The Canadian Medical Device Industry Adopts a Code of Conduct

Douglas C. Thomson, CEO
Canadian Orthopaedic Association

The subject of the relationship between health care professionals and industry has sometimes been said to be a tricky one to traverse. One’s view on the subject is often unconsciously coloured by the particular vantage point that the observer has at any given time.

Attendees of the COA/AOA Combined Annual Meeting in Victoria in June of 2002 will recall that one of the guest speakers was Dr. Jerome P. Kassirer. His recent book, “On the Take, How Medicine’s Complicity with Big Business Can Endanger Your Health” has received considerable attention in the United States. Dr. Kassirer has recently been in the news in Canada as he (and others) quit the Board of the Canadian Medical Association Journal over an issue of editorial independence.

Financial relationships between device companies and surgeons are not new and are most often legitimate payment for work performed on behalf of the payer. In the United States in particular, the device makers have become a big source of additional income for a few surgeons, many of whom are increasingly reliant on this source of income.

Such financial relationships have attracted government attention, and United States attorneys in Boston and Newark issued subpoenas last year to eight major manufacturers as part of a wide-ranging investigation into the relationships between doctors and device makers. This heightened scrutiny in the U.S. has caused some companies to scale back their efforts, industry consultants, lawyers and former employees say. In addition, the industry trade group AdvaMed has issued ethical guidelines for companies in the U.S. The Canadian national industry trade association, MEDEC, last year launched a voluntary industry Code of Conduct developed by its members.

According to MEDEC President Mr. Stephen Dibert, MEDEC proactively developed and adopted a “made in Canada” Code of Conduct for the Canadian medical device industry to guide ethical business practices and socially responsible industry conduct governing interactions with health care professionals. A broad definition is given to the term “health care professional”, with the intent to encompass anyone with material influence over purchasing decisions. MEDEC’s Code addresses these main areas:

• Industry sponsored product training and education:
  • The primary purpose of these activities should be to address the educational needs of the health care professionals and to ensure the ongoing independence of health care professionals.
  • Any hospitality should be modest in value and be subordinate in time and focus to the educational components of the programme.
  • Training staff should have proper qualifications and expertise to conduct the training.
  • Reasonable travel, lodging and hospitality costs may be paid for by the sponsor.
  • It is not appropriate for the sponsor to pay any expenses for guests of the health care professional or any person who does not have a bona fide professional interest in the information being shared at the meeting.
    
• Supporting Third Party Educational Conferences (ie. the Annual Meeting of the COA, for example):
  • Educational grants may be provided directly to the conference organizer to reduce conference costs or to a training institution or the conference organizer to allow attendance by health care professionals, medical students, residents or fellows. The Industry sponsor may not select the health care professional attendees who are in training and such grants should be paid only to organizations with a genuine educational purpose or function.
  • Meals and hospitality may be supported by funding provided to the conference sponsor and meals and receptions for health care professionals may also be funded. Such meals, receptions and hospitality should be reasonable in value.
  • Faculty expenses may be covered by a grant to the conference sponsor by the industry member for reasonable honouraria, travel and lodging for health care professionals who are bona fide conference faculty.
    
• Sales and Promotional Meetings
  •  Industry members can pay for reasonable travel and hospitality expenses for health care professional attendees at these types meetings. It is not appropriate to pay expenses for guests of health care professionals or anyone not attending meetings in a professional capacity.
    
• Arrangements with Consultants
  • Consulting arrangements should be written and signed by the parties and specify all services required.
  • Compensation paid to consultants should be consistent with the fair market value for the services provided.
  • Selection of consultants should be on the basis of the consultant’s qualifications and expertise to address the identified purpose and not on the basis of volume or value of business generated by the consultant.
  • Reasonable and actual expenses incurred by the consultant in carrying out the subject of the consulting agreement may be paid by the industry member.
  • In the case of research services, there should be a written research protocol.
    
• Gifts
  • Occasional and modest gifts may be made to health care professionals. Such gifts should have a fair market value of less than $100CDN.
  • Gifts may not be given in the form of cash or cash equivalents.
    
• Grants and Other Charitable Donations
  • Industry members may make donations for legitimate charitable purposes and donations should be documented.

The MEDEC Code of Conduct is a voluntary one and, according to MEDEC, acts as an open disclosure of the way the medical device industry operates in Canada through the provision of visible guidelines. Many companies have their own Codes of Conduct which a company and its customers may adhere to. The MEDEC Code does not replace these codes but rather, complement policies and practices within a company. COA members should consult with the device companies that they have business relationships with to ascertain whether they adhere to this useful Code. More information on MEDEC’s Code of Conduct may be found at www.medec.org.