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.

Pay for Delay DrugsMoneyGeneric V13F21

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.

Related article
Health Canada issues draft guidance on generics labelling and equivalence

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: Government of Canada

comment icon Comments (0)
Post your comment
Related content
Public consultation for the modification of the biosimilars regulation
02 AA010638
Home/Policies & Legislation Posted 16/01/2024
COFEPRIS promotes regulatory cooperation in the Americas
Latin America 1638px
Home/Policies & Legislation Posted 12/12/2023
ANVISA's decision on 'Skinny labels' for generics pending
Labelling V14I26
Home/Policies & Legislation Posted 14/11/2023
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010