Doc. 8738

5 May 2000

Biotechnologies

Report

Committee on Science and Technology

Rapporteur: Mr Jean-François Mattei, France, Liberal, Democratic and Reformers' Group

Summary

      Biotechnologies, life sciences and technologies and their application are part of the scientific revolution that we are experiencing as we enter a new century and a new millennium. These technologies are capable of revolutionising medicine, the pharmaceutical industry, certain industrial products, the environment and agriculture. At the same time, we have seen the emergence of a broad movement of public opinion, ranging from citizens through scientists to political decision-makers, which is raising questions as to the potential harmful effects of products engendered by the application of biotechnologies. Central to the debate are ethical, social and environmental considerations, which in many cases are at odds with economic interests. It is interesting to note to what extent biotechnologies can prompt either negative reactions and even outright rejection on the one hand or unreserved endorsement on the other hand. It is clear from the ardent sentiment underlying the different views that debate on these matters is both valuable and urgently needed.

      The present report stresses the importance of involving public opinion, scientists and media in the preparation of political decisions. As regards biotechnologies and their application, especially where humans and nature are concerned, it is recommended that the Committee of Ministers adopt the precautionary principle, which will be elaborated upon at a subsequent stage. It is proposed that careful analysis be made of the problems linked to the patentability of living matter and that an "ethical" label be introduced to clearly identify any product respecting the fundamental principles of human rights and human dignity. In conclusion, the Committee of Ministers is asked to convene a group of experts to consider the terms of a convention on the use of living matter.

I.       Draft recommendation

1.       Biotechnology has experienced huge advances in recent decades following the elucidation of the nature and functioning of the nucleic acids (DNA and RNA) in the 1950s and later work on molecular genetics and the mapping, sequencing and interpretation of entire genomes (human and others). The discovery that DNA molecules are interchangeable among animals, plants, bacteria and other organisms and the possibility to manipulate or change their units (genes) have given biotechnology enormous scope for applications, but have also resulted in serious public concerns about the safety and ethical acceptability of some of the new inventions.

2.       This new knowledge imposes choices regarding further developments and applications of biotechnology involving living matter, in particular because of possible consequences for different life forms, the Earth's eco-system and humanity. A central reference for choices to be made must be the preservation of human dignity and a healthy environment.

3.       It is increasingly important to include ethical considerations centred on humankind, society and the environment in deliberations regarding developments in biotechnologies: life sciences and technologies and their applications.

4.       Public opinion should be more strongly involved in political decision-making as regards scientific and technological choices and scientists should be encouraged to engage more in public debate.

5.       The hearing on scientific information and the European media (Paris, 11-12 October 1999) demonstrated the important informational and awareness-raising role played by the media in the field of biotechnologies.

6.       This is why, as regards biotechnologies, their development and applications, especially where human and nature are concerned, the Assembly recommends that the Committee of Ministers:

i.       ask the relevant steering committees to adopt the precautionary principle as a common tenet of decision-making, once its scope has been clearly defined. The Assembly welcomes in this context the agreement reached on 29 January 2000 in Montreal on an international protocol (the Cartagena Protocol) to the 1992 United Nations Convention on Biological Diversity, regulating trade in genetically modified organisms by including the application of the precautionary principle, but regrets that the decisions made regarding traceability and labelling were not more compelling;

ii.       continue to broaden its activities in the field of bioethics, as envisaged in Recommendation 1213 (1993) on developments in biotechnology and the consequences for agriculture. Due account should be taken of the findings of the Council of Europe International Conference on the ethical issues arising from the application of biotechnology (Oviedo, Spain, 16-19 May 1999), covering in particular the problems concerning the patentability of living matter and of Recommendation 1425 (1999) on biotechnology and intellectual property;

iii.       ask the Steering Committee on Bioethics (CDBI) to prepare, in co-operation with other relevant organisations, notably of consumers and representative associations, the introduction of a "bioethical label" to clearly identify any product derived from living matter that respects the fundamental principles of human rights and human dignity. A European bioethical label organisation (EBELO), based on the model of the European Union's proposal to create a European eco-label organisation for its Eco-Label Award Scheme, could be set up to manage such a new scheme after a large debate involving public opinion and with the participation of citizens;

iv.       convene a group of experts to elaborate, by involving a citizens' forum, the scope and provisions of a future convention on the use of living matter;

v.       involve all the partners concerned in a co-operation to that end, including the Parliamentary Assembly;

vi.       invite the national ethics committees to participate fully in these activities.

