In an article published by The Conversation, which only accepts articles from employees of Canadian universities, Joel Lexchin repeats a mantra entrenched among certain academic, political and union anti-biopharmaceutical activists that Canadians need cheaper medicines. The evidence presented are opinion poll results and an analysis produced by anti-industry activists that relies heavily on an assumption that US data apply to Canada.
High drug prices are the fault of Big Pharma, according to Lexchin and others, because companies dare to try to make money for their investors. They do this because, without investors, their businesses would not survive and medicine development would wither.
Dr. Lexchin criticizes the Liberal federal government for not moving forward with introducing draconian regulations for the Patented Medicine Prices Review Board (PMPRB), although the courts have been giving this rogue agency a hard time for overreach. The new regulations are anticipated to lead to severe reductions in the prices of high-cost ground-breaking drugs, which many Canadians, including several federal politicians and officials, believe will make them more accessible.
However, verifiable research from Canada, United Kingdom and United States shows that pharmaceutical companies delay launching new products in small markets like Canada’s, when regulated prices are low relative to per capita income. So, drastic price reductions are more likely to lead to less or no access for patients, not better access.
Canadians should actually congratulate Ottawa for recognizing that its revised regulations impose a burden on drug developers and an obstacle to meeting patients’ needs when it exempted COVID-19 vaccines and medicines from burdensome PMPRB scrutiny to get them to Canadians without difficulties. Without this exemption, Canadians’ access to vaccines and therapies would have been even slower than it was and is.
Developing a new medicine takes 10-15 years and millions of dollars, and only one in 10,000 compounds make it to regulated human use. Companies make high-risk investments in research and development in anticipation of high prices for their new products. In Canada, manufacturers must overcome resource and time-consuming health technology assessment and price negotiation processes to get a new medicine insured in government drug plans. This already results in delays and, in some cases, denial of access.
If developers are unable to achieve an adequate return on investment due to regulations harshly reducing drug prices, they will not invest in Canada. The result? Canadians will have some of the longest wait times for new therapies in the developed world and many more innovative medicines will not be launched here.
The many layers of process from drug regulation through health technology assessment and price negotiation to individual drug plan coverage approval already take too much time. Patients with aggressive lethal diseases, such as amyotrophic lateral sclerosis (ALS) from which Mr. Adams’ wife died, do not have time to wait.
Dr. Lexchin also suggests in his article that Big Pharma uses patients and their advocates as willing accomplices in furthering their financial objectives. His evidence for this opinion is that one patient group acknowledges (appropriately) support from the industry. This is a smear repeated by certain academics, politicians and the media that is inaccurate and offensive to advocates fighting for access to medications to save family members and others.
Patients and their caregivers are passionate and rightly impatient about gaining access to innovative medicines that can reduce suffering, extend lives or improve life quality. Fighting chronic debilitating illness not only has a toll on the patient but also on their entire family. The suffering and daily challenges of appointments, diagnoses, therapies and hospitalizations are demanding enough without having to cope with government-instituted obstacles delaying or denying access to medicines that can change or save lives.
Patients and their families recognize that governments will pay little attention to them unless they organize and actively advocate for access. This takes time, energy and resources, resources they often don’t have. Governments don’t provide support for them to lobby the same governments to cover medically-necessary drugs. Patients and their families raise funds for research and advocacy, but they can only raise limited amounts among themselves. Hence, they turn to manufacturers for financial support and participation in studies.
Ms. Vanstone’s daughter has cystic fibrosis (CF). She has worked tirelessly over the past decade to gain access to more effective medicines for her daughter and other CF sufferers. This included confronting the then premier of Ontario in the presence of the media to pressure her to take action.
More recently, she has been a leader in a campaign to encourage governments to cover new CF medicines including Trikafta, which has been described as a gamechanger in CF therapy. Although Trikafta was approved for use in the United States in October 2019, its manufacturer didn’t apply to Health Canada until December 2020, likely due to obstacles their previous CF medicines had to overcome. Trikafta was approved in June 2021 and is now covered by most Canadian government plans, but access criteria recommended by the Canadian Agency for Drugs and Technologies in Health are so restrictive that relatively few patients would benefit. Ms. Vanstone and other CF advocates have been successful in urging drug plans to remove some of the restrictive criteria to allow more patients to access Trikafta. This work takes time and energy.
Disappointingly, Lexchin, as a physician, never mentioned that many high-cost drugs are pioneering medicines that are life-saving and/or can significantly improve patients’ lives. Instead, he reduced the issue to only dollars and cents. However, real people are involved, with lives and suffering being saved by access to these drugs and lost when access is delayed or denied. Implementing severe price regulations will deny not only access but also hope. Patients without access to life-altering therapies are process victims subsidizing drug plan budgets by being denied treatment at the right time.
When the PMPRB was established in 1987, Canadians had no other defence against excessive drug prices. Times have changed. Canada now has health technology assessment agencies and a national price negotiation organization for government drug plans to ensure that no abuse of patents and non-excessive prices. The PMPRB is 34 years old and no longer fit for purpose.
The only Canadians the PMPRB protects from excessive pricing are those without access to either private or public drug plans, who frequently have lower incomes making it difficult to pay for their medicines. Government drug plans have safety nets for these Canadians, but they have gaps. A better method to assist these Canadians exists in Quebec where all residents without a private insurance plan are required to enroll in the provincial government’s plan with premium subsidies based on income. This or other approaches could be applied across Canada, making the PMPRB entirely obsolete.
Some 300 new medicines are expected to be launched worldwide over the next five years. Many will be drugs for disorders for which no effective therapy exists. How many of these medicines will come to Canada if developers are unable to realize their price expectations as a consequence of unilateral government rules rather than price negotiations? Instituting the PMPRB regulations will mean drug developers will go elsewhere, while Canadians who need these new medicines suffer and die waiting for access.
The federal government should learn from its exemption of COVID vaccines and medicines from PMPRB scrutiny and apply that to all new therapies or cancel the new regulations entirely. Its policy towards new patented medicines must change from punitive pricing to fostering biopharmaceutical innovation, research, manufacturing and patient access in Canada. Patients must be at the centre of this change working with governments and drug developers on sustainable solutions that allow them and their prescribing physicians to benefit from cutting-edge medicines without restrictive access criteria or unaffordable copayments.
Otherwise, patients will continue to suffer and die as a result of price regulations that prevent them from receiving the benefits of innovative new drugs.
Nigel Rawson is an independent researcher and an affiliate scholar with the Canadian Health Policy Institute. John Adams is cofounder and CEO of Canadian PKU and Allied Disorders Inc. and volunteer board chair of Best Medicines Coalition. Beth Vanstone is a tireless advocate for people with cystic fibrosis. The views expressed are the authors’ own and do not necessarily represent those of organizations with which they collaborate.