Distribution and marketing of drugs in Canada: overview

A Q&A guide to distribution and marketing of drugs law in Canada.

The Q&A gives a high level overview of distribution and marketing of drugs law, including pre-conditions for distribution; licensing; wholesale distribution; marketing to consumers; marketing to professionals and engagement with patient organisations.

To compare answers across multiple jurisdictions, vist the Distribution and Marketing of Drugs Country Q&A Tool.

This Q&A is part of the global guide to Distribution and Marketing of Drugs.

Jeffrey S. Graham*, Borden Ladner Gervais LLP
Contents

Distribution

Pre-conditions for distribution

1. What are the legal pre-conditions for a drug to be distributed within the jurisdiction?

Authorisation

Before a drug can be distributed in Canada, its manufacturer must receive a Notice of Compliance (NOC) from Health Canada, and the drug must be assigned a Drug Identification Number (DIN). The NOC represents the fact that the drug meets the required standards for use in humans and the DIN represents the fact that the drug has been evaluated and authorised for marketing and sale in Canada. A manufacturer can obtain a NOC by submitting a New Drug Submission (NDS) or an Abbreviated New Drug Submission (ANDS) for a generic drug. The ANDS scheme was implemented to make the approval process for generic drugs simpler and more cost effective with the hope that the cost of drugs for provincial governments and members of the public would in turn be reduced. To receive a NOC, under an ANDS, the manufacturer only has to prove that its product is pharmaceutically equivalent and bioequivalent with the innovator's drug. Because the decision on whether a medication will be listed on the Prescription Drug List is made during the review of the NDS, and therefore require a prescription before its distribution to a patient, both prescription, non-prescription and over-the-counter (OTC) medications must go through the NDS process.

Exceptions

A Notice of Compliance with Conditions (NOC/c) can be issued for drugs with promising but unverified clinical benefit. This designation is reserved for drugs that:

  • Potentially provide treatment, prevention or diagnosis of a disease or condition for which no drug is presently marketed in Canada.

  • Shows significantly improved efficacy or reduced risk compared to other available therapy.

A pre-condition to the grant of a NOC/c is that the safety of the drug must be reasonably established.

Another exception to the general drug approval and distribution process in Canada is the priority review process. Manufacturers can submit an application for priority review of their NDS if the drug provides therapy for a serious, life-threatening or severely debilitating disease or condition. If granted, priority review allows a drug submission to be fast-tracked through the approval process.

 
2. Do any types of named patient and/or compassionate use programmes operate? If so, what are the requirements for pre-launch access?

Under certain circumstances, Canadians can obtain access to unapproved drugs on a case-by-case basis through the Special Access Programme. The Special Access Programme provides for the emergency release of drugs that are not available in Canada and the non-emergency release of drugs that have not been approved in Canada but are used for the treatment of rare disorders. If access to a drug is granted via the Special Access Programme, the practitioner requesting access must follow specific reporting requirements, including the communication of the effect of the drug and any side effects, to the Director of the Therapeutic Products Directorate and the manufacturer.

There are also various provincial programmes that allow for access to drugs on a compassionate use basis, with requirements for approval determined on a province-by-province and case-by-case basis.

Licensing

3. What is the procedural structure regarding licensing a drug for distribution?

Regulatory authority

Health Canada is the federal body that regulates the drug approval process (see Question 1). Health Canada is the department of the government responsible for national public health, including ensuring that Canadians have access to safe and effective medical products, including drugs. The Food and Drugs Act (FDA) applies to all medical products (that is drugs, medical devices and natural health products) sold in Canada, whether manufactured in Canada or imported. The FDA and the Food and Drug Regulations (FDA Regulations) seek to ensure the safety of medical products by governing their manufacture, sale and advertisement.

While Health Canada is responsible for determining whether a drug requires a prescription or not, the distribution of drugs to the public is otherwise largely governed by provincial regulatory bodies. As such, despite the classification of a drug by Health Canada, provinces can place further restrictions on its sale and distribution.

Structure

The licensing of drugs is regulated by the FDA, and the associated FDA Regulations. Specifically, Part C of the FDA Regulations outlines the procedure and requirements for the licensing of a drug. A drug must receive a Notice of Compliance (NOC) and Drug Identification Number (DIN) before it can be distributed to the public, subject to certain exceptions (see Question 1).

