Brussels, 07/05/2002 (Agence Europe) - Tuesday, the chair of the European Ethics Group (EEG), Noelle Lenoir handed European Commission President Romano Prodi the opinion that the Group has just issued on the patentability of human stem cells. This opinion is in line with that of November 2000 on research concerning these cells of which the medical world expects a great deal for the treatment of certain degenerative diseases or cancer. At the time, the EEG, while placing emphasis on the need to respect subsidiarity, stated that research had to be authorised and accompanied. It recommended, notably,: - placing this type of research under the strict public control of a central authority; - prohibiting the marketing of human embryos or tissues of dead foetuses; - exercising control by public authorities on the import of human stem cells. Last year, President Prodi had also asked it for an opinion specifically on the patentability of human stem cells.
In its opinion, the EEG refused outright the option that would have consisted in prohibiting any patent relating to stem cells or stem cell lines. It would seem that this would have had as consequence of considerably slowing down research in the field, that it would have been contrary to the general interest and that of patients in particular. The Group does, however, consider that it is crucial to define the conditions and limits to patenability. "Isolated stem cells, that have not been modified, do not meet, as product, the legal requirements of patentability, notably as regards industrial applications", says the EEG, continuing: "In addition, such isolated cells are so close to the human body, the foetus or the embryo from which they come, that their patentability may be likened to a form of marketing of the human body". The Group also rejects the patentability of unmodified stem cell lines, notably as they have no one single use but a very wide range of undetermined potential applications. Consequently, it states that "only stem cell lines that have been modified by in vitro of genetic treatment to acquire the necessary characteristics in view of precise industrial applications meet the legal conditions for patentability". The EEG considers that there is no particular ethical obstacle to the patentability of proceeses involving human stem cells, whatever their source, on condition that they meet the criteria for patentability" novelty, inventive activity and industrial application.
The Group is of the opinion that all requests for patents concerning human stem cells must stipulate the source of these cells. It also places emphasis on donor protection: "When cells having been the subject of a donation may be part of the request for a patent, the donor must be informed of this possibility and may reject such a potential use of the cells. Except for a justified compensation, the donor may not receive any remuneration that could infringe the principle of non-commercialisation of the human body. These ethical demands should also be applied, as far as possible, to imported human stem cells". The Group again places emphasis on the need to avoid issuing patents whose field of application is too broad and risk impeding future research and development activities. In calls for the EU-wide creation of a register of unmodified human stem cell lines, that would include information on both embryonic cell lines and embryonic germinal cells. This register should be accessible to the public. It would guarantee transparency and access for the scientific community to the biological material necessary to conduct research. To ensure that the holders of patents do not abuse their prerogatives, for example by demanding excessive rights for the use of their invention, the EEG considers that recourse to the compulsory license should be encouraged when access to a diagnosis or treatment is blocked by an abusive application of patent rights. It stresses that it is up to States to establish a legal procedure for the issuance of compulsory licences and examine whether the preservation to fair and balanced access to health care warrants such a procedure. Finally, he EEG considers that it would be desirable for an ethical evaluation of requests for patents become an integral part of the examination procedures of national offices or European institutions like the OEB, and that advisory committee of independent experts be created to that end.
Disagreeing, Professor Gunter Virt (one of the twelve members of the EEG) said that he generally shared in the opinion issued by the Group, but opposed the possibility of patenting methods and products using matter to come from human embryos that have been destroyed. He states that "this usage as material is contrary to the dignity of the embryo as human being benefiting from the right to life that stems from that". He also considers that the "patentability of human embryonic stem cells and stem cell lines should encourage research into embryonic stem cells and eradicate the priority of using stem cells other tan embryonic cells".
At a press conference, President Prodi hailed the remarkable work done by Noëlle Lenoir, who chaired the EEG for more than eight years. He regretted her departure, noting that nobody was irreplaceable but Ms Lenoir was almost irreplaceable and that the Commission would be appointing two new members because Spiros Simitis was also resigning.
Both departures are due to problems of personal availability. At the press conference Ms Lenoir said that the extension of her teaching duties in the US meant she could not fully manage the EEG's work. She emphasised President Prodi's great sensitivity to ethical issues and the fact he got fully involved in the EEG's work.
She highlighted the great ethical and financial challenges posed by patenting stem cells, mentioning the weakening of European research and loss of European influence in the world, saying that the opinion offered a solution that made it possible to make the most of EU scientific and industrial potential and promote EU values.