2INTRODUCTION

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2.1. History and Philosophical Context

In the context of direct patient care, health care ethics typically focus on the individual, and looks to established moral principles as guides to ethical decision-making. The four principles that are most generally appealed to are:

  • autonomy (self-government)
  • beneficence (obligation to do good)
  • non-maleficence (obligation to do no harm)
  • justice (both procedural, and distributive).2

There appears to be a consensus in the Western health care ethics community that this form of principlism currently represents one of the best approaches to making ethical decisions in health care.

Generally, the principle of autonomy is prioritized above all the others when addressing individuals in health care. In provider interactions with individual patients, the providers seek to maximize and respect autonomous decisions. They also attempt to be beneficent, non-maleficent, and just in the process. In the case of justice, an attempt is always made to be as just as possible from both a procedural and distributive perspective. Procedurally, health care providers seek to treat like cases alike in the process of decision-making and, when considering distributive justice, they attempt to allocate goods and services in as fair and equitable a manner as possible.

While this prioritization of autonomy over other principles holds in general circumstances, it may not be possible or logical when discussing the optimal use of limited resources.3 In the context of priority setting (which is a public policy decision requiring the engagement of the entire society), it may be necessary to adopt a broader, more collective conception of ethical decision-making that might apply to decisions of individual treatment. Regarding the principlist approach, the notion of distributive justice becomes an overriding concern when allocating scarce resources. When determining optimal use of resources, attempts are made to maximize the aggregate good for the greatest number of people (i.e., an ethically consequentialist or utilitarian approach) rather than focusing exclusively on individuals and their rights per se (which constitutes an ethically deontological approach). Although priority-setting decisions should not come at the expense of individual rights and obligations, there may be circumstances where these rights and obligations will become secondary to the needs of greater society. As such, new sets of moral issues and tensions arise.

The use of quality-adjusted life-years (QALYs) as a methodological tool, which is used by CBS and CADTH to make their assessments of S/D plasma, represents a utilitarian approach. Historically, patient-centered approaches to health care ethics are concerned with the process of decision-making, and the ways in which that process can be enhanced. With societal concerns related to resource allocation, the focus shifts to the outcomes, or the consequences, of decision- making. While utilitarianism is not an ideal system, it may indeed be the most intuitive guide to ethical decision-making in the context of priority setting.4,5 Use of QALYs, however, should nonetheless be used with a degree of caution. Research by Nord et al. has suggested that patients value criteria other than utility, such as equity, or freedom from severe disability.6 This research indicates that the appropriateness and validity of QALYs is not given.

One of the challenges of resource allocation issues in a public health context is to make decisions as fairly and justly as possible given the circumstances and limitations present. It is important to remember that the need to make resource allocation decisions which will enhance the health of the greatest number of people does not obviate the obligation to install and maintain as fair, just, and defensible a process of decision-making as possible. Therefore, in terms of principles, a focus should be maintained not only on distributive justice, but, to the extent possible, on procedural justice, the importance of autonomy, beneficence, and non-maleficence. As it relates to QALYs, enhancement of the decision-making process may include consultation with appropriate stakeholders, transparent acknowledgement, and disclosure of any limitations inherent to the methodology, confirmation of a factual knowledge base, and so on. Despite the inability of a publicly funded health care system to satisfy everyone’s preferences when resources are finite, individual rights should always be respected to the greatest extent possible. Utilizing a recognized ethical framework, as will be seen in section 4.3, can add legitimacy to difficult decisions, including the one addressed by this assessment: the choice between open and restricted access to S/D plasma.