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No Patents on Life
A Briefing on the Proposed EU Directive on the Legal Protection of Biotechnological Inventions

Corner House Briefing 01

by Alan Simpson, MP, and Nicholas Hildyard and Sarah Sexton

first published 1 September 1997

Summary

Living organisms can now be patented as “inventions” if they are the result of genetic engineering techniques or of the transfer of genes between totally unrelated species of plants, animals and micro-organisms. Yet patents can hinder research, legalise biopiracy and restrict both competition and people’s access to health treatment.

Contents

Most people assume that their bodies are their own -- and no-one else's. They assume that their blood is theirs, unless they care to donate some of it. They assume that, while they are alive, their kidneys, their eyes, their spleens, their hearts are theirs -- and will go with them to their graves unless they chose to gift them to others. They might also assume that their genes -- the inherited biological material inside each of their cells -- are theirs, rather than anybody else's.

But they could soon find themselves on the wrong side of the law. In July 1997, the European Parliament voted in favour of a proposed European Directive on the "Legal Protection of Biotechnological Inventions". If approved by the European Council of Ministers later in the year, the Directive would take companies and individuals one step closer towards being able to patent animals and plants and isolated human genes and body parts after they have been removed from the body. Once patented, the genes and body parts would effectively become the property of the patent holder.1

There is intense public concern over the ethical and social implications of this Directive. A survey published by Eurobarometer in June 1997, for example, reveals a deep ambivalence amongst the European public "about much of modern biotechnology".

What worries people most is not the potential risk to the environment or human health -- risks which are in fact substantial -- but the morality that turns isolated parts of people and living organisms into property for others to profit from. In rural Dorset, the ethics of patenting genes has even made it on to the front page of a local free paper, The Blackmore Vale Magazine, an organ more usually preoccupied with local farm sales and village events.

Patenting Life

Until now, patents have primarily been granted for mechanical "inventions" -- not living things. But with the advent of new genetic engineering techniques (particularly that of transferring genes between totally unrelated species of plants, animals and micro-organisms), patents have been applied for and, in some cases, awarded not only on the processes to isolate and characterise genes but also on the genes themselves. As a group of British scientists recently pointed out, "if this principle had been applied in chemistry, the elements would have been patented".2

The patents on living organisms granted under existing patent law in Europe have generated much controversy and have been subject to protracted legal challenges. Hence, the biotechnology and related industries are now pushing for the patenting system explicitly to encompass living material; the proposed Directive effectively defines a gene not as a "discovery" (which cannot be patented) but as an "invention" (which can). The United States already allows such patents.

If industry gets its way, the genes associated with disorders such as cystic fibrosis and diabetes could become the property of a multinational drug company. In addition, members of the public who undergo genetic screening to see whether they are affected or not would have to pay a royalty to the company which owns the patent on the genes.

Already, under the existing patent system, the European Patents Office has granted Biocyte, a US-based company, a patent on umbilical cord blood cells from foetuses and new-born babies. The patent gives the company complete control over the extraction and use of the cells and over any therapies developed in connection with them. The cells can be used without permission of the "donors". The patent has been challenged by a wide range of medical and other groups. If the new Directive becomes law, however, the scope for future legal challenges will be severely curtailed, because the new law will explicitly allow such patents.

No Patent, No Cure?

In response to growing public unease over genetic engineering, the European biotech and pharmaceutical industries argue that without the "protection" that a patent affords, companies would be unwilling to invest hundreds of millions of dollars in developing biotech products.3 Potentially beneficial discoveries would therefore either not be made at all or would just languish in the laboratory and never find their way to the market to benefit all those potentially affected by genetically-inherited disorders. In effect, they claim, "No patents, No cures".

This view is wholeheartedly rejected, however, by numerous groups with long experience of working with or representing those with genetically-inherited disorders -- those who would seem to have the most to gain from the medical advances that biotechnology potentially offers. Such groups argue that, far from promoting research, patenting genes will actually hinder scientific inquiry and undermine medical progress.

