Health Canada has recognized for many years that the current regulatory regime on drug sampling, which significantly restricts the distribution of drug samples to both consumers and health care professionals, is outdated. For example:
- Over the counter (OTC) drug and natural health product (NHP) samples (e.g. sunscreen) cannot be provided by manufacturers directly to consumers;
- although manufacturers can provide samples of prescription drugs to certain health care professionals (e.g. physicians, dentists), who can then provide such samples to their patients, this approach is prohibited for other health care professionals who also have the ability to prescribe prescription drugs (e.g. nurse practitioners); and
- although certain health care professionals (e.g. physicians, dentists) can provide samples of prescription drugs (as well as OTC Drug Identification Number (DIN) drugs) to their patients, such distribution is not permitted for lower risk NHPs.
Amendments to the Food and Drug Regulations (FDR) (see here) and the Natural Health Products Regulations (NHPR) (see here) address the above, providing more flexibility to industry while offering public health benefits (e.g. hand sanitizer and sunscreen samples can be distributed at public events).
Three key items achieved by the amendments:
1. Certain OTC DIN and NHP Samples to Consumers Permitted
Distribution to consumers of certain low risk non-prescription DIN drugs and NHPs will be permitted. These products include certain topical acne therapies, medicated skin care products, diaper rash products, anti-dandruff products, antiseptic skin cleansers, athlete’s foot treatments, sunscreens, toothpastes, mouthwashes and throat lozenges. The exact lists of products are in the List of Certain Non-prescription Drugs for Distribution as Samples (List D) under the FDR and the List of Certain Natural Health Products for Distribution as Samples (List A) under the NHPR.
Restrictions on distribution of samples include that samples can only be provided to those 18 years of age or older, which will limit certain types of distribution (such as via random mail distribution); distribution is subject to the criteria and qualifiers set out in List D and List A and any other conditions for the drug; the individual distributing the sample must be able to answer questions about the drug relating to its risks, benefits and directions of use; and products must meet certain expiry date requirements before they can be distributed as samples.
2. Expanded Group of Health Care Professionals can receive Samples
The amended FDR permit the distribution of drugs as samples to an expanded group of health practitioners. Currently, samples of prescription drugs and OTC DIN drugs are only permitted to physicians, dentists, veterinary surgeons, and pharmacists. Under the amendments, samples may be distributed to practitioners and pharmacists, where “practitioner” refers to individuals who are entitled under their provincial law to treat patients with a prescription drug. This means health practitioners such as nurse practitioners, nurses, chiropodists (podiatrists), optometrists, naturopaths and midwives may receive samples of drugs which, under provincial law, are within their scope of practice (for OTC DIN and NHP drugs) or they are authorized to prescribe or dispense (for prescription drugs).
For samples which can only be obtained through a practitioner or pharmacist (i.e. any drug that is not included in List D or List A), the product should be accompanied by its Patient Medication Information when provided to patients.
3. NHPs subject to Similar Sampling Laws as OTC DIN Drugs
NHPs are no longer outright excluded from being distributed as samples, whether to consumers or to health care professionals. As mentioned, under the amendments (1) certain low-risk NHPs will be treated like certain low-risk OTC DIN drugs with respect to direct sampling to consumers; and (2) NHPs will be treated similar to OTC DIN drugs when provided to health care professionals for distribution to their patients.
Health Canada has issued a guidance document entitled Distributing samples of prescription drugs, non-prescription drugs and NHPs (Guidance) (see here), which sets out the full requirements applicable to sampling. Interestingly, the Guidance says:
... the determination of whether a drug is being distributed … as a sample will be based on any facts, circumstances and contextual factors surrounding the distribution that may be relevant to such determination. These include whether the distribution of a drug is:
- free of charge (or at a lower cost);
- intended or likely to induce the use of the drug on a trial basis;
- intended or likely to encourage future purchases of the drug; or
- in a lesser quantity of the drug than normally available for sale at retail.
With respect to the issue of sampling directly to consumers, industry historically engaged in creative approaches, such as charging consumers a nominal amount (e.g. a penny) on the grounds that such monetary consideration precluded the transaction from being considered distribution of a sample. The Guidance suggests that Health Canada will object to this type of approach being used by manufacturers to provide products directly to consumers if they are not included in Lists A or B.
The amendments do not impact sampling of narcotics, controlled substances and prescription drugs containing cannabis. Further, the amendments are made under federal law, and the provinces can impose additional restrictions.
The amendments to the regulations were made further to amendments to the Food and Drugs Act via the Canada–United States–Mexico Agreement Implementation Act (Bill C-4, assented to March 13, 2020). The amendments come into force on July 1, 2020, the day the Canada-United States-Mexico Agreement (CUSMA) comes into force.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.