Code of Conduct - Question & Answers

11. Service Oriented Items - May 2006

Question 1:
Is it acceptable to give doctors BP home cuffs for patients when considering the following?

• The equipment is for the patient, not for the doctor,
• The cuffs do not have the company or product logo,
• Doctors receive no remuneration to provide this equipment to their patients;
• The equipment is not tied to an expectation of increased scripts.

The purpose of this activity is to provide the patient with a better understanding of his/her condition as well as increase treatment compliance which is in line with CHEP guidelines. Currently, some companies are doing this activity without considering it as loaning of equipment, but more as service oriented items as per Section 11.2 of the code. Would this be correct?

Response:
Given that there is no promotional identification whatsoever that would be put on the blood pressure cuffs, and the primary goal of blood pressure (BP) cuffs could be said to enhance a patient's understanding of her/his condition, then this could be considered to be an acceptable service-oriented item, as per Section 11 of the Code.

BP cuffs are standard medical equipment for many HCPs, and although the intention is to make the BP cuffs available to individuals, HCPs are chosen to be the intermediaries to distribute them. However, the retail cost of the BP cuffs (approximately $110 - $140 per automatic unit; approximately $75 for a manual unit) is significant, thus raising issues related to Section 7A.1.2 (Gifts) and the Guiding Principles. Members are urged not to offer HCPs or their staff “any gift – in cash or in kind, or any promotional aid, prize, reward, or any other item which is intended for personal/ family benefit, or pecuniary advantage.” Furthermore, it is important to recall the Guiding Principles which states, “No monetary or other consideration is to be given to health care professionals for the purpose of gaining access or influence.” In general, therefore, this could be seen to contravene the Rx&D Code.

However, one can envisage exceptional and compelling circumstances for the free distribution of BP cuffs. For instance, there are cases whereby patients with serious medical conditions and limited financial resources could benefit from such medical devices. Rx&D members are strongly advised to establish formal protocols with HCPs to ensure that the devices reach their intended beneficiaries, while respecting the Guiding Principle and Code provisions cited above.

Question 2:
I recently submitted an EDSS card to PAAB that contained some branding elements. I was told that as per new Rx&D rules, service oriented vehicles should not contain branding elements. I was just wondering what I could say. Can I say, "provided by Company X Canada Inc, makers of Drug Y"? Can I keep the information related to treatment program as this is just our patient support program? Your guidance would be greatly appreciated.

Response:
In answering your question, it is important to recall the general principles of Section 11 (Service Oriented Items): “Members must ensure that the distribution of service-oriented items is not carried out for product promotional purposes.”

Furthermore, Section 11.2 makes it clear that “Acceptable service-oriented items are defined as items whose primary goal is to enhance the health care professional's/patient's understanding of a condition or its treatment.”

Thus, to answer your questions, it would certainly contravene the Code to mention the medicine, Y. In regard to the treatment program (the name of the patient support program), it is important to recall that although any acceptable service oriented items may only bear the company name and logo, associated acronyms, pictograms or other identifier to a product or a brand would likely contravene the spirit of the Code.

Question 3:
Perhaps you can help me understand what may have been sent out by Rx&D on the matter of providing physicians medical textbooks e.g. "book programs". It was my understanding that providing a textbook (even if it is PAAB compliant) is considered a "gift". Physicians can purchase medical textbooks and expense them to their business. They generally fall outside of section 11.2 because medical textbooks are usually not specific enough to help enhance the physician's or patient's understanding of a specific condition or its treatment. Medical textbooks tend to cover broad topic areas and have more value to physicians than patients e.g. CPS, surgical textbooks, Harrisons Principles of Internal Medicine, etc.
Are there scenarios where the giving of textbooks to physicians would be considered acceptable under Section 11.2 of the Rx&D Code and not in contravention of Section 7A?
Also, there may be benefit in clarifying the interpretation of the Code vis-à-vis book programs to Rx&D members because I am sure that many companies are being approached by this and other suppliers of medical textbooks.

Response:
In July 2005, the Industry Practices Committee (IPC) released the following Q&A on medical textbooks.
“Books that address either the health care professional (HCP) needs or the
patient's needs from the point of view of education would fall under SOI category.

According to Section 11.2 “Acceptable service-oriented items are defined as items
whose primary goal is to enhance the health care professionals/patient's understanding
of a condition or its treatment.”

There has been further discussion, especially since the publication of the Guiding Principles in the 2006 Rx&D Code of Conduct. It is important that Members interact with HCPs “in a highly professional, business like, and ethical manner.” Furthermore, “No monetary or other consideration is to be given to health care professionals for the purpose of gaining access or influence.” These new principles raise two important points. First, Members who donate medical textbooks to HCPs should be reasonable in the frequency and value of their donations. In addition, Members should bear in mind the public's perception of Members donating books that have no bearing on the conditions and/or treatments that the Members' products cover.