Transplantation Act (Germany)

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Basic data
Title: Law on the donation, removal and transfer of organs and tissues
Short title: Transplant Act
Abbreviation: TPG
Type: Federal law
Scope: Federal Republic of Germany
Legal matter: Special administrative law , medical law
References : 212-2
Original version from: November 5, 1997
( BGBl. I p. 2631 )
Entry into force on: December 1, 1997
New announcement from: September 4, 2007
( BGBl. I p. 2206 )
Last change by: Art. 16 G of 19 May 2020
( Federal Law Gazette I p. 1018, 1035 )
Effective date of the
last change: 		May 23, 2020
(Art. 18 G of May 19, 2020)
GESTA : M040
Weblink: Text of the law
Please note the note on the applicable legal version.

The Transplantation Act ( TPG ) has been regulating the legal requirements for the donation, removal and transfer of human organs, organ parts and tissues in the Federal Republic of Germany since 1997 . When organs are removed, the law distinguishes between organ removal from dead and living organ donors .

The extended consent solution applies, i.e. H. Transplantation is not permitted without the consent of the donor or immediate family members (in the case of brain death ) . With the Tissue Act of July 20, 2007, the law is also applicable to human tissue and fetal organs.

Although blood is also considered an organ, the Transplantation Act does not apply to blood, blood components and blood products. The transfusion law applies to these .

The Transplantation Act was passed by the German Bundestag on June 25, 1997 and, after the Bundesrat had approved it on September 26, essentially came into force on December 1 of that year.

Basic statements of the law

Organ removal from the dead

The German Medical Association, as the representative of the medical profession, defines the rules for proving death in guidelines. The legislature should only mark the point that must apply as a minimum requirement for organ removal. It was therefore necessary to stipulate that prior to organ removal, total brain death, i.e. the failure of the entire function of the cerebrum , the cerebellum and the brain stem, must be determined according to procedural rules that correspond to the state of the art in medical science. In this way, the legislature does not define death , but does define a minimum criterion for organ removal.

Organ removal from the living

Living organ donation is regulated in §§ 8 ff. TPG.

Such transplants - such as a kidney - are only possible under certain conditions:

  • Of legal age
The donor must be of legal age.
  • Informed consent
He must have given his consent , which requires comprehensive information on all risks associated with the intervention. This also applies to possible restrictions on insurance benefits.
  • fitness
The person concerned must be "suitable as a donor according to a medical assessment".
  • No risk beyond the intervention
There must also be no serious health impairment that goes beyond the operational risk.

According to current law, living organ donation is subsidiary to post-mortem donation, even if this is often criticized from a medical perspective.

The group of donors who donate living organs is limited to transfers to close relatives , spouses , registered partners or other persons who are obviously closely related to the donor and have particular personal ties.

The Federal Social Court has dealt with the problem of the (social law reimbursement of) so-called cross-over donations among the living .

Transplant centers

Transplantation of the vital organs, the heart , kidneys , liver , lungs , pancreas and intestines , is only allowed in approved transplant centers . They are obliged to cooperate, for which regional coordination offices are to be set up. Organs withdrawn abroad may only be mediated if there is no contradiction to the essential principles of German law. The aim is to counteract the illegal importation of organs from poorer countries.

Waiting lists

The transplant centers must keep waiting lists of people who need a donor organ that is subject to mandatory placement. A decision on the sequence of organ and tissue donations may only be made according to medical criteria such as the likelihood of success or urgency, not according to financial or social criteria. This does not apply to organ donations by the living to closely related persons. In 1967 Eurotransplant was founded, u. a. with the aim of improving the availability of donor organs and tissues.

Organ and tissue trade

The organ and tissue trade is prohibited and can be punished with up to five years imprisonment ( § 18 TPG). This does not apply to certain drugs obtained from organs, as well as fees for medical expenses such as organ removal, transport and preservation or infection protection .

enlightenment

The authorities should inform the population about the possibilities and requirements of organ donation and have organ donation cards ready. Health insurers should regularly ask their insured to make a personal decision about organ donation . A Europe-wide uniform organ donor card is sought. So far, only around 3.3% of the population are said to have completed organ donation cards. By increasing the quota of people who make express declarations for or against organ donation, the relatives should also be relieved of the decision to do so.

