Late summer reading: new regulations for patented medicines.

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The federal government has formally released its amendments to the Patented Medicines Regulations Act, with the publication of the August 21 edition of Canada Gazette Part II. The new regulations will come into effect on July 1, 2020.

With these amended regulations in hand, Canada’s Patented Medicine Prices Review Board (PMPRB) will proceed with significant reforms to how it sets price ceilings for patented medicines. This marks the biggest change to PMPRB’s regulatory framework in 30 years. PMPRB projects $8.8 billion in savings over the next 10 years, and on its website it states: “The amendments bring significant enhancements to the PMPRB regulatory regime and provide it with the tools and information it needs to protect Canadians from excessive medicine prices today and into the future.”

As summarized at TELUS Health’s annual conference this spring, the framework will change in three main ways:

  1. Pricing will be benchmarked against comparator countries that PMPRB has deemed to be more like Canada economically, and from the standpoint of consumer price protection.
  2. Regulatory price review will be based on actual prices paid in Canada, taking into account confidential discounts and rebates provided to payers.
  3. The maximum price will consider the overall value of a medicine using factors such as pharmacoeconomic analysis, market size, and affordability for both payers and patients based on national and per capita GDP.

The PMPRB will drop two countries from its current basket of seven countries—the U.S. and Switzerland—and it will add six countries, for a total of 11 comparator countries. The “PMPRB11” countries are: Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden and the United Kingdom. South Korea had also originally been proposed, for a total of 12 comparator countries, but is not included in the final list.

To operationalize the new regulations, PMPRB is drafting new Guidelines for patentees. It anticipates releasing the draft guidelines early in the fall, for consultations with industry stakeholders and members of the public. More details are available in a Q&A section on PMPRB’s website. The final report of a steering committee, comprised of multiple stakeholders tasked with providing input on technical and operational aspects for the new Guidelines, can also be found on the site.

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