Source: Official Journal C 96, 17/04/1989 p.165-171

10. Generic engineering

(a) Doc. A2-327/88


on the ethical and legal problems of genetic engineering

The European Parliament.

-having regard to the motions for resolutions Docs. 2-420/84. 2-596/84. 2-630/84. 2-638/84. 2-715/84.

B2-148/86. B2-1665/85. B2-534/86. B2-619/86. B2-704/86. B2-989/86 and B2- 72/88.

-having regard to the suggestion made by the President of the Commission on 15 January 1985 in the European

Parliament concerning the right of initiative ( 1 ).

-having regard to the conclusions of the hearings held by the Committee on Legal Affairs and Citizens´ Rights from 27 to 29 November 1985 and from 19 to 21 March 1986,

-having regard to its earlier resolutions on biotechnology and, in particular, its resolution of 16 February 1987 (2),

-having regard to its opinion of 15 February 1989 on the Commission proposal for a specific research programme in the field of health: Predictive Medicine: Human Genorne Analysis (1989-1991) (COM(88) 424 final- SYN 146) (3),

-having regard to the report of the Committee on Legal Affairs and Citizens' Rights and the opinions of the Committee on the Environment, Public Health and Consumer Protection, the Committee on Women's Rights and the Political Affairs Committee (Doc. A2- 327/88),

A. having regard to the discoveries made by science and research in the area of genetic engineering in the past and the prospect of further advances in the future,

B. having regard to research findings and their application in combating human infertility,

C. aware that genetic engineering is already having a lasting effect on society,

D. whereas genorne analysis may, on the one hand, bring about possible improvements in diagnostics, preventive medicine and therapy but on the other, entails the risk of creating compulsory eugenic and preventive objectives, of applying genetic analysis for the purposes of social control and the segregation of whole social strata, of selecting embryos and foetuses on the basis of their genetic characteristics alone and of producing fundamental changes in our society,

E. whereas there are no reliable scientific methods of assessing the medium and long-term consequences of the irreversible release of genetically manipulated organisms into the environment,

F. gravely concerned that experiments involving the release of such organisms are being carried out,

G. whereas the dignity of wornen and their right to self-determination must be taken into account in the necessary legislative measures,

H. whereas the problem of abortion is a separate issue from those raised in this resolution and no-one may refer to them in connection with the debate on abortion,

As regards methods:

1. Declares its intention of evaluating and assessing social, economic, ecological, health, ethical and legal aspects of new developments in the field of genetic engineering at the research and development stage including possible undesirable and unintentional (social) side-effects;

2. Calls on the Commission to support its ethical and legal assessments and to submit corresponding proposals for Community legislation in the areas within its jurisdiction;

3. Calls on the govemments and parliaments of the Mernber States to take corresponding action in the areas within their jurisdiction and looks to them to press for parallel initiatives in the Intenational organizations of which their States are members:

4. Asks the Parliamentary Assernbly of the Council of Europe and its Committee ofMinisters to take corresponding action;

5. Resolves, to this end, to take the initial steps towards setting up an international, pluralistic commission for the ethical, social and political evaluation of the results of human genome research and their possible applications. This commission should be responsible for:

(a) preparing a review of research programmes, objectives and results in connection with human genome analysis and making it available to the general public and political decisionmakers;

(b) delivering opinions on these research programmes and, if they are promoted by the European Community, following their development and monitoring their application;

(c) drawing up principles for using the results of human genetic analysis and allowing them to be the subject of public debate;

(d) to promote and organize international conferences and other ways of facilitating an ongoing exchange of information and views on this subject, the aim being to establish worldwide agreements and ethical principles governing the use to be made of the knowledge acquired by means of human genome analysis;

(e) supporting the decisions reached by the European Parliament, the Commission and the Council on all aspects of this subject with information, statements of opinion and measures intended to inform and involve the general public;

This commission should be made up of Members of the European Parliament, members of the national parliaments of the Member States, delegates from organizations representing the interests of those particularly affected (women, workers, consumers, the disabled, people working in the health sector, etc.) and experts;

6. Calls for this commission to be provided with the necessary funds to enable it to maintain a permanent secretariat which is independent of other bodies, to meet regularly and in particular to finance ancillary scientific research required;

