Update on the amendments to the Patented Medicines Regulations – Government will not proceed with certain amendments

3 minute read
21 April 2022

As previously reported, the coming into force of the amendments to the Patented Medicines Regulations was deferred until July 1, 2022.

On April 14, 2022, the Honourable Jean-Yves Duclos, Minister of Health, announced that the Government would only proceed with a portion of the amendments previously announced. The Minister's statement announced:

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.[1]

The Minister's announcement that certain portions of the amendments would not proceed comes after a decision by the Court of Appeal of Québec striking down the new price calculation and the new mandatory factors, holding those amendments to be ultra vires.

Once the amendments deemed by the Government to proceed come into force on July 1, 2022, the new basket of comparator countries will include Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, and the United Kingdom. The countries that will be removed from the basket of comparator countries are Switzerland and the United States.

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