Thursday Thinkpiece: Burningham on Courts, Challenges and Cures

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Courts, Challenges, and Cures: Legal Avenues for Patients with Rare Diseases to Challenge Health Care Coverage Decisions

Sarah Burningham | University of Saskatchewan College of Law
(2015) 1 Canadian Journal of Comparative and Contemporary Law 317

Excerpt: Part III

[Footnotes omitted. They can be found in the original via the link above]

III. Legal Mechanisms to Challenge Health Care Coverage Decisions

A. The Charter

In the years immediately following the adoption of the Charter, some scholars suggested that it should be interpreted so as to provide protection for socio-economic rights, including the right to health care. Such an interpretation would provide fertile ground to argue that the right to access particular therapies fell within its ambit. However, Charter claims seeking health care entitlements have been mostly unsuccessful to date.

Patients with rare diseases seeking to use the Charter to challenge health care coverage decisions have two potential avenues of argument. First, patients could argue that their section 7 “right[s] to life, liberty and security of the person” are unjustifiably infringed by legislation that limits access to medical services. Second, patients could argue that the government failed to live up to obligations created by either section 7 or section 15 of the Charter.

Using the first avenue, patients may argue that legislation which removes or narrows medical options available to them contravene section 7 of the Charter. This avenue contemplates legislation which expressly prohibits patients from obtaining certain treatments or medical services, such as the kind of legislation that was at issue in Chaoulli. In that case, a Quebec statute provided that patients could not obtain private health insurance for medical services available within the public health care system. A patient challenged the constitutionality of this legislation, arguing that the lengthy “delays resulting from waiting lists” in the public health system combined with removal of the option to obtain private insurance negatively impacted his health and thus infringed his section 7 rights to life and security of the person. Three of the justices of the Supreme Court of Canada agreed, finding further that the legislation was arbitrary and thus inconsistent with the principles of fundamental justice. One justice preferred to decide the case under the Quebec Charter of Human Rights and Freedoms and the three remaining justices upheld the provision under the Canadian Charter.

Patients with rare diseases will find Chaoulli of limited help, however, as their access to health care is impeded not by legislation that prohibits them from accessing certain services, but rather, by government inaction (e.g. not paying for necessary medical treatments or procedures). What is needed, from the perspective of patients with rare diseases, is a hook on which government obligation to fund treatment can be hung. The approach discussed below provides a more promising means to fashion such a hook.

In theory, governmental obligation may be created by either sections 7 or 15 of the Charter. In practice, however, courts have shied away from recognizing positive obligations under section 7 of the Charter. The Supreme Court of Canada has stated that “[t]he Charter does not confer a freestanding constitutional right to health care.” And, lower courts have similarly dismissed suggestions that the government is in violation of section 7 when it declines to cover the costs of a particular medical treatment.

Patients with rare diseases must then look to section 15 and the right to equality to establish any funding obligation. A section 15 analysis requires a court to ask: “(1) Does the law create a distinction based on an enumerated or analogous ground? (2) Does the distinction create a disadvantage by perpetuating prejudice or stereotyping?” As the Supreme Court has observed, “[t]he focus of the inquiry is on the actual impact of the impugned law, taking full account of social, political, economic and historical factors concerning the group” and “involves looking at the circumstances of members of the group and the negative impact of the law on them.”

Accordingly, a patient with a rare disease must establish that the refusal to pay for a particular medical service draws a distinction [that] create[s] a disadvantage.” The patient may point to the fact that the health care scheme created by federal and provincial legislation draws a distinction between insured and non-insured services, leading to differential treatment between patients whose medical care is covered and those whose medical care is not. The patient may further point to the fact that some of those in the latter group will include patients with rare diseases. It is not obvious on the face of the scheme that the distinction is drawn on the basis of an enumerated or analogous ground – in this case, rare disease or disability – as both those with rare diseases and those without rare diseases are denied funding if the service in issue is not covered by the public system.

