This article appeared in the 2012 edition of The International Comparative Legal Guide to: Pharmaceutical Advertising
1 GENERAL - MEDICINAL PRODUCTS
1.1 What laws and codes of practice govern the advertising of medicinal products in Canada?
The federal Food and Drugs Act (the "F&DA") establishes the main regulatory framework and provides the basic criteria for the lawful advertising of drugs in Canada. As a general rule, the F&DA provides that no person shall advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. The F&DA also sets out a number of more specific rules with respect to advertising certain types of drugs. For example, there is a statutory prohibition against advertising any prescription drug to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A of the F&DA, which includes a broad list of some forty conditions deemed sufficiently serious as to warrant this exclusion. That said, Schedule A prevention claims are permitted by regulation for over-the-counter ("OTC") drugs and natural health products. Some advertising that is not prohibited is nevertheless restricted under the F&DA. For example, the F&DA and its Regulations set limits on the advertising of any drug manufactured, sold or represented for use in the prevention of conception.
The federal Controlled Drugs and Substances Act ("CDSA") and its Regulations set out further rules specific to advertising narcotics including (i) a prohibition on any advertisement to the general public respecting a narcotic, and (ii) a requirement that any permitted advertisement of a narcotic must display the symbol "N" clearly and conspicuously.
The F&DA and CDSA are administered by Health Canada, the national regulatory authority for drug advertisements. It provides policies to regulate drugs, puts in place guidelines for the interpretation of the Regulations, and oversees regulated drug advertising activities. There are three Canadian advertising preclearance agencies ("APAs") that provide voluntary drug advertising material review services to advertisers and advertising agencies – namely, the Pharmaceutical Advertising Advisory Board ("PAAB"), Advertising Standards Canada ("ASC") and MIJO.
APAs use Health Canada guidance documents and their own codes of advertising to ensure that drug advertising materials submitted to them comply with the F&DA, the CDSA, and the respective Regulations. They review advertising for consistency with the Health Canada - authorised product monograph or terms of market authorisation ("TMA") and verify that the advertising is accurate, balanced and evidence-based, and does not expand upon or conflict with the TMA. They also offer independent complaint-resolution and appeal procedures and administer sanctions and remedial measures according to their own internal codes. During the preclearance review of a drug advertisement, or during the processing of an appeal or complaint, APAs may request clarification from Health Canada. Health Canada works in collaboration with APAs, but always reserves the right to enforce the drug advertising provisions contained in federal law whether or not the advertisement has been pre-cleared by an APA.
PAAB is recognised by Health Canada as the APA for advertising material for all health products directed to health professionals. It is an independent, multidisciplinary body that administers the PAAB Code of Advertising Acceptance (the "PAAB Code"). PAAB also provides advisory opinions on messages directed to consumers for prescription drugs and on educational material discussing a medical condition or disease. Like PAAB, ASC provides advisory opinions on direct-to-consumer drug advertising and direct-to-consumer drug information materials. It is an independent, national, not-for-profit, advertising self-regulatory body that administers the Canadian Code of Advertising Standards (the "ASC Code") which applies to all categories of advertising. As well, ASC has notified Health Canada that it has publicly self-attested to meeting Health Canada's recommended criteria for the preclearance of advertising material of non-prescription drugs - OTC products - directed to consumers. Like ASC, MIJO has notified Health Canada of its public self-attestation to meeting Health Canada's criteria for pre-clearing advertising of OTC products directed to consumers.
Pharmaceutical manufacturer industry associations have also established self-regulation regimes. Most notably, since 1988 Canada's Research-Based Pharmaceutical Companies ("Rx&D") has prescribed a Code of Ethical Practices (the "Rx&D Code") for its members. Likewise, since 2008 the Canadian Generic Pharmaceutical Association ("CGPA") has had a Code of Marketing Conduct (the "CGPA Code") governing the sale of generic pharmaceutical products in Canada (although the CGPA Code currently applies only in the provinces of Ontario and Quebec). Furthermore, the Canadian Association of Medical Publishers ("CAMP") has Guidelines for General Advertising, Supplied Advertising Inserts, & Journal Supplements (the "CAMP Guidelines"), which apply to all advertising appearing in publications directed to healthcare professionals.
Of course, more general laws regarding advertising also apply. These laws include the federal Competition Act and various provincial consumer protection statutes.
1.2 How is "advertising" defined?
The F&DA defines "advertising" very broadly to include any representation by any means for the purpose of promoting directly or indirectly the sale or disposal of any drug.
Health Canada has issued a set of Guidelines entitled The Distinction Between Advertising and Other Activities (the "HC Ad Guidelines") to clarify the definition of advertising under the F&DA. In particular, the HC Ad Guidelines seek to clarify the distinction between advertising and activities that are not primarily intended to promote the sale of a drug (e.g., education, scientific exchange, labelling and shareholders' reports). The distinction is drawn by determining the primary purpose of the message. The primary purpose is determined by looking at a variety of factors, including the context in which the message is disseminated, the primary and secondary audiences, the provider of the message, the sponsor of the message, the influence exerted by a manufacturer, the frequency or repetition of the message and, of course, the actual message content.
The ASC Code defines advertising as any message in which the content is controlled directly or indirectly by the advertiser, expressed in any language and communicated in any medium to Canadians (except media originating outside of Canada, and packaging, wrappers and labels) with the intent to influence their choice, opinion or behaviour.
The PAAB Code applies to all communications in which claims, quotations and references are made, and provides specific rules for the various defined "Advertising/Promotion Systems" ("APSs").
