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The double-edged sword of the proposed PMPRB framework

When the intention to protect Canadian consumers leads to less access to new and effective medicines

In the past few months, there have been discussions in the healthcare industry on Health Canada’s proposal to amend the Patented Medicines Regulations and modernize the Patented Medicine Prices Review Board (PMPRB)’s regulatory framework. If adopted, these amendments will significantly affect the lives of Canadian patients and the healthcare system as a whole.

Health Canada outlined five proposed regulations to modernize the current PMPRB framework. It stated that the 30-year old PMPRB regulatory framework no longer efficiently protects Canadian consumers from excessive prices and needs to be updated to reflect the current medicine market (Canada Gazette, Part I). It proposed amendments to give the PMPRB more tools and authority to exercise their regulatory and reporting mandate.

Among the proposed amendments are new price regulatory factors that would evaluate the patented medicine prices taking into consideration their value to patients and Canada’s willingness and ability to pay for them, and a requirement for patentees to report price and revenues, net of all price adjustments. Another proposed amendment would update the schedule of comparator countries from PMPRB7 to PMPRB12, removing the United States and Switzerland - considered to have higher prices - and replacing them with new countries such as Belgium, Spain, Norway, the Netherlands, Australia, Japan and South Korea.

NATIONAL’s assessment of the proposed amendments and their potential impact

Although the proposed amendments may have merit and a noble intent, the chosen approach focuses primarily, if not only, on an optimistic assessment that amending the current framework would allow the PMPRB to better fulfill its regulatory mandate. It is unclear, however, if any thorough evaluation was conducted to assess the impact or magnitude of such amendments on Canadian consumer health and the healthcare system as a whole. On the contrary, there is good reason to believe that without an exhaustive assessment of all possible outcomes, the proposed regulatory framework could penalize those same Canadian consumers it is mandated to protect.

In the proposed regulations, Health Canada has indicated they do not anticipate any impact on pharmaceutical industry employment or investment in the Canadian economy, a potentially dangerous assumption for consumers and the economy. If implemented, Health Canada estimates a loss of $8.6 billion in pharmaceutical patentees’ revenue over the next 10 years (Canada Gazette, Part I), a substantial amount that may have a significant negative impact on how pharmaceutical patentees allocate investments in employment and medicine R&D. Some of the current patentees, if not most, could feel forced to downsize, or worse, relocate R&D operations to other countries, and Canada could potentially lose important researchers making a difference in R&D and putting the country at the forefront of the Life Sciences and Health Technologies field. Furthermore, new investors or future pharmaceutical patentees may opt out of launching or distributing innovative medicines and technologies in Canada due to these proposed restrictions. The government of Canada could be seen as contradicting itself by setting backwards all the current federal and provincial efforts to stimulate medicine R&D by convincing foreign biopharmaceutical companies, researchers and investors to bring their cutting-edge innovations and technologies to our country. In the long run, Canada could eventually lose its status as one of the leaders in the North American Life Sciences and Health Technologies sector.

These significant consequences would have an unintended effect, jeopardizing patients’ access to innovative medicines in more therapeutic areas that neither the patients nor the healthcare system are equipped to handle. Some of the patients at risk of being penalized the most are those sorely in need of new, specialized and effective therapies in oncology, rare diseases and autoimmune diseases. New specialized medicines in those indications, although expensive, offer an undeniable and much needed therapeutic value to patients, often the difference between life and death or a much better quality of life for patients and their caregivers.

Health Canada and the PMPRB have held consultations with various stakeholders in the healthcare industry. Although some agreed with the proposed regulatory framework, others warned of the complexity of such amendments and urged policy makers to prioritize patient access to new medicines and adopt a more flexible regulatory framework that would go beyond the cost per QALY to consider patented medicines’ benefits and patients’ preferences. Most stakeholders also expressed concerns over the proposed reporting framework, mainly because the PMPRB did not clearly specify how it plans to use and protect confidential price adjustments without compromising existing agreements with public and private payers. The PMPRB is currently leading another consultation, assisted by a group of experts to help implement the proposed amendments. A report of the experts’ deliberations and recommendations will be submitted this month to the PMPRB’s committee, followed by a new draft of the price review process guidelines later this fall.

The report summarizing all the consultations, feedback and recommendations remains to be seen to determine if the process was fair and inclusive. Furthermore, it is unclear what influence the recommendations of those consulted, as well as the concerns submitted by other involved parties, will actually have prior to the implementation of the amendments on January 1, 2019.

Given the significant uncertainty surrounding the proposed amendments, one wonders if a model with a fair, consensus-led decision-making approach would not be more effective. Such a method could help the PMPRB reinforce its regulatory and reporting framework without endangering Canadian patients’ health through an abrupt and significant decline in patients’ access to new, specialized and effective medicines, and a subsequent shift in pharmaceutical employment, medicine R&D and investments outside of the Canadian economy.

NATIONAL Public Relations’ role in this dialogue

At NATIONAL, we understand the current healthcare environment and can leverage our extensive expertise in healthcare and public relations, and well-connected network to help you change the complex into the comprehensive through creative and integrated solutions.

We specialize in identifying key stakeholders, from patient advocacy groups and healthcare providers to government officials, and fostering a dialogue that changes beliefs, drives behaviour and delivers results. Our healthcare experts operate as one across Canada and can assist you with our broad strategic services in Patients’ Advocacy and Stakeholders’ Relations, Government Relations, Reimbursement and Market Access, Integrated Communications and Crisis Management.