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
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.
Ten years of reflection
The complex issue of the patentability of life has given rise to
almost 10 years of debates culminating in a directive harmonising
the regulations in force in the Member States. An initial proposal
for a directive was adopted by the Commission on 21 October 1988.
But it was 1 March 1995 before this was submitted to the European
Parliament, where it was rejected by 240 votes against, 188 for
and 23 abstentions. The Commission adopted a new proposal for a
directive on 13 December 1995. This legislative procedure reached
a positive conclusion on 6 July 1998 with the final passing of the
directive which entered into force on the day of publication in
the Official Journal of the European Communities, on 30 July 1998.
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
"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
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
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).