1.3 What arrangements are companies required to have in place to ensure compliance with the various laws and codes of practice on advertising, such as "sign off" of promotional copy requirements?
In reviewing for pre-clearance a proposed advertisement to healthcare professionals, PAAB requires the advertiser to complete a PAAB submission form that indicates "approval" by the advertiser's medical/regulatory department. The form must include the name of the responsible official in the advertiser's medical/regulatory compliance department and confirmation from the advertiser that the proposed advertisement is consistent with the approved product monograph and that the claims in the advertisement are supported by references and meet the standards of the PAAB Code. Neither ASC, nor MIJO, require such formal pre-clearance "sign-off".
1.4 Are there any legal or code requirements for companies to have specific standard operating procedures (SOPs) governing advertising activities? If so, what aspects should those SOPs cover?
See question 1.3 above. In a related vein, Health Canada requires ASC to implement SOPs for the pre-clearance of therapeutic comparative advertising claims to help advertisers ensure that their claims are consistent with Health Canada requirements. There are currently three SOPs describing the steps that the ASC's Consumer Drug Section will follow to evaluate a therapeutic comparative claim and to determine whether it is compliant with Health Canada's Therapeutic Comparative Advertising Directive and Guidance Document: (i) Efficacy; (ii) Onset/Duration of Action; and (iii) Side Effect Profile/Safety Information.
1.5 Must advertising be approved in advance by a regulatory or industry authority before use? If so, what is the procedure for approval? Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances?
Drug advertisements may be reviewed and pre-cleared by one or more APAs in accordance with their respective mandates. For details, see question 1.1 above. Each APA is an independent entity that is expected to obtain voluntary compliance with federal drug advertising laws, and when not obtained, the matter can be returned to Health Canada, which retains ultimate authority for compliance and enforcement. Although use of these voluntary advertising preclearance regimes is not mandatory, it is strongly encouraged by Health Canada.
1.6 If the authorities consider that an advertisement which has been issued is in breach of the law and/or code of practice, do they have powers to stop the further publication of that advertisement? Can they insist on the issue of a corrective statement? Are there any rights of appeal?
PAAB may withdraw clearance at any time and request suspension of publication if a complaint to PAAB has been upheld, medical advice suggests the advertisement may constitute an imminent or significant health hazard, new significant information has come to light, or there has been an error or omission of fact. PAAB must provide a written letter to the advertiser detailing the rationale for withdrawal of clearance and a schedule setting out by what date use of the material is to cease. A decision to withdraw clearance may be appealed to a PAAB review panel. The PAAB Code outlines the appeals process.
ASC does not explicitly have the power to stop further publication of advertisements that breach the ASC Code. However, ASC enforces compliance by advising exhibiting media of an advertiser's failure to co-operate with an ASC decision and requesting the media's support in no longer exhibiting the advertising in question. Furthermore, ASC may publicly declare that the advertising in question, and the advertiser who will be identified, have been found to violate the ASC Code. Both the complainant and the advertiser are entitled to appeal any decision. The ASC Code outlines the appeals process.
1.7 What are the penalties for failing to comply with the rules governing the advertising of medicines? Who has responsibility for enforcement and how strictly are the rules enforced? Are there any important examples where action has been taken against pharmaceutical companies? To what extent may competitors take direct action through the courts?
Failure to comply with the legislative requirements for drug advertising in Canada is a criminal offence, punishable by up to three years' imprisonment and/or a fine of up to $CDN 5,000. The Minister of Health is responsible for enforcing the F&DA. When Health Canada receives a complaint about a drug advertisement, it will take compliance and enforcement action as required using a risk-based approach. See question 1.8 below for more detail. In practice, criminal enforcement of the rules is infrequent in light of the Minister's power to refuse drug licences or otherwise create regulatory difficulties for non-compliant drug manufacturers.
Various codes provide mechanisms for the resolution of complaints between competing manufacturers. Sanctions for violations of the PAAB Code may include a direction to publish corrective notices in annual reports, newsletters or websites, or to issue public letters of apology. Violations of the Rx&D Code will be published on the Rx&D website and subject to a fine of $CDN 25,000/50,000/75,000 for the first/second/third violation, respectively, within a twelvemonth period. Upon the third violation, the Chief Executive Officer of the offending company will also be required to appear before Rx&D's board of directors, at which time the CEO must provide a detailed explanation of the violations and a comprehensive written action plan to ensure remediation. Each additional violation after the third one results in publication of the infraction in the Rx&D website and a fine of $CDN 100,000. While each unique violation of the Rx&D Code normally counts as one violation, Rx&D's Industry Practices Review Committee ("IPRC") has the discretion, for the purpose of setting penalties, to count any violation as two violations if the IPRC determines that such violation was a "deliberate" contravention defined as a contravention clearly not in compliance with one or more of the Rx&D Code's guiding principles. Compliance with sanctions is a condition of continued membership in Rx&D. Similarly, the CGPA has the power to impose penalties on advertisers who breach the CGPA Code which include a fine of $CDN 15,000/40,000/100,000 for the first/second/third offences, respectively, within a twelve-month period.
Under the general false and misleading advertising provisions of the Competition Act, a significant administrative monetary penalty ("AMP") may be ordered for non-criminal offences. For individuals, the maximum AMP is $CDN 750,000 for the first order and $CDN 1 million for each subsequent order, while for corporations, the maximum AMP is $CDN 10 million for the first order and $CDN 15 million for each subsequent order. For criminal offences (serious false and misleading representations made knowingly or recklessly, such as fraudulently promoting counterfeit cancer drugs), the maximum term of imprisonment is 14 years. A false or misleading representation is subject to action under the Competition Act even when made to the public outside Canada (e.g., through online or social media advertising), or in a non-public setting (e.g., by a sales representative). However, enforcement against drug companies on the basis of a Competition Act false and misleading advertising claim is rare given the other avenues available with specialised industry knowledge.
