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European Enforcement of Pharmacovigilance and Inspection Trends: Recent & Future Developments. Maurits Lugard, Partner June 7, 2007. Some Key Weaknesses in EU PhV Regime:. Legal framework is complex and difficult to rapidly understand Implementation is not the same in all MS - PowerPoint PPT Presentation
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BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG LONDON LOS ANGELES NEW YORK SAN FRANCISCO SHANGHAI SINGAPORE TOKYO WASHINGTON, D.C.
European Enforcement of Pharmacovigilance and Inspection Trends: Recent & Future DevelopmentsMaurits Lugard, Partner June 7, 2007
Some Key Weaknesses in EU PhV Regime:
• Legal framework is complex and difficult to rapidly understand
• Implementation is not the same in all MS
• Complex system with many players
• Duplication of work
• Quality management is lacking
• All available data are not used in systematic safety studies
• Resources vary considerably– 50 persons in Germany; a handful in some new Member States
• Funding is problematic
• Decision-making can be slow, especially at EU level
Instruments for Regulating PhV in the EU
• Council Regulation
• EU Directives
• EU Guidances
• National legislation
• International fora
Council Regulation
• Adopted by the Council and the European Parliament based on a proposal from the European Commission
• Directly applicable in EU Member States
• Consistency of law throughout the EU territory is safeguarded - “no discrepancies”
• Published in the Official Journal
• Available in all official languages
• Full legal certainty
- Council Regulation 726/2004 (for central authorization – in force since 20 November 2005)
EU Directives
• Adopted by the Council and the European Parliament based on a proposal from the European Commission
• National implementation is required – “not directly applicable”
• Discrepancies in national implementing laws
• Published in the Official Journal
• Available in all official languages
• Legal certainty, but no EU uniform regime
- Directive 2001/83/EC (for national authorization and mutual recognition – important amendments were to be implemented by EU Member States by 30 October 2005)
EU Guidances
Commission guidances• Drafted by DG Enterprise in consultation with EMEA and
other experts
• No systematic input from other Commission services
• No input from EU institutions, e.g. Council or European Parliament
• Legally binding?
• Sometimes ambiguous provisions
• Available only on Internet (DG Enterprise website) and in English
- Eudralex Volume 9A
EU Guidances
EMEA guidance documents• Drafted by Pharmacovigilance Working Party• Not adopted through a legislative process• Legally binding?
- EMEA/CHMP/313666/05 Note for Guidance on the
Exposure to Medicinal Products during Pregnancy: Need for Post-Authorisation Data (Adopted November 2005)
- EMEA/115735/2004 Note for Guidance on the Electronic Data Interchange (EDI) of Individual Case Safety Reports (ICSRS) and Medicinal Product Reports (MPRS) in Pharmacovigilance during the Pre-and Post-Authorisation Phase in the European Economic Area (EEA) (EudraVigilance TIG adopted September 2004)
National legislation
• Country specific
• Exists side-by-side with EU PhV legislation
• Complex network of 27 national rules in national languages
• Harmonization does not mean uniformity - rules are transposed differently and at different speeds in different Member States
• Necessary to comply with different national obligations, including reporting requirements and timeframes
• Duplication of national efforts ties up resources that could be better spent on drug safety
International Agreements
• International Conference on Harmonization (‘ICH’)
• Council for International Organizations of Medicinal Sciences (‘CIOMS’)
A PhV Council Regulation could address (certain) weaknesses in
EU PhV
• Detailed clear and concise provisions
• Directly applicable in EU Member States
• Eliminates national discrepancies
• Prepared with input from all interested parties
• Legally binding on all interested parties
• Published in the Official Journal in all official languages
Questions?
Thank you!
Maurits J.F. LugardPartner
Sidley Austin LLPSquare de Meeûs 35
B–1000 Brussels, BelgiumTel: + 32 2 504 64 17
E-mail: [email protected]