New drugs must go through extensive testing before being granted a NOC. During the pre-clinical phase, the efficacy and safety of drugs is examined before it is administered to patients. During the first three phases of clinical testing, the drug is given first to both healthy non-patient volunteers and then to patients suffering from the condition that the drug is intended to treat. The fourth phase of testing occurs after the drug has gone to market and consists of follow up studies designed to optimise the drug's use. The progression through the phases of pre-clinical and clinical trials is also governed by the FDA, and the results of the pre-clinical and clinical testing form a portion of the information that is required for a New Drug Submission (NDS).

The information supplied in a NDS must be detailed enough that the Minister for Health can make an assessment on the safety and effectiveness of the drug. A non-exhaustive list of required information includes:

  • A list of ingredients.

  • A description of manufacturing methods and equipment.

  • Reports of tests made to establish the safety of the new drug.

  • Evidence of the clinical efficacy of the new drug.

  • A copy of all clinical case reports where a subject died or suffered a serious or unexpected adverse reaction.

  • A statement of all the representations to be made for the promotion of the new drug.

If there is insufficient information contained in the NDS, the manufacturer is notified and a NOC is not granted. However, if an initial application is refused, the manufacturer can re-submit with additional data. Health Canada aims to have information submitted as part of a NDS screened for acceptability within:

  • 45 days of receipt for a regular submission.

  • 25 days of receipt after a request for priority review.

If the initial screening is deemed acceptable, a full review of the submitted information takes place. If the initial screening is deemed to be unacceptable, Health Canada issues a Notice of Deficiency (NOD), to which the manufacturer can respond. If the response is sufficient to meet the requirements, the review of the submission continues. If after the review process is complete the submission is found to be deficient or incomplete, Health Canada issues a Notice of Non-compliance (NON), to which the manufacturer can again respond. If the manufacturer responds, and the response is again deemed deficient, a NON-withdrawal letter is issued by Health Canada, and a NOC is not granted. However, the manufacturer can file a submission again in the future. If after review the information is found to be sufficient to establish the safety and effectiveness of the drug, a NOC and DIN is granted by Health Canada.

 
4. Is there a simplified licence proceeding, or relaxed licensing conditions, for drugs which have already been licensed for distribution in another jurisdiction?

Generally, there is no simplified licensing procedure for drugs that have already been licensed in another jurisdiction. The Special Access Programme (see Question 2) provides an exception to this general rule and there are further exceptions allowed for the importation of drugs for personal use. However, without one of these exceptions, Health Canada goes through the full drug review process before a drug is available for sale.

The Food and Drugs Act (FDA) and the Food and Drug Regulations (FDA Regulations) do not provide for parallel imports. Also, because the FDA Regulations require that both the inner and outer label of a drug display the Drug Identification Number (DIN) assigned by Health Canada, parallel importation is not legally possible.

 
5. Is virtual drug distribution possible from your jurisdiction?

Neither the Food and Drugs Act nor the Food and Drug Regulations specifically contemplate the virtual distribution of drugs. Therefore, there is no prohibition against the practice. However, the distribution of these drugs is subject to the legislation of the importing country.

 
6. What is the procedure to appeal (legal remedy) a licensing decision?

Manufacturers can formally appeal a drug licensing decision by going through the reconsideration process. Within 30 days of having a drug submission rejected, the manufacturer must submit a Letter of Intent to the Therapeutic Products Directorate outlining its intention to go through the reconsideration process. If the decision referred to in the letter of intent is eligible for reconsideration, the manufacturer receives an eligibility letter. Following receipt of the eligibility letter, the manufacturer has 45 calendar days to file a formal request for consideration. After reviewing the request, the Director General of Health Canada decides whether to uphold or reverse the previously made decision. Manufacturers also have the option of taking any issues with the review of its drug submission to court. However, if the manufacturer chooses to do so, any commenced reconsideration process is automatically terminated.

 
7. What are the costs of obtaining licensing?

From 1 April 2015, the fee for the review of a New Drug Submission (NDS) is CAN$328,498. The fee for the review of an Abbreviated New Drug Submission (ANDS) ranges from CAN$11,096 to CAN$166,383 depending on the type of information being reviewed.

Distribution to consumers

8. What are the different categories of drugs for distribution?

Drugs are categorised into one of three schedules defined by the National Association of Pharmacy Regulatory Authorities (NAPRA):

  • Schedule I drugs require a prescription to be distributed. Some Schedule I drugs are subcategorised as controlled substances by the Controlled Drugs and Substances Act (CDSA), and have different restrictions on their distribution than other Schedule I drugs under provincial pharmacy legislation.

  • Schedule II drugs, or behind-the-counter drugs, must be sold by a pharmacist from an area of a pharmacy that is not accessible to the general public.