As regards the legal framework:

7. Reaffirms the principle of freedom of science and research;

8. Regards the restraints imposed on the freedom of science and research, arising in particular from the rights of third parties and the society they constitute, as the expression in legal terms of the responsibility assumed by society as a whole for the action of the scientist and for research;

9. Recognizes that the rights from which these restraints derive are primarily the dignity of the individual and of the sum of all individuais;

10. Believes that the legislator has an absolute duty to define these limits;

11. Sees the role of ethical committees and professional regulatory bodies solely as translating into practice the rules laid down by legislation;

As regards genome analysis in general:

12. Considers that the absolute preconditions for the use of genetic analysis are that:

(a) genetic analyses and genetic counselling must be designed exclusively for the well-being of those concerned, and be based exclusively on voluntary agreement and the results of an examination must be communicated to those concemed at their request. This also means that a doctor shall not have the right to inform members of the family of those concemed without their consent;

(b) they must on no account be used for the scientifically dubious and politically unacceptable purpose of 'positively improving' the population's gene pool. negatively selecting genetically undesirable characteristics or laying down 'genetic standards'.

(c) the principle of a patient's right of self-determination must have absolute precedence over the economic pressures imposed by health care systerns since every individual has an inalienable right to know his genetic make-up or to remain in ignorance,

(d) the establishment of individual gene maps may only be carried out by a doctor; the forwarding, collection, storage and evaluation of genetic data by government or private organi zations shall be probibited;

(e) the development of genetic strategies for the solution of social problems must not be allowed since it would undermine our ability to understand human life as a complex entity which can never be compassed entirely by any single scientific approach,

(f) the knowledge acquired by means of genetic analysis must be absolutely reliable and enable unequivocal statements to be made about precisely defined medical facts, knowledge of which may directly benefit the health of the persons affected;

As regards genorne analysis on employees:

13. Emphasizes that the weeding-out of individual workers with a predisposition to illness must never be the alternative to the im provement of the working environment;

14. Calls for a statutory ban on the selection of workers on the basis of genetic criteria;

15. Calls for a ban on the general use of genetic analysis for mass examinaticns of employees;

16. Demands that genetic examinations of workers for the purposes of occupational medicine must not be permitted before they take up jobs and may be carried out only with their consent and with reference to their current state of health and the potential risks to their health inherent in their working in a specific place and be carried out by a doctor of their choice but not by a works doctor. The results of such examinations may only be made available to the individual concerned and may be passed on only by that individual. Any infringements of the right to obtain information are subject to prosecution;

17. Emphasizes that the worker concemed is entitled to be given detailed information and advice about the proposed analysis and the implications of the results before they are carried out and to refuse at any time and without giving any reasons, to allow genetic tests to be carried out, without having to anticipate any positive or negative consequences from such refusal;

18. Demands that genetic data on workers may not be stored and must be protected by special measures from abuse by third parties;

As regards genome analysis for insurance purposes:

19. Considers that insurance companies have no right to demand that genetic testing be carried out before or after the conclusion of an insurance contract nor to demand to be informed of the results of any such tests which have already been carried out and that genetic analysis should not be made a requirement for the conclusion of an insurance contract;

20. Asserts that the insurer has no right to be notifled by the policy holder of all the genetic data known to the latter;

As regards genome analysis in legal proceedings:

21. Dernands that genetic analysis in legal proceedings should be adrnissible only in exceptional circurnstances to be deterrnined by the judge alone and in certain limited areas; only those elernents of a genorne analysis may be used which are relevant to the case and do not allow conclusions to be drawn as to the genotype as a whole;

As regards somatic gene therapy:

22. Considers that gene transfers in human somatic ceIls are basically an acceptable form of therapy, about which the patient must be properly informed and for which his consent obtained;

23. Takes the view that a further precondition for gene therapy is careful consideration of whether the scientific basis for such transfers is sufficiently advanced for the attempted treat ment to be justified. that is a risk-benefit analysis;

24. Calls for a clear, statutory list, to be reviewed periodically to take account of the advances in medical science, to be drawn up of the hereditary diseases suitable for this type of therapy;

25. Advocates that there should be an assessment of the concepts of illness and of genetic defect to deal with the danger of defining as a medical disorder or genetic defect conditions which are merely deviations from the genetic norm;