Organ donation register

The Federal Ministry of Health can set up a central register to save declarations for or against organ donation .

Donating blood

Blood donations and stem cell donations are not covered by the law.

Determination of death (total brain death concept)

The TPG regulates the death of the potential donor as a removal requirement in Section 3 Paragraph 1 No. 2 and Paragraph 2 No. 1. According to this, it is necessary that the death of the donor has been determined according to the current state of knowledge of medical science and that it is an irreversible total failure of the cerebrum, cerebellum and brain stem. Since all essential brain regions are listed in Section 3 (2) No. 2 TPG, one speaks of total brain death.

The criteria for the diagnosis of brain death were first named in 1968 by a commission from Harvard University. After improved diagnostic methods had been developed, the Scientific Advisory Board of the German Medical Association formulated the first decision-making aids for determining brain death in 1982. Technical progress made it necessary to update the decision-making aids in 1986, 1991 and 1997. Before organ removal, the failure of the brain functions or the final, irreversible standstill of the donor's heart and circulation must be determined independently by two doctors. You may not be involved in the later organ transplant, nor be under the control of a doctor involved.

Consent to organ removal (decision solution)

Legal regulation

The Transplantation Act was supplemented by a more extensive Tissue Act . This is based on the European legal requirements of the EC Directive 2004/23 / EC. On May 23, 2007 the Tissue Act was passed in the Bundestag. It came into force on August 1, 2007.

On April 24, 2007, the National Ethics Council in Germany published a statement with the aim of increasing the number of organ donations. The objection rule was favored. The statement says u. a .: “In 2005, despite the mandatory reporting stipulated in the TPG, only 45% of hospitals with intensive care units took part in organ donation, ie at least made contact with the responsible coordination office. This deficiency can be traced back to a lack of incentives for hospitals to participate in organ donation, as well as a lack of sanctions for non-participation. ” In May 2007, an amendment to the Transplantation Act was rejected by Ulla Schmidt , Minister of Health from 2001 to 2009. After the federal election in autumn 2009 , the black-red grand coalition ended; Angela Merkel formed a black-yellow coalition and the Merkel II cabinet . First Minister of Health was Philipp Rösler , followed in 2012 by Daniel Bahr .

It met with a great public response when Frank-Walter Steinmeier , SPD chancellor candidate in 2009 and SPD parliamentary group leader since autumn 2009, donated a kidney to his wife in August 2010 . Politicians from several parties then initiated a debate about reforming the organ donation regime. Federal Justice Minister Sabine Leutheusser-Schnarrenberger said she wanted to openly discuss an objection regulation for organ donations. After that, an organ removal would have been permissible if the donor had not expressly objected to it.

On May 25, 2012, the German Bundestag passed a comprehensive reform of organ donation by a large majority, which the Bundesrat approved in June 2012. In Section 2 (1a) of the Transplantation Act and in Section 291a (3) sentence 1 numbers 7 to 9 of the Social Code Book V, the decision was implemented on November 1, 2012. According to this, the health insurance companies and private health insurance companies use regular letters to ensure that the insured make a decision on organ and tissue donation and that this decision is documented, in particular in an organ donation card . The electronic health card must be suitable for accepting declarations by the insured person on organ and tissue donation as well as information on the existence and storage location of such declarations (Section 291a, Paragraph 3, Clause 1, No. 7 and 8 of Book V of the Social Code).

Anyone who makes a declaration on organ and tissue donation can consent to a removal, object to it or transfer the decision to a named person of their trust (extended consent). The latter represents a special type of postmortem power of attorney . However, nobody is obliged to make a declaration at all to be submitted ( § 2 Paragraph 2 and Paragraph 2a TPG).

