February 12, 2019
The Quebec Court of Appeal has ordered Remicade to be reinstated on the Quebec List of Medications (RAMQ).
Back in February 2017, Quebec’s Minister of Health, Dr. Gaétan Barrette, removed REMICADE from the RAMQ and replaced it with the biosimilar, INFLECTRA, following the negotiation of a product listing agreement. As per s. 60.0.4 of the Act respecting prescription drug insurance, the Minister may suspend coverage when a competing drug has entered into a listing agreement.1
However, the Court found that the Minister did not meet the principles of fairness in that i) Janssen did not receive sufficient notice that such a decision was to be made, ii) Janssen did not have an opportunity to submit comments relevant to the decision and iii) Janssen was not provided reasons for the decision.
There had been five meetings between October 2015 and August 2016 between the Minister and Janssen and the last unit price offered by Janssen allowed substantial discounts for public finances. In these circumstances, basic procedural fairness required notice, an opportunity to meet with the Minister to understand the reasons for the government’s decision and to give Janssen the opportunity to respond.2
This Court of Appeal decision was based solely on the fact that procedural fairness was not met, given this was an administrative decision. We will monitor the situation as it evolves over next few months and keep everyone updated on changes to RAMQ.
For more information, please contact Ghislain Gauthier.