Legal Issues Concerning Organ Utilization from HBV Infected Donors

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Abstract

Organ transplantation is related to the risk of transmission of infection, including hepatitis B and the development of the disease in transplant recipient. This issue should be seen in several areas:

1. The use of organs from an infected donor of unexplored and unknown status;

2. The use of organs from infected donors, but with known and negative at the time of transplantation HBV status (infection during the window period);

3. Conscious use of organs from an infected donor and transplanted to properly selected and treated recipient with the respect of principles of organ allocation from donors of increased risk;

4. Conscious use of organs from an infected donor and transplanted to any recipient without respect of principles of organ allocation from donors of increased risk;

After the query and analysis of Polish and European legislation and recommendations we summarized that almost all of situations mentioned above is characterized by relativism, and may be as follows:

1. The use of organs from a donor with incomplete characterization is unintentional criminal act, exposing health or life of the donor (Polish Penal Code) but it may be defended by EU Directive 53/2010: "if According to a risk-benefit analysis in a Particular Case, including in life-threatening emergencies, the expected benefits for the recipient outweigh the risks posed by incomplete data, an organ may be considered for transplantation";

2. Situation fully corresponds to the definition of serious adverse event;

3. proceedings fully justified on the basis of the risk-benefit analysis and prediction of the results of transplantation;

4. Situation is rather clear, which is a medical mistake and crime against life and health (Polish Penal Code).

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