Tracing treatments on an ethical roadmap

Every measure taken in healthcare and social services has ethical significance. The aim is to do good and not harm. Measures should be based on the equal value and different needs of all people, where the greatest needs are given highest priority. The cost of interventions should be reasonably proportionate to the gains in health and quality of life that can be expected. The privacy and autonomy of individuals must be respected.

In situations where it is difficult to achieve all goals equally well, and where some ethical principle will be more or less compromised whatever the decision is, an ethical dilemma arises. Different ethical values must be weighed against each other. The dilemma is made especially clear in regard to controversial issues such as euthanasia, genetic screening, genetic modification and late-term abortion. But even everyday decisions about diagnostic procedures, treatments and care can entail ethically significant trade-offs and limitations. Clarification of what is at stake, given various courses of action, is included in SBU’s assessment of ethical aspects.
It is often important, even from an ethical standpoint, to analyse the economic consequences of various decisions. Expensive interventions that provide little benefit may displace others that are truly needed. Such impact is contrary to current legislation in Sweden and to the ethical platform that applies to such services.

Moreover, certain interventions are ethically questionable because they infringe upon the autonomy, independence and privacy of individuals and their families. The use of such methods among fragile and vulnerable people who may have difficulty expressing consent may pose highly significant ethical problems – even when intentions are good.
Therefore it is only natural that the SBU mission includes discussions of the ethical aspects of various interventions, as is reflected in the agency’s comprehensive assessments, which serve as the basis for healthcare and social services decisions.
The purpose is not to determine which interventions should or should not be implemented. Instead, it is to analyse the potential impact of various interventions on values that are linked to the goals of the Swedish Health and Medical Services Act and Social Services Act. These laws concern good health and care on equal terms for the entire population, and a reasonable standard of living under good conditions.

Highlighting ethical issues is particularly challenging when specific interventions and areas of use have been inadequately studied, such as completely new treatment options or new indications for old treatments. Scientific uncertainty regarding the benefits, risks and costs of the methods may complicate ethical reasoning. The potential impact of different decisions is difficult to predict.
Moreover, ethical consequences may vary among individuals, groups, situations, places and points in time. The impact is contextually dependent – for example, where, when, how and for whom a diagnostic method or treatment is intended. An intervention described by some as ethically uncontroversial may be considered unacceptable or highly questionable by others. Even in cases where everyone involved subscribes to the same fundamental values, individual attitudes towards specific interventions may diverge and even change over time.
Highlighting the ethical aspects of various interventions actually illuminates the values at stake, bringing to light ethical dilemmas, conflicting goals and differing perspectives, and allowing better-informed decisions to be made.
Among important considerations are the effects of the interventions on:

• equity and fairness: Is there a risk that the intervention could entail inequitable and unfair access to healthcare resources?
• autonomy: Does the patient/user have the opportunity to understand and participate in decisions when the intervention is used? Does the intervention affect the person’s potential to exercise self-determination in other situations?
• privacy: How does the intervention affect the physical and personal privacy of the individual and family members?
• third party: How are third parties (e.g. donors, close and biological relatives, surrogate parents) affected in terms of health equity, justice, autonomy, privacy, health and quality of life?

The impact on the structure and funding of health and social services can also have ethical implications. Included here are issues regarding

• cost effectiveness: What is the balance between the cost of the intervention and the benefits to the patient?
• resource allocation and organisation: Are there restrictions that may affect who gains access to the intervention, or that may overshadow other forms of care? Can the allocation of healthcare resources in the population be affected, and if so, who benefits or suffers? Is this in line with generally accepted guidelines for setting priorities, such that the allocation can be considered fair? Under current priority-setting rules, interventions that pertain to major healthcare needs are given priority over minor or insignificant needs.
• regulatory: Is the intervention of significance to something regulated by current laws?

Interventions within healthcare and social services may also have an impact on values and interests. What is considered desirable may be influenced by what is pragmatically feasible. For example, new diagnostic and treatment methods may change our vision of what can be considered illness, which diagnoses to look for and what should be treated. Consequently, there is reason to describe how an intervention relates to

• professional values: Do the values found within relevant healthcare professions influence use of the intervention in such a way as to lead to unequal access? What is the effect on freedom of action and the potential for healthcare providers to fulfil their professional roles in accordance with current professional ethics? Does the method impact professional identity?
• social norms: Is the method compatible with different beliefs – does it conflict with religious, political or cultural convictions?
• special interests: Do special interests have an influence on use of the intervention that may result in unequal access? Do researchers, policymakers, innovators, or manufacturers have a vested interest in use of the method or its evaluation?

SBU’s assessments of the scientific literature highlight both existing knowledge and evidence gaps. Research ethics issues may be of relevance in

• continued research: When there is no scientific basis to underpin the efficacy of the intervention, do ethical and/or methodological problems arise when conducting studies?
• prior research: Are there indications that the studies on which the assessment is based were conducted in a way that entails research ethics issues?

Finally, various long-term ethical implications need to be discussed, such as the impact on societal structure and culture. For example, use of a particular method may lead to new moral imperatives. When a screening programme is introduced to discover a particular disease, many of those who are diagnosed will also expect effective therapy. Such a situation may alter how society views the disease, indications for treatment, the responsibility of the individual and the healthcare system, as well as the doctor-patient relationship. Is patient self-esteem or standing and reputation in society impacted?
Assessing the ethical aspects of medical and social methods entails a description of the balance between probable ethical benefits and the risk of ethical disadvantages. Such issues are of relevance to most people, including their ramifications for autonomy, privacy and dignity. Ultimately, it becomes a question of the impact on human rights.

References

• Heintz E, et al. Framework for systematic identification of ethical aspects of healthcare technologies: the SBU approach. Int J Technol Assess Health Care 2015;31:124-30.
• Hofmann B. Towards a procedure for integrating moral issues in HTA. Int J Technol Assess Health Care 2005;21:312-8.
• SBU. Kapitel 13. Etiska aspekter. I: Utvärdering av metoder i hälso- och sjukvården och insatser i socialtjänsten: en metodbok. Stockholm: SBU, 2020. Downloaded 2021-09-14. Available at www.sbu.se/metodbok.