Submission to the European Parliament on the "Common Position"
of the draft Directive on the Patenting of Biotechnological Inventions

from the European Ecumenical Commission for Church and Society

Preamble and Summary

We are a working group on bioethics of the European Ecumenical Commission for Church and Society. It is a multi-disciplinary group of experts from a number of Protestant, Anglican and Orthodox national churches and councils of churches in Europe. The expertise of our group is in genetics, biochemistry, ethics, theology and law. In October 1996, we made a critical submission to the European Commission and the Parliament on the text of the December 1995 draft EC Directive on biotechnology patenting. The churches' position aroused considerable comment among both MEP's and the various sides in the debate. This led us to make a clarification statement in November 1996. We then had a meeting in December 1996 with officials of DGXV, and DGXII. We then presented our views to a group of MEP's in Strasbourg on 12 March 1997. It was clear that the MEP's who attended much appreciated our independent critique. We have been following closely the subsequent progress of the directive through the Parliament in July, the Commission's amendments of 20 August [COM(97) 446 (final)] and now the Council of Ministers Common Position of 23 February 1998 [CODEC 667].

As members of an official working group drawn from various churches across Europe, we are still deeply dissatisfied with the state of the Directive that has emerged from these negotiations so far. In the changes proposed by the Parliament in July, several of our most basic objections were not satisfied. The European Parliament passed some positive amendments, especially regarding an ethics committee, and consent and export procedures, but we are disturbed to see that the changes since made by the Commission and the Council have in a large measure negated several of these.

In summary our main concerns are as follows:

• that we have still not seen a proper basis given for the key ethical judgements which are implicit in the Directive, beyond merely commercial arguments which are not adequate,
  
• that there has been minimal consultation with the general public, and that significant numbers of ordinary people would probably have serious reservations about certain parts of the Directive,
  
• that we are very deeply concerned about the new, permissive wording of Article 3 of the Common Position, which explicitly sets out the principle that anything biological can be patented, with certain exceptions, thereby negating the basic distinction between discovery and invention,
  
• that the Directive continues to allow the patentability of animals and plants,
  
• that wording of Article 5 still does not make clear enough to us that the Directive considers that the patenting genetic sequences of human origin in themselves is not to be allowed,
  
• that the argument for the patenting of copy genes continues to be used to attempt to justify the patentability of human genetic sequences, despite the fact that it has been widely challenged as unsafe in both the scientific and ethical communities,
  
• the need to reinstate a clause about the proportionality of animal suffering and human benefit (Article 6.2(d)),
  
• the very important need to set up a separate ethics committee to assess the more important patent applications, since it is absolutely clear that the European Group on Ethics in Sciences and New Technologies cannot fulfil such a function (Article 7),
  
• to consider whether the legitimate concerns of the European Parliament which were expressed in its amendment 76 (regarding material of foreign and of human origin) are satisfied by its relegation to a recital in the Common Position.

Our Main Concerns

We remain deeply concerned that, as it presently stands, the Directive contains clauses whose wording would be unacceptable to a great many of our church members, and thus we believe to many ordinary people across Europe. We are also concerned that, despite the controversy raised over many years on the Directive, no serious steps have been taken to test out public opinion across Europe on the crucial value questions which, as many authorities have pointed out, are raised by the patenting of living organisms and biological material. As a result a serious gap is emerging in the level of public accountability of commercialisable inventions in biotechnology. Moreover, we have still not seen any adequate justification for key ethical judgments made in the Directive which on the one hand blur the distinction between discoveries and inventions, and life and non-life, and on the other make explicit distinctions among different life forms, and between genetic material and human body parts.

We wish to reiterate that the members of EECCS are not against biotechnology as such, nor its use in medicine and agriculture. We do not align ourselves with some in the "green lobby" who are opposed to most of such developments, nor with the biotechnology industry as such. We support certain genetic applications, while being critical of other ones. The churches are not opposed to the patenting of certain types of biotechnological inventions, but these would need to be in much narrower categories than those set out in the current version of the Directive. As it stands, the scope of what the Directive regards as patentable is far too broad, and as such would violate some basic ethical values of Christians and also of many ordinary people outside the churches. We strongly ask you as our parliamentary representatives to reconsider the position in the following areas.