However, the law protects individuals from discrimination that, while not obvious on the face of the statute in question, is apparent following deeper and more probing scrutiny of the statute. If, on closer examination, it becomes apparent that patients with rare diseases are disproportionately denied funding for medical services or disproportionately affected by denial of funding, then differential treatment is established. Such a conclusion may be reached by evidence illustrating how insufficient financing negatively impacts patients with rare diseases; patients may demonstrate that, without government funding, they cannot afford the treatment in issue, and, without that treatment, their pain and suffering is increased or their life expectancy shortened. On this point, if the scientific evidence is inconclusive on the matter of a therapy’s effectiveness, patients seeking these experimental treatments may be unable to tender compelling evidence that their physical pain is increased by the denial of coverage for that treatment. However, that is not the end of the matter, as these patients could underscore the emotional burden of being denied hope that experimental treatments offer. To establish that the law “create[s] a disadvantage by perpetuating prejudice or stereotyping,” patients with rare diseases may point to the economic disadvantage they shoulder by paying out-of-pocket for medical expenses. This burden increases the economic hardship on patients who may already be off work as a result of illness. Being denied access to treatment may also add to the sense of exclusion and stigmatization already experienced by patients with rare diseases.

If an infringement is established, the burden shifts to the government to prove that the breach can be justified under section 1 of the Charter. An infringement is defensible if the legislative objective is “pressing and substantial,” the chosen course is rationally connected to that objective, the injury to the right is small, and the infringement is proportionate to the benefit and effect of the impugned law. In the context of a section 15 challenge by a claimant with a rare disease, several factors will be relevant. At the section 1 stage, courts tend to show deference to government decisions that require balancing multiple and varied interests or allotting limited resources. Health care coverage decisions appear to be the sort of decision that will generally attract deference. Because courts require that the government establish an evidential basis for its impugned action, a government will not simply be able to assert that its action achieves health care objectives and meets the other section 1 requirements without furnishing evidence. However, as von Tigerstrom points out, it may be challenging for courts to evaluate the evidence put forward by the government: Are purported financial worries genuine or is cost used to shield a discriminatory decision? And when does cost justify a decision not to cover a certain treatment? Must it be too expensive for the public system to absorb, or is it enough that the government has decided to fund procedure x over treatment y, both being equally medically effective?

Two Supreme Court of Canada cases will be relevant to any claim brought under section 15. In Eldridge v British Columbia, the Court found that the failure of hospitals to provide sign-language services for hearing-impaired patients was a violation of section 15. In finding that the government’s decision constituted discrimination, Justice La Forest for the Court noted:

In order to receive the same quality of care, deaf persons must bear the burden of paying for the means to communicate with their health care providers, despite the fact that the system is intended to make ability to pay irrelevant … Once it is accepted that effective communication is an indispensable component of the delivery of medical services, it becomes much more difficult to assert that the failure to ensure that deaf persons communicate effectively with their health care providers is not discriminatory.

One could conceivably argue that patients with rare diseases who do not obtain necessary treatment are not receiving “the same quality of care” as those patients with or without rare diseases who have access to publicly funded treatments.

However, patients with rare diseases may find it difficult to establish an infringement of section 15 given the Supreme Court’s decision in Auton v British Columbia. In that case, families unsuccessfully argued that the government’s failure to provide therapy for their autistic children was discriminatory under section 15. In reaching its decision, the Court reviewed the provincial set-up, which distinguished between “core services” and “non-core services,” the first being those made available by physicians and hospitals, and the second being those performed by other health care professionals and insured only if so stipulated in the regulations. The Court held that the therapy, being a “non-core service” provided by professionals not designated under the regulations, was not “a benefit provided by law” as there was no legislative entitlement to it. The Court observed that “the legislative scheme does not promise that any Canadian will receive funding for all medically required treatment,” apparently even if the treatment is “essential to the health and medical treatment of an individual.” The Court also dismissed the suggestion that “the scheme itself [was] discriminatory,” finding that it was designed and intended to cover only some, not all, medical services. Thus, “exclusion of particular non-core services cannot, without more, be viewed as an adverse distinction based on an enumerated ground.” As the Court’s conclusions in Auton make clear, the rigors of a section 15 analysis will not be lessened even in the case of patients who argue that access to treatment is necessary for their health and wellbeing.

