June is global Amyotrophic Lateral Sclerosis (ALS) awareness month. ALS is just one of the many devastating rare diseases faced by far too many Canadians and their families. Rare diseases often entail complex treatment, complex management regimes and costly drugs to try to enhance some quality of life for individuals living with a condition. When an individual receives a diagnosis, their focus should be on their next steps to manage their health and not on if they can afford to do so. However, some private drug companies have tremendous market power and cause drugs price to skyrocket and hinder patients’ access.

To mitigate this, in August 2019, Health Canada proactively announced the final amendments to the Patented Medicines Regulations. These amendments give the Patented Medicine Prices Review Board (PMPRB) new tools to protect Canadians from excessive prices of patented medicines. Health Canada consulted, Canadian consumer and patient groups, employers, health professionals, health researchers, other levels of government, pharmaceutical industry, private insurers and more to ensure the amendment was made with comprehensive research and input. This is the first substantive update to the regulations in more than 20 years. We anticipate that with these regulatory changes, Canadians will save approximately $13.2 billion over the next 10 years on patented drugs.

The amendments were scheduled to come into force on July 1, 2020.  Unfortunately, the COVID-19 pandemic has increased demands on the pharmaceutical industry related to supply chains and shortages. As such, Health Canada is delaying the coming into force of the amendments by six months—until January 1, 2021. This delay will allow all parties to focus on Canada’s COVID-19 response and will allow the patented drug manufacturers additional time to make any necessary adjustments to comply with the new regulatory regime.

This amendment paired with advancing research with additional funding will help put the health and wellbeing of Canadians facing rare diseases first. Canada has a tremendous opportunity to be a world leader in striving for the eradication of rare disease. As member of the ALS Caucus and during our cross Canada tour visiting various leading-edge research centres in our country it is evident that we have the capacity to keep making positive progress in combatting rare diseases in Canada. The advancements made by our research community is making a difference for local families.

Currently many pharmaceutical companies are not coming to Canada and in order to attract them we must set up a strong collaborative network of all research institutes, hospitals, academia with Health Canada in relation to rare diseases. Moving forward this would enable pharmaceutical companies to have better access to Canada’s leading research institutions in turn creating more opportunities for clinical trials and to open up doors and offer hope with individuals living ALS, Cystic Fibrosis, Muscular Dystrophy and many more rare diseases.

Important investments were also made in Budget 2019 to tackle rare disease. Over $1 billion was allocated towards rare diseases and to spark change in the health care system. More specifically, the government will use this to create 3 key items: the Canada Drug Agency; establishing a national formulary; and a national rare disease strategy. This will keep holding drug companies accountable for their pricing and effectiveness, create an evidence-based list of prescribed drugs to be developed as part of the Canadian Drug Agency and ensure that the Government of Canada works collaboratively with provinces, territories, and stakeholders to establish the national strategy for rare disease.

Time is a precious resource for all and especially for those living with a debilitating rare disease. I encourage Nickel Belt – Greater Sudbury families to share their stories of living with rare diseases such ALS, Cystic Fybrosis, Muscular Dystrophy, and others. Know that we will continue to work hard to offer and hope and solutions. Although we can be proud of the strides we’ve made there is more work to do and we must continue to fight for a better future with a coordinated approach with the private sector and our departments.

Marc G. Serré
MP Nickel Belt
1-800-267-4829

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Important link
Patented Medicine Prices Review Board