In the February 2010 issue of CRST Europe, John Wilkinson and Aline Lautenberg introduced the Eucomed Code of Business Practice and explained how it pertains to the European ophthalmic industry. Starting in this issue, a three-article series will take a further look at the code and how it affects ophthalmic meetings and conferences, education and training, and research and agreements. This first article focuses on meetings and conferences.
In these cost-conscious times, health care spending is under the microscope. Governments and insurers are concerned not only with the control of pharmaceutical and medical device companies' prices and spending but also that prescribing decisions are based solely on cost/benefit considerations. One area under close watch is the relationship between companies and health care professionals (HCPs).
LEARNING FROM AMERICA
Controls on the promotion of pharmaceuticals are established in European law, but self-regulation by the industry and HCPs is the predominant mode of management. European law does not control the promotion of medical devices as strictly as the governing body in the United States, where it has been the subject of recent controversy. Members of the US Congress have expressed concern about financial relationships between medical device companies and physicians and have sought to introduce legislation to impose greater controls on these interactions. Additionally, several high-profile cases have reached settlements with companies and individual physicians under the antikickback statute of the Social Security Act, which established criminal penalties for individuals or entities that knowingly and wilfully offer, pay, solicit, or receive remuneration to induce business that is reimbursed under Medicare or state health care programs.
It is against this background that Eucomed, Europe's trade association for the medical device industry, decided to strengthen its Code of Business Practice. Eucomed members must follow these guidelines when interacting with member companies and HCPs. This code is a useful signpost to legislators and regulators that the industry and physicians have matters under control through self-regulation.
THE CODE FOR CONFERENCE ORGANIZERS
One area of particular concern to HCPs is the potential impact of Eucomed's code on educational conferences and meetings, many of which rely heavily on sponsorship and industry support. The code indicates that educational meetings and the educational component of conferences are appropriate and should be encouraged. Therefore, current practices should not suffer to any significant degree.
Under the code, companies can organize educational meetings and are permitted to provide financial, scientific, technical, and organizational support for thirdparty educational conferences. This provision can be applied to all major ophthalmic conferences. However, based on the code's principle of separation, it must be obvious that any support or sponsorship, via third parties or directly, is not intended to induce HCPs to purchase or prescribe company products.
The main elements of the Eucomed code relevant to conference organizers are summarized below.
•All company-supported events must take place at an appropriate location. Any location that risks becoming the main attraction or that would project the wrong image to the public is unsuitable. For example, luxury or world-renowned hotels or venues such as cruise ships, golf clubs, or ski resorts are inappropriate.
•Any hospitality must be commensurate with the educational purpose of the event. The venue should be centrally located, and easy access should be provided for the intended participants. If participants are primarily from one country, the venue should be in that country. If the meeting is international, some residents of the chosen venue's country must be in attendance.
•The standard of the conference facilities available is the most important factor in selecting a venue.
•If leisure facilities are available, the meeting agenda must be structured so that participants are not free to use them during the working day. Companies must also demonstrate that their sponsorship or support does not contribute to such activities.
•The code places no restrictions on the ability of companies to purchase advertising space or lease booth space for company displays. Companies may also sponsor satellite symposia, provided they are consistent with the overall content of the conference, and can provide financial grants to conference organizers to reduce the overall cost of attendance for participants and to cover reasonable honoraria and expenses of bona fide faculty members.
•Before a company can provide this type of support, it must receive a written request from the conference organizer; any sponsorship must be paid directly to the conference organizer or institution, not to the faculty member. If the faculty member wishes to be accompanied by a spouse, partner, other family member, or guest, a company cannot make any contribution to that person's expenses, unless that person is also a bona fide faculty member.
THE CODE FOR CONFERENCE DELEGATES
The Eucomed code also has relevance for conference
attendees. The key points follow.
•Financial support provided by companies can extend to covering the cost of conference attendance for HCPs, but it is limited to the registration fee and reasonable travel, meals, and accommodation costs.
•Sponsors must ensure that arrangements are open to scrutiny. If specific national regulations or rules of professional conduct are in place, they take precedence over the Eucomed code.
•If registration for a third-party conference includes the cost of a lavish conference dinner or social and cultural activities, the company is not permitted to pay for those elements. Modest gatherings, such as a welcome reception or dinner, are exempt provided that attendance is expected and the event is not extravagant.
•As with faculty members, if a conference delegate wishes to be accompanied by a spouse, partner, other family member, or guest, a company is not permitted to provide any support, unless the person in question is also a conference delegate.
These are the types of issues that politicians, regulators, and the public find suspicious and therefore must be taken seriously if a framework of self-regulation is to be maintained.
THE WAY FORWARD
Industry sponsorship remains a major source of support for conference and meeting organizers, helping professional bodies and health care institutions to organize and run high-quality events that encourage education and the dissemination of information.
A great deal of thought and care, however, must go into the arrangements and the way funding is structured. The prime consideration is that industry support must clearly be for education and the advancement of knowledge rather than to influence decision-making. To ensure that this goal is achieved, effective and transparent self-regulation must be the best way forward for all concerned.
Roger Amass, BPharm, MRPharmS, is a consultant to the medical device industry. Mr. Amass may be reached at e-mail: firstname.lastname@example.org.
Editor's Note: This article was reviewed by Eucomed before submission to CRST Europe and is supported by the following companies: Abbott Medical Optics Inc., Alcon Laboratories, Inc., Bausch + Lomb, and Rayner Intraocular Lenses Limited.