EECCS Bioethics Working Group

Who we are and whom we represent

We welcome the opportunity to present the comments on the draft EC Patenting Directive from a working group of the European Ecumenical Commission for Church and Society (EECCS) on bioethics. The group consists of specialists drawn from European Protestant churches and ecumenical associations in France, Germany, Italy, the Netherlands, the Nordic Council of Churches, Switzerland and the UK. EECCS is the body which enables Protestant, Anglican and some Orthodox churches in the EU member states and other European countries to relate to the institutions of the European Union and the Council of Europe.

Patenting is an unusually complex subject, even amongst bioethical issues. We do not approach these questions as experts in patent law, but as well informed Christians working in fields directly impinging on the issues. The range of our expertise includes biochemistry, chemistry, genetics, law, medical and technological ethics, and practical theology. Our group is united in a deep concern about the serious underlying implications of the present Directive, were it to be accepted in its present form by the European Parliament. Although varied viewpoints may exist among individual Christians, and possibly those churches who express a view on this issue, we believe the views expressed in this submission reflect those of a large number of people in our member churches, and that these views are also widely shared across our European society.

Our broad concerns.

Although we acknowledge the ethical significance of the notion of intellectual property in general and would have no objection, for example, to the patenting of a process for performing a particular genetic modification, we find the draft Directive to be fundamentally flawed and needing major changes before it should be accepted by the Parliament. The narrowly economic context in which the question of the patenting of biological material is presented fails to take regard for the many wider aspects of this issue for the whole people of Europe, and views it primarily in terms of the view of industry. It fails to give serious consideration to the many ethical issues which are inherent to the issue, and which underlay the Parliament's rejection of the previous version. Some articles are ethically unacceptable and, in parts, false logic is used in support.

We object to the patenting of living organisms, to the patenting of human genetic material of any sort, and to non-human genetic material which has not undergone a major change by inventive means.

The way in which we, as human beings, classify things also affects the way we treat them. Patenting makes an implied statement about the fundamental relationship between humans and nature. Simply extending the rules for inorganic materials to the biological sphere can encourage inappropriate attitudes to nature. We suggest that consideration should be given to developing an alternative form of intellectual property for biological material, free from the assumptions and associations of a system designed originally for mechanical inventions, and which explicitely recognises that "inventions" affecting living things are in a different category from all other activities and products of industry and commerce.

Our specific concerns

1. The context in which patenting is presented in the draft Directive does not properly reflect the range and complexity of the issues involved, but sees all in a narrow economic light, marginalising many important factors for European society.

2. Once the scope of patenting is extended to biological systems the ethical dimension becomes a central issue and no longer something peripheral. The failure of the draft Directive to lay down its ethical presuppositions and to discuss substantially the ethical objections expressed in this area means that it fails to be a suitable basis for legislation on such sensitive issues as these.

3. There is an ethical basis for the general notion of patenting, but this does not imply that every aspect or application of patenting is ethically acceptable.

4. The process to produce the genetically modified organism could be patentable Art. 5, 6.

5. Animate material presents a radical discontinuity from mechanical and chemical inventions, which requires a different way of thinking about intellectual property. Merely to "extend" patents to include animate material has approached the question in the wrong way.

6. Living organisms of any kind should not be patentable.

7. Patenting any part of the human genome is ethically abhorrent, in principle.

8. "Copy genes" should not be patentable.

   i. The argument that copy genes lose their original "identity" by being cloned is false because the same information is conveyed by the copy genes as the original gene.

   ii. No inventive step is involved in obtaining copy genes.

9. The use of the formula "a technical solution to a technical problem" to override the exclusion that elements of the human body are unpatentable is illogical and contrary to normal ethical understanding of the sanctity of the human body and its parts.

10. Exceptions to Patentability do not go far enough.

11. A new system of intellectual property rights should be considered for animate matter.

12. The need for a proper forum for public objection or approval on ethical matters in biotechnology, in order to be accountable to the people of Europe.

