On April 20, 2015, the Quebec National Assembly passed Bill 28, An Act mainly to implement certain provisions of the Budget Speech of 4 June 2014 and return to a balanced budget in 2015-2016 (Bill), which was tabled in November 2014 by the Minister of Finance, Mr. Carlos Leitao. The Bill, as passed, and now in force, introduces a range of measures in a number of sectors including health.
Among other things, the Bill allows the Minister of Health and
Social Services (Minister), before entering a
medication on the list of medications, to make listing agreements
with the manufacturers for drugs whose cost is covered under the
basic prescription drug insurance plan. However, such agreements
will only be possible if procurement of the medication is not
subject to the public call for tenders process.1
Once made, the listing agreements, which provide for the payment of sums by the manufacturers to the Minister (by means of a rebate or discount), will aim to reduce prescription drug procurement costs.
Possible temporary exclusion of medications from basic plan coverage
For the purpose of making such an agreement, the Minister may temporarily exclude from basic plan coverage any medication that is the subject of negotiations and whose cost would normally be covered by the Act respecting prescription drug insurance2. Such an exclusion will come into force on the date of its publication on the website of the Régie de l'assurance maladie du Québec and will remain in effect until a new notice ending the exclusion is published.3
Confidential nature of listing agreements
The Bill includes measures to ensure the terms and conditions of the listing agreements remain confidential. In this regard, the Bill specifies that despite section 9 of the Act respecting access to documents held by public bodies and the protection of personal information,4 "no person has a right of access to a listing agreement."5 The Act provides that only the name of the manufacturer, the name of the medication and the annual total sum received pursuant to the listing agreements (if at least three agreements made with different drug manufacturers are in force in the same fiscal year) will be published in the annual financial report of the Prescription Drug Insurance Fund.6
The Bill also provides that the recommendation of the Institut national d'excellence en santé et en services sociaux (INESSS) about a medication that is the subject of negotiations will not be published 60 days after it is sent to the Minister, as is the usual process under the law. Instead, the recommendation will be published at a time determined by the Minister, which, however, may not be later than 30 days after the publication of a notice ending the medication's exclusion.
Possibility of joining the Pan-Canadian Pharmaceutical Alliance
By permitting listing agreements, the Bill also allows Quebec to join the Pan-Canadian Pharmaceutical Alliance, which means Quebec will be able to work with other provinces and territories to obtain advantageous prices on brand name and generic prescription drugs covered under the public prescription drug insurance plans.
By permitting listing agreements, the Bill introduced major changes in the health sector. These provisions, in addition to altering the negotiating dynamics for the procurement of prescription drugs, will bring Quebec's practices into line with those of other provinces. It would now be interesting to see how the legislative changes afore-discussed will be implemented in relation to the other measures introduced by the Bill, and most particularly the budget-cutting measures.
1 CQLR c C-65.1.
2 CQLR c A-29.01.
3 The proposed amendments to the Act respecting prescription drug insurance specify, among other things, that such notices are not subject to the publication requirement or the date of coming into force set out in sections 8, 15 and 17 of the Regulations Act, CQLR c R-18.1, which means that such notice may come into force on the date of their publication on the website (or any other date specified in such notices).
4 CQLR c A-2.1.
5 Bill, s 179. (This principle will be integrated into section 116.1 of the Act respecting health services and social services, CQLR c S 4.2.
6 Act respecting the Régie de l'assurance maladie du Québec, CQLR c R-5, s 40.9.
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