Canadian Pharma Rx-DTC getting even more restrictive? Maybe!
If you had a voice on the future of pharmaceutical Rx direct-to-consumer (Rx-DTC) advertising in Canada, what would you recommend?
On January 21 2011, Health Canada held a meeting called “Technical Discussions on Regulatory Modernization”. This meeting had several regulatory-related topics on the agenda, but there was one topic that should be on the minds of all Canadian pharmaceutial stakeholders:
“The objective of the model proposed in this document is to ensure that advertising is accurate, fair, evidence-based, and consistent with the information contained in the market authorization for the product. Advertising should neither exaggerate potential benefits nor minimize possible risks, but support health care professionals and consumers in making informed choices about the therapeutic products that they use. In addition, it should be clear to the intended recipient that an advertisement is indeed an advertisement, and those who provide such representations should be transparent in their activities.
You can find the “Mock Framework for Discussion” (proposed model) below, verbatim from the document that Health Canada provided to the attendees of the meeting. Keep in mind that it is a draft, and amendments are likely to occur. Therefore this should not be considered the final copy whatsoever. But nonetheless, it does give you an indication of the direction in which Health Canada would like to move. A summary document of the technical discussions is supposed to be published on the Health Canada website, but this will probably take weeks if not months because there are other technical discussion meetings that took place prior to the promotional discussion which need to be posted before-hand, and they still have not been posted either.
Notice that there is no mention of an Rx-DTC clause in the document below. Does this mean that our current restrictive Schedule F Rx-DTC guidelines that only allow us as an industry to talk about drug name, price, quantity might be removed? It is a possibility.
So back to the original objective stated: “support health care professionals and consumers in making informed choices about the therapeutic products that they use”. Yeah, right (enter sarcasm detector here)! Canadian patients and the general public will have to continue to rely on the data that they find sourced from other nations. A step forward? I personally don’t think so, but then again, that’s just the opinion of one person. I am curious to hear what others think, those from the pharma industry (client and agency), patients, healthcare professionals and others.
If you were able to vote on this document, would you :
a) accept the removal of the clause (thus not allowing any kind of Rx-DTC which mention a drug name in Canada), or
b) fight to put it back in as it currently exists
c) fight to put it back in and amend it so that it is less restrictive (and what part would you make less restrictive – be specific if you can)
If you do comment, it would be helpful to know what your relationship is with the pharmaceutical industry, and whether your experience is Canadian or other.
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Mock Framework for Discussion
1. Definitions
- “advertise” means any representation by any means whatever for the purpose of promoting directly or indirectly the sale or use of a drug or medical device.
- “claim” means any representation made on behalf of a health product, including the indication for use.
2. Drugs
Prescription and Nonprescription
- No person shall advertise a drug that does not have a market authorization.
- No person shall advertise a drug in a manner that directly or indirectly represents that the drug:
o is not a drug,
o is a food, or
o is a cosmetic.
- No person shall advertise a drug for which the market authorization is suspended or revoked, or for which a particular indication (use) has been suspended or revoked.
- No person shall advertise a drug for an indication (use) that is not included in the market authorization for that drug.
- Advertising of drugs that have a market authorization with special conditions shall indicate the special conditions of authorization in the advertisement.
- Any advertisement shall be set out in such a way that it is clear that the message is an advertisement.
- Persons who receive compensation of any kind from a market authorization holder to promote, either directly or indirectly, a drug or device must declare such an affiliation.
- The advertising of a drug shall not exaggerate its benefits or minimize its risks, but provide factual information so that practitioners or consumers can make an appropriate and informed choice.
- Advertisements for drugs shall be consistent with the market authorization for the drug and its approved labelling, including:
o Indications (intended uses)
o Medicinal and non-medicinal ingredients
o Potential benefits, including efficacy
o Directions for use
o Dosage
o Administration
o Onset and duration of action
o Duration of use
o Potential harms, including adverse events.
- Any advertising claims, both direct and indirect, must be consistent with the market authorization, its special conditions (if any), and be supported by the scientific evidence submitted with the application for market authorization. This includes, but is not limited to, claims regarding:
o therapeutic comparisons with other products
o results of clinical tests
o reduction of risks and adverse events
o potency.