1. New doubts over the need for biotechnology patents to advance medical treatments

   We are deeply sympathetic to the concerns of support groups for those with genetic diseases. One of our group has a major genetic disease in his immediate family. We are, however, concerned that in some cases these patients' groups have been misled into too facile an acceptance of the bioindustry claims that only the strongest and widest of patents can realise their hopes for cures. We have found such claims to be exaggerated. Parliamentarians, who have very naturally been moved by arguments made apparently on behalf of sufferers from genetic diseases, should also be aware that several major patients' groups have now distanced themselves from the main position of the biotechnology industry. There seems to be growing evidence that the commercial desire to maximise patent protection can conflict with human welfare and medicine, quite apart from the ethical concerns it violates.

   We are also deeply anxious that those in industry who have vested commercial or political interests in the technologies may be raising unrealistic hopes about the potential for genetic therapies. In the opinion of world-leading gene therapy researchers in Edinburgh, cures would only very rarely be a realistic prospect for the foreseeable future. It has seemed to us, as independent observers, that claims from the biotechnology industry have often been exaggerated, which is itself a matter of concern in what should be a debate over the public good.

2. Unjustified ethical assumptions are made in the Directive, conflicting with public values.

   It has been frequently maintained that the Directive is only concerned with harmonising what is already common practice in patent law adjudications, and so raises nothing new. We think this is a misleading assertion. Patent case law judgements have largely been made far from most public involvement or even awareness. The Directive would enshrine in European law things which a great many of its citizens have not been consulted on and probably would not agree to, if they knew about them. The churches' membership is a wide cross section of ordinary European people, and our contact with our members leads us to believe that the Directive's assumptions about the patentability of sections of the human genome, transgenic animals and plants, as well as of certain types of discoveries, would run contrary to the values of a great many ordinary people in Europe. We know that these questions have never been tested in a major European public opinion survey. There is an urgent need for the Directive's assumptions to be tested on the European public by a properly conducted and impartial survey.

3. In Article 3, the amended Directive breaches the normal distinction between living creatures and non-living things.

   This new article brought in by the Commission in August 1997, and confirmed by the Council, goes much further than any previous draft in its permissive stance towards biological material. Taken together, the current wording of Articles 3.1 and 3.2 set out the overall principle of the draft Directive that anything biological is in principle patentable, with certain exceptions. We note that the Explanatory Memorandum to the original 1995 draft Directive, highlighted the need to answer the question "How should animate material be treated compared with inanimate material?" (* see note 1) The answer now appears to be that such a distinction is seen as essentially irrelevant to a patent.

   This is deeply unacceptable for a number of reasons. Most basically, it runs contrary to the clear distinction in almost every ethical system relevant to Europe between living organisms and non-living things, and between discoveries in nature and products of human invention. The Article declares that the functional importance of the industrial application of biological material takes precedence over, and indeed loses sight of, the fact that it is different from inanimate matter. This is to set the demands of commerce over respect for creation.

   In our previous submission we pointed out that the simple extension of the system of patenting from mechanical and chemical systems to living matter has already led to an inappropriate application by patent authorities of precedents based on what is permissible for chemicals to living material. (* see note 2) According to most ethical systems, the primary relationship for animate matter (like a living organism or genetic sequence) is that which links it to what is living, not what links it to its chemical composition or to a purely functional view of its industrial utility. The relationship with life should thus take precedence over its commercial value. The Directive would now reverse that priority, setting the commercial potential of biological material as the decisive ethical criterion. This is simply unacceptable.

   Secondly, it represents a perpetuation of the mistaken attitude of seeing nature primarily as a commercial resource, which has wrought so many environmental and other problems. The need for the Directive to maintain the distinction between life and non-life is not merely an idealistic view but has some important practical ramifications. Under competitive commercial pressure, the tendency to sail as close as possible to the wind of what is permissible in law has led to living things being treated in an instrumental way, as though they were little more than means towards ends. For example, despite numerous regulations, we can point to many animal welfare abuses which have resulted from an unconsidered application of the industrial reasoning to agriculture.

