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

Area of Science:

• Hepatology
• Public Health
• Healthcare Management

Background:

• Global call by the World Health Organization (WHO) in 2016 to eliminate viral hepatitis.
• Past suboptimal hepatitis C virus (HCV) therapies led to treatment failures and patient attrition.
• Current therapies offer high cure rates (>90%), but many patients, particularly those lost to follow-up (LTFU), remain untreated.

Purpose of the Study:

• To develop a nationwide strategy for retrieving LTFU patients in the Netherlands to contribute to HCV elimination.
• To address and propose solutions for ethical, methodological, and legal challenges associated with patient retrieval.

Main Methods:

• Identification of four major challenges: ethical considerations of retrieving LTFU patients, legal limitations on tracing patient files (minimum 15 years), determining the appropriate professional to identify LTFU patients, and the optimal method for inviting patients.
• Development of solutions including ethical justification for retrieval, adherence to file retention policies, defining roles for physicians and support staff, and utilizing municipal data for address retrieval.

Main Results:

• Ethical arguments in favor of retrieving LTFU patients were established, outweighing concerns.
• Methodological and legal challenges were addressed, providing a framework for tracing patient files and identifying appropriate personnel.
• A feasible method for inviting LTFU patients, including requesting address information from municipalities, was detailed.

Conclusions:

• The proposed nationwide retrieval strategy is feasible and addresses key ethical and legal barriers.
• The solutions offered are translatable to other healthcare settings, facilitating broader application.
• The project aims to reduce uncertainties surrounding patient retrieval and inspire similar initiatives for HCV elimination.