II. Draft order

      The Assembly, referring to its Recommendation … (2000) on biotechnologies and considering the importance of the precautionary principle mentionned in this text, invites its Committee on Science and Technology, together with other committees concerned, to draft a report elaborating measures to be applied when defining the precautionary principle.

III.       Explanatory memorandum by Mr Jean-François Mattei1

Table of contents

       Paragraphs

I.       Introduction       1-4

II.       Society and the life sciences and technologies       5-16

III.        First: the identification of genes       17-19

IV.       Next: the appropriation of genes       20-24

V.       Finally: the use of genes       25-39

VI.        Products derived from living matter:

      grounds for an international bioethical label       40-47

VII.       Conclusions       48-54

I.       Introduction

1.       Every branch of science, at some stage of its development, gives rise to genuine revolution. The current pace of scientific and technological progress is exponential in several fields. This applies in particular to information and communication technologies, as well as to the life sciences and technologies. The health and agro-food sectors and those branches of industry where the environment is a factor will be affected to an ever greater degree and could well be completely transformed as a result of the advances being made in biotechnology.

2.       The stakes are extremely high as we are entering a new century and a new millennium. I am well aware how terribly unoriginal it is to say these things by way of an introduction, but I have given in to the temptation of doing so because, whether by coincidence or otherwise, our civilisation too is at a turning point. This changeover can probably be ascribed to the simultaneous occurrence of two very important events: the end of a fools’ game of a century and the dawning of a scientific revolution.

3.       The end of a fools' game during which we marched to the drum of a pointless face-off between two ideologies, which resulted in the loss of traditional values and deadened the imaginative processes of so many. When historians look back on this century they will probably perceive it as one of particularly lacklustre thinking, unlike the two centuries which went before. They will conclude that, when ideologies collapse and collectively show themselves incapable of organising a world fit for humankind, humanity finds itself naked, disorientated and stripped of its points of reference. The human race has never been so vulnerable as at the close of this century.

4.       Yet, just as the century is bowing out, the third major social revolution of modern times is moving to centre stage. In the wake of the agricultural revolution and the industrial revolution, now the world is experiencing the scientific revolution. The past fifty years have seen greater advances in human knowledge than the previous fifty centuries. This new knowledge makes humankind more powerful than ever before. The contrast between vulnerability and power is striking. Thanks to the knowledge revolution, the human race is destined to rebuild itself on the ruins of this century which has proved such a disillusionment. And it is this rebuilding process and the attendant emergence of ethical values which may begin to form a new human being.

II.       Society and the life sciences and technologies

5.       Our new knowledge places us in new situations where we have to make new choices. Making a choice amounts to exercising a freedom, and new choices are synonymous with new freedoms. Availing oneself of a freedom means assuming a responsibility, and so we find ourselves with new responsibilities. “Freedom” and “responsibility” are two essential foundations of human dignity; clearly, this new knowledge raises questions about our understanding of human dignity. The most important stage, at the heart of the whole process, is that of making a choice, of asking oneself ethical questions. What attitude, what conduct, should be adopted? This questioning can of course take a personal form, as we scrutinise our philosophical, moral and metaphysical beliefs and engage in a debate with our conscience. It is such individual choices that give a direction to our lives. This is what Max Weber called the belief ethic. However, individual choices affect other people and have implications for the future. The notion of the other is already present in Kant's injunction that we do not do to others what we would not want to have done to us. And Jonas makes mention of the time element in his "Responsibility principle": "Ensure that the way you act is compatible with the preservation of a genuinely human life on earth". Broaching questions of temporality and alterity necessarily brings us to the issue of responsibility — what Weber called the responsibility ethic. We need common rules in order to live together because we are responsible not only for ourselves but also for others and for the future.

6.       So far the future has been decided through the subtle interplay, varying with time, of knowledge and power. At times those in power have been opposed to knowledge (the case of Galileo springs to mind); at others they have made use of it (as they have of genetics at certain periods). Knowledge may well have been countered or exploited by those in power, but in other eras — and probably in our own — knowledge has imposed itself on power, and the weaker the power is and the more enfeebled its convictions are, the more knowledge has gained the upper hand. Knowledge then becomes an alibi. Politicians no longer cite Socrates or Plato, but seek to justify their decisions by claiming them to be scientifically or statistically proven. They rely on experts and surround themselves with Nobel Prize winners. There was an illustration of this in 1992 at the time of the Rio Summit. Immediately after the summit a number of scientists launched what is known as the Heidelberg Appeal: “We (…) forewarn the authorities in charge of our planet's destiny against decisions which are supported by pseudoscientific arguments of false and nonrelevant data.” Science, technology and industry are of course worthy of trust.

