Innovators Applaud Canada’s Decision NOT to Proceed with Excessive Price Factor Amendments

In April, the Canadian Ministry of Health announced the government would not be proceeding with certain proposed amendments to the Patented Medicines Regulations which govern the Patented Medicine Prices Review Board (PMPRB)—amendments related to new excessive price factors. The decision, well-received by Innovative Medicines Canada, came after these controversial economic drug pricing factors, which included cost effectiveness, market size, GDP and the reporting of third-party rebates, were found to be unconstitutional by the Quebec Court of Appeal.

Alternatively, the Canadian government will proceed with the proposed amendments pertaining to the schedule of reference countries. This new basket of countries is due to consist of the so-called “PMPRB11” which removes the U.S. and Switzerland and consists of 11 countries that all regulate the price of medicines. This change could still have a significant impact on the prices of patented medicines and Innovative Medicines Canada expressed scepticism.

“Changing the basket of comparator countries to include a range of countries that is not reflective of the country’s economic status provides greater predictability but does little to cultivate the competitive market needed to attract global investment and to ensure access to the best medicines for Canadians,” read the organisation’s statement.

Originally proposed in 2012, the amendments were the first major update to the regulations in more than 30 years. During that time, the pharmaceutical landscape has evolved considerably, the COVID-19 pandemic raised a number of questions about accessibility and various initiatives to improve accessibility and affordability have emerged.

“This will improve access for Canadians to quality medicines while generating significant savings over the coming years. At the same time, these changes will ensure the sustainability of the healthcare system, while supporting innovation and investment in the pharmaceutical sector,” said Jean-Yves Duclos, Minister of Health.

The Amendments are set to come into force in July.