What should I be aware of when advertising medical devices?
Advertising Medical Devices: Not as simple as it sounds, watch out!
When advertising medical instruments, manufacturers must follow the demands stipulated in several acts and regulations, notably those of the Competition Act, the Charte de la Langue Française—Québec’s French-language charter—and both the Food and Drugs Act, and its dependent Medical Devices Regulations. This column will give an overview of the demands laid out in the Food and Drug Act, which we will call “the Act,” as well as those of the Medical Devices Regulations (“the Regulations”). More precisely, the Act poses its demands in Part I, Paragraphs 3 (1)(2)(3), 20(1)(2), and 21. As for the Regulations, they set out rules on the publicizing of medical devices in Paragraphs 24, 27, and 87.
The Food and Drugs Act and Advertising of Medical Devices
It is important to know that the Act governs advertising of medical devices through its Paragraph 3(1). This clause limits advertising to the general public for medical devices aimed at treating those diseases listed in Schedule A of the Act. While these rules are intended to limit advertising to the public at large, promotion aimed at health-care professionals is not subject to these restrictions. Paragraphs 3(2) and 3(3) aim to restrict the sale of a medical devices intended to treat one of the diseases mentioned in Appendix A, and to block the advertising of contraceptive devices and drugs, provided they are produced or sold with the intention of preventing conception.
Let’s move on to Paragraph 20 of the Act, which sets out rules prohibiting false or misleading publicity of medical devices. We’ll go over the principles underlying this a bit to better explain this paragraph: according to the terms of the Regulations, manufacturers of Class II, III, and IV medical devices must, before importing a device into or selling a device within Canada, receive regulatory approval. Licences issued under the regulatory process permit a manufacturer to import or sell the medical device in question for the purposes and usages described in their licence application. Consequently, publicizing a device for purposes or usages not described in the company’s regulatory application can be considered misleading.
Advertising can also be considered false if a manufacturer cannot furnish proof of the efficacy of a medical instrument. Paragraph 12 of the Regulations expects that the medical instrument must yield the results intended by the manufacturer and must be effective for the purposes and uses for which it is made, sold, or represented. In the absence of proof of a device’s effectiveness, any advertising for it may therefore be considered false. Furthermore, it is important to note that even Class I instruments are covered by this condition.
Finally, Paragraph 21 decrees that in case of the establishment of regulatory standards concerning a specific medical device, it is forbidden to label, package, or sell an item, as well as to publicize it, in a way which might cause people to believe it is that device, unless it does not conform to the standard.
The Regulations and Advertising Medical Devices
The rule underlying the Regulations is found in Paragraph 27. Under the terms of this paragraph, it is prohibited to promote the sale of a medical device of Class II, II, or IV unless the device in question has received regulatory approval.
At the same time, Paragraph 27 provides an exception: one can promote a medical device that hasn’t received approval, but only if the publicity is done through a catalogue and includes, legibly and in clear view, a notice that the devices advertised therein might not have been approved under Canadian legislation.
Also, special requirements apply to advertising contraceptives, particularly condoms; as mentioned above, this forms part of Paragraph 3 of the Act. Paragraph 24 of the Regulations contains further information on this subject.
Lastly, it must be mentioned that according to the terms of Paragraph 87 of the Regulations, publicizing medical devices aimed at investigational testing is forbidden, unless the person holds an authorization to import or sell the device in question subject to Paragraph 83 of the Regulations. Even then, the advertising must state explicitly that the medical instrument in question is for investigational testing, as well as naming the goal of these tests.
Louis-Paul Marin (Louis-Paul.Marin@bcf.ca)
Patent lawyer with BCF in Montréal.
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