12-Month Lobbying Summary - Consultant

Subject Matters

• Aboriginal Affairs
• Agriculture
• Arts and Culture
• Broadcasting
• Constitutional Issues
• Consumer Issues
• Defence
• Education
• Employment and Training
• Energy
• Environment
• Financial Institutions
• Fisheries
• Forestry
• Government Procurement
• Health
• Immigration
• Industry
• Infrastructure
• Intellectual Property
• Internal Trade
• International Relations
• International Trade
• Justice and Law Enforcement
• Labour
• Mining
• 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
• Canada's Food and Consumer Safety Action Plan as it relates to the regulation and protection of biopharmaceutical products.
• 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

• Anti-Counterfeit Trade Agreement (ACTA) as it concerns counterfeit drugs
• 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
• Canada-United States Regulatory Cooperation Council (RCC) initiatives related to the regulation of biopharmaceutical products
• Canadian Institutes of Health Research (CIHR) Clinical Research Initiative as it relates to public/private research and development partnerships
• 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)
• Free trade treaty agreement as it relates to the North American Free Trade Agreement (NAFTA) and free trade negotiations as it relates to Columbia, India, and the European Union
• 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
• Pharmaceutical pricing policy arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB)
• 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 potential policies & programs pertaining to the biopharmaceutical industry
• 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
• 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"

Regulation

• Food and Drug Regulations as it relates to data protection and the regulation and protection of biopharmaceutical products
• Health Canada's Regulatory Roadmap for Health Products and Food as it relates to the biopharmaceutical industry
• 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