As of April 15, 2021, Quebec brings into force its prohibition on drug manufacturers paying or reimbursing, in whole or in part, the price of a medication covered by the province’s prescription drug plan, except as provided by regulation.
In late 2016, Quebec adopted Bill 92, which introduced a number of prohibitions related to the distribution and pricing of medications listed on the provincial List of Medications. As previously reported here, Bill 92 amended the Act respecting prescription drug insurance by introducing Section 80.2(1), which would prohibit an accredited manufacturer, wholesaler or intermediary from paying or reimbursing a patient for the price, or part of the price, of a medication or supply covered by the basic prescription drug insurance plan, except as permitted by regulation. However, Bill 92 delayed the coming into force of this prohibition until the government made accompanying regulations. The regulation has now been introduced and, accordingly, the Section 80.2(1) prohibition will come into force on April 15.
More specifically, on March 31, 2021, Quebec published the 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. Despite the Section 80.2(1) prohibition, the new regulation allows manufacturers, wholesalers and intermediaries to pay or reimburse a person covered by the basic prescription drug insurance plan, all or part of the cost of medications entered on the List of Medications only in the following circumstances:
- where the lowest price method does not apply; or
- where a generic or biosimilar version is not entered on the list.
These exceptions are the same as the ones provided in draft regulations published in 2018.
The new regulations also provide that where a medication no longer falls within an exemption, a price reimbursement begun while the medication was exempted may continue for a further 30 days.
Finally, the regulation grandfathers anyone who was receiving a reimbursement of a drug’s price prior to the prohibition coming into force. Such people may continue to benefit from full or partial price reimbursements even after April 15.
Manufacturers frequently assist patients prescribed expensive medications by paying all or a portion of the price the patient would otherwise have to pay. This is done for a number of reasons. It may be for humanitarian reasons, assisting people who might otherwise have difficulty paying. It may be done to close the gap between the price of a brand drug and a generic drug. It is also sometimes offered as a temporary pricing bridge to allow a patient to immediately begin benefitting from a new but expensive medication in anticipation of it being added to the provincial List of Medications. With the new regulations coming into force, manufacturers will need to reassess their assistance programs.