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Rare diseases and resource allocation policy: the role of Canadian legal and ethical norms.

I. INTRODUCTION

Rare diseases have long caused profound health policy challenges, (1) particularly in the context of decisions around the allocation of health care resources. Rare diseases are generally understood to be those affecting less than 1 in 2,000 people. (2) Due to the relatively small market size, among other reasons, (3) the therapies are often tremendously expensive. (4) This makes decisions regarding funding difficult, particularly in the context of a publicly funded healthcare system. As a result, jurisdictions throughout the world have implemented policies on how to evaluate emerging science and support the equitable provision of therapies. (5) In Canada, there has been a good deal of recent activity to develop both evidence-based reimbursement policies and a comprehensive national strategy for rare diseases. (6)

While much progress has been made, (7) many issues associated with resource allocation in the context of rare diseases remain. One area that has received little attention, particularly in Canada, is the impact of legal norms on allocation policy. Much has been written about the way in which legal pressures and ethical obligations can impact physician behaviour and utilization decisions. (8) Given that physicians will play a critical role in deciding which patients will receive a particular resource, understanding how these pressures and obligations may play out in the context of rare diseases seems essential.

In this paper, we review the literature on how legal and ethical norms can influence physicians and clarify what the relevant law and ethical obligations require of physicians in relation to resource allocation decisions. As physicians must determine whether a particular treatment or test should be ordered for a particular patient, it is important to understand the norms that guide physician behaviour. Specifically, it is necessary to have a clear picture of the legal and ethical duties that physicians are under and how these pertain to physician decision making in the allocation of resources. This is particularly necessary in the rare disease context where health care resources are limited and treatment costs can be exorbitant.

In addition, understanding the impact of legal and ethical norms on allocation decisions has relevance beyond the current policy debates associated with rare diseases. As the field of personalized medicine continues to advance, it seems likely that an increasing number of common diseases, such as various forms of cancer, (9) will be subdivided and stratified (10)--thus drastically increasing the number of conditions and treatments that have health policy and economic challenges similar to traditional rare diseases. (11)

II. PRESSURES TO TREAT

There are numerous social forces, including what has been called a general "moral instinct", (12) that nudge physicians toward the provision of expensive healthcare services. Studies have consistently found that healthcare providers err on the side of providing treatment and diagnostic services regardless of cost, even in the face of economic and resource considerations--a tendency that has been called "the rule of rescue." (13) A study of ICU professionals, for example, found that there was a strong tendency to favour the rule of rescue over broader allocation policy because "clinicians perceived strong obligations to identifiable living patients." (14)

Legal and ethical pressures placed on physicians seem to magnify this tendency. Numerous studies have noted that concern about legal liability drives physicians' clinical decisions--a concern that is often disproportionate to the reality of the risk. (15) A well-known study from 2005, for example, found that a large percentage of specialists (93%) reported practicing defensive medicine and 43% of those individuals admitted to "ordering imaging technology in clinically unnecessary circumstances." (16) Of course, there are many other social forces that may cause physicians to favour the provision of treatment, even those that may be of questionable or uncertain clinical value. Media coverage strongly favours the needs of the individual patient over the needs of health systems. Indeed, a study of how the media covers the issues associated with patient access to Herceptin--an expensive cancer drug--found that the "'rule of rescue' dominated" media discourse and, as a result, "[r]ational, criteria-based public health policy will find it hard to resist the rule of rescue imperative." (17) Another study, published in 2015, analyzed over 500 newspaper articles on healthcare access issues and found that "Canadian news media favors a patient access ethos", which may have implications for the policy-making environment. (18)
TEXT BOX I: EMPIRICAL EVIDENCE OF THE IMPACT OF LEGAL NORMS ON
PHYSICIAN BEHAVIOUR

Empirical studies have demonstrated that legal norms affect
physician behaviour in a number of ways, including:

Ordering Diagnostic Tests

* In a survey of Swiss physicians "[f]orty-one per cent of general
practitioners and 43% of internists stated that they sometimes or
often recommend this [prostate specific antigen] test for legal
reasons." (19)

* Survey data from the United States indicates that "fear of
malpractice is associated with a defensive practice style in the
[Emergency Department] and accounts for significant variability in
triage and testing decisions." (20)

* A US study, linking physician survey data to patients' Medicare
claims, found that "physicians who reported concern about their
malpractice risk ... were significantly more likely to order
certain diagnostic tests". (21)

* Interviews with physicians and nurse administrators in the United
States revealed that "medicolegal concerns are an important factor
in preoperative test ordering." (22)

Disclosure of Errors

* Canadian telephone interviews with patient safety stakeholders
showed that "[respondents also spoke about legal obstacles
including the fear of litigation as being a barrier to reporting
errors." (23)

* In a study of focus groups in the US, "[m] any physicians said
that fear of litigation limited what they tell patients about
errors" (24) and "[m]ost physicians wanted to apologize but worried
that an expression of regret might be construed by the patient as
an admission of legal liability." (25)

Referrals and Consultations

* A US study, comparing malpractice environments to specialist
referral rates across different states, found that "a statutory cap
on non-economic damages of $250,000 had a significant and negative
effect on referrals." (26)

* Survey data of US neurosurgeons showed that "66% consulted other
physicians solely for defensive purposes." (27)

* A UK survey of general practitioners, assessing "the likelihood
of certain practice changes in response to the possibility of a
patient complaining", found that 63.8% of respondents indicated
they were "likely or very likely" to change their practice through
an "[increased referral rate". (28)

Avoiding High-Risk Patients or Procedures

* Survey data in the US shows that "[t]hirty-nine percent of
specialist physicians reported that they 'definitely will/already
decided to' avoid caring for high-risk patients" and "[o]ne third
of specialist physicians reported often avoiding certain procedures
or interventions". (29)

* A US study analyzing data from the National Natality Files
"show[ed] that the quantity of prenatal care is lower when
malpractice premiums are higher, which is consistent with ... negative
defensive medicine." (30)

* Survey data of Canadian physicians showed that "[n] early 90%
reported decreasing the scope of their practice or changing their
style of practice" with medicolegal concerns noted as an important
reason for these changes. (31)

* A survey of gastroenterologists in Japan showed that
"[o]ne-hundred and twenty-six (96%) of the 131 respondents reported
that they sometimes or often engaged in at least one of the two
forms of avoidance behaviour [avoiding certain procedures or
interventions, and avoiding caring for high-risk patients]". (32)


III. ETHICAL AND LEGAL NORMS

There are various ethical and legal norms that are relevant to physicians' decision making and role in resource allocation. Ethical norms have been codified in medical practice for more than a century and serve to help define the standards of the profession. (33) These codes of ethics address many aspects of physician behaviour and exist at multiple levels of practice, including provincial colleges, the Canadian Medical Association (CMA), and internationally. (34) These documents are accessible to the medical community and the norms they espouse are taught to aspiring physicians in medical school. (35) What these codes say about physicians' ethical obligations to patients and the health care system is therefore relevant to the discussion about resource allocation.