The Regional Genetic Service of Central Manchester Healthcare NHS Trust is unequivocal:

"We would not object to the patenting of a new novel technique, but the current directive could be open to serious abuse. If it is possible to patent a gene ... a single Biomedical company could completely control all future research and medical development, leading from the isolation of a specific gene. This would not foster research, it would kill it." [emphasis added]4

Likewise, in a joint 1994 statement, reaffirmed in June 1997, the UK Clinical Genetics Society, the Clinical Molecular Genetics Society, the Association of Clinical Cytogeneticists and the Genetic Nurses and Social Workers Association warn:

"The utilitarian argument ... that lack of patent protection would discourage commercial enterprises from engaging in gene isolation, does not persuade us ... Most gene isolation to date has been done by public sector institutions using government and charity funds, and greatly helped by the free interchange of materials and information which has up to now been the norm in the non-commercial sector, but which is threatened by the rise of gene patenting." [emphasis added]5

In continental Europe and in the US, patient groups have also rejected the "No Patents, No Cure" line promoted by industry. In Germany, for example, The Alliance of Self-Support Groups and Human Geneticists, a German-based group which represents patients suffering from inherited disorders, has stated:

"In our opinion, the correlation [between patenting and the beneficial development of therapeutic treatments] is not proven. Rather we have serious concerns that the possibility of patenting human genes will create a drawback for the affected ones. Free and immediate access to information ... is, according to our view, the prerequisite for the beneficial use of this information."6

Hindering Research

It is not only many of the supposed beneficiaries of genetic engineering who are opposed to the patenting of genes and living organisms. Researchers in the field warn that patents in science promote secrecy prior to the granting of a patent and hinder the free exchange of ideas and information necessary for co-operative scientific effort. As US biochemist Arthur Kornberg of Stanford University, who has been associated with a variety of biotech companies for 25 years, points out:

"Biotech companies are not in business primarily to do research and to acquire knowledge for its own sake; rather they are in research to do business and to turn a profit. They possess neither the mandate nor the tradition to advance scholarship ... Profit-driven ventures are more likely to promote secrecy to subvert academic units with patent agreements and joint ventures that demand exclusive access to discoveries."7

These threats are very real, particularly at a time when university scientists are being encouraged -- or compelled by restricted public funding -- to find industrial sponsorship for their work. Researchers, for example, may find companies reluctant to pay for their work if a key element of the basic knowledge involved is already "owned" by a competitor.

In other cases, research organisations, both public and private, which have been the first to isolate a gene may restrict the terms under which other scientists continue to work with that gene. Already, British charities which have spent millions of pounds on research into cystic fibrosis and breast cancer face the prospect of paying royalties to American or Canadian research groups -- even though the successful genetic "discoveries" of the latter may be built on the work of the whole research community.

Many scientists do not agree with the patenting of genes and living organisms: but, because others are patenting them, they feel obliged to do the same. If they do not, others could patent their work. In addition, they could find themselves paying royalties to patent holders, yet not be receiving royalties themselves.

As Professor Martin Bobrow, formerly at Guy's Hospital, London, has said:

"We, and many other university departments and public research institutions, are having to spend money taking out patents because we cannot afford not to."8

For poorer countries in the Third World, the impacts of patenting are likely to be especially severe. As Piet Bukman put it when he was responsible for development cooperation at the Dutch Ministry of Foreign Affairs: "A fence is being built around biotechnological know-how, which can only be opened from the inside."9 And it is the developed countries which hold the key.

Restricting the Research Agenda

Scientists are also concerned that, as the research agenda becomes increasingly commercialised, a process greatly enhanced by patents, funds will be channelled into what is commercially profitable rather than being used for the public good.