The legal regulation of the admissibility of post-mortem organ donation must, on the one hand, take into account the self-determination of every person beyond death . That is why the declaration on organ donation made during one's lifetime has absolute priority and must be strictly observed by everyone. The consent can be limited to the removal of certain organs. Adolescents can only consent to organ donation themselves from the age of 16; an objection is possible from the age of 14.

On the other hand, the Transplantation Act also regulates the vast majority of cases in which the deceased - for whatever reason - did not make a declaration of organ donation during his lifetime. This affects more than 90% of all deaths.

The next of kin, as the guardian of the personal rights that continue to have effect after death, is obliged to observe any known or presumed wishes of the possible organ donor when deciding on post-mortem organ donation. If there are no indications of a presumed will, the next of kin is called upon to make a decision in favor of the deceased according to an ethically responsible discretion within the framework of his or her right to care for the dead. In around 60% of the deaths eligible for transplantation each year , the next of kin give their consent.

Organ removal with the consent of the organ donor

  1. The removal of organs is only permitted if
    1. the organ donor had consented to the removal,
    2. the death of the organ donor has been determined in accordance with rules that reflect the state of the art in medical science, and
    3. the procedure is performed by a doctor.
  2. The removal of organs is not permitted if
    1. The person whose death has been determined objected to the organ removal,
    2. the final, irreversible failure of the overall function of the cerebrum , the cerebellum and the brain stem has not been established prior to the removal from the organ donor according to procedural rules that correspond to the state of the art in medical science.

The doctor must inform the next of kin of the organ donor about the intended organ removal.

Organ removal with the consent of other people

  1. If the doctor who is supposed to perform the organ removal has neither written consent nor a written objection from the possible organ donor, his next of kin must be asked whether he is aware of a declaration on organ donation from him. If the relatives are also not aware of such a declaration, the removal is only permitted if a doctor has informed the relatives about a possible organ removal and the latter has given their consent. When making a decision, the relative has to consider the presumed will of the possible organ donor. The doctor must point this out to the relatives. The relative can agree with the doctor that he can revoke his declaration within a certain agreed period.
  2. Next of kin within the meaning of this law are in the order of priority of their listing:
    1. Spouse or registered partner
    2. adult children,
    3. Parents or, if the possible organ donor was a minor at the time of death and only one parent, guardian or carer was responsible for caring for his person at that time , this custodial holder ,
    4. adult siblings ,
    5. Grandparents.
    The next of kin is only authorized to make a decision if they had personal contact with the potential organ donor in the last two years before the death. The doctor has to determine this by questioning the relative. If there are several relatives of the same rank, it is sufficient if one of them is involved and makes a decision; however, the contradiction of each of them must be observed. If a senior relative cannot be reached within a reasonable period of time, the participation and decision of the next subordinate relative is sufficient. The next of kin is equal to an adult who was evidently close to the possible organ donor with a special personal bond until his death; she steps next to the next of kin. This can e.g. B. also be a legal guardian according to § 1896 BGB . With regard to the necessary building of trust, all steps in the decision-making process should be comprehensively documented. The next of kin of the deceased and other people who are particularly close to him must be granted the right to inspect the documents relating to the determination of death , the procedure and scope of the organ removal, as well as the participation of other close relatives and persons particularly close to him.
  3. If the possible organ donor had delegated the decision about organ removal to a specific person, this person takes the place of the next of kin. The transfer of this decision is a post-mortem power of attorney .
  4. In the case of a dead embryo or fetus, only the woman who was pregnant with the embryo or fetus can consent to the organ removal. She is also considered a donor for the purposes of documentation, traceability and data protection.

Transplant registry

Since 2012, experts have been discussing uniform data collection for the entire process flow in transplant medicine (transplant register). Until then, the data had been collected in different institutions and under different specifications. In the opinion of the Federal Ministry of Health, the consolidation of the data and the objectives pursued with it required an in-depth professional discourse, which the Ministry must lead and promote.

