Winter 2005-2006
Rx&D HAS MORE BITE
Effective January 1, 2006, the self-regulatory industry association for Canada's research-based pharmaceutical companies, Rx&D, has amended its Code of Conduct (Code), available at www.canadapharma.org, in a number of significant respects.
New Section: Guiding Principles. The Code contains a new section called "Guiding Principles". It appears as the first section of the Code and sets out the following 11 principles which member companies must adhere to in their interactions with healthcare professionals:
1. The health and well being of patients and all Canadians is our first priority.
2. All interaction with health care professionals is to be conducted in a highly professional, business like, and ethical manner.
3. All product information provided to health care professionals must be accurate and fair balanced.
4. Clinical trials are developed to further science.
5. All Members must adhere to the Code and its intent as a condition of membership.
6. No monetary or other consideration is to be given to health care professionals for the purpose of gaining access or influence.
7. The purpose of Continuing Health Education (CHE) is to provide balanced and unbiased education to health care professionals.
8. The only acceptable form of hospitality for health care professionals are modest meals and/or refreshments.
9. Grants, donations and service-oriented items are never to be provided to health care professionals to promote specific prescription medicines.
10. Members' sales representatives may not participate in market research, clinical studies, advisory boards or consultancy arrangements.
11. Advisory boards and consultants are only to be used to gather scientific or commercial guidance.
The Code contains special means of enforcing the Guiding Principles. The Code enables Rx&D's Executive Committee (EC) to hold an urgent hearing concerning a deliberate contravention of the Guiding Principles. Further, the Code expressly states that any action by a member company found to deliberately contravene any of the Guiding Principles may be cause for expulsion.
Repeat Offenders. Rx&D has new means of enforcing the Code against "repeat offenders". A member company will be placed on a 12-month probationary period by the EC if it has: (a) five or more violations of the Code in one calendar year; or (b) at least three violations in two successive calendar years.
A member company on probation will be required to follow certain mandatory "probationary measures" set out in the Code, as well as other measures that the EC may direct. For example, the CEO of the member company must provide Rx&D's Board of Directors with written and verbal updates regarding remedial actions taken by the member company. The member company must also communicate its probationary status to all healthcare professionals affected by its violations indicating the sections of the Code violated as well as the steps taken by the member company to ensure that it abides by the Code in the future.
If the member company is found to be in violation of the Code during the probationary period, the Board of Directors will determine if, in its discretion, the violation is just cause to expel the company from Rx&D. A company may only reapply for membership after 24 months and on providing evidence of its "improved compliance environment".
Industry Practices Review Committee. A new Industry Practices Review Committee (IPRC) will adjudicate a reported Code violation by a member company. The composition of the IPRC includes Rx&D's legal counsel, two member representatives (marketing and regulatory) and two healthcare professionals (physician and pharmacist).
Increase in Fines. The fines for violations have increased from $5,000 to $10,000 for a first violation; from $10,000 to $15,000 for a second violation; from $15,000 to $25,000 for a third violation; and from $15,000 to $50,000 for each additional violation.
Advisory Boards/Consultants. Section 13 of the Code deals with member companies retaining healthcare professionals to sit on advisory boards or to act as consultants. This section has been amended to clarify the parameters onf these retainers. For example, the amended section requires the number of advisory board/consultant meetings to be limited. Except in limited circumstances, meetings must be held in Canada; must not be held in conjunction with social activities other than providing refreshments or a modest meal, and must have at least one non-sales individual from the member company's head office present to guide the meeting.
PAAB CLARIFIES "MEETING REPORTS" EXEMPTION
Effective January 1, 2006, the Pharmaceutical Advertising Advisory Board (PAAB) has also amended its Code of Advertising Acceptance (CAA) in an effort to clarify the exemption from review by PAAB for "Meeting Reports". The amended section 6.6a now reads (and exempts the following):
Meeting Reports (see s.11.11) of sections of accredited Health Professional Meetings or Continuing Education (CE) events/activities (see s.11.10) organized independently of the sponsor of the materials and that are not focused on, or provide emphasis on, the sponsor's product(s); and are produced and distributed once by independent publishers (see 11.12) in order to disseminate the educational content of the meeting. i.e. do not promote the sale of the sponsor's product(s)
According to PAAB, the definitions for "meeting reports" and "independent publisher" were deleted from the CAA as they "have not proven to be helpful and have been confusing to some".
REVIEW OF COMPARATIVE ADVERTISING FOR OTC DRUGS - APRIL 2006
On April 1, 2006, the Clearance Section of Advertising Standards Canada (ASC) will begin reviewing and approving comparative advertising directed to consumers regarding therapeutic attributes of over-the-counter drugs. In a letter dated January 6, 2006, ASC has stated that details of the submission and fee structure will be available in early 2006. In the meantime, ASC has also previously published Standard Operating Procedures (SOPs), which detail Health Canada's criteria and standards of evidence for making the comparative claims. The SOPs are available on ASC's website at www.adstandards.com. You can also contact our office for a copy of the SOPs and Health Canada's document entitled, "Therapeutic Comparative Advertising Directive and Guidance Document".
Speaking of IP …
Bereskin & Parr is a proud sponsor of the 11th Annual Conference on Marketing and Advertising Law, hosted by the Canadian Institute, in Toronto, Ontario. Jennifer McKenzie will be speaking on “Deconstructing Ontario's New Consumer Protection Act: How Will it's More Restrictive Provisions Affect the Way You Do Business?” on Thursday, January 26th. For more information go to www.canadianinstitute.com.
Cynthia Rowden of Bereskin & Parr will be moderating a panel on Wednesday, January 25th at 4:00pm, entitled “High-Risk Advertising and Marketing: Problems and Solutions.”
