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August 22, 2012
Ray Chepsiuk, the Commissionner for the PAAB (Pharmaceutical Advertising Advisory Board), recently made a comment about whether PAAB "kills creativity". You can listen to the podcast here (it is about 5 minutes in length, and his comments about 'creativity' can be heard near the end of the podcast). A written transcript will be made available very shortly. Here are the key points that Ray made:
- Creativity is delivering results within specified criteria.
- If you understand the rules, you can do great pharma marketing.
- It’s an excuse and a cop-out when people say that the regulations keep them from great pharma marketing.
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.
November 12, 2010
Several months ago, the PAAB (Pharmaceutical Advertising Advisory Board) held 3 social media marketing sessions called “Social Media Marketing in Pharma: What Works in Canada”, twice in Toronto and once in Montreal, where they provided some of their insights on Canadian regulations regarding pharmaceutical social media marketing. This meeting even had a representative from Health Canada as a panel member. Then earlier this month, they presented even more guidance at the Eye For Pharma eMarketing Canada conference. Just yesterday, they made their slides from the conference available on the PAAB website: PAAB Guidance on Social Media Marketing (61 slides). Enable audio on your computer as each slide has audio. The audio track on each slide is by Patrick Massad (Chief Review Officer at the PAAB). Beware - the file is huge. It slowed my computer down for several minutes. But once you go through the slides and audio, you will find that it is full of valuable information, some of which was not presented at the recent eMarketing conference due to lack of time. The PAAB has also made itself more available to the Canadian pharma community by setting up a LinkedIn, FaceBook and Twitter profile. The PAAB has been using these avenues to not only update the industry on PAAB activities, but also to share information about social media from other countries. On Twitter, the PAAB even posted a request for people to join one of their social networs and to start a discussion. As far as I know, the level of outreach by the PAAB to the pharma industry with regards to guidance on the regulations that impact social media marketing is the first of its kind worldwide. Please correct me if this is inaccurate. I am aware of the FDA meetings held a while back, but so far, no guidance has been made available since those meetings. Whether we like the regulations or not, and whether we feel the regulations are doing justice to the mantra of social media being open for engagement by all stakeholders, we have to give credit to the PAAB for their efforts in helping the Canadian pharma industry understand what we can and cannot do within the legal framework. I am not a fan of the current Rx DTC regulations in Canada. They are outdated, and I would like to see these regulations re-visited and modified. But I don't blame the PAAB for those regulations. They did not make the rules. They just help us work within them. The only recommendation that I would have for the PAAB (and Rx&D as well for that matter), is to include something about social media guidelines as part of their overall set of guidelines. Perhaps that is in the works and I am just not aware. Do you think the PAAB is doing a good job in educating the Canadian pharmaceutical industry on how to apply current regulations to social media campaigns? Do you have any suggestions for them to improve their outreach to the industry? Disclaimer: I have been involved with the PAAB on various social media activities, but this post is my personal opinion. The PAAB has not had any input or influence in the content of this article. Stay in touch, Natalie Connect with me on the following networks: FaceBook, Twitter, LinkedIn
November 4, 2010
Eye for Pharma organized the 1st eMarketing Canada conference, which was held in Toronto, on November 1-2 2010. Patrick Massad (Chief Review Officer at the PAAB, Pharmaceutical Advertising Advisory Board) presented an algorithm to facilitate the regulatory thought process when planning a social media promotional activity. Here is the suggested algorithm:
1) Is this advertising?
2) Who is the intended audience?
3) What restrictions should I consider for this audience with respect to disease and product schedules?
4) What mechanism will I use to limit access to that audience?
5) What is the sponsor’s tolerance for uncertainty & risk?
6) How will I align the site with this tolerance level?
7) What are the regulatory consequences of adding and/or linking other tools/content to my site?
Here are some highlights of Patrick's presentation with regards to the very 1st step to detemine if tactic in mind is advertising or not:Health Canada's definition of advertising is as follows: “any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device” (as per section 2 of Food Drugs Act). If this does not help to answer the question about whether the promotion is advertising or not, you can then refer to Health Canada's policy document “The Distinction Between Advertising and Other Activities", which lists the following 7 questions:
•What is the context in which the message is disseminated?
•Who are the primary and secondary audiences?
•Who delivers the message (the provider)?
•Who sponsors the message and how?
•What influence does the drug manufacturer have on the message content?
•What is the content of the message?
•With what frequency is the message delivered?
By answering these questions, the intent of the promotion becomes clearer as to whether the tactic is advertising or informational.
The intented audience and type of drug will determine which regulatory body needs to be consulted. See this article here if you need assistance to determine which Canadian regulatory body to consult for your promotional campaign. For more information about PAAB guidelines regarding social media, see Highlights from “Social Media Marketing in Pharma: What Works in Canada” What do you think of this algorithm? Would you add, delete or change any of the suggested steps? Please leave a comment below. Stay in touch, Natalie Connect with me on the following networks: FaceBook, Twitter, LinkedIn
May 13, 2010
A brave Canadian pharmaceutical company has taken the plunge and is giving FaceBook direct-to-consumer (DTC) advertising a try. King Pharmaceuticals has been promoting its EpiPen.ca website via the following English and French FaceBook ads: The call-to-action is to take the allergy risk test, but it appears as though the main objective of the site itself is to introduce the new EpiPen and EpiPen Jr (0.3 and 0.15 mg epinephrine) Auto-injectors ("EpiPen") to Canadian consumers and healthcare professionals. Both the FaceBook ads and the site are DTC advertising. Although King Pharmaceuticals launched the new EpiPen and EpiPen Jr Auto-Injectors on April 14 2010, I first noticed the FaceBook ad on Monday May 10th 2010. Of course, it is possible that the ad was launched sooner and that it just came to my attention later. Can a prescription Rx brand copy this social media model? EpiPen falls under “ethical pharmaceuticals” in the regulatory system. However, it is not a schedule F product (prescription required for sale). Therefore, section c01.044 of Canada's Food and Drug Regulations Act (which limits pharmaceutical DTC advertising to only product name, price, quantity) does not apply. To promote a prescription product (Schedule F) in a FaceBook ad (DTC), only the product name, price and quantity would be allowable because it is a public direct-to-consumer placement. Since the PAAB approves campaigns as a whole, this would also apply to any website that the FaceBook ad would link to. For more information about Canadian regulatory requirements for prescription products promoted in social media, see Highlights from “Social Media Marketing in Pharma: What Works in Canada" or contact Patrick Massad at the PAAB. If you are interested in learning more about Canadian regulatory guidelines for other types of healthcare products, you might like this article. Is this the first Canadian pharma ad on FaceBook? As far as the ads that I have seen on my personal FaceBook profile, this is the first one that I have seen from a Canadian pharmaceutical company. There may have been others. I might have missed them, or perhaps I was not part of the target market for the ad. So unless somebody tells me otherwise, I do believe that this is the very first branded FaceBook ad by a Canadian pharmaceutical company. In fact, I have not seen an unbranded FaceBook ad by any Canadian pharma companies. I you know of others, then please share in the comments section. Is the FaceBook ad driving traffic to the EpiPen.ca website? Since the EpiPen FaceBook ad seems to have the objective of driving unique visitor traffic to the EpiPen.ca website, it is reasonable to track traffic to the site as an ROI measurement. As an outsider, I will use data from Alexa and Compete. The following data and snapshot were taken on May 12 2010:
- Alexa traffic rank as of May 12 2010 is 1,562,812
- Alexa traffic rank in Canada is 27,244.
- 1,177 monthly unique visitors to the website in February 2010.