  • Schedule III drugs must be sold in a pharmacy, but they can be located in an area accessible to the general public.

Drugs that are not assigned to one of the three schedules are considered to be unscheduled, and their sale is not restricted to pharmacies.

 
9. Who is authorised to distribute prescription drugs and over-the-counter drugs to consumers?

Prescription drugs

The Food and Drugs Act states that a person cannot sell a prescription drug to a member of the general public unless they are licensed by a province to dispense prescription drugs. This means that the distribution of drugs to consumers is governed provincially in Canada. While each province has its own governing legislation, the dispensing and sale of drugs is generally considered to be a controlled act that is restricted to members of regulated healthcare professions. Regulated healthcare professionals must also be specifically authorised to sell and dispense drugs by the legislation that governs their profession. Most often prescription drugs are distributed to consumers from licensed pharmacies and by licensed pharmacists. However, other regulated healthcare professionals, such as physicians and dentists, are also authorised by their governing legislation to dispense drugs.

Over-the-counter drugs

Authorisation to distribute over-the-counter drugs is dependent on the National Association of Pharmacy Regulatory Authorities (NAPRA) schedule assigned to the drug. Schedule II and Schedule III drugs must be sold under the supervision of a licensed pharmacist (see Question 8). However, unscheduled drugs can be sold from any retail outlet and therefore no specific authorisation is required for a person to be allowed to sell them.

 
10. What drugs can an attending physician distribute and under what circumstances?

Physicians can distribute drugs to their patients by the provincial legislation that governs the practice of medicine in the relevant province (see Question 9). The authorisation is a general one and is not subject to restrictions on the type of drug, unless the restrictions have been specifically applied to the terms of an individual physician's licence, for example, as a disciplinary measure.

 
11. Who is authorised to prescribe prescription drugs to consumers?

Similar to the sale and distribution of drugs, the prescribing of prescription drugs is also an act that is governed by provincial legislation in Canada. Again, it is an act that is generally restricted to members of certain regulated healthcare professions. Generally, drugs are prescribed by physicians and dentists, although other regulated healthcare professionals (for example, nurses, pharmacists and midwives) can also prescribe prescription drugs in certain circumstances.

 
12. Is direct mailing/distance selling of drugs permitted in your jurisdiction?

Conditions

The distribution of drugs in Canada is governed in each province by provincial legislation (see Question 9). Direct mailing of medications under a prescription is generally allowed.

Cross-border sales

Cross-border sales of drugs are also generally allowed by provincial legislation. However, the dispensing and sale of prescription drugs must be under a prescription authorised by a Canadian prescriber. Therefore, if a person attempts to obtain drugs under a prescription written in another country, the prescription must be either co-signed by a Canadian physician or rewritten by a Canadian prescriber before it can be dispensed.

 
13. What regulatory authority is responsible for supervising distribution activities?

Distribution of drugs to consumers is largely regulated by provincial Colleges of Pharmacy or Pharmacy Boards (see Question 9), irrespective of the fact that drug scheduling and classification of narcotics and controlled substances occurs at the federal level. For regular prescription drugs, the rules for distribution to consumers are relatively uniform across the provinces with limited exceptions. One such exception is in the case of some vaccines, where some provinces require a prescription before they can be provided to consumers while other provinces do not. In the case of narcotic drugs and controlled substances, there is more inter-province variation in the requirements for distribution. The greatest differences are found in the requirements for prescriptions for narcotics and controlled drugs. For example, some provinces have a triplicate or duplicate prescription programme for narcotic drugs, whereas other provinces' prescribing requirements are similar to regular prescription drugs.

 
14. What is the procedure to appeal (legal remedy) a distribution decision?

Distribution decisions and any associated discipline are governed by the provincial College or Board of the healthcare professional involved in the activity that led to the decision. With drug distribution, this will generally be pharmacists, although physicians, dentists or other healthcare professionals could be implicated as well. Generally, an initial decision is made by a discipline committee or review board of the College or Pharmacy Board. From that point, the procedure for appeal varies depending on the province. Some provinces have an appeal process within the College or Pharmacy Board and a privative clause in the governing legislation indicating that decisions are final. Other provinces have legislation that explicitly provides for a right to judicial review by a court if the registrant is not satisfied with the decision of the committee or board. Canadian administrative law principles allow for judicial review of a decision even in the presence of a privative clause in the legislation. However, courts often show significant deference to the initial decision of the committee or board under these circumstances.

