PRESS RELEASE Eucomed Compliance Panel speaks out on sponsorship of medical conferences Compliance Panel interprets Eucomed Code of Ethical Business Practice Brussels, 23 December 2010 The Eucomed Compliance Panel, an independent body of three external opinion leading experts, has issued its first advisory interpretation regarding the sponsorship of third party educational conferences by Eucomed members. The panel elaborates in detail the six objectives that must be met in order to be compliant with the Eucomed Code. The objectives range from scientific rigorous programs, competent and qualified faculty, timely and accurate information, no leisure activities and minimum duration. The Eucomed secretariat formally requested the advisory interpretation due to the numerous requests by its members and congress organisers about sponsorship invitations regarding third-party congresses and conferences. The Compliance Panel made six points: 1. The Program must be rigorous from a scientific and/or educational point of view. This means that its content must include current scientific information of a nature and quality which is appropriate to the Healthcare Professionals who are attendees at the Third Party Educational Conference. 2. The faculty responsible for delivering the Program must be competent and qualified to make the particular delivery involved and must disclose that they are sponsored by a Eucomed Member, if this is the case. 3. Representatives of Eucomed Members should not act as faculty unless the Program is part of an appropriate Eucomed Member Sponsored Satellite Symposium. 4. Information on the Program and the identity of faculty should be made available to potential Eucomed Member sponsors sufficiently in advance in order for those sponsors to be able to make a reasoned judgment as to the rigor and quality of the Program, provided however that subsequent changes, deletions and additions to the Program made by the Third Party Conference Organizer are acceptable (including modifications made after a Eucomed Member has committed to sponsor either the Third Party Educational Conference, Healthcare Professionals and/or faculty) to the extent that such changes, deletions and additions are reasonable and do not significantly modify the quality or nature of the Program. 5. The Program should not include leisure or sports events and should not advertise leisure or sports events or sporting facilities which may be available at the Third Party Educational Conference location. Page 1 of 6
6. The Program must involve full days, with both morning and afternoon scientific and/or educational sessions, unless the Third Party Educational Conference is a half day event or commences or ends on a mid-day. Such half-day sessions are permissible, but there should not be any non-scientific or non-educational events or activities organized for the other part of the day. Furthermore, there should be no significant gaps in the Program which would permit Healthcare Professionals to engage in leisure, sports or other non-scientific or non-educational activities. For example, early morning sessions should not be followed by late afternoon or evening sessions with large blocks of free time in between. Neither Eucomed nor the Compliance Panel is in the position to make specific event sponsorship decisions on behalf of its members. The Panel clarifies the interpretation of specific aspects of the Code in order to assist companies to apply the Code in a more consistent way throughout Europe. The Compliance Panel, consisting of John T. McLoughlin, Nancy Russotto and Bernard Maillet, was appointed in March 2010 to help ensure the adherence to the Eucomed Code by all company members of Eucomed. Its main mission is to provide guidance on the interpretation of the Eucomed Code as well as drive European harmonisation with respect to Code implementation and comprehension. The Panel can also intercede in cases of disputes and complaints in countries where no national dispute resolution mechanism exists. ### Background information Appendix 1 Full version of the Eucomed Compliance Panel Advisory Interpretation Appendix 2 - Members of the Eucomed Compliance Panel Ethics section on the Eucomed website - http://eucomed.org/ethics.aspx About Eucomed Eucomed is the European medical technology industry association. Its mission is to improve patient and clinician access to modern, innovative and reliable medical technology. Eucomed represents directly and indirectly 4500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry invests some 5.8 billion in R&D and employs 435,000 highly skilled workers. For more information visit www.eucomed.org. More information Ingmar de Gooijer Director Communications E: ingmar.degooijer@eucomed.be T: +32 (0)2 775 92 24 M: +32 (0)492 97 14 70 Page 2 of 6
Appendix 1 Full version of the Eucomed Compliance Panel Advisory Interpretation EUCOMED COMPLIANCE PANEL ADVISORY INTERPRETATION OF THE EUCOMED CODE N 2010-001 December 20, 2010 Subject: Third Party Educational Conferences Sponsorship by Eucomed Members Program Content and Scheduling Background Statement 1.1 By letter dated December 3, 2010 (the Request Letter ) the Eucomed Secretariat has asked the Eucomed Compliance Panel to issue an Advisory Interpretation of the Eucomed Code relating to educational and scientific programs (the Programs ) provided to Healthcare Professionals at Third Party Educational Conferences which are sponsored by Eucomed Members or which are attended by Healthcare Professionals or faculty who are sponsored by Eucomed Members. 1.2 Specifically, the Request Letter asks the Eucomed Compliance Panel to address the issues of content and scheduling of Programs at such Third Party Educational Conferences. Definitions 1.3 The terms below are used in this Advisory Interpretation as so defined: a) Eucomed Code means all of the following documents: (i) the Eucomed Code of Ethical Business Practice (September 2008), (ii) the Eucomed Guidance Document Q&A on the Guidelines on Interactions with Healthcare Professionals (October 2010) (version 4), (iii) the Eucomed Competition Law Compliance Guidelines (February 2004), and (iv) the Eucomed Code of Ethical Business Practice: Procedural Framework (October 2009). b) Eucomed Member means any national association, company or organization which is a member of Eucomed, as more fully defined in Article 3 of the Eucomed Statutes. c) Healthcare Professional means individuals (clinical or non-clinical, including but not limited to, physicians, nurses, technicians and research co-ordinators) or entities (such as hospitals or group purchasing bodies) that directly or indirectly purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Eucomed Members s medical devices. (See the Preamble of the Eucomed Code of Ethical Business Practice) d) Programs have the meaning given in Paragraph 1.1 above. e) Request Letter shall have the meaning given in Paragraph 1.1 above. f) Third Party Educational Conferences means independent, educational, scientific, or policy-making conferences to promote scientific knowledge, medical advancement and to assist in the delivery of effective Healthcare. (See the Preamble of the Eucomed Code of Ethical Business Practice) g) Third Party Conference Organizer means any professional society or organization which organizes Third Party Educational Conferences. Page 3 of 6
