1 / 18

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.

della
Télécharger la présentation

I&EHL: EU Pharmaceutical Law

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. 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

More Related