Typically, these norms emphasize physicians' obligations to individual patients over societal considerations in determining a course of treatment. The CMA Code of Ethics, for example, declares that physicians must "[c]onsider first the well-being of the patient." (36) While the Code recognizes that physicians must also "[c]onsider the well-being of society in matters affecting health", (37) any conflicts of interest--including, one would assume, those associated with resource allocation and treatment cost--must be resolved "in the best interest of the patient." (38) The World Medical Association has noted that although considerations of justice and the societal impact of allocation decisions are increasingly being incorporated into medical decision making, physicians have retained "considerable discretion as to which resources their patients will have access." (39)
TEXT BOX II: RELEVANT ETHICAL NORMS ESPOUSED BY PROFESSIONAL
ASSOCIATIONS

Canadian Medical Association. Code of Ethics: (40)

* "Consider first the well-being of the patient"

* "Consider the well-being of society in matters affecting health"

* "Recognize and disclose conflicts of interest that arise in the
course of your professional duties and activities, and resolve them
in the best interest of patients."

* "Recognize the responsibility of physicians to promote equitable
access to health care resources."

* "Use health care resources prudently."

Quebec, Code of Ethics of Physicians: (41)

* "A physicians paramount duty is to protect and promote the health
and well-being of the persons he attends to, both individually and
collectively."

* "A physician must collaborate with other physicians in
maintaining and improving the availability and quality of the
medical services to which a clientele or population must have
access."

* "A physician must be judicious in his use of the resources
dedicated to health care."

* "A physician must, in the practice of his profession, take into
account  ... the means at his disposal."

* "A physician must safeguard his professional independence at all
times and avoid any situation in which he would be in conflict of
interest, in particular when the interests in question are such
that he might tend to favour certain of them over those of his
patient or where his integrity and loyalty toward the latter might
be affected."

The College of Physicians and Surgeons of Ontario. The Practice
Guide: Medical Professionalism and College Policies: (42)

* "A physician has professional responsibility to their patients,
individually and collective; their patients' families; their own
practice; and the health care system. However, at any given time a
physicians primary responsibility is to the individual patient
before them."

* "Patients' needs are paramount and must be considered before the
individual physician's needs, the needs of physicians as a group,
or the public as a whole."

* "[P]hysicians should, individually and collectively, advocate for
their patients. Advocacy involves the responsible use of expertise
and influence to advance patients' health care interests.... To
ensure that patients receive fair and efficient treatment by others
involved in their care, physicians should use their knowledge of
the [health care] system to assist their patients in successfully
navigating this network.... Physicians have a responsibility to
advocate on behalf of their patients to advance policies that
promote the health and well-being of the public."

* "Physicians should also collaborate with others for the effective
management of health care resources."

* "[I]f there is a conflict between a physician's obligation to a
patient and the obligation to the system (e.g., efficiency), the
profession's commitment to the value of altruism makes it clear
that the patient should always come first."

American Medical Association. Code of Medical Ethics: (43)

* "A physician shall respect the law and also recognize a
responsibility to seek changes in those requirements which are
contrary to the best interests of the patient."

* "A physician shall, while caring for a patient, regard
responsibility to the patient as paramount."

* "A physician shall support access to medical care for all
people."

World Medical Association. International Code of Medical Ethics: (44)

* "A physician shall strive to use health care resources in the
best way to benefit patients and their community."

* "A physician shall act in the patients best interest when
providing medical care."

* "A physician shall owe his/her patients complete loyalty and all
the scientific resources available to him/her."


It is clear that, although there is some recognition of the need to use resources judiciously, these ethical standards emphasize a physicians duty to his or her patients above all else. Similarly, with regard to the law, some scholars have gone so far as to suggest that existing legal norms not only compel physicians to provide, but should be viewed as a constructive framework that will ensure "the continued provision of treatments despite significant economic pressure to reduce funding." (45)

The existing Canadian law says remarkably little about balancing the needs of society against the needs of the individual patient? But, the law that is available points in a very clear direction. From the perspective of the law, the needs of the patient should almost always be viewed as paramount. (46) For example, in the case of Law Estate v Simice, which involved a physician's decision not to order a CT scan due to economic constraints, the Court held that:
   [I]f 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 severity of the harm that may occur to the
   patient who is permitted to go undiagnosed is far greater than the
   financial harm that will occur to the medicare system if one more
   CT scan procedure only shows the patient is not suffering from a
   serious medical condition. (47)


In McLean v Carr Estate, which similarly involved the failure to order a CT scan, the Court acknowledged that it would undoubtedly have been useful to scan the patient upon arrival to the hospital, but the question was one of cost-effectiveness of this precautionary measure. (48) As the defendants did not lead any evidence showing that it would have been prohibitively expensive in the circumstances to order a CT scan, the Court found that the scan should have been ordered given the potentially grave consequences to the patient. (49) These cases indicate that Canadian courts seem likely to be unsympathetic to resource constraints being raised as a defence in medical malpractice claims, unless the relevant treatment is truly prohibitively expensive. (50) While ordering a single CT scan or prescribing an expensive therapy for one individual rare disease patient may not be prohibitively expensive, the impact on the health care system of these treatments in the aggregate does not appear to be a significant concern of the courts in these decisions. In addition, some have raised concerns that cases like these will cause physicians to artificially adjust the standard of care--that is, create a standard not supported by the best available evidence--by ordering tests and treatments in more cases than they otherwise would in order to avoid liability. (51)

When there is genuine scarcity of resources, the law is more sympathetic to the necessity to provide less. (52) In Bateman v Doiron, for example, the New Brunswick Court of Queen's Bench considered whether a Moncton hospital breached its duty to provide adequate facilities, equipment, and personnel by staffing its emergency department with part-time general practitioners instead of specialists in emergency medicine. (53) After noting that "[t]he evidence [was] clear that the only way the defendant Moncton Hospital could staff its emergency department ... was by granting privileges on a part-time basis to general practitioners", (54) the Court found that the hospital met the standards that could reasonably be expected by the community it served. (55)

In a rural setting, physicians may not have access to as many resources as in a large urban centre, and in such circumstances it is less likely that a physician would be found liable for providing suboptimal care. (56) Physicians "have a duty to conduct their practice in accordance with the conduct of a prudent and diligent doctor in the same circumstances" (57) and determining whether a physician has met this standard of care requires examining what "could reasonably be expected of a normal, prudent practitioner". (58) In Mathura v. Scarborough General Hospital, the Ontario Court of Justice (General Division) commented on how the standard of care is impacted by resource constraints:
   The Court must take into account the availability and cost of
   procedures, medication and equipment to the attending physician at
   the time when the cause of action arose. This consideration will
   affect the standard of care in that a doctor cannot reasonably be
   expected to provide care which is unavailable or impracticable due
   to the scarcity of resources. (59)


