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Drugs - Executive Officer Recommendation. Shved v. Executive Officer, Ontario Public Drug Programs
In Shved v. Executive Officer, Ontario Public Drug Programs (Div Ct, 2026) the Divisional Court (two judge majority, one judge in dissent re remedy) granted a JR, this brought against the decision of the Executive Officer (EO) of the Ontario Public Drug Programs declining to recommend funding for the applicant's as-yet Ontario-approved cancer treatment. This first decision is interwoven with a technically separate decision by the OHIP General Manager and the HSARB to deny out-of-country medical services.
The court cites and considers an HIA regulation provision [General Reg 552, s.28.4] regarding out-of-country medical treatment, here where it also requires the recommendation of the "the executive officer appointed under the Ontario Drug Benefit Act" where "a service ... consists primarily of the administration of a drug" [also there is an obvious concern over tribunal 'bootstrapping' at para 3 (in the dissent) and 43]:[9] Aleksander Shved is dying of metastasized malignant melanoma. A new treatment offers hope for Mr Shved. His oncologists have recommended it. The clinical record supports their recommendation. The data available on the treatment, while far from definitive, is promising. The new drug that is a core component of the recommended treatment has been approved for use in Canada by Health Canada but is not yet available in Ontario.
[10] Mr Shved applied to the respondent General Manager of the Ontario Health Insurance Plan (the “GM”) to fund the cost of out-of-country medical services in Florida, where he can access the treatment. Such funding may be available pursuant to ss. 28.4(2) of Regulation 552:(2) Services that are rendered outside Canada at a hospital or health facility are prescribed as insured services if,
(a) the service is generally accepted by the medical profession in Ontario as appropriate for a person in the same medical circumstances as the insured person;
(b) the service is medically necessary;
(c) either,
(i) the identical or equivalent service is not performed in Ontario, or
(ii) the identical or equivalent service is performed in Ontario but it is necessary that the insured person travel out of Canada to avoid a delay that would result in death or medically significant irreversible tissue damage;
....
(7) An amount is payable for insured services prescribed by subsection (2) if the following conditions are met:
1. An application for approval of payment is submitted to the General Manager on behalf of the insured person,
i. by a physician who practises medicine in Ontario, or
ii. by an emergency patient referral service, but only in emergency circumstances.
2. The application mentioned in paragraph 1 includes written confirmation that the conditions set out in clauses (2) (a) and (b) and one of the conditions set out in clause (2) (c) are satisfied, from,
i. a physician who is a specialist, as defined in the schedule of benefits, in the type of service for which approval of payment is sought,
ii. a general practitioner, if the type of service for which approval of payment is sought is within the general practitioner’s scope of practice, or
iii. in emergency circumstances, a physician who practises medicine in Ontario or an emergency patient referral service.
3. In circumstances that are not emergency circumstances, a service that is identical or equivalent to the service for which payment is sought is not covered by a preferred provider arrangement entered into,
i. between the Minister and the operator of a hospital outside Ontario but within Canada under subsection 27 (1),
ii. between the Minister and the operator of a health facility outside Ontario but within Canada under subsection 27 (2), or
iii. between the Minister and a physician or practitioner outside Ontario but within Canada under subsection 27 (4).
4. For a service that consists primarily of the administration of a drug, including the provision of the drug that is administered, there is a recommendation from the executive officer appointed under the Ontario Drug Benefit Act for payment for the drug for a person in the same medical circumstances as the insured person. O. Reg. 135/09, s. 4; O. Reg. 83/11, s. 3 (2, 3). [11] Since the new treatment involves use of a new drug, not currently provided by Ontario, funding can be authorized by the OHIP GM only if it is recommended by the Executive Officer of the Ontario Public Drug Programs (the “EO”) (O. Reg. s. 28.4(7) par 4).
....
