Bill C-393, An act to amend the patent act (Drugs for International Humanitarian Purposes) legislation proposed to amend Canada's Access to Medicines Regime
Bill C51, Modernization of Food & Drug Act: support for proposed changes- progressive licensing framework; alignment with other regulatory bodies.
Bill C6 Canada Consumer Product Safety Act, (now retabled as C36) with regards to confidentiality provisions, penalty levels.
Health Canada's enforcement of Canada's Food and Drugs Act and Regulations as they relate to the cross border sale of drugs to the United States.
Policies or Program
Input to proposed changes to PMPRB Excessive Price Guidelines including: introduction of a fourth category of drugs and associated price tests; the evaluation of drugs in ANY Market; the inclusion of benefits/discounts in the calcuation of transaction prices; rebenching of prices and any other changes or expansions of mandate which PMPRB is seeking
The House of Commons Standing Committee on Health's (HESA) study of the Common Drug Review (CDR) with regard to progress accomplished on the recommendations.
Regulation
An amendment to the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations") regarding the right to appeal.
Health Canada's proposal to add the drug tramadol to the Schedule of the Narcotic Control Regulations (NCR) with regard to changing the status of this prescription product to a controlled substance and the scheduling process for new products
Subsequent Entry Biologics (SEBs): the need for regulatory amendments to facilitate their approval.