13. Ownership and the Third World.

14. Appendix - Exaggerated claims made for the patenting process.

The substance of our submission ⁽²⁾

1. The context in which patenting is presented in the draft Directive does not properly reflect the range and complexity of the issues involved, but sees all in a narrow economic light, marginalising many important factors for European society.

   We are deeply concerned that the dominant context in which the question of patenting of animate material is presented in this draft Directive ⁽³⁾ is the role of biotechnology in promoting economic growth, without reference to the many other social, environmental, moral and religious factors which biotechnological developments are widely expected to have for the people of Europe. The tone of what follows in articles of the draft Directive is determined by the emphasis that the EC sets economic growth as the primary social criterion for biotechnological innovation in para 24. This allows no place for other criteria - such as human welfare, animal welfare, care for creation, safety, concern for poverty and disease in the developing world, removing injustice from society, or the quality of life generally. Inventions are apparently viewed primarily with their value as economic entities, not whether they are worthwhile in themselves, nor whether their impact on society is desirable. Patenting is thus already framed as nothing more than a technical means towards a solely economic end. This industrial and commercial perspective dominates issues which have profound moral and ethical implications, in a way quite unacceptable to the churches. From this fundamentally misplaced context, much wrong thinking then follows in the draft Directive.

2. Once the scope of patenting is extended to biological systems the ethical dimension becomes a central issue and no longer something peripheral. The failure of the draft Directive to lay down its ethical presuppositions and to discuss substantially the ethical objections expressed in this area means that it fails to be a suitable basis for legislation on such sensitive issues as these.

   We are disturbed at the draft Directive's failure to address adequately the basic ethical concerns which underlay the European Parliament's rejection of the previous one - concerning in particular the patenting of living organisms and of genetic sequences. By focusing its attention on a "technical fix" through legal wording, instead of addressing properly these concerns, it seems that the EC have not learned the lesson of 1 March 1995. Where we would have expected a serious attempt to understand and discuss the ethical and moral dimension which was expressed in that rejection, we have instead legal formulae, and little else. Consequently, this new draft Directive deserves to fare no better than its predecessor, as it has not addressed the essential questions the people of Europe are asking in this area.

   Sociologists and ethicists have long pointed out that all technological activities including patenting involve the ethical and moral dimension. It might be argued that such issues tended to be on the periphery of patenting while its scope was restricted to inanimate objects and processes. As soon as biotechnological inventions and living organisms are brought into consideration, the whole situation changes, and the ethical dimension becomes just as central and integral to the patent as concepts of novelty or usefulness. This is a matter of plain common sense. It is futile to argue, as some have, that patenting should not involve ethics; it cannot avoid doing so where living material is involved.

   In para 13, the Commission appears superficially to agree with this view when it states: "The most important thing is to assess the ethical dimension of certain biotechnological inventions, which, unless otherwise clarified by the legislature, could turn out to be a Pandora's box from which emotive issues are constantly likely to emerge." On closer examination, however, these words appear to be rhetoric without substance, since the draft Directive makes no serious attempt "to assess the ethical dimension". It is largely ignored. The present draft Directive has left hidden under legal terminology what, by the Commission's own admission, is essential to be assessed. Before the draft Directive can be accepted, its preamble must make transparent the ethical presuppositions which it relies on, and as a matter of democracy, must offer these also to the Parliament for open debate.

   [We find the association of the "ethical dimension" with "emotive issues" most disturbing in its somewhat dismissive tone. This seems to take no account of contemporary understandings of different forms of rationality. It is as though firstly ethical concerns are mostly emotive interruptions to economic growth, and are not rightly raising matters of profound human concern, and secondly that legislation will somehow "put the lid on" all this emotion. From Max Weber onwards, sociologists have pointed out that the supposed distinction between rational and irrational, scientific and non-scientific, is far from clearcut, with much logic on the side of the non-scientific views and many hidden value judgments on the so-called rational scientific approach. Because of the strong positive associations of "reason" in European thinking, the idea of irrationality or emotion has become used as a means of trying to gain power and influence by labelling one's own view "rational" and opposing views as "irrational". We have seen numerous examples where industrialists, scientists and others have sought to do this in the ethical debates about biotechnology.]