Further, the Court held that once the position of the claimants in Auton was evaluated alongside the “appropriate comparator group” (e.g.persons without a “mental disability” desiring beneficial but novel medical services), “differential treatment either directly or by effect [was] not established” as the evidence did not indicate that the government gave additional consideration to or was more likely to grant applications for unproven therapies made by persons in the comparator group. Given the narrow characterization of the “comparator group” in Auton, the case would seem to preclude reliance on section 15 by persons seeking unproven treatments which are not included in the existing public insurance scheme, in the absence of evidence that other groups receive coverage for unproven therapies at greater rates. This reading of the case has significant implications for patients with rare diseases, given that many rare diseases have no treatment and thus a significant number of patients may desire to access unproven therapies.

Also relevant is the decision of the Nova Scotia Court of Appeal in Cameron v Nova Scotia. In that case, an infertile couple claimed that omission of ICSI from the provincial health plan discriminated on the basis of disability, as the plan covered IVF treatment for couples who suffered only from female infertility and thus did not require ICSI. The Court agreed that the policy was discriminatory, holding that denial of access to Medicare (“a cornerstone of social programs in Canada”) reinforced the “vulnerability” and ostracism of infertile couples. However, the Court found that the infringement was saved under section 1 of the Charter. As part of the section 1 analysis, the majority of the Court emphasized the importance of the purpose of the exclusion, namely ensuring “the best possible health care coverage to Nova Scotians in the context of limited financial resources.”

Based on Auton and Cameron, it seems that patients bringing a section 15 challenge to establish that a government has an obligation to fund a particular treatment will face an uphill battle, as courts generally show great deference to decisions of this nature. However, that hill may be mounted in a case with the right set of facts, a strong evidential foundation establishing discrimination, and weak government arguments at the justification stage. Additionally, equality jurisprudence appears to be undergoing transformation. As the Supreme Court further develops section 15 doctrine and principles – by, for example, moving away from the “comparator group” analysis – the likelihood of success of this type of claim increases. After all, the “comparator group” was one of the stumbling blocks in Auton. Without the “comparator group” hurdle, it will be easier for a claimant with a rare disease seeking unproven medication to establish the existence of “differential treatment.”

Even if a Charter challenge is not successful, there may be merit in bringing such a claim. For example, Charter challenges hold government actors accountable by compelling them to produce evidence justifying their actions and decisions in the health care realm. Of course, these benefits need to be balanced against the potential costs (in terms of both money and time) of Charter litigation.

B. Administrative Law

Patients with rare diseases may also consider using administrative law processes and procedures to challenge coverage decisions. Like Charter litigation, administrative law obliges governments to account for their actions and ensures that institutional decision-making is done in a fair and impartial manner. Administrative law may be preferable to Charter litigation, as it tends to be quicker and less expensive.

As noted above, some provincial administrative tribunals, like Ontario’s Health Services Review and Appeal Board, have limited authority to weigh in on health coverage decisions. For example, the Appeal Board can determine whether persons who contest denial of insurance are indeed covered under the provincial Act. The board is also empowered to make decisions on reimbursement for health care expenses incurred outside of Canada. However, the scope of the board’s jurisdiction is limited, and it has no general authority to evaluate coverage decisions.

In addition to these administrative mechanisms, a patient may turn to the courts for judicial review of either the substantive decision (i.e. the decision to cover (or not) a particular medical service) or the process used to make that decision. Under the principles of administrative law, government decision-makers must act within the ambit of power bestowed upon them by statute and they must act in a way that is sufficiently fair and transparent.

