Registration - In-house Corporation

Subject Matters

• Aboriginal Affairs
• Agriculture
• Constitutional Issues
• Consumer Issues
• Defence
• Economic Development
• Education
• Employment and Training
• Energy
• Environment
• Financial Institutions
• Government Procurement
• Health
• Immigration
• Industry
• Infrastructure
• Intellectual Property
• Internal Trade
• International Relations
• International Trade
• Justice and Law Enforcement
• Labour
• Regional Development
• Research and Development
• Science and Technology
• Small Business
• Sports
• Taxation and Finance
• Telecommunications
• Tourism
• Transportation

Subject Matter Details

Legislative Proposal, Bill or Resolution

• Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry, and related updates and to Federal budgetary policy.
• Income Tax Act as it relates to biopharmaceutical products.
• Patent Act as it relates to reporting requirements and pricing guidelines, and the protection of intellectual property in biopharmaceutical products.

Legislative Proposal, Bill or Resolution, Regulation

• Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies.
• Food and Drugs Act and Regulations and the Import and Export Permits Act with respect to cross-border trade as it relates to the export of Canadian biopharmaceuticals.

Policies or Program

• Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility". Merck is seeking to ensure Canada's continued compliance with its obligations under TRIPs relevant to the biopharmaceutical industry within all domestic legislation in addition to ongoing and future trade negotiations. Relevant domestic legislation includes the Food and Drugs Act, the Patent Act, and related regulations and guidance documents. Beyond TRIPs, Merck is seeking enhancements to increase the stability and global competitiveness of Canada’s intellectual Property legislation, regulations and policies relevant to the biopharmaceutical industry. Such enhancements may result from domestic policy in addition to bilateral and multilateral trade negotiations (e.g. Comprehensive Economic and Trade Agreement (CETA) and the Trans-Pacific Partnership (TPP).
• Anti-Counterfeit Trade Agreement (ACTA) as it concerns counterfeit drugs.
• Any and all free trade treaty agreements as it relates to the North American Free Trade Agreement (NAFTA) and trade negotiations between Canada as it relates to the European Union, India, Japan and the Trans-Pacific Partnership. International trade policies in support of the biopharmaceutical industry, including competitive and predictable intellectual property protection, product regulation and patient access to medicines.
• Canada's Access to Medicines Regime with respect to ensuring that the program allows for the delivery of timely access to needed medicines to the developing world supported by a business climate in Canada that continues to encourage research into further treatment and prevention of disease.
• Canadian Institutes of Health Research (CIHR) Clinical Research Initiatives as it relates to public/private research and development partnerships and to the Drug Safety and Effective Network (DSEN).
• Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework.
• Establish accountability with the federally financed Canadian Agency for Drugs and Technologies in Health (CADTH).
• Federal Government involvement in national strategies to address major chronic diseases having a significant burden on the Canadian health care system, such as Dementia, Diabetes, Hepatitis C and Cancer and major public health concerns such as Antimicrobial resistant.
• Health Canada's Legislative and Regulatory Modernization (LRM) as it relates to the review, approval, transparency and compliance activities of biopharmaceutical products. Health Canada's Regulatory Roadmap for Health Products and Food as it relates to proposed policy and regulatory changes related to the review, approval, transparency and compliance activities of biopharmacuetical products.
• National Pharmaceutical Strategy as it relates to the federal government's involvement in federal/provincial access to medicines framework.
• Partnership opportunities as it relates to Canada's policy and programs to improve health in the developing world, such as Maternal and Child Health.
• Pharmaceutical pricing policy issues arising from the jurisdiction of the Patended Medicines Prices Review Board (PMPRB) and R&D reporting.
• Plan design and reimbursement policies for drug plans administered by Federal Government including NIHB and Corrections Services.
• Policies and programs as it relates to vaccine approval, procurement and public awareness of immunization.
• Scientific Research and Educational Design (SR&ED) Tax Credit in respect of updating the system and increasing the expenditure limit for refundable credits.
• Subsequent Entry Biologics (SEBs) as it relates to Regulations, Policies, or Guidelines being developed by Health Canada, specifically the Draft Guidance Document on SEBs, the Notices of Changes to Health Canada's Guidance Documents on Data Protection and Patented Medicines Regulations (Notice of Compliance) Regulations.
• The government's Science and Technology strategy as it relates to the biopharmaceutical industry.
• US - Canada Regulatory Cooperation Council (RCC) as it relates to the regulation of biopharmaceutical products.
• World Health Organization issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernment Working Group (IGWG).

Regulation

• Food and Drug Regulations as it relates to data protection and the regulation and protection of biopharmaceutical products.
• New Substances Notification Regulations as it relates to the biopharmaceutical industry.
• Patented Medicines (Notice of Compliance) Regulations as it relates to the regulation of intellectual property for biopharmaceutical products.
• Patented Medicines (Notice of Compliance) Regulations with respect to ensuring that patent rights are respected and are internationally competitive.
• Patented Medicines Regulations as it relates to the regulation and protection of biopharmaceutical products.
• Smart Regulations as it relates to the biopharmaceutical industry.

Communication Techniques

• Written communication
• Oral communication

Government Institutions

• Agriculture and Agri-Food Canada (AAFC)
• Canadian Institutes of Health Research (CIHR)
• Canadian International Trade Tribunal (CITT)
• Competition Tribunal (CT)
• Employment and Social Development Canada (ESDC)
• Environment and Climate Change Canada (ECCC)
• Finance Canada (FIN)
• Fisheries and Oceans Canada (DFO)
• Global Affairs Canada (GAC)
• Health Canada (HC)
• House of Commons
• Indigenous and Northern Affairs Canada
• Innovation, Science and Economic Development Canada (ISED)
• Justice Canada (JC)
• National Research Council (NRC)
• Natural Resources Canada (NRCan)
• Natural Sciences and Engineering Research Council (NSERC)
• Office of the Information Commissioner of Canada (OIC)
• Office of the Privacy Commissioner of Canada (OPC)
• Patented Medicine Prices Review Board (PMPRB)
• Prime Minister's Office (PMO)
• Privy Council Office (PCO)
• Public Health Agency of Canada (PHAC)
• Public Safety Canada (PS)
• Public Services and Procurement Canada (PSPC)
• Senate of Canada
• Statistics Canada (StatCan)
• Treasury Board Of Canada Secretariat (TBS)
• Veterans Affairs Canada (VAC)

Address:
16750 TransCanada Highway
Kirkland, QC  H9H 4M7
Canada

Telephone number: 514-428-2638
Fax number: 514-428-2662  

Parent Company Information