7.       The reaction was not slow in coming. A few days later, a counter-appeal was issued by scientists and intellectuals who, describing themselves as thinkers and activists in favour of sustainable development, spoke out against those who sacrifice Man to nature and against a scientific imperialism which asserts that humanity can be saved through science alone. It is hardly surprising that we are in a state of crisis which shows that science is no longer sufficient and that politics is failing to assume its full responsibilities.

8.       The situation just described has led to the emergence of a third player alongside knowledge and power — the will. That is to say, public opinion, which is now discovering that the physical world is finite and is finding its confidence sapped by serious problems. Contaminated blood supplies, growth hormones and Creutzfeldt-Jakob disease, prions and bovine spongiform encephalopathy, perhaps even genetically modified organisms: all this is leading to a more general crisis, that of democracy. Citizens want to have their say. Representative democracy is gradually giving way to opinion-based democracy, and the outcome is a questioning of authority and doubts about progress. Nowadays, there is strong pressure for society to exercise control over science. There have always been movements against progress — nineteenth-century romanticism was a previous backlash against the world then being built — but it is now clear that public opinion will no longer tolerate being dictated to.

9.       This tendency affects all fields of human activity. Medicine and biology are naturally in the front line, because the questions raised concern life, death, suffering, people's differences and their destinies. This has opened up the vast sphere of bioethics, involving issues such as organ transplantation (is the human body common property?), medically assisted procreation (the right to a child, which may transform children into objects), the excesses — prescriptivism and eugenics — to which pre-natal diagnosis may give rise, and in the background the question of the place of the disabled and of other vulnerable people in our society, predictive medicine and the prospect of the need to decide between determinism and freedom, and, lastly, gene therapy and the possibility of changing the very essence of human beings. For more than fifteen years texts on these subjects have been drawn up by one country after another, by Unesco, more recently by the World Health Organisation and, naturally, by the Council of Europe, with its Convention on Human Rights and Biomedicine; attempts have also been made to establish common rules.

10.       However, alongside biomedicine another source of problems compels recognition: the application of biotechnology. From a semantic point of view, it is not uninteresting to note that the fashion for all things "bio" is also invading our vocabulary. We have had bioethics, biomedicine, a fair few neologisms and pleonastic expressions, and now we have biotechnology, or the technological exploitation of living processes, with all the artificiality that this entails.

11.       There are two background debates on these technologies. Firstly, it is claimed that biotechnology is about to revolutionise medicine, the pharmaceutical industry, the environment and agriculture, although not everyone is in agreement as to the scientific and technical consequences. Some people think that things are moving too fast, while others believe that inactivity and a wait-and-see attitude are dangerous, because progress is of benefit to humanity if “domesticated“ and under control.

12.       Secondly, since the advancing secularisation of society is increasingly going hand in hand with a pagan reinterpretation of the sacred and also with a new rhetoric balancing faith and reason, the very substance of ethics is determined by the image which we have of ourselves as human beings and the ideal of humanity that we are pursuing. Science must take care to avoid any form of rational conceit; in religion, there is a need to guard against another human weakness — that of unthinking belief.

13.       This was the background to the conference organised by the Council of Europe and held in Oviedo in May 1999 on ethical issues arising from the application of biotechnology. This paper was inspired by the conference.

14.       Biovision, the first International Forum on Life Sciences, which was held in Lyon, in March 1998, consisted of four parallel conferences, each dealing with a major issue in life sciences and chaired by two prominent figures, one a scientist, the other an industrialist. The themes of the four conferences were:

—       Feeding mankind;

—       The health of mankind;

—       Improving the quality of life and protecting the environment;

—       Public perception of biotechnology and risk management.

15.       The Forum was an opportunity to discuss the latest developments in the life sciences and technologies in the context of future challenges, in terms both of the prospects for progress and innovation and of the associated difficulties and risks. In opening the Forum, Raymond Barre, former French Prime Minister and Mayor of Lyon, remarked on how interesting it was, in an age when communication systems have provided universal access to a vast amount of information, to note the strength of reaction to what is generally known as biotechnology — a reaction which may be negative (extending all the way to outright rejection) or, in contrast, sometimes unbridled in its enthusiasm. The passion reigning in the opposing camps betrayed a marked level of interest and indicated how urgent it was to formalise talks on these issues, for example by setting up a process of debate on the life sciences to mirror that of the Davos Economic Forum.

16.       Broadly, three initial questions arise, concerning the identification, the appropriation and the use of genes. It is necessary to take stock of the situation, to establish a number of guidelines and to devise possible solutions permitting a consensus on these matters.