As discussed above, coverage decisions are made by numerous government actors, acting pursuant to statutory authority. Generally, coverage decisions are made by the provincial cabinet and Minister of Health, regional health boards, and other officials within the provincial health department. Judicial review is concerned with whether these bodies have properly acted within their jurisdiction and thus each case will require a detailed analysis of the governing statute and the action purportedly taken under it. General principles are canvassed below, but, of course, the old caveat rings particularly true in the context of administrative law: the outcome depends on the particular facts of the case.

In Lexogest Inc v Manitoba, the Manitoba Court of Appeal found that the Manitoba Heath Services Commission acted outside its jurisdiction by setting up a funding policy which covered abortion services if they were provided in hospitals, but not if they occurred in other health centres. While the Commission had legislative sanction to determine which services would be covered, it could not exercise this power arbitrarily.

The Ontario High Court of Justice in Re Koonar, dismissed an application brought by physiotherapists who sought review of the decision of the provincial health department to deny insurance coverage for their services. The Court found that “[t]he extent of that insurance was a policy decision, a legislative decision which is not subject to review.”

In another case, following a decision by a government official to withdraw a particular drug from availability through the Special Access Programme (which provides an exceptional means for patients to access unapproved drugs), patients sought review on the grounds that the official acted outside the scope of his statutory authority. The Federal Court agreed, holding that the official had, by limiting his decision in advance and in a manner not consistent with the legislative purpose, unlawfully fettered the broad discretion granted to him under the statute.

With that background set out, it is apposite to turn to the particular situation at hand, namely, an administrative-based challenge to a government decision to exclude from its insurance plan a treatment desired by a patient with a rare disease. First, a patient may consider challenging the procedure used to make the impugned decision. At common law, administrative actors owe a duty of procedural fairness to individuals whose rights or interests are affected by specific, individualized decisions. No duty is owed for general, policy decisions. Most often, decisions about which medical services should be funded will be policy decisions, involving the apportionment of resources among competing groups, and thus no duty of procedural fairness will attach. In some cases, a duty of procedural fairness may be owed to an individual if the decision is sufficiently particular to that individual. This would likely be the case for a patient who requests reimbursement for out-of-province treatment. While the content necessary to satisfy the duty of procedural fairness varies from case to case, it may require that the affected individual be given an opportunity to respond or to submit evidence for the decision-maker’s consideration. However, as noted, for the most part, patients with rare diseases who as a group seek coverage for medications are likely not owed administrative procedural fairness protections. The government may, on its own initiative and without legal compulsion, seek input from patients with rare diseases in making health care coverage decisions, and indeed, certain processes have been recently put in place to facilitate public participation in these types of decisions.

Second, a patient may challenge the substantive decision to include or exclude medical services from public insurance plans, by, for example, arguing that the decision-maker erred in giving weight to irrelevant considerations or misconstrued relevant evidence. A court must determine the governing standard of review, being either “correctness” (whereby the court embarks on a fresh assessment of the matter) or “reasonableness” (the more deferential standard, which asks “whether the decision falls within a range of possible, acceptable outcomes which are defensible in respect of the facts and law”). If a board is granted considerable discretion under its enabling statute and it is deciding a question within its domain of expertise, its judgment will often be shown deference by the reviewing court. This will frequently be the case for health coverage decisions, as many statutes grant power to administrative actors in general terms which impute significant discretion to the body in question. However, as noted above, outcomes in administrative law depend heavily on the context and the statute in issue, and thus the matter will turn on the particulars of the statute.

C. Human Rights Legislation

Canadian human rights legislation guarantees protection from discrimination in the provision of public services. Patients with rare diseases may seek to use human rights legislation to contest decisions that have the effect of denying them access to health care services. While it appears that no recorded cases have considered human rights legislation in the context of patients with rare diseases seeking treatment, this avenue has been successful in analogous situations, and thus a review of cases sheds light on how courts may decide claims brought by patients with rare diseases.

