Comprehensive Economic Trade Agreement with Europe (CETA) and pharmaceutical intellectual property protection.
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.
Legislative Proposal, Bill or Resolution, Policies or Program
The House of Commons Standing Committee on Health's (HESA) and the Standing Committee on Social Affairs review of the 2004-2014 Health Accord and renegotiation of the 2014 Health Accord
Policies or Program
Canada's Access to Medicines Regime. Continued conversation with parliamentarians regarding the work the Johnson & Johnson does in Africa and developing countries providing medicines and treatments
Input into the Patented Medicines Price Review Board evaluation of annual Research and Development investments by companies in Canada based on SR&ED tax rules. Working with PMPRB and legislators to ensure appropriate measures of R&D investment are in place.
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
Modernization of Food & Drug Act: support for proposed regulatory changes, modernization and international harmonizations with other regulatory bodies (EMA/FDA).
Subsequent Entry Biologics (SEBs): the need for regulatory amendments to facilitate their approval.