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Health

Policy Context

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.

Two major problems are 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:

  • Development of long-term cohorts;
  • Conducting clinical trials;
  • Developing ICT and its healthcare applications (e.g. e-Health);
  • Supporting innovation in health care research through a robust and cost-effective evidence base;
  • On-going development of the ERA in the context of the Health for Growth Programme and the European Innovation Partnership on Active and Health Ageing.

The European Commission is supported in health policy areas by a number of agencies concerning various aspects dealing with health in different areas: 

Consumers, Health and Food Executive Agency (Chafea)

The Consumers, Health and Food Executive Agency was created on 1 January 2005. In 2008, the Agency's mandate was prolonged and expanded to include actions in consumer protection and training for safer food. In December 2013, the Agency's mandate was further extended until 2024.

Chafea implements the EU Health Programme, the Consumer Programme and the Better Training for Safer Food initiative. The Agency provides a professional service in performing the tasks and activities entrusted to it by the European Commission, and it works closely with the Health and Consumers Directorate General.

Chafea manages relations with some 2800 beneficiaries and contractors involved in close to 400 projects/service contracts in the field of health, consumer protection and food safety.

European Agency for Safety and Health at Work (EU-OSHA)

EU-OSHA raises awareness and disseminates information on the importance of worker’s health and safety for European social and economic stability and growth. Its employees design and develop hands-on instruments for micro, small and medium-sized enterprises to help them assess their workplace risks, share knowledge and good practices on safety and health within their reach and beyond. EU-OSHA works side-by-side with governments, employers’ and workers’ organisations, EU bodies and networks, and private companies. Furthermore, EU-OSHA identifies and assesses new and emerging risks at work, and mainstream occupational safety and health into other policy areas such as education, public health and research.

European Medicines Agency

The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995.

EU Health Research

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.

The main health issues addressed by Horizon 2020 are:

  • 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.

Health & Economy: Horizon 2020 - Public-Private Partnerships Link to PPP once they’re established under EU R&D

Investment in health is not only a desirable, but also an essential priority for most societies. However, health systems face tough and complex challenges, in part derived from new pressures, such as ageing populations, growing prevalence of chronic illnesses, and intensive use of expensive yet vital health technologies.

A basic message has emerged: investments in health and the design of health financing policies should be addressed in terms of the interaction between health and the economy. Just as growth, income, investment and employment are a function of the performance and quality of the economic system, its regulatory frameworks, trade policies, social capital and labour markets, etc, so health conditions (mortality, morbidity, disability) depend not just on standards of living, but on the actual performance of health systems themselves. 

Solving the problems of rising health costs and population aging requires understanding the complex, and rapidly evolving, relation of new health care technologies and the economy. Many of the factors that could improve health and lower costs in future decades are linked to new research developments.

Following this path, the European Commission, EU Member States and European industry are joining forces and will invest in innovation for sectors that deliver high quality jobs. These research partnerships will boost the competitiveness of EU industry in key sectors. They will also find solutions to major challenges for society that are not being solved quickly enough by the market alone. 

Innovative Medicines Initiative 2 

An example of a health research initiative that will be incorporated within the Horizon 2020 framework is the Innovative Medicines Initiative (IMI2). 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.

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.

EU Strategic Implementation Plan of the European Innovation Partnership on Active and Healthy Ageing 

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:

  • improving the health status and quality of life of European citizens (with a particular focus
  • on older people);
  • supporting the long-term sustainability and efficiency of health and social care systems;
  • enhancing the competitiveness of EU industry through an improved business environment.

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.

eHealth Research

The EU has been moving toward the creation of a “European eHealth Area” since 2004, when the Commission adopted the eHealth Action Plan. The current eHealth Action plan 2012 – 2020 provides a roadmap to empower patients and healthcare workers, link up devices and technologies, and invest in research towards the personalised medicine of the future. This means providing smarter, safer and patient-centred health services. Given the fast growing uptake of smartphones and tablets, the action plan also includes a specific focus on mobile health (mHealth).

The goals of the EU concerning eHealth are:

  • to improve citizens' health by making life-saving information available – between countries when necessary – using eHealth tools
  • to increase healthcare quality and access by making eHealth part of health policy and coordinating EU countries' political, financial and technical strategies
  • to make eHealth tools more effective, user-friendly and widely accepted by involving professionals and patients in strategy, design and implementation.

