Updated August 5, 2020
BACKGROUND:
- In December 2017, the federal government proposed amendments to the Patented Medicines Regulations. These guidelines govern how the Patented Medicine Prices Review Board (PMPRB) sets the price at which companies sell their drug to distributors across the country.
- The PMPRB Amended Regulations were published in August 2018 in the Canada Gazette Part 1.
- In February 2018, ALS Canada submitted a response to the public consultation on the proposed amendments.
- On November 21, 2019, the PMPRB published a draft set of new guidelines for consultation with stakeholders and the public. The guidelines were set to come into force on June 1, 2020.
- In February 2020, ALS Canada submitted a response to the public consultation on the November 2019 draft guidelines.
- In April 2020, ALS Canada sent Minister Patty Hajdu a letter requesting the federal government pause the implementation of the guidelines due to COVID-19 as to allow sufficient time to consult with stakeholders.
- On June 1, 2020, the implementation of the guidelines deferred to January 1, 2021.
- On June 19, 2020, the PMPRB published another set of guidelines and launched a 30-day consultation period with stakeholders and the public.
- On July 8, the PMPRB extends the consultation period to August 4, 2020.
JUNE 2020 PMPRB GUIDELINES
ALS Canada has connected with a variety of stakeholders, including CORD, Health Charities Coalition of Canada, other health charities and industry, to understand the complex changes made in the June 2020 draft of the PMPRB guidelines (June 2020 guidelines) and how they could impact people living with ALS.
We understand that the revised PMPRB guidelines have been developed with the goal of making medicines more affordable to Canadians, and we appreciate the opportunity to provide feedback as well as the additional effort that has gone into updating them. However, our review of the revised guidelines in order to provide meaningful feedback on them has been a challenging undertaking.
The revised June 2020 Draft Guidelines, which could have significant implications for how medicines are priced in the future, is in itself a barrier to meaningful dialogue and feedback because the language used is not accessible to the Canadians it aims to protect.
We are concerned the lack of clarity around the real-world application of these proposed reforms and how this uncertainty could impact the number of clinical trials available in Canada, create longer timelines for the review of therapies, and ultimately result in fewer therapies coming to Canada limiting access for patient populations with an unmet need. Without case study validation of the guidelines, we cannot assess how Canadians will ultimately be affected.
At the same time, we are aware of numerous developments that have created a murky environment in which to implement the revised PMPRB guidelines.
Ultimately, we believe the guidelines implemented by PMPRB must result in fair prices for patented medicines. While we do not have the expertise or mandate to determine whether a drug’s price is too high or too low, the model used to determine pricing must balance affordability with access.
IMPACT ON PEOPLE LIVING WITH ALS
Affordable access to therapies is important for people living with ALS, but as a community that continues to face a devastating terminal disease, this cannot be achieved at the expense of timely access.
There is currently a significant pipeline of promising Phase 2 and Phase 3 clinical trials underway and Canadians living with ALS today – and those diagnosed with ALS in the future – need the ability to access these therapies in Canada. For this to happen, pharmaceutical companies must see Canada as a viable market to run clinical trials and pursue regulatory approval. Efforts intended to lower prices must be made in a balanced way that continues to encourage innovation and does not result in the delay of launches and introduction of new medicines in the Canadian market.
Any changes to Canada’s drug access pathway – including the PMPRB – must be flexible and responsive to the needs of people living with ALS and encourage more proven therapies to be developed, sold, and reimbursed in Canada. It is essential that tomorrow’s proven ALS therapies be accessible to Canadians in a timely, equitable and affordable way.
RECOMMENDATIONS:
Efforts to improve affordable access to therapies must be done in a way that ensures Canadians’ swift access to innovative treatments and clinical trials of new medicines and is representative of the needs, experiences and perspectives of all Canadians.
- Recommendation #1: That the Federal Government require PMPRB to engage an independent third party to conduct a formal assessment of the real-time and potential impacts of the reforms on access to therapies and research investment in Canada (including clinical trials), with specific consideration to therapies for rare diseases, before the PMPRB guidelines are implemented.
- Recommendation #2: That the PMPRB undertake a phased approach to enacting its proposed reforms in order to assess the impact of each change on research investment and access to therapies for both rare and non-rare disease therapies. Only then should additional reforms be considered.
- Recommendation #3: That the PMPRB implements a distinct pathway for medicines for rare diseases.
- Recommendation #4: That the Federal Government require that PMPRB decision-making and processes include patient representatives.
Read ALS Canada’s response to the June 2020 PMPRB public consultation here.