This week has seen a number of developments relating to the Patented Medicine Prices Review Board (PMPRB), including a six-month delay to the implementation of amendments to the Patented Medicines Regulations and renewed consultation by the Board on revised Draft Guidelines to implement those amendments. Meanwhile, the Federal Court is now considering a judicial review of those amendments.
Amendments to the Patented Medicines Regulations delayed
The federal government has delayed the implementation of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), which are now scheduled to come into force on January 1, 2021.
As we reported, the amendments had originally been set to come into force on July 1, 2020 and would have introduced a number of changes affecting the PMPRB’s review of patented medicine prices. These include new mandatory factors to be considered by the Board, such as pharmacoeconomic value; a requirement to include “adjustments” when computing average transaction prices reported to the Board; and a revised basket of international comparator countries for reference pricing that omitted the United States and Switzerland.
The Order in Council indicates that the purpose of the delay is:
- “to minimize the imposition of new administrative burden on industry as patented drug manufacturers face increased demands related to supply chains and shortages of existing products and, potentially, new treatments and vaccines in response to COVID-19; and”
- “to provide stakeholders a longer period in which to provide feedback to the Patented Medicine Prices Review Board’s Guidelines consultation process, which has been impacted by the COVID-19 pandemic.”
Revised PMPRB Guidelines consultation to launch soon
In parallel with the government’s decision to delay the implementation of the amendments, the PMPRB has announced that it will move forward with consultation on a revised set of Draft Guidelines to implement the amendments.
As we reported, the PMPRB’s first Draft Guidelines were released for 60 days of consultation on November 21, 2019. That consultation was subsequently extended and, according to the PMPRB, resulted in “extensive feedback” including at least 122 written submissions published to the PMPRB’s website.
The revised Draft Guidelines are expected to be released during the week of June 15, 2020 and are to be followed by a 30-day written consultation period.
Judicial review of the amendments heard in Federal Court
Meanwhile, a legal challenge to certain of the amendments was argued in a virtual hearing before Manson J. of the Federal Court on June 1 and 2. The Court has taken the matter under reserve in Court File No. T-1465-19.
For more information on virtual hearings in the Federal Court, see our recent post on this subject.