Brussels, 23/11/2001 (Agence Europe) - The European Ethics Group, chaired by Noelle Lenoir, organised, on Tuesday, to prepare its opinion on the ethical aspects of the patentability of inventions using human stem cells, a roundtable that illustrated the spectacular evolution of science during recent years and the difficulties faced by law in following this development, but also certain changes of course that require new regulations. The group should issue its opinion next February, or a few weeks before the next stage (on 22 April) of the challenge procedure underway at the European Patent Office (EPO) in Munich, concerning the patent granted to the University of Edinburgh for a method to select stem cells from embryos.
During the debate, the EPO Director, Andre Remond explained that the Office has at present received 1100 patent applications concerning human and animal stem cells, but only forty-odd, especially of American origin, concern embryonic cells. Basing himself on the 1998 Directive concerning the patentability of biotechnological inventions, he underlined that single human cells may be patented. While recognising that the embryonic origin of cells poses a problem in the patent requested by the University of Edinburgh, he revealed another problem residing in the reproducing capability of the invention at the time of its filing in 1994. Underlining that Article 6 excludes from patenting the use of human embryos, Mr Remond nevertheless felt that the use of non-viable embryos could possibly provide another perspective to the debate. Moreover, he noted that the Directive foresees that if marketing is possible, patentability must be, thus calling for reflection over the possibilities that may be provided by the ban on profits that applies in certain Member States, such as France, for parts of the human body. Mr Remond recalled that in certain cases such as blood, by-products may be patented. Finally, while underlining that cloning is banned, he stated that if the patent is silent on the procedure for obtaining the embryo, the EPO will not go searching for the origin of the stem cells.
Professor of Haematology Eliane Gluckman (St Louis Hospital, Paris) presented the point of view of the transplanting doctor with regards to grafts of haemotopoitic stem cells by providing a history of the work on blood cells from the umbilical cord, notably used for the treatment of leukaemia, meduallary aplasie or other hereditary blood diseases highly present in the Mediterranean basin and in Africa. Mrs Gluckman underlined that this technique does not present any specific ethical problems, since the placenta has until now been considered to be "operational waste" and that the blood taken from it has the advantage of presenting no infectious risk (in the absence of hereditary diseases), as infectious agents do not cross the placenta barrier. She explained the progressive creation of a network of donor banks, before speaking out against the practices of certain private companies that presently approach pregnant women, often around the time of giving birth when they are particularly vulnerable, to propose to them the gathering and preservation, at often high prices, of the born child's cord blood by explaining to them that this is an insurance in the interest of the child who could have a use for it at a later date. The representative of one of these American companies "Cryo-Cell Europe" presently operates from Belgium and the Netherlands, Marc Jan Waeterschoot, then spoke to explain that mothers should subscribe to the commercial offer from companies such as his, to the extent that they guarantee their clients the availability of the cord blood not only for present treatments, but also for those that will arise with the development of genetic therapies. He also insisted on the "moderate" price asked for by the his company: EUR 75 for the kit allowing to sample the cord blood and to carry it, EUR 225 after successful storage" (this concerns a freezing method) for stem cells, EUR 685 for their conservation for 20 years, or a total of EUR 985. Questioned over the limits in the use of stem cells, Mrs Gluckman underlined the need to reach a certain ceiling of concentration for the sampling to be used effectively. She indicated that research continues into the possible use of cells from two different bloods and which could be more effective. There is no know limit in terms of cell conservation, she added while indicating that samples taken from the oldest samples today (around 15 years) have shown that the products had retained all their properties. What is important, is the quality of the sampling and the conditions in which it is conserved, she added, while wondering whether the methods used by commercial cord blood conservation companies which carry a kit without even having a temperature check. At present, the donor banks may ensure a donor for a receiver, said Mrs Gluckman while underlining that there is thus no reason, outside profit, in the creation of private banks that can only damage the long-term collection of donations and hence solidarity. She went on to add that "autoplastic transplants do not work well". In answer to questions on the advice that she would give to her daughter if she were approached by a private bank, she said that her children live in the United States and had been approached when giving birth. She said her advice was to invest their money in something else. "I would not recommend this kind of approach, except in the case of families with a high incidence of cancer or a specific hereditary disease", she added.
Other speakers included Geertrui van Overwalle, Professor of Law (at the University of Leuven), who presented the typology of patents issued in the United States. There were also representatives of the pharmaceutical industry, like Paul Herrling (Novartis), who spoke in favour of patents recalling that they make a double contribution to research - on the financial level, but also by their public nature, by providing access for research workers to discoveries on which they may be able to build new research.
EUROPE recalls that the group should also give an opinion on banks of cord blood before examining the tricky issue of clinical trials carried out in the poor countries.