Karen Fortin

Communications regarding opportunities to speed patient access to live-saving medicines on publicly-funded drug formularies in Canada by reducing red tape. Innovation, Science and Economic Development (ISED)'s Health Emergency Readiness program, insofar as it pertains to growth and development of the life sciences industry in Canada. Communication regarding free trade agreements as they relate to the biopharmaceutical industry. The pan Canadian Pharmaceutical Alliance (pCPA) with respect to public formulary listing of new medicines, insofar as the federal government is a participating jurisdiction and holds a seat on the Board of Directors. Public Health Agency of Canada, regarding the federal response to the hepatitis C virus. Patented Medicine Prices Review Board (PMPRB) Guidelines with regard to prices charged by Rights Holders for patented medicines sold in Canada. Federal Government Non Insured Health Benefits program with respect to reimbursement of a prescription medicine and changes in type of reimbursement Engagement with Health Canada’s Regulatory Operations & Enforcement branch regarding supply chain resilience & integrity; mitigating and alleviating drug shortages. Communications with Heath Canada regarding modernization of the medical devices regulatory framework. Communications with Health Canada regarding the evolution of the regulatory framework to address advanced therapeutic products. Communications with Health Canada regarding the application of its nitrosamine guidelines. Communications with Health Canada regarding modernization of clinical trials regulations, including diversity and inclusivity of clinical trials. Communications with Health Canada regarding guidelines for pediatric action plans. Communications regarding the value assessment of new medicines by Canada's Drug Agency (CDA) and the design of proposed new work streams, insofar as the federal government is a funder and holds a seat on the Board of Directors. Communications regarding the design and implementation of the federal Drugs for Rare Diseases strategy. Communications regarding national pharmacare legislation, regulations, policies or programs. Communications regarding intellectual property protection of prescription drugs, including the Patent Act, the Patented Medicines Regulations, the Patented Medicine Notice of Compliance (PMNOC) Regulations, the Patent Term Adjustment regime and Health Canada’s Data Protection regime. Communications regarding Health Canada's Regulatory Innovation Agenda regarding proposed regulatory amendments and guidelines to enable agile licensing of drugs and medical devices. Communications regarding access to and approval of medicines addressing the growing public health threat of antimicrobial resistance.

To provide funding for the Canadian Collaboration to Cure ALS, to establish a coordinated national research ecosystem through which every Canadian living with ALS can participate in, and benefit from, cutting-edge science that will accelerate discoveries by Canadian researchers, advance understanding of the disease, and enable the development of therapies to treat this devastating terminal illness with greater precision. Sources of funding are to be determined. Policies or programs related to access to care and potential treatments for the ALS Community. Amendment to the compassionate care program to make it more accessible to caregivers and to increase the length of the benefit.

Public health and prevention programs including the Public Health Agency of Canada and efforts to support the development and procurement of innovative vaccines and therapies to address major public health issues such as pandemic preparedness and RSV Federally-funded public drug plans, including the Non-Insured Health Benefits program, Canadian Armed Forces Drug Benefit List and veteran programs, with respect to reimbursement for drug products for beneficiaries Canada's Drug Agency policies and processes as it relates to reimbursement recommendation decision-making process and framework Engage with Canadian government officials to discuss and provide input on Canada’s countermeasures and policies in response to foreign tariffs affecting the pharmaceutical industry, as well as free trade agreements as they relate to the biopharmaceutical industry Establish accountability with Health Canada, Canada’s Drug Agency and the pan-Canadian Pharmaceutical Alliance, as well as Regulations, policies and programs related to the review and reimbursement processes Patented Medicines (Notice of Compliance) Regulations as it relates to the regulation of intellectual property for biopharmaceutical products Patent Act as it relates to reporting requirements and pricing guidelines, and the protection of intellectual property in biopharmaceutical products Policy measures to ensure security of drug supply in Canada and preserve Canada’s attractiveness for biopharmaceutical launches, including in response to foreign pricing regulations Policies and frameworks to accelerate access to innovative medicines post-Health Canada approval, including efforts to reduce time-to-reimbursement and streamline federal/provincial listing processes Biomanufacturing and Life Sciences Strategy (BLSS) as it relates to the biopharmaceutical industry Pharmaceutical pricing policy issues arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB) Engagement with the Government regarding the Strategic Response Fund (SRF) (previously known as SIF) and investment in Canada Annual federal Budgets and Budget updates relating to the biopharmaceutical industry. Scientific Research and Experimental Development (SR&ED) Tax Incentive Program regarding eligible expenditures. Discussions on policies such as "patent box" and Investment Tax Credits.

Pharmaceutical pricing policy arising from the jurisdiction of the patented medicine prices review board (PMPRB). Arranging meetings to brief government officials on the business of Boehringer Ingelheim Canada Ltd.

Protect children and youth from online harms by advancing evidence-informed policies (Bill C-34) that promote safer digital environments, support healthy development and well-being, and strengthen protections against harmful online content, interactions, and platform practices. PT stream of the Build Communities Strong Fund, specifically the $5 billion announced specifically for healthcare infrastructure, making sure that children's healthcare needs are taken into account in the program development. Creation of an Indigenous Guiding Circle within Children's Healthcare Canada to provide guidance and counsel on how to better advocate for FNIM children and youth health issues. Protect the Public Health Agency of Canada’s critical work, building confidence in vaccines for children and combatting mis and disinformation influencing decisions impacting children’s health. Protect and expand capacity to deliver on Jordan’s Principle and the Inuit Child First Initiative (a federal responsibility); Top up and broaden the eligibility for the Youth Mental Health Fund, with a focus on prevention, early assessment and rapid intervention in the early years; Include Children’s Priorities in Nation-Building Investments : Asking for capital investments in the children’s healthcare system, including support for research, workforce planning, and the implementation of learning health systems. Advancing a National Children's Strategy to advance child and youth health and well-being outcomes.

Patient access to breakthrough cancer treatment continues to be met with consistent delays in Canada, especially compared to the US and Europe. Rethink Breast Cancer would like to meet with elected officials and policy makers to discuss opportunities to speed up access for cancer patients and improve overall coverage.