Statement from Minister of Health on the Coming-into-Force of the Regulations Amending the Patented Medicines Regulations

 OTTAWA, ON, April 14, 2022 /CNW/ - Today, the Honourable Jean-Yves Duclos, Minister of Health, issued the following statement:

The Government of Canada is committed to improving access to quality medicines for Canadians. Today, our government announced that it will proceed with Amendments to the Patented Medicines Regulations to provide the Patented Medicine Prices Review Board (PMPRB) with new tools to protect Canadians from excessive prices for patented medicines.

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.

After consulting with stakeholders on a way forward in March 2022, Health Canada will be moving forward with the implementation of the new basket of comparator countries and reduced reporting requirements for those medicines at lowest risk of excessive pricing. These Amendments will come-into-force on July 1, 2022.

The Government will not proceed with the Amendments related to the new price regulatory factors, nor with the requirements to file information net of all price adjustments. This will be reflected in Canada Gazette in late Spring 2022.

The Amendments, originally proposed in 2019, were the first substantive update to the regulations in more than 30 years. Since then, the pharmaceutical landscape has shifted dramatically, a new context has developed brought on by the COVID-19 pandemic, coupled with the progression of various initiatives seeking to improve accessibility and affordability for needed medicines.

In addition to these regulatory changes, the Government continues its work to streamline the approval of new drugs, advance on universal national pharmacare, develop a national strategy for drugs for rare diseases, and proceed with an ambitious biomanufacturing and life sciences strategy.

SOURCE Health Canada

Marie-France Proulx, Press Secretary, Office of Honourable Jean-Yves Duclos, Minister of Health, 613-957-0200; Media Relations, Health Canada, 613-957-2983, [email protected]