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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’)

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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: mlugard@sidley.com