May 3, 2011
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.
November 4, 2010
PAAB Offers Guidance on Regulatory Social Media Thought Process
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:January 21, 2010
Canadian Pharma/Healthcare Regulatory Guideline Revisions – Jan 2010
Love them or hate them, as a medical marketer, you have a ton of regulatory guidelines to follow. And they seem to change on a regular basis (some guidelines change more frequently than others). In this blog post, you will find a list of some of the Canadian healthcare guidelines with links that will lead you to the document(s) of interest. The only revisions that took place in January 2010 are in the Rx&D code (see below for details of these changes). A few other revisions for other sets of guidelines are expected over the next couple of months. Although the details on the other revisions have not been shared with me, I made a note of when the revisions are expected to take place. NOTE: If you have marketing collaterals or campaigns that need pre-clearance, but you are not sure which regulatory body to contact, take a look at yesterday's post; Algorithm on choosing the appropriate Canadian healthcare regulatory guidelines. ------------------------------------------ New 2010 Rx&D Code of Ethical Practices (not yet posted on the Rx&D website, but coming soon). Here's a peak at the upcoming changes. Only section 15 has been revised in the 2010 code: Section 15.4 Penalties
- In 2009, the 1st, 2nd and 3rd code infractions were published in the Rx&D Update. As of 2010, these infractions will be published on the Rx&D website. All postings will remain on the website for 24 months from the date of the final decision.
- Within ninety (90) days of the final decision date with respect to any Code infraction, the Member must clearly indicate in writing to Rx&D that they have halted the activity or otherwise addressed the issue that caused the infraction. A copy of this compliance statement will be posted on the Rx&D website with the relevant decision of the IPRC.
- In the event that Rx&D determines that the Member has not complied with this requirement, the Member will be deemed to have deliberately contravened one of the Guiding Principles, and the penalties set out in Section 15.3, 15.5.1 and 15.5.2 will apply.
- In exceptional circumstances, a Member, acting in good faith, may believe that more than ninety (90) days will be required to comply with this Section 15.4.1. In this case, the Member must file a written extension request with Rx&D within ten (10) days of the decision date, providing a detailed supporting rationale for the request, and an estimate of the time required. Rx&D will forward the extension request to the IPRC who will evaluate the extension request and make a recommendation to the Rx&D Executive Committee (EC) within ten (10) days of its receipt. The EC, in its sole discretion, may elect to grant such an extension to the Member.
- Several supplementary guidelines to the PAAB code exist. A recent example; "Guidance for Advertising/Promotional Systems (APS) Which Are Openly Visible in Healthcare Professional (HCP) – Patient Interaction Areas"
- Recently, PAAB has implemented the Health Canada document Interim Guidance on Fair Balance in Direct-to-Consumer Advertising of Vaccines
- You might also want to look at the PMCQ website for a list 100+ PAAB FAQs.
- No changes in the PAAB code.
- No changes in prescription DTCA guidelines
- Any change in ASC guidelines would be from a result of changes with the Health Canada documents. Since there have been no changes for the Health Canada documents, there have not been any changes for the 'Consumer Drug Advertising Clearance' documents of either the Prescription drugs or the Non-prescription / Natural health products (see the two boxes on the left of the ASC screen which allow you to choose the documents required based on the product type).
- Note that both PAAB and the ASC can provide an advisory opinion on DTC collaterals and campaigns.
- No changes for any of the following documents.
- The Distinction Between Advertising and Other Activities
- Advertising Campaigns of Branded and Un-branded Messages
- Product Package Representations in Branded Prescription Drug Reminder Ads Directed to Consumers
- ASC and MIJO can provide preclearance services with respect to consumer advertising of non-prescription drugs and natural health products.
- No changes for any of the following documents.
- Consumer Advertising Guidelines for Marketed Health Products (for non-prescription drugs, including natural health products)
- Therapeutic Comparative Advertising: Directive and Guidance Document
- Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products
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January 20, 2010
ALGORITHM: Choosing the Appropriate Canadian Healthcare Regulatory Guidelines
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) |
|
Promoting to Consumers |
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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January 7, 2010
Any Canadian AE’s Reported via Social Media?
Pharmaceutical companies have concerns about initiating social media campaigns due to the potential reporting of adverse events (AE). Having been on the client side for most of my career, I admit that this would be a concern of mine as well. To completely dismiss the possibility of AE’s being added to a social network would be irresponsible.
Have there been any Canadian AE’s reported via social media? I'm sure there have been AE's reported by Canadians on social networks, but whether they have been reported or even identified, that is unknown to the general public. Despite the fact that the public has access to the AE’s reported to Health Canada by searching the Canada Vigilance Adverse Reaction Online Database, this does not include data about the method of transmission of the report. Health Canada receives AE’s via fax, e-mail, telephone, mail, and online via MedEffect Canada which collects information about the AE, the reporter, the patient and the drug in question, but does not display the details about the method of transmission of the report itself. Therefore, there is no way for the general public to know if any Canadian AE’s have been reported to Health Canada via social media or online communities unless they do their own social media market research. If somebody has done this type of research in Canada, and it is allowed to share the information, please feel free to contact me via the comment section or send me an e-mail.
If you are looking for more information about AE reporting in Canada, you may want to take a look at Health Canada’s MedEffect Canada website.
The following data in this post is actually a bit old by now, so I will not dwell on the details.
In August 2008, Nielson Online published an article called “Listening to Consumers in a Highly Regulated Environment”. The author is Melissa Davies. You can download a complimentary copy of the article here. I first learned about this report via a blog post by Pharma 2.0.
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.
[caption id="attachment_223" align="aligncenter" width="416" caption="Nielson Online - August 2008"]
[/caption]
Jonathan Richman (Dose of Digital) recently did a few calculations of his own based on some of the additional information that he received from Ms. Davies, the author of the Nielson Online report. Here was his conclusion;
“The ENTIRE PHARMA INDUSTRY, assuming they were responsible for EVERY SINGLE discussion online, would have to manage 166 reportable adverse events per day. Divide that out across the number of companies out and there’s not a lot of work for people to do.”
Of course there are measures that you can take to reduce the risk of having AE’s mentioned on your company’s or brand’s social network (ie. such as removing the option to make comments, or editing comments with prior warning that mentions of AE’s or even just product mentions may be edited to remain within the industry’s guidelines), but these reduce the level of engagement with the consumers … and that is the whole point of social media. Die-hard social media gurus will warn you against such measures, but as somebody who has walked in the pharma clients’ shoes as well as the Health 2.0 advocates’ shoes, I realize that there sometimes is a need for commenting restrictions. Plus, our Canadian pharmaceutical promotional guidelines are quite different than those of the U.S., especially when it comes to promoting drug information to consumers. As a result, us Canadian medical marketers might find ourselves in a situation where we have no choice but to limit commenting abilities or take on the responsibility of editing consumer comments in order to abide by our industry’s promotional guidelines. The PAAB hosted social media workshops in 2009 to help Canadian pharmaceutical marketers better understand what could and could not be done on social media when promoting their brands.
Before jumping in, do some market research and take a look at the types of comments that have been made about your brand(s) on social networks over the past year. This will give you an idea of the sentiment of the comments and whether there are AE's being reported. As your company begins to embrace social media, allow yourself to take one step at a time as your level of comfort with social media grows. Your social network members will appreciate it far more if you add new social media features rather than if you remove them.
Stay in touch,
Natalie
Connect with me on the following networks:
FaceBook, Twitter, LinkedIn
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