Registration - Consultant

Subject Matters

• Consumer Issues
• Health
• Industry
• Intellectual Property
• International Trade
• Science and Technology

Subject Matter Details

Legislative Proposal, Bill or Resolution

• Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry, and related updates and to Federal budgetary policy.
• 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

• 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

• Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility". Relevant domestic legislation includes the Food and Drugs Act, the Patent Act, and related regulations and guidance documents. Beyond TRIPs, enhancements to increase the stability and global competitiveness of Canada’s intellectual Property legislation, regulations and policies relevant to the biopharmaceutical industry.
• Anti-Counterfeit Trade Agreement (ACTA) as it concerns counterfeit drugs.
• 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.
• 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.
• 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).
• Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework.
• 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 resistance.
• Health Canada's Regulatory Reform of Drugs and Devices (R2D2) 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 biopharmaceutical products.
• Innovation Strategy led by Industry, Science and Economic Development Canada, particularly with respect to the life sciences priority under the Innovation Strategy
• Partnership opportunities as it relates to Canada's policy and programs to improve health in the developing world, such as Maternal and Child Health.
• Pharmaceutical pricing policy issues arising from the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) and R&D reporting.
• Plan design and reimbursement policies for drug plans administered by Federal Government including NIHB and Corrections Services.
• Policies and programs as it relates to vaccine approval, procurement and public awareness of immunization.
• Scientific Research and Educational Design (SR&ED) Tax Credit in respect of updating the system and increasing the expenditure limit for refundable credits.
• US - Canada Regulatory Cooperation Council (RCC) as it relates to the regulation of biopharmaceutical products.
• World Health Organization issues concerning pharmaceuticals as it relates to Counterfeits, Access to Medicines, and the Intergovernment Working Group (IGWG).

Policies or Program, Regulation

• Food and Drugs Act, specifically with respect to the approval, regulation and life-cycle management of therapeutic products

Regulation

• Food and Drug Regulations as it relates to data protection and the regulation and protection of biopharmaceutical products.
• Food and Drugs Act Regulations, specficially with respect to approval, regulation and life-cycle management of therapeutic products
• 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.
• Smart Regulations as it relates to the biopharmaceutical industry.

Communication Techniques

• Written communication
• Oral communication

The lobbyist has arranged or expects to arrange one or more meetings on behalf of the client between a public office holder and any other person in the course of this undertaking.

Government Institutions

• Canadian Institutes of Health Research (CIHR)
• Finance Canada (FIN)
• Global Affairs Canada (GAC)
• Health Canada (HC)
• House of Commons
• Innovation, Science and Economic Development Canada (ISED)
• Patented Medicine Prices Review Board (PMPRB)
• Prime Minister's Office (PMO)
• Senate of Canada
• Treasury Board Of Canada Secretariat (TBS)

Address:
16750 Trans-Canada Hwy.
Kirkland, QC  H9H 4M7
Canada

Telephone number: 514-428-8600

Client representative

Rob Livingston, Associate Director, Policy and External Affairs Federal

Parent Company Information

Business address:
50 O'Connor St., Suite 901
Ottawa, ON  K1P 6L2
Canada

Telephone number: 613-782-2336