The revised Eucomed Code of Business Practice represents an attempt by Eucomed, Europe’s trade association for the medical device industry, to address increasing concerns among regulators, politicians, and the public about the interactions between companies and health care professionals (HCPs). This three-article series has explored the principles that should govern interactions between these two groups: separation, transparency, equivalence, and documentation. The first two articles discussed industry support and sponsorship of conferences, meetings, educational initiatives, and training programs. This last article reviews the provisions of the Eucomed Code that affect research activities in the field of ophthalmology.
A VITAL LINK
In the field of pharmaceuticals, practicing physicians are increasingly distanced from the drug-development process. In the field of medical technology, however, the research, development, and introduction of devices are virtually unimaginable without collaboration between industry members and the HCPs who constitute their primary customers. Most significant advances in ophthalmic surgery and diagnostics are rooted in the ideas of practicing clinicians. For instance, it was the imaginations and the astute observations of Sir Harold Ridley and Charles D. Kelman, MD, that led to the development of IOL implantation and phacoemulsification, respectively. Additionally, many surgical techniques and instruments are named after the clinicians who sparked their development.
It is common practice for HCPs to enter into arrangements with medical device companies to develop ideas or to assist in research. Typically the company will approach the HCP or groups of HCPs to provide assistance with an ongoing research program such as a clinical trial. The Eucomed Code treats these arrangements as consultancy services.
Under the code, a legitimate purpose for the consultancy agreement must be identified in advance, and the cooperation must provide potential scientific value. The company must demonstrate that selection of consultants is based on relevant qualifications and expertise and not on commercial relationships. As with any consultancy service, arrangements must be solidified prior to commencement of work in the form of a written agreement, which should describe the work and make reference to a detailed research protocol or schedule of work. Additional consents and approvals may be required, including ethics committee approval and appropriate certification from regulatory authorities.
Written notification of these arrangements must be made available to the hospital administration where the HCP is based or to the immediate superior of the HCP. According to the Eucomed Code, arrangements for research services must be in writing even if the HCP is not offered direct payment for the service provided.
In other circumstances, the HCP or group of HCPs may approach a company for assistance with further development or commercialization of a device or technique. The requirement for a clear written agreement remains the same, but, because the HCP has proprietary interest in the development, the arrangements for payment are likely to be structured differently.
FAIR PAYMENT OR INDUCEMENT?
Based on the principle of equivalence, any compensation for research services that HCPs provide must be calculated at fair market value and cannot be tied to use of a company’s products. The company can reimburse expenses that are incurred in relation to the contracted service, including reasonable travel, meals, and accommodation. Hospitality provided in conjunction with meetings between the HCP and the company should be modest and subordinate to the primary purpose of the meeting in time and focus.
When a service relates to assistance with research and the HCP has no proprietary interest in the subject, the agreement is fairly straightforward, and payment should meet fair market value for the work undertaken. When a contract relates to the development of intellectual property of the HCP, however, the situation is more complex. The HCP can be rewarded based on sales of a device or service that he or she was instrumental in developing; however, there must be no financial compensation for personal use of the device or service. This requirement maintains the principle of separation and ensures that the HCP’s clinical decision-making is not influenced by financial considerations.
Research is a prerogative of universities and centers of clinical excellence. The Eucomed Code allows companies to give grants that support independent medical research as long as they are not linked to sales or product use. All requests for research grants must state the nature and objectives of the research.
Transparency, documentation, and separation are key considerations in this process. Support should not be provided until both parties sign a written agreement, including provisions for adverse event reporting where appropriate. Full disclosure of any research grant must be made to the hospital administration or to the HCP’s superior. The recipient must acknowledge financial support in all oral or written presentations relating to the research and the results.
Companies may also provide reimbursement for documented expenses related to the research and can make support services available or provide free products. However, such assistance must not represent an inducement or potential inducement to use or prescribe a company’s products. If equipment is provided free of charge for use in connection with a research project, it should be removed once the research project is complete.
BRINGING IT ALL TOGETHER
The underlying Eucomed principles that relate to research are similar to those that control relationships relating to other forms of consultancy, sponsorship, and assistance provided for conferences and other forms of education and training. The basic idea behind every agreement is to ensure that the professional integrity of HCPs will not be compromised and that companies uphold high standards of behavior.
I began this series of articles by considering the concerns voiced within US political circles with regard to the potentially unhealthy relationships that can develop between HCPs and the device industry when they are left relatively unchecked. So far, any similar murmurs of discontent in Europe have been relatively muted. It is in the best interests of both HCPs and the industry to keep things this way. As with most potentially troublesome situations, moderation and common sense are the best way forward.
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: firstname.lastname@example.org.