Brussels, 7 May 2002
The European Group on Ethics in Science and New Technologies (EGE) has presented to the President Prodi on Tuesday 7th May 2002 its opinion n°16 on the "Ethical aspects of patenting involving human stem cells".
The Group is an independent, multidisciplinary and pluralist instance. The EGE reports directly to the President of the European Commission, Romano Prodi. It is composed of twelve members and a French lawyer, Noëlle Lenoir (France), chairs it. Its role is to advise the Commission on how the ethical values of European society can be taken into consideration in the scientific and technological development promoted by Community policies.
Following the publication of this opinion, Mrs Lenoir announced her decision to resign from the Group. She was member of the EGE since its creation in 1991 and Chairman for more than 8 years.
President Prodi declared that: "The work achieved by Mrs Lenoir is remarkable". She played a determining role in designing years after years a method of debate at community level on the ethical concerns raised by technological development in our society and she succeeded in making the European Group on Ethics a competent, independent instance, widely recognised inside and outside EU. Her personal merit in the achievements of this Group is unquestionable.
President Prodi declared that the commission who nominates the members of the EGE will take the necessary steps to nominate the new members replacing Mrs Lenoir as well as another resigning member Mr Spiros Simitis.
Mrs Lenoir presented the context of the opinion:
According to the 1998 EU Directive on the Legal Protection of Biotechnological Inventions and in particular article 7, calling the EGE to carry out an evaluation of the ethical aspects of biotechnology, the opinion expressly requested by President Prodi, aims to define the conditions and the limits of patenting of stem cells, not only in relation to ethical considerations, but also in the relevant processes securing ethical evaluations.
The opinion seeks to address the basic ethical dilemma arising due to the fact that patents can encourage scientific progress which can be used to the benefit of better healthcare and, in the same time, can also impair access to the health care due to the fees that will have to be paid to the patent holder. The EGE considers that the recourse to compulsory licence should be encouraged when the access to diagnostic and treatment is blocked by misuse of patent rights and stresses the fact that it is the responsibility of the States to establish legal procedure for the delivery of compulsory licence and to examine if fair access to health care justify such a procedure.
It is then necessary to secure the right balance between the inventors interests and the society's interest, in the sense that one task for the community is to secure ethical principles and values in the context of possible conflicting interests of stake-holders, namely: patients and patients' associations, inventors, and other researchers, donors, industry, inventors, healthcare providers and social insurance.
The Group considers that only human stem cells lines which have been modified by an inventive process to get new characteristics for specific industrial application are patentable. However, that stem cell which are been isolated and cultured but which have not been modified should not be considers as patentable inventions.
Concerning stem cells from embryonic origin, one member of the Group, Professor Gunter Virt, expresses a dissident view, considering that the patentability of inventions involving embryonic stem cells is ethically not acceptable as the obtaining of these cells require the destruction of human embryo.
Concerning cloning techniques aiming at obtaining human embryonic stem cells for therapeutic purposes, the Group calls for a cautious approach taking into account the excluding such invention from patentability.
The EGE finds important that patents on stem cells enables further research. In this sense the EGE calls for the creation of an EU Registry of unmodified human stem cell lines. The Registry should include both embryonic stem and embryonic germ cells lines. Such a Registry would ensure transparency and facilitate access by the research community.
For further information, please contact
The EGE's Secretariat in Brussels
Christiane Bardoux Agueda Ollero Montiel Fax: 0032 2 299 45 65 Tel: 0032 2 295 71 35 E-mail: christiane.bardoux@cec.eu.int
agueda.ollero-montiel@cec.eu.int
You can also consult our website at the following address: http://europa.eu.int/comm/european_grou p_ethics
DN: IP/02/675 Date: 07/05/2002