 
15. What are the legal consequences of non-compliance with consumer distribution laws?

The legal consequences of non-compliance with consumer distribution laws vary depending on the offence committed. Penalties associated with the contravention of the federal Controlled Drugs and Substances Act (CDSA) range from:

  • Fines of up to CAN$5,000.

  • Revocation or suspension of a registrant's licence.

  • Imprisonment.

Financial penalties under provincial statutes can be significantly higher, with fines of up to CAN$100,000 being allowed. Provincial Colleges and Pharmacy Boards can also impose conditions on, suspend or revoke the licence of a registrant.

Wholesale distribution

16. What is the legal regime regarding wholesale distribution of drugs?

The wholesale distribution of drugs is one of the activities that requires a Drug Establishment Licence (DEL) under the Food and Drug Regulations (FDA Regulations). A person wishing to sell drugs wholesale must apply to Health Canada for a DEL and provide a significant amount of information regarding, among other things:

  • The drug(s) that will be sold.

  • The establishment that they will be sold from.

  • The establishment where records of the business will be kept.

Provincial drug legislation also provides for the distribution of drugs by wholesale. Generally, a wholesaler must meet the requirements of the province's College of Pharmacy or Pharmacy Board and must be registered. Generally, wholesalers are also only allowed to sell drugs by wholesale to individuals who are authorised to sell the drugs by retail. Generally, wholesalers of drugs must also be accessible to an inspector of the provincial regulatory body and must be able to account for their drug inventory.

 
17. What regulatory authority is responsible for supervising wholesale distribution activities?

Regulatory authority

Regulatory authority for the wholesale of drugs comes from two sources (see Question 16):

  • Health Canada issues the Drug Establishment Licence (DEL) that is required to establish a drug wholesale operation.

  • The provincial Colleges of Pharmacy or Pharmacy Boards regulate the activity of wholesaling drugs.

Therefore, drug wholesalers must hold a valid federal DEL and be registered with the appropriate provincial pharmacy regulatory authority to sell drugs by wholesale.

Supervision

Supervision of drug wholesalers is again conducted on two regulatory levels:

  • The Minister of Health is responsible for supervising the DELs that Health Canada grants.

  • The provincial pharmacy regulatory bodies are responsible for supervising the activity of wholesaling drugs.

DELs require annual renewal and each year the licensee must submit all of the information required in the initial application for a DEL to the Minister for review. Before granting a licence renewal, the Minister can request additional information and order an inspection of any premises listed on the renewal application. The Minister can suspend the DEL if the licensee contravenes any provisions of the FDA or makes false or misleading statements in the DEL application. The Minister can cancel a DEL if it has been suspended for more than 12 months or if the holder of the DEL does not submit an annual renewal.

The provincial pharmacy regulatory authorities have supervisory authority over the activity of wholesaling drugs. While the legislation differs from province to province, generally wholesalers must sell their drugs to a person that is licensed to sell them by retail. Drug wholesalers must be registered in the province that they supply drugs in, and must supply information pertinent to their operations such as the name of the wholesaler and the address of each place of business.

Rights of appeal

With a DEL, the Minister cannot suspend or refuse to issue a licence without giving the licensee or applicant an opportunity to be heard. An exception to this general rule occurs where the Minister believes it is necessary to suspend a licence to prevent injury to the health of the consumer. Where a licence is suspended without the licensee being given the opportunity to be heard, the licensee can request in writing to the Minister that the suspension be reconsidered. Following such a request, the Minister must provide the licensee an opportunity to be heard within 45 days.

The appeal process for decisions made by the provincial regulatory authorities differs by province. However, there is a general administrative right to judicial review of a decision made by a provincial College or Pharmacy Board, and some legislation explicitly allows for an appeal to a court in the province.

 
18. What are the legal consequences of non-compliance with wholesale distribution laws?

Contravention of the Food and Drugs Act (FDA) or the Food and Drug Regulations on wholesale distribution of drugs can result in suspension or even cancellation of a Drug Establishment Licence (DEL), which effectively prohibits a person from distributing drugs by wholesale (see Question 17).

The legal consequences stemming from the contravention of provincial drug wholesale regulatory requirements differ by province. Irrespective of the fact that there is not always a penalty directly associated with contravention of drug wholesaling provisions of provincial legislation, governing legislation can contemplate penalties associated with contravention of the FDA generally. For example, in the province of Ontario, contravention of the applicable legislation can result in a fine of up to CAN$50,000 for a second or subsequent offence.

 

Marketing

Promotion

19. What is the general legal regime for the marketing of drugs?

Legal regime

The Food and Drugs Act (FDA) prohibits medical product advertising that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. Only drugs that have been authorised for sale in Canada by Health Canada can be advertised. The advertising must not exceed the terms of the market authorisation.

