European Enforcement of Pharmacovigilance and Inspection Trends: Recent & Future Developments

1. European Enforcement of Pharmacovigilance and Inspection Trends: Recent & Future Developments Maurits Lugard, Partner June 7, 2007

2. 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

3. Council Regulation EU Directives EU Guidances National legislation International fora Instruments for Regulating PhV in the EU

4. 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)

5. 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)

6. 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

7. 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)

8. 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

10. International Conference on Harmonization (‘ICH’) Council for International Organizations of Medicinal Sciences (‘CIOMS’) International Agreements

12. 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

13. Questions? Thank you! Maurits J.F. Lugard Partner Sidley Austin LLP Square de Meeûs 35 B–1000 Brussels, Belgium Tel: + 32 2 504 64 17 E-mail: mlugard@sidley.com