Registry of Lobbyists
| Subject matters | Details | Categories |
|---|---|---|
|
Health, Intellectual Property, International Development
|
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).
|
Policies or Program
|
|
Budget, Taxation and Finance
|
Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry, and related updates and to Federal budgetary policy.
|
Policies or Program
|
|
Health
|
Anti-Counterfeit Trade Agreement (ACTA) as it concerns counterfeit drugs.
|
Policies or Program
|
|
Intellectual Property, International Development, International Trade
|
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.
|
Policies or Program
|
|
Health, Research and Development
|
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.
|
Policies or Program
|
|
Environment, Research and Development
|
Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies.
|
Regulation, Legislative Proposal, Bill or Resolution
|
|
Health, Research and Development
|
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).
|
Policies or Program
|
|
Research and Development
|
Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework.
|
Policies or Program
|
|
Health, Industry, Science and Technology
|
Establish accountability with the federally financed Canadian Agency for Drugs and Technologies in Health (CADTH).
|
Policies or Program
|
|
Health, Research and Development
|
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.
|
Policies or Program
|
|
National Security/Security, Privacy and Access to Information
|
Food and Drug Regulations as it relates to data protection and the regulation and protection of biopharmaceutical products.
|
Regulation
|
|
Foreign Affairs, International Development, International Trade
|
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.
|
Regulation, Legislative Proposal, Bill or Resolution
|
|
Health
|
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.
|
Policies or Program
|
|
Taxation and Finance
|
Income Tax Act as it relates to biopharmaceutical products.
|
Legislative Proposal, Bill or Resolution
|
|
Federal-Provincial Relations, Health
|
National Pharmaceutical Strategy as it relates to the federal government's involvement in federal/provincial access to medicines framework.
|
Policies or Program
|
|
Health, Research and Development
|
New Substances Notification Regulations as it relates to the biopharmaceutical industry.
|
Regulation
|
|
Foreign Affairs, Health, International Development
|
Partnership opportunities as it relates to Canada's policy and programs to improve health in the developing world, such as Maternal and Child Health.
|
Policies or Program
|
|
Intellectual Property
|
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
|
|
Intellectual Property
|
Patented Medicines (Notice of Compliance) Regulations as it relates to the regulation of intellectual property for biopharmaceutical products.
|
Regulation
|
|
Intellectual Property, International Trade
|
Patented Medicines (Notice of Compliance) Regulations with respect to ensuring that patent rights are respected and are internationally competitive.
|
Regulation
|
|
Intellectual Property, Science and Technology
|
Patented Medicines Regulations as it relates to the regulation and protection of biopharmaceutical products.
|
Regulation
|
|
Intellectual Property, Research and Development
|
Pharmaceutical pricing policy issues arising from the jurisdiction of the Patended Medicines Prices Review Board (PMPRB) and R&D reporting.
|
Policies or Program
|
|
Consumer Issues, Internal Trade
|
Plan design and reimbursement policies for drug plans administered by Federal Government including NIHB and Corrections Services.
|
Policies or Program
|
|
Consumer Issues, Health, Research and Development
|
Policies and programs as it relates to vaccine approval, procurement and public awareness of immunization.
|
Policies or Program
|
|
Taxation and Finance
|
Scientific Research and Educational Design (SR&ED) Tax Credit in respect of updating the system and increasing the expenditure limit for refundable credits.
|
Policies or Program
|
|
Health, Industry
|
Smart Regulations as it relates to the biopharmaceutical industry.
|
Regulation
|
|
Health, Intellectual Property
|
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.
|
Policies or Program
|
|
Science and Technology
|
The government's Science and Technology strategy as it relates to the biopharmaceutical industry.
|
Policies or Program
|
|
International Development, International Trade
|
US - Canada Regulatory Cooperation Council (RCC) as it relates to the regulation of biopharmaceutical products.
|
Policies or Program
|
|
Health, National Security/Security
|
World Health Organization issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernment Working Group (IGWG).
|
Policies or Program
|
For over a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information about our operations in Canada, visit www.merck.ca and connect with us on YouTube and Twitter @MerckCanada.
Marwan Akar, PRESIDENT
Address:
16750 TransCanada Highway
Kirkland, QC H9H 4M7
Canada
Telephone number:
514-428-2638
Merck Canada Inc. does not have any subsidiaries that could have a direct interest in the outcome of the undertaking