Any person that promotes the sale of a specific health product is subject to this legislation, including physicians, when they use their websites or other means for this purpose.

With the marketing of drugs, Health Canada, with the assistance of advertising pre-clearance agencies, administers and directs compliance with the FDA and Food and Drug Regulations (FDA Regulations). Advertising pre-clearance agencies will review and pre-clear advertising material to help industry ensure compliance with the applicable regulatory provisions, and the various Health Canada guidance documents and codes of advertising (for example, Pharmaceutical Advertising Advisory Board (PAAB) Code of Advertising Acceptance).

Advertising material for all health products directed to healthcare professionals, including prescription and non-prescription drugs, is reviewed and pre-cleared by the PAAB. The PAAB, as well as Advertising Standards Canada (ASC), provides advice on messages directed to consumers for prescription drugs and on educational material discussing a medical condition or disease to ensure they meet the regulatory requirements.

Limits to marketing activities

Advertisement includes 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. Health Canada has issued guidance documents that explain how Health Canada uses contextual factors to help determine whether a given message is information or advertising. Some messages, depending on the content and the context in which they are disseminated, can be considered non-promotional. These could include:

  • Press releases.

  • Consumer brochures.

  • Help-seeking announcements.

  • Scientific exhibits.

  • Journal articles.

However, if the message is an advertisement, it must comply with the advertising provisions of the FDA and the FDA Regulations.

 
20. Are there other codes of conduct for the marketing of drugs (for example, by professional or industrial organisations)?

The Pharmaceutical Advertising Advisory Board (PAAB) publishes a Code of Advertising Acceptance that serves as guidance for drug advertisers. The Canadian Code of Advertising Standards of the Advertising Standards Canada (ASC) sets the criteria for acceptable advertising in Canada on advertising directed to consumers.

The Code of Ethical Practice of Canada's Research-Based Pharmaceutical Companies (Rx&D) applies to the activities of all member employees that interact with stakeholders for the purpose of commercialising prescription medicines. The Commercial Practice Standards of BioteCanada sets out standards to guide biopharmaceutical company members in their interactions with:

  • Healthcare professionals.

  • The scientific research community.

  • Government officials.

  • Public office holders.

  • The general public.

Marketing to consumers

21. What is the legal regime for marketing to consumers?

Legal regime

Specific regulatory provisions exist to limit the type or extent of advertisements of prescription drugs to consumers. For example, prescription drugs cannot be advertised to the general public in relation to specific diseases. Advertising of narcotic and controlled drugs to consumers is prohibited.

The Food and Drug Regulations (FDA Regulations) prohibit consumer-directed prescription drug advertising beyond the drug's name, price and quantity. This means, for example, that when a prescription drug is advertised by name to consumers, no reference can be made to its therapeutic use or benefits. The FDA Regulations also prohibit the advertising of new drugs that have not been authorised for sale by Health Canada. The advertising of pharmaceutical manufacturers must either be non-promotional in nature or must comply with federal advertising requirements. Under the regulatory framework, Health Canada has permitted two types of prescription drug messages directed to consumers:

  • Reminder ads, where the name of a prescription drug is mentioned but no reference to a disease state appears in the advertisement, are interpreted as not going beyond the name, price and quantity restrictions of the FDA Regulations.

  • Help-seeking messages, where a disease state is discussed but no reference is made to a specific prescription drug product, are considered information and not advertising when they meet the criteria outlined in Health Canada policies.

The Food and Drug Act (FDA) and the FDA Regulations prohibit consumer-directed advertisements for medical products that make claims to treat, prevent or cure any of the serious diseases listed in Schedule A to the Act (for example, alcoholism, arthritis, cancer, congestive heart failure, diabetes and obesity) other than prevention claims for over-the-counter drugs and natural health products.

Products

See Legal regime.

 
22. What kinds of marketing activities are permitted in relation to consumers and the products which may be advertised to them?
 
23. Is it permitted to provide consumers with free samples? Are there particular restrictions on special offers (for example, "buy-one-get-one-free")?

Free samples of drugs can only be provided to consumers by a person that is entitled to prescribe that drug. Therefore, samples cannot be provided to consumers directly from drug manufacturers. Under the Food and Drug Regulations, samples can be given to physicians, dentists, veterinary surgeons and pharmacists if:

  • The packaging of the drug conforms to the general labelling requirements.

  • The person ordering the sample has provided a written order to the person distributing it.

