Regulation of stem cell research in Italy
The derivation of embryonic stem cell lines is banned but it is permitted to use imported embryonic stem cell lines for research.
Current legal position
Stem cell research in Italy is regulated by the Law 40 (19 February 2004). Under this law, the embryo is recognized as a subject of rights from the moment of fertilization. The law prohibits the use of embryos for any research unless it is specifically aimed towards improving the therapeutic and medical condition of the embryo concerned. Instead, the 2004 Law gives widespread support to tissue (adult) stem cell research. It is estimated that around 30,000 supernumerary embryos have been stored frozen since before the introduction of this Law.
Law 40 was the outcome of a long and divisive debate between supporters and opponents of embryonic stem cell research and assisted reproduction. In 2005 the law was challenged in Italy’s highest court, the Constitutional Court, by opponents who included scientists seeking a review of the ban on the use of embryos for research. The Court allowed a referendum on several parts of the law, including on whether or not the prohibition on embryo research could be relaxed. The referendum was held in 2005 but failed because total votes fell below the minimum threshold of 50% of the Italian electorate. A 2009 Ministerial Decree that confined research funding to tissue (adult) stem cell research, so excluding embryonic stem cell research, has so far been unsuccessfully challenged by a number of Italian scientists following several appeal cases before the Italian courts.
Ethical and regulatory oversight
The Italian National Ethics Committee (Comitato Nazionale per la Bioetica) was set up in 1990 to deal with the ethical and legal issues raised by scientific research and use of technological applications on persons. Members of this committee, which is made up of scientists, physicians and ethics experts, are appointed by the government. The Committee has published many reports on embryo research and other related issues, but these have no binding authority. Other committees have recommended opposing opinions on some issues, including embryonic stem cell research.
Relevant laws, policies and links
- Law 40, 24 February 2004, Regulation of Medically Assisted Human Reproduction, Legge 24 Febbraio 2004, n. 40, Norme in materia di procreazione medicalmente assistita, G. U. N. 45 24-2-2004, at http://www.guritel.it/free-sum/ARTI/2004/02/24/sommario.html
- Referendum on the law of medically assisted procreation, Press Office of Italian Constitutional Court, (13 January 2005), Comunicato stampa sul "Referendum sulla legge in tema di procreazione medicalmente assistita". (Giovedì 13 gennaio 2005), Corta Constitutionelle di Republica Italia, at http://www.cortecostituzionale.it/comunicatiStampa.do, accessed 25 May 2011.
- Protection of the Embryo and the Human Foetus, Statement Concerning the Draft Protocol of the Bioethics Committee of the Council of Europe, Opinions, Italian National Ethics Committee, Comitato Nazionale per la Bioetica (CNB), 31 March 2000, at http://www.governo.it/bioetica/eng/opinions/embryo.html, accessed 26 May 2011.
- "Therapeutic use of stem cells", 27 October 2000, Italian National Ethics Committee, Comitato Nazionale per la Bioetica (CNB), at http://www.governo.it/bioetica/eng/opinions/embryo.html, accessed 26 May 2011.
- Blackburn-Starza, Anthony "Italian human stem cell scientists lose funding battle", 14 December 2009, Bionews, at http://www.bionews.org.uk/page_52117.asp, accesed 9 June 2011
- Appeal to the Council of State submitted by Elena Cattaneo, Elisabetta Cerbai and Silvia Garagna to overturn order no. 3477/2009 of the Regional Administrative Court of Lazio, European Centre for Law, Science & New Technologies, at http://www.unipv-lawtech.eu/lang1/abstract-council-of-state-appeal.html, accessed 21 July 2011