Looking ahead: ethical and social challenges of somatic gene therapy for sickle cell disease in Africa.

Somatic gene therapy will be one of the most exciting practices of genetic medicine in Africa and is primed to offer a "new life" for persons living with sickle cell disease (SCD). Recently, successful gene therapy trials for SCD in the USA have sparked a ray of hope within the SCD community in Africa. However, the high cost, estimated to exceed 1.5 million USD, continues to be a major concern for many stakeholders. While affordability is a key global health equity consideration, it is equally important to reflect on other ethical, legal and social issues (ELSIs) that may impact the responsible implementation of gene therapy for SCD in Africa. These include informed consent comprehension, risk of therapeutic misestimation and optimistic bias; priorities for SCD therapy trials; dearth of ethical and regulatory oversight for gene therapy in many African countries; identifying a favourable risk-benefit ratio; criteria for the selection of trial participants; decisional conflict in consent; standards of care; bounded justice; and genetic tourism. Given these ELSIs, we suggest that researchers, pharma, funders, global health agencies, ethics committees, science councils and SCD patient support/advocacy groups should work together to co-develop: (1) patient-centric governance for gene therapy in Africa, (2) public engagement and education materials, and (3) decision making toolkits for trial participants. It is also critical to establish harmonised ethical and regulatory frameworks for gene therapy in Africa, and for global health agencies to accelerate access to basic care for SCD in Africa, while simultaneously strengthening capacity for gene therapy.

Responding to Africa's burden of disease: accelerating progress.

Although Africa is home to about 14% of the global population (1.14 billion people), it is growing three times faster than the global average [1]. The continent carries a high burden of disease, but there has been real progress in eradication, elimination, and control since 2015. Examples are the eradication of wild polio in 2020 [2] and the eradication or elimination of neglected tropical diseases, such as dracunculiasis in Kenya in 2018; Human African trypanosomiasis in Togo in 2022; and trachoma in Togo, Gambia, Ghana, and Malawi in 2022 [3]. New HIV infections reduced by 44% in 2021 compared to 2010 [4], and in 2021 the African region passed the 2020 milestone of the End TB Strategy, with a 22% reduction in new infections compared with 2015 [5].

Responding to the cuts in UK AID to neglected tropical diseases control programmes in Africa.

The early termination of the Accelerating the Sustainable Control and Elimination of Neglected Tropical Diseases (Ascend) programme by the UK government in June 2021 was a bitter blow to countries in East and West Africa where no alternative source of funding existed. Here we assess the potential impact the cuts may have had if alternative funding had not been made available by new development partners and outline new strategies developed by affected countries to mitigate current and future disruptions to neglected tropical disease control programmes.