After receiving the samples, the physician, dentist, veterinary surgeon or pharmacist can distribute them to consumers provided that they would be entitled to prescribe the drug. The effect of this restriction is that samples of prescription drugs are generally given to consumers by physicians.

Given the limitations around providing drug samples to consumers, special offers on prescription drugs are not allowed. With non-prescription drugs, special offers, discounts and promotions at the point of sale to consumers are allowed.

 
24. Are there particular rules of practice on the use of the internet/social media regarding drugs and their advertising?

There are no specific legislative requirements for the advertising of drugs via the internet or social media. The content restrictions on advertising as outlined in the Food and Drugs Act and the Food and Drug Regulations apply to advertising through these mediums as they do to print and other forms of advertising.

 
25. What regulatory authority is responsible for supervising marketing activities to consumers?

Regulatory authority

See Question 21.

Supervision

See Question 21.

Rights of appeal

The Health Products and Food Branch (Inspectorate) of Health Canada has an internal appeal process for regulated parties who are unsatisfied with decisions that have been made against them. Each of the private sector bodies noted above have their own appeal process:

  • Pharmaceutical Advertising Advisory Board (PAAB).

  • Advertising Standards Canada (ASC).

  • Research-Based Pharmaceutical Companies (Rx&D).

  • BiotecCanada.

 
26. What are the legal consequences of non-compliance with consumer marketing laws?

The legal consequences of non-compliance with the Food and Drugs Act and the Food and Drug Regulation requirements for consumer marketing are assessed based on the health risk level of an advertisement. When a complaint is made, an assessment by Health Canada is conducted to determine the level of risk to human health associated with the exposure to the advertising. After the assessment is made, appropriate risk management actions are taken. These actions can range from the:

  • Issuance of a warning letter.

  • Request for the immediate cessation of the advertisement.

  • Suspension or cancellation of marketing authorisation or even prosecution.

Marketing to professionals

27. What kinds of marketing activities are permitted in relation to professionals?

Promotion of drugs to healthcare professionals is generally allowed. Physicians must follow their licensing body's code of ethics and the Canadian Medical Association policy when interacting with industry representatives, which means that they should not typically receive any sort of gift or significant monetary gain from their interactions with the drug industry.

 
28. Are there any restrictions on marketing to professionals?

Marketing activities

The restrictions around marketing to professionals relate more to the content of the material than to its form. Even when it is directed to professionals and not the general public, advertising:

  • Must not be false, misleading or deceptive.

  • Cannot be likely to create an erroneous impression regarding a drug's character value or safety.

Frequency

There are no explicit legislative requirements that address the allowable frequency of interaction with drug marketing representatives or what types of hospitality can be provided to healthcare professionals. Healthcare professionals are typically required by their respective provincial legislation, Colleges or Boards to avoid conflicts of interest. This serves as a guideline for healthcare professionals to judge what types of hospitality and what frequency of interaction are appropriate, but generally healthcare professionals must not receive personal benefit through interactions with drug industry representatives. With meals specifically, the provision of a meal to a healthcare provider and appropriate staff while a drug industry representative is informing them of a drug product is typically acceptable provided that the meal is not excessive in nature.

The Codes of Research-Based Pharmaceutical Companies (Rx&D) and BioteCanada also provide guidance to their members on what is considered to be acceptable for their respective members.

Provision of hospitality

See above.

 
29. What information is it legally required to include in advertising to professionals?

Health Canada has delegated the judgment of whether prescription drug advertising to professionals is appropriate or not to the Pharmaceutical Advertising Advisory Board (PAAB). The PAAB has several general requirements relating to the information contained in Advertising or Promotion Systems (APS). APSs must be designed to promote credibility and must be accurate, complete and clear. They must be presented in a way that accurately interprets research findings, while at the same time reflecting an attitude of caution regarding drug use and emphasising rational drug therapy. An additional requirement that is reflective of this cautious approach is that an APS cannot state or imply in absolute terms that:

  • Any product is safe.

  • It has guaranteed efficacy.

  • Its effects are totally predictable.

A general guideline is that an APS must provide the healthcare professional with sufficient information to allow them to properly assess the risks and benefits of use for their patients.

 
30. Are there rules on comparisons with other products that are particularly applicable to drugs?

Under the Food and Drugs Act (FDA), drugs cannot be advertised to any person in a manner that is:

  • False.

  • Misleading.

  • Deceptive.

  • Is likely to create an erroneous impression regarding its character or safety.

The Pharmaceutical Advertising Advisory Board (PAAB) has incorporated these requirements into its advertising standards for making comparisons of drugs. This means that comparisons between drugs must be made on the basis of:

  • The same indication for use.