III.       First: the identification of genes

17.       From blue algae to Homo sapiens, genetics has unravelled the strands of DNA and deciphered the code, showing that all living things have a genetic code. It has shown the universality and unity of the living world. The question of humankind's place in the universe, and, furthermore, in the hierarchy of living things, is now posed in different terms. The fact that the human race is capable of changing living organisms, and therefore has the power to change itself, does in fact raise questions. As genetics has moved on to isolate genes, to identify them and to track down those which are good and those which are less so, it has begun to pursue another objective, an objective which poses two problems: firstly, the relative importance to be given to genes in relation to their environment, since the omnipresence of genetics now seems to be making people overlook the reality of environmental influences; secondly, genetic recombination, in all its variety, and the way we humans influence this process.

18.       A further problem is the selection and the elimination of genes, preferably in order to keep those which are good and eliminate those which are less so. A great deal is at stake here: although nature exerts a selective pressure on genes, might it not be possible that human selection of genes will in turn bring pressure to bear on nature? The equilibrium of ecosystems is easily broken. What is at issue here is biodiversity versus bioselectivity.

19.       The probably most important project ever carried out in the history of Biology is the Human Genome Project. It aims at identifying all the genes of the Human Genome, approximately from 60.000 to 100.000, and will determine the sequence of the 3.000 million pairs of chemical bases, i.e. nucleotides, that make up human DNA. The Project is scheduled to have finished within one year, but this is likely to only be the starting-point of a new scientific revolution, which will include exciting fields such as biocomputing, theoretical biology and new physiology. This type of knowledge makes it possible to carry out comparative studies between species as different as yeast, worms or a mammal. If the difference and similarities between genomes of different organisms can be analysed, then the distance to practical applications is not far. It is known that a great number of cell functions are based on the actions of many genes that combine or co-ordinate to play a given role. A precise knowledge of the functions of genetic circuits and the possibility of interfering with these will give rise to new ethical considerations. The economic interests are evident.

IV.       Next: the appropriation of genes

20.       However, the possible appropriation of genes raises even more questions than their identification. We know that the question whether a patent can be obtained for living matter poses problems. The debate — in fact a clash of different cultures — is not yet closed. Much has been said about the need to distinguish discovery from invention. "Discovery" means learning about something so far entirely unknown but which already existed. An invention is the fruit of human intelligence and innovation and enriches the human heritage. To what extent is it possible to stake a claim to living matter which, by nature, already exists? Is it possible to have an exclusive right to exploit part of the living world, part of the common heritage which has its basis in the universal nature of living things? Don't living things belong to the whole human race? Since they are universal property, it seems unacceptable that anyone should have exclusive rights to them, especially since the confiscation of knowledge is a form of confiscation of the future. It establishes another form of organised dependence in economic, agricultural and industrial terms. However, where the three traditional criteria for granting a patent are fulfilled — namely that the object should be new, involve inventive activity and be susceptible of industrial application — patentability becomes logical and acceptable.

21.       The European directive on the legal protection of biotechnological inventions of 6 July 1998 shows a real change of attitude in this respect. In fact, article 5 contains two sub-paragraphs in full contradiction. In the first a completely theoretical ethical principle is put forward:

1.       "The human body, at the various stages of its formation and development and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions."

2.       "An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene may constitute a patentable invention, even if the structure of that element is identical to that of a natural element."

22.       And therefore, although, some people perceive the law as neutral and independent, in particular with regard to ethics, it is not. Granting a patent is in itself already an economic incentive. I personally, as citizen and also as a doctor and a geneticist, find it impossible to accept that gene sequences may now be covered by an industrial patent. I feel the same way about the fact that the tests used to detect a predisposition to breast cancer are now the monopoly of Myriad Genetics in Salt Lake City because of the patent on the sequence of genes concerned. I do not think it is possible to become the exclusive owner of a gene sequence. It is understandable that a technique may be patented, that a patent may protect all uses of that technique, but certainly not that a patent may cover a gene sequence itself.

23.       Moreover, the granting by the European Patent Office of a patent for the isolation, selection and propagation of animal transgenic stem cells can not be accepted on ethical grounds, in particular since the application of such techniques to humans are not explicitly excluded. In fact, it is stated that the term "animal cells" is intended to embrace all animal cells, especially of mamalian species, including human cells.

