Executive Summary: Key Legal and Evidentiary Issues

• Scope of the Minister of Health’s discretionary power under the Loi sur l’assurance médicaments to add a drug (Jorveza) to the public List of Medications, and whether that power can effectively be conditioned on the outcome of pan-Canadian price negotiations.
• Alleged breach of the constitutional right to life and security of the person under section 7 of the Canadian Charter and section 1 of the Québec Charter, based on the non-listing of Jorveza for patients with eosinophilic esophagitis.
• Reasonableness of the Minister’s decision (and prolonged inaction) in light of INESSS’s favourable therapeutic assessment of Jorveza and its recommendation to list the drug subject to “atténuation du fardeau économique.”
• Legality of relying on the Alliance pancanadienne pharmaceutique (APP) process, including the use of confidential negotiation mandates and consensus-based targets, as a gatekeeper to drug listing decisions in Québec.
• Evidentiary weight of expert and clinical proof on the seriousness of eosinophilic esophagitis, the inadequacy of “homemade” corticosteroid suspensions, and the budget impact estimates for the RAMQ if Jorveza were covered.
• Characterisation of the failure to reach a listing agreement as a permissible budgetary and policy choice, not an arbitrary or disproportionate restriction of fundamental rights, and the resulting refusal to grant judicial review or Charter-based remedies.

Background and medical context

The case centres on Jorveza, a budesonide-based orodispersible tablet commercialised in Canada by Avir Pharma Inc. under licence from a German manufacturer. Jorveza is designed to treat adults with eosinophilic esophagitis (OeE), a rare allergic inflammatory disease of the esophagus that causes chronic inflammation, dysphagia, chest pain, episodes of food impaction and a major loss of quality of life for patients and their families. If left ineffectively treated, the inflammation persists and progresses, leading to fibrosis, esophageal narrowing (stenosis) and potentially life-threatening choking episodes requiring emergency intervention. Approximately 3,500 Quebecers suffer from OeE. Conventional therapy for some patients involves proton pump inhibitors (PPIs), but these only address reflux and do not directly target the underlying eosinophilic inflammation, and they are not effective for all patients. Another option has been the off-label transformation of inhaled corticosteroid products into viscous suspensions that patients try to swallow to coat the esophagus. These “homemade” mixtures are outside approved indications, have not been rigorously tested for efficacy and long-term safety in OeE, are difficult to prepare correctly, taste bad, and show poor treatment adherence. Health Canada does not approve these concoctions as a proper treatment. By contrast, Jorveza is a tablet that melts in the mouth, taken twice daily, initially in a six-week induction phase followed by a maintenance phase, in which clinical and histological remission can be achieved and maintained in adults with OeE, allowing many to resume a normal life. Health Canada granted accelerated approval in 2019 (induction) and 2021 (maintenance) because no approved OeE therapy existed in Canada at the time.

Parties and their interests

Avir Pharma Inc. is a Canadian pharmaceutical company based in Blainville that seeks to make innovative therapies for rare diseases available in Canada through licensing and commercialisation arrangements. For Jorveza, Avir holds the Canadian licence and sells the drug nationwide, but reimbursement decisions remain provincial. Two individual co-applicants, Philippe Raymond and Sandrine Marineau-Lupien, are adults with OeE. Both experienced debilitating symptoms, including frequent choking, severe reflux and repeated esophageal blockages that significantly affected their daily lives. Mr. Raymond eventually accessed Jorveza through Québec’s “patient d’exception” mechanism in the provincial drug plan, after other treatments, including PPIs, failed. Ms. Marineau-Lupien continued to suffer substantial functional impairment from her disease. The defendants are the Minister of Health and Social Services, who is responsible under Québec law for establishing and updating the List of Medications guaranteed by the public drug insurance scheme, and the Attorney General of Québec, who represents the State in litigation.

The public drug insurance regime and key statutory framework

Québec’s Loi sur l’assurance médicaments establishes a general drug insurance regime (RGAM) whose stated object is to ensure reasonable and equitable access to necessary medications for the entire population. Public and private insurers must cover drugs listed on the Minister’s official List, and the RAMQ administers the public component. The regime is financed by patient contributions (deductibles and co-insurance, with protections for vulnerable groups), income-linked premiums, and a substantial balancing subsidy from the State, which in recent years has reached several billion dollars annually. Under section 60 of the Act, the Minister must “draw up and update” the List by regulation after considering recommendations from the Institut national d’excellence en santé et en services sociaux (INESSS). The List may specify conditions, indications, quantity limits, treatment duration, and age restrictions, and can designate certain medicines as “médicaments d’exception” subject to specific criteria. In 2015, section 60.0.1 was added to allow the Minister, before listing, to conclude an “entente d’inscription” (product listing agreement) with a drug’s manufacturer, under which the manufacturer pays amounts to the State through rebates or discounts that can be volume-based. The publicly posted List price does not reflect those confidential rebates. This contractual mechanism is central to the State’s strategy for managing the escalating costs of innovative therapies.

