also economically sustainable for future generations.
The European Commission stresses the need for an EU-level research and innovation response to these pressing social problems. Research in the health sector is a key theme of the EU Framework Programme, while directives are in place, which have a significant effect on the quality of clinical trials, new medical devices and medical research infrastructures. As a result, in a context where health care delivery follows directly from health care innovation, EU-level policies will play an important role in the provision of European health care into the future.
The tools at the EU's disposal are currently identified as:
In light of the Seventh Framework Programme's (FP7) completion in 2013, the Commission issued a work programme in July 2012 to consider a smooth transition towards the new research and innovation initiatives under Horizon 2020. This smooth transition requires an evaluation of the state of Europe's health-related socio-economic and societal challenges, while taking into consideration the new orientation given by the Europe 2020 strategy, such as fostering new ideas and innovation through industry-driven applied research as well as supporting growth in the workforce of the health research and services sectors.
The approach of Health 2013, which was developed within the FP7 "Cooperation" programme, is to stimulate innovation and SME participation via broad, bottom-up topics including the continued support of the overall public-private partnership with the pharmaceutical industry as well as the continued support of collaborative research. The Commission agreed that this transition can be achieved on two dimensions: one requires a strengthened procedure for putting knowledge into practice, and the other calls for an enhanced evaluation procedure, to improve the socio-economic impact of this knowledge.
The research priorities for Health 2013 are:
These priorities must be complemented by the ongoing horizontal activity of translating research into innovative applications for health.
Good health is considered a prerequisite for achieving the Europe 2020 goal of smart, sustainable and inclusive growth. All the health-related activities throughout the Union, therefore, will be undertaken to provide support throughout the research and innovation cycle grounding future EU Health Policy. With this goal in mind, it is crucial that policy measures be in place to ensure a smooth and coherent transition from the Seventh Framework Programme (FP7) initiatives and programmes to Horizon 2020.
Horizon 2020 is bound to a set of objectives, one of which is to address societal challenges facing European citizens in the present and future. In the Communication on Horizon 2020 - the Framework Programme for Research and Innovation, the Commission recognizes "health, demographic change and well-being" as a crucial societal policy goal for the Union. In principle, Horizon 2020 aims to stimulate new jobs and general growth related to addressing this societal challenge.
In Part IV of the 2011 “Proposal for a Regulation of the European Parliament and of the Council – establishing Horizon 2020” summarises the health issues which will be addressed by Horizon 2020:
• Health, demographic change and wellbeing;
• Nutrition and diet;
• A safe and secure food supply, sustainable agriculture and the bio-economy;
• New treatments and international cooperation to combat resistance to antibiotics on an EU level
Horizon 2020’s singular funding framework will prove useful to address these challenges and bridge the gap between health research and health-related policy. Specifically, Horizon 2020 will promote this objective through a funding scheme that not only covers a wide spectrum of health research activities but, moreover, is based on excellence of research. Following this rigorous funding scheme, Horizon 2020 can play a significant role in advancing health-based technologies, diagnostic and screening practices as well as in contributing to health and consumer protection through scientific and technical support in specific health research areas.
A major conceptual goal of Horizon 2020's framework is transnational medical research. If health research and innovation activities are limited to a national level, health care policy will not move forward coherently on a European level. Comparative analyses of the reform of public health systems in Europe and in third countries will be implemented under Horizon 2020 in addition to analyses of future health workforce needs, socio-economic inequalities as well as the assessment of patient safety solutions and quality assurance systems.
Under Horizon 2020, the over-arching health issues will be addressed by the following activities, which are included in a larger comprehensive activity list in the European Commission's 2011 Proposal for a Council Decision on the implementation of specific programmes in Horizon 2020:
Proposed in the Europe 2020 strategy and its Innovation Union flagship initiative, the European Innovation Partnership aims to increase by 2 the average number of healthy life years in the EU
by 2020, by securing the following:
The Strategic Implementation Plan of this Partnership was adopted in November 2011 by the Partnership's Steering Group, composed of 30 high-level stakeholders. This Plan develops key actions around three thematic pillars: prevention, screening and early diagnosis; care and cure; and active ageing and independent living.
