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Des sources du savoir aux médicaments du futur

 | 
Jacques Fleurentin
, 
Jean-Marie Pelt
, 
Guy Mazars

3. Médicaments du XXIe siècle

Medicinal plants and biotechnologies, a booster for the new economy?

Jean-Marie Pelt

Résumé

Genes are likely to play a major role in global economy in the 21st century au niveau de patenting some of them represent an enormous marketing potential. The battle for the appropriation of living organism is currently raging; it all started some twenty years ago when the U.S. Supreme Court granted a patent on a recombined micro-organism.
In the face of this development, the countries in the South, holders of the larger part of the earth’s biodiversity, try to counteract vigorously this what they view as an act of piracy against the world’s natural heritage and ancestral knowledge, and claim for a share of the financial spin-offs.
The distance between patenting natural resources and patenting human genes is very short and the U.S. Administration, together with some private corporations, have tried to cover it. Some recent victories in this respect suggest the pressure from public opinion will not in the long run be a match to counter the attacks launched by greedy multi-national companies.

Texte intégral

1At the beginning of the 60s, Medical Matter (translation of the title of a work by Dioscorides - a doctor in Nero’s time - counting the plants used for medical treatment at the time) could be considered moribund, as we were entering an era of triumphant synthetic chemistry.

2In the course of the last decades, we could witness the progressive disappearance of the knowledge fostered by traditional practitioners, healers, shamans, sorcerers. The heirs of these traditional specialists, affected by modernity and the American culture, were not any longer a link to transfer the ancestral knowledge of their elders. As a consequence, a widening gap was formed between this culture stemming from America and the traditional cultures threatened with disappearance, under the eyes of the few ethnologists who studied them.

3Some twenty years ago, the scene was slightly changed under the impetus of WHO and UNESCO (two institutions depending on the United Nations) which paid attention to this therapeutic heritage.

4In 1990, on the occasion of the First European Conference on Ethno-pharmacology, it appeared clearly that there was renewed interest in the world of medical treatment (the pharmaceutical industry and the world of medicine in particular).

5And in the past 10 years, this world has experienced a thoroughgoing change under the influence of 2 factors:

  • on the one hand, the Earth Summit Conference in Rio de Janeiro in June 1992, which disseminated the concept of biodiversity i.e. the wide range of the vegetable and animal species living on the planet, that should be preserved at all costs. By focussing attention on this topic, it created a new interest in the plants themselves and also in those who were the repositories of traditional knowledge;
  • and, on the other hand, transgenesis, a technique meant to facilitate the patenting of plants, in a way which can be considered as rather questionable.

6Under these two sources of influence, the multinational companies active in pharmacy and life sciences joined the rat race to get hold of this traditional knowledge and the vegetable world, so that our duty is now to contribute to the promotion of knowledge by publishing it, to slow down the movement aiming at appropriating areas of knowledge that now belong to the heritage of mankind.

7Genes represent the "green gold" of the century of biotechnologies. Having control on the genetic resources of planet will play the same role as having control on ores and fossil fuel resources during the industrial era. The point is currently to identify microbes, plants, animals and human beings carrying rare genetic features, to be able to exploit - after patenting - the commercial potential they represent, after having made sure that these genetic features have been properly modified by transgenesis so that they can be patented.

8As biodiversity is higher in the southern hemisphere, the genetic resources of the South are therefore coveted by the North. The South estimates then that they have a legitimate right to derive some benefit of this situation, just as the Middle East has with its oil... But the multinationals in the North claim that these genetic resources acquire some value only when recombined with the techniques of transgenesis. Here are two examples.

9Some years ago, researchers identified a very rare variety of Indian corn of which only a couple of thousands of individuals still existed in Mexico. This variety resists a mushroom which had worked havoc among the American crops in 1970.

10According to the geneticists and economists working for the companies producing seeds, the annual market value of this variety was estimated to be to several billion dollars.

11Likewise, Madagascar did not get a farthing for the use of their pink periwinkle that Eli Lilly Company transformed into a drug, making comfortable profits in the process: 160 million dollars in receipts in 1993! And Madagascar had absolutely no share in the profit.

