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

Document Type: Perspective

Authors

1 Department of Gastroenterology & Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands

2 Ethics Committee ‘CMO ArnhemNijmegen,’ Nijmegen, The Netherlands

Abstract

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.

Keywords


  1. World Health Organization (WHO). Global Hepatitis Report, 2017. Geneva: WHO; 2017.
  2. Beekmans N, Klemt-Kropp M. Re-evaluation of chronic hepatitis B and hepatitis C patients lost to follow-up: results of the Northern Holland hepatitis retrieval project. Hepatol Med Policy. 2018;3:5. doi:10.1186/s41124-018-0032-9
  3. Kracht PAM, Arends JE, van Erpecum KJ, et al. REtrieval And cure of Chronic Hepatitis C (REACH): results of micro-elimination in the Utrecht province. Liver Int. 2019;39(3):455-462. doi:10.1111/liv.13959
  4. Ekpanyapong S, Reddy KR. Hepatitis C virus therapy in advanced liver disease: outcomes and challenges. United European Gastroenterol J. 2019;7(5):642-650. doi:10.1177/2050640619840149
  5. van Dijk M, Kracht PAM, Arends JE, et al. Retrieval of chronic hepatitis C patients. A manifesto for action to eliminate hepatitis C in the Netherlands: the CELINE project. Neth J Med. 2019;77(4):131-138.
  6. Hofman R, Nusselder WJ, Veldhuijzen IK, Richardus JH. Mortality due to chronic viral hepatitis B and C infections in the Netherlands. Ned Tijdschr Geneeskd. 2016;160:D511.
  7. Willemse SB, Razavi-Shearer D, Zuure FR, et al. The estimated future disease burden of hepatitis C virus in the Netherlands with different treatment paradigms. Neth J Med. 2015;73(9):417-431.
  8. Davis KL, Mitra D, Medjedovic J, Beam C, Rustgi V. Direct economic burden of chronic hepatitis C virus in a United States managed care population. J Clin Gastroenterol. 2011;45(2):e17-24. doi:10.1097/MCG.0b013e3181e12c09
  9. Cipriano LE, Goldhaber-Fiebert JD. Population health and cost-effectiveness implications of a “treat all” recommendation for HCV: a review of the model-based evidence. MDM Policy Pract. 2018;3(1):2381468318776634. doi:10.1177/2381468318776634
  10. Cohen MS, Chen YQ, McCauley M, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365(6):493-505. doi:10.1056/NEJMoa1105243
  11. Health Council of the Netherlands. Screening of Risk Groups for Hepatitis B and C. The Hague: Health Council of the Netherlands; 2016.
  12. Dutch Medical Treatment Acts. Dutch Civil Code, section 7.7.5. http://www.dutchcivillaw.com/civilcodegeneral.htm. Accessed June 17, 2019.
  13. Personal Records Database Act [text in Dutch]. https://wetten.overheid.nl/BWBR0033715/2019-02-03#Hoofdstuk3_Afdeling1_Paragraaf1.  Accessed June 17, 2019.