- Visual representations and graphics included in advertisements shall not directly or indirectly represent indications (uses) or potential benefits for which the drug has no market authorization.
- Advertisements for drugs shall not be directed at children.
- Misleading advertising
o Advertisements are considered to be misleading if they:
§ represent a guarantee of benefit or an absence of any risk (e.g. statement of being “safe”)
§ represent that a drug:
- has ingredients that it does not have, or
- does not have ingredients that it does have
§ represent that the drug’s actions are due to the fact that it is natural
§ represent that the health of the user can be enhanced by the use of the drug.
- Where Health Canada is of the opinion that advertising is in violation of the regulations, it may issue a notice of direction to the market authorization holder instructing it to:
o cease such advertising immediately, or
o revise such advertising to bring it into compliance with the regulations.
- Such a notice of direction shall be issued in writing and include the following:
o Name of the drug
o Advertisement in question
o Reason(s) for the notice
o Date on which the advertising in question must cease, or be modified
o Instructions concerning requests for representations
o Date by which such a request must be made
o Contact name and information.
- The market authorization holder may request, in writing, the opportunity to make representations to Health Canada considering the notice of direction, by the date indicated in the notice of direction.
- After hearing representations, Health Canada will provide in writing to the market authorization holder confirmation if the notice of direction remains or an instruction regarding acceptable modifications to the advertising in question.
- Health Canada may suspend the market authorization of a drug if a market authorization holder is not in compliance with regulations regarding advertising or is not in compliance with a notice of direction.
Nonprescription drugs
- An advertisement for the general public shall contain the following minimum information:
o Name of the drug
o Information needed for the correct use of the drug, including potential risks
o Legible instruction to read the information on the outer or inner label, as appropriate.
Prescription Drugs
- Any advertisement of a prescription drug to a practitioner must include the essential information regarding the drug’s:
o Indications
o Dosage and dosage form
o Route of administration
o Frequency of administration
o Storage and preparation instructions
o Contraindications
o Warnings and precautions
o Adverse events.
- Any inclusion of material from medical or scientific journals in documentation provided to practitioners must include the date, be faithful reproductions, and indicate the source.
- Sales representatives shall provide to practitioners with each visit, or have available for them, current authorized product monographs or prescribing information.
Vaccines
- A person may advertise a vaccine to the general public if Health Canada is of the opinion that such advertising is in the interest of public health.
- Any advertising of a vaccine to the general public must meet the requirements of the regulations for advertising and include the following information:
- Name of the drug
- Indication(s)
- Information regarding the vaccine’s potential benefits and risks.
3. Medical Devices
Currently, there is no requirement for preclearance of advertising for medical devices in Canada. However, medical devices are subject to the provisions of the Food and Drugs Act (specifically Sections 3 and 19 – 21) and the Medical Devices Regulations (MDRs), as they pertain to advertising. No person shall advertise a device that does not have a market authorization.
Section 27 of the MDRs restricts the advertising of class II, III and IV devices to those devices which have licences. However, there is a provision for advertising of unlicensed devices in catalogues if a suitable disclaimer is present. The advertising of devices for investigational testing is restricted under section 87 which requires that the device be authorized and that the advertisement indicate that the device is the subject of investigational testing, along with the purpose of the testing.
There are also special requirements for the advertising of contraceptive devices under Section 24. This section interprets how the requirements of section 3(1) and (2) of the Act apply to these devices.
Any labelling or advertising claims which exceed or embellish the market authorization are not permitted. Complaints related to false or misleading advertising are addressed by the Health Products and Food Branch Inspectorate.
Proposals for consideration
The following proposals are provided for discussion purposes and reflect the principles put forward for drugs above, and also relate to topics from previous discussions:
- No person shall advertise a device for which the market authorization is suspended or revoked, or for which a particular intended use has been suspended or revoked.
- No person shall advertise a device for an intended use that is not included in the market authorization for that device.
- Advertising of devices that have a market authorization with special conditions shall indicate the special conditions of authorization in the advertisement.
- Any advertisement shall be set out in such a way that it is clear that the message is an advertisement.
