12-Month Lobbying Summary - Consultant

Details Regarding the Identified Subject Matter

Subject matters	Details	Categories
Health, Internal Trade, International Trade, Justice and Law Enforcement	Anti-Counterfeit Trade Agreement (ACTA) as it concerns counterfeit drugs	Policies or Program
Economic Development, Government Procurement, Health, International Development, International Relations, International Trade, Regional Development, 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
Consumer Issues, Health, Industry, Justice and Law Enforcement	Canada's Food and Consumer Safety Action Plan as it relates to the regulation and protection of biopharmaceutical products	Legislative Proposal, Bill or Resolution
Health, Intellectual Property, International Relations, International Trade	Canada-United States Regulatory Cooperation Council (RCC) initiatives related to the regulation of biopharmaceutical products	Policies or Program
Environment, Health, Science and Technology	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
Economic Development, Health, Intellectual Property, Research and Development, Science and Technology	Canadian Institutes of Health Research (CIHR) Clinical Research Initiative as it relates to public/private research and development partnerships	Policies or Program
Consumer Issues, Federal-Provincial Relations, Intellectual Property, Science and Technology	Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework	Policies or Program
Federal-Provincial Relations, Health, Intellectual Property, Science and Technology	Establish accountability with the federally financed Canadian Agency for Drugs and Technologies in Health (CADTH)	Policies or Program
Consumer Issues, Health, Intellectual Property, Research and Development	Food and Drug Regulations as it relates to data protection and the regulation and protection of biopharmaceutical products	Regulation
Health, Intellectual Property, International Relations, International Trade, Taxation and Finance	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
Health, Intellectual Property, International Relations, International Trade, Taxation and Finance	Free trade treaty agreement as they relate to The Canada-United States-Mexico Agreement (CUSMA) and free trade negotiations as it relates to India, the European Union, Japan, MERCOSUR and the Trans-Pacific Partnership	Policies or Program
Consumer Issues, Health, Industry, Intellectual Property, Research and Development	Health Canada's Regulatory Roadmap for Health Products and Food as it relates to the biopharmaceutical industry	Regulation
Health	Health Canada’s Interim Orders relating to COVID-19: The Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19; The Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19; The Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19; The Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to Covid-19	Legislative Proposal, Bill or Resolution
Health, Industry, Intellectual Property	New Substances Notification Regulations as it relates to the biopharmaceutical industry	Regulation
Health, Industry, Intellectual Property, International Trade, Research and Development, Taxation and Finance	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
Health, Intellectual Property, Research and Development, Taxation and Finance	Patented Medicines (Notice of Compliance) Regulations as it relates to the regulation of intellectual property for biopharmaceutical products	Regulation
Health, Intellectual Property, International Development, International Relations, International Trade, Taxation and Finance	Patented Medicines (Notice of Compliance) Regulations with respect to ensuring that patent rights are respected and are internationally competitive	Regulation
Health, Industry, Intellectual Property, International Development, International Relations, International Trade, Research and Development	Patented Medicines Regulations as it relates to the regulation and protection of biopharmaceutical products	Regulation
Consumer Issues, Health, Industry, Intellectual Property, International Development, International Trade, Research and Development, Taxation and Finance	Pharmaceutical pricing policy issues arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB)	Policies or Program
Constitutional Issues, Consumer Issues, Federal-Provincial Relations, Government Procurement, Health, Industry	Proposed pharmacare legislation related to any future national pharmacare program	Legislative Proposal, Bill or Resolution
Economic Development, Intellectual Property, Research and Development, Science and Technology, 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, Industry, Intellectual Property, Natural Resources, Science and Technology	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
Health, Industry, Natural Resources, Science and Technology	The government's Science and Technology strategy as it relates to the biopharmaceutical industry	Policies or Program
Health, Industry, Intellectual Property, International Development, International Relations, International Trade	World Health Organization (WHO) issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernmental Working Group (IGWG) World Intellectual Property Organization (WIPO) issues concerning the protection of and access to intellectual property	Policies or Program
Health, Industry, Intellectual Property, International Development, International Relations, International Trade	World Trade Organization (WTO) issues concerning the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility"	Policies or Program

• 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	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	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	Canada's Food and Consumer Safety Action Plan as it relates to the regulation and protection of biopharmaceutical products	Legislative Proposal, Bill or Resolution
  Subject matters were not required to be associated with subject matter details when this content was submitted	Canada-United States Regulatory Cooperation Council (RCC) initiatives related 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	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 Initiative as it relates to public/private research and development partnerships	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	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	Free trade treaty agreement as they relate to the North American Free Trade Agreement (NAFTA) and free trade negotiations as it relates to India, the European Union, Japan, MERCOSUR and the Trans-Pacific Partnership	Policies or Program
  Subject matters were not required to be associated with subject matter details when this content was submitted	Health Canada's Regulatory Roadmap for Health Products and Food 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	Health Canada’s Interim Orders relating to COVID-19: The Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19; The Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19; The Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19; The Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to Covid-19	Legislative Proposal, Bill or Resolution
  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	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 Patented Medicines Prices Review Board (PMPRB)	Policies or Program
  Subject matters were not required to be associated with subject matter details when this content was submitted	Proposed pharmacare legislation related to any future national pharmacare program	Legislative Proposal, Bill or Resolution
  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	World Health Organization (WHO) issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernmental Working Group (IGWG) World Intellectual Property Organization (WIPO) issues concerning the protection of and access to intellectual property	Policies or Program
  Subject matters were not required to be associated with subject matter details when this content was submitted	World Trade Organization (WTO) issues concerning the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility"	Policies or Program

  Subject matters in previous versions

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

Government Institutions

• Agriculture and Agri-Food Canada (AAFC)
• Canada Revenue Agency (CRA)
• Canadian Institutes of Health Research (CIHR)
• Canadian International Trade Tribunal (CITT)
• Canadian Tourism Commission (CTC)
• Employment and Social Development Canada (ESDC)
• Environment and Climate Change Canada (ECCC)
• Fisheries and Oceans Canada (DFO)
• Global Affairs Canada (GAC)
• Health Canada (HC)
• 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)
• Patented Medicine Prices Review Board (PMPRB)
• Prime Minister's Office (PMO)
• Privy Council Office (PCO)
• Public Health Agency of Canada (PHAC)
• Public Services and Procurement Canada (PSPC)
• Senate of Canada
• Statistics Canada (StatCan)
• Treasury Board Of Canada Secretariat (TBS)
• Veterans Affairs Canada (VAC)

Government institutions added through a communication report:

• House of Commons

Communication techniques

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

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

Alexander MacDonald, Consultant (Business address and contact information)

Public offices held