Proposed regulatory changes denying access to life-saving drug for thousands of Canadians
OTTAWA (March 11, 2020) – Cystic Fibrosis Canada leaders and patient advocates are meeting with government officials in Ottawa, and across the country, to call for changes to proposed regulatory reforms that are blocking access to a new breakthrough drug to treat cystic fibrosis.
Trikafta is a new drug that could help up to 90% of patients living with cystic fibrosis but it is not available to Canadians living with the disease. Trikafta is already approved and currently available in the United States, and is being hailed as the single biggest advancement in treating cystic fibrosis in history.
The manufacturer of Trikafta, Vertex Pharmaceuticals, says its concern about proposed changes to Canada’s regulations for patented medicines is the reason the product has not been launched in Canada.
Cystic Fibrosis Canada is calling on the federal government to reconsider the proposed changes to Canada’s regulations for patented medicines so that Canadians can get access to potentially life-saving therapies.
The regulatory changes were first proposed in 2017 by the Patented Medicines Prices Review Board (PMPRB). The proposed regulations would change the way the Board determines whether a drug is being sold at an “excessive” price. It’s estimated the new regulations would force patented drug manufacturers to drop their prices as much as 45-75%.
For more than two years, patient groups and health charities have consistently raised concerns that the changes will reduce the availability of new, expensive drugs.
“Despite repeated assurances from the PMPRB and the federal government that these proposed changes would not impact the availability of new medications, we are here to say today that not only have the proposed changes delayed access to a life-saving treatment for cystic fibrosis patients, but the changes will affect other Canadians living with different illnesses and diseases in the future,” said Kelly Grover, CEO of Cystic Fibrosis Canada. “We appreciate the need to limit excessive pricing, but any changes must not create additional barriers to access to life-saving drugs for Canadians.”
Cystic Fibrosis Canada is also calling on federal and provincial governments, regulators and the manufacturer to work together to fast-track the approval of Trikafta so that it gets to those who need it now. The lives of thousands of Canadians depend on immediate action.
For more information or to arrange an interview, please contact:
Kenya Francis, Associate, Corporate Communications
Cystic Fibrosis Canada
Tel: 416-485-9149 ext. 203
Tel: 1-800-378-2233 ext. 203
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