Challenging the “Six-month Sober” Rule for Liver Transplants in Canada

Contributed by Annelise Harnanan

Introduction: The Six-Month Sober Rule

Many of the transplant programs across Canada require patients to abstain from alcohol for six months before becoming eligible to be placed on a waitlist for a liver transplant. Generally, reasons for the rule (often referred to as the “six-month sober rule”) are based on the scarcity of donated livers available for transplantation. Indeed, in 2017, Ontario’s transplant agency, Trillium Gift of Life Network, (Trillium) stated that “the number of patients needing a transplant continues to exceed organs available for transplant.”

The six-month rule appears to stem from a concern that a person with alcohol-related liver disease will return to a pattern of alcohol consumption, which could cause complications with the new liver or a recurrence of liver disease. It has been suggested that this perception is based on a study published in 1994 on recidivism after liver transplants in patients with end-stage alcohol liver disease. The authors of the study claimed that only one variable was associated with a return to alcohol abuse: sobriety from alcohol for less than six months. The authors concluded that this finding supported sobriety from alcohol for at least six months as a selection criterion for liver transplants. The six-month rule could also be based on a perception that this period of abstinence would provide sufficient time for a patient’s health to improve “to the point that liver transplantation may not be needed.”

13041_lores.jpg A liver tissue extract from an individual with alcohol liver disease. || (Source: Centers for Disease Control and Prevention Public Health Image Library // World Health Organization)

Despite mounting criticisms, Trillium stated that it did not intend to abolish the rule given that there was insufficient evidence to support such a change. Trillium did, however, launch a three-year pilot program in 2018 to gather evidence to determine whether or not there is a scientific basis for changing the rule. 

Challenging the Rule: Science-based and Social Criticisms

With the emergence of new scientific research, healthcare professionals have started questioning the rationale behind the rule. An oft-cited study that has been swaying professionals was published in the New England Journal of Medicine in 2011 by French researchers. Though there was a stringent selection process and the study’s sample size was small (only twenty-six patients had severe alcohol related liver disease), the authors’ findings showed that patients who did not abstain for six months prior to a transplant had similar rates of recurrence as those who did abstain for six months.

Following this, researchers at Johns Hopkins Medicine published two review papers based on data collected from a six-year pilot study. They found that the rate of post-transplant alcohol relapse among patients who did not have a period of abstinence from alcohol and patients who had six months of sobriety was the same. These studies have cast significant doubt on the legitimacy of the scientific basis for the policy and have been a major source of social criticism for the rule.

Patients who did not abstain for six months prior to a transplant had similar rates of recurrence as those who did abstain for six months […]casting significant doubt on the legitimacy of the scientific basis for the policy. 

Social criticisms of the rule include allegations that it indirectly discriminates against persons of a lower socio-economic status. Furthermore, the policy has been said to disproportionately affect Indigenous people. Recently in British Columbia, an Indigenous man named David Dennis with end-stage liver disease critiqued the six-month abstinence rule. Given Canada’s historical mistreatment of Indigenous peoples through racist policies, and the resultant intergenerational trauma they have experienced, Indigenous people experience elevated rates of alcohol use. This has resulted in a concern that “if the policy were applied too rigidly, [they’d] lose a lot of [their] people.” Although the BC transplant agency recently changed its policy and no longer has a strict “six-month sober” rule, Dennis’ objections remain pertinent in regions where the rule still exists.

Using the Legal System to Challenge the Rule

Trillium’s pilot project discussed above indicates its willingness to change the rule if, in their opinion, there is sufficient scientific evidence to support such a change. In the interim, however, the Canadian legal system might be an avenue for change. Specifically, the Canadian Charter of Rights and Freedoms (Charter) and Canadian courts can play an instrumental role in shaping Canadian laws and policies. The Charter forms part of the Canadian Constitution, which is considered “supreme law” in Canada because other laws must be consistent with it. Individuals can launch a challenge in court against the government’s laws and policies on the basis that they are inconsistent with rights and freedoms guaranteed in the Charter.

Recently, the family members of two men who died from alcohol related liver disease launched a constitutional challenge against the Trillium Gift of Life Network and a hospital that denied the men liver transplants. The hospital, University Health Network (UHN), is the only one in Ontario that performs “inter vivos” transplants (transplants from live donors). It adopted Trillium’s criteria. Under Trillium’s criteria, patients with alcohol related liver disease must abstain from alcohol use for six months prior to becoming eligible for a transplant. Because of their alcohol consumption, neither man met the criteria to be placed on a transplant waitlist. The family members of the men sought from the court a declaration that Trillium’s criteria, as well as the UHN’s policy adopting them, violated the men’s rights under sections 7, 12 and 15(1) of the Charter. Respectively, these sections protect the right to life, liberty and security of the person; the right not to be subjected to cruel and unusual treatment; and the equality of all individuals under the law.

The UHN brought a motion to dismiss the application against them, arguing that as a private entity, they should not be subject to the Charter. This motion was denied on the grounds that private entities can be subject to the Charter when they act “in furtherance of a governmental program or policy”, a principle that had been established by the Supreme Court of Canada in 1997. As the sole hospital in Ontario that performs inter vivos transplants, the UHN’s services could be viewed as actions done in furtherance of the Canada Health Act, and thus subject to the Charter.  

7300314768_095cf55924_k.jpg A representation of the liver in the torso. || (Source: Flickr // Providence Health Care Vancouver)

The Charter Challenge

For the applicants’ upcoming Charter challenge to succeed, a number of steps must be met. The judge hearing the Charter challenge itself must first agree that the Charter applies. If the Charter is found to apply, the judge will conduct a section 7, 12, and 15(1) analysis to see if any of these rights have been violated. If the six-month sober rule is found to infringe one of these sections, the judge may declare, pursuant to section 52(1) of the Charter, that the rule is of no force or effect. It is important to note that the rights guaranteed by the Charter are not absolute, and prior to declaring a law invalid, the judge must conduct a section 1 analysis. This section states that the rights and freedoms guaranteed by the Charter are “subject to reasonable limits prescribed by law as can be demonstrably justified in a free and democratic society.” If their policies are found to be Charter-infringing, Trillium and UHN may argue that they are reasonably and demonstrably justified. In order for a judge to make such a finding, however, the limit must be “prescribed by law” and satisfy the criteria of the Oakes test, which has been established by Courts to help determine whether a law is justified. The advancing scientific research in this area may factor into the judges’ assessment of whether the infringement was reasonable in a fair and democratic society.

Conclusion

In a world of scarce resources, it is sensible for hospitals and transplant agencies to establish criteria to determine how best to distribute available organs. However, when rationing resources, it is important to weigh scientific evidence in an attempt to seek the fairest outcome possible. Policies requiring a six-month period of abstinence from alcohol prior to receiving a liver transplant are currently being challenged scientifically and socially. If further studies demonstrate that the six-month sober rule is not supported by scientific evidence and transplant agencies are slow to act, Canadian courts may have a role to play in changing the rule.

Annelise Harnanan is a Senior Online Editor with the McGill Journal of Law and Health. She is in her second year of the B.C.L./ LL.B. program at McGill University’s Faculty of Law, and has a keen interest in health policy. She holds a BA with distinction in Political Science from Dalhousie University.

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