In the case of agriculture, for example, a handful of commercial crops -- cotton, tobacco, maize, potato, soya bean, tomato and rapeseed-- have received the lion's share of funding for biotech research. Companies are less interested in low value crops, such as wheat; minor crops, such as melons and carrots; or staple foods grown primarily in the developing world, such as millet and cassava.10

Worryingly, as far as human genetic disorders are concerned, the quest for patentable products is likely to divert much-needed funding from research into preventative health measures, such as minimising exposure to industrial and other pollutants, that would benefit the public but bring few profits to biotechnology corporations. It has been estimated, for example, that at least 90 per cent of human breast cancers are unrelated to breast cancer genes but are triggered by environmental pollutants, diet and lifestyle factors. The search for a technofix, however, means that alternative approaches to reducing disease get little or no funding.

Restricting Competition

Patent law, as it currently stands, not only permits monopoly control of new technologies and processes but actively endorses such powers. Far from encouraging competition -- and thus new research -- it inhibits it. This is especially true for broad patents.

Gene patents would give biotechnology companies even greater monopoly powers than they already enjoy. One reason lies in the scope of many of these patents. The chemical company, Monsanto, for example, holds a patent in both Europe and the US on all genetically-engineered cotton -- that is, any cotton engineered with any kind of gene by any company, individual or institution. Even the US government has asked the US Patent Office to revoke this patent, concerned about the negative effects on agricultural development.

Monsanto itself has in fact challenged such broad patents in the past. When agriculture company Agracetus took out a broad spectrum patent on all transgenic soya beans, rival companies including Monsanto challenged the patent. They argued that such a "species patent" would prevent them from selling their products and would result in just one company having an effective monopoly on transgenic soyabeans. Monsanto then bought up Agracetus -- and dropped its challenge.

In medicine, as Paul Martin of the Science Policy Research Unit at the University of Sussex points out, companies holding patents are often being given a complete monopoly over the development of all therapeutic protein products derived from the gene. "In some cases, the granting of a gene patent to a firm interested in the treatment of one disease has forced others to abandon well-established programmes developing the same protein for other disease indicators."

Chiron, a California-based biotech company, for example, owns a patent on the screening kit for hepatitis-C, an infectious disease of the liver. The test uses information about the proteins that make up the coating of the virus, proteins which the company's scientists discovered. And the patent includes exclusive rights to the use of that information. So Chiron can determine who can use it and on what terms.

In 1994, the US High Court rejected an appeal against the patent by one of Chiron's competitors, even though the presiding judge admitted that a patent holder's rights to restrict competition and raise the price of its products was "contrary to the public interest". He described this as "the price that has to be accepted" to secure the advantages of the patent system.

In addition, the proposed European Directive explicitly bars patents on living organisms in their natural state. This means that the products of plant or animal breeding which use genetic engineering -- a technique which involves isolating living material from its natural state -- could be patented, but those derived from conventional breeding practices could not. To offer direct incentives to one industry over another is to promote unfair competition.

Exploiting Publicly-Funded Research

The extraordinary advances in biomedical knowledge over the past 40 years have not -- in the main -- resulted from investment by venture capitalists and pharmaceutical firms. They have resulted from publicly-funded education and research, financed with money from the taxpayer or charitable bodies. The public will thus have to pay the price of research twice over if patents are granted on genetic "discoveries".

In the UK, for example, the Conservative government played a major role in financing biotech research carried out by both universities and other research institutes. The government also provided a significant proportion of the start-up capital for two of the country's most prominent biotechnology companies: it later sold its interest in one company -- Celltech -- to a group of private investors.

Furthermore, public financing will have to continue if the biotechnology industry is to survive. "The publicized vigor and successes of biotech companies may foster illusions that basic research can be left to industry," points out Kornberg. In the US:

"More than 90 per cent of such research has, in the past, and must be, in the future, done in university and other academic settings, requiring massive support to the tune of billions of dollars from the taxpayer through the federal government."11

In addition to benefiting from taxpayers' money, the biotech industry has also profited from the goodwill and co-operation of the public. The gene for inherited breast cancer, for example, was only found with the help of other doctors and researchers -- and indeed the numerous families with hereditary breast cancer who took part in a worldwide research programme. The programme was largely publicly-funded.