12The American Government is currently storing in Colorado more than 400,000 varieties of seeds coming from the whole world. Similar gene banks are being developed in many countries; they specialise in rare micro-organisms, in embryos of frozen animals.

13The outcome of millions of years of genetic evolution is currently being transformed into private intellectual property.

14The appropriation of life started in 1971 when an Indian microbiologist, Ananda Chakrabarty applied for a patent on a genetically modified micro-organism able to absorb the petrol of oil slicks. PTO (Patents and Trademark Office: the American equivalent of the French Institut National pour la Propriété Industrielle) turned his application down as the American legislation makes the patenting of live beings impossible. Chakrabarty and the General Electric company, by which he was paid, appealed to the decision. They won their case and the motive for this success was that the micro-organism patented "was closer to inanimate chemical compounds... than to horses, bees, raspberries or roses". The implicit inference was that, if the application had applied to a mouse or some other animal, it would most probably have been rejected. PTO appealed again to the decision, this time to the Supreme Court. And in 1980, with five votes against four, the judges of the Supreme Court decided in favour of Chakrabarty and granted the first patent on a form of genetically modified life. This judgement, as could be expected, was considered as a precedent. From then on, biotechnology was deprived of its scientific virginity and entered the the world of big business. Numerous specialists even announced that the miracles of science would become the economic engine of the post-industrial era.

15October 14, 1980, a few months after the decision of the Supreme Court authorizing the commercial exploitation of life, the Genetech company put on the market one million share for 35 dollars each. The rate of the share rose within twenty minutes to 89 dollars, even though the company had not marketed any product yet... Knowing that patents could be granted to biotechnologies and genetically modified live beings gave a mighty boost to the development of this branch of industry. From now on, the line of distinction - in terms of business - between live beings and inanimate objects vanished.

16Moreover, the organisms obtained by genetic engineering were to be regarded as an invention, in the same way as a computer or a machine. Live beings were deprived of their aura of sacredness and were endowed with a commercial value.

17In a second stage, in 1987, PTO decreed that, from now on, any multicellular living organism, including animal, were potentially patentable. The lawyers commenting on this new position advocated by PTO made the point that man was not concerned by this development, due to the 13th Amendment in the American Constitution which makes slavery illegal. However, embryos, foetuses, genes, cell lines, genetically modified tissues and human organs could be patented. All things considered, a human being is susceptible of patenting, if not entirely, at least in pieces... However, a molecular biologist has never created any gene, cell, tissue, organ or organism ex nihilo. All the same, what was originally a discovery came to be looked upon as an invention. Isolating a gene in order to establish the properties and functions was sufficient to patent it as an invention.

18Can a chimpanzee, whose genetic stock is 99 % similar to man’s, be patented as a human invention as soon as a new gene is introduced into its body? According to PTO, the answer is yes.

19The third stage was reached in 1988, one year after having admitted the principle of patentability of the living world in its entirety. PTO granted for the first time a patent on a mammal, a genetically modified mouse harbouring a human gene predisposing it to cancer. It was marketed by the Du Pont corporation as a research model for investigation on cancer. Recently, the Scottish team which fathered Dolly, the cloned ewe, filed an application for a generic patent meant to give them exclusive property of all cloned mammals, including clones of human beings.

20These generic genes represent the fourth stage in the process of extending the patentability concept to any living being. Agracetus, after being bought up by Monsanto, was granted a patent "covering all cotton seeds and seedlings containing a recombined (i.e. genetically modified) gene". This patent gives to one single multinational corporation an unprecedented power to control the cultivation of cotton in the whole world. Under the pressure of competition, PTO, fearing that they might have operated beyond the limits of their scope of competence, reconsidered their initial decision. The case is currently re-examined (appeal).

21At the same time, the W.R. Grace Company has applied for a patent in 1994 - the application was accepted - to protect a technique making it possible to introduce genes into any variety of soy.

22These patents covering such a wide scope of application gave rise to vivid reactions. Some people considered that this was no less than an economic "robbery", "...something that, just with the stroke of the pen, wiped out the research efforts of innumerable farmers and scientists".

23A merciless and unprecedented war is thus being waged, with various companies eager to patent genes, organisms and techniques for manipulation with a view to reinforcing their individual share of the market and their competitiveness.