3. There is an ethical basis for the general notion of patenting, but this does not imply that every aspect or application of patenting is ethically acceptable.

   Christian teaching acknowledges the tendency in human nature towards the unjust exploitation of others. This would include using inventions of other people and claiming them as if they were one's own. There is thus, in general, a moral case for patenting in order that a person or organisation can protect its investment in research against such an injustice. This does not, however, mean that everything and anything may be patented. There are other ethical criteria which restrict what may be patented, quite apart from the legal limitations of what is an invention, novelty, application, etc.

4. The process to produce the genetically modified organism could be patentable. (Art. 5,6)

   We would draw attention to a distinction between the notion of patenting:

   • a whole organism, such as a sheep, which had undergone a genetic modification,

   • the novel gene construct, such as would be made by inserting a human gene into a sheep,

   • the process by which the genetic modification was achieved.

   Patenting the third category - that of a biotechnological process - raises no intrinsic ethical problem for us. As discussed later, however, it might be better to remove it from the sphere of patenting, to become part of a special, separate system which needs to be developed for biological material as a whole. Our objections are to the first category - the idea of patenting the whole organism - and to the second category - that of gene themselves.

5. Animate material presents a radical discontinuity from mechanical and chemical inventions, which requires a different way of thinking about intellectual property. Merely to "extend" patents to include animate material has approached the question in the wrong way.

   This draft Directive takes entirely the wrong approach in asking only how patent law can be extended to animate material, without first asking the basic question of whether it is right to do so. It is necessary instead to go back to first principles and ask what system of property rights would best serve the case of biotechnology, given that living organisms are involved, which have a different moral and ethical status to objects, machines and chemical processes. The failure to do so is at the root of most of the controversies involved with the draft Directive, and could have been avoided and a lot of the EC's time, effort and expense spared if the right question had been asked at the start.

6. Living organisms of any kind should not be patentable.

   Implicit in the above assumption of the draft Directive is that living organisms can be regarded as an extension of inanimate objects, such as chemicals or chemical processes. The draft Directive has focused primarily on the ways in which living organisms are like things, rather than their special characteristics as life. This is one of the crucial ethical assumptions which should have been spelt out in the preamble to the draft Directive. We are used to distinguishing the categories of "people" and "things", and our legislation regarding them differs fundamentally as a result. Living organisms do not fit either category, however. Patent law addressed intellectual property in relation to things; simply to extend it to living organisms automatically evaluates them in the category of "thing".

   According to Christian ethics, and many other ethical systems which draw a distinction between animate and inanimate matter, this is morally wrong. A special respect is due to any living creature, because it is ultimately a creation of God, with its own life. Boundaries need to be drawn to make this distinction clear, to avoid reducing life conceptually to being merely an economic commodity, and then treating it as such. Living organisms have an inherent significance which sets them apart as "products of nature" from all "products of industry".

   We deplore the implications of the various US court decisions regarding patenting of living organisms that have led to the notion that animals, plants and living organisms generally are now thought of as nothing more than "products of industry", having no more status than a mechanical part of a machine. This represents an unacceptable paradigm shift in how life forms are regarded, with respect to patenting. ⁽⁴⁾ This view sees nature entirely in anthropocentric terms of its utility to humans, as tools and products, and has lost the sense of respect for animal or plant as of value in itself. This perception runs contrary to Christian understanding that all of creation owes its existence to God, and its significance is first of all what it is before God, irrespective of any use to which human beings might think of putting it. This seriously limits what human beings may legitimately do to other living creatures, because they are God's first, and not ours to do exactly what we like with. This is not simply a matter of "sentience", although the actual harm done to an animal is of course a matter of great importance, but a matter of status.

