Doc. 9002

19 March 2001

Protection of the human genome by the Council of Europe¹

Opinion

Committee on Legal Affairs and Human Rights

Rapporteur: Mr Michael Asciak, Malta, Group of the European People's Party

I.       Conclusions of the committee

1.        The Committee on Legal Affairs and Human Rights approves the draft Recommendation contained in Doc 8901 by the former Committee on Science and Technology. This committee fully agrees to the following points.

a)        that all European countries should have a national authority dealing with the monitoring, advisory and information aspects of research on the human genome and the safeguarding of respect for life and human dignity.

b)        that the Council of Europe sets up a Pan-European body or Authority on a permanent basis, which body would have the same function as the national authorities described in (a) above with particular attention to ethical details. This European Authority would have a mandatory function of consultation, regulation and inspection on all public and private European research institutes. This institution together with the national ones, would also have the important function of educating the public and passing the correct and full information to the media and to certain professions such as the health related professions and policy makers.

c)        Notwithstanding the fact that the Bioethics Convention of the Council of Europe has been finalised since 1996, many member states of the Council of Europe and others who are able to sign it, have still not done so. It is essential for member states of the Council of Europe to accede to this convention and particularly the role of PACE parliamentarians is important in bringing pressure to bear on their respective governments and proceed to sign and ratify.

2.        The Committee on Legal Affairs and Human Rights would, however, propose the following amendment to the draft recommendation tabled by the Committee on Science and Technology:

Amendment

In the draft recommendation, add a new paragraph 10.vi, to read as follows:

"to ask all Council of Europe member States to strive to change the basis of patent law in international fora such as the WTO, as far as the ownership of human being tissue and genes is concerned, into law pertaining to the common heritage of mankind."

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II.       Explanatory memorandum by Mr Asciak, Rapporteur

A.        Introduction

1.        The recent spate of rapid development in the field of molecular genetics has led to a rapid precipitation of issues surrounding biotechnology and genetics, some of which may pose a serious threat to the ecological balance of our environment, but above all, to the dignity of the human person. For the first time since the existence of man, it is now possible for him to read and re-write the information regarding the physical characteristics (phenotype) which constitute the essence of any living creature from microbes to man. This information is encoded within a specific chemical (DNA) which constitute several genes, together making up the genome or genotype of that particular organism. The genotype of a particular organism is converted into the phenotype by a process of biochemical “reading” of the genotype which then translates into a structured protein synthesis resulting in a particular physical being. Since evolution has been shared by all living organism, one finds a high degree of compliance between the genetic information of all living things, even between animals and plants. The percentage difference between the genome of a human person and that of a chimpanzee is less than 1.5%! Since man is biologically considered as an animal, the human genome, like that of other organisms, may be subjected to the same changes and manipulations as other living creatures, through the intricate changes of the chemicals making up the genome, via biochemical molecular processes. This allows the human genome to be read and also to be altered, opening up several problems in the fields of ethics and human rights.

2.        At this juncture it is essential to stress that these new developments in molecular biology also offer man immense opportunities in controlling several biological problems within our environment and offer fantastic new possibilities and hope within the fields of agriculture, pharmacology, criminal and investigative law, ecology and above all, medicine. Within the field of medicine, it will become possible for the first time, not only to have an early possibility for diagnosis of many illnesses, even when the foetus is still “in utero”, but also to actually “cure” many diseases which up to this point could only be “controlled”, not to mention anything of vaccines. This procedure would particularly be possible by the genetic processes of changing the actual genome of a person to delete the malfunctioning genes, so called “gene therapy”.

3.        Since genes code not only for illnesses, but other constituents of the human phenotype such as intelligence, personality, besides colour of hair, eyes, height, etc, the ethical implications to the dignity of the human person, are manifold.

