New ban on reimbursements affecting patient support programs

As of April 15, 2021, manufacturers, wholesalers and other intermediaries in the drug supply chain are subject to a new prohibition as a result of the enactment of the Regulation respecting exceptions to the prohibition against paying or reimbursing the price of a medication or supply covered by the basic prescription drug insurance plan¹ (the “Regulation”). As its name implies, this Regulation expands on the list of business practices already proscribed by prohibiting the above-mentioned stakeholders from paying or reimbursing anyone covered by the basic prescription drug insurance plan for the price of a medication or supply covered by this plan. Although exceptions are listed in the Regulation, the ban may affect the continuity of existing patient support programs and establish limits that must be considered in the implementation of new programs by pharmaceutical industry stakeholders in Quebec.

The coming into force of this prohibition is part of an ongoing legislative and regulatory process that began in December 2016 with the adoption of Bill 92, An Act to extend the powers of the Régie de l’assurance maladie du Québec, regulate commercial practices relating to prescription drugs and protect access to voluntary termination of pregnancy services.² The legislator’s expressed intention in passing the Bill was to tighten the framework of commercial practices for those involved in the marketing of medications.³ The addition of section 80.2 to the Act respecting prescription drug insurance⁴ (“APDI”), which specifies the prohibited commercial practices, including the one governed by the Regulation, is in line with this intention.

The provision in question reads as follows:

80.2. An accredited manufacturer or wholesaler may not, nor may an intermediary,

1. pay or reimburse to a person covered by the basic plan all or part of the price of a medication or supply covered by the plan, except to the extent provided for by ministerial regulation, in particular for humanitarian reasons;

[…]

The coming into force of section 80.2(1) APDI was subject to the enactment of a regulation setting out its scope.⁵ On July 4, 2018, a first (and only) draft regulation on permitted exceptions to the prohibition in section 80.2(1) APDI was published. It remained dormant until March 31 of this year when the Regulation was finally published in the Gazette officielle du Québec. It came into force 15 days later, on April 15, 2021.⁶

The Regulation creates limited exceptions to the prohibition in section 80.2(1) APDI. It specifies the circumstances in which manufacturers, wholesalers and intermediaries may pay or reimburse the price of a medication to a person covered by the basic insurance plan. Specifically:

• when the medication is included on the List of Medications (the “List”) but is not subject to the lowest price method;⁷
• when no generic or biosimilar version is listed;⁸ or
• when a person covered by the basic plan was already benefiting from such financial treatment for this medication before the coming into force of section 80.2(1) of the Act on April 15, 2021.⁹

The Regulation thus provides a “grandfather” clause, which allows for the continuation of existing support programs if the patient was receiving payment or reimbursement for the medication prior to the coming into force of the Regulation, even if the medication is not now otherwise included in the exceptions.

Furthermore, if a medication covered by these exceptions ceases to be included in these categories—either because it becomes subject to the lowest price method or because a generic or biosimilar version is added to the List—the stakeholder may continue to pay or reimburse the patient for up to 30 days following this change.¹⁰

Interestingly, while section 80.2(1) APDI suggests that this prohibition could be subject to an exception for humanitarian reasons, the Regulation is silent on this point.

It should be noted that the Regulation leaves some room for interpretation with respect to the application of the first two exceptions. First, with regard to medications that are not subject to the lowest price method, it is not clear whether this concept is limited to medications listed in Schedule V of the List or whether it also includes medications not subject to the lowest price method because of a “do not substitute” statement on the prescription, or for other reasons set out in the List.¹¹ Similarly, the terms “generic” and “biosimilar” are not defined by the legislator or the Regulation.

Consequently, there remains some ambiguity about the scope of these exceptions, both for existing support programs and those under development. It is therefore essential for all industry stakeholders, from drug manufacturers to specialty pharmacists, to ensure that their support programs are compliant with this new regulatory reality.

¹ Ministerial Order 2021-014 of the Minister of Health and Social Services dated 15 March 2021: Regulation respecting exceptions to the prohibition against paying or reimbursing the price of a medication or supply covered by the basic prescription drug insurance plan.
² Bill 92 (2016, c. 28).
³ Ministry of Health and Social Services, Analyse d’impact réglementaire : Projet de loi visant à accroître les pouvoirs de la Régie de l’assurance maladie du Québec et modifiant diverses dispositions législatives, 14 November 2016.
⁴ Chapter A-29.01.
⁵ Bill 92 (2016, c. 28), s. 84.
⁶ Regulation respecting exceptions to the prohibition against paying or reimbursing the price of a medication or supply covered by the basic prescription drug insurance plan, s. 4.
⁷ Regulation respecting exceptions to the prohibition against paying or reimbursing the price of a medication or supply covered by the basic prescription drug insurance plan, s. 1(1).
⁸ Regulation respecting exceptions to the prohibition against paying or reimbursing the price of a medication or supply covered by the basic prescription drug insurance plan, s. 1(2).
⁹ Regulation respecting exceptions to the prohibition against paying or reimbursing the price of a medication or supply covered by the basic prescription drug insurance plan, s. 3.
¹⁰ Regulation respecting exceptions to the prohibition against paying or reimbursing the price of a medication or supply covered by the basic prescription drug insurance plan, s. 2.
¹¹ See section 2.2.3 of the List of Medications (April 14, 2021).