   To Christians, as well as those of other religious traditions, living creatures and the biological material derived from them are owed a duty of respect as those who share with humans God's gift of life. The Article and its corresponding recital should therefore be amended to make clear that, notwithstanding the commercial or human benefits which may legitimately be derived from biological material, this basic distinction must continue to be respected explicitly. The basic approach of the Directive Article 3 to the patenting of biological material is "Yes, provided". It should be "No, unless".

4. Article 3.2 would blur, or even remove, the distinction between a discovery in nature and the product of human invention.

   Here is our most central concern. The implication of Article 3.2 is that as soon as human technique could synthesise the same entity as a natural product or organism, the natural form of the product itself would be considered as a human invention also. As it stands, this article would have the effect of ending the concept of a discovery of nature. This would be in contradiction to recital 34 of the Common Position which affirms the distinction between discovery and invention. The wording of Article 3.2 is in this sense at odds with the basic philosophy of patent law.

   We urge MEPs to press for an amendment to the wording to make clear that the scope of a patent on a natural biological product made by a technical route applies only to the product made by that route, and could never extend to the product in itself. This must not remain ambiguous.

5. Article 4 is unacceptable in allowing for the patenting of living organisms in themselves.

   Neither the Parliament's nor any subsequent amendments have done anything to address our profound objection to living organisms being patentable in themselves. We believe that these are ultimately as much God's creation and products of nature as we are ourselves, and are therefore beyond any claim to be human inventions. Adequate protection of the intellectual property for transgenic animals and plants could in our view be achieved by patenting the novel genetic construct (ref 3), that had never existed before in nature. There would be no need to resort to the indignity of claiming to have invented an entire animal or plant simply by virtue of changing one or two of its genes. The scope of this article should therefore be reduced so that it allows only the patentability of novel genetic constructs.

6. The Copy Gene Argument (Article 5.2) is unsafe and should be removed.

   As we have argued in our previous submissions, it has become clear that the so called "copy gene" argument, as laid out in article 5.2 and in the relevant recitals of the Directive, is regarded as unsafe and unproved by many in the scientific and genetic research communities. Many who are in a good position to know, including the geneticists in our own group, regard the argument as illogical and unfounded. Since there is clearly no scientific consensus on its validity, we are disturbed to see the Directive continuing to cite the copy gene argument. The article 5.2 should be deleted as unnecessary.

7. Clarification is needed of Article 5.3 regarding Patenting Human Genome Sequences.

   Although some progress appears to have been made, the overall wording of Article 5 and its recitals remain ambiguous in respect of material of human origin. We still require the clarification which we asked for in our earlier submission, as to whether patentability is restricted to a particular and specified application of a genetic sequence, or could extend to all applications of the sequence. If it is the former, we would have no objection. If it is the latter, we would be fundamentally opposed, as explained in more detail in our previous submission. Article 5.3 might have satisfied the churches if it meant that the resulting patent only applied to the specified uses of the gene, and not to all potential uses of the gene. If it means, on the other hand, that a patent on gene A specifying purpose X also gives the patent holder protection for each and any other use of gene A, including uses of which the inventors had not thought, the churches would be opposed to this. We are not clear which of these is the case. We have asked the views of several patent experts and they disagree on which would be the case. There is an urgent need for the Directive to make this point clear.

   We are concerned that the breadth of such a patent can discourage the very investment in genetic research that the publication of a patent is meant to encourage. By the biotechnology industry's own logic, unless a company can hope to obtain a patent people will not invest in research. So if one company holds an essentially all-embracing patent regarding a genetic sequence, a second company will think twice before starting a long and expensive research programme into another fruitful application, because they are not confident they would win a patent on it. They would be deterred by the risk that the first company would claim that it infringed their existing patent rights, even though their patent had never envisaged the second company's application. This is especially the case if the second company were small and lacked the financial resources to risk a lengthy court battle. If the patent coverage were more narrowly conceived such a situation would arise less often, and more genetic developments would be possible than in some of the sweeping patent claims that have been made hitherto.