The availability of resources and the cost of treatment were not raised by the defendants in this case, and the Court did not elaborate on what constitutes an "impracticable" level of scarcity. However, in comparison to McLean v Carr Estate, "impracticable" may be a lower standard than "prohibitively expensive" in determining when the standard of care should be lowered due to resource constraints. Nevertheless, physicians have an obligation to do their best--and to strive to satisfy the established standard of care--with the resources that are available. (60)

Indeed, rural physicians faced with resource constraints have an obligation to recognize this limitation and refer patients to specialists and urban facilities when appropriate. (61) It is more legally problematic when physicians are placed in the situation of having to make clinical decisions to use more, less, or different types of care based on resource or economic considerations. In Kangas v Parker, (62) a dental surgeon was found negligent for complications during the extraction of a patient's teeth that led to the patient's death. Part of the Court's decision was based on the fact that the defendant, motivated by his own convenience, scheduled the procedure to take place in an anaesthetist's office and did not give the patient the choice to have it performed in a hospital where appropriate preliminary testing and emergency care would have been available. (63) This case indicates that when there is a choice between potential facilities for treating a patient, the medical interests of the patient should be paramount over concerns of efficiency for the treating physician. (64)

Additionally, where a particular test or treatment is not publically funded, but available to patients either privately or in another jurisdiction, physicians may have an obligation as part of the informed consent process to disclose its availability to patients. (65) For example, in Thibault v Fewer, the Court acknowledged that even if a procedure with fewer risks is only available outside the relevant province of residence, the physician should nevertheless provide information about the procedure for the patient to consider. (66) Additionally, in St. Jules v Chen, the Court had to consider whether physicians had met their informed consent obligations in warning a pregnant patient about the lack of resources and inadequacy of labour and delivery facilities in the community where the patient lived. (67) Upon hearing conflicting testimony and assessing the credibility of the witnesses in that case, the Court found that the physicians discharged their duty of disclosure by informing the patient of the need to deliver her twin babies at a more fully equipped centre. (68)

These cases indicate that physicians may have a duty to disclose the existence of treatments that are not available to patients in their region due to resource constraints. Specifically, physicians are under an obligation to disclose all the relevant information that a reasonable person in the patient s position would want to know. (69) In the context of medication for rare diseases, which can be very expensive, the potential financial burden on patients who may need to pay out-of-pocket for medications that lack provincial funding would likely not be a valid reason for a physician to withhold information about the treatment. (70) The Court in Thibault v Fewer specifically noted that the financial consequences to the patient of pursuing treatment in another jurisdiction was a matter for the patient to decide. (71) By extension, this reasoning would likely apply to the need to disclose information about potentially effective medication that may need to be privately paid for, as this is something that a reasonable person in the patient's position would want to know. (72)

Existing fiduciary law also compels Canadian physicians to place the interests of their patients above all other concerns. (73) Indeed, Canadian fiduciary law is arguably among the strongest anywhere in the world. (74) In the 1992 case of Norberg v Wynrib, McLachlin J stated that "the most fundamental characteristic of the doctor-patient relationship is its fiduciary nature." (75) The existence of a fiduciary relationship between physicians and patients is characterized by "trust of a person with inferior power that another person who has assumed superior power and responsibility will exercise that power for his or her good and only for his or her good and in his or her best interests." (76)

This seminal case has been cited with approval by many courts, which have further considered the content and scope of this duty. (77) By accepting an individual as a patient, the physician "under[takes] a duty of loyalty, good faith and avoidance of conflicting interests." (78) A "relationship of trust" exists between the physician and patient that obliges physicians to exercise the power they hold over their patients "solely for the patient's benefit." (79) Fiduciary law in Canada also compels physicians to disclose information that may compromise patient care, which presumably would include practices motivated by cost containment measures that affected clinical decision making. (80) Specifically, if cost containment measures impose incentives for physicians to alter behaviour, there could be an obligation to disclose this as a potential conflict of interest. (81)

In Kangas, the Court found that the dental surgeon breached his duty to his patient by furthering his own interests in scheduling surgery at a location that was most convenient for him at the expense of his patient s safety. (82) Similarly, in De Vos, the Court had to determine whether the defendant physician breached her disclosure obligations by administering a general anaesthetic on the plaintiff without giving him the option of having surgery under an epidural or spinal anaesthetic. (83) At trial, time constraints and the need to use the most efficient form of anaesthesia were raised as issues, but the Court stated:
   No doubt there are budgetary and time constraints involved in
   scheduling day surgeries such as those undergone by the plaintiff
   but, in my view, this is a case where those constraints worked
   against the patient's interest by inhibiting the doctors in their
   judgment of what should be done for him. That is to be deplored. I
   raise this in passing only to point out that there were a number of
   references to the effect of time constraints on the treatment of
   this patient. I respectfully say it is something to be carefully
   considered by those who are responsible for the provision of
   medical care and those who are responsible for financing it. I also
   say that if it comes to a choice between the physicians
   responsibility to his or her individual patient and his or her
   responsibility to the medical system overall, the former must take
   precedence in a case such as this. (84)


The strong fiduciary nature of physicians' obligations is clear. Physicians' scheduling and budgetary concerns are secondary to the patient's best interests, and these factors should not be considered by physicians if they conflict with or impede physicians' decisions about what is best for a particular patient.

The question of how far this fiduciary duty extends, and specifically whether physicians have a duty to advocate on behalf of their patients when it comes to issues of access to limited health care resources, has become a subject of ethical and legal concern. (85) An appellate level court in California grappled with this question in Wickline v California. (86) In this case, the plaintiff's physician determined it was medically necessary to extend the plaintiff's hospital stay by eight days as a result of complications that arose after surgery; however, Medi-Cal (the state's Medicaid program) only authorized a four-day extension. The plaintiff was therefore discharged after four days and developed further complications that eventually led to the amputation of her leg. (87) At trial, Medi-Cal was found responsible for the plaintiff's injuries; however, this finding was reversed on appeal. (88)

Specifically, the appellate Court found that it was ultimately the treating physicians responsibility to determine when to discharge a patient. (89) In this case, the treating physician could have called the Medi-Cal reviewer to discuss the decision or sought a further extension but he failed to do so. In this regard, the Court stated, "the physician who complies without protest with the limitations imposed by a third party payor, when his medical judgment dictates otherwise, cannot avoid his ultimate responsibility for his patient's care" (90) and that the treating doctor in this case "should have made some effort" to keep the plaintiff in the hospital if he thought that was in her best interest. (91)

The Wickline decision has been discussed as imposing a duty on physicians to advocate on behalf of their patients to access scarce health care resources and to challenge cost containment measures when they run counter to their patients' best interests. (92) However, in that case, the treating physician was not named as a defendant so the Court did not actually impose liability on the physician as a result of his failure to challenge the Medi-Cal decision. Assuming a duty to advocate does exist, questions remain as to how far it extends and whether it might apply on a policy level to the specific treatments that a payor decides to fund.

