On March 23, 2023, the Minister of Health (the "Minister") introduced Bill 15, an Act to make the health and social services system more efficient (the "Bill").
As described in our previous bulletin, "Bill 15: The Quebec Government Wants to Limit the Specific Medical Necessity Measure", an essential aspect of this legislation modifies the specific medical necessity measure by introducing additional conditions of patient eligibility.
Parliamentary work on the Bill resumed on August 21 when the Minister introduced 150 amendments. This bulletin focuses on the amendments proposed regarding the specific medical necessity measure.
Concerns Raised When the Bill Was First Introduced
Since its introduction, the Bill has raised several concerns among healthcare professionals. In particular, the Bill stipulates that decision-making power will now be centralized in the hands of a committee within the health institution, the Committee of Pharmacology. This committee will be required to provide written authorization where professionals wish to use exceptional treatments for patients suffering from severe conditions and having few therapeutic alternatives. As a result, prescribers will lose all their discretion if a drug is not listed on the Liste des médicaments – Établissements.
In addition, the first version of the Bill completely prevented the use of drugs that did not have therapeutic value recognized by the Institut national d'excellence en santé et en services sociaux ("INESSS") for the therapeutic indication for which authorization was sought.
The Amendments Proposed by the Minister
Following concerns raised by various stakeholders, including the Council of Physicians, Dentists and Pharmacists, the Minister has proposed amendments to the new rules surrounding the specific medical necessity measure.
One of the amendments proposes to add an exception permitting patients to obtain a drug under the specific medical necessity measure, even if INESSS has previously denied to recognize the drug's therapeutic value for the therapeutic indication for which authorization is sought.
Nevertheless, decision-making power remains centralized in the hands of the Committee of Pharmacology, from which health professionals must obtain written authorization to use a treatment for exceptional purposes.
Authorization may be granted only if the severity of the patient's condition necessitates the drug, and if delaying treatment could lead to short-term complications, that may result in irreversible deterioration of the patient's condition, or death. The severity of the condition, the speed at which it deteriorates, and the length of time it will take for new data to become available, which enables INESSS to reassess the therapeutic value of the treatment, are all factors to be taken into account when making a decision.
Although, except in emergencies, institutional prescribers remain obliged to defer to the decision of the Committee of Pharmacology, the amendment proposed by the Minister offers a certain flexibility that the first version of the Bill does not allow.
However, it is questionable how these new measures will be applied in practice. Will these changes reduce access to treatment for exceptional purposes for patients with severe conditions?
As the Bill is still in progress, we await comments on the proposed amendments. Fasken's Life Sciences group closely monitors new developments and remains available to help industry players navigate through these changes.
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