   We conclude that living organisms themselves should not be patentable, whether genetically modified or not. It is wrong in principle. An animal, plant or micro-organism owes its creation ultimately to God, not human endeavour. It cannot be interpreted as an invention or a process, in the normal sense of either word. In genetic engineering, moreover, only a tiny fraction of the makeup of the organism can be said to be a product of the scientists. Patenting is inappropriate for biological material itself, in recognition of the "differentness" of such material from inanimate objects and processes. We would wish to see a clear distinction between "intellectual property" of a living organism, which has a life of its own, and inanimate matter, which does not. A genetically modified mouse is in a completely different category from a mouse trap.

7. Patenting any part of the human genome is ethically abhorrent, in principle.

   It is our contention that human genes should not be patentable under any circumstances, whether as the genes as naturally occurring in the body, as "copy genes" or as modified sequences or constructs. It is unethical and immoral. It is abhorrent to a Christian understanding of the nature of the human person, of self respect and respect for others, that the information relating to any aspect of the human body should be seen as "intellectual property". If it "belongs" to anyone, it is the individual concerned, or else the common property of all humanity equally. It should never be the exclusive right of any third party. It is of profound concern to the churches that the EC would wish to endorse such a concept.

   Our objections are supported by the terms of the draft Bioethics Convention of the Council of Europe whose purpose is to protect "the dignity and identity of all huamn beings" and guaranteeing "respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine" (Article 1). Moreover, Article 21 states that "the human body and its parts shall not, as such, give rise to financial gain". To apply for a patent implies an intent to seek financial gain from a part of the human body, namely a genetic sequence. Article 3 of the Patenting draft Directive is in direct conflict with this.

8. "Copy genes" should not be patentable.

   i. The argument that copy genes lose their original "identity" by being cloned is false because the same information is transferred irrespective of how many copies are made.

   We do not accept the argument that copy genes lose their original "identity" by being cloned. It is clear that they have the same moral status as the originating gene, because they are carriers of the same information. The reason that the genetic sequence would be utilised in an industrial application would be in virtue of the information which it represented in the organism which it came from. To illustrate this we could cite the example of the production of the transgenic sheep at Roslin in Scotland, in which a gene of human origin is put into a sheep in order to express the human version of the protein alpha-1-anti-trypsin in the milk of the sheep. This protein is chemically slightly different from the alpha-1-anti-trypsin produced naturally by the sheep. It is therefore the instruction which the gene represented in the human body, i.e. to produce that particular human version of the protein, which the researcher would like to reproduce in the sheep. It does not matter how many times the gene was copied, it still delivers this human information. It is therefore not true to claim that a gene, once cloned, loses its connection or identity with the organism which the original gene came from.

   Regardless of the scientific arguments, many people regard a copy gene of human origin as remaining "human" because of the way they understand the notion of identity - that it is primarily to do with connections and relationships, not atomised entities. It is nonsense for an expert committee or an EC Directive to declare that the copy gene is no longer "human", if a significant proportion of the European population consider that it remains human no matter how many times it is cloned. Indeed, the churches and many others are becoming increasingly concerned that developments in biotechnology are making it more and more possible to separate and isolate the functions of living organisms - both human and non-human - from the organism as a whole. This reductionist trend may be a useful scientific tool, but it also carries the danger of losing sight of the connection of all the separated parts with each other and with the whole.

   ii. No inventive step is involved in obtaining copy genes.

   The interpretation of an invention as something that is "both practical and technical" (para 38) means that sections of genome or other genetic material cannot then be inventions. The "technical" step is absent. The process of cloning is part of a standard technique in genetic identification, obvious to anyone "skilled in the art". The copy genes are examined and characterised as though they were the original gene. To promote the idea that the copying process somehow makes the gene novel is both mistaken and disingenuous.

   If a scientist claims to have identified a genetic sequence, what is identified is a discovery and unpatentable. If what was identified is patentable because it is not the same as the genetic sequence in its natural state, then the scientist cannot claim to have identified the natural sequence, but only some derivative of it. The EC's draft patenting Directive wants to have it both ways.

9. The use of the formula "a technical solution to a technical problem" to override the exclusion that elements of the human body are unpatentable is illogical and contrary to normal ethical understanding of the sanctity of the human body and its parts.

