On April 21, 2015 the Québec government called a special legislative sitting in order to fast-track Bill 28 through the National Assembly. As previously reported, one of the key measures in Bill 28 explicitly allows the Minister of Health and Social Services (the "Minister") to conclude a listing agreement with a drug manufacturer before it is entered on the List of Medications. This is a significant shift in Québec's reimbursement policy.
These listing agreements would, in most cases, provide for the payment of sums by the manufacturer to the Minister in the form of a rebate or discount which will vary according to the drug sales of the product.
The language of Bill 28 suggests that these agreements should apply only before a product is listed. Therefore, in principle, Bill 28 should not have a retroactive effect on drugs already on the List of Medications.
For pharmaceutical manufacturers, listing agreements may provide an opportunity to gain public reimbursement for their products. They can be especially useful when the province has refused to list a product based on cost effectiveness.
For its part, the province can gain better access to certain drugs, even leading to economies of scale when volume discounts or rebates are involved.
Recent Amendments to the Bill
A number of important amendments were made to the initial version of the Bill:
First, for the purpose of concluding a listing agreement, the Minister may temporarily exclude a drug covered under the "Patient d'exception" (General List of Medications) or covered under "Medicines for specific medical requirements" (Health Institutions' List of Medications) from public reimbursement.
The exception patient measure allows for exceptional financial coverage of drugs not appearing on the List of Medications. This measure can be used only under exceptional circumstances; as a treatment of last resort for a chronic and serious medical condition, to pay for medications (for an authorized period) that would otherwise not be covered by the basic plan. In such cases, however, the treating physician must send the Régie de l'assurance maladie du Québec ("RAMQ") a payment authorization request.
Likewise, in the hospital setting, a health care institution can furnish a drug that is not on the List of Medications – Institutions for specific medical requirement purposes. In such cases, the physician or dentist who intends to use or prescribe this drug must first request authorization from the Council of Physicians, Dentists and Pharmacists of the institution.
The government will publish a notice advising of the exclusions mentioned above on the RAMQ's website. However, it appears that this notice will not specify the duration of the exclusion. Instead, the government will issue a second notice to provide the date at which the exclusion ceases to apply.
Second, for medications that will undergo listing negotiations, the Institut national d'excellence en santé et en services sociaux ("INESSS") recommendations may not be published according to the current delays (i.e., 30 days after they have been provided to the Minister). Rather, these recommendations will be published at a time determined by the Health Minister but no later than 30 days after the exclusions mentioned above cease to apply. This practice appears not to be in line with the national process where recommendations are made public once they are finalized and prior to any negotiations.
Third, the Minister has an obligation to report on the impact of Bill 28's Health Measures by October 2017. According to some stakeholders, this will likely draw some attention to the impact of listing agreements which may ultimately encourage the government to reconsider allowing private payers to benefit from them in 2017.
Entry into force
These provisions came into effect with the adoption of the Bill on April 21, 2015. Listing agreements can now be submitted to the Minister. A number of questions still remain, including: whether Québec will join the other provinces in the pan-Canadian Pharmaceutical Alliance (pCPA); and what types of listing agreements will be made beyond the traditional volume discount agreements.