Within each pillar, it sets out the following limited number of specific actions:
For Prevention, Screening and Early Diagnosis, priority action areas include health literacy, the use of innovative tools and services to identify early stages of declining health as well as personalised health management. These priority action areas are accompanied by a set of specific actions, including identifying innovative solutions to ensure better adherence to treatment at a regional level and at an individual health management level.
For Care and Cure, the priority action areas are capacity building and replicability of successful integrated care systems based on innovative tools and services. Specific actions involve promoting integrated care models for chronic diseases.
For Active Ageing and Independent Living, priority action areas involve extending active and independent living through Open and Personalised solutions. The specific action required under this pillar is the development of ICT solutions in order to assist the elderly in remaining independent and active for longer.
These thematic pillars are complemented by a set of cross-cutting priorities and horizontal issues such as regulation, the marketplace and effective funding. These pillars, along with the horizontal issues, give forth to a new vision of EU (age-friendly) innovation through accessible buildings, cities and environments.
The Commission prioritises the setting up of the necessary support framework for specific actions in line with its objectives, under the Partnership on Active and Healthy Ageing in the scope of the Health for Growth Programme. Specifically, the Commission will take responsibility for ensuring the appropriate and effective funding allocation, under Horizon 2020,
to the Partnership Plan priorities n this Communication, the Commission also proposes, in the Connecting Europe Facility, to finance support for the roll-out of trans-European digital services infrastructures which enable cross-border telemedicine and monitoring.
In supporting the above strategic activities related to healthcare research and innovation, the Commission has requested the set-up of strategic steering panels, which will consist of high-level experts in the field of health. The common role of the panels is to provide on-going strategic advice on actions planned to take place under Horizon 2020.
Specifically, the panels will work to define research and innovation programmes and provide instruments needed to promote interaction and synergies on a large scale. This will maximise the impact of Union level actions in the realm of healthcare. Support standards and common guidelines.
An example of a health research initiative that will be incorporated within the Horizon 2020 framework is the Innovative Medicines Initiative (IMI). This initiative already existed under the proceeding framework programme as Europe's largest public-private partnership aiming to improve the efficiency and pace of the drug development process and thereby provide better and safer medicines for patients. IMI was established as a Joint Undertaking between the EU and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
With a €2 billion budget, the IMI's focus has been on creating an interactive ecosystem for pharmaceutical R&D and innovative healthcare in Europe which is supported by collaborative research projects and networks of industrial and academic experts. The IMI acts as a neutral third party in creating such innovative partnerships. Projects are selected through open call for proposals. IMI already provides an online partner search tool for people, organisations and enterprises interested in participating in future IMI projects.
Before the conclusion of IMI funding activities in 2014, IMI’s Stakeholder Forum will take place 13 May 2013, which will be held in Brussels, Belgium.
On 25 December 2012, a report was released by an Independent Expert Panel accompanying the Commission's assessment on launching a European Public-Private Partnership (PPP) in life science research – the Innovative Medicines Initiative 2 (IMI2). The Independent Expert Panel recognises the potential of expanding and enhancing the IMI's work under Horizon 2020. IMI2 will be the successor programme to the IMI. The IMI2 will remain a joint technology initiative but adopt the Horizon 2020 initial objective of "scientific excellence" by focusing on the enhancement of research training, the inclusion of SME's in its projects, improving networks of information exchange and dissemination of results. On a broad policy scale, this initiative will serve the Europe 2020 objectives of smart, sustainable and inclusive growth to address the societal challenges of health, demographic change and well-being.
The EU has been moving toward the creation of a “European eHealth Area” since 2004, when the Commission adopted the eHealth Action Plan. eHealth was chosen as one of the EU Lead Market and involves the use of electronic processes and communication to support the delivery of health care. In practice, it encompasses a range of ICT-based tools that are used to assist and enhance the management of health issues – from prevention to diagnosis, treatment and monitoring. This Action Plan will be strategically important to attaining Horizon 2020's objective to address societal challenges (including health).