B.        The Dignity of the Human Person

4.        Since the human person is the only living creature that is capable of being “rational” or “self conscious”, there is universal agreement that man has to be treated with respect in accordance with the upholding of the dignity which emanates from this special position. Those who ascribe the dignity of man to his transcendental relationship with God, i.e. the “soul” as the cause of his self-consciousness, would surely strive to keep this dignity untouched. Other ascribe this “self-consciousness" of man to his superior brain, that is to the superior physical and biochemical composition and development of his neural tissue as compared to other creatures. Therein, there arises a secular viewpoint of human dignity based on the KANTIAN principle of man’s cognisance of natural law particularly natural moral law. Whether one partakes to the “spiritual” view of human dignity or the “secular” one, there remains the fact that all human beings are equal in the respect due to them from other human beings and the fundamental rights inherent to this dignity.

5.        Definitely in all the issues surrounding the human genome and the interventions that take place upon it, one consideration must surely supersede all other considerations that may conflict with this aspect. The respect for human dignity must remain an absolute value in this context. Definitely it will prove to be the one guiding principle that will help to extricate solutions as to whether a procedure on the human genome is to proceed or not. Several authors tend to simplify this dilemma by opting positively for all treatment alternatives such as curing genetic illness while opposing any procedures aimed at enhancing a person’s physical characteristics such as colour of eyes, skin, height or intelligence. Reality dictates that this dichtomoy although usually a good guideline, is not always a sharp enough distinction whether to proceed with a particular therapy or not. For example, short stature may produce severe anxiety and depression in individuals within a society that adulates height. In such a case, gene therapy would not remain simply a matter of enhancement but becomes a matter of therapeutic application. The better single criterion in all these cases, is the maintenance of human dignity. Would a particular course of action improve or reduce a particular person’s dignity? This is the fundamental question which we must all strive to answer. As the report of the Committee on Science and Technology clearly shows, the threat to human dignity does not only arise from the issues of therapy but also from procedures pertaining to genetic testing, what to do with the results, whether to inform the patient and other effected members of his immediate family and whether to allow society to have access to these results.

6.        Such tests may have a profound negative effect on individual rights if wrongly applied in the sphere of insurance, employment and educational purposes. If these tests are used within the pre-natal period, several questions have to be asked and answered, particularly in relation to the rights of the parents to ask for, and how to deal with the situation. The biggest threat of course, is to the dignity of the human being in the form of the foetus, if it is diagnosed as defective in any way. Such pre-natal diagnosis not only threatens our perceptions of the value of handicapped persons in our society and builds misconceptions about human perfection as perceived by modern society. It also presents a threat to the physical integrity of the foetus, as abortion, legal or otherwise, will in these circumstances present itself as a viable option to the parents, even if the genetic defect is a minor one! For this reason, one must not underrate the fact that these tests should always be accompanied by professional genetic counselling.

7.        Another problem that could have a bearing on human dignity is the fact that since the human genome project is now nearing completion, the information thus unearthed, would be wrongly appropriated in the form of “patents” thereby commodifying the discovery of these genes and placing this “information” in the hands of trans-national companies to the detriment of individuals and ethnic groups. This would also shift this information and financial investments from developing into developed countries, thus widening the North/South divide in economical development. As far as the human genome is concerned, as this issue has ramifications in the genomes of other living creatures, the problem may be boiled down to two simple matters. The first is the ownership of human genes and the second is the ownership of human living tissue such as cells.

8.        Although the ownership of human genes has now been excluded by the UNESCO declaration on the human genome and other legislation, there is still an effort by several biotech companies to patent gene sequences of unknown use, so called “c-DNA”. The European Union has banned such patenting, but the situation in other countries is not so clear.

9.        Another issue that needs addressing is whether it should be possible to patent living things. Although this problem is usually related to the patenting of plants and animals which is now legally accepted, there remains the problem that human body tissue which is separated from the body of origin and used in a technical process may be patented. Many people are of the opinion that living things should not fall under patent law but under so-called common law. Definitely, this situation should be considered for human body tissue, which is living tissue. Some people have suggested extending patent rights not only to the inventor but also to the human source of the cells. However, I believe that under common law, both can receive a financial reward, without ownership of the living cells themselves being a necessity. One has to distinguish between the patenting of a gene here, which is a chemical, although containing profoundly sensitive information, and the patenting of a living human cell-line, say from the bone marrow or liver of a particular individual. Although I believe that common law should apply to both cases, the ownership of human living cells, in my opinion presents a more profoundly disturbing enigma as far as fundamental human dignity is concerned!

