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News from Europe: Recent Developments in EU Pharmaceutical and Medical Device Legislation Thirteenth Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum

Prof. Vincenzo Salvatore - Senior Counsel Washington DC, November 6, 2012

Outline

The EU pharmaceutical legal framework at a crossroads:

• New Pharmacovigilance Legislation

• New (revised) Penalties Regulation

• New Clinical Trials Regulation

• New Medical Device Legislation

• New Falsified Medicines Legislation

• New Information to Patients Legislation

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New Pharmacovigilance Legislation (1/2)

• The clock is ticking: • Regulation (EU) 1235/2010 entered into force on 2nd July 2012

• Directive 2010/84/EU was due to be implemented by 21st July 2012

• Commission Regulation (EU) 520/2012 applies as of 10th July 2012

• Most important legislative change since EMA was established

• Medical errors are included

• EMA also becomes responsible for products authorized by individual EU Member States (MRP and DCP)

• New Scientific Committee (PRAC) – it replaces the PhVWP

• ADRs to be reported at European level to the Agency also for nationally authorised products (lesson learned from Mediator)

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New Pharmacovigilance Legislation (2/2)

• From a prêt-a-porter to a tailor made system: proportionate and according to risk relevance (list of products subject to further monitoring)

• New obligations may be placed upon MAHs (including PASS and PAES) – FUMs’ season is over

• EMA may require the MAH to operate a risk management system

• Strengthened transparency

• New urgent (fast track) procedure (Article 107, Regulation 1235/2010)

• Public hearings

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New (revised) Penalties Regulation

• Commission Regulation (EU) No 658/2007 of 14 June 2007

• Commission Regulation (EU) No 488/2012 of 8 June 2012

• 21 June 2012: European Medicines Agency acts on deficiencies in Roche medicines-safety reporting Source: EMA website

• Infringement/enforcement procedure

• Inquiry – Statement of objections

• Right to be heard/to reply – Oral hearing (it shall be granted)

• Commission Decision

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New Clinical Trials Regulation (1/3)

• At any point in time 12,000 CT’s are ongoing in Europe

• More than 5000 thousand applied for in 2007, number dropped to 3800 in 2011

• Decline in clinical trials in the EU in recent years of about 25%

• Streamline the submission process and create a single submission portal (one-stop-shop principle)

• Introduce cooperation amongst MS’s in the assessment of CT

• Assessment process for CT’s strictly separated from “scientific advice”, i.e.: keep the body indicating what data is desirable (scientific advice) separate from the one that determines whether a clinical trial is acceptableSource: European Commission

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New Clinical Trials Regulation (2/3)

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New Clinical Trials Regulation (3/3)

• Coordinated Applications Assessment •“The reporting Member State shall assess the application with regard to the following aspects: […].” (Art. 6)

•“Each Member State concerned shall assess, for its own territory, the application with respect to the following aspects: […].” (Art. 7)

• Part I: “reporting Member State” (rMS) in charge of dossier validation and assessment of common elements

•Concerned MS must follow rMS decision, except:• “significant differences in normal clinical practices btw MS concerned and

reporting MS [...].” (Art. 8(2)(a))

• “infringement of national legislation [...].” (Art. 8(2)(b))

• Part II: Each concerned MS assesses ethical and local elements• Decision: Final decision on application is made by each concerned

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New Medical Device Legislation (1/2)

• Public consultation on the medical devices directives recast (2008)

• Defective breast implants (PIP)

• Need to restore patient confidence

• EP Resolution of 14 June 2012

• From certification to assessment?

• Target: provide a better guarantee of the safety of MDs

• Strengthen the legislation in relation to market surveillance, vigilance and functioning of notified bodies

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New Medical Device Legislation (2/2)

• Legislative proposal submitted by the Commission on 26 September 2012

• From Directives to Regulations

• Stricter requirements for clinical evidence to ensure patients safety

• Strengthened control and monitoring of notified bodies by national competent authorities

• Introduction of a Unique Device Identifier (UDI) to enhance post-marketing safety

• Widening the scope of the legislation to include implants for aesthetic purposes

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New Falsified Medicines Legislation

• Directive 2011/62/EU of 8th June 2011

• Falsified not counterfeit

• An obligatory authenticity feature on the outer packaging of the medicines

• Strengthened requirements for control and inspections of plants manufacturing active pharmaceutical ingredients

• Strengthened record-keeping requirements for wholesale distributors

• Strengthened rules on inspections

• The obligation for manufacturers and distributors to report any suspicion of falsified medicines

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New Information to Patients Legislation

• 1 new Regulation and 1 new Directive to come

• From the right of the company to inform to the right of the patient to receive reliable information

• Prescription-only medicines

• Draw the line between promotional and public health information

• Pre-approval mechanism / Freedom of information

• Limited channel of communication

• Should meet quality criteria

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List of acronyms

• ADRs = Adverse Drug Reactions

• CTs= Clinical Trial(s)

• DCP = Decentralised procedure

• EP = European Parliament

• EU = European Union

• EMA = European Medicines Agency

• FUMs = Follow-up Measure(s)

• MAH = Marketing Authorisation Holder

• MDs = Medical Device(s)

• MRP = Mutual recognition procedure

• MS = Member State

• PASS = Post Authorisation Safety Study

• PAES = Post Authorisation Efficacy Study

• PhVWP = Pharmacovigilance Working Party

• PIP = Poly Implant Prothèse (i.e. Breast implant)

• PRAC = Pharmacovigilance Risk Assessment Committee

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Thank you!

Prof. Vincenzo Salvatore | Avvocato - Senior Counsel | Sidley Austin LLPNEO Building, Rue Montoyer 51 Montoyerstraat, B-1000 Brussels

T: +32 (0) 2 504 6478 | M: +32 (0) 490 445 718 | F: +32 (0) 2 504 6401www.sidley.com

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