Canadian courts have not squarely addressed the question of whether physicians have a duty to advocate for their patients although it has arisen somewhat tangentially. The Quebec case Landry c Hopital St-Francois D'Assise involved a claim brought against a hospital and physician by a plaintiff who was injured as a result of outdated hemodialysis equipment that lacked a water purifier. (93) The physician in that case had written numerous letters requesting that the hospital purchase the purifier that went unheeded. The hospital argued before the Court that the physician should have been more insistent in requesting the appropriate equipment. The Court ultimately found the hospital and physician jointly liable, although this appears to primarily be based on the physician's failure to inform his patients of the dangers of undergoing dialysis with unpurified water and his failure to adequately monitor the aluminum content in his patients blood. (94)

In Allen v University Hospitals Board. (95) two defendant obstetricians were found negligent in their care of a pregnant patient who delivered her baby by emergency C-section. One of the defendants claimed that it took longer than anticipated to book the operating room, as there were no operating rooms designated specifically for C-sections. (96) However, the Court found that if it was difficult to book an operating room, the doctor should have inquired into the room's availability a couple hours earlier when he became aware that there was a "distinct possibility" that a C-section would be required, and that he should have "explore [d] the potential need with the appropriate administrative personnel". (97) While this case seems to go further than Landry by recognizing at least a minimal duty to advocate for patients' access to resources in the context of securing an operating room for emergency surgery, it is unclear whether this finding would extend beyond these relatively narrow and emergent factual circumstances.

A recent Ontario decision engaged the question of whether a physician's duty to advocate for her patient's best interests compromised the independence of a medical report she wrote for her patient to use as evidence in an administrative proceeding. (98) While the Court did not explicitly take a position on the question of whether the physician had a duty to advocate or whether such a duty compromised the independence of her report, it did ultimately hold that the treating physicians report was inadequate and that it was "entirely reasonable" for the patient to undergo an independent medical examination by a different doctor. (99)

Notably, the Iacovelli decision referred to the College of Physicians and Surgeons of Ontario's Practice Guide: Medical Professionalism and College Policies, which explicitly recognizes that physicians have a duty to advocate for their patients. (100) Specifically, this document defines advocacy as "the responsible use of expertise and influence to advance patients' health care interests" and provides that "[p]hysicians have a responsibility to advocate on behalf of their patients to advance policies that promote the health and well-being of the public." (101) Although this Practice Guide also provides that "[p]hysicians should also collaborate with others for the effective management of health care resources", (102) it is emphatic that in conflicts "between a physician's obligation to a patient and the obligation to the system (e.g., efficiency), the profession's commitment to the value of altruism makes it clear that the patient should always come first." (103)

In summary, existing legal and ethical norms place tremendous pressure on physicians to act in the best interests of their patients. This ethos has undoubtedly contributed to the perception that the needs of individual patient should drive health care decisions, regardless of broader resource allocation policy. Moreover, although Canadian courts have not directly addressed the question of physicians' duty to advocate for their patients or how far such a duty would extend, there appears to be greater support for this proposition in physicians' ethical guidelines.

IV. DISCUSSION

Given existing legal norms, physicians who work with rare diseases seem to be faced with a profound conflict. As an increasing number of expensive therapies emerge for rare diseases and for diseases stratified by personalized approaches to treatment, it seems likely that physicians--and healthcare systems more broadly--will need to make tough allocation decisions. Providing the best available care for all patients simply will not be sustainable. (104) As such, it seems inevitable that physicians will be increasingly called to implement, at the point of care, allocation policy. (105)

Existing legal norms--which emphasize the best interests of the patient over societal needs--do not sit comfortably with this reality. Fiduciary and medical malpractice law focus on the needs of individual patients and adherence to the standard of care with little or no regard to the impact of escalating treatment costs on the health care system as a whole. (106) And, it should not be forgotten that these forces seem likely to play out in the context of personalized medicine as well. (107) The result is that physicians are essentially being encouraged to provide the best possible options for their patients, regardless of costs. Even where comprehensive allocation policies are in place, these pressures, codified in law and professional standards, nevertheless persist. The pressure on physicians to advocate for their patients could even be heightened when a physician is faced with an individual patient whose treatment is excluded by an allocation policy.

Malpractice law tends to encourage physicians to provide more treatment, which increases costs to the health care system. (108) This is at odds with a growing movement towards decreasing excessive and unnecessary treatment to reduce wasted health care expenditures (estimated in the US to amount to approximately 30% of all health care costs) (109) and the associated harms of overtreatment to patients. (110) In particular, the "Choosing Wisely" campaign is calling attention to the most egregiously overused tests and procedures in a range of medical specialties and encouraging physicians to order treatments whose usefulness is demonstrated by evidence. (111) Given the significant role physicians play in resource allocation, their support for this movement is essential. (112) To the extent that fear of liability is driving the overuse of tests and procedures, this may be a source of resistance among physicians to efforts of this nature. (113) In addition, it is not always clear whether a given treatment will be beneficial or wasteful for a particular patient, (114) and given the legal and ethical pressures placed on physicians, physicians may err on the side of providing more.

It is important to revisit the long-term viability of allocation policy rooted in this "rule of rescue" imperative. (115) In particular, in the rare disease context, healthcare budgets may seem capable of accommodating expensive treatment for a handful of patients with a specific condition; however, as more orphan drugs continue to be developed and able to treat more and more patients, the ability of healthcare systems to keep pace is questionable. (116) At a minimum, future rare disease and personalized medicine policy will need to consider the evidence regarding the impact of legal and ethical norms on physician and system behaviour. (117)

(1) See Nick Dragojlovic et al, "Challenges in Measuring the Societal Value of Orphan Drugs: Insights from a Canadian Stated Preference Survey" (2015) 8:1 The Patient 93; Sheena Gosain et al, "Resource Allocation for the Treatment of Rare Diseases" (2013) 67:10 J Epidemiology & Community Health e2; Ida Vanessa D Schwartz et al, "Clinical Genetics and Public Policies: How Should Rare Diseases be Managed?" (2014) 34:2 Clinical & Biomedical Research 122; Samir Gupta, "Rare Diseases: Canada's 'Research Orphans'" (2012) 6:1 Open Medicine e23; Abbas H Panju & Chaim M Bell, "Policy Alternatives for Treatments for Rare Diseases" (2010) 182:17 CMAJ E787; Marlene E Haffner, "Adopting Orphan Drugs--Two Dozen Years of Treating Rare Diseases" (2006) 354:5 New Eng J Med 445.

(2) See Canadian Organization for Rare Disorders, "About CORD", online: <www.raredisorders.ca>; European Commission, "Rare Diseases: Policy", online: <ec.europa.eu/health/rare_diseases/policy/index_en.htm>. In the United States, rare diseases are understood to be those affecting fewer than 200,000 people. See National Institutes of Health, "Rare Diseases Clinical Research Network", online: <report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=126>.