1.8 What is the relationship between any self regulatory process and the supervisory and enforcement function of the competent authorities? Can, and, in practice, do, the competent authorities investigate matters drawn to their attention that may constitute a breach of both the law and any relevant code and are already being assessed by any self-regulatory body? Do the authorities take up matters based on an adverse finding of any self-regulatory body?
Although APAs and self-regulatory organisations may assume preclearance responsibilities, Health Canada retains ultimate regulatory authority with respect to federal drug advertising laws. Moreover, Health Canada acts as an advisor to PAAB and is an ex-officio observer on PAAB's board of directors. Also, Health Canada has access to the complaints and appeals procedures under the PAAB Code and ASC Code. The flow of information between Health Canada and the APAs, their respective roles, and the adjudication of complaints and processes to submit requests for clarification are all outlined in the Health Canada's Guidance Document – Health Canada and Advertising Preclearance Agencies' Roles Related to Health Product Advertising.
The underlying principle behind Health Canada intervention or involvement is a perceived breach of federal drug advertising laws.
With respect to the advertising pre-clearance process, Health Canada will review advertisements when they contravene federal drug advertising laws and may present an imminent or significant health hazard, or when the contravening advertising arises from a failure of the self-regulatory system as a result of wilful nonparticipation in, or non-compliance with, the PAAB or ASC Codes. PAAB and ASC are expected to refer such matters to Health Canada. Even if advertising materials are approved by PAAB, Health Canada can ask that they be held back and not used if Health Canada is concerned that the materials pose a health threat under federal drug advertising laws.
The same principles apply to the self-regulatory complaints and appeals processes. PAAB and ASC will bring complaints to the attention of Health Canada where, in their judgment, the complaint relates to advertising that contravenes federal drug advertising laws and presents an imminent or significant health hazard, or contravenes such laws and the self-regulator has been unable to bring about compliance (again, through wilful non-participation or noncompliance with the self-regulatory system). Complaints concerning the promotion of unapproved drugs are sent to Health Canada for investigation should they be sent to a self-regulatory body in error. Issues raised for consultation with Health Canada are limited to claims or attributes that would require pre-market review and authorisation.
1.9 In addition to any action based specifically upon the rules relating to advertising, what actions, if any, can be taken on the basis of unfair competition? Who may bring such an action?
Features of drugs, such as their colour and shape, are entitled to protection under Canadian law. An action for unfair competition may be brought under the common law action of passing off, or under the federal Trade-marks Act. Individuals, trade associations and companies may have standing to initiate legal proceedings for unfair competition.
The Supreme Court of Canada has noted that competing laboratories must avoid manufacturing and marketing drugs "with such a similar get-up that it sows confusion in the customer's mind". Nevertheless, in order to be entitled to protection, it is necessary to show that the "trade dress" has acquired "secondary meaning", and that the unauthorised use of a similar trade dress has caused or is likely to cause confusion. In addition, it may be necessary to defend the trade dress against an attack that it is functional or offers a safety advantage. Manufacturers may argue that an overriding concern with respect to the colour, shape and size of a drug is safety, and that making drugs look similar as opposed to distinct is actually an advantage for healthcare professionals and patients.
2 PROVIDING INFORMATION PRIOR TO AUTHORISATION OF MEDICINAL PRODUCT
2.1 To what extent is it possible to make information available to health professionals about a medicine before that product is authorised? For example, may information on such medicines be discussed, or made available, at scientific meetings? Does it make a difference if the meeting is sponsored by the company responsible for the product? Is the position the same with regard to the provision of off-label information (i.e. information relating to indications and/or other product's variants not authorised)?
Advertisement of a drug before it has been approved for the Canadian market is prohibited by the Regulations to the F&DA. The prohibition is not, however, intended to impede the free flow of information within the scientific community. The HC Ad Guidelines establish criteria for distinguishing between "promotional" activities and "non-promotional" activities. Information regarding unauthorised medicines may be presented and freely discussed at scientific meetings, provided that such meetings constitute "non-promotional activities". The distinction between promotional and non-promotional activities is generally dependent on the nature of the particular activity, the probable audience and the extent to which the activity is intended to promote the sale of a drug.
For example, scientific meetings may be considered non-promotional where there is no ancillary commercial or promotional activity relating to drug products and discussion of an unauthorised drug includes a statement indicating that the drug has not been authorised for the Canadian market. Where a pharmaceutical manufacturer sponsors the meeting, the sponsor is prohibited from influencing the content of the agenda or the content of any presentation (where it concerns a drug manufactured by the sponsor). Also, a manufacturer must fully disclose the nature of its sponsorship role.
Under the PAAB Code, a study involving off-label use that has been completed or has been presented at a medical meeting, and includes information that is not included in the Health Canada terms of market authorisation, should not be mentioned in advertising. Reference to research or ongoing studies about off-label information may be made in a non-promotional context with no prominence of information that has not been authorised by Health Canada.
Under the Rx&D Code, member companies do not support product discussion that is inconsistent with the approved prescribing information in the product monograph. Promotional activities must never involve solicited discussion of unapproved or off-label uses. However, if a speaker at a scientific meeting chooses to speak about such uses of a product, they must be required by contract with that product's manufacturer to inform the audience of this fact at the start of the presentation and a disclaimer should be written on the presentation.
