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Synthesis/Regeneration 14   (Fall 1997)

European Greens Confront Patents, Novel Food, & Cloning

by Steve Emmott,
Biotechnology Coordinator, Green Group, European Parliament

The European Parliament (EP) is a peculiar institution. Despite being the only democratically elected pan-European institution, it has only very limited legislative powers and is the junior partner alongside the European Commission (EC, which is the "civil service," but with the sole power to propose legislation) and the Council of Ministers (from each of the Member States, which exercises the real decision making authority). However, the EP's powers are growing slowly and in much recent legislation it has the role of co-decision making, which in extreme cases allows it to veto laws of which it disapproves. Its main function is to scrutinize draft legislation and to propose improvements, but it can and often does express its opinions on current and controversial topics. In short, it has the right to be consulted and to advise and just occasionally it can bite.

The Parliament has 626 MEPs altogether, with the Greens as the sixth largest grouping. The Green Group consists of 28 elected Deputies (MEPs) from 9 of the 15 member countries of the European Union (EU). 12 are from Germany, 4 each from Italy and Sweden, 2 each from Belgium, and Ireland, and 1 each from Austria, France, Finland, and the Netherlands.

Despite its relatively small size, the Group of Green MEPs is often disproportionately influential in promoting debate and raising the profile of subjects about which they care passionately.

Despite its relatively small size, the Group of Green MEPs is often disproportionately influential in promoting debate and raising the profile of subjects about which they care passionately. The Group has taken a lead role in criticizing genetic engineering policy in the EU and in promoting widespread public debate on these issues. This article looks at three areas of genetic engineering policy in which Green pressure has played a part in shaping developments and in which it continues to offer a critical perspective.

1. The legal protection of biotechnological inventions

Each of the 15 member states of the European Union (EU) has its own national patent law, based on the European Patent Convention (EPC) (1973 ), to which they are all signatories. It was enacted before widespread development of genetic engineering, but it does contain some apparent restrictions on patentability in this area.

The First Patent Directive. The biotechnology industry evidently did not think that the EPC would afford them sufficient protection. In the 1980's, their lobby pressured the EC, arguing that the uncertainties in European patent law were damaging research and development investment in genetic engineering. They told the Commission that industry would be tempted to relocate to the US or to Japan where patent regimes were less restrictive. The EC decided against recommending a renegotiation of the EPC, which would have been a long process and which in any event did not sit neatly within the EU framework. In 1988 it published its own draft directive and built the need for this law into its policy objectives as a key requirement for the promotion of biotechnology in Europe. The EC's in-house bioethics advisory group concluded that there were "no ethical grounds for opposing the patentability of inventions relating to living matter in principle…" The Eurocrats must have assumed that adoption of this legislation would be a fairly speedy and straightforward process. On the contrary, its publication provoked a storm of opposition from the Greens and the Non Governmental Organization (NGO) movement.

The directive was defeated in March 1995 after a prolonged campaign inside the EP by Green MEPs and outside by environmentalists, human rights groups, animal welfarists, women's movements, farmers, third world development agencies, and other NGOs. It was the first time the EP had exercised its new powers of rejection under the co-decision making procedure adopted as part of the Maastricht Treaty, and may prove a turning point in the search to apply socially acceptable and ethical criteria to the uses of genetic engineering.

Although farming and animal welfare considerations were factors of serious concern to MEPs, the fundamental basis of their hostility to the directive was that it failed to exclude from patentability human genetic material and germ-line therapies (genetic intervention in the sperm or eggs that will alter the characteristics of future generations). One of the factors troubling MEPs was the case of US citizen John Moore. While receiving medical treatment in California for leukemia, his enlarged spleen was removed. His white blood cells were found to contain unusual and commercially valuable blood proteins. A cell-line was created, which was patented and licensed to several pharmaceutical and biotechnology firms. Moore was not told of the unique properties and value of the cell-line, nor that his doctor had "invented" it and profited from its commercialization. The California Supreme Court refused to allow him proprietary rights in his own tissue. While it may be right that Moore should not have been able to profit personally from his human genetic attributes, they should surely not have been privatized either.

The Second Patent Directive. Despite the defeat of the 1988 directive, the EC decided to try again. In early 1996 it launched a new draft directive. Although the EC has re-written some of those parts which caused so much concern to MEPs, the changes are likely to prove controversial. Germ line therapy is now expressly excluded from patentability and human genetic material in its natural state is unpatentable, but if it is isolated from the body, it becomes open to patenting, even if it is identical to the natural material. This time the Commission and industry, having learned not to take the EP for granted, are investing much more time and resources in courting the parliamentarians. The Greens managed to secure positions as Rapporteurs (who prepare the various internal Opinions on the draft legislation) on three out of the six committees concerned, and proposed that:

The outcome will be known by late summer 1997. It is too early to say whether there will be a repeat of the 1995 outcome, but we're working on it!

...events such as the mad cow crisis have shifted the focus onto human health questions and consumer distrust of government, scientists, and non-natural food products.

2. Gene Food

The story on gene food in the EU is probably as long running as the patent saga. After 13 redrafts and months of heated negotiations, we finally adopted a Regulation on Novel Food and Food Ingredients which came into force in May 1997. Memorably criticized by a Green MEP as being "just a collection of loopholes," it was intended to be a centerpiece law to deal with the safety and labeling of genetically engineered food.