24.       The result may be the monopolisation of an entire category of living material of human origin, and I deliberately use the word human because another problem arises here. The question of the patentability of genes gives new force to the debate on where the frontier between human and non-human lies, since human and non-human gene sequences may be so similar as to engender confusion. Is a human gene fundamentally different from a non-human gene? Should the rules for material of human origin differ fundamentally from those for other material, or should they be the same for all living matter? Genes will be used to create transgenic plants, which can be patented, or transgenic races of animals, likewise patentable. In all logic, the same should therefore apply to human material, beginning with modified embryo stem cells, and why not tissue, organs and entire transgenic human beings?

V.       Finally: the use of genes

25.       This brings us to the question of the use of genes, posed firstly in traditional terms, that is to say above all as a question of common sense, of generally accepted principles whereby use of genes is admissible if it has a curative effect, but not if it causes illness. According to this line of reasoning, the end justifies the means, the end being human good health. Anyone can see that such reasoning has a perverse effect if taken to extremes. However, let us accept it nonetheless in the case of biotechnology. Moreover, it has to be said that, where it is a question of introducing genes into cells in order to produce substances with a therapeutic effect, such as insulin, the growth hormone or interferon, the word therapy acts as an "open sesame". Then the technique is hailed as the birth of a new form of pharmaceutical industry, and draws no serious public criticism. If erythropoietin is today under fire in the media, this is not because it is a product of biotechnology but because it has been diverted from its medical use as a means of cheating in sports events.

26.       Nor has there been much criticism of the idea of introducing genes into plants or animals for therapeutic purposes. It is a well-known fact that plants are used for such purposes — we need look no further than tobacco and haemoglobin and plants with a vaccinating effect. Use of transgenic animals — colourfully referred to in the media as walking pharmacies — is also well accepted provided the ethical rules on animal welfare are respected. Production of albumin or of coagulation factor VIII in cow's milk, and more recently of anti-thrombin III in goat's milk, likewise does not meet with any disapproval; nor does genetic modification of pigs with a view to xenotransplantation. Even the cloning of animals did not cause any serious public dissent. The uproar began only when it became clear that adapting the techniques in order to clone human beings was possible, if not imminent. The statements made by certain scientists, who attempted to reassure people by explaining that there was no cause for concern because the technical difficulties remained too great for the process to succeed, failed to dispel the fears. The public instinctively understood that this is a field where technical or economic arguments against using a method are valueless, as, once those arguments have been overturned, one finds oneself disarmed, having already conferred legitimacy on the technique in principle.

27.       Here it is indeed the metaphysical aspect of the question which prevails over all other considerations. What is at stake is the singularity of human beings, the freedom to be oneself, not a copy of someone else. There is also the temptation for immortality. In these circumstances the simple rules of ethology laid down by Konrad Lorenz become applicable to humans. Human beings react when the limits beyond which they feel threatened are exceeded, when the end does not seem to be justified, when they feel that, instead of making use of progress, they are being used by it. In just a few years, things have changed considerably, as can be seen from the example of genetically modified organisms or GMOs.

28.       When all is said and done, the issue is quite simple. The controversy — one might almost say the outrage — about genetically modified organisms can be explained by the fact that one public health crisis has followed another. The situation provides a perfect illustration of everything I have said so far. The scientific community is under suspicion, the politicians have been discredited, and the public is in a position where it can make demands. Assuming that GMOs are not dangerous, what we have here is a case of once bitten, twice shy.

29.       That being the case, all one can do is pose the necessary questions, without neglecting any aspect of the issue.

30.       Firstly, what are the real priorities here? Is the end being served a noble one — that of feeding the planet? Does it serve lesser objectives, such as improving certain plant characteristics or making a profit?

31.       Secondly, as to the methods for example, is it justifiable to make use of genes conferring resistance to antibiotics, when it is widely known that such resistance is one of the health problems of modern times? Such an approach flies in the face of common sense. Similarly, using Bt toxin to eradicate the European corn borer appeared to be the perfect solution, except that, as was to be expected, some of these insects have now developed a resistance to the toxin, and this resistance is probably a dominant genetic character; as a result the US Environment Protection Agency’s recommendations are rendered obsolete. A situation of this kind would necessitate a relentless search for a new toxin every year. Would that be at all reasonable?

32.       Thirdly, transparency regarding implementation and assessment of these techniques. For example, what are the possible risks for nature arising from GM crops, as regards possible gene flows? Similarly what are the risks for consumers or the social implications? It is therefore understandable that there should be such a fierce debate on the subject, revolving around two main concerns — health security and social acceptability — which I now wish to address.

