Transfusion Act

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Basic data
Title: Law regulating the transfusion system
Short title: Transfusion Act
Abbreviation: TFG
Type: Federal law
Scope: Federal Republic of Germany
Legal matter: Administrative law
References : 2121-52
Original version from: July 1, 1998 ( BGBl. I p. 1752 )
Entry into force on: July 7, 1998
New announcement from: August 28, 2007
( BGBl. I p. 2169 )
Last change by: Art. 11 G of 19 May 2020
( Federal Law Gazette I p. 1018, 1034 )
Effective date of the
last change: 		May 23, 2020
(Art. 18 G of May 19, 2020)
GESTA : M040
Please note the note on the applicable legal version.

The Transfusion Act (TFG) has been regulating the collection of blood , blood components and blood products in the Federal Republic of Germany since 1998 , as well as their use in humans for blood transfusions . It also contains comprehensive documentation requirements. The Transfusion Act regulates a special case of tissue donation for which the Transplantation Act does not apply in accordance with Section 1 (2) sentence 2 TPG. This is expressly stated in Section 29 sentence 2 TFG.

Origin of the law

In 1993, in the so-called " blood scandal ", it became known that several hundred people in Germany had been infected with the HIV virus through blood transfusions in the 1980s . This led to a lively debate about the need for precise legal regulation of the blood donation system with comprehensive control obligations, which finally resulted in the enactment of the first transfusion law in 1998.

The law was comprehensively amended in 2005 in order to implement European requirements in national law. For example, the documentation requirements have been extended from the previous fifteen to thirty years.

Regulatory matter

Framework conditions for blood donation

The law emphasizes the relevance of blood donations to the community. For this reason, according to Section 3 (3) TFG , they should be looked after "in a particularly trustworthy and responsible manner". The donation facilities must be adequately staffed, structurally, spatially and technically equipped and should support each other if necessary. The latest amendment to the law also makes it clear that the blood donation process requires a licensed medical person who is responsible for the blood donation ( Section 4 No. 3 and Section 7 Paragraph 2 TPG). Of course, this must be done in accordance with the current state of medical science and technology ( Section 7 (1) TPG).

Education and consent

According to § 6 TFG, the donor must be informed about the nature, significance and risks of the donation collection, the examination of the donated blood as well as the collection, processing and use of personal data and consent to this ( informed consent ). The consent must be given in writing.

Donor immunization and blood stem cell collection

Section 8 of the TFG regulates the special case of donor immunization , which on the one hand is necessary to obtain hyperimmune plasma, but on the other hand is associated with risks for the donor. Section 9 TFG regulates the extraction of blood components such as blood stem cells or blood plasma . Both paragraphs refer to the responsible state authorities and provide for comprehensive control and documentation obligations. A separate register for blood stem cells was set up at the German Institute for Medical Documentation and Information .

Expense allowance

According to § 10 TFG, the donation should be taken free of charge. The donor may, however, be paid an expense allowance, which should be based on the immediate effort of the respective type of donation.

documentation

The donation facilities have comprehensive documentation requirements in accordance with Section 11 TFG. According to the new regulation, the previous obligation to keep the documents on blood donations for fifteen years now has a period of 30 years. This traceability is e.g. B. important for severe side effects .

Blood deposits as well as application, storage and transport

Section 11a makes it clear that the strict provisions of the Transfusion Act apply not only to donation facilities, but also to blood stores. Further regulations concern the use of blood products ( § 13 TFG) and the precise documentation of this use ( § 14 TFG). The transport, storage and disposal of unused blood products ( Section 17 TFG) are also precisely regulated.

Tracing

In the event that a donor is infected with HIV , hepatitis or other pathogens, Section 19 TFG provides for a suspicion check and tracing procedure. In this way, infected donations should be withdrawn from circulation as quickly as possible.

Further regulations

The other provisions of the TFG concern a coordinated reporting system, the collection of epidemiological data, a working group of experts ( working group blood ), notification obligations of authorities and other ancillary provisions.

Applicability to autologous blood therapy

As part of the specification of Section 28 TFG, it is disputed whether the Transfusion Act is also applicable to the various variants of autologous blood therapy .

criticism

After the transfusion guidelines of the German Medical Association , the Guidelines for Hemotherapy as "guidelines for collection of blood and blood components and to the use of blood products (hemotherapy) (RiliBÄK blood)" in agreement with the competent federal authority, the Paul Ehrlich Institute decided homosexual and bisexual men, along with members of other risk groups (drug addicts, male and female prostitutes and prisoners are also explicitly mentioned ) as blood donors are out of the question. This regulation meets with criticism from homosexual associations, which point out that it is discriminatory to assume that homosexuals generally lead an unreflective way of life and that the recipients are endangered by potentially infectious blood. Potential donors should therefore no longer be asked about their sexual orientation, but about the frequency of changing sexual contacts.

literature

  • H. Blaius: The "blood scandal". in: Deutsche Apothekerzeitung. 12/1999, pp. 52-63.
  • M. Böck: Amendment of the transfusion law: consequences for practical work. in: Bayerisches Ärzteblatt . 2005, pp. 390-392.
  • H.-D. Lippert, WA Flegel: Commentary on the Transfusion Act (TFG) and the hemotherapy guidelines. Berlin 2002.
  • A. Preuss: For the exclusion of gay men from donating blood according to the Transfusion Act of July 1, 1998. Master's thesis. Leipzig 2003.
  • M. Schmidt: blood and paragraphs. News from the transfusion law. in: Deutsche Apothekerzeitung. 35/2005, pp. 63-67.
  • S. Schreiber: The Transfusion Act of July 1, 1998: Basic Legal Issues. Jur. Diss., Göttingen 2000, Frankfurt am Main 2001.
  • Reinhard Latza: International quality standards for human blood products. Habilitation thesis, Free University of Berlin 2006

Web links

Individual evidence

  1. ↑ Spickhoff, Medical Law, 3rd edition 2018, § 28 TFG Rn. 3.
  2. ↑ Guidelines for the collection of blood and blood components and for the use of blood products (haemotherapy). Set up according to §§ 12a u. 18 Transfusion Act by the German Medical Association in agreement with the Paul Ehrlich Institute. Second amendment of the guidelines in 2010 in the version approved by the Board of Directors of the German Medical Association on April 16, 2010. The agreement of the Paul Ehrlich Institute was made on May 4, 2010 .
  3. ↑ Bundesärztekammer.de ( Memento of December 14, 2010 in the Internet Archive ) (PDF; 82 kB): German Medical Association, explanations on the exclusion of blood donation for men who have sexual intercourse with men (MSM).
  4. ↑ Bad blood. In: Süddeutsche Zeitung . February 23, 2009. Retrieved September 19, 2012 .