As previously reported, the Protecting Canadians from Unsafe Drugs Act received royal assent on November 6, 2014, and became law in Canada. The amendments to the Food and Drugs Act contained in this new legislation are intended to further protect Canadians from the risks related to drugs and medical devices by substantially increasing Health Canada's pre and post-market powers over industry stakeholders, and radically changing the consequences for violating the Food and Drugs Act and its regulations.
Over the last several weeks, Health Canada has been advising stakeholders that the Office of Legislative and Regulatory Modernization (OLRM) will meet with industry representatives in December 2014 and January 2015 to discuss how Health Canada will balance its new power to disclose confidential business information (CBI) with industry's need to protect sensitive business interests. In addition, Health Canada has also provided the following preliminary clarification on a number of points related to the disclosure of CBI in an informal "Next Steps" documen[1]:
(1) The broad public disclosure of CBI under Section 21.1(2) of the amended Food and Drugs Act (i.e. authorized disclosure where the Minister believes that a drug or device product may present a serious risk of injury to human health) will be subject to the following parameters:
- CBI disclosed under this provision should only be that which is necessary to mitigate the serious risk of injury to human health;
- In order for the Minister to use this power, she must have reasonable grounds to believe that the therapeutic product may present a serious risk of injury to human health; and
- There must be documented evidence that the therapeutic product could pose such a risk.
(2) The more limited disclosure of CBI to persons who carry out functions relating to the protection or promotion of human health under Section 21.1(3) of the amended Food and Drugs Act (i.e. authorized disclosure where the purpose is related to the protection or promotion of human health or the safety of the public) will be subject to the following parameters:
- In order for the Minster to use this power, the purpose of the disclosure of CBI must be related to the protection or promotion of human health or the safety of the public;
- The "protection or promotion of human health" is intended to allow Health Canada to disclose CBI for the purpose of either protecting patients from safety risks or promoting the safe use of therapeutic products;
- "Promotion" should be interpreted narrowly, in keeping with Health Canada's role as a health regulator and its safety-related mandate to promote and protect the health of Canadians. In this context, the disclosure of CBI for the purpose of "promotion of human health" could include CBI disclosure for the purpose of determining the appropriate prescribing of therapeutic product therapies in order to optimize their use.
Health Canada has also confirmed that in connection with its new powers it will, upon request, share scientific CBI with scientists and academics whose function is to carry out research to optimize the safe use of therapeutic products. Before releasing CBI to researchers, as part of its policy practice, Health Canada will verify the researcher's study protocol and have the researchers sign a non-disclosure agreement to prevent them from using the CBI for commercial purposes.
Further details on the exercise of Health Canada's new power to disclose CBI will be included in a publication entitled The Guide to New Authorities, which Health Canada expects to post on its website for comment in January 2015.
In order to move forward with the development of new regulations and formal policies related to the collection and disclosure of information obtained from drug and device manufacturers, Health Canada will also conduct a public consultation in early 2015 to seek feedback from end-users on their transparency needs. End users will include:
- Patients and their caregivers;
- Healthcare professionals and associations representing them (pharmacists, nurses, nurse practitioners, physicians, dentists);
- Health technology assessors;
- Governments (federal, provincial, territorial and Aboriginal);
- Organizations representing Aboriginal peoples;
- Academic researchers with an interest in therapeutic product safety;
- Industry associations and companies involved in therapeutic products; and
- Web and application developers.
According to Health Canada, the consultation will focus not only on the types of information different groups need, but also how they would like to receive the information, and from whom. The consultations will also specifically address clinical trial registries and information requirements across the life-cycle of Health Canada's regulatory decisions with respect to therapeutic products.
It appears that Health Canada has wasted little time focussing its attention on the operationalization of the new powers granted to it under the amendments to the Food and Drugs Act. Drug and device manufacturers and others with a stake in this industry are encouraged to actively participate in the public consultation process once it is formally initiated in the new year.
[1] Health Canada, "Amendments to the Food and Drugs Act - Next Steps", (November 2014)