On April 30, 2013, the BMG commissioned the BQS Institute for Quality & Patient Safety with the preparation of an expert opinion for a national transplant registry. This opinion was submitted on August 8, 2014.

The transplant registry was established with effect from November 1, 2016. The rules were as §§ 15a-15i inserted into the Transplantation Act and as a § 299 para. 5 in the SGB V . With the transplant register, data from deceased organ donors, organ recipients and living donors will be centralized nationwide and linked for the first time.

See also

literature

  • Erik Hahn: Transplantation law - the living donation and its requirements at a glance , in: Drygala / Klesczewski / Francke / Richter (eds.): Leipziger legal seminar papers (yearbook), Leipzig 2006, pp. 61–82. ISSN  1861-2857
  • Wolfram Höfling: Commentary on the Transplantation Act , 2nd edition. Berlin 2013. ISBN 978-3503129270
  • Lars Christoph Nickel, Angelika Preisigke: Admissibility of a cross-living donation according to the Transplantation Act . MedR 2004, 307ff.
  • Adrian Schmidt-Recla: The dead live longer: Is brain death a sufficient criterion for organ donation? . MedR 2004, pp. 672-677
  • Wolfram Höfling: 20 years of the transplant (prevention) law - a critical balance . In: ZRP . 2017, p. 233 ff .

Web links

State law on the TPG

Individual evidence

  1. ↑ BVerfG, decision of August 11, 1999 - 1 BvR 2181/98 u. a. No. 2
  2. ↑ by amendment or insertion of §§ 3 and 4a TPG
  3. ↑ Cf. Transplantation Medicine in Germany will receive new impulses: Transplantation Law came into force. ( Memento of the original from September 27, 2007 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. (in Werner Schells ( Memento of the original from June 13, 2007 in the Internet Archive ) Info: The archive link has been inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. Legal almanac) and Section 26 TPG @1@ 2Template: Webachiv / IABot / www.wernerschell.de @1@ 2Template: Webachiv / IABot / www.wernerschell.de
  4. ↑ Federal Social Court, judgment of December 10, 2003 - B 9 VS 1/01 R -, MedR 2004, 330 ff.
  5. ↑ Directive 2004/23 / EC
  6. ↑ Amendment and entry into force of the Tissue Act
  7. ↑ Statements of the National Ethics Council ( Memento of the original dated July 2, 2007 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / www.ethikrat.org
  8. ↑ Sueddeutsche.de: "The existing transplantation law is good"
  9. ↑ tagesschau.de ( Memento from August 31, 2010 in the Internet Archive ), thanks to Steinmeier (leading article)
  10. ↑ 182nd meeting on May 25, 2012, Item 31 Transplantation Act ; Broad majority for new regulation: Bundestag resolves reform of organ donation ( memento from May 25, 2012 in the Internet Archive ) at tagesschau.de, May 25, 2012 (accessed on May 26, 2012);
  11. ↑ Organ donation: New transplantation law passes Federal Council at Spiegel Online , June 15, 2012 (accessed on June 15, 2012).
  12. ↑ Law regulating the decision-making process in the Transplantation Act of July 12, 2012, Federal Law Gazette I, 1504
  13. ↑ Law regulating the decision-making solution Federal Center for Health Education , accessed on March 26, 2017
  14. ↑ Changes in transplant law, Düsseldorf Bar Association, accessed on March 26, 2017
  15. ↑ Christof Veit, Sven Bungard, Dennis Eichwald, Kerrin Schillhorn, A. Trümner: Expert opinion on a national transplant register Status report on data collection and suggestions for the design of a transplant register, August 8, 2014
  16. ↑ Art. 1 of the law on the establishment of a transplant register and the amendment of other laws ( BGBl. I p. 2233 , pdf)
  17. ↑ Bundestag passes law on the establishment of a transplant register Website of the Federal Ministry of Health , July 8, 2016
  18. ↑ BT-Drs. 18/8209