Leonard Fleck is a well-known philosopher and ethicist who has written extensively on various ethical issues in health care, including healthcare rationing. Although he writes from a moral perspective, the topic is also relevant to health lawyers. Healthcare rationing, interpreted as the denial or delay of necessary medical care for non-medical reasons, raises serious issues of equal access to health care as a human right, informed consent and shared decision-making (SDM), well-known concepts in contemporary legal doctrine. Long waiting times and delays in medical treatment, substantial co-payments, or restrictions in health insurance access can be considered a form of de facto rationing, challenging the right to health care as a human right.
Fleck’s Precision Medicine and Distributive Justice: Wicked Problems for Democratic Deliberation discusses healthcare rationing in the context of new pharmaceutical innovations, including precision medicine, targeted cancer therapies and immunotherapies. These are highly promising but costly drugs (ranging from $100,000 to $475,000 in total costs per treatment) mainly used with metastatic cancer, a terminal illness. Most patients with access to these drugs will gain only a few extra weeks or months of life (P. 11.) Is society willing to pay for each patient’s life-prolonging targeted therapy with marginal gains at general public expense?
Although Fleck focuses on health ethics and policy (distributive justice), the central question of who will decide what treatment should be provided/reimbursed and based on what criteria also has legal implications. The law may set not only the decision-making procedures but also the substantive (medical, economic, ethical) criteria for selecting healthcare services for which we are willing to pay.
The book includes nine chapters, starting with a review of the medical literature regarding metastatic cancers and cutting-edge therapeutic interventions. From an economic perspective, none of these treatment options appear reasonably cost effective. This raises the notion of what Fleck calls wicked or “ragged edge” problems (P. 22). These are situations for which no ethical theory can provide a satisfactory answer and every proposed solution seems as problematic as the issues it is intended to solve.
Fleck argues that, because rationing is unavoidable, a respectful process of democratic deliberation is the only way to solve these problems of “rough justice” (P. 23.) From a legal perspective, notions like equal access to healthcare, non-discrimination, right to life, informed consent, shared decision-making, transparency and participation, and the need for legal remedies provide a valuable framework for thinking about the rationing issues generated by targeted therapies. A public debate addressing the abovementioned concepts would enable society to make more just choices on life-extending targeted therapies. A shared understanding of rationing or selection criteria at the policy level (severity of disease, clinical and cost-effectiveness, equal access, etc.) will help to formulate socially agreed-upon ideas about a threshold of basic healthcare and its limits. Ultimately, this will help physicians make more reasonable decisions on targeted therapies in individual cases.
