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March 29, 2011
Canadian pharmaceutical professionals who work for Rx&D member organizations follow the Code of Ethical Practices, which, among other guidance, provides guidelines on when and how the organization can provide financial or other type of incentive to physicians. These guidelines help maintain trust in the pharmaceutial industry by consumers and all other healthcare stakeholders, and also provide some consistency in how healthcare professionals (HCP) are treated from one organization to the other.
But how would you feel if all financial and other types of gifts that you provide to physicians for their services were made public for the whole world to see? That's exactly what will be happening in the U.S. in January 2012 (only 9 months away). This is a result of the "Sunshine Provisions" Act, which was passed in March 2010.
Paul Meade of Thought Leader Select (disclaimer: Thought Leader Select is my blog sponsor) has written an article questioning the benefits of the transparency that will be offered by the Sunshine Provisions Act: " Transparency and the Sunshine Provision – Is This a Good or Bad Thing?
Canadian Pharmaceutical Advertisement Advisory Board (PAAB) Commissioner, Ray Chepesiuk, kicks off the discussion with the following comments:
Paul Meade asks "So why are we so concerned with knowing what healthcare professionals get paid for advising healthcare manufacturers?" He goes on to answer his question "Maybe we just want to know that a medical expert is receiving fair compensation for his consultative services in a way that would not bias their judgment. But the transparency that is most important to me when receiving medical care from one of these experts is more about disclosure and conflict of interest, than it is about how much compensation that expert makes for advising manufacturers." That may be a small part of the concern. The large part of the concern from a public health and societal good point of view is "what influence do these key opinion leaders have on the broader population of physicians and the provision of health care services?" This effect may be more profound on public health and on the payers.
Looking at this issue from a broader perspective can help one see why there is a perception that excessive payments from pharma to health professionals may not be a good thing. See the effect of actual cases at Emory and Harvard Universities. The final paragraph states "Disclosure serves a valuable purpose, especially for investigative reporters and attorneys. But the real problem of pharmaceutical industry gifts and payment to doctors is not secrecy, but influence. Doctors who take money or gifts from a pharmaceutical company are more likely to prescribe that company's drugs, write favorable journal articles about the drugs, give lectures recommending the drugs and suggest adding the drugs to a hospital formulary. That influence does not disappear when the payments are disclosed. To fix that problem, the payments must be eliminated."
For those who are less familiar with the Canadian Rx&D Ethics guidelines, here are a few excerpts that highlight how Canadian pharma can and cannot compensate healthcare professionals. For the full code of ethical guidelines, go here.
- 6.1.3 Members must never provide a donation, directly or indirectly, in order to have access to a health care professional.
- 6.2 Access Fees: Under no circumstances shall a Member company pay a “clinic room rental fee”, “clean-up fee” or any other similar type “fee” that can reasonably be construed as a direct or indirect payment in order to gain access to a HCP.
- Advisory boards: 13.3 Remuneration must be in the form of an honorarium (fair and reasonable). Travel, accommodation and out-of-pocket expenses in providing the consulting service, where warranted, may be reimbursed.
- CHE: 4A.3.4 Member companies should not be involved in the development of, or payment for social functions conducted in conjunction with any CHE event.
- 4A.3.5 Grants and honoraria may be provided to health care professionals who speak at or moderate CHE programs. Such grants and/or honoraria do not apply to other health careprofessionals attending the program. Members may provide financial support for a maximum of ten (10) individuals to any one international CHE event. Notwithstanding the provisions in Section 7B.1.3. a member company may extend hospitality to all their duly sponsored health care professionals to international CHE event. For hospitality, please refer to sections 7B.1.4 and section 7B.1.5.
January 20, 2010
As a pharmaceutical marketer, you need to be creative and innovative to achieve your brand's strategic and financial objectives, but you must do so while staying within the regulatory guidelines. In Canada, there are several sets of regulatory guidelines and codes that relate to Canadian pharma / healthcare advertising and promotion. How do you know which ones to follow for which circumstances? Patrick Massad, the Chief Review Officer at the PAAB, presented an algorithm at the “Social Media Marketing in Pharma: What Works in Canada” workshop, which is meant to help identify which set of guidelines to follow in certain circumstances. A modified version is found below. When in doubt, contact the various regulatory bodies and explain your specific situation to determine which organization is responsible for clearing your advertising / promotional collaterals and campaigns. Note that the Health Canada Food & Drugs Act is the basis for the policies, guidelines, and regulations on drug advertising. Regulatory bodies enforce these.
|TYPE OF PRODUCT|
Rx and Schedule D product
Non-prescription / Natural health product
|Promoting to Healthcare Professionals||Pharmaceutical Advertising Advisory Board (PAAB)||Pharmaceutical Advertising Advisory Board (PAAB)|
|Promoting to Patients (have a prescription for the product)||Pharmaceutical Advertising Advisory Board (PAAB)||Pharmaceutical Advertising Advisory Board (PAAB)|
|Pharmaceutical Advertising Advisory Board (PAAB) OR Advertising Standards Canada (ASC) can provide an opinion on behalf of Health Canada||Advertising Standards Canada (ASC) OR MIJO (Formerly BCA)|
For those who are curious, the following is a list of promotional guidelines for some other countries; Australia: Medicines Australia Medical Technology Association of Australia Brazil: Agência Nacional de Vigilância Sanitária (Anvisa) / (Brazilian Health Surveillance Agency). Promotional guidelines in Portuguese only. Denmark: Danish Medical Association (LF), Danish Pharmaceutical Association (DA), Danish Association of the Pharmaceutical Industry (Lif), Danish Generic Medicines Industry Association (IGL), Parallel Importers of Pharmaceuticals (PI) Europe: European Federation of Pharmaceutical Industries and Associations (EFPIA) EFPIA Code on the promotion of prescription only medicines to, and interactions with, healthcare professionals EFPIA Code of practice on relationships between the pharmaceutical industry and patient organisations France: Les Entreprises du Médicament (LEEM) United Kingdom: Association of the British Pharmaceutical Industry (ABPI) United States of America: Pharmaceutical Research and Manufacturers of America (PhRMA) Division of Drug Marketing, Advertising, and Communications (DDMAC) Advanced Medical Technology Association Note that I am not a pharmaceutical regulatory expert. I am providing these resources as a service to my blog's readers. If you have specific regulatory questions, please contact the appropriate organization. Stay in touch, Natalie Connect with me on the following networks: FaceBook, Twitter, LinkedIn
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