Transplantation law

In Germany, the Act on the Donation, Removal and Transfer of Organs and Tissues, also known as the Transplantation Act (TPG), came into force in 1997. It regulates the legal aspects of transplantation (Kuhlmann 2015), which include donation, removal, procurement and transfer of organs donated after death or during life (Braun 2020). The last amendment was made after a decision by the Bundestag on 16.03.2020 (Bundesministerium der Justiz und für Verbraucherschutz 2020).

The guideline competence for organ transplantation lies with the Federal Medical Association

(Herold 2018). These guidelines, established by the German Medical Association in relation to the respective state of scientific knowledge, are summarised in Section 16 of the TPG (Bundesministerium der Justiz und für Verbraucherschutz 2020).

The guidelines for the "determination of brain death" were first documented in 1982 and last revised in 2015 (Richter- Kuhlmann 2017). They detail the procedures for determining brain death or irreversible loss of brain function (IHA) (Herold 2018).

The examinations are performed by two physicians who have several years of experience in the intensive medical treatment of severely brain-damaged patients and who are board-certified specialists. At least one of the two physicians must be a specialist in neurology or neurosurgery (Richter- Kuhlmann 2017). These physicians must not be part of the transplant team (Herold 2018).

The diagnosis of the IHA repeats itself in a precisely timed rhythm (Brandt 2018). The apparativefailure of all brain functions is documented by the cerebral circulatory arrest (CT- angiography) (Herold 2018).

The organ removal itself may only be carried out by doctors.

(Federal Ministry of Justice and Consumer Protection 2020).

Various areas are strictly separated from each other in terms of organisation and personnel in the TPG. These include:

• Organ donation
• Organ procurement
• Organ transfer

(Braun 2020)

In the Benelux, Germany, Croatia, Austria, Slovenia and Hungary donor organs are reported to Eurotransplant(ET) based in Leiden (MacFee 2012). From there, the procurement of donor organs takes place (Herold 2020).

• Cadaveric donation

In the case of cadaveric donation, according to the TPG the donor must have consented to donation during his lifetime by means of a so-called "donor card".

If there is no written consent and also no objection, next of kin can make this decision - taking into account the presumed will of the donor - within a reasonable time. However, next of kin are only authorised to make a decision if they have had personal contact with the deceased in the last two years (Federal Ministry of Justice and Consumer Protection 2020).

• Living donation

The TPG specifies exactly who is eligible for living organ donation (Kuhlmann 2015).

Donors can be close relatives or persons from the person's immediate environment who are personally closely connected to the recipient (Herold 2020).

Relative contraindications for living donor are:

- esity

- paired glucose tolerance

- creased risk of developing diabetes mellitus type 2

(Kuhlmann 2015)

1. Brandt S A et al (2018) Significance of irreversible brain function loss as a sure sign of death. Deutsches Ärzteblatt (41) 675 - 681
2. Braun F et al (2020) Changes in the Transplantation Act and impact on donor volume in Germany. The Surgeon (91) 905 - 912
3. Federal Ministry of Justice and Consumer Protection (2020) Act on the donation, removal and transfer of organs and tissues (Transplantation Act - TPG) § 1 - $ 26.
4. Herold G et al (2018) Internal medicine. Herold Publishers 649 - 650
5. Keller C K et al (2010) Practice of nephrology. Springer Publishers 330 - 331
6. Kuhlmann U et al (2015) Nephrology: pathophysiology - clinic - renal replacement procedures. Thieme Verlag 764 - 765
7. MacFee I et al (2012) Handbook of renal and pancreatic transplantation. Wiley- Blackwell BMJ Fig 8.4.
8. Richter- Kuhlmann E (2017) Irreversible brain dysfunction: currently no amendment of the guideline. Deutsches Ärzteblatt (29 - 30) A 1422 - 1423