- Persons who receive compensation of any kind from a market authorization holder to promote, either directly or indirectly, a device must declare such an affiliation.
- The advertising of a device shall not exaggerate its benefits or minimize its risks, but provide factual information so that practitioners or consumers can make an appropriate and informed choice.
- Advertisements for devices shall be consistent with the market authorization for the device and its approved labelling, including, as appropriate:
o Intended uses
o Potential benefits, including efficacy
o Directions for use
o Duration of use
o Potential harms, including adverse events.
- Any advertising claims, both direct and indirect, must be consistent with the market authorization, its special conditions (if any), and be supported by the scientific evidence submitted with the application for market authorization. This includes, but is not limited to, claims regarding:
o therapeutic comparisons with other products
o results of clinical tests
o reduction of risks and adverse events.
- Visual representations and graphics included in advertisements shall not directly or indirectly represent intended uses or potential benefits for which the device has no market authorization.
- Advertisements for devices shall not be directed at children.
- Misleading advertising
o Advertisements are considered to be misleading if they:
- represent a guarantee of benefit or an absence of any risk (e.g. statement of being “safe”)
- represent that a device:
- has components that it does not have, or
- does not have components that it does have
- represent that the health of the user can be enhanced by the use of the device.
- Where Health Canada is of the opinion that advertising is in violation of the regulations, it may issue a notice of direction to the market authorization holder instructing it to:
o cease such advertising immediately, or
o modify such advertising to bring it into compliance with the regulations.
- Such a notice of direction shall be issued in writing and include the following:
o Name of the device
o Advertisement in question
o Reason(s) for the notice
o Date on which the advertising in question must cease, or be modified
o Instructions concerning requests for representations
o Date by which such a request must be made
o Contact name and information.
- The market authorization holder may request, in writing, the opportunity to make representations to Health Canada considering the notice of direction, by the date indicated in the notice of direction.
- After hearing representations, Health Canada will provide in writing to the market authorization holder confirmation if the notice of direction remains or an instruction regarding acceptable modifications to the advertising in question.
- Health Canada may suspend the market authorization of a device if a market authorization holder is not in compliance with regulations regarding advertising or is not in compliance with a notice of direction.
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23 responses to “Canadian Pharma Rx-DTC getting even more restrictive? Maybe!”
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In the current era of highly accessible information it is better to regulate rather than ban communications. Currently the quantity of accessible information is high but the credibility is questionable. Restricting pharma communications cuts off one credible channel while ignoring unregulated channels.
As a representative of a patient advocacy group I deplore being restricted in any way from talking to pharma. I think the question needs to be reversed. Should the public have free and unfettered access to pharma?
You know, Peter Drucker said in the 60′s that when information became freely accessible, the trade/transfer of information would not be able to be contained like goods or services. Smart guy, Drucker.
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It would be both counter-productive and anti-democratic to prohibit the pharma industry from talking to the public. Given the current regulations requiring accuracy, fairness, balance and a non-promotional approach, what more does Health Canada want? What harm are they imagining, given reasonable enforcement of what is already on the books?
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Thanks all for your feedback. What surprises me is that very few people have even reacted to this post. Maybe they are not surprised by Health Canada’s suggested model to remove all potential for Rx-DTC in Canada, or maybe they feel it won’t change much from current status (how many brands can turn a decent ROI with just brand name, price and quantity anyway, other than Viagra of course), maybe the title of the article is just not dramatic enough and not catching people’s attention. Either way, I thought more people would get upset about the fact that the Rx-DTC laws might be changing in a regressive fashion. Maybe I was just being naive, or maybe I’m an extremist on the issue (until recently, I thought I was the norm). Sigh … it would have been nice to get an uproar going and get Health Canada to think twice before removing the statement completely.
In my mind the there are two aspects that need to be considered in this question.Should Canadian Pharmas should be allowed to talk with customer. I will say yes. Also they are already doing so by in beeing involved in patient associations.Should Canadian Pharma directly promote their drugs to the public. I will say no. Because promotion is , generally, incomplete and biased information.