2.2 May information on unauthorised medicines be published? If so, in what circumstances?
Information concerning unauthorised medicines may be published in reference texts, peer-reviewed journal articles and government publications. Such publications will constitute non-promotional activities only where no link can be established between the text and promotion of the drug. In addition, the manufacturer of the drug is prohibited from influencing the writing or editing of the publication and summarising or interpreting the published material.
Manufacturers may also sponsor the publication of a journal supplement, which is usually a collection of related articles, provided as a separate issue or second part of a journal. Sponsorship of such a publication, in whole or in part, may constitute a "non-promotional" activity where:
- the insert consists of unedited symposium proceedings which address issues relating to a variety of diseases or drug treatments;
- the insert discusses various treatment approaches for the same medical condition;
- the publication specifically targets health professionals or the scientific community;
- there is no obvious link between the drug discussed and the identity of the pharmaceutical manufacturer that sponsors the supplement; and
- the supplement is clearly distinct from the regular journal edition.
Failure to meet one or more of the conditions listed above may result in a supplement being construed as advertising. Pharmaceutical manufacturers must also take care in restricting their influence over the content and circulation of a sponsored supplement. Journal supplements that are disseminated or edited by their sponsors may be considered advertising. In addition, placement of a conventional advertisement for a drug product within close proximity of an article discussing the unauthorised use of the same drug product may constitute advertising.
2.3 Is it possible for companies to issue press releases about medicinal products which are not yet authorised? If so, what limitations apply?
In Canada, it is common practice for pharmaceutical manufacturers to release information to the press concerning new research developments or the introduction of a new drug to the market. As with scientific meetings and publications, to avoid being subject to advertising regulations, such press releases must constitute "non-promotional" activities. To be considered "non-promotional", the contents of a press release must be limited to: the name of the drug; its proposed therapeutic use; and a statement that the safety and efficacy of the drug is still under investigation and that market authorisation has not been obtained. In addition, the announcement must be directed at shareholders or potential shareholders. Where a manufacturer provides a press release to another targeted audience (e.g., physicians), the press release may be considered advertising.
Manufacturers are also prohibited from making statements regarding the degree of safety or efficacy expected from the drug or making comparisons with other treatments. Undue emphasis on the therapeutic benefits of the drug and hyperbolic descriptions of the drug as a "breakthrough" may be considered advertising. Finally, manufacturers may not influence the placement, visibility or emphasis of their announcement in subsequent publications. Any fees paid by a manufacturer to have a message published or broadcast will factor into the message's ultimate characterisation as advertising.
2.4 May such information be sent to health professionals by the company? If so, must the health professional request the information?
Information, including material concerning unauthorised products, may be provided to a health professional by a pharmaceutical manufacturer, only where the information has been requested by the health professional. Manufacturers are prohibited from soliciting such requests.
2.5 How has the ECJ judgment in the Ludwigs case, Case C- 143/06, permitting manufacturers of non-approved medicinal products (i.e. products without a marketing authorisation) to make available to pharmacists price lists for such products (for named-patient/compassionate use purposes pursuant to Article 5 of the Directive), without this being treated as illegal advertising, been reflected in the legislation or practical guidance in Canada?
The ECJ judgment in the Ludwigs case has not been reflected in Canadian legislation or in practical guidance from Health Canada, any APA (such as PAAB, ASC and MIJO), or any Canadian pharmaceutical industry associations (such as Rx&D and CGPA).
2.6 May information be sent to institutions to enable them to plan ahead in their budgets for products to be authorised in the future?
Institutions seeking information for budgetary purposes are limited to sources detailing a pharmaceutical manufacturer's philosophy, activities, product range (by name), financial details and areas of future research and development. The pertinent information may be found in the manufacturer's brochures, published articles, prospectuses and annual reports. Any references to a drug product must be limited to the name and therapeutic use of the product and no emphasis may be placed on that product. Dissemination of such information will be considered a "non-promotional activity" where the clear purpose of the communication is to provide information about the manufacturer's company and not the drugs being marketed, researched or developed. Information provided by the manufacturer in response to an unsolicited request is also considered a "non-promotional activity".
2.7 Is it possible for companies to involve health professionals in market research exercises concerning possible launch materials for medicinal products as yet unauthorised? If so, what limitations apply? Has any guideline been issued on market research of medicinal products?
Subject to the following limitations set out in the Rx&D Code, companies may involve health professionals in market research exercises prior to the authorisation of medicinal products:
- market research should always be conducted for the sole purpose of collecting legitimate market information, following proper and accepted principles guiding the collection and dissemination of market research information and the treatment of the respondents and the information they provide;
- the market research questionnaire or programme should not be designed in a manner that could be interpreted to be leading to a specific response or product conclusion. It should not be used to promote the use of a company's prescription medicines. Nor should it be used as a disguise for selling or developing sales contacts or as a substitute or disguise for clinical research;
- the number of experts consulted should be reasonable in light of the total number of health professionals part of that specialty;
- companies should take appropriate steps to ensure health professionals should not leave any market research meetings with any kind of promotional material;
- the purpose of the market research program and, if applicable, the use of recording devices and presence of research "viewers" must be made clear to participants at the start of the interview. The research viewers' identity must remain anonymous to participants to preserve respondent objectivity. Viewers may not include company sales representatives, nor any other field-based personnel who have contact with and the ability to influence participants;
- even when a consent form is signed, the confidentiality and anonymity of participants and their individual responses must be preserved to the fullest extent possible. The identity of participants must not be revealed for purposes of promoting a company's prescription medicines to them in the future. The purpose of the market research as well as the way the responses will be transmitted to the company organising the research should be transparently stated in the consent form;
- direct contact with the participants in the market research project, in which the identity of the sponsoring company is intentionally masked, should be limited to marketing research personnel only with no company sales representatives influence or involvement. There should be no follow-up by sales representatives or staff derived specifically from these market research projects;
- honoraria offered to health professionals who gather or provide market research information should be based on industry accepted rates for market research activities and should be similar to (and not higher than) their usual rate of compensation; and
- companies must separate market research from other types of activities unrelated to the sole purpose of gathering legitimate market information.