Wendy Watson, founder of the Hereditary Breast Cancer Foundation and one of several women who have had a preventative mastectomy, has stated:

"Nobody has the right to patent this kind of information, which was only found with the help of the many families who have suffered a case of hereditary cancer. It is morally wrong that any company should benefit from that kind of information."12

Other genetically-inherited diseases whose discovery rested on publicly-funded research include Polycystic Kidney Disease and Huntingdon's Disease.

Restricting Access to Treatment

No one is suggesting that companies should ignore the marketplace or forgo profits. But what's good for business may not always be good for cancer patients, farmers, the disabled or the poor.

Indeed, an increasing number of patient groups, such as Disabled Against Animal Research and Exploitation (Daare), are concerned about the implications of patents on genes for medical treatment for those on low incomes.

Daare, representing people with serious and incurable conditions which may have genetic links, such as motor neurone disease and Parkinson's disease, believe that the proposed European Patent Directive would increase health costs and place the fruits of public research into private hands to benefit the few.

Manchester Regional Genetics Centre, for example, recently received a bill from a Toronto-based company demanding a $5,000 licence fee, plus a royalty of $4 every time the centre uses a cystic fibrosis gene screening test on which the Canadian company had filed a patent application. Currently, the centre does not need to pay the fees, since the patent is for Canada. However, if the EU Directive becomes law, North American patents will apply in the EU under an international agreement. The Manchester centre could not afford the resulting costs.

Similar concerns have been expressed over the implications of patenting for breast cancer screening. The US company, Myriad Genetics, has applied for a European patent on the breast cancer gene BRCA1, as well as on all therapeutic and diagnostic applications resulting from the knowledge of the gene.

If the patent is granted, Myriad Genetics will be able to charge patients or the health service every time a diagnostic screening test is carried out. It currently costs the NHS some £600 to screen for the two breast cancer genes which have been discovered, BRCA-1 and 2, and some £30-35 for each subsequent test: in the US, Myriad Genetics charges $2,400 (£1,500) to screen for the genes and some $500 (£300) for each subsequent test. Were similar charges to operate in the UK, the National Health Service would be unable to bear the royalty payments.

And this is for just one gene test. If extra money is not made available to the NHS, it will have to ration or charge for many services that were previously free. Private health insurers are also likely to have to put up their costs. Many patients will simply be unable to pay, exacerbating inequalities in health care.

Indeed, the Regional Genetic Service of Central Manchester Healthcare NHS Trust warns that patenting genes could make:

"the possibility of genetic testing for disorders such as heart disease or breast cancer so prohibitively expensive it would be beyond the scope of the NHS. While new techniques will soon allow rapid and inexpensive analysis of genes, if a royalty has to be paid on each gene analysed, testing for breast cancer predisposition (which could involve 10-15 different genes) would be too expensive."13

Securing Markets, Not Jobs

It is also argued that without the proposed EU patent directive, Europe's biotechnology companies will flee to the United States, where the industry is afforded a greater degree of patent protection -- to the detriment of European jobs and profits.

In fact, EU companies have more than adequate patenting rights under existing legislation to protect their products which use, or are based on, human genes. The vast majority of drugs used in Europe, for example, are based on "small molecules"; while such drugs are not composed of DNA sequences, their development will increasingly make use of genetic knowledge, in particular, of DNA sequences and protein products which can provide targets for the drug to act against. These drugs have been protected by patents for years.

Moreover, more than half the UK biotechnology companies interviewed for a 1994 survey published by Arthur Andersen and the BioIndustry Association said they preferred the British patenting system to the US one, which they viewed as more costly, more time-consuming and more complex.

Critically, less than 40 per cent of companies regarded secure intellectual property rights -- for example, through patents on genes -- as important to their competitive advantage. And more than half said that existing UK patent law offered them adequate security of intellectual property rights and competitive advantage.

Management consultants Ernst & Young's latest survey of the biotechnology industry reports that, in 1996, expenditure on biotechnology research and development in Europe went up 20 per cent, without explicit patent protection, compared with three per cent in the US.

