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The Québec Court of Appeal Orders the Minister of Health to put Remicade Back on the List

Fasken
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Intellectual Property Bulletin

The highest court in Québec recently rendered its decision in Janssen inc v. Ministre de la Santé et des Services sociaux,[1] reversing the Superior Court judgment and ordering the Minister of Health to reinstate Remicade on the list of drugs approved for reimbursement under Québec's public drug plan.

The Court of Appeal quashed the Minister's decision to remove Remicade from the reimbursed drug list, breaking with usual practice by the courts to defer to ministerial decisions. The Court's main basis for reversing the decision was that the Minister had not followed the principles of procedural fairness in his relations with Janssen.

Fasken (Julie Desrosiers, Christian Leblanc, Marie Lafleur and Patricia Hénault) represented Janssen in this landmark case.

Background

Every province maintains and updates a list of drugs that are covered by the basic prescription drug insurance plan and for which reimbursement is provided by the province. If a drug is not on a provincial list, it is not reimbursed, and accordingly it is less likely to be prescribed.

In Québec, according to the Act respecting Prescription Drug Insurance of Québec ('the Act'), the Minister of Health is responsible for establishing, maintaining, and updating the List of drugs that are reimbursed by the Québec public drug plan ('the List'). This List is regularly updated by Regulation according to section 60 of the Act.

Remicade is a breakthrough drug that has been marketed by Janssen for over 20 years. It is particularly effective for patients with certain chronic inflammatory diseases, including rheumatoid arthritis and Crohn's disease.

Remicade is approved by Health Canada and is prescribed Canada-wide. It is on numerous provincial reimbursement lists and had been on the Québec List since 2000.

In February 2017, the Minister of Health decided to remove Remicade from the Québec List, without consulting or advising Janssen and without providing any reasons for his decision. The Minister issued a notice on the RAMQ's website informing the public that Remicade would no longer be reimbursed for new patients.

Janssen successfully challenged this decision before the Québec Court of Appeal.

Administrative decision or regulatory decision?

A key issue in the case was whether the Minister's delisting decision was administrative or legislative in nature. Indeed, since the List is updated by regulation, does the decision to list or delist a drug amount to a Regulation? According to the Court of Appeal, the characterization has practical importance because, "issues of procedural fairness and reasonableness of the decision both hinge on that qualification."[2]

The Superior Court found that the Minister's decision was legislative in nature. The judgment thus set a questionable precedent: it allowed the Minister to make decisions with a substantial impact on both the patients being treated with the drug and the drug's manufacturer while holding the government to a lower standard of procedural fairness and reasonableness obligations.

The Court of Appeal explained that a legislative instrument like a statute or regulation is general and impersonal.[3] It is normally directed to an indeterminate number of persons, and therefore [translation] "should not, in principle, apply specifically to individuals or individual situations."[4] While exceptionally there are some regulations that apply only to one person due to factual circumstances, they are nonetheless written in general, normative terms.[5]

In the context of the List of drugs approved for reimbursement, even though the List is updated by regulation, that periodic update can be distinguished from "the Minister's individual decisions regarding the [specific] medications listed or removed" from the List.[6] Those individual decisions are made prior to the update, "one by one, on a case-by-case basis, according to each medication in question".[7]

The Court of Appeal therefore held that the Minister's decision was fundamentally an administrative decision. This in turn determined the framework within which the Minister must exercise his powers, both in terms of reasonableness and procedural fairness.

Procedural fairness

The Court of Appeal concluded that the Minister's decision to remove Remicade from the List of drugs approved for reimbursement in Québec was an administrative decision and that, as a result, the Minister had to respect the rules of procedural fairness.

After examining the applicable criteria established by the Supreme Court in the well-known Baker decision,[8] the Court of Appeal concluded that the Minister had an obligation to:

  1. Give Janssen sufficient notice that he intended to remove its medication from the List of drugs approved for reimbursement in Québec;
  2. Give Janssen an opportunity to make submissions relating to the decision; and
  3. Give reasons for its decision. [9]

The Court of Appeal concluded that, in spite of the great deference that the courts must show for ministerial decisions,[10] the Minister had not met its procedural fairness obligations.

In the instance, Janssen had not received notice that Remicade was going to be removed from the list;[11] it had not been invited to a meeting with the Minister in order to disclose the reasons for the delisting and he did not give Janssen a chance to respond.[12] Moreover, the Minister did not provide any reasons for his decision.[13] The Court of Appeal therefore allowed the appeal, set aside the Minister's decision, and ordered that Remicade be reintroduced on the List of drugs approved for reimbursement in Québec.

Was the Minister's decision reasonable?

Having concluded that procedural fairness had not been respected, and having set the Minister's decision aside on that ground alone, the Court of Appeal did not rule as to the reasonableness of the decision. That question therefore remains open for future debate.

Lessons learned

The decision in Janssen is reassuring, since it reaffirms the basic duty of procedural fairness that is owed to everyone who is subject to administrative action or who otherwise interacts with a ministry or government entity.

This decision reminds government bodies that they are bound by the rules of procedural fairness in the actions they take and the decisions they make.

More specifically, in the context of delisting decisions from public drug plans:

  1. A party must be informed of the decision that the government intends to make;
  2. It must have the opportunity to present its position and submit its arguments; and
  3. In the event that the government nonetheless decides to make an unfavourable decision, sufficient reasons must be provided to support that decision.

[1] Janssen inc v. Ministre de la Santé et des Services sociaux, 2019 QCCA 39 [Janssen].

[2] Janssen, supra note 1 at para. 34 [translation].

[3] Janssen, supra note 1 at para. 49.

[4] Janssen, supra note 1 at paras. 39-40.

[5] Janssen, supra note 1 at para. 50.

[6] Janssen, supra note 1 at para. 45 [translation]. This is the case not only for the decision at issue (i.e. to remove Remicade from the list), but also for a series of other decisions that may be made concerning drugs that are or are not added to the list, the manufacturers of the drugs, etc. (see paras. 46-48).

[7] Janssen, supra note 1 at para. 44 [translation].

[8] Janssen, supra note 1 at paras. 79-80.

[9] Janssen, supra note 1, at para. 81.

[10] Janssen, supra note 1 at para. 80.

[11] Janssen, supra note 1 at paras. 84-85.

[12] Janssen, supra note 1 at para. 84.

[13] Janssen, supra note 1 at para. 83.

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