Update – PMPRB Response to the April 14, 2022 statement from Minister of Health on the Coming-into-Force of the 2019 Regulations Amending the Patented Medicines Regulations

In August 2019, the Government announced the adoption of Health Canada-sponsored amendments to the Patented Medicines Regulations which, upon coming into force, would change how the PMPRB regulates the ceiling price of patented medicines These amendments were originally slated to come into force in July of 2020 but were pushed back to July 2022 owing to the ongoing COVID-19 pandemic. After a recent round of consultations with stakeholders, on April 14, 2022, the Minister of Health, the Honourable Jean-Yves Duclos, issued a statement regarding Health Canada’s intentions with respect to the coming into force of these amendment.

In October 2020, after a year-long consultation, the Board issued revised guidelines which would operationalize the August 2019 regulatory package upon its coming into force. In the meantime, the PMPRB continues to administer the regulatory framework based on the existing guidelines. As neither the existing nor the October 2020 guidelines contemplate the regulatory framework which is now expected to come into force on July 1, 2022, it will be necessary for the Board to consult on a new and different set of guidelines in the coming months. In order to provide stakeholders with a reasonable period of time to provide feedback on these new guidelines, it will not be possible to finalize them by the July 1, 2022, coming into force date of the regulatory amendments. As a result, although rights holders will be required, by operation of law, to begin reporting price information based on the new group of countries as of July 1, 2022, the PMPRB will not have any guidelines to apply at that time. Accordingly, once a final set of new guidelines is issued and the price tests that apply to the new basket of countries are known, rights holders will be provided with a reasonable period of time to take the necessary steps to come into voluntary compliance with them on a go forward basis. In the interim, the Board will also hold an expedited written consultation on what price tests should apply during this temporary period when neither the old nor the new guidelines are in effect.

Details on the upcoming consultation process will be communicated upon publication of the new draft guidelines.  The Board will make every effort to develop and publish the new draft in a timely fashion but no timetable can be set for doing so until the revised regulatory package is reflected in the Canada Gazette later this Spring. Once that happens, the Board will issue draft guidance on the provisional price tests to apply during the above-mentioned interim period, followed by a targeted consultation with key stakeholders.