COCIR Code of Conduct

Nicole DENJOYCOCIR Secretary General

The International Medical Device Compliance Congress and Best Practices Forum May 2008 page 2 of 6

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

The International Medical Device Compliance Congress and Best Practices Forum May 2008 page 3 of 6

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

The International Medical Device Compliance Congress and Best Practices Forum May 2008 page 4 of 6

Differences from NEMA

European Solution for Europe

NEMA was the foundation Founded on 4 fundamental ethical principles Covers geographical Europe – multiple

jurisdictions

The International Medical Device Compliance Congress and Best Practices Forum May 2008 page 5 of 6

The principle of separation

clear separation between anyadvantages or benefits granted byMembers to Healthcare Professionalsand business transactions betweenthem

the purpose is to ensure that suchadvantages 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.

The International Medical Device Compliance Congress and Best Practices Forum May 2008 page 6 of 6

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