26. lnsists that gene therapy must only be carried out in recognized centres and by qualified staff;

As regards genetic manipulation of the germ line:

27. Calls for an absolute ban on all experiments designed to reorganize on an arbitrary basis the genetic make-up of humans;

28. Calls for legislation prohibiting any gene transfer to human germ line cells;

29. Considers that the legal status of the human embryo must be defined to provide unequivocal protection of genetic identity;

30. Considers that even a recombination of genes only partly alters the genotype the identity of the individual is falsified which is both irresponsible and unjustifiable because a very individual legal asset is involved;

As regards research on embryos:

31. Considers that the zygote also needs protection and therefore must not be subject to arbitrary experimentation; takes the view that it is not enough to regulate this problem by means of guidelines within the medical profession;

32. Calls for the possible applications of research, diagnosis and therapy, particularly at the prenatal stage, to be the subject of legaIly binding definitions so that procedures involving live human embryos or foetuses or experiments on them are justified only if they are of direct and otherwise unattainable benefit in terms of the welfare of the child concerned and its mother and respect the physical and mental integrity of the woman in question;

33. Calls for neonatal screening to be restricted to curable diseases and to be voluntary, with refusal not pe:nalized in any way;

34. Calls for it to be a criminal offence to pass on such information;

35. Considers that the use of dead embryos or foetuses for diagnostic purposes can be permitted only when there is a justifiable reason;

36. Considers it should be a criminal offence to keep human embryos alive artificially with a view to removing tissues or organs as the need arises;

37. Demands that the use of dead human embryos for therapeutic or scientific purposes be restricted in the same way as the use of human corpses;

As regards the use of embryos for commercial or industrial purposes:

38. Insists that any commercial or industrial use of embryos or foetuses, whether it involves the production of in vitro fertilized embryos for such purposes or imports of embryos or foetuses from third countries must be a criminal offence;

As regards cryopreservation:

39. Advocates that human embryos should be frozen only for a limited period and if they are to be implanted to produce a pregnancy in the woman from whom eggs were removed for this purpose;

40. Calls for trade in frozen embryos for scientific, industrial or commercial purposes to be prohibited and made a criminal offence;

As regards clones:

41 .Considers that the only possible response to the possibility of producing humans by cloning and to experiments with a view to the cloning of humans must be to make them a crimical offence;

As regards chimaera and hybrids:

42. Calls for the following to be prohibited as criminal offences:

-the generation of viable hybrid embryos with various genomes and using human DNA,

-fertilization of a human egg cell with animal sperm or the fertilization of an animal egg cell

with human sperm to produce a viable embryo,

-the transfer of the cell combinations or embryos referred to above to a woman,

-all experiments designed to generate chimeara and hybrids using human and animal genetic


As regards military research and applications:

43. Calls for the Convention of 10 April 1972 on the Prohibition of the Development, Production and Stock-piling of Bacteriological (biological) and Toxin Weapons and on their Destruction to be extended to all possible applications of genetic engineering;

44. Calls for legislation prohibiting biological weapons research and for the scientifically untenable distinction between 'offensive' and 'defensive' research, which still appears in the 1972 Convention, to be abandoned:

As regards safety:

45. Considers that detailed directives on 1aboratory safety should be drawn up and adopted for research institutes and production units working in the field of genetics laying down binding regulations on:

-work involving pathogenic micro-organisms and the classification of micro-organisms - including genetically altered organisms - and pathogens on the basis of the dangers involved and, in particular, their ability to interact with other organisms.

-appropriate qualifications for staff to ensure that they are able to assess the previously unknown dangers of the new techniques and to act appropriately;

46. Calls for a ban on the release of genetically altered organisms until the Commuility has adopled binding safety provisions and calls on the competent comrnittees to exarnine whether, in view of the residual biological risk, the extent or nature of which cannot be assessed, a total ban should not be imposed:

47. Instructs its President to forward this resolution and the report of its committee to the Council, the Commission, the parliaments and governments of the Member States and to the Secretary-General of the Council of Europe.


  1. Debates No 2-321. p.38
  2. OJ No. C76. 23.3.1987. p.25
  3. See minutes of that sitting (Part II. Item 10)