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www.bakernet.com

May 26 – 27 2008Thomas DEVRED

Baker & McKenzie - Paris

The International Medical Devices Compliance Congress and Best Practices Forum

The new Italian and French Compliance Laws

ETHICAL CONTROL OF PHYSICIANS

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Legal framework

1993 « Anti-Gift » Act

HCPs legislation (not pharma legislation)

Application Decree: 25 March 2007

Recent guidelines: Work Document adopted by Leem, SNITEM and CNOM: 21 June 2007

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Anti-Gift Act

HCPs are prohibited from receiving any pecuniary advantages or benefits in kind from companies producing or commercializing Rx products

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Ethical control: by physicians

In addition to the self-regulatory control of health products companies

Prior Control by the Professional Association of Physicians: CNOM (national level) CDOM (regional level: districts)

Level of control: opinion (not approval)

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Scope

Contracts relating to research activity and/or scientific evaluation

and Hospitality (invitations to congresses,

symposia or other events)

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Procedure

Application for opinion submitted by the company, at least: For contracts: 2 months before the « effective date » For hospitality: 1month before the date of the event

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Examination

CNOM examines the level of remuneration, which must: Be proportionate to the services provided by the physicians

(contracts) Remain reasonable (hospitality)

For research contracts other than clinical trial contracts: CNOM also examines the protocols/methodologies

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Opinion addressed to the company

If negative: the company must inform the physician(s)

The CNOM decision is an opinion, i.e. not binding

A decision must be taken (risk assessment)

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Sanctions

Non compliance with the anti-gift law can trigger criminal sanctions: Against individuals (both the physician and the manager of the

company) : fine (up to € 75.000) + imprisonment (up to 2 years)

Against companies (as legal entities): fine (up to € 375.000) + possible prohibition from presenting offers in bid procedures for procurement contracts with public hospitals

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Some figures (2006)*

Hospitality: 30.000 applications / Negative opinions: 5-10 %

Clinical Trial Contracts: 2.000 applications / Negative opinion: 3-5 %

Other Contracts: 500 applications / Negative Opinions: 10%

* Dr Chanu: President of the Section « relationships with industries » - CNOM