Health Canada says it’s delaying the implementation of long-awaited changes to Canada’s drug-pricing regime by another six months.
A spokesman for the department, says the amendments to patented medicine regulations, which were set to take effect Jan. 1, will now come into force on July 1. Geoffroy Legault-Thivierge says the postponement is intended to give pharmaceutical manufacturers more time to adjust to new reporting requirements while dealing with the challenges posed by the coronavirus pandemic.
The overhaul is set to recalibrate how the arm’s-length Patented Medicine Prices Review Board calculates fair prices for patented medicines. Drug manufacturers and patient advocates have balked at the plan, citing concerns that the regulations could stifle scientific innovation and reduce access to therapies for rare diseases.
Legault-Thivierge says federal and Quebec courts have upheld most of the amendments but struck down key provisions that would require manufacturers to disclose third-party rebates, including deals with provincial drug programs. He says the federal ruling is under appeal and Ottawa is reviewing the Quebec decision while it determines its next steps.
It’s been a long road to get to this point, with the PMPRB publishing draft guidelines back in November 2019 and launching an 85-day consultation period. It later released new draft guidelines and launched a 30-day consultation in June 2020. Despite the prolonged process, Innovation Medicines Canada applauded the latest delay.
“We support Health Canada’s decision to delay the implementation of the Patented Medicine Prices Review Board’s amended regulations until July 1, 2021,” said Innovative Medicines Canada in a statement on its website.
“This delay provides the time and the opportunity for government to work closely with industry, patients and other health system stakeholders on a better path forward. To that end, industry has put forward a proposal that would allow the government to achieve its public policy objectives without undermining patient access to potentially life-saving medicines, clinical trials in Canada, or investment in the country’s life sciences sector.”
Meanwhile, Canada’s life and health insurers continue to support the amendments and guidelines.
“Canada’s life and health insurers remain strong supporters of these changes,” said the Canadian Life and Health Insurance Association in an emailed statement to Benefits Canada.
“These guidelines are an important step to allow the PMPRB to continue to meet its mandate to protect Canadians from excessive prescription drug prices. Through workplace benefit plans, insurers provide employers and their employees with access to over 11,000 patented medicines — which include an increasing number of high-cost drugs. Lower drug costs will help to keep these workplace plans sustainable. We are disappointed that the implementation of these reforms has been further delayed and encourage the government to move forward in July with no further delays.”