3 ADVERTISEMENTS TO HEALTH PROFESSIONALS
3.1 What information must appear in advertisements directed to health professionals?
The PAAB Code requires that all pharmaceutical advertising directed to health professionals include the following:
- the brand or trade name of the drug;
- the non-proprietary (generic) name of the drug;
- the federal drug schedule of the drug; and
- the therapeutic and/or pharmacologic classification of the drug.
3.2 Are there any restrictions on the information that may appear in an advertisement? May an advertisement refer to studies not in the product monograph?
The PAAB Code places restrictions on claims and/or quotations in advertisements. Clinical/therapeutic claims must be based on published, well controlled and/or well designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis and post-hoc analysis are generally regarded as not being high-level evidence to support claims in drug advertising. Non-clinical claims must be well supported by evidence.
Unpublished data is regarded as having received independent review when there is evidence that the full study manuscript has been accepted by the editor of a peer-reviewed journal for future publication and when the data has been reviewed as part of a submission to Health Canada and there is evidence of acceptance indicated by inclusion in the product monograph.
Non-evidence based statements such as those from adverse drug reaction reporting systems or testimonials are not acceptable. Claims based upon laboratory or animal testing reports should be separated and cannot be used to imply clinical significance unless there is evidence of a valid clinical correlation. Claims or quotations which are out of context or inconsistent with the conclusions of the cited author(s) are not acceptable.
3.3 Are there any restrictions to the inclusion of endorsements by healthcare professionals in promotional materials?
The Rx&D Code prohibits an advertiser's promotional materials from being signed by personnel who work in that advertiser's medical, regulatory or medical/scientific information services; nor should promotional materials be signed by someone acting on their behalf, regardless of to whom they report. Signed communication from all such personnel should be limited to responses to medical/scientific information requested by the healthcare professional and essential, new medical safety information which has been requested (for example, covering letters for new product monographs and letters that advise on product safety, the withdrawal of a product, new warnings, precautions and contraindications).
Advertising or promotional campaigns that include the results of healthcare economic studies must be reviewed and approved by PAAB following the same approval system that applies to products or services that contain clinical claims. Claims made as a result of a pharmacoeconomic study or model should be consistent with the Guidelines for Economic Evaluation of Pharmaceuticals: Canada.
3.4 Is it a requirement that there be data from any or a particular number of "head to head" clinical trials before comparative claims are made?
There is no specific minimum number of clinical trials required to support a comparative claim, but such claims are subject to general and industry specific advertising laws and guidelines. A comparative claim must be supported by adequate and proper testing concluded before the representation is made. Furthermore, claims regarding the therapeutic aspects of drugs must be based on testing that has considered all relevant data and is scientifically accurate, unbiased, reproducible, and in line with current scientific standards using established research methodologies and validated end points. While the question is fact-specific, it seems unlikely that a comparative claim could meet the required standards without having conducted head-to-head clinical trials.
3.5 What rules govern comparative advertisements? Is it possible to use another company's brand name as part of that comparison? Would it be possible to refer to a competitor's product which had not yet been authorised in Canada?
Comparative claims are governed by a Health Canada policy entitled Principles for Comparative Claims Relating to the Therapeutic Aspects of Drugs. The PAAB Code adopts and adds to this policy, setting out various rules, which include the following:
- the compared drugs must have an authorised indication for use in common and the comparison must be related to that use or, in addition to the common indication, a second authorised indication is claimed as an added benefit of the advertised drug;
- the comparison must be drawn between drugs under the same conditions of use in a similar population;
- the claim must not conflict with the TMA of the compared drugs;
- the claim must be of clinical relevance in humans;
- the evidence generated to substantiate the claim must be conclusive and based on (i) consideration of all relevant data, (ii) scientifically accurate, unbiased, reproducible data obtained from studies conducted and analysed using established research methodologies and validated end points, and (iii) appropriate interpretation of the data (i.e., extrapolation beyond the actual conditions of the supporting studies is not acceptable); and
- the claim and its presentation must (i) identify the compared companies (i.e., hanging comparisons such as "better", "faster acting", are unacceptable, as are vague statements such as "compared to the leading brand"), (ii) identify the medicinal use related to the claim, (iii) not obscure the therapeutic use of the advertised drug (i.e., the comparative claim should be afforded no more prominence than the therapeutic use), (iv) not attack the compared drug in an unreasonable manner, and (v) must be expressed in terms, language and graphics that can be understood by the intended audience.
The PAAB Code also provides that advertising making comparative claims must acknowledge competitors' trade-marks.
3.6 What rules govern the distribution of scientific papers and/or proceedings of congresses to doctors?
The distribution of scientific and medical papers to healthcare professionals at conventions and clinic displays is permitted, provided such papers are reprinted verbatim and are not presented in a manner which differs in any way from the official product monograph.
3.7 Are "teaser" advertisements permitted that alert a reader to the fact that information on something new will follow (without specifying the nature of what will follow)?