A specific focus was recently - at the eHealth Forum on 13 May 2014 in Athens - put on how technology can bring positive changes into healthcare systems and turn today's health and ageing challenges into economic growth. During the forum, the eHealth Network - the leading body for EU cooperation on the interoperability of eHealth, met to discuss guidelines for the interoperability of ePrescriptions, due to be adopted in November.

Clinical Trials

A new Clinical Trials Regulation

On 2 April the European Parliament adopted a new Regulation on clinical trials on medicinal products for human use, the Council followed on 14 April 2014.

The new Regulation will make it easier to conduct multinational clinical trials, i.e. conducted in more than one Member State, in the EU. Further changes to the hitherto in force Clinical Trials Directive are:

- A straightforward authorisation procedure allowing for a fast and thorough assessment of the application by all Member States concerned and resulting in one single assessment outcome. 

- Simplified reporting procedures so that researchers no longer have to submit largely identical information on the clinical trial separately to various bodies and Member States.

- The possibility for the Commission to conduct controls in EU countries and third countries to make sure the rules are being properly supervised and enforced.

- The legal form of a regulation ensures that the rules for conducting clinical trials are identical throughout the EU. This is vital to ensure that Member States, in authorising and supervising the conduct of a clinical trial, base themselves on identical rules.

The application of the Clinical Trials Regulation is linked to the full functionality of the EU portal and database under development by the European Medicines Agency. The regulation is expected to come into effect in mid-2016 at the earliest.

ISC and Clinical Trials

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.

Staff Briefing in US Congress

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.

Medical Devices

Regulatory framework and guidelines

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, it is expected that the guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions.

Revision of the regulatory framework

In recent years a number of drivers have come into play that necessitate an urgent simplification and strengthening of the legal framework.
 

  • With three main directives and five modifying or implementing directives, the framework has been criticised as being too fragmented and difficult to follow, especially for SMEs. Moreover, uniform implementation has been hampered by national variation in the areas of definition of a medical device, national registration procedures, classification and interpretation of guidance.
  • Key elements such as market surveillance, vigilance, notified bodies, clinical evaluation, and transparency, have suffered in terms of coherence and uniformity of approach due to the lack of efficient coordination between Member States.
  • New and emerging technologies have challenged the current framework, highlighting gaps or pointing to potential loopholes including the scarcity of expertise needed to independently assess them.The medical devices market is a global one, and major trading partners increasingly align their legislation to the Global Harmonisation Task Force for Medical Devices (GHTF) model. To keep European industry competitive, the European legislation also needs to further converge on this model.
     
    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).The European Parliament voted on the amended proposals on the 2nd of April 2014 and is now waiting for the Council of the European Union to form a decision.

International Cooperation

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.

 

Global Challenges

Health challenges and their related socio-economic implications are increasingly global and, therefore, the future of medicine can only be efficiently addressed by applying an international and interdisciplinary scope. 

Diseases related to ageing societies will result in increased healthcare costs causing fundamental threats to the global economic stability. Globalisation of travel, human and animal mobility has been a benefit to society but it can also be the basis for the transfer of pathogens or their vectors into new regions. Today’s most pressing environmental problems such as climate change, global warming, and lack of quality in water supplies will affect health in general. They are of a scale or complexity that goes beyond the reach of most national resources.

These emerging threats can only be addressed by innovative solutions developed in an international and interdisciplinary collaborative scientific effort. Across all scientific disciplines, research activity increasingly involves international collaboration. This represents a means to balance the supply and demand equation, with the scale of challenges increasingly global in impact. The urgency affixed to important societal issues requires remarkable efforts to bring together a critical mass of expertise, to integrate and structure resources, and to streamline research efforts to common goals.

In this context, a systems-based understanding of diseases will be required to prepare the way for new type of personalised and preventive medicine. Systems-based approaches - involving the integration of genomic, molecular and physiological/clinical data – are equipped to address the complexity of disorders and to understand the interplay of genetic and environmental factors impacting on human health.

In order to support a systems-based-understanding of diseases, the establishment of a new research framework that integrates and coordinates current lead initiatives, such as ESFRI research infrastructures, Innovative Medicines Initiative, Joint Programming, FET-Flagships, and other programmes is required. In recent years there has already been a shift from individual research groups focusing on very specific aspects to large distributed teams following a more holistic approach. The fragmentation of scientific communities is an obstacle to attaining improved insight into complex mechanisms and systems such as those underlying human health: a proper framework for the collation of resources as well as the access to and integration of high-end technologies and expertise required to efficiently address key scientific questions has become an imperative.