It came directly into force in every Member State, leaving little discretion for improvement or tighter rules. The Green Group has consistently opposed this law, arguing that it was flawed in its scope and practicalities, and that there were as yet insufficient data on human health and environmental risks to justify the use of genetically modified organisms (GMOs) entering the food supply. Following Green initiatives, the European Parliament has passed two critical (but non-binding) resolutions recently. The first, couched in unusually straight language, condemned the Commission for the way in which it approved the Ciba Geigy/Novartis maize gene in the face of strong opposition from some national governments, as well as consumers and the food retailers. The second called for much more clarity in the way the law will work and pressed for a parallel system of positive labeling of gene-tech-free food.

Although the legislation originated as an industrial harmonization measure, not a consumer issue, events such as the mad cow crisis have shifted the focus onto human health questions and consumer distrust of government, scientists, and non-natural food products. The appointment of a new Commissioner to take overall responsibility for food safety has marked a substantially different approach to consumer protection and information. Already several national governments have challenged earlier decisions on gene food marketing approval and claim the right to make their own decisions on behalf of their citizens.

The concept of a Novel Food as something that has not previously been part of the European diet is open to wide interpretation. There is no clear explanation of when food products made using genetic engineering cease to be Novel. It is possible that many products on the supermarket shelves will, in a few months time, be deemed to be routine gene foods and excluded from the applicability of this Regulation.

Where the Commission's in-house Scientific Committees are required to evaluate the manufacturer's own safety submissions, there are to be no independent long-term health studies.

The scope of the Regulation is highly restrictive. Additives, flavorings, and processing aids, such as enzymes, are excluded. In many cases there is to be no independent safety or environmental assessment because the system permits the food manufacturer simply to notify the authorities at the same time that food products are placed on the market. Where the Commission's in-house Scientific Committees are required to evaluate the manufacturer's own safety submissions, there are to be no independent long-term health studies. In the light of the mad cow scandal, this is irresponsible in the extreme.

Although the Commission's Scientific Committee on Food has recommended that genetically engineered ingredients should not be used in baby foods, there is no apparent restriction on this.

Article 8 of the Regulation provides for labeling of Novel Foods but is constructed in such a way that only foodstuff containing a living GMO or which have a detectable change in composition or known health or ethical problems will require compulsory labels. Even in these cases the format of the label is not specified and industry could therefore have the opportunity of using promotional slogans such as "produced with the benefit of modern biotechnology." Industry is pressing the Commission to make these labeling criteria even harder to apply and at the same time has started to use DNA-destroying enzymes to obscure the use of gene technology.

One of the major defects of the labeling provisions is the acceptance of mixed bulk consignments of food crop products. Modified maize and soya are already being imported from the USA in shipments mixed with conventional produce which renders any meaningful identification or labeling impossible. Where retailers wish to supply consumers with non-engineered products, labeled as such, they are being prevented from doing so by this system.

The US biotechnology trade lobby is making increasingly threatening noises about barriers to trade...

Any attempt to regulate products of gene technology being placed on the market must take account of and be consistent with other legislation on this subject. Directives on the Deliberate Release of GMOs and on Seed Marketing are in the process of revision and may take a fundamentally different approach to consumer protection and information, accepting the need for a consistent regulatory regime from the "plow to the plate." The Agriculture Commissioner has announced that he intends to introduce new legislation on genetically engineered animal feed which will go further than that required for human food. This will require complete segregation of conventional from modified produce and labeling for all commodities made using gene technology, not just those containing living GMOs in the end-product. He has also agreed to Green Group proposals that the use of gene technology should be banned in organic farm produce.

However, enter geo-politics in the shape of the World Trade Organization. The US biotechnology trade lobby is making increasingly threatening noises about barriers to trade and discriminatory practices and is actively arm-twisting in Brussels to stop "non-scientific" criteria being applied to product approval and labeling. This story will run a while longer.

What should have been an opportunity to reflect on the direction toward which gene technology is leading…turned into a minimalist exercise in damage limitation.

3. Cloning

The announcement in early 1997 of the production of Dolly, the sheep, from cloning by nuclear transfer from a mature cell, bypassing the normal fertilization process, gave rise to a flurry of ethical reviews in Europe, much as it did in the USA. Having labored long and hard, the only conclusion reached was that cloning whole people should be banned. What should have been an opportunity to reflect on the direction toward which gene technology is leading and on the rights, wrongs, and risks of creating "new nature," turned into a minimalist exercise in damage limitation. In the meantime, the Roslin Institute in Scotland has applied for world-wide patents on the Dolly techniques for all mammals, including humans. This is not, they say, because they intend to produce human clones, but so that they can stop others from doing so without a license. Without doubting their integrity, it is an absurd situation in which to find themselves.

Cloning merges into questions of other reproductive technologies, the production of embryos for research or tissue transplantation purposes (human spare parts), and the use of animals or animal/human hybrids for the manufacture of pharmaceutically useful human proteins-so-called "animal pharming." None of these subtleties is addressed in the EU Ethical Advisory Opinion which concludes that "cloning of farm animals may prove to be of medical and agricultural as well as economic benefit." Since when did economic benefit become a criterion for ethical approval?

Again it is the Green Group that has been consistently opposed to the use of gene technology, now including cloning, as a means of further industrializing farm animals. I guess we have to wait for another Beltsville pig (given human growth hormones and born arthritic, heart-diseased, and generally crippled) before the rest of the world catches up.

To end on an optimistic note, the platform provided to the Green Group of MEPs in the European Parliament gives us the opportunity to raise the profile of objections to the misuse of genetic engineering. Without us, much would go by default. With us, there is a chance to mitigate and occasionally to change the direction of genetic engineering policy making.

A lawyer by training, Steve Emmott has worked on genetic engineering issues since 1989, firstly for Friends of the Earth European Unit in Brussels and then with the UK NGO Genetics Forum

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