2 - 1998
Biomedicin and Genetic Engineering
Man is Indivisible
Why genes must not be patented
by Evelyne Gebhard
Genes and gene sequences are essential units of the human organism. They are safeguarded by the protection of individual life and must on no account be commercialised. Evelyne Gebhardt speaks out against a directive for the protection of biotechnological inventions passed by the European Parliament last July. - The author is Member of the European Parliament and lives in Brussels.
The new possibilities of biotechnology have great potential for medical progress. We should and must take advantage of the opportunities offered by modern biotechnology and genetic engineering in particular. But, at the same time, we must be aware of the challenges that, in their novelty, pose an ethical challenge nobody is really prepared for.
Over the last few months, the European parliament dealt with such a challenge in its directive on the legal protection of biotechnological inventions. Regrettably, the solution it came up is hardly satisfying from an ethical point of view and failed to solve the really crucial problems. Inventing discoveries
The directive on the legal protection of biotechnological inventions primarily aims to protect inventions, in other words to ensure that inventors reap the well-earned rewards of their inventions. Basically, you can’t really object to that. But, this only holds true on condition that what you are patenting is really inventions. Making an "invention" in genetic engineering really means discovering genes and gene sequences and identifying the effects of these genes and how they can be used or are already used for therapy purposes or the production of new drugs. Since the 1980s, traditional patent law has already covered so-called product protection. This means that not only the inventions but also the discovered active ingredients are protected by patent law, although they are not actually inventions but discoveries.
The text adopted by the European Parliament on 18 July 1997 followed this line of thought. Article 3 (2) reads, "Any isolated element of the human body or part, including the structure or substructure of a gene won by any other technical method, may be a patentable invention, even if the structure of the element may be identical to that of a natural element."
Human integrity
This view has grave consequences and gives rise to serious ethical problems. Biotechnology and genetic engineering don’t just deal with substances or things but with life and parts of the human body. It’s all about genes and gene sequences, in other words the smallest units of the human body. In this light, the question inevitably arises whether we can treat parts of the human body like any other organic substance. The answer is a very clear no! The societies of the European Union all believe in the principle that the human body and its parts, for example organs like the heart or eyes, must on no account be commercialised. They may not be the object of commercial transactions. They may not be sold or bought. If they were only discovered today, it would be completely unimaginable for them to be patentable, in other words subject to the exclusive right of exploitation of an individual.
Why should this be different for a gene or a gene sequence? Because a kidney is bigger than a gene? Could you say that everything you can’t see or touch is no longer part of the human body? But who would set the limits, and how and where? This throws an interesting light on the issue and illuminates a fundamental problem which has faced us even before the Australian moral philosopher Peter Singer developed his theses: the creeping erosion of the unconditional protection of individual human life due to progress in medical technology. Making genes and gene sequences patentable means turning them into objects and depriving them of the special protection that man and the human body normally enjoy. It means sacrificing the integrity of the human being. It paves the way for a school of thought that is no longer willing or able to see man in his entirety and indivisibility.
Reconsidering the decision
From this angle, the European Union’s decision to make genes patentable has such a great impact that it needs to be rediscussed and reconsidered. This opportunity will arise when the decision is put to the European Council and needs to be discussed by the individual governments of the EU member states, including our German government.
It is crucial that we decide once and for all on the philosophy we want to adopt. On the one hand, we have, to put it roughly, the approach that gradually propagates the idea that man is divisible in "human" and "non-human" parts. This reminds us of the discussion raised by the so-called Bioethics Convention regarding human dignity in research on people who are unable to consent (small children, coma patients, the mentally disabled). Or would we rather follow the philosophy that fully respects human dignity and personal integrity and allows no inequality of the individual and his or her parts.
There are many positive approaches that show awareness of the necessity of such a basic discussion. For example, the European Parliament has a multi-party working group on bioethics that wants to aid decision-making in the field of biotechnology with ethical discussions. The European Commission wants to put its advisory group for ethical issues in biotechnology on a more official footing, and the German parliament is discussing the creation of an advisory ethics council, which it will hopefully put into practice.
Be it ethics council, advisory group or working group, the important thing is that ethical counselling bodies are transparent and take account of all relevant social strata with the aim of intervening before and not just after decisions have been made.
.Reprint from »Evangelische Kommentare«, no 9/1997, slightly abridged and translated for publication in this magazine.