It is in fact US-based companies with biotech interests which are lobbying the hardest for Europe to adopt patent protection. If Europe adopted patent legislation similar to that in the US, such companies would be able to charge European companies, hospitals and research labs for using the genes and DNA sequences that they have patented under US law. At present, European companies do not have to pay US patent royalties and licence fees on genes patented in the US. Patenting is about securing markets, in this instance, the European market. Indeed, since 1990, US companies have filed three times as many European patents as EU companies.

The competitiveness of EU biotechnology companies will depend on the saleability of their products, not just on legal patents. DuPont's experience with its patented oncomouse -- the mouse genetically engineered to be predisposed to cancer -- illustrates that patents do not equal profits nor, in the long term, jobs. By 1993, the chemical giant had not persuaded a single pharmaceutical company to buy a licence to use the mouse -- it was too expensive.

Certainly, EU pharmaceutical companies have been buying up or investing in US biotechnology companies in recent years. But this trend is due far less to a lack of patent protection in Europe than to the fact that the patents held by many of these companies on their existing (non-genetically engineered) drugs expire within the next few years. The companies need new products and new markets.

Consequently, both EU and US pharmaceuticals, which are in a similar position, have been globetrotting in search of small biotech laboratories which have products and expertise but no money to finance their further development. The Economist spelled out the rationale behind biotech mergers back in May 1995:

"Never was a romance more obviously made in heaven. On one side their stands a string of destitute young biotechnology firms,abandoned by their previous lovers on Wall Street just as their spiffing new products are about to enter the costliest phase of clinical trials. On the other is a group of pharmaceutical giants, all desperate for new R & D ideas as the patents on their existing drugs expire and -- by biotechnology standards -- with cash to burn. No wonder there has been a certain amount of hopping in and out of bed."14

It is this more than anything which explains the pharmaceuticals' rush to buy up or fund biotech laboratories and to secure monopoly marketing rights to the fruits of their (often publicly-funded) research through patents on genes.

A 1997 commercial survey of UK biotechnology companies carried out by management consultants Arthur Andersen predicted that:

"Over the next three years, US [biopharmaceutical] alliances [with UK companies] are expected to take a clear lead. This reflects both the size of the US market and the market position and power of the pharmaceutical companies. In addition, many observers believe the domestic US bio-partnering market is now close to saturation and that US companies may therefore turn increasingly to Europe to acquire promising technology."15

In addition, many companies in the US have to spend, or at least reserve, a substantial part of their monies to defend any legal challenge to a patent they have been granted or to mount such challenges themselves. One of the leading US biotechnological companies, Genentech, has four times as many lawsuits to protect its patents as it has products.16 At least one company has been created in the US whose "main business", according to the Wall Street Journal, "is buying up broad patents and then suing other companies for alleged infringements".17 Concludes biochemist Arthur Kornberg of the US situation:

"Patent litigation in industry and academia and the new patent consciousness in academic circles have become serious and highly counterproductive preoccupations".18

Legalising Biopiracy

Much of the plant and animal varieties which companies are seeking to patent -- the "raw material" of biotechnology -- originate from the countries of the South. "Biodiversity brokers" are openly offering large sums of money to institutes throughout Europe and North America, which have built up botanical collections since colonial times, in exchange for their corporate clients being given exclusive use of the germplasm held in the collections.19 Companies and research institutes, meanwhile, have been scouring the South in search of commercially-valuable (or potentially valuable) plants that have so far escaped the collectors, taking them back to the North and patenting them (primarily under the US patent system) without any innovation taking place. Blood samples have been taken from various peoples in the South and some of the resulting cell lines patented.

Throughout the process, companies and researchers have capitalised on the knowledge of local people in identifying potentially useful agricultural or medicinal varieties. Much of the South's agricultural biodiversity exists only because generations of Southern farmers, villagers, indigenous peoples and city dwellers have actively engaged in the art and science of breeding and adapting plants: they systematically observed, experimented, intervened and selected plants and animals to serve their social, economic, cultural and political needs, particularly for food security.

The proposed EU Directive would legitimise such "biopiracy", and the appropriation and subsequent privatization of knowledge built up collectively by generations of anonymous experimenters. It would provide industry with a new means of establishing control over areas of nature previously held in common by communities in the South.

