12-Month Lobbying Summary - In-house Corporation

• Subject matter details in previous versions

  Details Regarding the Identified Subject Matter

  Subject matters	Details	Categories
  Subject matters were not required to be associated with subject matter details when this content was submitted	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
  Subject matters were not required to be associated with subject matter details when this content was submitted	Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry, and related updates and to Federal budgetary policy.	Legislative Proposal, Bill or Resolution
  Subject matters were not required to be associated with subject matter details when this content was submitted	Anti-Counterfeit Trade Agreement (ACTA) as it concerns counterfeit drugs.	Policies or Program
  Subject matters were not required to be associated with subject matter details when this content was submitted	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
  Subject matters were not required to be associated with subject matter details when this content was submitted	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
  Subject matters were not required to be associated with subject matter details when this content was submitted	Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies.	Legislative Proposal, Bill or Resolution, Regulation
  Subject matters were not required to be associated with subject matter details when this content was submitted	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
  Subject matters were not required to be associated with subject matter details when this content was submitted	Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework.	Policies or Program
  Subject matters were not required to be associated with subject matter details when this content was submitted	Establish accountability with the federally financed Canadian Agency for Drugs and Technologies in Health (CADTH).	Policies or Program
  Subject matters were not required to be associated with subject matter details when this content was submitted	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
  Subject matters were not required to be associated with subject matter details when this content was submitted	Food and Drug Regulations as it relates to data protection and the regulation and protection of biopharmaceutical products.	Regulation
  Subject matters were not required to be associated with subject matter details when this content was submitted	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.	Legislative Proposal, Bill or Resolution, Regulation
  Subject matters were not required to be associated with subject matter details when this content was submitted	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
  Subject matters were not required to be associated with subject matter details when this content was submitted	Income Tax Act as it relates to biopharmaceutical products.	Legislative Proposal, Bill or Resolution
  Subject matters were not required to be associated with subject matter details when this content was submitted	National Pharmaceutical Strategy as it relates to the federal government's involvement in federal/provincial access to medicines framework.	Policies or Program
  Subject matters were not required to be associated with subject matter details when this content was submitted	New Substances Notification Regulations as it relates to the biopharmaceutical industry.	Regulation
  Subject matters were not required to be associated with subject matter details when this content was submitted	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
  Subject matters were not required to be associated with subject matter details when this content was submitted	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
  Subject matters were not required to be associated with subject matter details when this content was submitted	Patented Medicines (Notice of Compliance) Regulations as it relates to the regulation of intellectual property for biopharmaceutical products.	Regulation
  Subject matters were not required to be associated with subject matter details when this content was submitted	Patented Medicines (Notice of Compliance) Regulations with respect to ensuring that patent rights are respected and are internationally competitive.	Regulation
  Subject matters were not required to be associated with subject matter details when this content was submitted	Patented Medicines Regulations as it relates to the regulation and protection of biopharmaceutical products.	Regulation
  Subject matters were not required to be associated with subject matter details when this content was submitted	Pharmaceutical pricing policy issues arising from the jurisdiction of the Patended Medicines Prices Review Board (PMPRB) and R&D reporting.	Policies or Program
  Subject matters were not required to be associated with subject matter details when this content was submitted	Plan design and reimbursement policies for drug plans administered by Federal Government including NIHB and Corrections Services.	Policies or Program
  Subject matters were not required to be associated with subject matter details when this content was submitted	Policies and programs as it relates to vaccine approval, procurement and public awareness of immunization.	Policies or Program
  Subject matters were not required to be associated with subject matter details when this content was submitted	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
  Subject matters were not required to be associated with subject matter details when this content was submitted	Smart Regulations as it relates to the biopharmaceutical industry.	Regulation
  Subject matters were not required to be associated with subject matter details when this content was submitted	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
  Subject matters were not required to be associated with subject matter details when this content was submitted	The government's Science and Technology strategy as it relates to the biopharmaceutical industry.	Policies or Program
  Subject matters were not required to be associated with subject matter details when this content was submitted	US - Canada Regulatory Cooperation Council (RCC) as it relates to the regulation of biopharmaceutical products.	Policies or Program
  Subject matters were not required to be associated with subject matter details when this content was submitted	World Health Organization issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernment Working Group (IGWG).	Policies or Program

  Subject matters in previous versions

  • 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

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
• 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)

Communication techniques

Communication techniques that have been used or are expected to be used in the course of the undertaking:

• Written communication
• Oral communication
• Arrange one or more meetings

Senior Officers whose lobbying activities represent less than 20% of their Duties

• David D. Jones, PRESIDENT | No public offices held
• Jennifer Chan, Vice President, Policy & Communications | No public offices held
• Jeffrey Malawski, National Manager, Public Health | No public offices held
• Sandra Wainwright, Director - Regulatory Affairs | No public offices held

Senior Officers and Employees whose lobbying activities represent 20% or more of their Duties

• Kathy Armstrong, Manager, Patient Access - Ontario | No public offices held
• Jean-Philippe D’Aoust, Associate Director, Policy and Government Relations | No public offices held
• Chad Jarema, Dir, Market Access, Strat Pricing Contracting & Negotiation | No public offices held
• Sean Kinney, Associate Director - Patient Access | No public offices held
• Robert Livingston, Director, Federal Government Affairs | No public offices held
• Wendy Morton, Manager, National Policy | No public offices held
• Octavio Rego, Dir, Key Account Management, Policy & Ext Affairs - Quebec/Atlantic | No public offices held