Human rights legislation has been successfully relied upon by trans-persons seeking public insurance coverage for sex reassignment surgery. In Waters v British Columbia, the BC Human Rights Tribunal found that the provincial health plan, which paid for vaginoplasty for trans-women but did not cover the whole cost of phalloplasty for trans-men, was discriminatory. Similarly, in Hogan v Ontario, a majority of the Ontario Human Rights Tribunal held that the government’s decisions to remove sex reassignment surgery from the list of funded services and not to extend stop-gap funding to cover the claimants who were in the midst of the procedure was a violation of the Human Rights Code, as the government had not established it was incapable of accommodating this group of claimants. The majority carefully noted that the government retained the power to make coverage decisions and to remove therapies from coverage. But, in this case, it was unacceptable for the government to “pull the plug” on claimants who were well into the process.

In two recent cases, male patients argued that provincial insurance plans, by covering screening for breast and uterine cancer but not covering screening for prostate cancer, discriminated on the basis of sex. The complaint was dismissed in both cases. In Armstrong v British Columbia, the BC Court of Appeal upheld the conclusion of the adjudicator who found that the coverage decision was not related to sex, but rather based on medical efficacy, as prostate cancer screening, unlike breast and uterine cancer screening, was not proven to be effective. Similarly, in Cochrane v Ontario, the Ontario Human Rights Tribunal found that the evidence did not prove that prostate cancer screening increased survival rates and thus, like in Armstrong, efficacy – not sex – was the motivation for the decision. In both cases, the adjudicative body tied coverage decisions to evidence of efficacy, perhaps cementing a requirement that coverage decisions be evidence-based. If the approach in Armstrong and Cochrane is followed in the future, it seems unlikely that courts will order that the government pay for experimental treatments that lack at least some evidence of medical efficacy.

The BC Human Rights Tribunal similarly focused on evidence of efficacy in Turnbull v British Columbia. Under the provincial health plan, venous angioplasty was not covered for multiple sclerosis (MS), but was covered for other conditions. Turnbull argued that this constituted discrimination on the basis of disability, because the treatment would be covered if he had a different disease instead of MS. The fact that the treatment was novel and untried for MS factored heavily into the tribunal’s decision to dismiss the complaint.

In the well-known case of Canada v Buffett, however, Buffett successfully argued that the failure of the Canadian Forces to pay for in intra-cytoplasmic sperm injection (ICSI) for male service members while paying for in vitro infertilization (IVF) for female service members constituted discrimination on the basis of sex and disability.

Also relevant are decisions related to the obligation of governments to fund special programming for children with disabilities. In Moore v British Columbia, the Supreme Court of Canada found that the province acted discriminatorily when it abolished special programming that benefited a child with a mental disability. The Court rejected the assertion by the province and the school district that their action was necessary to tackle a “budgetary crisis,” as “the cuts were disproportionably made to special needs programs” and no consideration was first given to other ways in which the financial crisis could be resolved. Extrapolating principles from this decision to the health care context, it would seem that, while budgetary considerations can justify delisting or excluding medical services from coverage, patients with rare diseases must not bear the brunt of financial constraints. In other words, governments cannot justify coverage decisions based on economic arguments if those decisions disproportionately impact patients with rare diseases.

As this brief review highlights, individuals have had mixed success in using human rights legislation to challenge governmental resource allocation decisions. For patients with rare diseases to make use of this tool, they must “demonstrate prima facie discrimination … [by] show[ing] that they have a characteristic protected from discrimination under the [relevant human rights] Code; that they experienced an adverse impact with respect to the service; and that the protected characteristic was a factor in the adverse impact.” Their efforts in this regard will be furthered by the types of arguments and evidence recounted under the discussion of section 15 of the Charter. In order to establish that “the protected characteristic was a factor in the adverse impact,” patients may need to present evidence that the sought treatment is likely to be effective. If they are unable to do so, they may fail to prove that the impugned decision was in fact made on the basis of disability, rather than on the grounds that the therapy is not scientifically proven.

