In practice, the laboratories confirm their compliance with the legislation: for instance, AstraZeneca states that it complies with “local, national and international regulations and guidelines” (http://www.astrazeneca.com/Responsibility/Research-ethics/Stem-cell-research). Moreover, most of them, such as Johnson & Johnson, Merck, Novartis and Roche, have established an ethics committee in order to validate their approaches. Lastly, some of them only use embryos for which there is no longer a “parental project”.
United-States of America
Most of the world’s States authorize research on embryo stem cells, on the grounds of medical progress. Thus, in the United States, on March 9, 2009, by decree, President Barack Obama lifted all restrictions limiting the financing of research on embryo stem cells by the Federal Government. In Great Britain, the creation of human embryos for medical research purposes and “therapeutic” cloning are authorized. The Act of May 17, 2007 authorizes the in vitro creation of human/animal hybrid embryos for scientific research purposes.
Via the “Embryonenschutzgesetz” (Law on the Protection of the Embryo), which came into force in January 1991, Germany, which is highly vigilant regarding eugenics, authorized all analysis of an embryo provided that its integrity is respected, with the objective being implanting it in the mother’s uterus with a view to a birth. Therefore, research on embryos is prohibited there, with the notable exception of research relating to cells imported and created prior to January 1st, 2002, for projects with “blue chip research objectives”.
In France, the Law of August 6, 2004 laid down the principle of a ban on research on embryos, but introduced an exemption for a 5-year period “for research of a therapeutic nature for which there is no possible alternative research offering comparable effectiveness”. It authorized parents to donate their frozen embryos to research under the framework of in vitro fertilization. Prior to that time, they had been able to transfer them to the mother’s uterus, ask for them to be destroyed, or give them to another couple.
The Law of July 7, 2011 maintains the principle of a ban on embryo research, but expands the framework of the exemptions by no longer imposing a time limit on them. It authorizes research when “the scientific relevance of the research project is established” and “the research is likely to enable major medical progress”. Moreover, it needs to be “expressly established that it is impossible to achieve the result counted on via research that does not resort to human embryos, embryo stem cells or stem cell lines”. Even so, the law does introduce the possibility of conscientious objection: “No researcher, engineer, technician or research assistant whatsoever, and no doctor or medical assistant, is obligated to take part in any capacity whatsoever in research on human embryos or on embryo stem cells authorized pursuant to Article L. 2151-5.” (Art. L. 2151-7-1 of the Public Health Code). It also sets out, in Article L. 2151-5, that “alternative research to research on the human embryo and which complies with ethical requirements must be favored”.
On December 4th 2012, the senators voted a Bill authorizing research on human embryonic stem cells, without any restriction.
On July 16th 2013, the MP voted a law authorizing the destruction of human embryos for scientific purpose.
From that time, the human embryo can be considered and treated like any other object. It seems the human species should not benefit from the same protections as some animal species… However, should there even be doubts persisting about the embryo belonging to the human genus, the very least one could do is to apply the precaution principle, for the embryo’s benefit…
The ambivalence of most of the national European legislation (a ban in principle, accompanied by broad-ranging exemptions) contradicts the Order of the European Court of Justice of October 18, 2011 defining the human embryo as:
- “a human ovule, from the stage of its fertilization, and whenever this fertilization is of such a nature as to trigger the development process for a human being;
- an unfertilized human ovule, in which the nucleus of a human cell has been implanted;
- an unfertilized human ovule induced to divide itself and to develop by means of parthenogenesis”.
Recognizing the embryo as a human being endowed with potential (and not as a “potential human being”), the European Court of Justice rules out the patentability of “any process which, by sampling stem cells obtained from a human embryo at the blastocyst stage, leads to the destruction of the embryo”. Consequently, a scientist who may develop a new technical application based on a line of human embryo stem cells, regardless of its provenance, could not avail himself of any intellectual property right, with this applying even if this line came from an embryo who had been destroyed several years before in another country.