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A Presentation to Members of the European Parliamentfrom theEuropean Ecumenical Commission for Church and SocietyStrasbourg, 12 March 1997 |
We welcome this opportunity to present the views on the draft EC Patenting Directive from a group of national European Protestant churches to your attention. As you may know, we made a Detailed Submission to the EP and EC on 17 October 1996. After this some people misunderstood what we were saying, so we wrote a note of Clarification Statement on November 1996. We have presented our views to Dominique Vandergheynst of DGXV, author of the draft Directive and Jose Elizalde of ESLA department of DGXII, and we welcome this chance to discuss with MEP's why the churches are concerned about certain parts of the Directive and what we would like you as MEP's to do about it.
This submission comes from a working group of experts - a mixture of scientists, ethicists and theologians - of the European Ecumenical Commission for Church and Society (EECCS) on Bioethics, representing the Protestant, Anglican and some Orthodox churches and ecumenical associations in Europe from all the member states of then EU, and we also include a Roman Catholic representative. While we are not presenting a magisterial view, we believe the views we express to you today reflect those of a large number of people in our member churches, and constitute the most widely representative church group who has presented views to the Parliament on this subject.
From the point of view of democracy, we are the spokespeople a constituency of people numbering many millions. The churches are perhaps indeed the largest single identifiable grouping of ordinary voters in Europe, and perhaps the most directly in touch with grassroots opinion of ordinary people. No European survey has ever been done on public attitudes to patenting, but we would dare to suggest that we are the nearest thing you are likely to hear to a voice of the broad view of the people of Europe.
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We ask: Is simply extending the patenting system to include animate matter the most appropriate means of addressing intellectual property rights in this area?
We disagree with "industry" perspectives 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. This is prophecy not a fact, and we have little evidence that it is true. When the Parliament rejected the previous directive, the general opinion expressed in the scientific press in the UK was that it would have no effect one way or the other on the biotechnology industry.
The Directive gives the impression that patenting is a wonderful mechanism indispensible for economic growth. We think this is exaggerated. We now from our experience, that the patenting process is not always so effective for everytone in biotechnology. It can discriminate against smaller organisations.
The Parliament should not feel under pressure that it has to accept this Directive in its present form on the basis of an exaggeration on the part of the Biotechnology industry.
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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 a right to manufacture, but only to prevent others from marketing theinvention as if it was their own. Patent lawyers are not equipped in this area, and not sufficiently accountable to the public for their decisions.
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. A licence from such a body must be made a precondition for granting a patent on the invention.
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 ostensibly on its behalf, as the recent Roslin cloning discovery has made very clear.
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This stands against the ethical notion the intellectual property of living things, if it exists at all, is something common to all humanity, or to God. They are living creatures over which human beings cannot claim invention, God's creation and the natural result of evolution. It is not necessary to patent the animal or plant. It is sufficient to patent the novel genetic sequence or gene construct used in a transgenic animal.
To patent an animal would represent one step too far in treating our fellow creatures as though they are essentially commodities. In the light of the numerous abuses of animals as a result of commercial pressure, we need such a limitation on patenting, to remind ourselves that while we use animals as commodities they are still creatures.
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We would therefore object to a patent on a genetic sequence in itself, covering all and any applications of it. It is part of the inheritance of all people, not the exclusive right of any. 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. To many people, copying a piece of genetic material does not lose the identity with where it came from.
Such an all-embracing patent would hinder the progress of medical research and human benefits, since no other company would be likely to invest in research whose products another company would claim as its exclusive right. It is, quite simply, commercial greed.
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There is serious ambiguity in the wording of Article 3 paragraph 2, and of paragraph 48 of the preamble to the Directive. It is not clear whether these assert that the knowledge of the genetic sequence itself (without any stated practical application) is patentable, or whether only the application of the known sequence to a specific technical problem is patentable. This must be made absolutely clear.
If it is the former - the patenting of human genetic sequences in themselves - then we and many others are opposed to it on ethical principle. If it is the latter - the patenting of the specific and narrowly defined application of a sequence, for example, as a means to produce a new therapeutic drug - we would have no objection in principle, and would support this part of the Directive. We note that the final sentence of the view of Dietmar Mieth, regarding section 2.5 of the opinion of the EC's Group of Advisors on Bioethics, is close to our position on this point.
We do not claim to be patent experts, but it appears that the objectives of promoting active and innovative European research into beneficial and ethical genetic applications could be achieved by patenting only the specific application of the sequence. There is no need to patent sections of the human genome or their so-called copy genes as such. In this way much of the present opposition to the Directive could be removed.
The industry argument that process patents are harder to defend than process patents is not sufficient. If company A has a process patent, and company B makes a small change to the process and claims originality, then company A has a strong case that it was "obvious to one skilled in the art". If the change is inventive and not obvious, then company A has no grounds to object. So the industry claim is not a matter of justice but convenience, which is not a sufficient cause to violate an ethical principle held by many people of Europe.
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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European Churches' Submissions 1996-98
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Patenting Life?
... Home Page on Patenting Living Organisms, with a short simple introduction to the issues involved.
Church of Scotland Report on Patenting Living Organisms
... The SRT Project's Report to Church of Scotland's Assembly, to be debated on 22 May 1997, containing the main substance of a formal submission to the European Commission and European Parliament on this issue
SRT Pages on Genetic Engineering and Cloning
This page has been produced by the Society Religion and Technology Project of the Church of Scotland. For more about our work on other issues, see our Other SRT Project pages, or our SRT Publications List, or our On-line SRT Newsletter.
We'd also welcome any comments you may have. We don't claim to have said the last word!
If you want to send us a comment or obtain further information or receive our latest Newsletter,
email us at :
mailto:srtp@srtp.org.uk
or send an ordinary letter or fax to :
Dr.Donald M.Bruce,
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This page was last revised on 26 April 2002
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