The consequences for livelihoods in the South -- particularly for small-scale farmers -- are severe. Once patents have been established over some of the genes of a particular plant or animal, the ability and right of Third World farmers to grow that crop or raise that animal and to trade them will be severely curtailed. In many cases, farmers may have to pay for what was previously free and theirs.20 For poorer sections of the community, the result is likely to be increased debt and, ultimately, bankruptcy and dispossession. Further flows of finance from South to North are likely, especially given the control that Northern multinationals have managed to gain during the last few decades over all aspects of agriculture.

Many countries of the South are attempting to resist such biopiracy by devising their own legal systems to safeguard public access to traditional knowledge and biological and genetic resources. The Trade Related Intellectual Property (TRIPs) agreement of the World Trade Organisation (WTO) currently permits countries to develop their own sui generis systems of intellectual property rights and to exclude plants and animals from patenting.

In 1999, however, the WTO is due to review TRIPs. Sui generis systems are already being strenuously opposed by the US. By introducing legislation that would permit the patenting of living material, the EU Directive would preempt a full and open discussion of this WTO clause. It would intensify the already substantial pressure on Southern nations to adopt US-style patent legislation and would undermine their bargaining power within the negotiations.

Starving the World

By placing control over germplasm in the hands of the most powerful players in agriculture -- effectively allowing them to control the production and distribution processes from seed to stomach -- patenting will do little to "feed the world", but rather the reverse.

In addition, the fact that many agricultural applications of biotechnology are connected with the transport and processing of food suggests that marketing foods and enhancing profits is the preoccupation of industry rather than feeding poorer people or encouraging food security. Delayed ripening or rotting of fruit and vegetables, for instance, will improve the appearance of produce, allowing it to be transported over longer distances and kept on supermarket shelves for longer periods of time.21

Furthermore, the bulk of transgenic crops are being developed by large corporations which are not in business to give away their products: they sell to those who have the money to buy them. In the global supermarket, only those who have the income to translate their biological needs into "effective demand" get to eat. Increasing agricultural production (assuming this is possible through biotechnology) whilst leaving the structural causes of poverty and hunger intact is a recipe not for feeding the world but for continuing to starve sizeable numbers within it.22

Conclusion

The push for patents on genes is not altruistic. It is not about encouraging scientific endeavour or pushing the frontiers of medical knowledge. It is not about feeding the world or promoting the health and well-being of all. It is about ring-fencing knowledge. It is about privatizing the very basis of life. The current proposals on biotech patenting have little to do with public good and much to do with private greed.

The overwhelming share of money which sits in the treasure chests of global companies has been put there from public funds. Research grants, sponsorship, university funding, charitable donation and, yes, health and agricultural payments for patented products themselves are the rich public source of what has become private bounty.

It is for these many reasons that the UK Working Group on Legislation for Collective Knowledge and Biodiversity (WGLCKB), a grouping of scientists, parliamentarians and concerned citizens, is proposing that the European Parliament and the Council of Ministers should evolve a framework for legislation that explicitly excludes specified processes and products from patentability, in particular those which involve living material, in contrast to its current approach of explicitly including life forms as patentable entities.

Some regulation in the EU of intellectual property rights, as they relate to biotechnological products, is certainly needed (this could in fact be achieved by reform and clarification of the existing European Patent Convention). Significant and far-reaching legislation should not be rushed through, however, without wide-ranging, informed public debate and scrutiny of the developments in biotechnology, including patenting, and their implications, nor without independent substantive assessments of the environmental, social and economic impacts of the legislation. At the very least, the EU should delay.

Britain, meanwhile, should campaign for a different approach which would aim to:

  • Encourage innovation in the biological sciences for the benefit of the public good and the environment;
  • Establish a boundary between the public and the collective in society and the private, particularly as far as "property" is concerned, such that the public good is enhanced and not undermined;
  • Opt for the precautionary principle in assessing the risks of biotechnology and establish strict liability guidelines;
  • Establish mechanisms to enable patents to be challenged before they are granted rather than after, particularly on the grounds of protecting the public good and preventing violations of collective rights;
  • Recognise and protect collective knowledge processes as part of the collective domain of humanity; and
  • Establish a system for monitoring scientific advancement for the public good.