Role of INESSS and its recommendations on Jorveza

INESSS, a Crown agency, has the statutory mission of promoting clinical excellence and efficient use of resources in health and social services. For drug listing, its enabling statute (article 7) requires it first to assess therapeutic value, and, if value is demonstrated, to analyze price fairness, cost-effectiveness, system impact, and alignment with the object of the public drug regime. Avir applied to INESSS in October 2019 for the induction therapy, and again in 2020 for maintenance. In 2020 (induction) and 2021 (maintenance), INESSS issued detailed opinions recommending that Jorveza be listed as a “médicament d’exception” for adults with OeE who meet defined clinical criteria, including prior trial of PPIs, but expressly subject to the condition that the manufacturer “participate à l’atténuation du fardeau économique.” INESSS acknowledged that Jorveza produced significantly higher clinico-histological remission rates than placebo and presented an acceptable short-term safety profile. However, it saw little evidence of incremental therapeutic value versus existing topical steroid formulations (including off-label viscous suspensions) and noted that Jorveza’s list price was far higher than those comparators. For both induction and maintenance, INESSS projected additional RAMQ costs in the hundreds of thousands of dollars over three years and concluded that coverage could be justified, from a distributive justice perspective, only if the use was appropriately circumscribed and the manufacturer contributed to reducing budget impact through price concessions.

The pan-Canadian Pharmaceutical Alliance and negotiation process

Parallel to Québec’s internal processes, the pan-Canadian Pharmaceutical Alliance (pCPA or APP) plays a central role in negotiating confidential price rebates on behalf of participating federal, provincial and territorial drug plans. Initially an informal coalition beginning in 2010, it became a federally incorporated not-for-profit corporation in 2022, with a board composed of representatives from all provincial and territorial governments and the federal government. Québec joined the alliance in 2015. The APP operates on a consensus model: for each drug file, one province leads negotiations with the manufacturer according to a mandate that includes pricing and rebate targets, developed and agreed by the participating jurisdictions. Provinces are free to opt out of particular files, but solidarity across jurisdictions is intended to maximize bargaining power and achieve better prices than each could obtain individually. If negotiations succeed, the parties sign a non-binding letter of intent outlining the agreed terms, after which each jurisdiction may enter its own binding product listing agreement with the manufacturer. If no agreement is reached, the APP closes the file and, as a matter of practice and internal rules, participating jurisdictions do not proceed with separate product listing negotiations for that drug. In the Jorveza case, after INESSS’s positive-but-conditional recommendations, the Minister’s officials decided to refer the file to the APP to seek economic mitigation through a rebate. Ontario acted as the lead province for the negotiations with Avir, while Québec was represented within the APP’s governance structure. The APP opened the Jorveza file in 2021, notified Avir that the case had advanced to in-depth assessment, and then began formal negotiations covering both induction and maintenance indications. There were multiple exchanges of offers and counter-offers focused on the level of price reduction necessary to satisfy the alliance’s mandate. Ultimately, the parties failed to reach the rebate levels targeted in the APP’s mandate. In July 2022, the APP sent letters to Avir informing it that negotiations were terminated and clarifying that the participating jurisdictions would not consider concluding product listing agreements for Jorveza. The letters also noted that Avir remained free to submit a new unsolicited proposal, which the APP could decide, at its discretion and by consensus, to accept for renewed negotiations. Avir later did submit an unsolicited proposal, but the APP, again with Québec’s representative concurring, decided not to reopen the negotiations, assessing that a new round was unlikely to produce a different outcome.

Ministerial handling of the Jorveza file

While INESSS was issuing its opinions, the Ministry’s internal memoranda advised the Minister to delay listing of Jorveza because of the pending or forthcoming APP negotiations. In June 2020 and May 2021, the Minister formally notified the RAMQ that he would “suspend” his decision to list Jorveza in upcoming updates to the List, expressly because the drug was under negotiation within the APP process. Importantly, beyond those suspension notices, the Minister never subsequently issued an express, reasoned decision either granting or refusing listing. After the APP’s July 2022 termination of negotiations, Avir wrote to the Director of Pharmaceutical Affairs in July 2023, urging the Minister to exercise his statutory discretion under section 60 and list Jorveza despite the failed APP talks. The reply from the Ministry was brief: it reminded Avir of the possibility of submitting a new unsolicited offer to the APP and suggested that Avir contact INESSS concerning potential reimbursement criteria, but it did not state that the Minister would independently reconsider listing outside the alliance framework. No formal decision letter followed. Avir and its co-applicants argued in court that this prolonged inaction, together with the reliance on the APP outcome, amounted in substance to an unreasonable refusal to list Jorveza.

