July 7, 2011
How Healthcare Companies Should Conduct Social Media Activities (A Legal Advisor’s Perspective)
This is a guest post by Timothy Dunn, Legal Advisor to Healthcare Companies Doing Business in Canada. You can find Timothy on Twitter here, and here is his website. If you have any questions, or would like to discuss a particular matter, you can contact Timothy at tdunn@canadianhealthcarelaw.com or (450) 951-1335.
How Healthcare Companies Should Conduct Social Media Activities
Social media activities (“SMA”) are changing the way Canadian healthcare companies engage stakeholders. SMA can be used to “speak” or disseminate messages, as well as to “listen” or receive messages. In Canada, healthcare companies’ messages are regulated by myriad laws, regulations, guidelines, professional order codes of conduct, advertising preclearance agency codes, industry association codes, supranational rules, public company legislation, social media website terms of use and frequently the firm’s own policies ( “Regulations”). These apply to both ‘speaking’ as well as ‘listening’ SMA.
Healthcare companies should conduct SMA within the scope of legally acceptable risk, which takes into account all of the relevant sources of exposure. I will share some thoughts about my approach to legal review of SMA. While I believe it to be true as of the time of posting, this information should not be taken as legal advice. You should always consult with a lawyer to discuss the implications of specific SMA to your healthcare company.
Regarding the legal review of ‘speaking' SMA, my practice is to perform a categorical analysis of the piece or project to determine which Regulations apply, then perform a qualitative analysis of the piece or project against the relevant Regulations to determine scope of the risk of exposure.
1) The first step in my categorical analysis is assessing whether the SMA is either informational or promotional in nature. A useful instrument in this analysis is Health Canada’s Distinction between Advertising & Other Activities.
2) Where products are involved, how are these categorized (prescription drugs, Class I medical device, natural health product, etc.) and which Regulations become relevant?
3) Next, I determine the intended audience of the SMA: healthcare professionals, patients, or the general public. This analysis will determine which Regulations apply, as each of these audiences is regulated differently. In the former two cases, are the strategy and tactics deployed necessary or sufficient to restrict access to the appropriate populations?
Only after I position the SMA within the above matrix do I begin to analyze its content. What restrictions do Regulations impose on acceptable condition-related or product-related representations? Because SMA is predominantly interactive, control of editorial content is directly correlated with risk management of exposure to non-compliance with Regulations; it is inversely correlated with communitarian and interactive notions which inform and influence SMA strategies and tactics. My practice is to educate brand managers and other marketing professionals about the scope of the risk, suggest strategies and tactics to mitigate or manage it, and leave the ultimate decision to the business people.
Turning now to the ‘listening’ or receiving of SMA messages from stakeholders, healthcare companies should be mindful of privacy law, personal health information law, and pharmacovigilence/adverse event reporting obligations. Again, my practice is to perform a categorical and qualitative analysis based on these five questions:
1) is there informed consent for the collection of all information being collected and all purposes for which it will be used?
2) Where will the information be stored, is this being disclosed to the stakeholder, and what are the regulatory implications for transmitting the information outside of the jurisdiction in which it was collected?
3) What safeguards are there to maintain the confidentiality of the information; are these necessary or sufficient?
4) Does the client have an acceptable privacy policy and a designated privacy officer?
5) Which legislative regime will apply to the collected information (privacy law, personal health information law, adverse event reporting law, other?)
Exercise extreme caution when the collected information about a specific product is publicly available.
The way in which healthcare companies engage stakeholders is changing from a didactic paradigm of information dissemination to an interlocutory paradigm which necessarily entails a relinquishing of control over information content. The reality is that healthcare companies need to use SMA in order to remain engaged and relevant to their stakeholders. Because SMA tactics and strategies are evolving faster than the Regulations, legal risk increases. Healthcare companies should consult closely with legal counsel who has expertise in the regulation of advertising and promotion of therapeutic products, at all stages of the development and execution of SMA, in order to effectively manage this necessary risk.
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.
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