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-ŕ-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
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.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
Health Canada is proposing to change the way that it regulates non-prescription drugs, natural health products and cosmetics in Canada, which will now be referred to collectively as "self-care products."
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