28 June 2000
Committee on Agriculture, Rural Development and Food
Rapporteur: Mr Wolfgang Wodarg, Germany, Socialist Group
1. In his outstanding report Professor Mattéi quite rightly recognises the exceptional significance of the latest developments in biotechnology. In medicine in particular they open up new possibilities of treatment for many medical conditions which it used to be impossible to deal with adequately if at all. Even though the great hopes that genetic treatment techniques would soon be available have proved wildly optimistic, genetic engineering will still revolutionise the production of medicines in the foreseeable future.
2. In many areas of life, biotechnology will prove to be the technology of the new century and transform both industrial and agricultural production.
3. In his report Mr Mattéi shows clearly why, alongside all the cause for optimism, faith in progress and fascination with technological innovation, there is also much reason for worries and fears. At the heart of the debate are unanswered ethical and social questions which affect people directly in the way they see themselves as individuals and members of the community. The great opportunities that these technologies open up are accompanied by equally great dangers, particularly in the natural world, where nature’s ecological balance is under long-term threat. Just as we hope that genetic engineering will provide us with definitive solutions, so there is a danger of definitive and irreparable damage.
4. The combination of biology and information technology enables us to interfere radically with the living world. Though it might be argued quite rightly that human beings have always shaped plants and animals through their efforts at cultivation and animal breeding, the transfer of genes from one species to another suddenly gives us an option which nature not only does not provide but prevents by numerous mechanisms. We have neutralised these mechanisms by technical means and created new life forms which are in keeping with our notions of utility and are expected to function as reliably as the machines we once built. Life forms however can only be partly compared with machines: for one thing, they have the ability to reproduce, an ability which, along with the constant possibility of emergence of new characteristics, lies beyond our control, especially in the smallest life forms.
5. Accordingly the Rapporteur rightly insists on adopting the precautionary principle as a guiding rule in decision-making on biotechnological innovations. A further report on the subject has been promised. Because of the risks involved, it is even more important to heed the precautionary principle where humankind and nature are directly affected than with technologies based on chemistry and physics. Our past irresponsibility in assessing the impact of new techniques has already saddled us with major environmental problems. If as little responsibility is shown with new biotechnologies, then the probable danger far exceeds any environmental pollution risks encountered hitherto.
6. The Rapporteur presents a careful analysis of the question of the patenting of life forms or parts of them and recommends that the Council of Europe should step up its activities in this area in accordance with existing recommendations (Recommendation 1213 (1993) on developments in biotechnology and the consequences for agriculture; Recommendation 1425 (1999) on biotechnology and intellectual property). In hardly any other area is economic influence on politics as clear as it is here. The European Union directive on the legal protection of biotechnological inventions (98/44 EC), adopted by the European Parliament after lengthy debate in 1998, in large measure accommodates the demands of the major pharmaceutical companies with its inconsistencies concerning protected status of the human body, and the Rapporteur rightly suggests that this directive represents a completely new approach in Europe to life forms, describing them as “biological material” and hence unacceptably treating them as commodities or conventional technical products.
7. The overwhelmingly critical public reaction to which Professor Mattéi repeatedly refers in his report requires that politicians carefully weigh short-term economic gains from which not everyone will benefit against long-term consequences which everyone will have to bear.
8. The two most important demands made by the Rapporteur - adoption of the precautionary principle and the stepping up of efforts to establish an alternative system of intellectual-property protection where living matter is concerned - should be strongly endorsed.
9. The latest developments at the European Patent Office - the patenting of human embryos and of plant species - and public discussion as to whether human genes can be patented, show that there is at present an urgent need for clear legislation, reliably indicating the limits of patenting in the case of animate nature. In particular, ethical aspects and the distinction between technical achievements, which can be patented, and discoveries and biological processes need to be adequately regulated.
10. The Council of Europe’s Recommendation No. 1425 (1999) of last September on “biotechnology and intellectual property” has already shown the way in this area.
11. The European Union’s Directive on the legal protection of biotechnological inventions (98/44/EC), now awaiting incorporation into domestic law, does nothing to clarify these questions. On the contrary, it creates additional grey areas and legal uncertainties, and is thus completely unable to produce answers to these questions.