33.       Health security is a general concept whose origin lies in the problems posed by use of health and food products liable to cause environmental damage. Health security is now perceived as something to which citizens have a right and which states have a duty to ensure, just as they ensure civil and military security. Although the public may sometimes oversimplify matters — as when, on the subject of mad cow disease, people assert that a herbivore was made into a carnivore because cattle were fed with meat meal, and scientists know how inaccurate that assertion is — public opinion is a reality which cannot be ignored, especially since, although its expression may be clumsy, the public fully understands that technical progress is never devoid of risk. The simple fact is that it is all the less willing to accept a risk which is not absolutely essential. Furthermore, the scientific experts working on GMOs concur that additional research is needed to identify the potential long-term risks.

34.       Hence the problem of social acceptability. This is primarily a question of freedom of choice, of economic implications, of the impact on employment and of new forms of solidarity — it is therefore a question which is posed in terms of individual freedom and choice of the kind of society one wishes to live in.

35.       The public regards interference with individual freedom as even more reprehensible than inadequate health security. Rejection of GMOs is, first and foremost, a refusal to allow other people to take control of the content of our dinner plates: eating is a personal act, which has to do with individual freedom, and consumers are reasserting their right to know in order to be able to choose; hence the demand for openness, for information, for traceability and for suitable labelling. Some countries have already understood this, as have some of the mass marketing networks.

36.       For underlying these concerns is the public’s choice of society. This is a choice which raises a large number of economic questions. What are its implications for employment? What about farming? Can we accept the technology of the "terminator" gene, which renders seeds sterile and therefore prevents farmers from saving seeds from one season for sowing in the next, resulting in de facto dictatorship by those holding the industrial and commercial monopoly on seeds?

37.       From the standpoint of solidarity, the questions raised are of equally crucial importance. How will North-South relations be affected? Where will developing countries which cannot afford the technology stand? Can GMOs really help to reduce under nourishment, which today affects 800 million people worldwide? Could they guarantee a safe, secure food supply for a planet which in twenty-five years' time will have 9 billion inhabitants?

38.       In fact, with regard to all these questions, there is often a striking contrast between the rhetoric and the little that is actually done to help the poorest countries. Is it not true that the first to benefit from improvements are farmers in the industrialised world? And is there not a growing gulf between the industrialised countries and those still seeking to develop their economies? An even greater cause for concern is that some genetic innovations result in the development of substitutes for products which had so far only been obtainable from the developing countries. Therefore, although progress is the official agenda, things are very different in reality and in some cases the situation is completely nonsensical. The sometimes irrational, but often well-founded reactions of a disenchanted society seeking a new meaning to existence should therefore come as no surprise.

39.       It is in this context that your rapporteur welcomes the agreement reached by negotiators from 130 countries on 29 January 2000 in Montreal on the so-called Biosafety Protocol to the 1992 United Nations Convention on Biological Diversity. This new agreement (to be called the Cartagean Protocol, after the Colombian city where an earlier round of negotiations ended inconclusively last year) will require exporters to identify genetically modified organisms, and allow importing countries to judge whether they pose environmental or health risks. The agreement states that bulk shipments of genetically modified foods will be labelled as containing genetically modified organisms, and that a computer database maintained by the exporter will provide importing countries with information about their contents. Importers can block shipments, even without "scientific certainty" that a commodity poses a risk. This is the first time that the precautionary principle has been incorporated in an international agreement. The Protocol does not claim precedence over the rules of the World Trade Organisation (WTO), and exporters who believe they are being treated unfairly will still have recourse to the WTO. It is important in this context that clear rules be established for the labelling of products containing more than 1% of genetically modified material. Strict procedures must also be applied allowing the tracing of any such product. The decisions made regarding traceability and labelling were far from satisfactorily.

VI.       Products derived from living matter: grounds for an international bioethical label

40.       With the development of new techniques based on its use, living matter has emerged as a brand new raw material which could serve as a basis for a new industrial activity and possibly trade. These techniques, dubbed biotechnologies, doubtless represent an unprecedented advance in dealing with a great many human diseases, be it in terms of diagnosis or treatment. They also offer massive industrial potential. There is clearly no question, therefore, of refusing them or discrediting them in principle. On the contrary, I believe it indispensable to give them every necessary support so that they can establish themselves without dispute. We do know, though, that, by their very nature, they raise difficult ethical questions and that the replies given in various quarters often differ, triggering conflicts made all the more implacable by the clash of economic imperatives with philosophical and cultural principles.