PAAB has issued guidelines entitled Administrative Guideline for the Review of Pre-NOC Advertising Submissions, which note that under PAAB's mandate, it can only provide acceptances for advertising that will be disseminated after a notice of compliance has been granted. PAAB will not issue acceptances for any promotional activities carried on prior to authorisation, such as "teaser advertising". However, there is no clear delineation of the scope of such "teaser advertising", nor any express prohibition provided a product is not specified.
4 GIFTS AND FINANCIAL INCENTIVES
4.1 Is it possible to provide health professionals with samples of products? If so, what restrictions apply?
The Regulations to the F&DA permit the distribution of product samples to registered physicians, dentists, veterinarians, surgeons or pharmacists provided that: (i) the drug is not a narcotic, a controlled drug or a drug that is not yet approved; and (ii) the drug is labelled in accordance with the Regulations. In addition, whenever a manufacturer distributes a sample of a drug, it must also maintain (and keep for a period of at least two years) records showing: (a) the name, address and description of the sample recipient; (b) the brand name, quantity and form of the sample distributed; and (c) the date upon which the sample was provided. The Rx&D Code provides further and more detailed restrictions regarding the distribution, storage, disposal and inventory of samples (also called "clinical evaluation packages") consistent with the F&DA. For example: samples must only be given to authorised health professionals who, before distribution, have signed an order for samples; if no order is made when the samples are supplied, the samples must be documented on a separate "no charge" invoice; all samples must be labelled "Not for resale"; and giving out samples at convention/clinic displays, business meetings/events, or learning programmes is prohibited.
4.2 Is it possible to give gifts or donations of money to medical practitioners? If so, what restrictions apply?
The provision of gifts or donations to medical practitioners is governed by both the manufacturer-side and the practitioner-side codes of conduct and guidelines.
On the manufacturer side, the Rx&D Code states that member companies must not offer to any healthcare professional, or to any member of a healthcare professional's clinical/administrative staff, any gift (in cash or in kind), or any promotional aid, prize, reward, or any other item which is intended for personal/family benefit, or pecuniary advantage.
On the practitioner side, in addition to guidelines issued by provincial regulatory bodies such as The College of Physicians and Surgeons of Ontario, provincial regulations address this issue. In Ontario, for example, the Health Professions Procedural Code and the Professional Misconduct Regulation state that accepting any benefit or gift, whether direct or indirect, could lead to a conflict of interest that may result in the medical practitioner committing an act of professional misconduct.
4.3 Is it possible to give gifts or donations of money to institutions such as hospitals? Is it possible to donate equipment, or to fund the cost of medical or technical services (such as the cost of a nurse, or the cost of laboratory analyses)? If so, what restrictions would apply?
Hospitals, like medical practitioners, are regulated provincially. Provincial regulations generally do not prohibit either giving gifts or donations of money, or donations of equipment and funding for medical or technical services, to institutions such as hospitals. However, the provision of such benefits should be made to the institutions themselves, and not to healthcare professionals employed by such institutions. Otherwise, the restrictions discussed in question 4.2 above may apply.
In addition, section 426 of the Criminal Code (Canada) prohibits hospital employees from corruptly accepting benefits in order to act contrary to the interests of their employer. Acceptance and/or provision of such "secret commissions" is a criminal offence punishable by imprisonment of up to five years.
4.4 Is it possible to provide medical or educational goods and services to doctors that could lead to changes in prescribing patterns? For example, would there be any objection to the provision of such goods or services if they could lead either to the expansion of the market for or an increased market share for the products of the provider of the goods or services?
The provision of medical or educational goods and services to healthcare professionals is generally allowed, provided that the goods and services do not amount to promotional efforts. Under the Rx&D Code, the provision of service-oriented items is not prohibited, so long as their distribution is not carried out for product promotional purposes. Any such service is disallowed if it could not be justified if subjected to scrutiny by members of the health professions and the public. "Acceptable" service-oriented items are defined as those whose primary goal is to enhance the healthcare professional's or patient's understanding of a condition or its treatment. A corporate logo or name is allowed, but an item must not bear the name of any medicine. If a promotional purpose were suspected, an objection could be launched in the form of a complaint to the Industry Practices Review Committee (IPRC) under the enforcement mechanism of the Rx&D Code. A potential increase in market share or market expansion would have to relate to an underlying promotional purpose in order to hold up as a sound objection to the item in question.
It should also be noted that if an educational or service-oriented effort amounts to paid advertising, it should be cleared with PAAB. Editorial materials that are objective, balanced and scientifically rigorous, as well as unrelated to any particular product, must still be submitted to PAAB for review and clearance if it amounts to a paid advertisement. In any event, such a form of advertising (i.e., editorial/educational) should not be tied to promotional claims.
4.5 Do the rules on advertising and inducements permit the offer of a volume related discount to institutions purchasing medicinal products? If so, what types of arrangements are permitted?
Provincial laws govern the permissibility of offering volume-related discounts to institutions purchasing prescription drugs. For example, Quebec prescription drug insurance laws prohibit such products from being given without consideration or sold by manufacturers or wholesalers to buyers with a rebate, discount or premium. Similarly, Ontario law restricts manufacturers from giving rebates or professional allowances to wholesalers and pharmacies as an incentive to stock the manufacturer's drug products.
4.6 Is it possible to offer to provide, or to pay for, additional medical or technical services or equipment where this is contingent on the purchase of medicinal products? If so, what conditions would need to be observed?