Nature of the judicial review and relief sought

The applicants brought a proceeding titled “Demande de pourvoi en contrôle judiciaire et en jugement déclaratoire.” They sought declaratory relief that: the Minister could not lawfully fetter or condition his statutory discretion to list a drug on the achievement of a consensus decision of the APP and the conclusion of a letter of intent; the refusal to add Jorveza to the List violated the right to life and security of Québec OeE patients under the Canadian and Québec Charters in the particular clinical and evidentiary circumstances of this case; the Minister’s non-decision and de facto refusal were unreasonable in light of INESSS’s favourable recommendations, the identified health need, Jorveza’s documented therapeutic value and limited budget impact, Avir’s willingness to reduce the economic burden, and the structure and objectives of the Loi sur l’assurance médicaments; and the elapsed time since the file was submitted in November 2019, without a formal decision, was itself unreasonable. As primary remedial relief, they asked the Superior Court to substitute its own decision by ordering the Minister to implement INESSS’s recommendations and add Jorveza to the List within 30 days. In the alternative, they asked the Court to order the Minister to render a duly reasoned decision within 30 days, explicitly addressing Charter rights, the statutory objective of equitable and reasonable access, INESSS’s clinical and pharmacoeconomic assessments, the modest budgetary impact, and Avir’s demonstrated willingness to attenuate that impact. They also sought ancillary orders to require the Minister to take all necessary steps to give full effect to the judgment and notify all affected parties, together with provisional execution notwithstanding appeal and costs, including expert costs.

Charter arguments on the right to life and security of the person

On the constitutional side, the applicants relied on section 7 of the Canadian Charter of Rights and Freedoms and section 1 of the Québec Charter of Human Rights and Freedoms, which protect, respectively, the right to life, liberty and security of the person and the right to life, security, integrity and liberty. They argued that the non-listing of Jorveza deprived economically constrained OeE patients of effective access to the only approved and clinically validated treatment for their condition, thereby endangering their physical integrity and security by exposing them to progressive esophageal damage, emergency choking events and severe ongoing suffering. They invoked precedents such as Chaoulli and PHS Community Services Society, where State-imposed barriers to access to health care were found to infringe section 7. The Attorney General conceded that the individual co-applicants, as patients, had standing to raise the Charter claim, but challenged Avir’s standing and maintained that section 7 was not engaged in the circumstances. The Court first addressed the applicable standard of review. Drawing on Vavilov and Doré, it held that because the applicants were not challenging the constitutionality of a statutory provision itself but arguing that an administrative decision (or non-decision) unjustifiably limited Charter rights, the proper standard was reasonableness, not correctness, even where constitutional rights are invoked. Turning to the substance, the Court distinguished between two broad families of section 7 claims: those involving the penal or coercive apparatus of the State (such as criminal law) and those involving State measures that, by their own operation, directly restrict life, liberty or security. The non-listing of a drug fell into neither category in a way that would transform section 7 into a guarantee of a minimum level of publicly funded health services. The Court emphasized that section 7 is a legal right, modeled on article 9 of the International Covenant on Civil and Political Rights, and not a freestanding social right to a particular level of governmental provision. Cases such as Gosselin, Auton, Alberta v. Elder Advocates, and other appellate decisions on social and economic rights confirm that section 7 is ill-suited to judicially enforce minimum funding thresholds for public programs. The Court underlined the inherently political, resource-allocation and polycentric nature of drug funding, the institutional limits of the judiciary, and the fact that the statute itself already embeds the objective of promoting life and security through an equitable and reasonable access framework constrained by finite resources. It concluded that, applying the reasonableness standard, the Minister’s decision not to list Jorveza in the face of failed price negotiations did not amount to an unreasonable breach of the right to life or security of the person. Given that no section 7 violation was established, it was unnecessary to go further into principles of fundamental justice such as arbitrariness, overbreadth or gross disproportionality, or to conduct an analysis under section 1 of the Canadian Charter.