A 2010 Declaration from EU ministers outlined policy priorities for the next ten years on how to make eHealth more accessible, interactive and customised to patients. The declaration called for policy coordination among the various areas where eHealth can have an impact on citizens' health, and recognises the need for stronger synergies with policy areas like competitiveness, research and regional development at European and national levels.
In March 2011, the European Commission launched a consultation period on the second eHealth Action Plan for the period 2012-2020. In its 6 December 2012 Communication concerning he eHealth Action Plan 2012-2020, "Innovative healthcare for the 21st century," the Commission expressed its confidence in the future market potential for eHealth. This confidence was founded on the observation that global telemedicine market has grown from 9.8 billion USD in 2010 to 11.6 billion USD in 2011. This growth is expected to continue exponentially.
Aside from this confidence, the Commission used this Communication to identify the major obstacles to this growth, including lack of awareness and confidence in eHealth, limited large-scale evidence, inadequate legal frameworks to support eHealth, and regional differences in ICT services amongst EU Member States.
All this aside, the Action Plan addresses the following operational objectives to overcome these obstacles:
Following Article 185 of the Treaty of Functioning of the European Union, the EU is allowed to participate in programmes undertaken by Member States. Therefore, Horizon 2020 will open up calls for the following national programmes:
Societies around the world face challenges which are global in nature and therefore require global collective action. The EU has identified global health as a key priority for the coming decade in its proposals for Horizon 2020.
The conference EU Science: Global Challenges, Global Collaboration organised by ISC Intelligence in Science on 4-8 March 2013 in the European Parliament in Brussels provided policy makers, scientists and industry a platform to engage in fruitful discussions on how to address global health challenges through science collaboration.
To this end, a plenary entitled Future of Medicine – A Policy Basis for a New System [Materials] acted as forum to present health as a case of a global challenge which requires a global response and which can serve as an example for scientific and policy learning across all scientific disciplines. The plenary explored the range of health challenges facing society and the related costs emerging from them. These included diseases related to an ageing population, emerging threats that can only be addressed by innovative and international solutions, the need for a systems-based understanding of disease and the requirement of a new research framework that integrates and coordinates leading initiatives.
A number of scientific seminars picked up the issues addressed during the plenary with the purpose of identifying and investigating specific thematic and cross-thematic areas for research and collaboration. Seminars were held covering the following issues:
New Regulatory Science in System Toxicology - Part I: Is an Update Needed, What Would Be the Critical Elements and by When? & Part II: Is an Update Needed, What Would Be the Critical Elements and By When? [Materials]
In April 2011, ISC organised a dinner debate on clinical research, hosted by MEP Peter Liese (EPP, Germany) and the European Clinical Research Infrastructures Network (ECRIN). MEPs, European Commission officials, European associations, large pharmaceutical companies, physicians and researchers came together to discuss the challenges faced by the sector.
Key issues included the need for 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. In addition to the legislative framework, participants tackled such issues as the need for infrastructure providing professional support to clinical research, funding for multinational investigator-driven clinical trials, and the promotion of transparency.
A Congressional Presentation on Global Biomedical Science Cooperation was organised on the 5th of June 2012 in Washington DC by ISC.
The presentation highlighted the challenges faced by researchers all over the world concerning clinical trials, focussing on the European Clinical Research Infrastructures Network (ECRIN).
The objective of the congressional presentation was to develop the potential for exploitation and cooperation from the point of view of standards, regulation, legislation, policies, funding and programmes operation. The aim was to raise awareness of the international importance of this initiative. Even though they’re currently European in scope, their success depends on international support and proper integration into a global context.
In a policy context where health care remains the competency of EU Member States, the rationale for EU legislation concerning clinical trials flows from the EU’s competency over the Single Internal Market. Specifically, the smooth functioning of an internal market for medicinal products necessitated the simplification and harmonisation of administrative procedures governing clinical trials in Europe. Thus, EU legislation was required that could facilitate a competitive internal market while simultaneously protecting public health. It was with this in mind that the European Parliament and Council of Ministers established the Clinical Trials Directive of April 4 2001. The Legal context to the market for medicinal products in Europe was further enhanced in 2005 with the adoption of The Good Clinical Practice Directive which elaborated on issues such as the role of clinical trial sponsors and the Ethics Committee.
