The Food and Drug Regulations were amended in June to provide for importation and use of drugs authorized for sale in the United States, European Union or Switzerland to meet an urgent public health need. Health Canada also consulted on proposed amendments to the Food and Drug Regulations including relating to: Vanessa's Law (some of the proposed amendments would establish rules for the exercise of the new powers to require assessments, tests and studies, and new foreign incident reporting rules); pharmaceutical equivalence (a notice of intent only, proposing to allow a generic drug to have a different salt, ester, or complex of the medicinal ingredient in the Canadian Reference Product (CRP)); and public release of certain clinical information once regulatory review is complete (comments will be received until February 22, 2018). Health Canada released a number of new/revised guidance documents including regarding: data protection; disclosure of Confidential Business Information; interpretation of "identical medicinal ingredient" (an Interim Policy relating to whether the medicinal ingredient in a subsequent entry product is the same at the input stage and/or finished dosage form as the CRP); and use of a foreign-sourced reference product as a CRP.
Separately, in Ontario, on December 12, Bill 160, the Strengthening Quality and Accountability for Patients Act, 2017, received Royal Assent. It enacts the Health Sector Payment Transparency Act, 2017 (Transparency Act) which, when in force, will require payors, including pharmaceutical manufacturers, to report financial relationships with health care professionals and organizations, as well as other prescribed recipients.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
