Registration - In-house Corporation

Subject Matters

• Consumer Issues
• Health
• Industry
• Intellectual Property
• Internal Trade
• International Relations
• International Trade
• Science and Technology
• Small Business
• Taxation and Finance

Subject Matter Details

Legislative Proposal, Bill or Resolution

• Participation in consultations and providing input into the modernaization of the Food and Drugs Act and related Regulations with respect to pharmaceuticals.
• Provide input into the Government of Canada's negotiations regarding the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) with respect to pharmaceuticals, counterfeit medicines, border measures and intellectual property.
• Provide input into the government of Canada's negotiations regarding the Anti-Counterfeiting Trade Agreement (ACTA) and bilateral trade agreements with respect to pharmaceuticals, counterfeit medicines, and intellectual property.

Policies or Program

• Health Canada and Finance Canada regarding the need for appropriate, dedicated resources for the Therapeutic Products Directorate to meet performance targers for the review of generic drug submissions.
• Health Canada regarding the need for effective implementation of the National Pharmaceuticals Strategy by federal and provincial governments.
• Improvements to Canada's Access to Medicines Regime to ensure access by developing and least developed countries to Canadian manufactured generic pharmaceuticals in times of health crises.
• Industry Canada's Science and Technology startegy regarding the need for a balanced intellectual property regime and the important role completition plays in encouraging innovation.
• Participate in Health Canada and parliamentary consulations with respect to department's cost recovery proposals for therapeutic products.
• Patented Medicine Prices Review Board (PMPRB) regarding claims of jurisdiction with respect to generic durg products associated with a patent.
• Proposals related to Health Canada's Identical Medicinal Ingredient Policy.
• Proposals to enhance transparency of the Health Canada Reconsiderations Policy for drug submissions.
• Providing input into the development and implementation of an approval pathway for Subsequent Entry Biologics (SEBs) by Health Canada.
• Support for finalization of the Health Canada Draft Guidance Documents: Conduct and Analysis of comparative Bioavailability Studies and Comparative Bioavailability Standards: Formulations used for Systemic Effects.
• To encourage the Government of Canada to continue to participate in truly international discussions with respect to effective measures to combat counterfeit pharmaceuticals in Canada and around the world.

Regulation

• The need for amendments to the Patented Medicines (Notice of Compliance) Regulations of the Patent Act and address operational concerns: bring finality to proceedings under the Regulations, allow generic manufacturers to amend a Notice of Allegation (NOA), and provide meaningful damages and other disincentives to discourage abuse of the Regulations by brand-name companies.

Communication Techniques

• Written communication
• Oral communication

Government Institutions

• Finance Canada (FIN)
• Health Canada (HC)
• Industry Canada
• Office of the Commissioner of Lobbying (OCL)

Address:
2680 Matheson Blvd. East
Suite 200
Mississauga, ON  L4W 0A5
Canada

Telephone number: 905-219-8820  Ext. 8840
Fax number: 905-602-4216  

Parent Company Information