24As could be expected, the nations of the South are voicing their opposition to the greed of multinational companies and new terms such as "biopiracy" or "biocolonialism" have been coined. Is this not similar to the situation we had when nations were competing for spices or, later, for the Brazilian rubber. We remember that, in the latter case, some seedlings were stolen by the Britons who then took them to South-East Asia and this gave them a decisive advantage on the world market, ruining the action of the United States to seize control of its production in the New World. But now we are not talking any more of plant prospectors, but rather of gene prospectors seconded by the great multinational companies to all parts of the South hemisphere. Thus also applies to research on the drugs used in native medicine.

25The nations of the South claim that what the companies of North call "discoveries" are actually no less than ways to seize the heritage of traditional knowledge held by native peoples. They consider that a minor genetic modification applied to a cultivated variety is trivial when weighed against the meticulous care that people have had to bestow over many centuries to these organisms to preserve their invaluable and rare features - these values which are now so eagerly coveted by researchers. The Melia azedarach case is a proper illustration of this problem. The W.R. Grace Company obtained a patent on specific processes for the exploitation of this tree, which unleashed a strong reaction of anger in India and in the whole world. The case was taken over by the NGOs as Melia is a symbol of India that has near-to-mystical status in this country. Age-old texts refer to this plant as a "blessed tree" endowed with multiple healing virtues.

26Moreover, the twigs can be used as tooth-brush and the young shoots are eaten on New Year’s day The leaves and bark are used to cure acne and villagers use it to protect their crops from vermin. The tree is in fact a natural pesticide, with properties that are more powerful than certain chemical insecticides. The W.R. Grace company isolated azadirachtine, the most active principle in Melia seeds and obtained from PTO several patents on the extraction of this principle. But the Indian researchers declared that companies and researchers in India has been treating seeds for many years following similar procedures, without thinking of applying for any kind of patent, as this knowledge was public domain... Now, they feared that the W.R. Grace patents would prevent the Indian peasants from producing and using the pesticides produced on the basis of these seeds. The case is pending in court (appeal).

27Ayahuasca is another example illustrating the argument. This name refers to a liana found in Western Amazonia; it is used by shamans - who are key characters in South American societies- who chew them to enter the spiritual world. Under the influence of this plant, they have visions providing information about the therapeutic properties of other plants. Ayahuasca is thus regarded as the "mother-plant", the mother of all others because, due to its "hallucinogenic capacity", it discloses their curing properties.

28This plant, which plays a key role in the culture and religion of Amazonian ethnic communities, was patented by an American pharmaceutical laboratory. These traditional societies were considerably upset as, from now on, they were supposed to pay royalties to this pharmaceutical corporation for the use of ayahuasca.

29The Indian natives, being well informed about the industrial world, protested vehemently and arraigned the patent granted by the Patents and Trademark Office, taking the case to American courts. PTO was condemned and the patent on ayahuasca was rescinded.

30Another example is that of Thaumatococcus danielli, a plant with high sweetening capacity growing in West Africa. A Korean pharmaceutical company called Lucky Biotech Corporation, with links to to the University of California, showed an interest in this plant in 1993 and obtained American and international patents for a genetically modified sweetening substance extracted from this plant. But the African villagers who had used this plant since the dawn of time to sweeten their food and which are the real inventors of this plant will not derive any profit from it. And yet, the future of this sweetening substance is all the brighter as it is low-cal.

31Some institutes, such as the National Cancer Institute, have signed agreements with various countries, promising royalties should a molecule stemming from a plant growing in these regions provide a drug. Various private companies have also made agreements with source countries to share the profits to be derived from the patented products. This applies, for instance to the agreement made between Merck and Costa Rica. Costa Rica has granted for a modest million dollars bioprotection rights to a corporation boasting a USD four-billion turnover in sales; they can now freely prospect one of the wealthiest territories of the earth in terms of animal and vegetable biodiversity. Moreover, the grantee has acquired a right to sell prospecting concessions in an area on which they have no historical right whatsoever and the native populations will not receive a single farthing in compensation.

