Regulation of stem cell research in Germany
The derivation of embryonic stem cells is banned but embryonic stem cell lines can be imported specifically for research if the line was generated before a defined cut-off date.
Current legal position
The use of embryos for research is heavily restricted in Germany under the Embryo Protection Act (Embryonenschutzgesetz) 1991, which makes the derivation of embryonic stem cell lines a criminal offence. The embryo is also protected under the German Constitution (Grundgesetz). The Basic Law states that “human dignity is inviolable” and that “everyone has the right to life and inviolability of his person.” Nonetheless, it also states the freedom to pursue science and research.
German law gives priority to adult stem cells under the 2002 Stem Cell Act (Stammzellgesetz) but the importation of embryonic stem cell lines into Germany is permitted under strict conditions approved by the German parliament. The 2002 Act included a ‘cut-off date’ of 1 January 2002 – imported ES cell lines must have been derived before that date. In 2008, as a result of pressure from scientists, the act was amended to move the cut-off point to 1 May 2007. In addition to these criteria, embryonic stem cell lines can only be used for research if they are vital in developing new medical and scientific knowledge.
Ethical and regulatory oversight
Any applications to import stem cell lines for research must be approved by the Central Ethics Commission for Stem Cell Research (ZES), which comprises scientists, physicians and experts in ethics. The German National Ethics Council (Geschäftsselle des Nationalen Ethikrat), set up in 2007, advises and issues opinions to the government and public alike on scientific and medical issues that concern society and human health.
Relevant laws, policies and links
- Act ensuring Protection of Embryos in connection with the importation and use of human embryonic stem cells, Gesetz zur Sicherstellung des Embryonenschutzes im Zusammenhang mit Einfuhr und Verwendung menschlicher embryonaler Stammzellen Stammzellgesetz (StZG- Stem Cell Act), 14 August 2008 at http://bundesrecht.juris.de/stzg/index.html
- Act ensuring Protection of Embryos in connection with the importation and use of human embryonic stem cells, Stammzellgesetz (StZG- Stem Cell Act), 28 June 2002 at http://bundesrecht.juris.de/stzg/index.html
- Act for the Protection of Embryos, Gesetz zum Schutz von Embryonen Embryonenschutzgesetz (ESchG- The Embryo Protection Act), 13 December 1990, at http://www.gesetze-im-internet.de/eschg/BJNR027460990.html
- Basic Law of the Federal Republic of Germany (Grundgesetz für die Bundesrepublik Deutschland), 1949, English translation, PDF.
- Opinion, "The Import of Human Embryonic Stem Cell", English translation, German National Ethics Council (Geschäftsselle des Nationalen Ethikrat), December 2001.
- Opinion, "Should the Stem Cell Law be amended?" English translation, German National Ethics Council (Geschäftsselle des Nationalen Ethikrat), July 2007.
- Central Ethics Commission for Stem Cell Research (Zentrale Ethik-Kommission für Stammzellenforschung - ZES).
- Gretchen Vogel, "Scientists lobby European Court to bring Stem Cell Patents", Science, 27 April 2011.
- Brüstle v Greenpeace, Preliminary Opinion of the Advocate General of the European Court of Justice.
- Brüstle v Greenpeace, Final Judgement of the European Court of Justice (listed as "Brüstle").