The government then has the onus of proving that denial of funding is justified and may argue that budgetary constraints and the high cost of orphan drugs warrant the impugned action or decision. However, as the Supreme Court of Canada stated in Moore, “accommodation is not a question of ‘mere efficiency’, since ‘[i]t will always seem demonstrably cheaper to maintain the status quo and not eliminate a discriminatory barrier’.” The budgetary circumstances must be such that funding cannot reasonably be extended to cover the requested therapy without causing serious difficulties for the government. Given the exceptionally high cost of some orphan drugs, the government may be able to establish that it could not reasonably afford to cover these treatments. It should be noted, however, that data from Europe suggests that fees paid for orphan drugs constitute only a small fraction of the overall health budgets of many countries. Further, if the cost of the treatment is minor, the court may reject the government’s assertion that covering the cost of therapies for patients with rare diseases would be an unreasonable burden.

D. International Law

International covenants affirm that facilitating access to health care is a crucial component in attaining the overall wellbeing of all people. By way of example, the Universal Declaration of Human Rights states that “[e]veryone has the right to a standard of living adequate for the health and wellbeing of himself and of his family, including … medical care.” Similarly, Article 12 of the International Covenant on Economic, Social and Political Rights (ICESPR) recognizes “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.” Parties to the Covenant commit to “achieving progressively the full realization” of this right, including “[t]he creation of conditions which would assure to all medical service and medical attention in the event of sickness.”

Canada is a party to the ICESPR and thus has obligations under international law to fulfill the commitments made under that treaty. The ICESPR has not found its way into domestic implementing legislation, however. Thus, while it cannot ground a claim by a patient with a rare disease in Canadian courts, it does form part of the background in which judicial interpretation of domestic legislation in, say, an administrative or Charter case, occurs. The impact of international covenants is succinctly explained in a report to Parliament:

[W]hile unincorporated treaties do not necessarily alter Canadian domestic law, they can and do influence its interpretation. A common law doctrine, which applies in Canada, holds that in interpreting legislation, courts should presume that Parliament intended to legislate in a manner consistent with its international treaty obligations … [I]t is clear that the courts can make use of international human rights law in interpretation.

Accordingly, patients with rare diseases cannot directly rely on the guarantees contained in international treaties. However, patients would be well advised to emphasize Canada’s international obligations if bringing claims under domestic legislation or the Charter, particularly given the generous scope of some provisions in international documents. For example, if the benchmark set out in the ICESPR were adopted by Canadian courts, then entitlement to many medical services would likely follow. These services would include therapies that are necessary to extend life or ease pain, and also, arguably, experimental therapies that, while unproven, are reasonably anticipated by patients to have some positive effects. The latter category is suggested on the basis of the stress, disappointment and feelings of hopelessness associated with denial of funding for treatment (and thus, in effect, denial of treatment if costs make it unattainable). These emotional responses should be taken into account when considering what services are necessary in order for patients to achieve the “highest attainable standard of physical and mental health” as provided for by the ICESPR.

E. Tort Law

Tort law is another potential tool for patients seeking funding for desired medical services. This section addresses the issue of whether a patient who is unable to access treatment as a result of a government’s refusal to fund that treatment could claim against the government on grounds of negligence. This question considers the matter of resource allocation at the macro-level (i.e. the policy phase where “big picture” resource allocation decisions are made), as well as at the micro-level (i.e. everyday, individual decisions about how to make use of and expend resources). The discussion thus far has focused on legal claims brought to challenge the decision of governments or government actors, not individual physicians, though they too make a type of resource allocation decision at a patient’s bed-side when they decide whether to administer treatment. This section of the paper considers whether individual physicians and other health care providers who refuse to provide treatment in order to conserve system resources could be liable if the patient then suffers harm. In other words, can physicians rely on what Caulfield calls the “cost-containment defence”?

At the macro-level of resource allocation, what use can be made of tort law to contest allocation decisions? In a recent review of Canadian jurisprudence, Lorian Hardcastle identifies several types of claims that may be brought against the government: claims for mishandling pandemics; claims related to system management failures; and claims for deaths caused by long wait times. A brief review of some of these cases is in order before a discussion of the probability that patients with rare diseases will succeed with system-level negligence claims.