The Competition Act governs whether additional medical or technical services or equipment can be offered or paid for where such offer is contingent on the purchase of other medicinal products. The Competition Act prohibits manufacturers from engaging in "tied selling", which is defined as a practice whereby a supplier: (i) requires a customer as a condition of supplying product; or (ii) induces a customer by offering better purchase terms, to either purchase another product from the supplier or refrain from using another product that is not the supplier's. However, the tied selling provision will only be triggered where the conduct is engaged in by a major supplier or is widespread in a market, the conduct in question constitutes a practice, the restrictive practice discourages a firm's entry into, or expansion in, the market and the practice has substantially lessened competition, or is likely to do so. The only remedy available to the Competition Tribunal is to order the supplier to remove the contingency regarding the purchase of other medicinal products. Consequently, the scope of restrictions on this contingent purchase requirement is limited and the potential implications of non-compliance are relatively benign.
4.7 Is it possible to offer a refund scheme if the product does not work? If so, what conditions would need to be observed? Does it make a difference whether the product is a prescription-only medicine, or an over-the-counter medicine?
The licensing standards for drugs (whether prescription or over-the-counter) require that they be effective and safe. If the product is not effective or safe, it must be recalled. There are no Canadian laws or regulations prohibiting the offer of refunds for recalled products.
4.8 May pharmaceutical companies sponsor continuing medical education? If so, what rules apply?
Pharmaceutical companies may sponsor continuing medical education, subject to various Rx&D Code restrictions respecting learning programmes for healthcare professionals. The restrictions draw distinctions between accredited and unaccredited continuing health education ("CHE") programmes, as well as so-called "other learning activities" such as preceptorships (where a healthcare professional spends time with a trainer, who is a recognised expert in their field, to gain a better understanding into a therapeutic area or disease state) and speaker/faculty training workshops (where an appropriate number of healthcare professionals may be trained on legitimate learning programmes, new products, new indications or disease states or significant label changes for the sole purpose of disseminating this information at subsequent CHE events). Among these Rx&D restrictions:
- acknowledgment of sponsorship should appear on all programme-related materials;
- remuneration of the speaker or moderator must be in the form of an honorarium calculated at fair market value reflective of usual rates of compensation and may be provided only after the service has been rendered. Also, reasonable travel, accommodation and out-of-pocket expenses may be reimbursed;
- remuneration and/or reimbursement of expenses to other healthcare professionals attending the learning programme are prohibited;
- attendance of member company sales representatives at learning programmes is acceptable. While they cannot detail product at a learning programme, they may have a booth set up at a congress that is segregated from the learning programme; and
- member companies should not be involved in the development of or payment for entertainment in conjunction with any learning programme.
5 HOSPITALITY AND RELATED PAYMENTS
5.1 What rules govern the offering of hospitality to health professionals? Does it make a difference if the hospitality offered to those health professionals will take place in another country?
Health professionals in Canada are governed by a variety of provincial statutes and regulations, along with policies and ethical codes established by each profession's regulatory body. Most ethical codes place general constraints on a health professional's ability to participate in activities which call into question their professional integrity. Such activities may include accepting inappropriate offers of hospitality. In several Canadian jurisdictions, including Ontario, breach of ethical codes of conduct will constitute an act of professional misconduct, which may be subject to disciplinary proceedings.
The Rx&D Code contains numerous restrictions relating to hospitality provided by member companies to health professionals, including:
- at a business meeting, a member company may provide reasonable meals/refreshment to health professionals, but only if they are ancillary to the legitimate business activities of the meeting. No other form of stand-alone hospitality or entertainment can be provided to health professionals and thus the provision of tickets and vouchers is not permitted;
- members may not hold meetings in personal residences and must avoid venues that are excessive or extravagant;
- honoraria must not be provided to health professionals attending a business meeting;
- no more than five health professionals may attend a business meeting where the interaction is informal. A member may invite more than five health professionals to a business meeting provided the legitimate purpose of the meeting is documented through the formality of a written agenda; and
- under no circumstances can meals and refreshments be extended to the spouses/companions or administrative staff of attending health professionals.
The limitations on acceptable hospitality also apply to hospitality that will take place outside of Canada. In addition, the Rx&D Code provides that members must respect the applicable laws, regulations and self-regulatory codes of the country where the business meeting is being held.
5.2 Is it possible to pay for a doctor in connection with attending a scientific meeting? If so, what may be paid for? Is it possible to pay for his expenses (travel, accommodation, enrolment fees)? Is it possible to pay him for his time?
All provincial regulatory authorities allow physicians to accept reasonable honoraria and reimbursement for travel, lodging and meal expenses for speaking at or moderating scientific meetings or CHE events. However, most colleges prohibit non-participating physicians from accepting travel, lodging or personal expenses associated with simply attending a scientific meeting.
Similarly, provided there is an agreement in writing, the Rx&D Code allows pharmaceutical manufacturers sponsoring scientific meetings or CHE events to provide physicians who speak or moderate at such events with remuneration by way of honoraria. Any such payments must be calculated at fair market value reflective of usual rates of compensation and may only be provided after the service has been rendered. Reasonable travel, accommodation and out-of-pocket expenses, where warranted, and in line with the Rx&D Code, may be reimbursed. Remuneration and/or reimbursement of expenses of physicians merely attending the programme are prohibited.
5.3 To what extent will a pharmaceutical company be held responsible by the regulatory authorities for the contents of and the hospitality arrangements for scientific meetings, either meetings directly sponsored or organised by the company or independent meetings in respect of which a pharmaceutical company may provide sponsorship to individual doctors to attend?
