Global Ethical Considerations of Advanced Cell Therapies from Dr. Erica Koranteng's Tandem Meetings Transplantation & Cellular Therapy Meetings of ASTCT® and Meeting Session

In the past 2024 Tandem meetings Erica Koranteng MD, investigator from Ghana interested in medical ethics currently working in the Dana Farber Cancer Institute, shared her view with a global scope in the session entitled the Space Between Value and Payment in Cell Therapies, Sustainability, Evaluation and Operational Cost. Here we delve further into Dr. Koranteng’s insights and share a Q&A that took place after the meeting:

What has the research shown regarding equity in access to advanced cell therapies, both in resource-rich and resource-limited settings?
In resource-rich countries there are disparities evident in the groups of people with increased access to therapies, with the wealthier tending to have increased access. In the US, racial disparities have been noted in clinical trial enrollment, and the geographical locations of these trials have been cited as a contributing factor. There is generally an underrepresentation of black people in these trials, and states with highest proportion of Black residents often have less than three or no ongoing trials. Majority of resource limited setting have no access to advanced cell therapies or very limited access. Clinical trials, which provide one pathway to accessing therapies are distributed very unevenly across the globe. Entire continents, such as South America and Africa, lack any ongoing trials, further highlighting the global inequity un access to advanced cell therapies.

Where they are available, what are the ethical considerations clinicians and administrators should think about when facing a choice of using a limited resource like advanced cell or gene therapies?
It is important to fulfill our professional duty to provide the highest standard of care for patients. To navigate the limitations surrounding advanced cell and gene therapies, it is crucial to employ priority-setting frameworks such as the Accountability for Reasonableness, to ensure a collaborative and transparent process in determining relevant allocation principles. However, we must also acknowledge the inherent flaws within different rationing principles. For instance, the first-come, first-served principle, commonly practiced in the United States, tends to favor individuals who already benefit from greater healthcare access due to factors like geographic proximity and early referrals. Therefore, it is critical to select rationing principles that not only reflect our societal aspirations but also to recognize and address their potential drawbacks to minimize inequities.
What are the ethical considerations to address when thinking about implementing advanced cell therapies in lower resource settings?
In LMICs, allocation of already healthcare resources is one of the chief concerns. Introducing expensive therapies may lead to some diversion of resources from essential services such as infectious disease control and basic maternal healthcare. This diversion risks exacerbating existing health disparities, with the wealthy potentially accessing advances therapies while the majority might see a reduction in basic healthcare provision. Another consideration is that the infrastructure in many LMICs may be inadequate for such complex treatments as they often lack trained personnel, facilities and essential supportive services including access to blood products and vaccines. While expanding access to advance medical treatments is a noble goal, these challenges and ethical dilemmas must be addressed.

How can we think about solving the global inequities in advanced cell therapies? Is there a path towards ethical implementation of cell therapies worldwide?
Addressing global inequities in advanced cell therapies requires embracing communitarian ethics, where the responsibility for providing access is collectively assumed by every stakeholder within the region in question and possibly, the entire global community. It is important that the goals surrounding access to advanced therapies are rooted in the shared values and priorities of the region in question. Various stakeholders then play their parts in realizing this vision. For example, researchers can conduct cost-effectiveness studies, institutions can foster collaboration to enable on-site manufacturing of therapies, and patient assistance programs can be set up for patients who lack the required socio-economic support for these therapies. It also becomes essential to choose geographical locations of clinical trials based on our equity goals and not merely on convenience.

For LMICs, the ethical implementation of cell therapies involves a carefully phased introduction that takes into account the local context and needs. Efforts should be geared towards empowering LMIC institutions to take the lead in this process, ensuring that they can adapt cell therapy processes effectively. While challenges such as cost and infrastructure limitations exist, exploring manufacturing possibilities in lower-cost regions, like India, could be beneficial. However, it is essential that such strategies do not compromise the quality of the therapies and that local institutions are equipped and supported to provide access that is both equitable and sustainable.