The Ontario Court of Appeal has struck claims brought by patients and health care professionals who argued that the province failed to protect them and to manage the hospital system properly after they contracted communicable diseases. The Court soundly rejected the plaintiffs’ arguments in Eliopoulos Estate v Ontario (Minister of Health and Long-Term Care), observing:

[T]o impose a private law duty of care on the facts that have been pleaded here would create an unreasonable and undesirable burden on Ontario that would interfere with sound decision-making in the realm of public health. Public health priorities should be based on the general public interest. Public health authorities should be left to decide where to focus their attention and resources without the fear or threat of lawsuits.

Similarly, the Quebec Court of Appeal dismissed an application for the certification of a class action brought by cancer patients who accused the government and hospitals of negligently delaying their treatment. The clear policy nature of the decision did not warrant allowing the claim to proceed.

In contrast, the Ontario Court of Appeal in Heaslip Estate v Mansfield Ski Club declined to strike the claim of plaintiffs who argued that the government acted negligently by failing to send air-based medical support to transport an injured teenager, contrary to the government’s own guidelines. The Court believed that the situation fell within the pre-existing class of duties which entailed liability if “a public authority… negligent[ly] fail[ed] to act in accordance with an established policy where it is reasonably foreseeable that failure to do so will cause physical harm to the plaintiff.” The Court added that a duty could be found on an Anns negligence analysis. The Court distinguished the type of government decisions that are immune from liability due to policy considerations from the claim before it, as this claim was “based upon the negligent failure to respond to a specific request for a service that is being provided under an established policy” rather than a challenge to the development of general policy.

This review of cases suggests that tort law is not a promising prospect for patients with rare diseases who seek to challenge government health care allocation decisions. As Hardcastle notes, many of these cases are decided at the duty stage, and courts have been unwilling to find the requisite proximity between the plaintiffs and the defendant governments or hospitals which is necessary to base a duty of care. Chief Justice McLachlin explained the proximity requirement in Hill v Hamilton-Wentworth Regional Police Services Board as follows:

The most basic factor upon which the proximity analysis fixes is whether there is a relationship between the alleged wrongdoer and the victim, usually described by the words “close and direct”. This factor is not concerned with how intimate the plaintiff and defendant were or with their physical proximity, so much as with whether the actions of the alleged wrongdoer have a close or direct effect on the victim, such that the wrongdoer ought to have had the victim in mind as a person potentially harmed. A sufficiently close and direct connection between the actions of the wrongdoer and the victim may exist where there is a personal relationship between alleged wrongdoer and victim. However, it may also exist where there is no personal relationship between the victim and wrongdoer.

Undoubtedly, government decisions about what medical services to fund or not fund will deeply and significantly impact some individuals. However, it seems unlikely that courts would expect the government to ave individual patients “in mind” as “person[s] potentially harmed.” In a general sort of way, the government will expect that its decisions in the health care realm will affect people’s lives, but, generally, it will not anticipate the specific harms that may result or the particular persons (or groups of persons) that will be impacted. Unlike in Hill, where police were found to be adequately proximate to an individual suspect to ground a duty of care, no patient is “singled out” or “particularized” when the government makes general health coverage decisions. The government is dealing with – to use the language from Hill – “the universe of all potential” patients.

Even if plaintiffs establish proximity, a court may find that the duty should be abrogated for policy reasons under the second branch of the Anns test. In Hill, McLachlin CJC explained that “the final stage of Anns is concerned with ‘residual policy considerations’ which ‘are not concerned with the relationship between the parties, but with the effect of recognizing a duty of care on other legal obligations, the legal system and society more generally’.” For example, under the “residual policy consideration” criterion, a court should ask whether there is “potential for conflict between a duty of care in negligence and other duties owed by” the government, such as, “duties [owed] to the public at large.” This concern motivated the Ontario Court of Appeal in Eliopoulos Estate (discussed above) to hold that “impos[ing] a private law duty … would create an unreasonable and undesirable burden … that would interfere with sound decision-making in the realm of public health.” Courts are likely to find that duties to individual persons are inconsistent with the government’s overarching responsibility to provide a cost-effective, reliable and fair health care system. Courts will thus “negate” the duty on the basis of policy-related worries that the imposition of such an obligation would unduly interfere with the government’s discretion to allocate resources in a manner it believes best meets the needs and expectations of all Canadians.

