Proposed Treatment of Confidential Business Information Under Vanessa’s Law (Bill C-17)

On June 16, 2014, amendments to Bill C-17, Protecting Canadians from Unsafe Drugs Act (the Bill)¹, were announced. Among the amendments was a key change, which, if passed, would broaden Health Canada’s powers vis-à-vis disclosure of confidential business information (CBI). CBI is defined in the Bill as follows:

"[C]onfidential business information", in respect of a person to whose business or affairs the information relates, means—subject to the regulations—business information

a. that is not publicly available,

b. in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available, and

c. that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors.

A proposed amendment to the Bill provides Health Canada with the authority to disclose CBI, without notice, if the therapeutic product in question may pose a serious risk of injury or if disclosure is in the interest of human health or public safety. The distinction between these two scenarios lies in the scope of persons to whom Health Canada can disclose the CBI; if Health Canada believes the therapeutic product may present a serious risk of injury, there are no limits on the scope of disclosure, whereas if Health Canada believes the proposed disclosure is in the interest of human health or public safety, Health Canada can only disclose CBI to (i) certain government bodies, (ii) persons from whom Health Canada seeks advice and (iii) persons who carry out functions relating to human health and public safety promotion.

While the government has authority under the Access to Information Act to disclose similar types of commercial information (if it is in the interest of public health and safety or environmental protection), the proposed language in the Bill appears to grant broader powers of disclosure to Health Canada. The Bill has now passed a third reading in the House of Commons and will need to be passed by the Senate before coming into effect.

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¹The Act was given the alternate name Vanessa’s Law by the Canadian government in honor of Vanessa Young. http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2013/2013-174-eng.php