Introduction & Orientation
As part of ongoing discussions about a National Health Insurance (NHI) scheme, there is a commitment to establishing a health priority-setting process to navigate tough choices about which health services, products, and programmes to publicly fund.
Priority-setting for health raises many ethics questions about how to use scarce resources. Decision-makers must balance the needs of individuals with the broader health needs of the population, while also taking into account equity considerations and the many ways that health interventions impact other aspects of wellbeing.
An ethics framework can help navigate these challenging decisions and trade-offs, providing a method and structure for exploring morally relevant ethics considerations associated with a decision. When used in the context of health priority-setting it can help ensure that, for every proposed health intervention, consideration is given to:
- Identifying and evaluating relevant social values;
- Acknowledging, discussing, and explaining any trade-offs when a decision involves promoting one social value at the expense of another;
- Transparently explaining and justifying recommendations to the public.
The South African Values and Ethics for Universal Health Coverage (SAVE-UHC) Project developed this Ethics Framework to identify the specific domains and considerations that reflect South Africa’s core values for health priority-setting. The framework was shaped by a collaborative, multi-stakeholder South African Working Group of policymakers, civil society and patient group representatives, academics, providers, and payers, drawing upon various sources of literature, policy documents, and the collective experience and perspectives of the Working Group members.
The starting point of the Framework was the eight ethical principles expressed in the 2015 NHI white paper.
The SAVE-UHC Ethics Framework was developed with a specific priority-setting process in mind called “Health Technology Assessment” or HTA. HTA is an increasingly popular approach for guiding policy decisions about whether a specific health intervention should be added or subtracted from a health benefits package. It relies on a transparent process in which:
- a specific health intervention is identified for consideration;
- relevant evidence is compiled about that intervention; and
- an appraisal committee reviews and discusses the evidence to systematically evaluate the anticipated properties and expected impacts of the intervention before issuing a policy recommendation.
The Ethics Framework was designed to apply after a health intervention is proposed for inclusion or prioritisation and selected for review. It lays out a set of morally relevant considerations to inform the types of evidence that are gathered and guide discussions and deliberations during the appraisal. In line with good practices for evidence-informed decision-making, those using the framework should search for the best available evidence for each domain, assessing the rigour, quality, and relevance of the data to the South African setting, while recognizing that there may be limited or different types of evidence for different kinds of morally relevant considerations.
Although the SAVE-UHC Ethics Framework was designed with HTA in mind, it is likely to be useful for many other kinds of health priority-setting activities. It can be used to help decisionmakers assess investments in health interventions in light of South Africa’s core values and ethics, and in line with the principles laid out in the 2017 NHI White Paper.
While this framework can be helpful in supporting ethical and evidence-informed decisions about what types of health interventions should be publicly funded, it is not intended to do everything. Evaluating a particular health intervention against the domains raised in the framework is only one part of the larger health priority-setting process. There are many other decisions regarding the design and financing of any public health programme that this framework does not address.
The SAVE-UHC Ethics Framework answers the question:
“Once a health intervention is proposed for inclusion under NHI or another health programme, how should it be assessed?”
This framework focuses on the substantive ethical considerations that should be taken into account when evaluating health interventions. It does not directly address ethical considerations in the decision making process, including issues of transparency, participation and representation, and minimising conflicts of interest. The framework supports these procedural values by establishing a clear set of evaluation criteria, giving the public greater insights into what is taken into account in decision-making and giving decision-makers a way to publicly communicate and justify policy positions.
Orientation to the ethics framework
The SAVE-UHC Ethics Framework has 12 domains that should be considered when assessing whether a particular health intervention should be included under a government-run health scheme. Figure 1 below provides a snapshot of these 12 domains.
In the pages that follow, we present more details on the 12 domains and the specific considerations to inform analysis, deliberations, and decision-making about health interventions in a health priority-setting process.
As indicated in the figure, two of the domains in the Framework operate somewhat differently from the other 10, and those are presented first. Systems Factors & Constraints, in the centre of the diagram, shows that context-specific features of the health system and broader infrastructure can have cross-cutting implications for how the delivery of the health intervention may play out — decisionmakers should think about this real-world context when assessing the other domains. Because this domain is cross-cutting, affecting considerations under other domains, the general considerations are laid out first, then more specific “Systems Factors & Constraints” considerations are identified throughout the Framework under each domain using this icon:
The Burden of the Health Condition provides the backdrop for deliberating about any health intervention. This domain addresses how serious the health condition is, with details about how many and who within the population is affected, setting the scene for how the proposed health intervention may help address that burden.
Following these two, we then present the domains that are most commonly used in a health priority-setting or HTA process: Health Benefits & Harms, Cost-Effectiveness, and Budget Impact. These are followed by the expanded set of domains and morally relevant considerations identified specifically for the South African Values and Ethics Framework: Equity, Respect and Dignity,Impacts on Personal Financial Situation, Impacts on Personal Relationships, Ease of Suffering, Impacts on Safety and Security, Impacts on Solidarity & Social Cohesion.
The SAVE-UHC Ethics Framework does not assign specific importance or weighted scoring to any particular domain. That is because one domain may be really important when assessing a certain type of health intervention, and much less important when looking at a different type of intervention. For example, a new type of contraceptive may raise important ethical considerations that relate to promoting Respect & Dignity—including women’s reproductive rights and personal choices around pregnancy intention—as well as Impacts on Personal Relationships. These domains and related considerations may feature much more centrally in decisions about adopting new family planning interventions, while other types of health interventions may not raise serious issues around meaningful personal choices and effects on families.
Additionally, while most domains will apply to most health interventions, there are some cases where a domain may not be relevant at all. For instance, Ease of Suffering may only apply to interventions such as palliative (pain) care, end-of-life care, or in cases where two treatments have similar effectiveness, but a newer one involves a much less painful or unpleasant experience for patients. In these cases, relief of suffering may be a central feature of the intervention. In other cases, however, there may be no special considerations related to Ease of Suffering that go beyond what is already reflected directly under Health Benefits & Harms.
Rather than assign specific weights or scores to the domains, and acknowledging that not all domains will always be relevant, the SAVE-UHC Ethics Framework is meant to guide deliberative decision-making so that the relevance and significance of particular domains and their considerations can be discussed in the context of a coverage decision. These relevant and significant considerations should be clearly communicated to the public support transparency about how the framework is applied.