On March 10, 2016, Health Canada published a Draft Guidance Document relating to the disclosure of confidential business information ("CBI") under paragraph 21.1(3)(c) of the Food and Drugs Act (the "Guidance Document"), which is open for public comment until May 24, 2016.
The CBI provisions in paragraph 21.1(3)(c) of the Food and Drugs Act were part of the amendments to the Act contained in Bill C-17 (a.k.a. Vanessa's Law), which came into force in November 2014.
Section 21.1(3)(c) provides:
The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection or promotion of human health or safety of the public and the disclosure is to:
- a government;
- a person from whom the Minister seeks advice; or
- a person who carries out functions relating to the protection or promotion of human health or the safety of the public.
Given the broad description of the circumstances in which Health Canada is authorized to disclose CBI belonging to a stakeholder (e.g. drug submission sponsor or DIN holder) and the potential consequences of disclosing sensitive CBI, this provision has been the subject of significant controversy in the Canadian drug and device industry. In effect, Section 21.1(3)(c) of the Act has the potential to side-step the federal Access to Information Act which would otherwise apply when a member of the public seeks disclosure of CBI held by a government agency.
The Guidance Document is intended to establish the parameters within which Health Canada will exercise this new power to disclose. According to the Guidance Document, the principles which will guide Health Canada's exercise of this power are as follows:
- Health Canada will be judicious in its exercise of this new authority, notwithstanding the broad application of Section 21.1(3)(c);
- Information disclosed under this new power should contribute to improving the health of Canadians, and requests for disclosure should clearly define how the information relates to this objective;
- Use of this power should be necessary to achieve the purpose for which the information is requested, such that other means of achieving that purpose have been exhausted;
- Information disclosed under this authority should be kept confidential and used only for non-commercial purposes. To this end, Health Canada will require that all recipients of information disclosed under this power sign a legally binding confidentiality agreement; and
- Health Canada will maintain the integrity of its regulatory function, and will consider the consequences of disclosure on its capacity to evaluate and regulate therapeutic products in the interests of the health of Canadians.
In terms of the class of persons to whom CBI may be disclosed, the Guidance Document states, among other things, that individual requestors are expected to be qualified health professionals with an expertise in the subject of the request, and that corporate requestors have a corporate mandate that is relevant to the protection or promotion of human health or the safety of the public. It is also expected that the representative of the corporation making the request have qualifications in a health profession and demonstrated expertise in the topic of the research.
As to whether the purpose of the request for disclosure is related to "the protection or promotion of human health or the safety of the public", the Guidance document includes a list of criteria that Health Canada will take into account in making such a determination, including:
- Whether the information relates to the safety, efficacy or quality of a therapeutic product that is currently exposed to the public;
- The relevance of the project for which the information is requested in relation to the protection or promotion of human health or the safety of the public;
- The severity of the health or safety issue to which the request relates; and
- The impact of the proposed use of the CBI on the health and safety of Canadians.
Examples of the types of CBI that Health Canada may disclose cited in the Guidance document include:
- CBI associated with a product's market authorization, including clinical trial data;
- CBI obtained by Health Canada through post-market surveillance, such as information obtained from market authorization holders relating to potential new risks, and information obtained through periodic safety reports (PSUR) or mandated risk management plans; and
- CBI obtained by Health Canada through its compliance and enforcement activities, including CBI obtained during the course of an inspection.
The Guidance Document also sets out Health Canada's intention in relation to the protection of personal information, the protection against commercial use by the recipient, and the process to review requests for disclosure by a newly established Review Committee.
Whether the Guidance Document will provide comfort to stakeholders who are at risk of having their CBI disclosed by Health Canada under this new power remains to be seen. In any event, stakeholders who wish to comment on the Guidance Document are invited to do so by the May 24, 2016 deadline.