Clinical trials conducted within the EU must operate within the framework established by the Clinical Trials Directive. Clinical trials conducted outside the EU, but which are submitted in an application for marketing authorisation in the EU, must follow principles which are equivalent to the directive's provisions. This is required by Annex 1 of Directive 2001/83/EC concerning medicinal products for human use.
There has been on ongoing period of consultation and Commission activity in relation to addressing shortcomings of the Clinical Trials Directive. A 2008 Communication from the Commission announced that an impact assessment would be made concerning the directive’s application. The responses to a subsequent 2009 public consultation highlighted three key problematic issues with the Directive:
A roadmap was subsequently published by the Commission which explicitly proposed options to directly address these issues.
Concerning divergent application of the Directive, the commission identified three options, which can be summarized as: (a) streamlining clinical trial authorization, (b) a clarification of certain provisions of the Clinical Trials Directive and/or (c) adoption of the Clinical Trials Directive as a Regulation.
Concerning the increased administrative burden, identified policy options are (a) revision of the Clinical Trials Directive and/or (b) a review of implementing guidelines to address the issues.
Concerning the global scale of clinical trials, the three proposed options are (a) strengthening international dialogue and cooperation (b) closer alignment of existing implementing guidelines with international developments and (c) stricter scrutiny of results of trials performed in third countries.
Various legislative and political instruments were proposed for achieving these results, in particular:
a) Amending the Clinical Trials Directive
b) Replacing the Directive (partly) with a Regulation
c) Revision of guidelines and infringement procedures
d) Relying on the voluntary cooperation of Member States
In February 2011, the Commission launched a concept paper on the revision of the Clinical Trials directive outlining a 'preliminary appraisal' of which options appear optimal for addressing key issues and presenting the main figures that are being used to evaluate the impacts of different policy options. The purpose of the paper, and the responses to it, was to generate discussion of more detailed ideas regarding issues that were outlined in a broader fashion during the 2009/10 public consultation.
On 17 July 2012, the Commission adopted a "Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use." After seeing a drop in the number of clinical trials across Europe since the initial Clinical Trial Directive was put into effect, the Commission called for repealing Directive 2001/20/EC. The major developments in this Regulation call for a simplification of the rules for conducting clinical trials that will be applied identically throughout the Union.
In addition to the clinical trial guidelines put forth in the original Directive, this Proposal outlines the following concrete proposals:
This legislative proposal is currently discussed in the European Parliament - Ms Willmott Glenis was appointed Rapporteur in the responsible committee ENVI - and the Council and is expected to come into effect in 2016.
An EU regulatory framework for Medical Devices was constructed during the 1990s to strengthen the Single Market while protecting public health. The core legislation is composed of a series of three directives which harmonized national laws regarding the market for Medical Devices: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic (IVD) medical devices. These have been supplemented over time by several modifying and implementing directives, the last technical revision having been brought about by Directive 2007/47/EC.
In addition to this primary legislation, a body of implementing measures exists in the form of Commission Decisions and Directives: Directive 2002/364/EC and Directive 2009/886/EC concerning technical specifications for in vitro diagnostic devices and Directive 2003/32/EC regarding devices manufactured utilising tissues of animal origin.
Finally, a body of directive guidelines has been established, most prominently in the MEDDEVs. These aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health. While the MEDDEVs are not legally binding, they do reflect the positions of the competent authorities, Commission services and industry representatives. As such, its is expected that the guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions.
The Commission has engaged in a number of policy and regulatory dialogues with its counterparts in the key trade partners of the EU in the field of medical technology. This bilateral cooperation is mainly carried out with the Australia, Canada, Japan and the USA, and feeds a multilateral framework named GHTF (the Global Harmonization Task Force). The active participation of Europe in GHTF aims at contributing to the definition of a global regulatory model for medical device and diagnostics technology and the drafting of guidance documents agreed by consensus.