Basis of Authority for this Advisory Interpretation: 1.4 This Advisory Interpretation is issued by the Eucomed Compliance Panel pursuant to the authority granted to it under Section 5.1, subparagraph 2, of the Eucomed Procedural Framework. 1.5 In rendering this Advisory Interpretation, the Eucomed Compliance Panel has specifically taken note of the following Sections of the Eucomed Code of Ethical Business Practice: Section I (Preamble), Section III (Supporting Third Party Educational Conferences). Advisory Interpretation: 1.6 Based on the foregoing, the Eucomed Compliance Panel interprets the Eucomed Code, and more specifically those Sections referred to in Paragraph 1.5 of this Advisory Interpretation, to mean that Programs which are presented at Third Party Educational Conferences organized by Third Party Conference Organizers and which are sponsored by Eucomed Members and/or which are attended by Healthcare Professionals or faculty sponsored by Eucomed Members must meet the following tests in order to be compliant with the Eucomed Code: a) The Program must be rigorous from a scientific and/or educational point of view. This means that its content must include current scientific information of a nature and quality which is appropriate to the Healthcare Professionals who are attendees at the Third Party Educational Conference. b) The faculty responsible for delivering the Program must be competent and qualified to make the particular delivery involved and must disclose that they are sponsored by a Eucomed Member, if this is the case. c) Representatives of Eucomed Members should not act as faculty unless the Program is part of an appropriate Eucomed Member Sponsored Satellite Symposium. d) Information on the Program and the identity of faculty should be made available to potential Eucomed Member sponsors sufficiently in advance in order for those sponsors to be able to make a reasoned judgment as to the rigor and quality of the Program, provided however that subsequent changes, deletions and additions to the Program made by the Third Party Conference Organizer are acceptable (including modifications made after a Eucomed Member has committed to sponsor either the Third Party Educational Conference, Healthcare Professionals and/or faculty) to the extent that such changes, deletions and additions are reasonable and do not significantly modify the quality or nature of the Program. e) The Program should not include leisure or sports events and should not advertise leisure or sports events or sporting facilities which may be available at the Third Party Educational Conference location. f) The Program must involve full days, with both morning and afternoon scientific and/or educational sessions, unless the Third Party Educational Conference is a half day event or commences or ends on a mid-day. Such half-day sessions are permissible, but there should not be any non-scientific or non-educational events or activities organized for the other part of the day. Furthermore, there should be no significant gaps in the Program which would permit Healthcare Professionals to engage in leisure, sports or other non-scientific or non-educational activities. For example, early morning sessions should not be followed by late afternoon or evening sessions with large blocks of free time in between. Page 4 of 6
Qualifications: 1.7 The foregoing Advisory Interpretation constitutes a limited interpretation of the Eucomed Code by the Eucomed Compliance Panel. It is advisory in nature only. Eucomed Members must make their own determination as to the appropriateness of a particular Third Party Educational Conference which they sponsor as well as its compliance with the Eucomed Code. 1.8 There are other provisions of the Eucomed Code which apply to Third Party Educational Conferences. The fact that a particular Third Party Educational Conference meets the tests set out in this Advisory Interpretation does not necessarily mean that the Third Party Educational Conference is fully compliant with the Eucomed Code. 1.9 This Advisory Interpretation does not take into account applicable laws and regulations or local Eucomed Member codes of ethics, codes of conduct or other codes which may apply to a Eucomed Member company or to a sponsored Healthcare Professional or Third Party Educational Conference faculty member or to Third Party Conference Organizers. John McLoughlin Chairman, Eucomed Compliance Panel Nancy Russotto Member, Eucomed Compliance Panel Bernard Maillet Member, Eucomed Compliance Panel Page 5 of 6
Appendix 2 - Members of the Eucomed Compliance Panel John T. McLoughlin John T. McLoughlin (American/Irish) is Attorney at Law in Washington, D.C. and Avocat in Paris. He founded McLoughlin & Avocats, Paris, France and was the managing partner until 2007. He is a specialist of Medical Devices Law, Corporate Law/ Mergers and Acquisitions, Computer Software and Labor and Employment Law. Today, he is Counsel to Winston & Strawn (Chicago and Paris) and BMH Avocats (Paris). Nancy Russotto Nancy Russotto (American/Swiss) led the Association of Plastics Manufacturers in Europe, PlasticsEurope, for over 16 years. After an early retirement in 2006, Nancy Russotto became European Affairs Advisor in the Brussels office of the Washington D.C.-based law firm Steptoe & Johnson LLP. In this capacity, Nancy Russotto offers business consulting, regulatory and advisory services to corporate clients from various world regions operating in the European Union. Nancy Russotto is a law graduate of the Université Libre de Bruxelles. Bernard Maillet, MD Bernard Maillet (Belgian) is a pathologist working at the Laboratorium voor Medische Ontledingen" since 1996. He is a member of the Flemish Chamber of the Board for Specialists for Pathology, the Secretary General of the Union of European Medical Specialists (UEMS) and Treasurer of Belgian Association of Specialists (VBS-GBS). Page 6 of 6