32In short, two philosophies can be set against one another: the multinational companies claim that prospecting activities under patents correspond to a basic need so that they can devote financial resources and years of research work to the development of new and useful products. The nations of the South contend that the energy to be applied to research has already been displayed on their country in the past and demand that a share of the spin-offs of the technological revolution. But a growing number of NGOs and certain nations remind us persistently that the genetic heritage is not for sale; it should rather be available - free of charge and without restrictions - to all present and future generations.

33Moreover, it can be noted that protection by patents runs counter the freedom of movement for information and is a real obstacle to research.

34Finally, it further reduces the ever narrowing scope of freedom of researchers, both in the public and the private sector, towards the companies financing their work in the framework of contracts. Incidentally, we can see that more and more researchers become shareholders in these corporations.

Patenting man

35In 1993, the American Administration filed patent applications for a virus isolated in the cell line of a Guarani Indian woman originating from Panama. The genome of these Indians is of great interest for the researchers of the National Institute of Health because it carries a virus stimulating production of antibodies that, according to researchers, could be of great value to combat AIDS and leukaemia.

36The Guarani Indians protested vigorously against the idea of being thus patented collectively, and the American Administration had to withdraw their application. But they soon repeated this action, this time concerning the cell lines of people originating from the Solomon Islands and Papua-New-Guinea. The patent - on the lymphotrophic virus of human T lymphocytes - was granted by PTO. It was the first time that a cell line stemming from a native community was ever patented. Facing the outcry that this event caused, the American Administration discreetly withdrew its patent application in 1996.

37In 1997, a scientific expedition headed by a Toronto geneticist and financed by the Sequana Therapeutics company of California (a company specialising in genetic prospecting) went to the island of Tristan Da Cunha - with a population of a few hundred inhabitants who are endogamous and half of them suffer from asthma. Scientists hope to identify the gene(s) to be blamed for that condition and to patent them. Blood sampling has been done with 260 inhabitants out of 300. But no result has been published. The company has declared that its raison d’être is the commercial exploitation of the human genome...

38There is no need to go that far to find examples of the problem. In California, a businessman has realized that certain parts of his body had been patented - without his knowing it - by the University of California and had been transferred under licence to the Sandoz company. The tissue of John Moore’s spleen produces a protein facilitating the growth of leucocytes, which are invaluable anti-cancer agents. On the basis of tissue from John Moore’s spleen, the university has created a cell line which was patented in 1984. The value of this cell line is estimated three billion dollars. Moore took the case to court and claimed a right of ownership on his own tissues; he was nonsuited by the Supreme Court of California.

39The American company Biocyte obtained a patent giving them the ownership of all the blood cells taken from the umbilical cord of a new-born baby and used for therapeutic purposes. However, these cells play a significant role in bone-marrow transplantations, so that they have enormous market value. The patent is based on the fact that this company managed to separate these blood cells and to freeze them. It did not change anything to the blood itself. However, it has managed to obtain a patent giving them trading rights on this part of the human body. In the same way, human genes are currently being patented as their specific action is identified; in extreme cases, patenting occurs before identification. For instance, Dr Venter, the head of the research team working on the human genome at NIH, resigned from his position to become the manager of a genetech company. He filed an application to patent over two thousand of the genes coding human neurons; this initiative caused an outcry. Most probably, in less than ten years’ time, each of the hundred thousand genes making up the human genetic stock will have been patented and have become the sole property of multinational corporations.

40Strong opposition to this kind of practice is currently rising, in particular in the United States. In Europe, in 1995, the European Parliament turned down a draft Directive aiming at harmonizing the various procedures applying to patent rights in the Member States, by putting them in line with the very lax criteria paramount in the United States. The European Parliament decided against the patentability of genes, cells, tissues, human organs and embryos, claiming that they are there nature’s creations and not "inventions", only discoveries. However, in 1997, the European Commission has tabled a new draft Directive, following strong pressurizing of the European Parliament, which eventually adopted the new text.

41A great battle is thus underway about the issue of the patentability of life. Several American clerics have formed in 1995 an alliance to fight against the patentability of life, claiming that life is God’s creation, not Man’s creation. Consequently, they vehemently oppose any attempt by man to pose as an initiator and a sovereign architect of life on earth.

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