Clarification of the Submission on the EC draft Patenting Directive
from the European Ecumenical Commission for Church and Society
to the European Commission and the European Parliament
From various reactions we have received regarding our Submission on the EC draft Patenting Directive of October 17, it seems that our views have been misunderstood, and perhaps even misrepresented. We therefore make this statement of clarification, to make quite clear on the points of contention what we are saying and what we are not saying.
Who we represent
- It is an informed view from an official working group of scientific, ethical and theological experts, nominated by Councils of Churches and churches which are members of the European Ecumenical Commission for Church and Society. It is thus a representative view, and while it does not claim to be "The Official View" of the Protestant, Anglican and Orthodox churches of Europe, we believe that the opinions expressed would be accepted by a large number of members of our churches.
We are not against Biotechnology and Patenting
- We are not opposed to biotechnology or genetic engineering or medical research. On the contrary, some of our group, which contains two geneticists, a biochemist and a chemist, are or have been researchers in the medical application of genetics.
- We are sympathetic to the concerns of patient support groups, and count among our own families some who have suffered the consequences of genetic disease.
- As Christians, we regard nature as God's creation, but this does not make nature "sacred" or untouchable. On the contrary, God has given us the dual responsibility to develop and also take care of what he has created. But we are stewards and companions to nature, not its owners. Consequently we have no property rights, intellectual or otherwise, over what is merely natural. It is free to all.
- We are not against patenting as a principle, however, for human inventions. Indeed we see that it is ethical - a matter of justice - to provide appropriate protection for the commercial applications of inventiveness and originality in many circumstances. But we have objections, in certain circumstances, regarding patenting living organisms.
Our problems with the Directive
- We approve of the notion of an EC Directive to harmonise the laws of EU member states in the area of patenting. The present draft contains some serious flaws, however. In order to be acceptable, it would need to be amended on a number of significant points laid out in our submission, and also to have addressed a number of issues it fails to address.
- We disagree with "industry" perspectives expressed to us that the failure of the Directive in its present form, or the inability to patent sections of the human genome as such, will inevitably lead to the collapse of the biotechnology industry and of medical research in Europe. We have seen no evidence sufficient to justify this prediction.
Animate matter, the ethical dimension and the patent process
- The extension of the scope of patenting to include "animate material" presents a number of ethical problems, with regard both to material of human origin, and also animals and other living organisms. We note that the opinion of the EC's Group of Advisors on Bioethics (para 2.1) seems to be making a very similar point. If patent law is now to include this area, it is no longer largely a matter of novelty, inventive steps, etc., but it involves ethical questions in a more central role.
- Given that this is the case, we do not see evidence that enough consideration has been given by the EC to the question "Is simply extending the patenting system to include animate matter the most appropriate means of addressing intellectual property rights in this area?" It was not designed with living things in mind. We do not presume expertise to know the answer to this question, but we ask that this it should be considered, and the reasoning and the results of any consideration should be stated.
Need for a public forum to debate the ethical acceptability of biotechnological inventions
- While we consider that the patenting process cannot exclude consideration of the ethical dimension, we note with concern that much of the debate about the ethical acceptability of biotechnological inventions has become focused on the patenting process, because of the absence of suitable European and/or national bodies where this can be given public debate.
- We consider that patenting is not the right forum in which to decide ultimately whether it is ethical acceptable for an invention to be produced and marketed. There are several reasons for this. Patenting does not confer the right to manufacture, but only to prevent others from marketing the invention as if it was their own. Patent lawyers are not normally equipped in this area, and there is not an adequate system of public accountability for such a task.
- We therefore call for an appropriate European body by which the ethical acceptability for the implementation of an invention can be decided, with statutory rights for the public to present their views, and for appeals to be made.
- In the absence of such a body there are at present insufficient means for the people of Europe to weigh up the acceptability of the research being done on its behalf.
The Directive has not adequately addressed the ethical dimension
- Given that the ethical dimension is involved in the patenting process itself, we are concerned that the Directive has not given a proper examination of the ethical dimension of the issues concerned. It also does not make clear what are its own ethical assumptions.
- In particular, by asserting that one may be patentable and the other may not, the Directive seems de facto to have drawn an ethical distinction between genes of human origin and other parts of the human body, which is unacceptable to us. Opinions we have sought show us that both among the general public and within the scientific community, we are by no means alone in finding unconvincing the arguments which the Directive presents - that by copying a piece of genetic material it has lost any identity with where it came from.
Genetic sequences of human origin
- There seems to be ambiguity in the wording of Article 3 para 2, and of paragraph 48 of the preamble. It is not clear to us whether it is asserting the patentability of the knowledge of the genetic sequence itself (without any stated practical application), or only of the application of the known sequence to a specific particular technical problem. The wording seems to be able to be read both ways. If it is the former - the patenting of human genetic sequences in themselves - then we are opposed to it on ethical principle. If it is the latter - the patenting of the specific and narrowly defined application, for example, as a means to produce a new therapeutic drug - we would have no objection in principle. We would object to a patent on the sequence itself, covering all and any applications of it.
- We note that the final sentence of the view of Dietmar Mieth, regarding section 2.5 of the opinion of the Group of Advisors, is close to our position on this point.
- We do not claim to be patent law experts, but it appears that the objectives of promoting and maintaining active and innovative European research into beneficial and ethical genetic applications could be achieved, without the need to patent sections of the human genome or their so-called copy genes as such.
5 November 1996
On behalf of the Working Group on Bioethics and Biotechnology,
European Ecumenical Commission for Church and Society,
8 Rue du Fosse des Treize
F-67000, Strasbourg.
France
Tel. +33 3 88 15 27 60
Fax +33 3 88 15 27 61
eeccs@media-net.fr
http://www.cec-kek.org/English/cs-bioethics.htm
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