Last but not least, the acts have to be signed and certified by the current Federal President Joachim Gauck (“Bundespraesident”) and promulgated in the Federal Law Gazette to become effective (Art. 82 of the German Constitution). On July 12, 2012, the Bundespraesident, the German Chancellor Dr. Angela Merkel and the German Health Minister D. Bahr signed the Law to Regulate the Opt-In Solution for Organ Transplantation. It is published in the Federal Law Gazette Number 1, BGBI. I 33/2012, p 1504 and becomes effective on November 1, 2012. The signature for the Act to amend the German Transplantation Act is still pending, but is expected soon. The goal of both laws is to increase the number of organ donations.
The Act to Amend the German Transplantation Act
The Act to Amend the German Transplantation Act (BR-Drs. 292/12) results from the implementation in national German law of the European Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation. Directive 2010/45/EC only applies to organs used in research where they are intended for transplantation into the human body, Art. 2 Subsec. 2 Directive 2010/45/EU.
The Act to Amend the German Transplantation Act not only amended the TPG, but also the Social Act related to the statutory health insurance (Social Security Code 5), statutory accident insurance (Social Security Code 7) and the Act of Continued Payment in Case of Sickness (“Entgeltfortzahlungsgesetz”, “EFZG”). The new regulations shall ensure the quality and safety of human organs and improve the transplantation processes in hospitals. Each hospital with an intensive care united must appoint a transplantation officer (§§ 9a, 9b TPG as amended).
The rights of living donors are also enhanced. Each living donor is now entitled to claim reimbursement for medical treatment expenses, travel expenses, expenses for rehabilitation and sick payments related to the transplantation from the organ recipient’s statutory or private health insurance (§ 3a of the Act of Continued Payment in Case of Sickness; Paragraphs 27 Subsec. 1a, 44a Social Security Code 5). The private health insurance companies entered into a voluntary agreement on February 9, 2012 to cover the expenses of living organ donors, including medical treatment, travel, lost earnings, and rehabilitation. In addition, organ transplantation is now considered as unemployment through no fault of the donor so that the living donor now can claim continued payment of remuneration for six weeks. Medical treatment of donors will be provided by highly specialized physicians.
The most important change addresses the statutory accident insurance for any health damages caused by the organ donation procedure, which exceed the regular impairment of health (§ 12a Social Security Act 7). In this case, any claim related to the health damage, e.g. kidney failure after kidney donation, will be covered by the accident insurance instead of the health insurance. The Act to Amend the German Transplantation Act also covers cases of health damages occurred since 1997 (§ 213 Subsect. 4 Social Security Act 7). With these new regulations, statutory health insurance does not have to cover the costs and will be financially relieved.
The Law to Regulate the Opt-In Solution for Organ Transplantation
To increase the willingness to donate organs among the citizens, the Law to Regulate the Opt-In Solution for Organ Transplantation regulates the opt-in solution for living and post mortem donations. The extended approval has been changed to informed consent (opt-in). The new informed consent requirement is regulated in § 1 Subsec. 1 TPG (as amended) as follows:
"(1) Goal of this Act is to support the willingness of organ donation in Germany. Thus, each citizen has to be put in a position to question the own willingness to donate organs on a regular basis and to document the decision. To ensure a voluntary and informed consent a broad general education about the possibilities to donate organs and tissues is included." (my translation)The new law, while protecting donors, asks each German citizen to make a decision on organ transplantation. Each German citizen older than 16 years will receive a letter from the health insurer informing them about the possibility to donate organs (§ 1 Subsec. 1a TPG as amended). Everyone will be informed and asked on a regular basis. To ensure that a voluntary consent is given, the German Federal Centre for Health Education (“BZgA”) as well as the statutory and private health insurances are responsible to educate the citizens as well.
Consequences for Research with Human Cells and Tissue?
The most recent changes to the TPG do not have direct consequences to biobanks and research with human cells and tissue. However, the TPG justifies the necessity to obtain an informed consent from study subjects before using human cells and tissues in research. Specifically, based on the regulations in the TPG, informed consent is required prior to post mortem donations of cells and tissue for research. The use of human cells and tissue in research is not directly regulated under German laws. Therefore, other laws such as the TPG are applied to the research use. Thus, the same standard that applies to organ donations should also apply to research donations. As such informed consent is now, more than ever, mandatory.
These developments lead to important questions. For example: How, following the organ donation model, can increased education about the use of human tissue in research improve patients willingness to be research donors? Would it be ethical to require people to make a decision to donate their cells and tissue for research? Would such a regulation have an influence on the voluntariness of informed consent?
In addition, the Act to Amend the German Transplantation Act only regulates that donors of organs and tissue will be reimbursed for their expenses (see above). The Act does not state explicitly if this regulation is also applicable for donors of organs and tissues used in research. At the same time, nothing in the act says that the new regulation is not applicable for the research donations. Can the act be used to reimburse “research donors”? Would it be legal and ethical to reimburse research donors in the same way as organ donors? Should a research donation be seen in the same way as the commonly known organ transplantation?
I intend to address these and other questions in a separate publication that I will describe in future posts.
-- Bianca Buechner, Ph.D., LL.M. Candidate
Indiana University Robert H. McKinney School of Law
Indiana University Robert H. McKinney School of Law