1. European Public Health Alliance Recent trends in EU policy and legislation Tamsin Rose Oslo, 15 December 2005

2. What is the current landscape in Brussels? Uncertainty. After the French and Dutch ‘no’ votes, a period of ‘reflection’ on the Constitutional Treaty. What about the countries that have already ratified? No agreement on the EU budget in June 2005. A deal expected today?. Delays expected for many programmes which are currently doing through their legislative passage. Institutional indigestion - extra time needed for recruitment, translation and for the CEE political personalities and styles to emerge. Looking for the next big vision or idea that can drive the EU.

3. Political themes that have weight Lisbon Strategy and competitiveness. Growth and jobs are the new mantra ‘Platforms’ rather as a key new policy-making process, strong involvement or leadership by industry Better regulation agenda - exploring alternatives to legislation to be explored including ‘do nothing’, self- regulation and co-regulation Impact assessment and ‘sound science’ vs the ‘precautionary principle’

4. Policy-making has changed Meetings being held at the ‘request’ of industry - advertising roundtable and WFA. Individual companies closely involved in debates about alcohol policy. Multi-stakeholder platform on diet includes all the major food industry groups. McDonalds playing a leading role Technology platforms to determine the trend in R+D spending on pharmaceuticals, food, energy, chemicals Sustained attack on NGOs as undemocratic, unaccountable, unelected, untransparent and vulnerable to fraud and terrorism

5. Transparency is an increasing theme Council to open their debates and meetings. Commission - just published lists of all of their Committees but not the membership. Parliament - Declaration of MEPs financial interests. Pressure to be more open about their staff and how they use their allowances. Ombudsman - rules in favour of access to documents. Lobbyists - who they are, what they represent. New rules for access to the Parliament designed to enhance clarity.

6. Key drivers for health policy Healthcare issues - patient mobility, health technology assessment, patient safety Emergency preparedness - terrorism, major accidents, pandemic planning Green papers on nutrition, mental health published. 2006 - alcohol, health strategy Information - EU Health portal to go ‘live’ in 2006 UK Presidency - inequalities and patient safety AU Presidency - diabetes, women’s health FI Presidency - Health in all policies DE Presidency - HIV/AIDS?

7. The basics of Better Regulation Implementation - closer monitoring of how laws are implemented at national level. Consultation - with a wide range of stakeholders particularly at an early stage. Impact assessment of proposed initiatives including the administrative burden, impact on economic operators. Rationalisation - streamline existing legislative acts into single framework. Simplification - withdraw proposals or legislation that are too complex, provide insufficient added value. Alternatives to regulation - self regulation, co- regulation, do nothing.

8. Better Regulation process In 2005, 70 laws or proposed laws were withdrawn. “Ensure that EU actions are necessary, coherent and as simple as possible to meet the desired effect, and in ensuring that we act where action at EU level can provide a clear added value”. Tools: Monitoring framework on alternatives to regulation (target: July 2006), SANCO Stakeholder Consultation Guidelines (target: December 2006) Methods: Impact assessment, data collection, economic analysis, stakeholder consultation. Result: Majority of SANCO new initiatives are non legislative, e.g platforms, communications, resolutions, recommendations and opinions.

9. Better Regulation - specific examples from SANCO workplan Active involvement of stakeholders in developing alternatives to regulation (target: to develop best practice on effective self-regulation in Advertising by organising a European round table process in 2006). Pilot monitoring framework for self-regulation (target: to be applied by the end of 2006 to commitments undertook in the context of nutrition platform. DG SANCO will work with stakeholders to improve their capacity to participate in discussions leading to the adoption of regulatory or non-regulatory frameworks on the basis of objective, science based information.

10. ECJ leads ‘competence creep’ Unanimity required for measures that lead to tax harmonisation except for VAT and customs duties. On VAT issues the ECJ has generally ruled against the taxpayer but on other issues taxpayers have won >80 % of cases referred to the ECJ. A range of cases pending on tax issues including legality of sales taxes, group tax relief etc. Most ECJ rulings enforce the principle that national rules cannot discriminate against non-resident people or companies. The M&S ruling argued on the grounds of the internal market of ‘freedom of establishment’. “The impression is left that the court will conjure up creative excuses to exert EU precedence over national tax laws”, Times Newspaper

11. Member States in the firing line  ECJ C-176/03 (09/05)  Upholds Commission challenge to the Council using a Justice and Home Affairs process (intergovernmental competence) to adopt a Framework Decision to allow criminal penalties for environmental pollution.  Rules that although criminal law and penalties are not an EU competence, environmental protection is an essential EU function and nothing prevents the Commission from taking action to meet the goal of environmental protection even if the action has an impact on criminal law if it is effective, proportionate and dissuasive.

12. Some final thoughts MS could not agree on a coordinated response to avian flu, emergency planning will dominate the agenda and be an ongoing difficult subject. No solidarity or trust. EU resources for health likely to remain very small. UK Presidency offer represents a 40 % cut to Commission proposal. Opportunities to input into policy-making will increase in number and importance. Health organisations must seize these opportunities because they will set the agenda and will have strong participation from industry. Health community needs to have a coherent position on self-regulation. What are our criteria to measure independence, transparency, accessibility? Should we participate?

13. European Public Health Alliance 39-41 Rue d´Arlon B-1000 Brussels Belgium Tel : +32-2 230 30 56 Fax : +32-2 233 38 80 epha@epha.org www.epha.org