An introduction to the EU and its legislation

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An introduction to the EU and its
legislation
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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)
  

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EU
374 million citizens
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EU after enlargement 2004
450 million citizens
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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

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European Commission

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

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Legislative process

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

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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

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First stageCommission proposal

• Commissions 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

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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

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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

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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

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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
• Commissions review proposals finalised end 2001
• outside the scope of this review

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Commission consultation paper

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

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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

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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

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Prerequisites

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

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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