  • The same conditions for use (that is in a similar patient population).

  • Must not conflict with any of the terms of market authorisation for any of the compared products.

The comparison must also be of clinical relevance to humans, and rely on evidence that is conclusive, complete and scientifically accurate. At a minimum, when comparing two or more drugs, the Advertising or Promotion Systems (APS) must:

  • Identify the compared drugs.

  • Identify the medical use related to the claim.

  • Not obscure the therapeutic use.

  • Not attack the compared drug in an unreasonable manner.

  • Be expressed in terms that will be understood by the intended audience.

The PAAB also provides more specific guidelines around drug comparisons, over and above those that stem from the FDA requirements. The overarching theme is that:

  • Comparisons are made in a fair and accurate manner.

  • All relevant evidence is considered.

  • It is of good quality.

 
31. What other items, funding or services are permitted to be provided to professionals?

Discounts

To prevent a real or apparent conflict of interest, healthcare professionals are generally not allowed to accept personal gifts or compensation of any kind from drug industry representatives in return for seeing them in a promotional capacity. Discounts from a drug company generally fall into this description in many cases, and therefore are not allowed. This framework for assessing things received from drug industry representatives is applicable to all other types of indirect benefits as well.

Free samples

Free samples can be accepted from drug industry representatives by certain healthcare professionals. However, these samples must be distributed to patients and not used by the healthcare professional or a member of his family. Distribution of free samples to healthcare professionals for personal use could be considered a gift or other form of compensation, which would not be appropriate.

Sponsorship of professionals

Sponsorship of professionals can occur in a variety of ways, such as sponsorship of an educational event or conference or sponsorship of research studies. While this type of sponsorship is not prohibited, any healthcare professionals that are involved are still expected to maintain professional autonomy and independently ensure the validity and accuracy of any information they are presenting. With research specifically, it is the responsibility of the healthcare professional to ensure that the research is conducted in an ethically and scientifically defencible manner and that it complies with all relevant guidelines, such as the Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS-2). An over-arching requirement of any kind of healthcare professional sponsorship is that the professional must disclose the nature of the relationship between himself and the sponsoring industry representative.

 
32. What regulatory authority is responsible for supervising marketing activities regarding professionals?

Regulatory authority

Health Canada and the Pharmaceutical Advertising Advisory Board (PAAB) are responsible for supervising the content of marketing and advertising material provided to healthcare professionals regarding prescription drugs (see Question 29). With the provision of gifts, sponsorship and other benefits, the provincial Colleges or Boards of the healthcare professionals have regulatory authority.

Supervision

The supervision over the content of advertising provided to healthcare professionals is the responsibility of Health Canada, the PAAB and other independent agencies in the case of non-prescription drugs (see Question 29). The supervision of other interactions between healthcare professionals and drug industry representatives is the responsibility of the provincial Colleges or Boards that govern the profession. This supervisory role includes the assessment of real or apparent conflicts of interest described in the preceding sections.

Rights of appeal

Any right of appeal is determined by the relevant supervisory body. Rights of appeal range from a reassessment of the decision by a committee of the provincial regulatory body to a right of appeal to a court in the province.

 
33. What are the legal consequences in case of non-compliance with professional marketing laws?

With drug marketers, non-compliance with Pharmaceutical Advertising Advisory Board (PAAB) standards can result in various types of penalties and remedial measures. Non-compliance with Health Canada or federal legislative requirements can result in fines or potentially loss of marketing authorisation.

With healthcare professionals, consequences of non-compliance vary depending on the offence committed and its severity. Potential consequences can include:

  • Fines.

  • A reprimand by the College or Board.

  • Imposition of terms or conditions on a professional's licence.

  • Suspension or revocation of a healthcare professional's licence.

Appropriate consequences are generally decided by a committee of the appropriate College or Board that is responsible for member discipline.

 

Engagement with patient organisations

34. What kinds of activities are permitted in relation to engagement with patient organisations? What are the restrictions that are imposed on relationship with patient organisations?

There are no specific rules governing interactions between drug advertising representatives and patient organisations. Allowable activities are determined using the same principles discussed above, such as whether activities are promotional in nature and whether they are directed to the general public or to a healthcare professional (see Questions 19 to 33).

The Codes of Research-Based Pharmaceutical Companies (Rx&D) and BioteCanada also provide guidance to their members on what is considered to be acceptable for their respective members.

