Over the past several years, ALS Canada, together with the ALS community and a coalition of patient groups across Canada, has raised the alarm about the consequences of the proposed changes to Patented Medicine Prices Review Board (PMPRB) regulations for Canadians.  

Our concern was that the new proposed changes – which included additional price regulatory factors and increasing the number of countries from which PMPRB compares drug prices – would create further barriers to accessing innovative therapies for people living with ALS.  

And so, together with community advocates, we joined the voices of people across Canada and asked the government to balance efforts intended to lower prices in a way that encourages innovation and provides flexibility for the needs of Canadians living with rare diseases.

On April 14, 2022, Hon. Jean-Yves Duclos, the Minister of Health, announced that the government will not proceed with the amendments related to the new price regulatory factors – meaning the reforms will only move forward with changes to the comparator countries.  

This announcement is a significant milestone for the ALS community in reforming the drug access processes and shows that by working together to approach government through a combination of channels at an organizational level and at an individual level, we can make our voices heard.  

ALS Canada thanks the members of the ALS community for their inspiring and invaluable advocacy efforts. 

“The need for timely access to therapies for people living with ALS is critical, which is why we want to see Canada as a first-place country for ALS therapies. We are encouraged by the government’s decision to not proceed with the regulations as proposed. This is just one step of many in making sure the entire drug access processes are streamlined and meet the needs of Canadians.” Tammy Moore, ALS Canada CEO 

Why were the PMPRB reforms an issue?  

  • The PMPRB is a federal regulatory and reporting agency that sets the price at which companies sell their patented medicines to distributors across the country. 
  • While the proposed changes to the PMPRB guidelines were intended to result in lower drug prices, they had several potential implications for people living with ALS, specifically regarding access to innovative therapies.  
  • The proposed changes created potential barriers for Canada to be seen as a viable market to run clinical trials and bring therapies to market.  
  • This could have meant that ALS therapies being tested in clinical trials today might not be available to Canadians down the road as urgently as they are needed, even after they are deemed by Health Canada to be safe and effective. 
  • With several ALS therapies currently in clinical trials worldwide, we believe it is essential for Canada’s drug access pathway to encourage more proven therapies to be developed, sold, and reimbursed in Canada while ensuring these therapies are accessible to all Canadians in a timely and affordable way. 

Raising our voices together:

  • ALS Canada began advocating around this issue as a member of the Health Charities Coalition of Canada (HCCC) in December 2017, when the federal government proposed the amendments. 
  • Over the course of five years, we have reached out to the government directly by leveraging opportunities to respond directly to the PMPRB: 
  • In 2020, ALS Canada joined a coalition with other health charities that launched a campaign to inform the public and elevate the issue of PMPRB regulations with government. The coalition continues today and advocates for reforms to the drug access process.  

How you helped create change: 

  • The government’s decision not to proceed with the amendments that would create barriers for companies to bring innovative medicines to Canada indicates that our voices were heard, and the government responded.  
  • This change was made possible thanks to the members of the ALS community and other patient groups as they raised their voices against PMPRB reforms and advocated for Canadians’ access to innovative therapies. 

What happens now?

  • The changes to the regulation will be reflected in the Canada Gazette in late Spring 2022 and come into force on July 1, 2022 
  • This is an astounding win for people living with ALS, their loved ones, and all Canadians living with rare diseases.  
  • ALS Canada will continue to advocate for Canadians living with ALS to access proven ALS therapies in a timely, equitable, and affordable way. 
  • Update – December 2022: In October 2022, the Patented Medicine Prices Review Board (PMPRB) released its new draft Guidelines and launched a consultation period with stakeholders. Read ALS Canada’s feedback on the consultation and letter to Health Minister Duclos as a Protect Our Access coalition member. 
Posted in: Advocacy