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BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG HOUSTON LONDON LOS ANGELES NEW YORK PALO ALTO SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C.
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
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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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