 

Reform

35. Are there any plans to reform the law on the distribution and promotion of drugs in your jurisdiction?

Canada has the second highest level of per capita spending on drugs after the US. Historically each Canadian jurisdiction has managed its public drug plans independently of other jurisdictions. The Canadian provinces and territories have recently taken collective action to bring drug prices more in line with the experience of other countries. A Pan-Canadian Pharmaceutical Alliance (pCPA) has been created to facilitate the creation of collective purchasing strategies for drugs.

*With assistance from Rocky Swanson, student lawyer.

 

Contributor profiles

Jeffrey S. Graham, Partner

Borden Ladner Gervais LLP

T +1 416 367 6174
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E jgraham@blg.com
W www.blg.com

Professional qualifications. Lawyer, Canada and the United States of America

Areas of practice. Life sciences; biotech; pharmaceutical law.

Non-professional qualifications. BComm. (Honours Economics), McGill University; BCL and LLB, McGill University; LLB, Cambridge University; LLM, Columbia University

Recent transactions

  • Acts for life science companies in commercial negotiations, including financial and commercial transactions including research and development, manufacturing and licensing.
  • Assists pharmaceutical clients in the listing of products in provincial drug plans, including negotiating with drug plans and advising on types of formulary listings.
  • Acts for clients in the promotion and distribution of food, drug and natural health products and medical devices, including advising on the appropriate structure for the transaction.
  • Provides advice on Codes of Conduct applicable to manufacturers, distributors and healthcare professionals.
  • Advises on good manufacturing practice (GMP) requirements and procedures relating to the production of food, drug and natural health products and medical devices.
  • Advises clients in crises, such as recalls of defective or non-compliant products, food contamination, food tampering, fraud on the regulator, diversion of samples, diversion of product to unauthorised purchasers, illegal promotion and counterfeit products.
  • Guides clients through the regulatory approval processes with Health Canada, CFIA and CPMA and PMPRB and provincial regulatory agencies.
  • Provides assessments and strategic advice on potential challenges to legislative and regulatory changes.

Languages. English, French

Professional associations/memberships

  • Member of the Law Society of Upper Canada.
  • Member of the Bar of Ontario.
  • Member of the Bar of District of Columbia.

Publications

  • A New Heath Care Model, National Post (14 August 2015), Jeffrey Graham (Toronto) (Co-Author).
  • Canadian Food and Drug Legislation and Commentary, LexisNexis, Jeffrey Graham (General Co-Editor) 2014/2015.
  • Protecting Canadians From Unsafe Drugs Act (Vanessa's Law), Contact Canada, Jeffrey Graham (Author) 2014.
  • Commercialisation of Healthcare, Jurisdictional Comparisons, Thomson Reuters, European Lawyer Reference, Jeffrey Graham (Co-Editor and Author of Canada Chapter), 2013.
  • Espionage: A Legal Perspective, BIO Business (September/October 2011), Jeffrey Graham (Co-Author).
  • The 2011-2012 Biotechnology Public Policy Agenda, Biotechnology Focus (September/October 2011), Jeffrey Graham (Author).
  • Commercialisation of biotechnology in Canada, Biotechnology Focus (July/August 2011), Jeff Graham (Author).
  • The PMPRB - Jurisdictions and the Courts, Contact Canada (November 2010), Jeffrey Graham (Co-Author).
  • Our medicine review board is broken: The government should undertake a comprehensive review of the Patented Medicine Review Board, National Post (12 August 2009), Jeffrey Graham (Co-Author).
  • Government of Canada proposes to update regulatory framework for National Health Products, Contact Canada (NHP Directory 2008), Jeffrey Graham (Author).
  • End ad paternalism: Patients who can research their conditions on the Web consider outdated laws that direct drug ads only to doctors, National Post (17 April 2008), Jeffrey Graham (Author).
  • Medicare myths: Canada's healthcare system must be reformed to meet the needs of a changing world, National Post (14 September 2007), Jeff Graham (Author).
  • Ontario bill shackles brand-name drug makers, National Post (27 May 2006), Jeffrey Graham (Toronto) (Co-Author).
  • Recent Developments of Importance, 2006 Lexpert Directory - ALM Top 500 Guide, Jeffrey Graham (Co-Author).
  • The Regulation of Stem Cell Research in Canada, Biotechnology Focus (January, 2004), Jeffrey Graham (Co-Author).
  • Mergers and Acquisitions: Transactions with the North American Biotechnology Sector, 2004 Lexpert/American Lawyer Media, Jeffrey Graham (Co-Author).
  • Carefully negotiated agreements can increase the potential for success, BioCanada June 2002, Jeffrey Graham (Co-Author).

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