Regulations on Drug Manufacturers and Pharmacists Proposed for Québec

On October 5, the Québec government introduced Bill 148, An Act to regulate generic medication procurement by owner pharmacists and to amend various legislative provisions.1 If enacted, the amendments to legislation would prohibit a pharmacy from purchasing more than 50% of its generic drugs from a single manufacturer.

What You Need To Know

If the proposed amendments come into force:

  • Pharmacies would be prohibited from procuring more than 50% of the value of all generic drugs listed on the Régie de l'assurance maladie du Québec's (RAMQ) list of medications purchased within a year from the same drug manufacturer.
    • A pharmacy may exceed the 50% limit by up to 5% in a calendar year provided the limit is reduced accordingly the following year.
  • Pharmacies will be required to report their purchases of each brand of generic drugs on an annual basis.
  • Contravention of this regulation could result in a fine between $10,000 and $100,000.

Background

Québec has been active in introducing new regulations which impact the pharmaceutical sector. We have previously reported on Bill 922 which regulates the commercial practices between drug manufacturers, wholesalers, and pharmacies, and limits a manufacturers' ability to offer financial assistance or reimbursement to patients.3

More recently, Québec proposed legislation to reinstate a 15% cap on professional allowances paid to pharmacies.4 Bill 148 is the latest proposal and is aimed at prohibiting exclusive supply chain arrangement in this industry.

We will continue to monitor the progression of this Bill and report on developments in this sector.

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1 See: http://www.assnat.qc.ca/Media/Process.aspx?MediaId=ANQ.Vigie.Bll.DocumentGenerique_132523en&process=Default&token=ZyMoxNwUn8ikQ+TRKYwPCjWrKwg+vIv9rjij7p3xLGTZDmLVSmJLoqe/vG7/YWzz

2 See: https://www.torys.com/insights/publications/2017/01/the-impact-of-quebecs-bill-92-on-arrangements-between-manufacturers-and-pharmacies-and-patient-support. Certain provisions are not yet in force, pending enactment of regulations.

3 See: http://www.assnat.qc.ca/en/travaux-parlementaires/projets-loi/projet-loi-92-41-1.html

4 See: https://www.torys.com/insights/publications/2017/08/the-cap-is-back-quebec-to-reinstate-professional-allowances-cap

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.

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