Thanks Robert. I agree that promotion of a drug would be inappropriate, and that guidelines should be put in place for any type of communication that takes place between the two parties. One suggestion might be to allow pharma to quote certain sections of the product monograph verbatim, and maybe even enforce balance info as they currently do on all their PAAB-approved materials.
However, we disagree on the point that pharma is talking to to consumers via patient associations. While this might be the case for some patient associations, it is not usually the case for the majority of the patient associations. They’ll accept and ask for donations from pharma, but they often go to extremes to ensure that they do not appear to be associated with the pharma company. One example of a patient association trying to stay as far away from pharma is the Canadian MS Society: they won’t even let their online social networks know about the Novartis “Maybe Someday” campaign which is raising money for the MS Society by having people write their ‘hope’ for MS in the future. No produt mentioned in the campaign, but they still refuse to even retweet it or post it on their FaceBook page. I remember many other similar examples from my days in pharma.
Bonjour Nat :
I agree with you regarding Patient Association when I wrote what I did, I
was generalizing and it is a mistake from my part.
What it is concerning me is sentence like this one:
They’ll accept and ask for donations from pharma, but they often go to
extremes to ensure that they do not appear to be associated with the pharma
company. Are they or they are not associated with Pharma?
The best association that I worked with, when I was in Pharma, were the
ones that recognized support for Pharma, that say they have common interest
which is improving the well being of patients but that they have different
means. Also they do not allowed any Pharma or Pharma personals on their
board or distribute any material company material.
In my time we called these kind of donations; donation with no string
attach! But it was not always like that.
We have to recognize that the Pharma industry will want to influence
associations, as well as patients and physicians. If it done openly I am OK
with this.
Regards
Robert
Merci Robert. You make some excellent points.
Talking to the public is one thing, but has the drug industry ever demonstrated that we know how to listen to the public? Seems self-defeating to want the former, and indicate no interest in the latter.
Thanks Mitchell. Seriously, I always look forward to your comments. So here is my rebuttal:
I definitely agree that a lot of pharma companies are not ‘listening’. Some are even scared to because they are scared of what they might find out. They should not be as concerned though. In August 2008, Nielson Online published an article called “Listening to Consumers in a Highly Regulated Environment”. The key message from this report is that from an analysis of 500 random healthcare-related messages on social networks, only 1 actually met all 4 criteria for being a reportable AE ; 1) identifiable patient, 2) identifiable reporter, 3) specific drug / medication, and 4) an adverse event. But this might not be enough to convince all companies to listen. It’s too bad, because the pharma companies who are listening, whether or not they are able to communicate back, are the ones who will have the winning edge over their competitors.
But isn’t it a bit extreme to forbid all pharma companies from being allowed to communicate with the public because some pharma companies are not listening? What about consumer goods companies? Do you think they are all listening? I see a lot of them shouting on Twitter about their promo’s and sales, and that’s it. These are some of the sources that Canadians will have to rely on if pharma is never allowed to communicate wtih the public. Is that fair to Canadians who are looking for accurate, balanced information on their disease or medication?
And thank you, Nat, for once again introducing an interesting topic that encourages group members to mix it up. I completely agree with you that the handful of pharma organizations who have taken the time to listen are the ones who will prosper. As for those timorous companies you described, the agoraphobic drug marketers too frightened to want to learn the truth, they really need to get into a less-demanding business, unrelated to the life sciences. Perhaps there’s a used-paperback store on a side-street in Orillia they might want to consider purchasing, where they can babble all day and night to the inventory, and never worry that they might be overheard or criticized.
Thanks Mitchell. As always, your comments are so colorful that they make me smile. Your alternative suggestion might be a bit harsh, but you are getting the message across. In defence of my marketing colleagues, I have heard some feedback that they are usually interested in listening – but other departments put the brakes on for them. This is just feedback from some friends and colleagues, but it would be interesting to know if this was the case in general or not for the entire industry.
I believe that the information in one form or another is available to consumers on the web. The problem with this web based information is its quality and its objectivity. I would hope that the information provided by the pharma companies woud be of very high qulaity and objectivity, so that the mis-infirmaton provided by many can be corrected.