Administrative law review of the reasonableness of the Minister’s conduct

In the administrative law analysis, the Court framed the central question as whether the Minister’s handling of the file respected the statutory purpose of the Loi sur l’assurance médicaments and the legal constraints surrounding his discretion, including the requirement to consider INESSS’s recommendations and the possibility of entering into an entente d’inscription under section 60.0.1. The applicants argued that the Minister failed to weigh critical relevant factors, such as the severity of OeE, the lack of alternative approved treatments, the inadequacy of unapproved “homemade” steroids, the modest budget impact given the small patient population, and Avir’s willingness to provide rebates. They also criticised the long delay and the absence of a formal decision. The Attorney General responded that INESSS had, in fact, assessed therapeutic value, budget impact and distributive justice considerations and had conditioned its positive recommendation on sufficient economic mitigation, which was never achieved; and that the Minister pursued that condition through a legitimate negotiation process without any promise or guarantee of success. The Court strongly reaffirmed that when it comes to the management of public funds within a statutory regime, the executive enjoys a wide discretion, and the judiciary’s role is limited to ensuring that the decision is within the bounds of legality and reasonableness, not to substitute its own policy judgments. Having considered the record, including confidential negotiation material available only to counsel, the Court found no basis to say that the determination that the budgetary burden had not been sufficiently attenuated was unreasonable. The Minister had followed the statutory scheme: obtained INESSS’s recommendations; sought to implement the economic mitigation condition through the APP; and accepted the outcome when negotiations failed. The fact that the process did not lead to rebated prices or listing did not transform the result into an unreasonable or unlawful exercise of discretion. The Court declined to undertake a micro-analysis of the negotiation positions, targets and cost-effectiveness modelling (including expert evidence on QALYs and incremental cost-effectiveness ratios), viewing that as both institutionally inappropriate and beyond its proper role in judicial review.

Legality of relying on the pan-Canadian alliance

Finally, the Court considered whether the Minister’s reliance on the APP process unlawfully fettered his discretion, amounted to an illegal delegation or abdication of statutory power, or otherwise breached the rule of law. The applicants highlighted several troubling aspects of the APP: it is a private not-for-profit corporation; its decisions are not subject to appeal or judicial review; its internal operation is relatively opaque; it decides by consensus, so a single province could, in theory, drive rebate targets that other provinces find excessive; and its rules effectively bar individual provinces from negotiating separate listing agreements if the APP process fails. They contended that by tying his decision to the APP’s outcome, the Minister had unlawfully made his statutory power dependent on an extra-statutory, non-accountable body. The Court acknowledged that these features raise legitimate rule-of-law concerns and that multiple “yellow lights” flash when an external alliance plays such a decisive role in access to medicines. However, it followed and applied the Québec Court of Appeal’s earlier decision in Janssen, which held that the Minister’s participation in the APP does not constitute an unlawful delegation or abdication of power. Instead, by joining the APP, the Minister has chosen a method of exercising his discretion—collective negotiation—to better achieve the statutory objective of securing advantageous prices for Québec’s population. The Minister remains responsible for any illegality in the process: if the APP were to act unlawfully, its conduct could be impugned indirectly through judicial review of the Minister’s decision that adopts or relies on that conduct. In this case, no such illegality was demonstrated. The statutory framework itself anticipates negotiation; section 60.0.1 and related amendments to the INESSS statute contemplate that listing may be preceded by negotiations to conclude an entente d’inscription and even adjust the timing of public release of INESSS recommendations where such negotiations are underway. Accordingly, the Court held that using the APP as the vehicle for those negotiations, and accepting the outcome when no agreement is reached, is a “sensible” and legally permissible way of exercising the Minister’s discretion and not a fetter, delegation or abdication.

Outcome and practical implications

Bringing these strands together, the Superior Court concluded that: there was no unreasonable or unconstitutional violation of the right to life or security of the person; the Minister’s de facto refusal to list Jorveza, following unsuccessful price negotiations, fell within the range of reasonable outcomes under the statutory scheme; and participation in, and reliance on, the APP did not vitiate the legality of the decision-making process. Because the core condition set by INESSS—adequate attenuation of the economic burden via rebate—had not been met, the Court found no basis to compel the Minister either to list Jorveza or to re-decide the file on a different basis. The application for judicial review and declaratory relief was therefore dismissed. Recognising, however, that the applicants had raised issues of significant public importance concerning access to innovative therapies, federal-provincial collaboration, and the interaction between Charter rights and public drug funding, the Court expressly departed from the usual rule that costs follow the event. It dismissed the proceeding “sans frais de justice,” meaning that the successful parties—the Minister of Health and Social Services and the Attorney General of Québec—obtained no monetary award, and no damages, costs or other sums were ordered in favour of any party; in practical terms, the outcome for Jorveza is that it remains off the List of Medications in Québec, and the total amount granted or ordered by the Court is zero or otherwise not determinable as any positive monetary recovery.