1. v1 - 082807 www.bakernet.com May 26 – 27 2008 Thomas 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

2. 2 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

3. 3 Anti-Gift Act  HCPs are prohibited from receiving any pecuniary advantages or benefits in kind from companies producing or commercializing Rx products

4. 4 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)

5. 5 Scope  Contracts relating to research activity and/or scientific evaluation and  Hospitality (invitations to congresses, symposia or other events)

6. 6 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

7. 7 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

8. 8 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)

9. 9 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

10. 10 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