Notes and references

1 A patent gives monopoly rights for 17 or 20 years (depending on the country granting the patent) to the patent holder to use an invention for commerical gain. To be patentable, an invention -- a product or a process -- must meet three criteria: novelty; involve a non-obvious inventive step; and have a commercial application. A patent holder has the right to charge others a licence fee for the use of the patented product or process and to extract a royalty on any commercial applications derived from it.

2 Dalton, H., et al, "Patent threat to research", Nature, 1997.

3 The main industrial sectors currently exploring commercial uses of biotechnology are pharmaceuticals, food and agriculture, chemicals, diagnostics and instrumentation, and environmental clean up.

4 Letter from Gareth Evans and others, Regional Genetic Service, Central Manchester Healthcare NHS Trust to all members of the European Parliament, 1st July 1977.

5 Statement by the UK Clinical Genetics Society, the Clinical Molecular Genetics Society, the Association of Clinical Cytogeneticists, and the Genetic Nurses and Social Workers Association, 1994, reconfirmed 1997.

6 Statement by the Alliance of Self Support Groups and Human Geneticists, May 1997.

7 Kornberg, A., The Golden Helix: Inside Biotech Ventures, University Science Books, Sausalito, California, 1995, p.247.

8 Martin Bobrow, File on Four, BBC Radio 4, December 1994.

9 Bukman, P., "The government role in biotechnology and development cooperation", Trends in Biotechnology, Vol. 6, No. 1 January 1989.

10 Stephen Dumford, quoted in Schmidt, K., "Whatever Happened to The Gene Revolution?", New Scientist, 5 January 1995, pp.21-25.

11 Kornberg, A., The Golden Helix: Inside Biotech Ventures, University Science Books, Sausalito, California, 1995, pp.247-248.

12 Wendy Watson, Hereditary Breast Cancer Foundation, quoted in The Sunday Times, 20 April 1997.

13 Letter from Gareth Evans and others, Regional Genetic Service, Central Manchester Healthcare NHS Trust to all members of the European Parliament, 1st July 1977.

14 "Biotechnology mergers: Unseemly couplings", The Economist, 13 May 1995, pp.98-101.

15 Arthur Andersen, Andersen Worldwide SC, UK biotech '97--making the right moves, London, 1997.

16 Fowler, C., "Biotechnology, Patents and the Third World", in Shiva, V. and Moser, I., eds., Biopolitics: A Feminist and Ecological Reader on Biotechnology, Zed Books, 1996, pp.214-225.

17 cited in Fowler, C.

18 Kornberg, A., The Golden Helix: Inside Biotech Ventures, University Science Books, Sausalito, California, 1995, p.233.

19 Von Weizäcker, C., personal communication.

20 Patent holders have the right to levy royalties on the seeds of patented varieties, even when the seeds have been saved from the farmers' previous year's crop -- and even when the crop is the end product of the farmers' own centuries-long research. While the proposed EU Directive does allow farmers to save and plant seed gathered from the harvest of a patented crop without paying further royalties, this exemption is linked to the exclusion list contained in another piece of legislation, the Plant Variety Regulation. Neither maize or soya are on this list, which means that the exemption in the Directive will not apply to these crops, nor to many vegetable crops.

21 Steinbrecher, R., "From Green revolution to Gene Revolution: The Environmental Risks of Genetically-Engineered Crops", The Ecologist, Vol.26, No.6, 1996.

22 Kloppenburg, J. and Burrows, B, "Biotechnology to the Rescue? Twelve Reasons Why Biotechnology is Incompatible with Sustainable Agriculture", The Ecologist, Vol. 26, No.2, 1996.

End Note

Briefing prepared by Alan Simpson, MP, with Nicholas Hildyard and Sarah Sexton of The Genetic Engineering Monitoring Project