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THE FIRST INTERNATIONAL MEDICAL DEVICE COMPLIANCE CONGRESS Global Device Codes of Ethics/Conduct Roundtable Paris, France May 27, 2008 Philippe Laroche.

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Presentation on theme: "THE FIRST INTERNATIONAL MEDICAL DEVICE COMPLIANCE CONGRESS Global Device Codes of Ethics/Conduct Roundtable Paris, France May 27, 2008 Philippe Laroche."— Presentation transcript:

1 THE FIRST INTERNATIONAL MEDICAL DEVICE COMPLIANCE CONGRESS Global Device Codes of Ethics/Conduct Roundtable Paris, France May 27, 2008 Philippe Laroche Member Comite of Ethic of SNITEM Sales and Marketing Director, Division Surgical of Covidien France

2 2 The 1st International Medical device Compliance Congress – Global Device Codes of Ethics/Conduct Roundtable – SNITEM – May, 27th, 2008 Copyright © 2008 - SNITEM - Tous droits réservés SNITEM’s Charter  Decided and Created in June 2003  Approved and signed by all the SNITEM Members  Updated in 2006

3 3 The 1st International Medical device Compliance Congress – Global Device Codes of Ethics/Conduct Roundtable – SNITEM – May, 27th, 2008 Copyright © 2008 - SNITEM - Tous droits réservés SNITEM’s Charter  By signing that Charter, the Medical Technology Companies have a committment to the 5 mains actors:  The patient  The healthcare professional  The Institutions and Organizations  The other Medical Technology companies  And … Their Trade Association

4 4 The 1st International Medical device Compliance Congress – Global Device Codes of Ethics/Conduct Roundtable – SNITEM – May, 27th, 2008 Copyright © 2008 - SNITEM - Tous droits réservés SNITEM’s Charter Medical technology companies have a commitment to:  The patient: at the center of the Medicinal Device Industry’s concerns The Medical Device Industry undertakes:  to continuously foster innovation with this aim in mind,  to abide by the regulations related to quality and safety that have been set up for the patient’s benefit.

5 5 The 1st International Medical device Compliance Congress – Global Device Codes of Ethics/Conduct Roundtable – SNITEM – May, 27th, 2008 Copyright © 2008 - SNITEM - Tous droits réservés  The healthcare professional: the Medical Technology Industry’s main partner With regard to them, the Medical Device Industry undertakes particularly:  With regard to trading practices, to abide strictly by:  The provisions in the section on “competition” in the act concerning “New Economic Regulations” (rule N°2201- 420 dated 15th May 2001);  The provisions of the current acts and regulations, in particular those in article L. 4113 of the French Public Health Code;  The guidelines, procedures and recommendations drawn up, where appropriate, by SNITEM in pursuance  Of these laws, within the limits of its scope and to the exclusion of any practice forbidden by the French “Code du Commerce” (commercial regulations). SNITEM’s Charter Medical technology companies have a commitment to:

6 6 The 1st International Medical device Compliance Congress – Global Device Codes of Ethics/Conduct Roundtable – SNITEM – May, 27th, 2008 Copyright © 2008 - SNITEM - Tous droits réservés  The Institutions and Organizations: players involved in the healthcare system  Through the trade association that represents it – SNITEM – the Medical Technology Industry promises collectively, and each company individually, to conduct itself as a fully committed, responsible partner that is aware of the imperative stakes and choices involved in Public Health.  Over and above its natural diversity, the profession undertakes:  to formulate coherent stands and proposals as and when appropriate, that each of its constituent parts shall promote  and defend as soon as these have been duly passed by the Association’s governing authorities and approved, if need be, by the General Assembly. SNITEM’s Charter Medical technology companies have a commitment to:

7 7 The 1st International Medical device Compliance Congress – Global Device Codes of Ethics/Conduct Roundtable – SNITEM – May, 27th, 2008 Copyright © 2008 - SNITEM - Tous droits réservés  The other Medical Technology companies, by adopting exemplary behaviour Membership of SNITEM implies the ability to manage and overcome the inevitable pressures of competition that are likely to appear between companies at commercial level and out in the field Members undertake:  to observe conduct that excludes any disparagement, any incorrect information and any unfair action, with respect to their competitors,  to show solidarity with regard to companies in the profession, both as individuals and as part of work groups, authorities and proceedings set up by SNITEM. SNITEM’s Charter Medical technology companies have a commitment to:

8 8 The 1st International Medical device Compliance Congress – Global Device Codes of Ethics/Conduct Roundtable – SNITEM – May, 27th, 2008 Copyright © 2008 - SNITEM - Tous droits réservés  Their Trade Association, by subscribing to a strong professional commitment Being a member of SNITEM means contractually agreeing to any individual and collective duties without prejudicing the observance of the competition law and, in particular:  Observance of the statutes, especially:  Collective discipline (article 42),  And joint consultative action (article 43);  Defending the profession’s image;  Involvement in professional initiatives;  Involvement in professional statistics. SNITEM’s Charter Medical technology companies have a commitment to:

9 9 The 1st International Medical device Compliance Congress – Global Device Codes of Ethics/Conduct Roundtable – SNITEM – May, 27th, 2008 Copyright © 2008 - SNITEM - Tous droits réservés Professional Code of Ethics and Good Practices Commission  SNITEM’s Board of Directors appoints the members of this Commission  Composition:  three board members  and a former board member or key figure who has had important functions within our Industry. ➭ Their term of office is for two years and is renewable.  The Commission elects a Chairman from among its members for an identical term of office.

10 10 The 1st International Medical device Compliance Congress – Global Device Codes of Ethics/Conduct Roundtable – SNITEM – May, 27th, 2008 Copyright © 2008 - SNITEM - Tous droits réservés Professional Code of Ethics and Good Practices Commission  Submission of a case to the Commission  By SNITEM’s Board of Directors,  By a member company,  By one of its members if it is aware of conduct that is contrary to the provisions of this Charter.  Missions:  To make sure that the provisions of this Charter are complied with, in both the letter and the spirit,  To examine possible disputes relating to violation of the Association’s code of ethics,  To hear the explanations given by the company or companies concerned,  To try to reconcile the points of view and to see to it that both sides are duly heard in the proceedings,  To request, if need be, an additional investigation by calling on outside experts.

11 11 The 1st International Medical device Compliance Congress – Global Device Codes of Ethics/Conduct Roundtable – SNITEM – May, 27th, 2008 Copyright © 2008 - SNITEM - Tous droits réservés Professional Code of Ethics and Good Practices Commission  Sanctions : Depending on how seriously the Association’s code of ethics has been violated, and applied together where appropriate:  A warning,  Publication of information in SNITEM’s internal communication media, the content of which is decided on by the Ethics Commission,  Expulsion from the Association.


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