[18] Turning to the main issue on appeal, we would quash the EO’s decision not to recommend the requested treatment, and we would remit the matter back to the EO for a fresh determination in accordance with these reasons. We would direct that the EO provide his fresh determination no later than 4:00 pm, Friday October 2, 2026, and would exhort him to do it even faster if possible.
[19] The decision of the GM was predicated on the EO’s decision, which we have set aside. It necessarily follows the decision of the GM must be set aside. We would ask the OHIP GM to render a decision within one week of receiving the fresh decision of the EO; if this difficulty poses a problem, the parties may seek a firm deadline from the court by way of email.
Reasons
[20] Time is short and our reasons shall be brief. The EO’s original decision, made May 26, 2026, declines to recommend funding because the drug in question, though it has been approved for use in Canada, is still going through the process that may lead to funding approval for use in Ontario. The EO applied this context as a categorical bar to his recommending funding with no other analysis.
[21] After the decision of the EO, the subsequent decision of the GM, rejection of Mr Shved’s appeal by the HSARB, and after the application for judicial review had already been commenced and Mr Shved had delivered his application materials, the EO decided to reconsider his original decision. This was not done at Mr Shved’s request or with his consent.
[22] The Reconsideration Decision was released on August 19, 2026. In it, the EO again concluded that he would not recommend funding the requested treatment, but he provided materially different reasons for this conclusion. He found that the current status of the drug purchase process weighs strongly against recommending funding the treatment, which, taken together with the high cost of the treatment, the uncertain prospects of material benefit from the treatment, and the uncertainty over how many others might be eligible for funding such treatment out-of-country if it were authorized for Mr Shved, all led to the conclusion that the treatment should not be recommended by the EO.
[23] While the EO previously identified the facts that lifileucel was undergoing finding review as a “categorical bar” the EO’s reasons now provide the following statement:Finally, I have considered Ontario's longstanding policy approach regarding out-of-country funding requests for drug therapies that are undergoing, or are expected to undergo, the Canadian drug review processes (regulatory approval, reimbursement recommendation, and price negotiation). Lifileucel has received Health Canada authorization with conditions and is currently under review (CDA-AMC) for reimbursement recommendation. In my view, routinely funding drug therapies through the out of country program in advance of completion of these evidence-based review and negotiation processes would undermine the incentive structure that encourages manufacturers to participate in Canada's drug review processes. Maintaining the integrity of these processes serves an important public interest by supporting evidence-based decision-making, equitable access, and value for Ontario patients as a whole.
Having considered all of the foregoing factors collectively, including the patient's circumstances, the available evidence regarding clinical benefit and safety, the cost associated with treatment, the current ongoing Canadian evidence review and reimbursement process, and my responsibility for stewardship of public resources within Ontario's publicly funded drug system, I conclude that funding through the Out-of-Country Prior Approval Program is not warranted. (Emphasis added) [24] It is difficult to reconcile or understand the EO’s conclusions based on the findings within the report and for this reason the decision must be set aside. At paras 25-41 the court further casts doubt on the practical rationales behind the EO drug decision, and then continues:Overall Assessment
[42] We appreciate that decisionmakers involved in this case have tried to respond swiftly to Mr Shved’s request, mindful of the practicalities of his situation. Judicial review is not a treasure hunt for error, and our task is to sensibly construe the reasons the EO has declined to recommend funding the treatment. We conclude that the sole reason in the initial decision was the core reason in the Reconsideration Decision, and it is unreasonable: the “policy” referenced by the EO hearkens back to a 2007 recommendation that out-of-country funding should not circumvent a decision in Ontario not to purchase a drug treatment: to construe this policy to bar funding for any drug treatment that is not available in Ontario would preclude that which is plainly contemplated to be available in an appropriate case.
[43] The other reasons read as superficial and mentioned to buttress and qualify the categorical reasoning in the initial decision, an impression reinforced by the EO’s unilateral decision to “reconsider” his decision while the matter was sub judice. An Ontarian in Mr Shved’s position is entitled to more than this to justify a decision to withhold funding for potentially life-altering treatment.
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