12. The following are some of the text’s unacceptable shortcomings:
i. The provisions on the ethical limits of patenting are inadequate.
ii. Incorporation of the Directive into domestic law would result in a serious imbalance between inventions and the patent claims derived from them.
iii. The Directive is incompatible with the wording and purpose of various international agreements and laws.
iv. Moreover, because it fails to regulate various questions uniformly, it does not provide the necessary legal security, and is thus incompatible with the general principles of EU law.
13. The Directive’s most serious shortcoming, which cannot be rectified even when it is incorporated into national law, is its failure to indicate the limits of patent law in connection with animate nature. In principle, it permits the patenting of plants and animals, parts of the human body and the genome of all living organisms.
14. This cannot be reconciled with the basic principles of modern patent law, which provides for the patenting of technical inventions only.
15. The EU Directive redefines living organisms as “biological material” and, in so doing, trivialises violations of basic ethical principles.
16. Less welcome is the proposal in paragraph 6.iii of the Recommendation to introduce a “bioethical label”. We have to establish a procedure for early technological-impact assessment in order to stimulate, support and take forward values-oriented discussion of the possible undesirable consequences and social side-effects of new technology in medicine and biology. The danger with an ethical label, as with other labels (eg eco-labels), is that the label would salve people’s consciences and there would be no in-depth debate. Furthermore, clear and identifiable criteria in ethical debates can only be established if, fundamentally, there is social consensus on the matter, as is the case on the question of child labour for instance. If this consensus does not exist then the only possibility is either to content ourselves with a minimum ethical standard or dogmatically lay down a set of moral precepts. Neither approach is desirable.
17. A society’s perception of its basic values is the result of an ongoing and arduous process of discussion which should not be cut short or simplified by the introduction of a label encouraging ethical thoughtlessness.
18. The CDBI should devise a system for transnational monitoring of standards. In consultation with national ethics councils, research projects and projects for industrial production in the biotechnology field must be subjected as early as possible to technological-impact assessments. This will provide a means of analysing and evaluating the social and political consequences of new technologies in good time.
19. This means that our first aim must be to identify and juxtapose the relevant ethical principles, compare them and see how powerfully each applies. For instance the utilitarian principle or the principle of benefit to the majority has quite different force from the principle of respect for human dignity, which is more concerned with the individual.
20. In his report the Rapporteur already establishes a very important principle when he argues that patients' hopes of the new medical possibilities opened up by biotechnology must not be the sole criterion. He reminds us (paragraph 25) that the end does not justify the means. How ill-advised it would be in private life to take our selfish wishes as the guiding principle of our actions. Even if the desired end were achieved, other extremely important considerations could be overlooked, such as the rights of other individuals or the complex interplay of cause and effect within our ecosystem.
In the light of the above, the Rapporteur suggests the following two amendments to the draft recommendation:
Amendment N° 1
Replace paragraph 6.iii. by the following
"ask the Steering Committee on Bioethics (CDBI) to prepare, in co-operation with other relevant organisations, for the introduction of an assessment method for ascertaining whether new technologies in medicine and biology are compatible with fundamental ethical principles, human rights and human dignity. This should take into account the decision–making procedures of individual countries and relevant international organisations as well as the different cultural, religious or social traditions or conventions in the member states".
Amendment N° 2
After paragraph 6, insert a new paragraph, as follows:
“Calls on the member states of the European Union not to incorporate Directive 98/44/EC of the European Parliament and the Council of 6 July 1988 on the legal protection of biotechnological inventions into national law. An immediate moratorium should be introduced, leaving time for the necessary public discussion and the finding of an appropriate solution.
In this connection, those member governments which have already brought complaints against Directive 98/44/EC before the Court of Justice of the European Communities should be supported.”
Committee for report: Committee on Science and Technology (Doc. 8738).
Committee for opinion: Committee on Agriculture, Rural Development and Food.
Reference to committee: Doc. 8102 and Reference No. 2401 of 26 May 1999.
Opinion approved by the committee on 20 June 2000
Secretary to the committee: Mr Sixto.