(3) Such as increased commercialization costs, a lack of alternative options for patients, and extra services, such as patient advocacy and education and physician training. See Mark Zitter, "Managing Drugs for Rare Genetic Diseases: Trends and Insights" (2005) Managed Care 14:2 52 at 57, online: <www.managedcaremag.com>.

(4) See ibid at 58.

(5) See Canadian Organization for Rare Disorders, "Now is the Time: A Strategy for Rare Diseases is a Strategy for all Canadians" (2015), online: <www.raredisorders.ca /content/uploads/Exec-RD-Strategy-Summary-FINAL-EN.pdf>; Gupta, supra note 1; Panju & Bell, supra note 1.

(6) See e.g. Mike Paulden et al, "Value-Based Reimbursement Decisions for Orphan Drugs: A Scoping Review and Decision Framework" (2015) 33:3 Pharmaco Economics 255.

(7) To address some of the challenges faced by rare disease patients, jurisdictions around the world have implemented regulatory mechanisms to incentivize the research and development of orphan drugs, resulting in an expanding number of orphan drug designations and growing market for these products. In addition, some jurisdictions are taking a more flexible approach to health technology assessment and evaluation for orphan drugs to facilitate patient access. See Canadian Agency for Drugs and Technologies in Health, Drugs for Rare Diseases: Evolving Trends in Regulatory and Health Technology Assessment Perspectives, by Lili Loorand-Stiver, Tara Cowling & Christine Perras (Ottawa: Environmental Scan, 2013), online: <www.cadth.ca>; BIOTECanada, The Canadian Rare Disease Therapies Landscape: Bridging Opportunity to Reality, White Paper Report (Ottawa: BIOTECanada, 2015), online: <www.biotech.ca>.

(8) See e.g. David M Studdert et al, "Defensive Medicine Among High-Risk Specialist Physicians in a Volatile Malpractice Environment" (2005) 293:21 J American Medical Assoc 2609; Daniel P Kessler & Mark B McClellan, "How Liability Law Affects Medical Productivity" (2002) 21:6 J Health Economics 931.

(9) See Maria Schwaederle et al, "Association of Biomarker-Based Treatment Strategies with Response Rates and Progression-Free Survival in Refractory Malingnant Neoplasms: A Meta-Analysis", online: (2016) JAMA Oncology, at E2 <oncology.jamanetwork.com> DOI: <10.1001/jamaoncol.2016.2129>.

(10) See Mark Trusheim, Ernst R Berndt & Frank L Douglas, "Stratified Medicine: Strategic and Economic Implications of Combining Drugs and Clinical Biomarkers" (2007) 6:4 Nature Reviews Drug Discovery 287.

(11) See Timothy Caulfield & Amy Zarzeczny, "Defining Medical Necessity in an Age of Personalised Medicine: A View from Canada" (2014) 36:9 BioEssays 813. As personalized medicine continues to grow, there may be an increasing number of treatments tailored to specific genetic variants of particular diseases. This increasingly stratified approach to treatment may have policy and economic implications, particularly when it comes to health resource allocation. See Caulfield & Zarzeczny, ibid, for a detailed discussion of this issue in the Canadian health law and policy context.

(12) Emily A Largent & Steven D Pearson, "Which Orphans Will Find a Home? The Rule of Rescue in Resource Allocation for Rare Diseases" (2012) 42:1 Hastings Center Report 27 at 27.

(13) See e.g. Rachel Kohn et al, "Rule of Rescue or the Good of the Many? An Analysis of Physicians' and Nurses' Preferences for Allocating ICU Beds" (2011) 37:7 Intensive Care Medicine 1210; Nicholas S Ward et al, "Perceptions of Cost Constraints, Resource Limitations, and Rationing in the United States Intensive Care Units: Results of a National Survey" (2008) 36:2 Critical Care Medicine 471; The Society of Critical Care Medicine Ethics Committee, "Attitudes of Critical Care Medicine Professionals Concerning Distribution of Intensive Care Resources" (1994) 22:2 Critical Care Medicine 358.

(14) Kohn, supra note 13 at 1210.

(15) See Text Box I. See e.g. NP Pereira et al, "Attitudes about Medical Malpractice: An American Society of Neuroradiology Survey" (2014) 35:4 American J Neuroradiology 638; Emily R Carrier et al, "Physicians' Fears of Malpractice Lawsuits are Not Assuaged by Tort Reforms" (2010) 29:9 Health Affairs 1585.

(16) Studdert, supra, note 8 at 2609.

(17) Ross MacKenzie et al, "Media Influence on Herceptin Subsidization in Australia: Application of the Rule of Rescue ?" (2008) 101:6J Royal Society Medicine 305 at 305.

(18) Christen Rachul & Timothy Caulfield, "The Media and Access Issues: Content Analysis of Canadian Newspaper Coverage of Health Policy Decisions" (2015) 10:102 Orphanet J Rare Diseases, DOI <10.1186/s13023-015-0320-z>.

(19) Johan Steurer et al, "Legal Concerns Trigger Prostate-Specific Antigen Testing" (2009) 15:2 J Evaluation in Clinical Practice 390 at 391.

(20) David A Katz et al, "Emergency Physicians' Fear of Malpractice in Evaluating Patients with Possible Acute Cardiac Ischemia" (2005) 46:6 Annals Emergency Medicine 525 at 530.

(21) Emily R Carrier et al, "High Physician Concern about Malpractice Risk Predicts More Aggressive Diagnostic Testing in Office-Based Practice" (2013) 32:8 Health Affairs 1383 at 1387.

(22) Steven R Brown & Jaclyn Brown, "Why Do Physicians Order Unnecessary Preoperative Tests? A Qualitative Study" (2011) 43:5 Family Medicine 338 at 341.

(23) Health Canada, Patient Safety and Healthcare Error in the Canadian Healthcare System: A Systematic Review and Analysis of Leading Practices in Canada with Reference to Key Initiatives Elsewhere: A Report to Health Canada, by G Ross Baker & Peter Norton (Ottawa: HC, 2001) at 122.

(24) Thomas H Gallagher et al, "Patients' and Physicians' Attitudes Regarding the Disclosure of Medical Errors" (2003) 289:8 J American Medical Assoc 1001 at 1004.

(25) Ibid at 1005.

(26) Xiao Xu et al, "The Effect of Medical Malpractice Liability on Rate of Referrals Received by Specialist Physicians" (2013) 8:4 Health Economics, Policy & L453 at 464.

(27) Brian V Nahed et al, "Malpractice Liability and Defensive Medicine: A National Survey of Neurosurgeons", online: (2012) 7:6 PloS One e39237 at 4 <journals .plos.org/plosone>.

(28) Nicholas Summerton, "Positive and Negative Factors in Defensive Medicine: A Questionnaire Study of General Practitioners" (1995) 310:6971 Brit Med J 27 at 28.