   We are deeply disturbed by the ethical implications of para 43, where it asks: "Regardless of whether the limb, organ or bodily fluid concerned ranks as a discovery, the questions arises as to what constitutes the technical solution to a technical problem."

   We regard as contrary to reason and common sense that a natural product, such as a genetic sequence from a human being or other living organism, which is used as a part of some such "technical solution", becomes itself turned into an invention as a result, in order that it could be patented. We would agree that the process, of which the natural product forms a part, could truly be an invention and could therefore be patentable, but not the natural product. This implies to us, and indeed to industry observers also, that the draft Directive primarily wants to find a way in which it can argue that human genetic sequences can be patented.

   We see no essential distinction between patenting a genetic sequence and patenting the human eye or any other element of the human body. It is impossible to isolate any element from the human body without a technical process of some sort. If the eye should not be patented, then neither should a genetic sequence. It seems that the article is trying to make a special distinction for human genetic material which is false.

   We profoundly object to the claim in para 51 that "Elements isolated from the human body by means of a technical process are artificial and thus qualify as inventions, since they are technical solutions invented by man in order to solve technical problems." Simply finding a technical use for that element does not change that element into something "invented by man". There are also serious theological implications, in that human beings are claiming to have invented something that was created by God.

10. Exceptions to patentability do not go far enough.

    While we agree with the exceptions in Article 9, it is clear from our numerous points above that we consider these are insufficient to encompass the types of ethical objections that arise from biotechnology and genetic engineering. The wording of the article leads to the dangerous conclusion that the draft Directive supports Bentham's argument that the only thing to ask about animals is "do they suffer?". In the case of animals, there are many potential uses which are degrading and uncaring, whether or not the animal suffers pain or physical handicap. These should be included in the scope of paragraph 9.

11. New system.

    Consideration should be given to developing an entirely separate intellectual property system for living organisms from patenting, which recognises the fundamental distinction between living creatures and non-living things. In support of this we would also point to the accepted understanding that plant and animal varieties cannot be patented. If this is the case, then it should not be possible to patent genetically modified organisms either. We also note the concept of "farmers privilege" which acknowledges that plants are reproducing organisms, and not merely industrial components. We welcome the draft Directive's intentions to extend this to animal breeding, which is long overdue, bringing animal breeding into line with the existing plant breeding arrangements.

    In para 35 the Commission rightly implies that patenting can only be done within the limits placed on inventions in wider legislation. It is of great concern to the churches, however, that this legal framework only makes reference to the issues of health, safety, environmental and consumer protection. No reference is made to any legal framework by which inventions might be limited on the grounds of morality or ethical acceptability. As the Commission rightly points out, a patent does not confer the right to exploit an invention without restriction, but at the same time, as we have observed above, it is clear that any patenting involving animate material must involve a significant ethical dimension. If a patent is refused on ethical grounds, it is plain nonsense if this does not also automatically result in the prohibition of the applicant, or any other party, from exploiting the invention.

12. The need for a proper forum for public objection or approval on ethical matters in biotechnology, in order to be accountable to the people of Europe.

    The above anomaly highlights a much wider problem of how new biotechnological research and its products are vetted for their ethical and public acceptability. The present system is not accountable enough to the people of Europe. The Commission will be well aware of the suspicion and even opposition to biotechnology amongst a significant number of people in member states. This suspicion has been made worse not only by the current concern over BSE, but also by technological developments in areas such as baby milk products, the transfer of sperm between species, and the cloning of animals. One of the most commonly voiced complaints is that the public have too little prior knowledge of what is going on in biotechnology, especially in the private sector, and too little effective opportunity to comment or to object, prior to any inventions reaching the market. Studies of public opinion are finding a growing and widespread cynicism as a result of feeling disenfranchised from these matters.

    Rapid advances are now being made in biotechnology, both in the health and agricultural sectors, which are raising many ethical and moral issues on areas which the public consider they have the right to debate, well in advance of the development reaching the stage of implementation. One of the reasons that the issue of patenting arouses such controversy and opposition is that it is often the first time that members of the public have heard about the research in question, or have had any opportunity to voice an opinion on it. This means that, de facto, patenting becomes the arena in which the ethical dimension of the research is debated, which is an inadequate state of affairs.

