As a company founded on the principles of innovation and collaboration, we pride ourselves on being a leader in the science of the pathology of disease and how it responds to medicines. This commitment has resulted in Roche Canada making direct investments into the Canadian healthcare system since we first began operations here in 1931. Over time these investments have grown in both significance and impact. Looking at 2017, we’re proud to say that we’ve invested $52 million in clinical research alone in Canada.
This has allowed our company to bring cutting edge investigational medicines and diagnostics to Canadians and has also helped us alleviate strain on the healthcare system by allowing us to support care for over 2,500 patients who participated in one of our trials last year.
We know our mission to continue advancing science depends on the long-term sustainability of our healthcare system, which ultimately provides patients with access to our innovations. So we understand and support the government’s desire to find efficiencies within the current healthcare budget. The conversation about the affordability and accessibility of medicines has taken centre stage over the past several months as our federal government looks to reform regulations that govern how patented medicines are priced in Canada, so we feel it’s important for us to share our views on this topic.
Creating a Funding System that Prioritizes the Health of Canadians
We understand that governments and payers have the arduous task of managing a growing health budget and are looking for ways to reform our system with a focus on sustainability.The Patented Medicine Prices Review Board (PMPRB) is a federal government agency that regulates the prices of patented medicines in Canada with the mandate to ensure that these prices are not excessive. The federal government is currently proposing changes to the ways in which the PMPRB assesses the price of a medicine, which include looking at standards like the market size for a drug, the gross domestic product growth rate, and pricing comparisons to a larger list of similar countries. Although these changes are aimed at improving the affordability and accessibility of medicines, we fundamentally believe that a discussion about the value of innovation in the healthcare sector cannot and should not be limited to discussions of cost and the need to change how medicines are funded in our country.
The current access framework in Canada has built-in checks and balances that allow the government and public drug plans to evaluate the price, value and patient impact of a medicine before it is reimbursed. We also believe that the current framework is built on a pragmatic, step-wise approach, which offers the government various negotiation points, including
- The assessment of whether the price of a new medicine is non-excessive through the PMPRB;
- The opportunity to establish the cost-effectiveness of a medicine (i.e., the clinical and societal impact the medicine will have in the real world) via the Canadian Agency for Drugs and Technologies in Health (CADTH) or Institut national d’excellence en santé et en services sociaux (INESSS);
- An opportunity for the federal, provincial and territorial drug plans to further negotiate this price collectively through the pan-Canadian Pharmaceutical Alliance (pCPA); and
- The added opportunity for each province to build their individual needs into a Product Listing Agreement (PLA) that ultimately enables a medicine to be funded by the public drug plans.
Changing any one pillar of this framework will require a re-assessment of the entire process to ensure the system does not fail the interests and needs of patients and healthcare providers.
Research and Development: Sharing the Whole Story
The topic of healthcare sustainability and affordability has garnered significant attention amongst key stakeholders in the months since the proposed changes to PMPRB were announced. However, some of this dialogue is predicated on the belief that the pharmaceutical industry does not and has not invested sufficiently in research and development (R&D) in Canada to warrant the prices of our medicines. Our greatest concern with this belief is that current regulations that outline how we account for R&D expenditure do not recognize significant portions of our investment into Canada as research and development.
The Scientific Research & Experimental Development (SR&ED) Program, for example, specifically does not credit R&D investments made by the global headquarters of Canadian subsidiaries of multinational corporations like ours. This is problematic as these investments fuel clinical trials, support partnerships with Canadian entities (e.g., hospital institutions, academic centres, other Canadian businesses), and provide grants, donations or research funding to hospital institutions. In addition to global investments, the SR&ED Program also does not account for local investments into patient support programs that help Canadians secure access to the medicines and diagnostics they require to live a healthy life, as well as grants and donations that support initiatives to improve access to information and services within our healthcare system.
Ensuring Canada’s Place in the Life Sciences Ecosystem
We believe Canada has the ability to lead on a global stage by becoming a prime destination for clinical research and innovative medicines. While a focus on affordability is important, it must not be viewed with a narrow lens and must not erode our collective commitment to build a system that responds to the needs of every Canadian.
Sound public policy requires that all impacts be taken into consideration, including those on patients, caregivers and taxpayers, as well as employees and employers. There is no question that healthcare system sustainability is of paramount importance… as is access to innovation, job creation, and a strong life sciences ecosystem that serves as the backbone for a healthy future for our nation.
The patented medicines pricing regulation changes proposed by the federal government will have detrimental implications for investments and employment within Canada’s life sciences industry. A recent PDCI Market Access report suggests that the industry could see its revenues reduced by at least 20%. For an industry that supports 30,000 high-quality jobs, $19.2 billion in annual economic activity and invests nearly 10% of its gross revenues into research and development, this reduction will be a significant deterrent to global direct foreign investment into our country.
Medicines change lives. Patients are able to live longer and better thanks to medical innovations. But medicines do not change lives on their own – patients, their caregivers, volunteers, patient organizations, healthcare practitioners, researchers, institutions, industry and government all have a role to play in bettering the lives of Canadian patients. As a company, we are keen to partner with all relevant stakeholders to help build a system that is not only fair, but effective and efficient; a system that is built for the needs of Canadians today and tomorrow.
May 4, 2018