C.        Legal instruments (International conventions)

10.        It would be beneficial at this junction to dwell on the international and European legal instruments that affect legislation on the human genome.

i.       The UNESCO Declaration on the Human Genome

11.        This “Declaration” is not a treaty, but underscored the moral obligations agreed to by the signature states when dealing with the above-named subject. One important article (1) of the document is to declare the human genome as the “common heritage of humanity” thereby making a strong reference to the concept of “common law” rather than ownership. There is also a particular reference to foster scientific knowledge and cultural cooperation between industrialised and developing countries (article 17). In 1998 the General Assembly of the United Nations unanimously endorsed this declaration.

ii.        The Council of Europe Convention for the Protection of Human Rights and dignity of the Human Being with regard to the Application of Biology and Medicine (known as the Convention on Human Rights and Biomedicine) and its first Protocol regarding human cloning

12.        This milestone piece of legislature material passed by the Council of Europe in 1997 contributes significantly to the protection of the human genome on several points. Besides establishing a formal protocol for consent and the protection of persons not able to consent, it also points out the primacy of human being over the sole interest of society or science. It lays down the right to private life and information and the criterion of non-discrimination on grounds of genetic heritage. It lays down the parameters within which predictive genetic tests may take place coupled with genetic counselling, and also those of interventions on the human genome. Selection of sex is forbidden. It prohibits the creation of human embryos for research purposes and ensures adequate protection of the embryo where the law allows such research to take place. The first protocol prohibits the cloning of the human genome for whatever purpose, either so-called reproductive or therapeutic cloning.

iii.        Trade related aspects of intellectual property rights (TRIPS) of the World Trade Organisation (WTO)

13.        In Part II section 5 of this agreement, one finds internationally agreed clauses establishing the regulation of patentable subject matter. Articles 27, 28 and 29 of this agreement signed by all our national governments (or most) lays down conditions for patenting products or processes (they must be new, involve an inventive step and are capable of industrial application) thereby excluding the patenting of simple discoveries such as c-DNA). It also lists the possibility for countries to exclude from patentability inventions that go against “ordre public” or morality, if they so wish. Members may also exclude from patentcy, diagnostic, therapeutic and surgical methods for the treatment of humans or animals. Whole plants and animals other than micro organisms may also be excluded.

iv.        The United Nations Convention on Biological Diversity (CBD)

14.        This convention signed in 1992, lists certain provisions of interest to our case. Article (1) established the “fair and equitable sharing of benefits arising out of the utilisation of genetic resources. Article (8j) promotes the equitable sharing of knowledge and benefits of scientific innovations, with indigenous and local communities. Article 16 lays down that “in the case of technology (including biotechnology) subject to patents and other intellectual property rights, such access and transfer shall be provided on terms which recognise and are consistent with the adequate and effective protection of intellectual property rights”. Articles 19, 20 and 21 on the handling of biotechnology and the financial distribution of its benefits, are also relevant.

v.        European Union Directive 98/44/EC on the “Legal Protection of Biotechnological Inventions”

15.        In accordance with its international obligations with 3 and 4 above, in 1998, the European Union passed Directive 98/44/EC (co-decision by the European Parliament and the Council) on the “Legal Protection of Biotechnological Inventions”. This milestone piece of legislation, although not in any way perfect or satisfying all tastes, was a landmark compromise between the European Parliament and the Commission and Council, with much “toing and froing”. It effectively allows for the patenting of biological material and inventions including industrial processes involving human genes and their products. It incorporates a long list of biological material which in fact may not be patentable for ethical reasons and this is one of its strongest assets.

16.        It excludes the patentability of plant and animal varieties, essential biological processes for the production of plants or animals. The human body at its various stages of development and the simple discovery of its elements and gene sequences, may not be patentable. Isolated elements may however be patentable if they are isolated from the human body by means of a technical process or if they are produced by such a process, as long as they are new, involve an inventive step and have a particular industrial application. This means that genes may be patented under these conditions and so may human live tissues and cell-lives extracted from the body, if they have an industrial use. Their products may also be patentable (eg insulin or growth hormone).