The Rx&D Code provisions concerning learning programmes for healthcare professionals, and in particular CHE, apply to member companies, as well as third party organisers. The specific content of a CHE programme must be developed by consensus among the member(s) and their CHE partner(s). The content of such a programme or meeting must reflect a professionally accepted understanding of what constitutes the 'basic health sciences, clinical sciences and clinical practice of the professions'. Under the PAAB Code, materials created by the academic organisers of a continuing education event do not amount to advertising if distributed at the event or, at a later date, to registrants of the same meeting. A sponsor company that distributes such materials after the event to non-participants must submit the material to PAAB for review where the material contains product or therapeutic claims, comparative data or statements regarding the sponsor company's products.
According to the Rx&D Code, a member company should not be involved in developing or paying for entertainment in conjunction with such an event. Hospitality arrangements are acceptable where limited to reasonable meals/refreshment, which may not be extended to the spouses/companions or administrative staff of healthcare professionals (unless they are also a healthcare professional). See question 5.1 above.
5.4 Is it possible to pay doctors to provide expert services (e.g. participating in focus groups)? If so, what restrictions apply?
All provincial regulatory authorities allow physicians to accept fees for services rendered, provided that such services are not a disguise for gifts or donations. For example, the Regulations to Ontario's Medicine Act provide that receipt of any fee for services rendered by a physician, will be a conflict of interest if it cannot be evidenced by a written contract. Conflicts of interest are considered acts of professional misconduct and may result in disciplinary proceedings against the conflicted physician.
Provided there are written agreements specifying the nature of the services to be provided and the basis for payment of those services, the Rx&D Code allows manufacturers to offer an honorarium to physicians who participate in market research. The amount of the honorarium is limited to an amount calculated based on the physician's usual rate of pay. In addition, pharmaceutical manufacturers which conduct market research must ensure that the market research is not a disguise for selling or developing sales contacts and must refrain from attempting to sway the opinion of participating physicians. Consultant meetings (which include consulting meetings, advisory boards, and investigator meetings) must be held in Canada and may not include more than twenty individual consultants per meeting, excluding chairs, presenters and facilitators. In special circumstances, a consultant meeting may be organised by a member's global head office and/or an international affiliate. If held outside Canada, these consultant meetings may include a maximum of ten Canadian health professionals.
5.5 Is it possible to pay doctors to take part in post marketing surveillance studies? What rules govern such studies?
Physicians may be paid for their participation in post-registration clinical studies provided the pay reflects costs incurred in conducting the study, such as salaries of study staff and expenses for laboratory tests. Payments must be made pursuant to a written agreement and may be in the form of a monetary grant, travel to attend scientific and medical meetings, or provision of equipment needed for and relevant to the study. Payments must not be based on continuing administration of the medicine to patients after the study protocol has been completed.
5.6 Is it possible to pay doctors to take part in market research involving promotional materials?
Pharmaceutical companies may seek the advice and guidance of physicians on any number of issues, including product development and marketing. There must be a written agreement confirming the purpose, objectives and nature of the consultation services to be provided. Remuneration must be in the form of a fair and reasonable honorarium, in addition to any warranted reimbursements for reasonable travel, accommodation or other out of pocket expenses incurred in providing the consulting services. Honoraria offered to physicians who gather to provide market research information should be based on rates similar to, and not more than, their usual rate of pay.
5.7 Is there a requirement in law and/or self-regulatory code for companies to make publicly available information about donations, grants, benefits in kind or any other support provided by them to health professionals, patient groups or other institutions? If so, what information should be disclosed, from what date and how?
The 2012 Rx&D Code includes new Guidelines for Transparency in Stakeholder Funding which include the following:
- companies should post on their corporate websites their commitment to engage in transparent funding practices;
- companies should regularly disclose, by means of their websites and annual reports, a list of all stakeholders to which they provide direct funding; and
- companies should ensure that they are identified on materials to which they contributed financially or in kind.
6 ADVERTISING TO THE GENERAL PUBLIC
6.1 Is it possible to advertise non-prescription medicines to the general public? If so, what restrictions apply?
Non-prescription drugs may be advertised to the general public, but such advertisements are subject to the F&DA and Regulations and the various other codes, guidelines and laws discussed above. Both ASC and MIJO provide a review and pre-clearance service for consumer-directed non-prescription drug advertising.
6.2 Is it possible to advertise prescription-only medicines to the general public? If so, what restrictions apply?
Advertising of prescription drugs to the general public is permitted in Canada, although very stringent rules are imposed under the Regulations to the F&DA. No person shall advertise a new prescription drug unless the Minister has issued a Notice of Compliance to the manufacturer of the new drug. The law prohibits any direct-to-consumer advertising of narcotic drugs and controlled drugs. Prescription drugs, known in the legislation as Schedule F drugs, may not be advertised to the general public other than with respect to the brand name, proper name, common name, price and quantity of the drug. Furthermore, the F&DA prohibits any advertising to the general public of prescription drugs as a means to prevent, treat or cure conditions listed in Schedule A of the F&DA (although Schedule A prevention claims are permitted for OTC products and natural health products). There are currently 40 conditions listed in this schedule including alcoholism, anxiety, cancer and heart disease. Schedule D vaccines that would require a prescription for sale in Canada may be advertised subject to satisfying the "fair balance" requirement as described in Health Canada's Interim Guidance – Fair Balance in Direct-to-Consumer Advertising of Vaccines – namely, the advertising must present accurate, truthful, objective and balanced information on the benefits and risks of the vaccine. The F&DA also prohibits the distribution of a drug as a sample, except in the case of distribution to designated healthcare professionals (such as doctors and pharmacists). Finally, the F&DA makes it an offence to advertise a drug in a deceptive manner.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.