(29) Studdert, note 8 at 2613.

(30) Lisa Dubay, Robert Kaestner & Timothy Waidmann, "Medical Malpractice Liability and its Effect on Prenatal Care Utilization and Infant Health" (2001) 20:4 J Health Economics 591 at 606.

(31) Christel A Woodward & Walter Rosser, "Effect of Medicolegal Liability on Patterns of General and Family Practice in Canada" (1989) 141:4 CMAJ 291 at 297.

(32) Torn Hiyama et al, "Defensive Medicine Practices Among Gastroenterologists in Japan" (2006) 12:47 World J Gastroenterology 7671 at 7672.

(33) See Jeanne F Backof & Charles L Martin Jr, "Historical Perspectives: Development of the Codes of Ethics in the Legal, Medical and Accounting Professions" (1991) 10:2 J Business Ethics 99; Heather MacDougall & G Ross Langley, "Medical Ethics: Past, Present and Future", at Part I: Laying the Foundations, online: Royal College of Physicians and Surgeons of Canada <www.royalcollege.ca>.

(34) See Text Box II.

(35) See Lisa Soleymani Lehmann et al, "A Survey of Medical Ethics Education at U.S. and Canadian Medical Schools" (2004) 79:7 Academic Medicine 682.

(36) The Canadian Medical Association, CMA Code of Ethics, Ottawa: CMA, 2004, art 1, online: <www.cma.ca/Assets/assets-library/document/en/about-us/PD04-06-e.pdf> [CMA Code of Ethics].

(37) Ibid, art 4.

(38) Ibid, art 11.

(39) World Medical Association, WMA Medical Ethics Manual, 3rd ed, by John R Williams (Ferney-Voltaire Cedex, France: WMA, 2015) at 71, online: <www.wma.net /en/30publications/30ethicsmanual/pdf/ethics_manual_en.pdf>.

(40) Supra note 36, arts 1, 4, 11, 43, 44.

(41) Code of Ethics of Physicians, CQLR c M-9, r 17, s 3, 3.1, 12, 42, 63.

(42) The College of Physicians and Surgeons of Ontario, The Practice Guide: Medical Professionalism and College Policies, 2007, at 8, 12, 14, 16, online: <www.cpso.on.ca /uploadedFiles/policies/guides/PracticeGuideExtract_08.pdf>.

(43) American Medical Association, AMA's Code of Medical Ethics: Principles of Medical Ethics (2001), art 3, 8, 9, online: <www.ama-assn.org/ama/pub/physician-resources /medical-ethics/code-medical-ethics/principles-medical-ethics.page>.

(44) World Medical Association, WMA International Code of Medical Ethics, online: <www.wma.net/en/30publications/ 10policies/c8/index.html.pdf?print-media-type&f ooter-right=%5Bpage%5D/%5BtoPage>.

(45) Hanna I Hyry et al, "The Legal Imperative for Treating Rare Disorders" (2013) 8:135 Orphanet J Rare Diseases 1 at 1.

(46) See Commission on the Future of Health Care in Canada, How Do Current Common Law Principles Impede or Facilitate Change?, by Timothy Caulfield, Discussion Paper No 24 (Saskatoon: CFHCC, 2002).

(47) 1994 CarswellBC 1117 at para 28, 21 CCLT (2d) 228 (BCSC), aff'd [1996] 4WR 672, 27 CCLT (2d) 127 (BCCA).The need for a physician's responsibility to his or her patient to take precedence over his or her responsibility to the medical care system was echoed by the Ontario Superior Court of Justice in De Vos v Robertson, 2000 Carswell Ont 44 at para 57, 48 CCLT (2d) 172.

(48) (1994), 116 Nfld & PEIR 271 at para 74, 1994 Carswell Nfld 68 (NLSCTD).

(49) See ibid at 79.

(50) The Canadian Medical Protective Association has noted this reality in their handbook for physicians on medical-legal issues: "In the event of a choice between a physician's duty to a patient and that owed to the medical care system, the duty to the patient must prevail. To date, the courts appear unwilling to accept a defence based solely on cost containment to justify withholding treatment or services from a patient": Canadian Medical Protective Association, Medical-Legal Handbook for Physicians in Canada, 8th ed (Ottawa: CMPA, 2016), at 48, online: <www.cmpa-acpm.ca>.

(51) See e.g. Robert-Jean Chernier, "Resource Allocation and the Standard of Care of Physicians" (2004) 83:1 Can Bar Rev 1.

(52) See e.g. Bateman v Doiron, (1991), 118 NBR (2d) 20,8 CCLT (2d) 284 (NBQB), aff'd (1993), 141 NBR (2d) 321, 18 CCLT (2d) 1 (NBCA) [Bateman, cited to NBR].

(53) Bateman, surpa note 52.

(54) Ibid at para 40.

(55) Ibid at para 48. See also Thompson Estate v Byrne, where the Court, in deciding whether the availability of surgical residents as opposed to anaesthesia residents met the standard of care, noted that "[n]o hospital could afford to have anaesthesia residents always at hand, waiting around without other responsibilities until such time as a patient might have occasion to require their services", indicating a willingness by the Court to consider cost as a factor in determining the standard of care: 114 NSR (2d) 395 at para 148, 1992 CarswellNS 134 (NCSC).

(56) The Court in Rodych Estate v Krasey found the defendant physician, who lacked appropriate facilities, was forced to examine a patient on the side of the road in the middle of the night, not liable for failing to detect the patient's serious injuries and waiting until the morning to order x-rays. See Rodych Estate v Krasey, 4 WWR 358, 1971 CarswellMan 40 (MBQB). See also Bernard Dickens, "Medical Negligence", in Jocelyn Downie, Timothy Caulfield & Colleen M Flood, eds, Canadian Health Law and Policy, 4th ed (Markham, ON: LexisNexis Canada Inc, 2011) 115 at 125; Ellen I Picard & Gerald B Robertson, Legal Liability of Doctors and Hospitals in Canada, 4th ed (Toronto: Thomson Canada Limited, 2007) at 241-55.

(57) Ter Neuzen v Korn, [1995] 3 SCR 674 at para 46, 127 DLR (4th) 577.

(58) Crits v Sylvester, 1 DLR (2d) 502 at 508, 16 OR (2d) 532 (ONCA). Courts in some cases have acknowledged that the community in which a physician works may impact the expected standard of care. See e.g. McCormick v Marcotte, [1972] SCR 18, 20 DLR (3d) 345 at 346. In Wilson v Swanson, the Supreme Court of Canada (SCC) articulated the appropriate standard of care in cases of medical malpractice to be the "reasonable degree of learning and skill ordinarily possessed by practitioners in similar communities in similar cases": [1956] SCR 804, 5 DLR (2d) 113 at 124. See also Pierre (Next-Friend of) v Marshall, [1994] 8 WR 478 at paras 34-36, 152 AR 161 (ABQB); Williamson v Kozak, 2003 ABQB 953 at paras 74-76, [2004] 5 WWR 716; Bear (Litigation Guardian of) v Lambos, 2005 SKQB 148 at paras 38-40, [2005] 10 WWR 145. However, other decisions and commentators have criticized the lowering of the standard of care for rural physicians. See e.g. Crawford (Litigation guardian of) v Penney, 14 CCLT (3d) 60, 2003 CarswellOnt 82 at paras 250-54 [Crawford]; Picard & Robertson, supra note 56 at 148-251.