41.       The problem first arose with the use of blood and blood derivatives. No one denies the necessity of covering the costs of preparing these products, from collection to delivery, with all the intermediate phases this entails. However, is it conceivable to make substantial profits from a raw material obtained free of charge thanks to the generosity of voluntary donors? The same question arises with the use of placentas collected free of charge in maternity wards, or tissue removed during surgery. The transplanting of organs has also been called into question as regards the status of living matter. The issue has been yet further complicated by the development of cell and tissue therapy. Once it is realised that the human body is a potential store-room of spare parts which can be used as such or in some modified form to save other human lives, it is not easy to find points of agreement. But it has now become established, in many countries, that the human body, in whole or part or product form, is neither for sale nor purchase: it is not a negotiable commodity! Such provisions now incorporated in certain national legislations are to be found in international instruments such as the Council of Europe's Oviedo Convention on human rights and biomedecine.

42.       These issues have been stoked to glowing point by the development of biotechnologies based on the use of genes or genetic sequences of human origin. Obviously, this new industrial activity, involving the production of human proteins with therapeutic effects through the introduction of human genes into a foreign body, brooks no argument as regards its purpose. Nevertheless there remains the key question as to the patentability of genes, in whole or in part, their appropriation by some, who lay claim to exclusive ownership in return for the sole obligation of paying substantial royalties to the individual who first made the discovery. There is also the question of genes of living organisms as a whole, human and non-human, in the light of the ever more frequent creation of genetically modified living organisms, which are given foreign genes for assimilation. And there is already the question of the use of embryonic or multipotential stem cells after nucleus transfer.

43.       Beyond the scientific controversy, it is vital that we never lose sight of the pitfalls to avoid. Under no circumstances must man be exploited by man, in whatever form, be it a single gene, cell or tissue. Fundamental rules must be respected, as regards the donor's free, informed consent, the non-payment and anonymity of doning, final cost calculation and consideration of needs world-wide, where solidarity must be practised between solvent and insolvent countries. It is a matter of elementary respect for human dignity.

44.       At a time when a label guaranteeing that certain items have not been manufactured through illegal child labour is gradually being introduced, I propose that we create an "bioethical label" that would guarantee for all products derived from living matter, via biotechnologies, that they comply with the principles laid down in the Declaration of human rights and the international instruments inspired by it. We are talking about the primacy of the individual, respect for the human being from the very start of his life, the inviolability and integrity of the human body, the impossibility of treating it as a commodity, as well as respect for the integrity of the human species. Such an bioethical label, far from hampering the development of biotechnologies would on the contrary enable them to shake off criticism, sometimes justified but often ill-intentioned, since it would serve as a guarantor for respect for human dignity.

45.       There are a few labelling schemes that could serve as points of departure for the development and introduction of a new bioethical label. There are first of all the Eco-labelling systems in place in different countries. These are well known and accord an Eco-label for a product having a distinct ecological advantage such as organically produced foodstuffs or recyclable products. Some of these schemes are voluntary schemes and may be controlled by the producers. Others are formally controlled by an appointed body -normally including representatives of consumers as well as producers and representatives of the competent administration(s). The European Union has proposed a Council Regulation establishing a revised Community Eco-label Award Scheme (COM (96) 603) which proposes the creation of a European Eco-label Organisation as a network structure involving national competent bodies. Some criticism has been voiced as to the lack of involvement or representatives of interested parties and with regard to the complexity of the scheme (graded labels).

46.       Another labelling initiative which has been elaborated by the International Labour Organisation (ILO) concerns social labelling as a way of combating child labour. Different national schemes have been studied also with a view to include such measures in the ILO Convention and Recommendation concerning the Prohibition and immediate Action for the Elimination of the worst Forms of Child Labour.

47.       The two examples clearly show the strategy of establishing labelling schemes at national level first. The promotion of such schemes in a broader context can be achieved through international initiatives. International organisations can also help co-ordinate and harmonise such schemes and develop legal instruments and control mechanisms for their implementation. The introduction and development of a bioethical label could follow the same strategy. A first step in this context could be the involvement of the Steering Committee on Bioethics and National Ethics Committees followed by the involvement of the relevant broader organisations. Consumer unions and Producers should also be represented on bodies developing and controlling this new bioethical label. It seems highly relevant to adopt the same strategy as for the European Union Eco-Label Award Scheme by setting up a European Bioethical Label Organisation (EBELO).

VII.       Conclusions

48.       I wish to conclude with some comments on five matters: the constancy of humankind, the humanisation of the world, the ethical debate, the decision-making process and what is at stake in our joint reflection.

49.       First, humankind's constancy throughout history.

50.       Paradoxically, it is because the human race gives the impression that it is capable of mastering the world that the world is becoming more human. Humankind's relationship with the world is changing, particularly in the two fundamental spheres of space and time. Space is a fast-shrinking commodity on earth as the planet becomes a global village, and if Dolly the cloned sheep raises the spectre of human clones, if GMOs point to a denatured world, it is because the human being has become the measure of all things. The same applies to time. All humans now think in terms of their children, of the future generations from whom they hold today's world in trust.

