Legislative Proposal, Bill or Resolution, Policies or Program

• Patent Act with respect to Canada's Access to Medicines Regime (ss. 21.01-21.09)

Legislative Proposal, Bill or Resolution, Regulation

• Food and Drugs Act and Regulations, specifically with respect to the approval, regulation and life-cycle management of therapeutic products

Policies or Program

• Federal public drug plans, specifically the Non-Insured Health Benefits Program (Health Canada), with respect to decisions and policies that impact reimbursement of therapeutic products for plan beneficiaries
• Health Canada policy as it relates to pharmaceutical management strategies
• Patented Medicine Prices Review Board with respect to the regulation of pricing of patented drug products
• Science and Technology Strategy led by Industry Canada, particularly with respect to the life sciences priority under the S&T Strategy

Policies or Program, Regulation

• Health Canada Legislative and Regulatory Modernization program as related to the regulation and life-cycle management of therapeutic products and Orphan Drugs Regulatory Framework
• Health Canada policies with respect to authorization of subsequent entry biologics (SEBs) under the Food and Drugs Act and Regulations

Regulation

• Food and Drugs Act Regulations with respect to Data Protection under C.08.004.
• Patent Act Regulations as they relate to the regulation of intellectual property for therapeutic products, specifically the Patented Medicines (Notice of Compliance) Regulations.
• Patent Act as it relates to the regulation of intellectual property for therapeutic products