With the Royal Assent of Québec Bill 28, the Minister of Health and Social Services (the Minister) can now enter into product listing agreements (PLAs) with pharmaceutical drug manufacturers. Bill 28 was an omnibus bill tabled at the Québec National Assembly last November, with the overall goal of balancing the Québec budget.1 The provisions related to PLAs are in force as of April 21, 2015.
What You Need To Know
- Bill 28 amends the Act respecting prescription drug insurance and the Act respecting health services and social services to permit the Minister to enter into a PLA with a drug manufacturer prior to having the manufacturer’s drug added to Québec’s provincial formulary (List of Medications).
- PLAs will not be entered into with respect to drug products that are subject to the public tender process.
- In line with the overarching purpose of Bill 28 to reduce government costs, the stated purpose of a PLA is to permit payments to the Minister “by means of a rebate or discount which may vary according to the volume of sales” in Québec.
- The amendments provide that third parties do not have a right of access to PLAs under provincial freedom-of-information legislation; however, an annual report will be published that will list the names of manufacturers that have entered into PLAs, the products to which the PLAs pertain, and the total annual sum received by the Minister pursuant to PLAs, provided that at least three PLAs are in force in the given year. This level of disclosure is consistent with the approach taken by the Ontario Ministry of Health and Long-Term Care.
The amendments present an opportunity for drug manufacturers to reconsider market access strategies in Québec. Many drug manufacturers will be familiar with PLAs from their interactions with other provincial governments, and will now have to consider what rebates they are willing to offer the Minister given the volume of sales in Québec, and what commercial impact these rebates will have on Canadian business as a whole.
1 For Québec Bill 28, see: http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=5&file=2015C8A.PDF.
To discuss these issues, please contact the author(s).
This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.
For permission to republish this or any other publication, contact Janelle Weed.
© 2017 by Torys LLP.
All rights reserved.