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Quebec cracks down again: a bill to regulate generic medication procurement by pharmacists

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Life Sciences - Health Bulletin

The Minister of Health and Social Services tabled Bill n° 148 – An Act to regulate generic medication procurement by owner pharmacists and to amend various legislative provisions during the October 5, 2017 session.

The purpose of the bill is to impose new restrictions on the commercial practices of owner pharmacists in Quebec.

More specifically, Bill n° 148 provides that an owner pharmacist may not, in a calendar year, procure generic medications from the same manufacturer in excess of 50% of the monetary value of all the generic medications purchased by that pharmacist during that year, subject to certain exceptions.

Current exceptions would allow for the limit to be exceeded by a maximum of 5 percentage points during a calendar year, in which case, the purchase limit is reduced accordingly the following calendar year. [Our interpretation: If a pharmacist purchases 52% of generic medications from the same manufacturer in a given year, the purchase limit for the following year will be 48% rather than 50%.]

The new measures introduced by Minister Barrette are in line with recent amendments to the Act respecting prescription drug insurance (CQLR, c. A-29.01) (APDI), which are aimed at banning certain commercial practices in connection with the distribution chain for medications listed on the List of Medications and reimbursed by the Régie de l’assurance maladie du Québec (RAMQ). Under section 80.1 of the APDI, currently in force, “[a]n accredited manufacturer may not enter into an exclusive agreement with an accredited wholesaler or an intermediary to supply a pharmacy with a medication or supply entered on the list of medications.” The additional restriction provided for in Bill n° 148 would impose, in addition to the above exclusivity ban, a limit on generic medications purchased by a pharmacist from the same manufacturer.  For the time being, the proposed additional restrictions do not appear to apply to transactions between wholesalers and owner pharmacists, who would not be affected by the 50% limit under the current wording of the proposals.

Moreover, to monitor owner pharmacists and identify any non-compliance with the proposed restrictions, Bill n° 148 also requires all owner pharmacists to report annually to the RAMQ on their purchases of each brand of generic medication procured.

Fines of as much as $100,000 would be imposed on non-compliant owner pharmacists.

It goes without saying that the new restrictions introduced on October 5 will bring about a real paradigm shift for all stakeholders involved in Quebec’s distribution chain for generic medications, particularly owner pharmacists and generic drug manufacturers, but also wholesalers and major pharmacy chains.

The proposed restrictions could also impact patient rights, including the right of patients to choose their pharmacist. For instance, if a pharmacist has reached his or her limit for supply by a generic drug manufacturer and the patient wishes to continue on this manufacturer’s medication, then the patient will have no choice but to go to another pharmacy. In this context, the new 50% rule appears inconsistent with the most recent APDI amendments, which seek in particular to protect the patient’s freedom of choice.

Bill n° 148 will undoubtedly be the topic of much discussion. It could be modified or amended as it makes its way through the National Assembly. We strongly urge key stakeholders to make their voices heard as soon as possible.





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