Dubé Reform | Concerns about access to exceptional medicines

(Quebec) Liberal MP André Fortin is concerned that the Dubé health reform “complicates” access to exceptional medications by adding “an incredible burden” to treating doctors. Concerns shared by the Regroupement québécois des Maladies Orphanes (RQMO).


The MP for Pontiac asked Minister Christian Dubé to abandon certain legislative changes in his reform affecting the prescription of treatments for rare diseases. “What the minister is doing is making access to exceptional medicines more complex. We take the current regime and add a layer [pour les médecins] “, lamented Mr. Fortin on Thursday.

Mr. Fortin was accompanied by Julie Carignan who suffers from a rare form of bile duct cancer. She says she fears that doctors will be discouraged by the steps required to justify the use of a drug for which the National Institute of Excellence in Health and Social Services (INESSS) has refused to recognize the therapeutic value for care.

Section 336 of Bill 15 provides that the pharmacology committee of a hospital “may not grant authorization” for the use of a medication if INESSS has already provided an unfavorable opinion to the minister. If applicable, the doctor must then establish, in writing, “the potential for favorable effectiveness of the medication and, on the other hand, the other reasons justifying his request”.

In addition, the doctor “must submit scientific data in support of his request demonstrating that the medication he wishes to use will significantly meet the user’s particular need.”

“We are adding an incredible burden to the doctor, who is ready for him, on factual bases, with perhaps international studies […] to say: well, I’m going to try it on my patient,” laments Mr. Fortin. The RQMO is also concerned since “the vast majority of rare disease drugs receive a negative opinion in relation to the therapeutic value”, according to general director Jonathan Pratt.

Dubé wants to be reassuring

Faced with concerns, Mr. Dubé tabled an amendment providing for an exception “if taking medication cannot be delayed” without risk of leading to “irreversible deterioration” of the patient’s condition. These articles are currently being examined as part of the detailed study of the reform project. These arrangements are insufficient in the eyes of Mr. Fortin and Mr. Pratt.

According to the RQMO, the criterion of “irreversible deterioration” adds a “notion of urgency” even though this could limit access to medications for patients whose disease progresses slowly.

However, Christian Dubé wants to be reassuring: “We must stop scaring Quebecers. No patient will lose access to medication. Our priority is to ensure access to care, we will never compromise on that,” said the minister in a statement sent to The Press.

“We are now saying that if doctors wish to prescribe a medication which has received an unfavorable opinion from INESSS, they must provide a written opinion […] and he can continue to prescribe it. This does not affect drugs which have not received any advice. We also tabled another amendment this afternoon which proposes relief for doctors,” he argued.

The detailed study of Bill 15, which aims to restore the health and social services network, resumes on Tuesday, October 3.


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