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An introduction to the EU and its legislation

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.

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An introduction to the EU and its legislation

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  1. An introduction to the EU and its legislation

  2. Member Statescurrently 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)

  3. EU 374 million citizens

  4. EU afterenlargement 2004 450 million citizens

  5. 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

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

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

  8. 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

  9. First stageCommission 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

  10. Second stageLegislative procedures • 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

  11. Third stageImplementation • 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

  12. 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

  13. Timing of consultation • 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

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

  15. 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

  16. 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

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

  18. 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

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