Eucomed, Europe's trade association for the medical device industry, revised its Code of Business Practice in 2008 and defined four key principles that should govern interactions between industry and health care professionals (HCPs): separation, transparency, equivalence, and documentation. In the first of three articles, I considered the implications of the revised code for the support and sponsorship of conferences and meetings. This second article evaluates other educational initiatives and training that involve the industry.
Continuing education is essential to the practice of medicine, and the emphasis placed on it has never been greater. Education relating to the introduction and application of technological advances in ophthalmic surgery and diagnostics is often best provided by the companies involved in their development. Companies both provide financial support for individuals and organizations and sponsor or organize educational events and training courses.
Eucomed's code recognizes the importance of the safe and effective use of medical technology, and it encourages product education and training to facilitate these goals. However, it stipulates that industryorganized educational and training events must be legitimate rather than promotional.
LOCATION AND HOSPITALITY
Training programs and educational events should occur at appropriate venues, taking into account convenience for attendees and the nature of the training while avoiding the provision of excessive hospitality. These requirements are similar to those for conferences and other meetings. Suitable venues include clinical, laboratory, educational, and conference settings. A company's own premises or a commercially available meeting facility are appropriate, provided the venue is conducive to effective transmission of knowledge, such as hands-on training.
Under the Eucomed code, educational and training events can include reasonably priced meals, such as a meal with wine at a conference hotel. If an overnight stay is justified, then reasonable hotel accommodation can be provided. Similarly, reasonable travel costs incurred by HCPs may also be met. However, air travel must be economy or standard class unless the flight time is more than 5 hours; in that case, premium economy or business class may be considered if permissible under national laws, regulations, or professional codes of conduct.
This part of the Eucomed code does not envisage that partners or guests will accompany attendees. Payment of expenses for such third parties is not allowed, unless the individual has a bona fide professional interest in the event. If an attendee arranges and pays for his or her spouse, partner, or other guest to attend, that person should not be permitted at eventrelated activities, including meals.
The main thrust of the Eucomed code is that any hospitality provided for training or an educational program or event should be reasonably valued and subordinate in time and focus to the educational purpose of the training.
Another area addressed by the Eucomed code is the provision of educational grants, which can be made to training institutions, health care institutions, or professional societies for medical education programs. Such grants are permissible in the form of financial support for fellowships and other scholarship awards. Grants must be provided to the institution without strings attached, and their award should be at the discretion of the institution rather than the company concerned. Such grants must not be tied to the purchase or use of any company products or services.
A company may invite HCPs to educational conferences provided that the conference relates to educational needs and not to a commercial relationship. The preferred practice is for expenses to be reimbursed retrospectively against invoices or receipts; however, payment can be made to a supplier or intermediary agency. It is not acceptable to deliver a cash advance to cover costs of attendance or other expenses directly to HCPs.
Companies can engage the services of HCPs with specialist knowledge or experience or those who were involved with the development of a product or service to assist in the delivery of training or educational programs. The code outlines that individuals in this role are considered consultants and that a written agreement should describe and define the service to be provided, fully explaining any legal or professional considerations.
The agreement also must define the fee for services, which must be commensurate with the HCPs' normal rate of remuneration. The usual requirements governing payment of expenses and the provision of gifts or hospitality must also be followed.
The subject of contracts will be considered in more detail in the final article in this series.
Roger Amass, BPharm, MRPharmS, is a consultant to the medical device industry. This article was reviewed by Eucomed before submission to CRST Europe and is supported by Abbott Medical Optics Inc., Alcon Laboratories, Inc., Bausch + Lomb, and Rayner Intraocular Lenses Limited. Mr. Amass may be reached at e-mail: email@example.com.