Registry of Lobbyists
| Subject matters | Details | Categories |
|---|---|---|
|
Budget
|
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
|
|
Health
|
Biologics and Genetic Therapies Directorate as it relates to policies affecting the review and approval of submissions
|
Policies or Program
|
|
Environment
|
Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies.
|
Regulation
|
|
Health
|
Clinical Trials environment in Canada: operational issues, investment, enrollment
|
Policies or Program
|
|
Health
|
Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework.
|
Policies or Program
|
|
Intellectual Property
|
Discussions around the World Trade Organization consideration of a TRIPS Patent Waiver - Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility".
|
Legislative Proposal, Bill or Resolution
|
|
Health
|
Economic Growth Initiatives as it relates to pharmaceutical, clinical trials investment, life sciences industry
|
Policies or Program
|
|
Health
|
Federal Public Drug Plans, with respect to the reimbursement of therapeutic products for Federal plan beneficiaries
|
Policies or Program
|
|
Health
|
Food and Drugs Act and Regulations, as they relate to drug export and cross-border trade, establishment of an approval framework for subsequent entry biologic products, provision of data exclusivity for innovative drug products, review and approval of new drug submissions and post market surveillance of drug products and/or data protection and the regulation and protection of biopharmaceutical products.
|
Legislative Proposal, Bill or Resolution
|
|
Health
|
Food and Drugs Act Modernization initiative as it relates to reform of drug submission review and approval process
|
Legislative Proposal, Bill or Resolution
|
|
Health
|
Health Canada/PMPRB proposed regulation changes to the Patented Medicines Regulations.
|
Regulation
|
|
Health
|
House of Commons Standing Committee of Health's (HESA) as it relates to Pharmacare, vision health, rare disease and/or any other pertinent legislative proposal before the committee
|
Legislative Proposal, Bill or Resolution
|
|
Science and Technology
|
House of Commons Standing Committee of Industry and Technology (INDU) as it relates to Artificial Intelligence and/or any other pertinent legislative proposal before the committee
|
Legislative Proposal, Bill or Resolution
|
|
Research and Development
|
House of Commons Standing Committee of Science and Research (SRSR) as it relates to Science in Canada and/or any other pertinent legislative proposal before the committee
|
Legislative Proposal, Bill or Resolution
|
|
Taxation and Finance
|
Income Tax Act as it relates to biopharmaceutical industry.
|
Policies or Program
|
|
Health
|
Monitoring and engaging on the Government’s commitment (Budget, SFT, Fall Economic Update) to create a national strategy for drugs for rare diseases; create a new Canadian Drug Agency; and the implementation of national, universal pharmacare.
|
Policies or Program
|
|
Health
|
Monitoring and engaging the Government and Parliamentarians on policies and programs related to Canada's biomanufacturing and life sciences sector strategy
|
Policies or Program
|
|
Taxation and Finance
|
Monitoring and engaging the Government and Parliamentarians on policies and programs that would provide greater clarity and predictability in the tax outcomes and improvements to tax measures such as the Manufacturing & Processing (M&P) credit and the Scientific Research & Developmental (SR&ED).
|
Policies or Program
|
|
Health
|
National Pharmacare (Bill C-64, An Act respecting pharmacare)
|
Legislative Proposal, Bill or Resolution
|
|
Health
|
National Strategy for Drugs for Rare Disease as it relates to separate regulatory pathways for drugs for rare diseases and the government strategy.
|
Regulation
|
|
Health
|
Patent Act and Patented Medicines (Notice of Compliance) Regulations, as it relates to the regulation of intellectual property, approval for therapeutic products, changes to modernize the Right of Appeal
|
Regulation
|
|
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
|
Patented Medicines Prices Review Board (PMPRB), as it relates to reporting requirements, pricing guidelines, and dispute resolution
|
Regulation
|
|
Intellectual Property
|
Pharmaceutical intellectual property protection as it relates to international trade agreements
|
Policies or Program
|
|
Health
|
Pharmaceutical policy and any negotiations of a Health Accord or agreement with the Provinces/Territories, as it relates to National Pharmacare/universal or catastrophic drug coverage, Drug policies & Pricing.
|
Policies or Program
|
|
Health
|
Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions
|
Policies or Program
|
|
Health
|
Policies related to the importation of pharmaceuticals from Canada to the United States
|
Policies or Program
|
|
Health
|
Policies related to the National Strategy for Drugs for Rare Disease as it relates to separate regulatory pathway for drugs for rare diseases and the government strategy.
|
Policies or Program
|
|
Health
|
Regulations, policies and programs related to the reimbursement recommendations decision-making process and framework done by the Canadian Agency for Drugs and Technologies in Health (CADTH)/Common Drug Review as well as the review times and processes conducted by Health Canada for the purpose of obtaining a notice of compliance.
|
Regulation
|
|
Economic Development
|
Standing Committee on Finance (FINA) as it relates to pre-budget consultations.
|
Legislative Proposal, Bill or Resolution
|
|
Economic Development
|
Strategic Innovation Fund, as it relates to any initiative submitted or supported
|
Grant, Contribution or Other Financial Benefit
|
|
Research and Development
|
The Department of Innovation, Science and Economic Development and the Innovation Agenda for the life sciences sector: policy or program initiatives to support life science research and development conducted in Canada and manufacturing capability, and as it relates to Canada’s Biomanufacturing and Life Sciences Strategy.
|
Policies or Program
|
|
International Trade
|
The Food and Drugs Act, or the Export and Imports Permits Act (Export Control List) or any other legislative and regulatory means in order to protect the Canadian supply of drugs in light of importation legislation in the United States.
|
Regulation
|
Hoffmann-La Roche Limited deals with the healthcare system in the prevention, screening, diagnosis, treatment and management of acute and long-term disease and supports leading research and development - including clinical research, clinical trials and genetic research.
BRIGITTE NOLET, PRESIDENT AND CHIEF EXECUTIVE OFFICER
Address:
7070 Mississauga Road
Mississauga, ON L5N 5M8
Canada
Telephone number:
905-542-5555
Ext.
5765
Fax number:
905-542-5507
Hoffmann-La Roche Limited does not have any subsidiaries that could have a direct interest in the outcome of the undertaking