1. T HE ROLE OF STAKEHOLDERS IN EU POLICY MAKING EAMBES CONTRIBUTION TO BME IN EU Leire Solis Rohde Public Policy 1

2. B ACKGROUND Background: –Created in 2002 by Sebastian Rohde –Reason: Create new approach for policy development in health policy by including all relevant stakeholders at all stages of policy making at EU level Objective: Development and positioning of health and research topics at political level based on expert opinion and political reason Means: Development of long-term partnerships with policy makers, high-level scientists and other stakeholders Areas of expertise: healthcare and healthcare/related areas (patient access to therapies, research and innovation, social policy, nutrition, disabilities, demography, market access, etc) 2

3. H OW WE UNDERSTAND “ POLICY DEVELOPMENT ” Objective: Support development of policy based on consensus and working for an improved regulatory and political environment supporting better health Establishing political and scientific consensus With all parties affected, including policy makers, high-level scientists and other stakeholders Encouraging our partners to extend their work to involve other non commercial partners such as patient groups, research and medical experts 3

4. I MPORTANCE OF EXTERNAL OPINION FOR POLICY MAKING Objective: building long-term consensus and partnerships among different stakeholders, policy makers and the scientific community. Creating new and sustainable alliances sharing similar objectives Building working relationships based on expertise Bringing added-value and second opinions to the policy- making process 4

5. H EALTH POLICY = S OCIETAL POLICY Every health topic has a great societal effect Employment, Economics, Demography, etc. Societal interests need to be reflected Example: Hepatitis B Appears to be an infection BUT It actually includes:  Health & safety at work  Migration  Civil liberties Sustainable policy is limited if these groups are not included in the development of policy 5

6. BME IN EU POLICIES Consolidation in different policies: –To improve health –To foster innovative research –To develop a new sector with great potential for innovation –To tackle societal challenges BME is now understood as being part of various fields BUT with a supportive legislation it will develop into a recognised innovative sector on its own right Example of Biotech policy and biotech sector: Early 1990s: research sector part of food, plants, chemicals, health Biotech became a sector in its own right with ability to develop into specific field of policy and societal value Horizontal (Biotech patents Directive) and vertical (OMP Regulation) policies supported creation for better health, economic growth and innovation in Europe 6

7. EAMBES CONTRIBUTION TO BME PROMOTION IN EU POLICIES Currently: Value of innovation understood by EU policy makers Need: concrete examples from involved actors in policy implementation EAMBES added value: –Only representation of BME at EU level –One voice for approx 8000 European experts on BME EAMBES contribution: –Sharing expertise and knowledge with EU decision makers and stakeholders (i.e. public consultations) –Working relationship with relevant EU policy makers (European Commission, European Parliament) –Development of policy forum for discussion of EU policy 7

8. Thank you for your attention 8