Legal and Ethical Challenges in Developing a Dutch Nationwide Hepatitis C Retrieval Project (CELINE)

In 2016 the World Health Organization (WHO) called upon nations worldwide to eliminate viral hepatitis. Due to suboptimal hepatitis C virus (HCV) therapies in the past, many patients could not be treated or cured. With the current options, all patients can be treated and >90% is cured. However, these developments have not reached all patients, especially those who were lost to follow-up (LTFU) in previous years, an estimated 30% in the Netherlands. Retrieving these patients can contribute to HCV elimination. In light of this, we aimed to develop a nationwide retrieval strategy. During development we identified four major challenges. The first challenge is ethical and arises from the aim of the project: should physicians retrieve LTFU patients? We argue that the arguments in favour outweigh those against. The three other challenges are methodological and mainly legal in nature. Firstly, how far back are we allowed to trace LTFU patients? In the Netherlands, patient files should be kept for a minimum of fifteen years, but in chronic disease they may be archived longer. Secondly, which professional should identify the LTFU patients? Ideally this would be the treating physician, but we describe the circumstances that allow inclusion of assistance. Lastly, what is the proper way to invite the LTFU patients? We found that we can often request current address information from municipalities, and explain this process in detail. The offered solutions are feasible and translatable to other healthcare environments. We hope to take away any insecurities people may have about the ethical and legal nature of such a retrieval project and hope to inspire others to follow in our footsteps.