Patenting life

European safeguards for bioethics

After a long and complex debate, the European Parliament, Commission and Council of Ministers have reached agreement on setting clear, effective and ethical regulations on the controversial subject of the "patentability" of life. RTD Info discussed the subject with Alain Pompidou, Member of the European Parliament and a man who is very closely involved in a subject of vital importance to the growth of biotechnologies.

The Commission submitted an initial proposal for a directive on the protection of biotechnological inventions to the European Parliament in 1995. It was rejected by a majority of MEPs. For what reasons?
Alain Pompidou: To my mind, the initial proposal was based on two considerations only: harmonisation of the single market and the protection of intellectual property. The text failed to take sufficient account of the ethical dimension. Yet this is an essential element when it comes to patenting and marketing processes and products obtained from human beings. The Directive's rejection was therefore the point of departure for a genuine and essential debate. Parliament has done a considerable job in shedding light on the questions raised in this field. The some 66 amendments finally tabled have radically changed the original text.

What is the overall effect of the proposed amendments?
The Directive first stipulates a fundamental point, namely the field of what is or is not patentable in the area of living organisms, together with the precise significance of the intellectual property rights conferred by a patent. You cannot patent a scientific discovery which, by definition, is universal and must remain accessible to everyone. A researcher, laboratory or company cannot acquire ownership of a living organism and in particular all or part of a human being at any stage of its development. The protection can only relate to an invention, that is a value added linked to intelligence and know-how which is likely to lead to a new application, product or process.
We must also remember that registering a patent does not mean automatic authorisation to market it. Protection of the inventor does not give him automatic marketing rights.

What are the ethical safeguards introduced by the new text?
Without going into the details, as the Directive covers many different ethical considerations, I would cite three major cases in which patenting is out of the question. The first concerns all processes resulting from research on embryos that are not for their direct benefit. Then there are inventions based on modifications to the genetic identity of human germ-line cells as well as any cloning process for the purposes of human reproduction.

"This Directive will make it possible to mobilise research bodies and stimulate the registering of patents."

How are these major principles going to be translated in legal terms?
The EU Member States will have two years in which to transpose them into national legislation. The Directive fixes the terms of reference, but it clearly does not close the debate on bioethics. Its application will require further discussion as the sociocultural contexts and approaches can vary significantly from one country to another. Whereas France and Germany already have a strict policy banning any experimentation on the embryo, the United Kingdom allows this type of research until the 14th day of embryo formation, arguing that during this period the nervous system is not yet formed.

Another example is human cloning. As the position recently adopted by the United States shows, there is a consensus on the principle of banning it, but that does not rule out the possibility of certain exceptions, which are at present being debated by the experts. Examples of these include multiplying embryos in order to produce a sufficient stock to attempt an implant in cases of sterility where oestrogenic hyperstimulation is dangerous, or obtaining embryos which are not going to be developed but used to take samples of stem cell lines to be used for skin grafts, or nerve, endocrine or blood cells for the treatment of Parkinson's disease, diabetes or leukaemia. This is cellular cloning for therapeutic purposes. It has nothing to do with manufacturing a new child.

80% of Europeans approve of biotechnological developments in the field of health. They have many more reservations about their use for agri-foodstuffs purposes.

Could processes of this kind be patented?
The process which results in reproducing stem cell lines is already patented, not on cloned embryos but from blood taken from the umbilical cord for the treatment of leukaemia.

Similarly, although the Directive clearly establishes that the identification or decoding of the partial or total sequence of a human gene cannot be a patentable invention, this would not apply if this sequence were to be used to produce a protein with a known function for an industrial application. For example, there is already a patent on the use of the human gene which codes relaxin, a hormone produced by the uterus and placenta during pregnancy. The gene protein and sequence exist naturally but are not accessible. The expertise which permits their extraction is indeed linked to an invention.

But are these not subtleties which are difficult for the non-specialist to appreciate, but which it must nevertheless be possible to explain when life sciences become part of the democratic debate?
The perception of what a gene can represent is not always very clear to the public. For many people it is something which passes on hereditary characteristics and the basis of identity. For scientists, the gene is primarily a key element in the cell system, and genetic engineering consists of drawing benefit from a fundamental natural mechanism which is able to lead to previously unimagined progress. If clearly understood, this perception can make it possible to dispel ideas of the gene as an instrument with which to exercise fiendish control over human beings.

How are the attitudes of Europeans to biotechnologies changing?
Associations of parents of myopathic or diabetic children and of families with serious genetic predispositions are mobilising in favour of research in this field. This movement is highlighting the social implications which underlie biotechnological advances. A recent EU-wide survey shows that 80% of people approve of scientific developments where health is concerned. On the other hand, the use of biotechnologies for agri-foodstuffs purposes meets with quite strong distrust. But it is not unthinkable that one day in the not too distant future tomatoes labelled "guaranteed transgenic" will be all the rage.

One of the implications of this Directive - and not the least important - is economic: 65% of patents originating in biotechnological research in the pharmaceutical sector are registered in the United States, compared with 15% in Europe. Will this new legal framework help to correct this imbalance?
I have personally made strenuous efforts to move forward this ethical debate and to arrive at the compromise which we now have, as the previous legal vacuum certainly resulted in a lot of European capital ready to be invested in this sector going to the United States. But we are very strong in biotechnology and this Directive will now make it possible to mobilise research bodies and stimulate the registering of patents. I believe not only that this draining of European venture capital can be halted, but also that our scientists can attract funds from countries outside the EU. The creation of the euro zone also raises hopes of increased investment in many fields, and biotechnology in particular.

Doctor of medicine and science, Alain Pompidou teaches at the René Descartes University (Paris). He is President of the STOA (European Parliament scientific and technological options assessment) and member of the Conseil d'Application de l'Académie des Sciences (France).