The Québec government's draft Regulation1 under the Act respecting prescription drug insurance (Act), concerning exceptions to the general prohibition on a manufacturer covering some or all of the costs of a drug for a patient, was published in the Gazette officielle du Québec on July 4.2
What You Need To Know
If the Regulation is enacted as currently drafted, a manufacturer, wholesaler or intermediary in the drug supply chain would be permitted to provide free or discounted drug products for drugs that are covered by RAMQ, in the following circumstances.
- The drug is not subject to the lowest price method on the RAMQ List of Medications.3
- The drug does not have a generic or biosimilar version on the RAMQ List of Medications.
- If the patient has already received payment or reimbursement for that same drug before the coming into force of s. 80.2(1) of the Act, that patient may continue to receive free or discounted drug product.
This regulation only applies to drugs that are covered by the public drug plan, administered by RAMQ.
Impact on Drug Manufacturers
Section 80.2(1) of the Act, which will come into force at the same time as the finalized Regulation, provides that manufacturers, wholesalers and intermediaries are prohibited from paying or reimbursing a medication or supply covered by RAMQ, except to the extent provided by Regulation, in particular for "humanitarian reasons."
Although many expected the government to provide clarification on what constitutes "humanitarian reasons," this was not set out in the draft Regulation. Rather, the Regulation provides three circumstances where a person covered by RAMQ can receive payment or reimbursement for a drug. Thus the impact of the draft Regulation is less far-reaching than was initially anticipated, given that manufacturers can still offer support which does not need to be limited to patients who demonstrate financial need. The prohibition is more directly aimed at brand loyalty card programs (i.e., programs where a brand product would be made available to a patient at the cost of the generic drug).
Manufacturers are permitted to provide support to patients for a branded drug until a generic or biosimilar of the drug is entered on RAMQ's List of Medications. Manufacturers should inform patients that the support will be terminated once a generic or biosimilar is insured by RAMQ, in order to ensure transparency from the patient's perspective.
Free or discounted drugs may continue to be provided in the case of branded drugs if a patient received such product or reimbursement by the manufacturer for that same drug before s. 80.2(1) of the Act comes into force, regardless of whether the product has a generic or biosimilar version. New patients may not participate in these programs once s 80.2(1) of the Act comes into force.
Comment Period and Coming Into Force Date
Anyone may submit written comments on the draft Regulation to the Minister of Health and Social Services by August 18, 2018. The Regulation, as well as s. 80.2(1) of the Act, will come into force 15 days after the final Regulation's publication in the Gazette officielle du Québec.
Read "The Impact of Québec's Bill 92 on Arrangements between Manufacturers and Pharmacies, and Patient Support" for more insight from our team.
1 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.
2 See s. 80.2(1) of an Act respecting prescription drug insurance (CQLR c A-29.01) [Act].
3 See Schedule V of the List of Medications, published pursuant to s. 60 of an Act respecting prescription drug insurance, CQLR c A-29.01.
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.
© 2018 by Torys LLP.
All rights reserved.