A discussion document of the Working Group on Bioethics
Church and Society Commission, Conference of European Churches
The working group on bioethics of the Conference of European Churches and its predecessor EECCS has for several years been engaging with the issues surrounding the patenting of biotechnological inventions. The group consists of specialists drawn from European Protestant and Orthodox churches in Finland, France, Germany, Greece, Italy, the Netherlands, Russia, Slovakia, Switzerland and the UK. Our range of expertise includes biochemistry, chemistry, genetics, law, medicine, medical and technological ethics, and practical theology.
This is a discussion document which does not at this stage necessarily represent the views of CEC or its member churches. It was prepared on behalf of the working group by Dr Donald Bruce, 16/11/01 for the Round Table of the European Commission’s European Group on Ethics in Science and New Technologies in Brussels on 20 November 2001.
General Comments on Biotechnology Patenting
Between 1996 and 1998 we presented a series of Submissions to the European Parliament and the European Commission during the debates which led up to passing of the EU Biotechnology Patenting Directive 98/44/EC. The churches are not opposed to the patenting of certain types of biotechnological inventions, but we regard the scope of what the Directive regards as patentable as too broad. The Directive presents many ethical problems, to which many others have also drawn attention. On the one hand it blurs the distinction between discoveries and inventions, and between living and non-living things, and yet it makes dubious distinctions between genetic material and human body parts, and between genes in their natural state and the same genes examined and copied in the laboratory. There is also inadequate provision for ethical review of specific patent applications
We remain deeply concerned that the Directive contains certain articles which would be unacceptable to a great many church members, and we believe, to many people across Europe. In 1996, we saw this as a symptom of an emerging gulf between public values in Europe and the driving forces biotechnology. We have warned of the consequences if crucial public value questions continued to be dismissed primarily because they impeded commercial goals. In 1998 Commissioner Monti exemplified this approach in a letter in reply to our concerns in which he said that ethical concerns should not be allowed to “interfere with the patenting process”. The subsequent public opposition over GM food showed that our concerns were more than justified. We note several other examples of a belated official recognition of the validity of the concerns we expressed in 1996-98. These include the declaration of President Clinton and Mr Blair in 2000 which urged against undue commercial control over the human genome, the opposition of the French National Ethics Commission to the patenting of human genes, and the opposition or delay to implementing Directive 98/44/EC by several member states.
Particular Comments on the Patenting of Human Cells
Against this background, we are therefore anxious that similar mistakes are not now made over patenting in connection with the exciting developments which are emerging in research with human stem cells, and regarding the potentially very wide ranging applications these may offer for the treatment of serious human diseases. In such an important new area of medicine the desires of those organisations who wish to exploit these developments commercially must not take automatic precedence over wider social concerns.
We are aware that the a US patent has been granted on “cells which come from the early human embryo and are pluripotent”, which in effect means that in the USA all human embryonic stem cells (ES cells) are now subject to a monopoly of one company. It is most important that such a patent on human stem cells should not be granted in Europe. We give the following reasons.
1. To grant a patent on any human body cells seems to us to be a violation of ethical norms, in that cells of the human body are common heritage of all people. This applies both the stem cells and to particular types of differentiated cells generated by applying chemical factors to stem cell cultures. All such cells should not be subject to any form of commercial property rights. This would also violate Article 21 of the Council of Europe’s Bioethics Convention, “The human body and its parts shall not, as such, give rise to financial gain.”
2. All such cells are discoveries and not inventions. They have merely been isolated from an embryo or adult tissue, or allowed to differentiate from the resulting stem cells. They are in no sense a human invention. They should therefore not be granted a European patent.
3. According to leading experts in the field, the isolation of human ES cells was not in any case novel, because a similar experimental protocol is used that had been used to isolate mouse ES cells in 1981. Any small differences would be obvious to anyone “skilled in the art”.
Most fundamentally, human stem cells and the body cells derived from them represent an example of something which should be now added to the exclusions under Article 6 of Directive 98/44/EC. The potential for treatments is extremely wide, constituting an entire new area of medicine. We and others consider that it would be contrary to the concept of ordre publique to give anyone a broad monopoly over what may prove to be an entirely new way of treating a wide range of otherwise incurable human diseases. It would not be in the public good for anyone organisation to have control over the use of the basic techniques to provide replacement cells. This is information which should properly be for anyone to access, use and develop therapies from. This is consistent with Article 3 of the Council of Europe Bioethics Convention, “Parties ... shall take appropriate measures to providing equitable access to health care of appropriate quality.” We note that the ethical advisory committee of Geron Corporation have stressed the importance of making the results of stem cell technology available to the widest range of sufferers and not merely the richest patients. To allow patents on this technology would in our view prejudice the equitable access of European citizens to the wide range of potential therapies which this research may enable.
4. A number of studies have shown the deterrent effect on research which was caused by granting very broad patents at the early stages in the development of some otherwise promising new areas of biotechnology. Stem cells represent an area where the maximum encouragement should be given. It might be valid to grant a narrow patent on a method to induce stem cells to become particular types of differentiated cell, provided this applied strictly to that method only, and did not amount to a patent on all means to produce that type of cell.
On behalf of the…
Working Group on Bioethics and Biotechnology
Conference of European Churches Commission for Church and Society
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The Church and Society Commission of the Conference of European Churches is the result of the merger of CEC’s work on church and issues and the European Ecumenical Commission for Church and Society (EECCS), which was completed on 1 January 1999. Its tasks are to help the churches study church and society questions from a theological social ethical perspective, especially those with a dimension; to represent the member of CEC in their relations with political institutions working in Europe.