(59) 1999 CarswellOnt 43 at para 83, [1999] OJ No 47 (ONCJ) [citations omitted].

(60) See Crawford., supra note 58, aff'd 26 CCLT (3d) 246, [2004] OJ No 3669 (ONCA).

(61) The Court in Crawford noted that "a physician practicing in a small town must be particularly vigilant to risk factors because of the lack of availability of immediate help. The need to refer patients to specialists, therefore, may be greater in a rural setting than in an urban setting.... These physicians [in rural areas] and localities must recognize their limitations and refer patients, where possible, to experts and to larger medical facilities": supra note 58 at paras 253-54.

(62) [1976] 5 WWR 25, 1976 CarswellSask 57 (SKQB), aff'd [1978] 5 WWR 667, 1978 CarswellSask 78 (CA) [cited to CarswellSask] [Kangas].

(63) Ibid at paras 33-35.

(64) See Picard & Robertson, supra note 56 at 242-43.

(65) See ibid; J Thomas Curry, "Are Cuts to Health Care Funding Changing the Legal Standard of Care?" (2000) 22:3 Adv Q 337 at 350-51. See also Medical-Legal Handbook, supra note 50 ("Physicians might also discuss with the patient, as part of the consent process, limitations in availability of healthcare resources and the reasonable alternatives available to the patient, including seeking treatment elsewhere" at 49).

(66) 2001 MBQB231 at para 61, [2002] 1 WWR 204.

(67) 1990 CarswellBC 2169, [1990] BCJ No 23 (BCSC).

(68) Ibid at paras 46-48.

(69) See Reiblv Hughes, [1980] 2 SCR 880, 114 DLR (3d) 1 at paras 26-27 [cited to DLR].

(70) Indeed, Canadian courts have consistently noted that there are only rare circumstances when you can withhold information for the good of the patient. See e.g. ibid (where the SCC noted "it may be the case that a particular patient may, because of emotional factors, be unable to cope with facts relevant to recommended surgery or treatment and the doctor may, in such a case, be justified in withholding or generalizing information as to which he would otherwise be required to be more specific" at 13). See also McInerney v MacDonald, [1992] 2 SCR 138, 93 DLR (4th) 415 [McInerney] (where the SCC stated that "records should be disclosed upon the request of the patient unless there is a significant likelihood of a substantial adverse effect on the physical, mental or emotional health of the patient or harm to a third party" at 430). Courts have since interpreted this exception narrowly. See Bryan v Hicks, 1993 CarswellBC 1721, [1993] BCWLD 1076 (BCSC), aff'd [1995] 10 WWR 145, 103 WAC 109 (BCCA) (where the Court noted, "[i]t is not appropriate for a surgeon to forego a discussion of the risks associated with the surgery because the patient would be 'scared off'. He or she has a duty to give the patient sufficient information to make an informed decision and give an informed consent to the proposed surgery" at para 53). In Pittman Estate v Bain, a physician decided against disclosing to his patient that he may have been infected with HIV as a result of a previous blood transfusion, partly on the basis that the patient was emotionally fragile and had suffered from depression in the past: (1994), 112 DLR (4th) 257 at 195-196, 19 CCLT (2d) 1 (ONCJ). The Court in that case found that the physician's decision to withhold this information was not in the patient's best interests and did not fall within an exception to the standard of disclosure. See ibid at 214-20.

(71) Supra note 66 at para 61 ("the decision with respect to the financial consequences of choosing to undergo a procedure outside of the patient's province of residence should be left with the patient" at ibid).

(72) See Bernard Dickens, "Informed Consent" in Downie, Caulfield & Flood, supra note 56 at 129 (where it is noted that physicians should disclose information about private alternatives "because the option may be material to a patient's choice between accepting the lesser care or seeking superior care elsewhere" at 133). See also Timothy A Caulfield & Diana E Ginn, "The High Price of Full Disclosure: Informed Consent and Cost Containment in Health Care" (1994) 22:3 Man LJ 328: Timothy Caulfield & Kerry Siminoski, "Physicians' Liability and Drug Formulary Restrictions" (2002) 166:4 CMAJ 458.

(73) See McInerney, supra note 70 at paras 19-22; see also Norberg v Wynrib, [1992] 2 SCR 226, (1992) 92 DLR (4th) 449 [cited to SCR].

(74) See TA Faunce and SN Bolsin, "Fiduciary Disclosure of Medical Mistakes: The Duty to Promptly Notify Patients of Adverse Health Care Events" (2005) 12:4 JL & Medicine 478 at 479-80. Moe Litman, "Fiduciary Law in the Hospital Context: The Prescriptive Duty of Protective Intervention" (2007) 15:1 Health Law J 295 at 312-13, 323. See also Mark Vincent Ellis, Fiduciary Duties in Canada, vol 1 (Toronto: Thomson Reuters, 1988) at ch 10; Nola M Ries & Timothy Caulfield, Accountability in Health Care and Legal Approaches, Health Care Accountability Papers No 3 (Ottawa: Canadian Policy Research Networks, 2004) at 18-19. See generally College of Physicians and Surgeons of Ontario, supra note 42 ("[p]hysicians have a fiduciary duty to their patients--because the balance of knowledge and information favours the physician, patients are reliant on their physicians and may be vulnerable. The patient must always be confident that the physician has put the needs of the patient first" at 9); College of Physicians and Surgeons of British Columbia, Diagnostic Accreditation Program Committee 2014/15 Annual Report, online: <www.cpsbc.ca/files/pdf/2014-15-AR-Committee-Reports .pdf> ("[t]he legal character of the relationship of physician and patient is one of 'fiduciary'--the highest level of trust. A fiduciary must act in the best interests of the other person, even if the result is harm to the fiduciary" at 8).

(75) Supra note 73 at 271 [emphasis in original].

(76) Supra note 73 at 272 [emphasis added].

(77) See e.g. Gorman v Tyhurst 2001 BCSC 369 at paras 120-21, 2001 CarswellBC 820; RK v JA (2000), 233 NBR (2d) 291, 601 APR 291 (NBQB).

(78) Grewal v Sandhu 2012 BCCA 26 at para 82, 535 WAC 170.

(79) Ibid.

(80) See Ries & Caulfield, supra note 74 at 18-19.

