Mylan Pharmaceuticals ULC
Registration:
9
of
11
(2015-08-31
to
2016-10-11)
Legislative Proposal, Bill or Resolution
- Provide input into the Government of Canada's negotiations regarding the Anti-Counterfeiting Trade Agreement and bilateral trade agreements with respect to pharmaceuticals, counterfeit medicines, and intellectual property.
- Provide input into the Government of Canada's negotiations regarding the Canada-European Union Comprehensive Economic Trade Agreement with respect to pharmaceuticals, counterfeit medicines, border measures, and intellectual property.
Policies or Program
- Industry Canada's Science & Technology strategy regarding the need for a balanced intellectual property regime and the important role competition plays in encouraging innovation.
- Patented Medicine Prices Review Board regarding claims of jurisdiction with respect to generic drug 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
- Provide input into guidance with respect to the process for the approval and renewal of foreign sites for Drug Establishment License (DEL) holders.
- Provide input into policy discussions regarding the potential development of a national pharmacare program governments.
- Providing input into the development and implementation of an approval pathway for Subsequent Entry Biologics by Health Canada.
- To encourage the Government of Canada to continue to participate in truly international discussions with respect to effective measures to combat counterfeit pharmaceutical both nationally and globally.
- participation in consultations, providing comments on modernization of the Food and Drugs Act and related regulations regarding pharmaceuticals
Regulation
- The need for amendments to the Patented Medicines (Notice of Compliance) Regulations of the Patent Act and address operational concerns such as bringing finality to proceedings under the Regulations; allowing generic manufacturers to amend a Notice of Allegation; and providing meaningful damages and other disincentives to discourage abuse of the Regulatioins by brand name manufacturers.