In recent years a number of drivers have come into play that necessitate an urgent simplification and strengthening of the legal framework.
In 2008, the Commission held a public consultation concerning the recast of the medical devices directives, receiving responses from authorities, industry, notified bodies, health professionals and patient groups. This was complemented by a public consultation held in 2010. This was regarding the technical aspects of the revision of the in vitro diagnostic medical devices directive, with stakeholders providing feedback concerning the different options. This process shall lead to a fundamental revision of the existing directives in order to simplify and strengthen the current EU legal framework for medical devices. The most recent landmark in the process came with the publication of a roadmap concerning challenges in 2011 and beyond.
The Commission proposed two regulations to streamline the legislation hitherto in place concerning medical devices: the Regulation on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and the Regulation on In vitro diagnostic medical devices repealing Directive 98/79/EC (26.09.2012). Both are currently under debate by the European Parliament and the Council and are foreseen to have their first reading in Plenary in November 2013.
Surgery has had a small presence within EU health research priorities, in spite of its consideration as the ‘‘gold standard’’ treatment for many pathologies (cancer, cardiovascular diseases…), with significant results reported for short- and long-term outcomes. While European citizens regularly face the prospect of surgical experience, surgeons lag behind other healthcare professionals in receiving financial support for research in clinical innovation and advancements.
In spite of this, Europe led the breakthrough event which hit healthcare systems in the early 1990s, with the introduction of minimally invasive surgery. Europeans were the first to perform most interventions, to introduce remote surgery, and to develop new access to the abdominal cavity. At the same time, the work of surgeons has supported progress in other important medical areas and will become even more important in the future.
There is a low level of awareness of surgery amongst policy and decision-makers which needs to be addressed. Surgery needs to be included as a key priority within EU health research funding mechanisms, particularly Horizon 2020, the successor programme to FP7.
In contrast to the low amount of resources assigned to surgery by the EU, there are many innovative fields of research that deserve substantial grants. Regarding biotechnologies, there are innovative therapeutic approaches and interventions that must be developed; natural orifice transluminal surgery (NOTES), for instance, is one of the most promising areas of research within the noninvasive or minimally invasive approaches. Also, innovative therapies for diabetes have been addressed as a possible cure for Alzheimer’s disease; this would be of great interest to Europe given the continent’s ageing population.
In the field of optimizing the delivery of healthcare to European citizens, one activity under Horizon 2020 is particularly crucial: the translation of results of clinical research outcome into clinical practice. It is crucial to introduce and register surgical interventions in a systematic and standardized way. Collecting and measuring this type of information to develop procedural standards will help to reduce errors, design better curricula and portfolios for surgeons in training, and reduce the learning time. The same principle should be applied to surgical clinical trials. Currently in Europe, most clinical trials are financed by private companies that are interested in supporting the introduction of novel products or techniques, which results in a lack of credibility for European clinical trials. If the EU wants to remain competitive in the field of surgical innovations, new mechanisms for conducting surgical clinical trials must be put into place.
Surgery is one of the most important applications for medical technology and therefore a key element of competitiveness for the European economy. The European medical technology industry already invests €5.8 billion in R&D and employs nearly 529,000 highly skilled workers. There were approximately 11,000 medical technology companies in Europe in 2005. More than 80% of them are SMEs. FP7 already recognized their importance and actively seeks to engage them in project participation. SMEs working in the field of surgical applications and devices could benefit enormously from those changes if surgery is given the appropriate recognition in future research programs.
A market-based approach should always be balanced with the public financial support for pure surgical R&D. Manufactures and health-related private companies only perform specific research programs to develop with new techniques and technologies that can be profitable. However, that does not guarantee the development of the necessary basic research to advance in fields that do not have such a high sales potential. This is precisely one more reason why there is an urgent need to incorporate surgical R&D into the EU’s health policy agenda and related research programs.