(81) See Timothy Caulfield, "Medical Malpractice, the Common Law, and Health-Care Reform" in Gregory P Marchildon, Tom McIntosh & Pierre-Gerlier Forest, eds, The Fiscal Sustainability of Health Care in Canada (Toronto: University of Toronto Press, 2004) 81 at 96.

(82) Supra note 62.

(83) Supra note 47.

(84) Supra note 47 at para 57 [emphasis added]. The Court further noted that the specific needs of the individual patient must be considered and should not be outweighed by concerns of efficiency:
   It is difficult in this case to resist the observation that the
   patient's problems were at least in part related to what might be
   described as 'production Line medicine' in that the procedures
   which were followed and the standard of disclosure applied might be
   considered acceptable in the vast majority of cases being handled,
   but this patient did not fit the mould, he had an unusual situation
   which required care and treatment which was not in accordance with
   the usual routine and it was not offered to him ...


Ibid at para 57 [emphasis in original].

(85) See e.g. The College of Physicians and Surgeons of Ontario, supra note 39; Curry, supra note 65; Chernier, supra note 51; Picard & Robertson, supra note 56.

(86) 239 Cal Rptr 810, 192 Cal App 3d 1630 [cited to Cal Rptr] [Wickline].

(87) Wickline, supra note 86 at 813-15.

(88) Ibid.

(89) Ibid at 819.

(90) Ibid.

(91) Ibid.

(92) See Curry, supra note 65 at 359; Brian A Liang, "Cost Containment and Physician Obligations: Mandates for Patient Advocacy", online: (2006) 8:3 AMAJ Ethics 157 <journalofethics.ama-assn.org/2006/03/hlaw1-0603.html>.

(93) (1995), [1996] RRA 218, JE 96-370 (QCSC).

(94) Ibid at paras 78, 88. While this case does not equivocally indicate that physicians have a duty to advocate for their patients, at a minimum, it provides support for the notion that physicians have a duty to disclose to their patients the risks of receiving substandard treatment as a result of resource constraints. See also Chernier, supra note 51.

(95) Allen (Next Friend Of) v University Hospitals Board, 2000 ABQB 509, 268 AR 201, aff'd 2002 ABCA 195, [2003] 1 WWR 621.

(96) Ibid at para 109.

(97) Ibid.

(98) See Iacovelli v College of Nurses of Ontario, 2014 ONSC 7267, 325 CCR (2d) 71.

(99) Ibid at para 71.

(100) Supra note 42.

(101) Ibid

(102) Ibid at 14.

(103) Ibid at 16.

(104) See Largent & Pearson, supra note 12; Brian P O'Sullivan, David M Orenstein & Carlos E Milla, "Pricing for Orphan Drugs: Will the Market Bear what Society Cannot?" (2013) 310:13 J American Medical Assoc 1343.

(105) See Caulfield & Zarzeczny, supra note 11.

(106) See Ries & Caulfield, supra note 74 at 16-19.

(107) See Caulfield & Zarzeczny. supra note 11.

(108) See Ries & Caulfield, supra note 74 at 16-18.

(109) See Howard Brody, "Medicine's Ethical Responsibility for Health Care Reform--The Top Five List" (2010) 362:4 New Eng J Med 283 at 285.

(110) See Donald M Berwick & Andrew D Hackbarth, "Eliminating Waste in US Health Care" (2012) 307:14 J American Medical Assoc 1513: Christine K Cassel & James A Guest, "Choosing Wisely: Helping Physicians and Patients Make Smart Decisions about their Care" (2012) 307:17 J American Medical Assoc 1801.

(111) See ABIM Foundation (2015), Choosing Wisely, online: <www.choosingwisely.org> and Canadian Medical Association (2015), Choosing Wisely Canada, online: <www.choosingwiselycanada.org>; Brody, supra note 109; Cassel & Guest, supra note 110.

(112) See Cassel & Guest, supra note 110 at 1801; Brody, supra note 109.

(113) See e.g. Marwan Badri, "Wise but Difficult Choices" (2012) 105:9 Southern Medical J 491; David Katz, "Choosing (Medicine) Wisely: Good Answers for Good Questions" (9 April 2012), Huff Post Healthy Living: The Blog, online: <www.huffingtonpost.com /david-katz-md/roucine-tests_b_1409769.html>.

(114) See Howard Brody, "From an Ethics of Rationing to an Ethics of Waste Avoidance" (2012) 366:21 New Eng J Med 1949.

(115) See Largent & Pearson, supra note 12 at 27; R Cookson, C McCabe & A Tsuchiya, "Public Healthcare Resource Allocation and the Rule of Rescue" (2008) 34:7 J Medical Ethics 540.

(116) For example, the cystic fibrosis drug, ivacaftor (Kalydeco[R]), is priced at roughly $300,000 per patient per year. As it is only effective at treating 4-5% of the cystic fibrosis patient population with specific genetic variants of the disease (representing approximately 180 Canadians), the decision by provinces to fund this high price drug may not seem to be a significant issue. However, a new combination drug, lumacaftor/ivacaftor (Orkambi[R]), is aimed at a much larger portion of the cystic fibrosis patient population (representing approximately 1,500 patients in Canada). Reportedly priced at $259,000 per patient per year, decisions to fund this drug could have a much larger impact on healthcare budgets. See Cystic Fibrosis Canada, "Kalydeco", online: <www.cysticfibrosis.ca>; Cystic Fibrosis Canada, "Orkambi", online: <www.cysticfibrosis.ca>; John Tozzi, "This Medical Charity Made $3.3 Billion From a Single Pill", Bloomberg Business (7 July 2015), online: <www.bloomberg.com /news/features/2015-07-07/this-medical-charity-made-3-3-bilIion-from-a-single-pill>.

(117) See Genome Canada, Personalized Medicine and Health Care Policy: From Science to Value, by Christopher McCabe & Don Husereau, Policy Brief No 9 (Ottawa: Genome Canada, 2014).

Timothy Caulfield & Maeghan Toews ([dagger])

([dagger]) Timothy Caulfield, Canada Research Chair in Health Law and Policy, Trudeau Fellow, Professor, Faculty of Law and School of Public Health, and Research Director, Health Law Institute, University of Alberta. Maeghan Toews, Research Associate, Health Law Institute, Faculty of Law, University of Alberta. Authors are listed in alphabetical order. We would like to thank Christopher McCabe, Carina Chiu, Meika Ellis, Robyn Hyde-Lay, and our colleagues at the Health Law Institute, University of Alberta for their support in the preparation of this paper, and acknowledge the generous support of the Canadian Institutes of Health Research (CIHR) through an Emerging Team Grant on "Developing Effective Policies for Managing Technologies for Rare Diseases"; PACEOMICS funded by Genome Canada, Genome Alberta, CIHR, and Alberta Health & Wellness; Genome Canada, Genome Quebec, Genome Alberta and the Canadian Institutes for Health Research (CIHR) for their generous support of PEGASUS; and the Canadian National Transplant Research Program.
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