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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
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