Regulation 536/2014 on clinical trials - Need for national implementation? Rechtsanwalt Markus Ambrosius Sträter Rechtsanwälte Kronprinzenstraße 20 D-53173 Bonn Fon: +49 (0) 228-934 54-0 Fax: +49 (0) 228-934 54-54 [email protected] www.straeterlawyers.de www.straeterlawyers.de Legal acts of the Union Art. 288 TFEU Regulation Directive Decision Ø general application Ø directly applicable Ø binding re. results Ø form and method choosen by MS Ø binding on the addressee www.straeterlawyers.de 2 1 Ethics Committee Art. 4 "The ethical review shall be performed by an Ethics Committee in accordance with the law of the Member State concerned." www.straeterlawyers.de 3 Ethical review Ø May encompass aspects addressed in Part I or Part II of the AR as appropriate. Ø Review within the timelines for the authorisation procedure Ø Opinion is valid for the entire MS www.straeterlawyers.de 4 2 Member State Decision Ø Refusal of Member State to authorise in case of: • Disagreement with RMS on grounds referred to in Art. 8 (2) – opt-out • Negative opinion of ethics committee Ø Applies also to • Subsequent addition of MS (Art. 14 (10)) • Substantial modifications (Art. 19 (2), 20 (7), 23 (4)) www.straeterlawyers.de 5 Ethics committees and national legislation Procedural aspects: Ø Timing Ø Additional requests for information Ø Competence of ethics committees (LKP) Ø Language requirements www.straeterlawyers.de 6 3 Ethics committees and national legislation Material aspects: Ø Scope of ethical review Ø Dossier requirements (Part I, Part II, additional aspects?) Ø Grounds for refusal Ø Room for detailed guidance of EU? www.straeterlawyers.de 7 Directive 2001/20 and Ethics Committees www.straeterlawyers.de 8 4 Decision-making process Subject to national law Ø Consideration of ethics committee opinion Ø Competence of national authorities Ø Language issues Ø Conflicts of interests and independence www.straeterlawyers.de 9 General rules Art. 9 Ø Protection of personal data www.straeterlawyers.de 10 5 Manufacturing/import Art. 61 Ø Rules re. manufacturing and import licence need modification www.straeterlawyers.de 11 Legal Representative Art. 74 Ø Opt-out re. concept of legal representative www.straeterlawyers.de 12 6 Damage compensation Art. 76 Ø System for compensation for any damage in the form of an insurance, guarantee of similar arrangement Ø Form of system to be choosen by Member State www.straeterlawyers.de 13 Corrective measures - Art. 77 Ø Revocation of CTA Ø Suspension of CT Ø Modification request - Detailed rules to be implemented nationally - Revocation of Ethics Committee opinion? www.straeterlawyers.de 14 7 Inspection/Fees Ø General framework available in Art. 78 and 86, 87 Ø Detailed provisions to be drawn up by Member States www.straeterlawyers.de 15 Amendments of national legislation Ø AMG + GCP-V need to be revised completely re. CTA system by NCA Ø Ethics committee procedure needs to be aligned with new timelines for authorisation procedure Ø National legislator needs to decide on the dossier requirements www.straeterlawyers.de 16 8 What about other issues? Ø Authorisation requirement pursuant to StrahlenSchutzVO? Ø Could remain unchanged (Art. 91) www.straeterlawyers.de 17 Discussion www.straeterlawyers.de 18 9 Thank you very much for your attention! Rechtsanwalt Markus Ambrosius Sträter Rechtsanwälte Kronprinzenstraße 20 D-53173 Bonn Fon: +49 (0) 228-934 54-0 Fax: +49 (0) 228-934 54-54 [email protected] www.straeterlawyers.de 10