8. Article 6.2(d) should have the clause of proportionality reintroduced.

   It is not sufficient to identify "substantial medical benefit" if it causes gross suffering to the animal. We were deeply concerned that the Parliament did not pass the amendment in which the notion of proportionality of suffering was specified. This is unsound logic. In general, where there are two competing ethical principles, as in this case, it is not sufficient simply to cite the magnitude of one in order to claim precedence for it, if the magnitude of the other is also great. It also does not agree with other legislation in the area, in which proportionality is the key. Merely pointing to the human benefit is not enough to protect the animal : it has to be in proportion.

9. The exceptions listed in Article 6.2 are piecemeal and bear no relation to the much longer list of ethically controversial applications of biotechnology.

   We pointed out in our previous submission that the patenting process is not the place where the ethical acceptability or otherwise of biotechnological inventions should be decided. It is therefore of concern to see on the one hand a very partial list of exclusions in article 6.2 - why is there no exclusion for routine animal cloning, for example? - and, on the other, a completely inadequate provision for external ethical assessment in Article 7.

10. The Commission's amendment of Article 7 fails completely to address the Parliament's requirement for a committee to assess ethical aspects of patents.

    We welcomed the Parliament's proposal (amendment 78) for a committee to "assess all ethical aspects of biotechnology and its utilisation, in particular with regard to patents." This seemed a good step towards meeting one of the main concerns of our original submission - to have an independent process of ethical assessment of patent applications, to run in parallel with the patent process itself. It is of the utmost concern that the Commission and Council have removed the force and purpose of the Parliament's amendment by merely referring to what is now the EC's European Group on Ethics in Science and New Technologies. This will not suffice.

    The claim of Article 7 that this group "evaluates all ethical aspects of biotechnology" is false and misleading. The method of working and terms of reference of the group make it plain that it can only tackle a very limited number of very general issues. Indeed, with the much broader remit since 1 January 1998, there will be even less opportunity to assess "aspects of biotechnology". It is thus very clear that this group cannot hope to assess the ethical aspects even of the more ethically controversial patent applications. Thus the status quo will remain, in which there is no adequate system to determine whether or not a biotechnological invention for which a European patent has been applied is itself ethically acceptable. As we have repeatedly pointed out, the failure of existing system is the primary reason why patents have become the focus of so much ethical concern. It will also remain the case that a European patent could be refused on ethical grounds, but no powers exist to prevent the unethical invention being marketed across Europe.

    We therefore urge the Parliament to reinstate and strengthen its original proposal, to require a new body to be set up specifically to deal with the ethical aspects of the particular inventions about which patents have been applied for. What is currently proposed in Article 7 will not achieve this urgent need.

11. Consideration should be given to the reinstatement of the Parliament's amendment 76 of July 1997 (its Article 8a).

    The European Parliament's condition of due consent, in respect of material obtained from human subjects or from Third World countries, expressed a bare minimum of justice. We are profoundly concerned at the removal of article 8a, first by the Commission and then by the Council. The reason seems inadequate. If other treaties make the Parliament's wording inappropriate, the correct solution is surely for the Directive to include an Article comprising words that cover the situation, rather than simply to relegate this matter to recital 56, with only a watching brief on such questions. We would call for the reinstatement of this article in a suitably modified form.

The Need for a Proper Level of Public Debate

It is clear that the underlying assumptions of this Directive concern issues of great public concern, but that the public has little knowledge that such proposals are being made on its behalf. There is a serious deficit of unbiassed and straightforward information on the ethics of biotechnology in general and patenting in particular. We call for a major European programme to provide such information, mediated in an non-directive fashion, and not merely seen as presented through the perspectives of industrial, political or environmental lobbies.

28 March 1998

Notes

1. Para 3 of the Explanatory Memorandum to Proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions, COM (95) 661, 13 December 1995.
   
2. The fact that certain natural chemicals may be patented is not in itself a sufficient justification for patenting biological material.
   
3. By "novel genetic construct", we understand the combination of a gene or genes, a vector and any other necessary genetic elements produced in vitro, for the purpose of genetically modifying the target organism.