An introduction to the EU and its legislation

Member States currently 15 –Austria- Ireland –Belgium- Luxembourg –Denmark- Netherlands –Finland- Portugal –France- Spain –Germany- Sweden –Greece- UK –Italy - (plus 10 more with next round of enlargement in 2004)

EU 374 million citizens

EU afterenlargement 2004 EU after enlargement million citizens

European Institutions European Parliament –directly elected members (MEPs) –shares legislative powers with Council Council of the European Union –main decision-making body –embodies Member States European Commission –driving force in system –initiates legislation

European Commission College of 20 members –President and Vice-president –appointed by MSs, approved by EP – 5 year term Administration –general services –Directorates-General

Legislative process Three steps 1.Commission proposes 2. Competent institutions adopt 3. Member States implement

EC legislation Art. 249 of the treaty establishing EC –Regulations e.g. Regulation 2309/93/EEC –Directives e.g. Directive 2001/83/EC –Decisions e.g. central marketing authorisations

First stage Commission proposal Commission’s right of initiative –delimits scope of possible amendments –has to be exercised in a constructive manner –proposal may be changed before Council has acted Consultations –principle of subsidiarity + Commission “should consult widely” before proposing (Protocol to Amsterdam Treaty) + in particular: Green and White Papers –no strict rules or formats

Consultation procedure Cooperation procedure Codecision procedure –EP and Council are co-legislators on equal footing –more than 50% of all acts based on EC Treaty –e.g. Art. 95 and Art. 152 EC –3 phases Assent procedure Second stage Legislative procedures

Third stage Implementation Subsidiarity/Proportionality –as much scope for national measures as possible –Directive preferable Ways to implement –separate national provisions –reference to EC provisions Time limits and obligations to notify Infringement procedure

Commission proposal on Better medicines for children Lack of suitable medicines for children recognised for some time Various national initiatives EU level initiatives –EMEA round table 1997 –ICH guideline 2000 –Council resolution 2000

Orphan regulation adopted December 1999 –shows that incentives can work for small markets, rare diseases Clinical Trials directive adopted April 2001 –provides the underlying harmonised framework Commission’s review proposals finalised end 2001 –outside the scope of this review Timing of consultation

Commission consultation paper followed brainstorming with MSs identified common aims and objectives described possible solutions encouraged input from stakeholders comments requested before 30th April

The carrots and the stick Incentives for industry –extension of intellectual property provisions (new medicines) –exclusivity/data protection for paediatric indication (adaptation of old medicines) Obligations –legal requirement for companies to perform studies Public funding possibilities for research on old medicines

Other avenues to explore Transparency - central database – Database of existing (and future) treatments New EMEA expert group – identification of priorities, advise on trial performance and suitability, formulation aspects, organisation of tenders for research contracts? Creation of EU paediatric network

Prerequisites Compliance with ethical principles in clinical trial directive (Directive 2001/20) Avoidance of unnecessary trials EU harmonised approach Adaptation of existing EU structures

Current position and next steps May - Analysis of comments received June - Preparation of Commission proposal (draft regulation) June - Oral presentation Health Council July/ - Adoption of proposal Sep