Developing national and global agendas for the ethics of post-trial arrangements in LMICs during pandemics/epidemics

The COVID-19 pandemic has highlighted significant inequalities in global health systems and revealed disparities between high-income countries (HICs) and low- and middle-income countries (LMICs) in access to medical innovations. Despite their major contributions to hosting clinical trials, LMICs have often been left without timely access to the resulting treatments. The Pandemic Ethics project aims to address these inequalities by developing and promoting equitable post-trial access (PTA) schemes that ensure that LMICs receive appropriate benefits from clinical research conducted during pandemics and epidemics. One of the critical challenges LMICs face during health crises is their uneven access to medical treatments, even when these countries play an active role in hosting trials. Despite international ethical guidelines that emphasize the importance of providing post-trial access to trial participants and their communities, in practice LMICs often face significant barriers to accessing these benefits. This failure is due to a limited regulatory framework, unclear guidelines, and a narrow interpretation of ethical responsibilities as merely contractual obligations between study sponsors and participants. PTA remains more the exception than the norm in LMICs. Addressing these gaps is essential to advancing health equity. Pandemic Ethics aims to transform this approach by promoting a comprehensive ethical understanding of PTA that goes beyond contractual constraints and views equitable access to health services as a fundamental responsibility of all actors involved. Pandemic Ethics is designed to establish an equitable framework for PTA by drawing on lessons learned from past health crises such as HIV, Ebola, and most recently COVID-19. The project encompasses six LMICs-Brazil, India, Kenya, Nepal, the Philippines, and Tanzania-and includes Norway, which represents the perspective of a high-income country. This diversity of countries provides a wide range of contexts in which PTA can be studied and improved. A primary objective of Pandemic Ethics is to map the current PTA landscape across these countries to understand existing regulations, public perceptions, and socio-cultural factors that influence access. Through detailed analysis, the project aims to uncover the complex factors that influence PTA, covering legal, regulatory, and stakeholder perspectives. This understanding is essential for creating practical and equitable policies that address the needs of LMIC communities and improve the ethical conduct of clinical trials. Based on this understanding, Pandemic Ethics will propose both global and country-specific policies to make PTA more equitable and practical. These recommendations aim to ensure that LMIC communities benefit from the medical products and knowledge generated from trials, especially during pandemics when timely access is crucial. The project is also rooted in the Human Development Approach to International Research, which views PTA not as a simple contractual clause but as a collective ethical responsibility. By considering clinical research as an integral part of human development, this approach ensures that LMICs' contributions to global health are recognized and rewarded. To ensure long-term adoption of ethical PTA practices, Pandemic Ethics will also focus on educating and building the capacity of stakeholders in LMICs. This will be achieved through training programs, including a "train-the-trainer" module that will educate local communities, researchers, and policymakers on the ethical obligations and practical implementation of PTA. By empowering local stakeholders, the project aims to foster an environment where the rights of LMICs are protected and respected in the research process. Pandemic Ethics is coordinated by the University of Oslo (UiO), led by Professor Rosemarie de la Cruz Bernabe, a specialist in medical research ethics. The project is a collaboration involving ten organizations from seven countries, spanning four continents-Asia, Africa, Latin America, and Europe. It includes six academic institutions, three government or regulatory agencies, and one patient organization. The partner institutions include (country codes in brackets): KEM Hospital and Research Center (IN); University of the Philippines National Institutes of Health (PH); Philippine Alliance of Patient Organizations (PH); National Institute for Medical Research (TZ); Nepal Health Research Council (NP); Tribhuvan University (NP); University of Nairobi (KE); and Federal University of Santa Catarina (BR).