17.        Inventions which go against public order or morality are again listed as unpatentable, as are specifically processes for cloning human beings, processes for modifying the germline genetic identity of human beings and the use of human embryos for industrial or commercial purposes. This also applies to processes for modifying the genetic identity of animals causing them unnecessary and useless suffering.

vi.        European Patent Convention (EPC)

18.        On the 16 June 1999, the Administrative Council of the European Patent Office (EPO) decided to endorse a new chapter entitled Chapter VI “Biotechnological Inventions” wherein the conclusions reaches by the above mentioned EU Directive were endorsed into the EPC.

vii.       Other legal instruments

a.        Council of Europe Parliamentary Assembly recommendations

19. The Council of Europe Parliamentary Assembly has also approved two Recommendations which deal with biotechnology and intellectual property (Rec. 1425 of 1999) and biotechnologies in general (Rec. 1468 of 2000). Both these recommendations brought out the fact that the Assembly was unhappy with patenting of living matter in particular and with the patenting system for genes and human genes in general. Consequently, the Assembly rightly suggested that the national governments of the Council of Europe member states push for the universal agreement of a new system termed a new “World Patent Convention”, to be established under the auspices of an international institution or organisation, whichever it may be. Such a new convention would base itself on common heritage principles rather than the monopolization of genes and living matter under the present regimen of patent law. This approach necessitates constancy and perseverance.

b.        Other Council of Europe work on the human genome

20.        It would be incomplete to opt not to mention other work being done by the Council of Europe, particularly the work on the human genome. The Steering Committee on Bioethics (CDBI) through its working party on human genetics is busy identifying the main issues which could be included in the additional protocol of the Convention on Human Rights and Biomedicine concerning the human genome (CDBI-CO-GT4). The Parliamentary Assembly of the Council of Europe through its (former) Committee on Science and Technology has launched an initiative termed the European Forum on Human Genetics. The aims of this Forum is to involve the citizens of all the member states of the Council of Europe to engage via discussion with themselves and with their politicians at European level particularly the PACE regarding the issues surrounding human genetics. The media is also to be involved in this forum in a very intricate and complete manner. The forum’s key aims are to support the PACE’s decision-making process on the Protocol on the Human Genome, by having the issue of human genetics and the related policy areas assessed from the perspective of a pan-European panel of citizens. Another aim is to stimulate wider public debate on human genetics beyond the Council of Europe. The work is to be continued by the new Committee of Education, Culture and Science.

c.        Charter of Fundamental Rights of the European Union

21. In the recently adopted Charter of Fundamental Rights of the European Union, the EU’s declaration has included in black on white, certain provisions which pertain to the safeguarding of certain rights as far as the human genome issue is concerned. Article 1 states full respect for human dignity and the necessity of its respect and inviolability. Article 3 mentions specifically the prohibition of Eugenic Practices and the selection of persons on those grounds. It prohibits the commodification of the human body and its parts and also the reproductive cloning of human beings. An interesting departure from the Bioethics Convention of the Council of Europe here, is that it says nothing of therapeutic cloning, that is the cloning of human embryos for the specific use of cannibalised parts of certain cells called “Stem Cells”, for research purposes. This is in fact human cloning nonetheless. Article, 21, lists the prohibition of discrimination on several grounds but also includes genetic features, thereby setting the tone for the prohibition of genetic results for the purpose of discrimination within employment, insurance, health and educational milieux.

Reporting committee: Committee on Science and Technology

Committee for opinion: Committee on Legal Affairs and Human Rights

Reference to committee: Doc 8773 and Reference No. 2520 of 26 June 2000

Opinion approved by the committee on 5 March 2001

Secretaries to the committee: Mr Plate, Ms Coin, Ms Kleinsorge and Mr Cupina

¹ See Doc 8901 tabled by the Committee on Science and Technology.