miércoles, 24 de septiembre de 2014

Can the Juncker Commission address Europe’s challenges for rare diseases?

Can the Juncker Commission address Europe’s challenges for rare diseases?

Eurordis, Rare Diseases Europe


Can the Juncker Commission address Europe’s challenges for rare diseases?

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A changing of the guard: the new European Commission
President-elect Jean-Claude Juncker has now presented the new allocation of European Commission portfolios. The appointment of the College of Commissioners opens a new phase for the European Union, one that will run from November 2014 through the next five years. As the executive body of the European Union, the European Commission is responsible for proposing legislations, implementing decisions, upholding the EU treaties, and the day-to-day running of the EU. The Juncker Commission is much more political than any previous Commissions, a real Government for Europe composed of former Prime Ministers, Vice-Prime Ministers, Ministers and MEPs. Its focus is clearly on the highest EU political/economic priorities, including growth, euro, energy, the digital economy, foreign affairs, and the reduction of bureaucracy.
Is public health a priority?
In the Treaty of the European Union, the transfer of competence from Member States (MS) to the Community is extremely limited. Still, nothing prevents the EU – one day – from having an ambitious Public Health programme. During the past ten years, the Commission and different stakeholders have tried to make the most of the limited political leverage available. The room for manoeuvre that the new Commission will have in the next five years currently seems to be even further contained, both politically and financially.
The new Commission is first and foremost focused on the economic challenges that the EU and the Member States face in terms of growth, employment, and the euro. "Within this context, we can fear that the public health priority will be pushed back to its lowest level in the last 20 years. Indeed, the topic of health is mentioned only once in the Political Guidelines that President-elect Juncker issued in July as a roadmap for the newly appointed commissioners, and this reference is made only within the context of the Free Trade Agreement with the USA," observes Flaminia Macchia, EURORDIS European Public Affairs Director.
While economic priorities come first in the current environment to address the highest needs of European citizens, it is critical to continue building on the considerable achievements of the European Commission and the MS in key areas where there is high community added-value in Public Health. EU citizens, when interviewed on their long-term concerns and expectations from the EU, regularly rank "Health" as one of the three top priorities. In our view, the high community added-value areas to allocate political attention and resources to obtain short term results and build an EU health agenda for the future are: 1. health threats, including epidemics such HIV, emerging diseases, or bioterrorism; 2. disease areas having high EU added-value such as rare diseases, cancer, ageing, and preventable diseases; 3. Cooperation and collaboration between Member States, such as Cross-border Healthcare, enabling mobility of data, expertise and patients, as well as the comparison of health care systems across Europe, enabling to improve the quality health output of national and regional health care systems.
"In a context of weak political willingness and scarce financial resources, the most effective way to improve health outcomes across Europe, is to work together with all stakeholders, especially dynamic stakeholders such as patient groups, professional organisations, learned societies, healthcare service managers, and the health industry. Much more can be achieved through smart policies combining intelligence and resources in a cost-effective manner, via public-private partnerships," states Terkel Andersen, EURORDIS President.
The Directorate-General for Health and Consumers (DG Sanco) will have to work closer with DG Research, coordinating work programmes in order to ensure that public health priorities will be implemented through the financial instruments of the Horizon 2020 research programme.
Turning an economic driven agenda into patients' opportunities
New opportunities for the rare disease research infrastructures and research projects have emerged through Horizon 2020 in both the "Health & Well-being" and "Science & Society" programmes.
In the new scheme of responsibilities of the new Commission, the European Medicines Agency (EMA) and EU pharmaceutical-related legislation are transferred back from DG Sanco to DG Enterprise and Industry. It is also understood that European Health Technology Assessment (HTA) networking has transferred to DG Enterprise.
"Hopefully, this move indicates that the new Commission intends to enhance medicines development in the EU with a more attractive, and market-driven approach based on innovation and competitiveness. The transfer of the EMA and HTA to DG Enterprise may be turned into an opportunity to create a real EU single market for medicines through greater collaboration between Member States - not only on marketing authorisation of medicinal products but also on HTA, as well as pricing & reimbursement. Although we might risk losing some public health dimension, this shift may provide potential and substantial opportunities for greater regulatory flexibility and medicine adaptive pathways. Furthermore, there is the potential to closely align the decision-making process between regulatory authorities, Health Technology Assessment (HTA) independent bodies, and pricing and reimbursement competent authorities. This would greatly improve fast and equitable access to medicines across Europe," develops Yann Le Cam, EURORDIS Chief Executive Officer.
Supporting growth and innovation will mean relative stability in the regulatory environment, allowing predictability for all players while creating a stimulating environment. It calls for a new culture that will be much less risk-adverse and more open to progress. It also calls for open partnerships with new responsibilities and commitments for all stakeholders.

Louise Taylor, Communications and Development Writer, EURORDIS
Page created: 24/09/2014
Page last updated: 23/09/2014

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