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I&EHL: EU Pharmaceutical Law

I&EHL: EU Pharmaceutical Law. André den Exter Andre.denExter@ua.ac.be. Outline. History Legal framework: Pharmaceutical chain Latest developments. History. Thalidomide drama Pharmaceutical strategy (Directive 65/65/EEC) Divergence in interests between different stakeholders.

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I&EHL: EU Pharmaceutical Law

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  1. I&EHL: EU Pharmaceutical Law André den Exter Andre.denExter@ua.ac.be

  2. Outline • History • Legal framework: Pharmaceutical chain • Latest developments

  3. History • Thalidomide drama • Pharmaceutical strategy (Directive 65/65/EEC) • Divergence in interests between different stakeholders

  4. EU Pharmaceutical Policy: Regulating the pharmaceutical chain • From R&D towards using medicines: R&D, clinical trials, patents, registration, distribution, wholesale, packaging and labelling, pricing, retail, advertising, and privacy)

  5. Legal Framework • Public Health, Art 168 TFEU (4): (c) measures setting high standards of quality and safety for medicinal products and devices for medical use. • Pharmaceutical law (pharma chain) • Internal market and competition rules

  6. What’s a medicine?

  7. What is a medical product? Directive 2001/83/EC Art. 1: presentation or function CJEU case law: case-by-case approach - Borderline products - Differences in classification Relevance

  8. Research & Development: Clinical Trials • CTDirective 2001/20/EC • Protection of clinical trial subjects • Ethics Committee: pre-trial approval • Notification adverse effects • Good clinical practices

  9. Manufacturing: Directive 2001/83/EC Basic requirements manufacturing: • Manufacturing authorization MS • Labelling and package leaflet • Classification • Advertising and information • Pharmacovigilance

  10. Marketing Authorization • Directive 2001/83/EC • Regulation 726/2004/EC • Art. 6: MA required to place a medicinal product on the market, UNLESS… • Compassianate use supply • Pharmacy exemption (“Magistral formula”) • Renewal of MA (art 24) • Refusal of MA (art 26)

  11. MA procedures • National Procedure: • Application tonational competent authority • Procedures governedbynationallaw • Transparency • First step towards MR procedure • Mutual Recognition/Decentralised Procedure • Application to reference member state (RMS) • Grounds for refusing to recognise RMS approval • EMA Commission referral for arbitration • Centralised Procedure • Scope: high-technology medicinal products • Application to EMA: Eur. Cie.

  12. Specific procedures • Orphan Drug Products (Reg.No 141/2000 (ODR) • Purpose • Community marketing authorisation • Market exclusivity (art 8) • ‘breaking’ market exclusivity • Criticism ODR • Medicinal products for paediatric use(Reg.1901/2006) • Purpose • Paediatric population • Paediatric Committee • Marketing Authorization requirements

  13. Information and Advertising (ART. 86-100) • Complete harmonization • Classification of products • General/specific conditions advertising • Latest regulatory proposal: information to patients

  14. Inducement: GSK vioxx training course at Arabella Golf Resort Mallorca

  15. Retail sale: Pharmacies • No harmonizedrules (exceptforlabelling/ leaflets and advertising) • Onlyrules on classification • Ownership, free movement, and public health exception • Infringementproceedings

  16. Pricing • Directive (89/105/EEC) • Transparency pricing measures: • Directly controlled price • Use of international price comparisons: maximum price • Profit controls • Not harmonised: Reimbursement • Assessment of therapeutic benefits/clinical relevance, cost-effectiveness and outcomes • Positive and negative lists • Reference price systems • Co-payments, substitution and bonus system

  17. Pharmacovigilance • What is pharmacovigilance? • Legal requirements pre- and post authorization phases: • 2001/83/EC and 726/2004/EU: • Establishing pharmacovig. system MS (art 102) • Qualified person and systems (art. 103) • Reporting of Adverse reactions • Spontaneous reporting • Periodical reports all adverse reactions 104(6) • Eudravigilance system • Pharmacovig. inspections (art. 111) • EMA’s role in pharmacovigilance • Supervision and sanctions (art 116 )

  18. Latest developments • Legislativeproposals: • Tackle counterfeit medicines (Dir 2011/64/EU) • Information prescription-onlymedicines • Pharmacovigilance 2012 amendments • Outsourcing/offshoring CTs in developing countries • Seizures of In-Transit Medicines

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