At the end of 2016, the previous Quebec government prohibited a number of common commercial practices by drug manufacturers and pharmacists with the aim of fostering greater price competition between drug manufacturers and reducing the cost of the public drug insurance scheme.1
Among the new prohibitions was one that would prohibit a manufacturer from offering any financial assistance to patients to help cover the cost of a drug on the provincial List of Medications (Quebec's formulary). The aim was to end the practice of brand name drug manufacturers covering the patients' portion of the cost of brand name drugs in order to make them as attractive to patients and physicians as lower cost generics. However, financial support, often offered as part of manufacturer-financed patient support programs, can also make it possible for patients to access expensive medications that would otherwise be unavailable to them. Therefore, the new prohibition provided a "humanitarian exception" which allowed financial support to continue in cases to be determined by regulation. Notably, the coming into force of the prohibition was suspended pending the adoption of such regulation.
After a long wait, the current government has now adopted a regulation creating exemptions from the prohibition.2 Both the prohibition and the regulation came into force on April 15, 2021. It is now prohibited in Quebec for a drug manufacturer, wholesaler or "intermediary" (e.g., pharmacy banner) to pay or reimburse all or part of a patient's cost of a medication listed on the Quebec List of Medications unless the medication falls within an exception set out in the new regulation.
The regulation sets out two conditions under which financial assistance will be allowed notwithstanding the prohibition:
- Where, under the Quebec insurance scheme, the medication is not reimbursed using the "lowest price method";
- Where no generic or biosimilar version of the medication is entered on the List of Medications.
The lowest price method applies where two or more drugs of the same generic name are listed on the List of Medications, subject to several exceptions such as where a patient is allergic to a non-medicinal ingredient found in the generic drug but not in the brand drug. The lowest price method also does not apply to biosimilars.
The government has not released any official guidance on how the exemptions will be interpreted or applied. It remains to be seen how the exemptions will be applied in practice. For instance, the regulation is unclear about whether a medication is exempt (and thus financial assistance allowed) if either or both conditions are satisfied. It also remains to be determined how the regulation is applied to biosimilars.
1. Prohibited Commercial Practices in Chapter IV.1, particularly section 80.2, of the Act respecting prescription drug insurance, CQLR c A-29.01.
2. Regulation respecting the exceptions to the prohibition against paying or reimbursing the price of a medication or supply covered by the basic prescription drug insurance plan, published in the Gazette officielle du Québec, March 31, 2021, Vol. 153, No. 13, http://www2.publicationsduquebec.gouv.qc.ca/dynamicSearch/telecharge.php?type=1&file=2021A%2F104957.PDF.
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