As reported earlier this month, the Patented Medicine Prices Review Board has published a new draft of its guidelines and launched a 30-day written consultation period.

While the law and regulations have already been passed, the implementation has been delayed from July 1, 2020 to Jan. 1, 2021. The new draft guidelines are in response to stakeholder feedback on an earlier draft that was released in November 2019 for an 85-day consultation period.

Read: PMPRB to publish new draft guidelines, open up final consultation

“PMPRB guidelines are necessary to operationalize regulatory amendments,” says Suzanne Lepage, a private health plan strategist. “The guidelines outline the mechanisms of how PMPRB staff will administer the regulations and how pharmaceutical companies should comply with the filing requirements.”

The new legislation and regulations have already created two new drug categories, she notes. “Once PMPRB has classified new patented drugs as either high or low priority based on their anticipated impact on Canadian consumers, the high priority drugs are subjected to a more comprehensive price review.”

In the new draft guidelines, the thresholds for identifying high-priority drugs has changed. “It will take time before industry drug pricing experts can analyze and determine the full impact of these new draft guidelines on Canadian drug prices and the pharmaceutical market,” says Lepage.

Read: What will PMPRB drug pricing changes mean for plan sponsors?

In a statement, Innovations Medicine Canada said it will be examining the revised guidelines closely, in consultation with its members.

“We remain deeply concerned about the impact the amended patented medicines regulations will have on Canadians’ access to affordable, innovative medicines and on the country’s ability to attract investment to our life sciences sector. As the COVID-19 crisis has shown, Canada’s innovative medicines companies are vital to the health and well-being of all Canadians and we need a regulatory environment that encourages it to grow and thrive. We look forward to actively participating in the 30-day consultation process.

“It is not too late to find a solution that will prevent negative consequences of the amended regulations, while still allowing the federal government to meet their public policy objectives.”

Read: Proposed PMPRB changes could limit Canada’s access to new drugs: report

The PMPRB will also be hosting two webinars on the new draft guidelines. The first, on June 29, is for the industry and the second, on July 8, is for the public. It will also host three research webinars on topics expected to inform the consultation:

  • On June 23 — Insight into spending on expensive drugs for rare diseases and insights into market size for patented medicine in Canada;
  • On July 6 — Drug pricing and its impact on R&D investments, clinical trials and availability of medicines in Canada; and
  • July 16 — Drug shortages in Canada.

Visit the PMPRB for more information or to register for the webinars.

Read: Pharma companies launching challenge to PMPRB changes