An Ethical Analysis of Post-Clinical Trial Access in South Africa

Abstract

Clinical trials began in the 1940’s and have evolved over the last 80 years with rigorous global regulations to support ethical trial conduct and participant safety. However there still exists a ‘grey area’ for what are appropriate and fair post-clinical trial access conditions. The ongoing ethical debate around post-trial access is common in developing countries especially as participants transition back to inferior medication following a clinical trial. Furthermore, there are fast-paced changes in clinical research such as the introduction of more innovative technologies and modernized protocols which have a knock-on effect for fair and equitable post-trial access conditions. Even though global regulations like ICH-GCP and the Declaration of Helsinki 2024 give clear directives that access to clinical trial medication should be available to participants for as long as clinically benefiting, country regulations can differ with the interpretation and implementation of this clause. In South Africa, the SAHPRA Guideline (South African Health Product Regulatory Authority) Continued access/Post-trial access (CA/PTA), version 4.0, 2022 is the cornerstone to define adequate post clinical trial access medication conditions. Hence it is vital that these guidelines1 include the context of the South African participant’s healthcare vulnerabilities to establish a fair framework. For this research report, I have evaluated the relevant literature around post-trial access by assessing both the benefits and challenges in provisioning of research medication 1 There are other guidelines in South African that impact the principles and decision making of post-trial access such as NDOH in Research 2024 and SA GCP 2020. However, the SAHPRA guidance, Version 4.0 is the specific focus in the context of this research. Page 6 of 72 once a trial is completed. Thereafter, I delve into the precise limitations with the current SAHPRA Guideline in the healthcare context (public and private) of the South African patient by focusing on three core premises. This is specifically for 1) ‘Standard of care’ as an alternative form of effective medication after a trial is completed, 2) The ‘minimum four- year access’ period to trial medication that is permitted by SAHPRA, 3) Advanced medicines technology, and innovative research designs and the post-trial consequences for trial participants. Each viewpoint and critical analysis are supported by examples and ethical theories to show the injustices that can occur for trial participants. At the end of each argument, I propose an alternative to how post-trial access guidance can be revised to have a more inclusive approach for the South African patient healthcare context.