Canada amends its drug pricing regulations

Home/Policies & Legislation | Posted 25/10/2019 post-comment0 Post your comment

The Canadian Government has released final amendments to its Patented Medicines Regulations. The amendments, according to the Canadian Government, represent ‘the most significant reforms to the regulations since their introduction in 1987’ and are also a significant departure from the existing framework.

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Canada has in the past paid more for generics than other developed nations [1]. The amendments aim to better protect Canadians from excessive prices of patented drugs by giving the Patented Medicine Prices Review Board (PMPRB) new regulatory tools.

Major changes to the regulations introduced by three amendments including:
• Changing the ‘basket’ of countries Canada compares when setting drug prices, so that prices here are judged against countries that actually look like Canada in terms of population, economy and approach to health care.
• Providing the PMPRB with the actual market price of medicines in Canada – rather than inflated list or ‘sticker’ price – to more accurately assess whether a price is reasonable when setting a price ceiling.
• Allowing the PMPRB to consider whether the price of a drug actually reflects the value it has for patients.

The two countries with the highest prices – US and Switzerland – will no longer be comparison countries under the amended regulations. A move the government says will allow the ‘basket’ to better reflect Canada's population, economy and approach to health care.

Minister of Health, Ginette Petitpas Taylor, said that the country has taken ‘the biggest step to lower drug prices in a generation’. She added that the country is building on the progress it has already made towards lower drug prices, and that ‘these bold reforms will both make prescription drugs more affordable and accessible for all Canadians – saving them an estimated CA$13 billion dollars in the next decade – and laying the foundation for National Pharmacare’.

The amendments were originally proposed back in 2017, with a target date for the amended regulations to come into force in January. However, opposition led to their entry into force being delayed. The amended regulations will now come into force on 1 July 2020.

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1. GaBI Online - Generics and Biosimilars Initiative. Canada’s generics are too expensive []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 25]. Available from:

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Source: Government of Canada

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