COCIR Code of Conduct Nicole DENJOY COCIR Secretary General.

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Presentation transcript:

COCIR Code of Conduct Nicole DENJOY COCIR Secretary General

page 2 of 6 The International Medical Device Compliance Congress and Best Practices Forum May 2008 Why a Code of Conduct? Increased Regulatory scrutiny Increased enforcement activity New more stringent laws enacted New Code Commitment to ethical corporate behaviour Current code more than 10 years old Distinction from NEMA

page 3 of 6 The International Medical Device Compliance Congress and Best Practices Forum May 2008 Basic Approach Interactions between companies and Healthcare Professionals (“HCPs”) –individuals and institutions –that purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe medical technology products Covered Interactions –meetings –travel expenses –hospitality –gifts –consultancy arrangements –research agreements –donations

page 4 of 6 The International Medical Device Compliance Congress and Best Practices Forum May 2008 Differences from NEMA European Solution for Europe NEMA was the foundation Founded on 4 fundamental ethical principles Covers geographical Europe – multiple jurisdictions

page 5 of 6 The International Medical Device Compliance Congress and Best Practices Forum May 2008 The principle of separation  clear separation between any advantages or benefits granted by Members to Healthcare Professionals and business transactions between them  the purpose is to ensure that such advantages or benefits do not influence business transactions between Members and Healthcare Professionals. The principle of proportionality  any consideration given to a Healthcare Professional in exchange for a service or other performance provided should not exceed normal market value. Basic Principles The principle of transparency  advantages or benefits granted to Healthcare Professionals have to be disclosed and, when appropriate, approved by their institution’s administration or management. The documentation principle  the granting of any advantages or benefits to Healthcare Professionals by Members shall be documented.

page 6 of 6 The International Medical Device Compliance Congress and Best Practices Forum May 2008 Status at Today Working Group created in July 2006 with approval of COCIR Board WG includes the Senior Counsel Reps from key company members Draft being “pressure tested” in the companies Training package and Q&A being developped Final stage prior to validation at the next COCIR General Assembly COCIR Code of Conduct Working Group