I agree Andrew. As the pharma industry regulates itself with the information that we share with healthcare professionals, one would expect that even tighter guidelines would be developed when communicating with consumers. The industry seems to be successful in managing its information with HCP’s, so I don’t see why we would not be as successful with consumers. Health Canada should take that into consideration before removing all potential to communicate with the public, especially in an era where most consumers are spending a lot of time searching for health info online and sharing on social networks.
I needed to ponder this one before getting on line with my thoughts – it is a pretty “hot” issue that requires contemplation. There already is some back and forth but these are usually more private communications for help for meds, status of studies, patient association groups etc. They may not be as formal but there are discussions/communications taking place. I think removing all communication between the two groups is not appropriate. Yes – for general introductions directly to consumers, there should be guidelines so the consumer can compare apples to apples. I think that consumers should know the drug names and the condition it treats so they have more options available to discuss with their physicians directly. Physicians and patients are often partners in care and the physician will discuss options and the patient is free to choose/trial one of the options. I like this approach because both have researched aspects of treatment that meets the overall need of the patient and their lifestyle or preferences. Some of the condition ads with corporate logos don’t really make sense to the consumer as they have no idea what the associated treatment is. I also agree with both Christopher and Nat – some patient groups welcome the support and will welcome recognition to illustrate that they are unbiased and the condition is well supported and being studied. Basically – more logos shows that the group is concerned about the condition and is reaching out to all groups and pharma that can help make this condition better to live with. Other groups don’t mention support at all and some patients will wonder where the information and the sponsorship is coming from. One source? Five sources? Any options missing? I believe in transparency to open the dialogue. I’ve been involved with multi-sponsorships simply because they want to eliminate the perspective of bias single-based sponsorship. Yes – pharma does want to influence but if they are working with the right partners – who’s ultimate goal is patient care – each pharma will be well represented and acknowledged where appropriate.
Thanks, Nat, for the reference to the Neilsen study of reportable AEs on social media. What I have seen in pharma is the spread of exaggerated fears about both listening and talking. Both will lessen as the companies actually engage in social media and they will have to engage sooner or later. This is the direction of all communications.
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I agree that pharma should be able to directly interact with consumers in Canada. Many of the regulations presently in place by PAAB seem a bit extreme and do not benefit patients. These regulations were meant to protect patients from pharma companies pushing their products on them. However, given the bleed over effect by US advertising where the regulations over DTC are not as stringent as it is in Canada, patients are getting that information regardless of the barriers to DTC in Canada. I think we need to encourage more direct interaction between patients and pharma companies rather than less. However, regulations should still be in place that ensures that all claims made my pharma companies are evidenced based so that patients are not misled.
Thanks Godfrey. Just a clarification that PAAB does not regulate Rx-DTC communications. Health Canada does. PAAB will give advice on this though, as they are well versed on the guidelines. I agree that spillover from US Rx-DTC has an impact on Canadians, whether on TV or online. I wish our Canadian citizens could get information from their Canadian pharma affiliates (within guidelines, of course).
The feds already monitor contents in cyberspace, and PAAB would really be hard pressed to get involved.
It should a joint effort between the feds and the pharma industry to monitor itself, with a clear definition as to acceptable content.
There are too many snake oil salesmen involved in the cyberspace, and we must always bear in mind………What is not legal, moral or ethical in the real world should bear the same consequences if disseminated to the public in cyberspace.
I hate to disagree with you, but advertising and communication from pharma to the public could open up a Pandora’s Box, and we may end up with a pandemic of hypochondria.
Just a few thoughts.
BrianJ
After 35 years of practice, counter prescribing will take on the pattern of third world countries. The companies who can wine and dine most lavishly will win. Most of you may not remember the days when Upjohn outfitted every grad with a medical leather bag completed outfitted.
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Have you forgotten the words of Pierre Trudeau ( PM)? “Canada is like a mouse sleeping in bed with an elephant”
Tweet me softly /cs33ca.
Seems self-defeating to want the former, and indicate no interest in the latter. Currently the quantity of accessible information is high but the credibility is questionable. As a representative of a patient advocacy group I deplore being restricted in any way from talking to pharma.
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