51.       In adopting a new set of values, humankind is becoming aware of the need for a meaning to existence and for an ethical debate. Make no mistake about it — the revival of philosophy is more than a passing fashion. It is a sign of a need, which neither science — in some cases a source of worry — nor the dashed hopes of political ideology can satisfy. But philosophy teaches people to think; it rarely teaches them to live. Hence the need for an ethical debate, to find a maxim which can rule our conduct. However, that entails a process of reasoning and argumentation. Argumentation does not mean no longer thinking for oneself; on the contrary, it means looking within oneself to find solutions valid for others and bridging the gap between individual thinking and otherness.

52.       It is this absolutely essential process which must be followed before any decision is taken.

53.       The decision-making process is becoming more and more difficult. Henceforth politicians will increasingly be required to take hard decisions based on weak scientific evidence, whereas, traditionally, things were the other way round — the scientists produced hard evidence, and the politicians held weak opinions. Faced with uncertainty, we now have no choice other than to apply the famous precautionary principle. However, unless we are prepared simply to leave things as they are — but this would be fatal — we must not forget that uncertainty is part and parcel of decision making, since if there were no uncertainty society would have no need for decision makers. It is by recognising the risk that we will be able to progress from a risk that is acceptable to one that is accepted because it is managed in a culture of caution. The more uncertainty there is around us, the more the role of decision maker becomes necessary. The greater the uncertainty, the more the decision-making process must be formalised and subject to public debate, and the more the approach adopted to arrive at a decision must be open, coherent and clear. Otherwise, the decision makers run the risk of consciously sacrificing humankind and human health on the altar of economic competitiveness. They would then lose all credibility and a crisis would loom. In this connection, the failure of the talks held in Cartagena in February 1999 on regulating trade in transgenic products is a continuing cause for concern. This is what is at stake in our joint reflection. It is not easy to steer a course between the legitimate aspirations of consumers and the need for fair trade, but failure to respond to public concern would wear away support for the trade liberalisation process. We must therefore identify the ethical issues, bring together the elements on which a decision can be based, and define common guidelines. We must strive wholeheartedly to do this, in order to improve our lives together and build a society which reflects our concept of humanity. We must attempt to improve our understanding of the world, as that is the only way of making it a fairer world, and therefore, quite simply, a more human world.

54.       It is our duty to discuss the issue of using living matter if we are to identify guidelines for our action in this field. In so doing we must base our deliberations on respect for life, in order to grasp all the ethical, social and environmental problems surrounding biotechnology and its applications.

Reporting committee: Committee on Science and Technology.

Budgetary implications for the Assembly: None.

Reference to committee: Doc. 8102 and Reference No. 2401 of 26 May 1999.

Draft recommendation and draft order unanimously adopted by the committee on 6 April 2000.

Members of the committee: MM. Rakhansky (Chairman), Birraux (Vice-Chairman) (Alternate: Mattei), Tiuri (Vice-Chairman), Lekberg (Vice-Chairman), About, Alevras, Aron, Asciak, Bartos, Brunhart, Bulic (Alternate: Mrs Biga-Friganovic), Cherribi, Cioni, Colla, Cunliffe, Dolazza (Alternate: Provera), Duka-Zolyomi, von der Esch, Mrs Faldet, MM. Fayot, Felici, Fernandez Aguilar, Gligoroski, Ivanov, Jackson, Kitov, Kittis, Kjaer, Kolb, Kurucsai, Leers, Lengagne, Libane, Liiv, Lotz, Maas, Marmazov (Alternate: Strizhko), Mateju, Melnikov, Minarolli, Monteiro, Moreels, Moynihan-Cronin (Alternate: Connor), Mozgan, Nabholz-Haidegger, Niculescu, Nigmatulin, Nikologorsky, Onaindia, Patarkalishvili, Pawlak (Alternate: Luczak), Plattner (Alternate: Schmied), Ragnarsdottir, Rapson, Raskinis, Rokos, Roseta, Scheer (Alternate: Wodarg), Steolea, Tanik, Turini, Wittbrodt, Yürür, Wurm.

N.B. The names of those members present at the meeting are printed in italics.

Secretaries of the committee: Mr Lervik, Mr Torcătoriu


1 This report is largely based on the general introduction presented by the Rapporteur to the International Conference of the Council of Europe on Ethical Issues Arising from the Application of Biotechnology, Oviedo (Spain), 16-19 May 1999.