    The EC's Group of Advisors on Bioethics represents only one level of assessment - that of a limited group of experts discussing largely in private. It serves a purpose of advising the Commission, but it does not serve the purpose of public debate and comment. Just as there exists the statutory right of the public to lodge objections to patent applications for biotechnological inventions, there should be an equivalent legal appeal mechanism for the public to object to the implementation of such inventions on ethical grounds. The EC should urgently bring forward legislation to provide a proper mechanism to achieve this, if it is not to be in serious danger of losing the economic benefits it anticipates from biotechnology because the public has turned against it, as has happened to a considerable extent with nuclear power.

13. Ownership and the Third World.

    The draft Directive shows no awareness of the implications of patenting modified plants and plant products for farmers in developing countries. Serious ethical concerns are raised if research organisations and trans-national corporations are granted patents without due recompense to the farming communities from whose lands the plant was taken, for the use of their indigenous knowledge. The breadth of some patents can also put at a disadvantage the very people who need most urgently to gain from the benefits which biotechnology can bring, and widen the gap of rich and poor still further.

8th October 1996

When examined critically, the claims made by industry and the EC for the benefits of the patenting process are found to be exaggerated. It is not true that patenting necessarily "encourages early and beneficial dissemination of knowledge which, without such protection, might be kept secret". ⁽⁵⁾ This is a widespread mythology about patenting, but in practice it is only a half-truth. Patenting can indeed lead to the dissemination of information, but there is also much information which remains secret. Many companies regard some things as too sensitive even for patent protection, and some may be secret "in the national interest". The high cost and lengthy timescale of seeking patent protection can often be a deterrent for research institutes or small and medium enterprises, when compared with a relatively short market advantage. Once a patent application is put into the hands of patent lawyers, the questions asked - for example to widen the application of a viable but narrow patent - inevitably divert a company's effort and personnel, which may set back the company's ongoing research programmes, and lose its competitive edge in the next potential area of discovery. The litigation that can result from rival companies claiming "prior art" can make patenting a doubtful and even more expensive business.

On occasions, patenting is abused by companies as a strategy deliberately to block a competitor from developing potential products in a field which might rival an existing product, but have no intention of ever bringing it to market. In such cases, public knowledge is reduced by patenting.

It is presented as a point of dogma that uncertainty in Europe over patenting is "hampering research investment" ⁽⁶⁾, but evidence shows this to be a dubious claim. The growing stream of developments which are being brought to market from European biotechnology research demonstrates that investment in Europe has not been hanging back for 7 years awaiting a resolution of the uncertainty in the patenting system. Moreover, the failure of the previous EC Directive in 1995 was not apparently greeted by the biotechnology industry with expressions of fear about hampered research.

We note that in areas like medical research, where resources are not unlimited, the competitive element of having many different groups on the same project running to be the "first" may not be the most productive for human good. Significant duplicated resources could be freed for other areas of research. The pressures of a cut-throat competitive culture on scientists have led to serious cases of scientific fraud. ⁽⁷⁾

PLEASE ALSO SEE CLARIFICATION OF NOVEMBER 1996

NOTES

1. A submission to the European Parliament and the European Commission, Strasbourg, Sept. 1996.

2. For reasons of space the Draft Directive itself is not published here, the critique being largely comprehensible on its own.

3. For example paragraphs 2, 19 and 24.

4. Stephen Crespi, Patents in Biotechnology: the Legal Background, Proceedings of an International Conference on Patenting Life Forms in Europe, Brussels, 7-8/2/89, p.7.

5. Paragraph 7 of the Explanatory Memorandum.

6. Paragraph 7 of the Explanatory Memorandum.

7. See for example the articles: A. Coghlan, "Europe kills off patents on life", New Scientist, 11 March 1995, page 7; N.R. Scott-Ram and A.G. Sheard "The Rise and Fall of the EU Patent Directive", Biotechnology 1995, 13, pp. 734-5.