1 / 18

Introduction to EU Legislation & Member States: An Overview

Explore the EU legislative process, Member States, and key institutions like the European Parliament and Commission. Learn about the implementation of EU laws and recent initiatives in healthcare regulations.

thatcher
Télécharger la présentation

Introduction to EU Legislation & Member States: An Overview

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related