Additionally, it must be noted that, pursuant to the Supreme Court’s decision in Just, governments are not liable for “true policy decisions” that “involve or are dictated by financial, economic, social or political factors or constraints.”Health care coverage decisions, as they involve resource distribution and financial wrangling, are likely the type of decision for which a government will not be liable.

Thus, for patients with rare diseases, the policy hurdles to establishing a duty of care will be difficult to overcome. A patient would need to establish that the impugned decision is in fact an “operational decision” which executes established policy. One could attempt to characterize the decision to deliver accessible, high-quality health care a “policy decision” and choices about individual services “operational decisions” made in the course of realizing that policy. This approach may avoid running afoul of the Supreme Court’s observation that, “[a]s a general rule, decisions concerning budgetary allotments for departments or government agencies will be classified as policy decisions,” because funding (or not funding) individual services may not implicate larger budgetary decisions if the “operational decisions” are made by “lower level” actors within the parameters – including ultimate financial constraints – of the policy. That is, the decision regarding how much money to allocate to overall health spending may be a “policy decision” immune from liability, but, provided the budget is not exceeded, decisions about how to spend that money (on treatment x and not treatment y) may be “operational decisions.” However, based on Canadian case law, this approach, in so far as it seeks to challenge listing and delisting decisions, is unlikely to find favour before the courts unless and until courts perceive “money decisions” to be operational ones.

Turning to micro-level decision-making, physicians and other medical service providers are unlikely to escape liability for malpractice by arguing that fiscal restraints justified their decision not to provide a particular service. In Law Estate v Simice, the British Columbia Supreme Court rejected the physician’s defence that he did not send the patient for a CT scan because of monetary restrictions. The Court noted: “if it comes to a choice between a physician’s responsibility to his or her individual patient and his or her responsibility to the medicare system overall, the former must take precedence in a case such as this.” The Court observed that the physical harm to the patient is “far greater than the financial harm” to the system.

This line of reasoning will be useful if a patient with a rare disease is denied an expensive treatment by a physician on the basis of cost considerations. However, it is unclear whether this scenario is common and thus Simice may not be particularly helpful for patients with rare diseases.

A lawsuit pursued against an individual physician will require consideration of whether the physician has met the requisite standard of care, which is assessed in comparison to “the conduct of a prudent and diligent doctor in the same circumstances.” The efficacy of the sought drug may be relevant at this stage of the analysis. If, for example, the drug is experimental and unproven, a defendant physician can more easily establish that he or she acted “in accordance with the conduct of a prudent and diligent doctor in the same circumstances,” by arguing that his or her peers would be cautious about administering medication without the belief that the drug has at least some chance of benefiting the patient. The fact that the patient has a rare disease – and not a common illness – may also be relevant to the determination of whether the health care provider has fallen below the standard of care. Some lower courts have found that the rare nature of an illness militates in favour of a finding that the defendant met the applicable standard, as physicians in the same setting with the same experience would not recognize the unusual disease.

Even if claims against individual health care providers were likely to be successful, it should be added that tort law challenges to individual decision-makers may not be ideal from the perspective of patients with rare diseases as a group, as the individualized outcome in tort cases does not necessarily lead to the larger, policy change desired by many patients. As Caulfield notes:

[T]ort law is not the best tool for effectuating health care reform. Malpractice lawsuits are determined on a case-by-case basis. They focus on the rights and legal duties of individual physicians and patients. And while the principles of tort law obviously have social utility, such as the compensation of patients who are injured by negligence, the rights and duties of patients and physicians are rarely subordinated to the needs of the broader health care system.

While an individual patient may win his or her case, the larger group of patients is still left without access to treatment.

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