EU Pharmaceutical law. André den

Transcription

1 EU Pharmaceutical law André den

2 Outline Occasion EU Pharmaceutical law: regulating the pharmaceutical chain What is a Medicine? Clinical Trials Marketing Authorization Distribution of medicines Information and Advertising Recent developments & Conclusions

3 EU Pharmaceutical Politics: No consistent strategy Thalidomide drama Pharmaceutical strategy (Directive 65/65/EEC) Unrealistic approach Results

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

5 What is a medicinal product?

6 Borderline products Medical devices Food (supplement): Red rice; Garlic capsules Cosmetics Cosmeuticals nutriceuticals

7 What is a medical product? Directive 2001/83/EC EUCJ case law: case-by-case approach Differences in classification Relevance: placing on the market Market authorization

8 R&D: CT Directive 2001/20/EC What s a CT?; Why CTs? Ethics Committee: pre-trials approval Good clinical practices (2005/28/EC) Declaration of Helsinki Role of Sponsor Notification adverse reactions EUdraCT: trial identification number Implementation in national law Subject to revision (Reg. 536/2014/EU)

9 The Secrets of Seroxat Video: The Crook Report (part 1-2)

10 Obtaining a Marketing Authorization (MA) Rules on MA: - Directive 2001/83/EC - Regulation 726/2004/EC Art. 6: MA required to place a medicinal product on the market, UNLESS.. - Compassionate use supply Renewal of MA Refusal of MA

11 MA procedures National procedure (2001/83/EC): - application national authority - procedure governed by national law - first step towards MR procedure Mutual recognition/decentralised procedure: - Application to reference member state (RMS) - Based on trust - Grounds for refusing to recognise RMS approval - EMA commssion referral for arbitration Centralised procedure (Reg. 726/2004) - high-tech med. products - EMA application

12 Distribution: Wholesale (Art /83) International distribution chain Wholesale distribution Subject of licensing Key obligation: GDP compliance

13 Distribution: Retail sale No harmonised rules Pharmacies and hospitals Ownership, free movement, and public health exception Infringement proceedings

14 Information and Advertising (arts , 2001/83) Complete harmonisation General/specific conditions advertising Latest regulatory proposal: information to patients about prescription medicines

15 Gifts & Inducement: GSK Viox training course at Lighthouse Golf Resort Bulgaria

16 Orphan Drug Products (Regulation (EC) No 141/2000 (ODR) Purpose Community marketing authorisation Market exclusivity (art 8) breaking market exclusivity Other incentives Criticism ODR

17 Pharmacovigilance Legal requirements pre- and post authorization phases: /83/EC and 726/2004/EU: Establishing pharmacovigilance 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 EU Pharma law: Recent developments Tackle counterfeiting life-saving medicines: Directive 2011/62/EU Distance selling and European Logo (Art. 85c) Rare diseases and Directive 2011/24/EU Pharmaceutical Sector Inquiry monitoring reports (to be continued)

19 Conclusions Pharmaceuticals highly regulated field Internal market, public health, human rights driven Incomplete area as pricing/reimbursement remains national affair Attempts failed so far (updating Transparency Directive)

20 Seminar: Discussion Outsourcing CTs in developing countries How to regulate online sales medicines (prescription only)? Direct-to-consumers advertising