THE DIRECTIVE IS DEAD

March 1995

THE DIRECTIVE IS DEAD

A brief history: NGOs raise alarm

The patenting directive was officially published on 12 October 1988. It was prepared by DG-III, the European Commission's services for industry, largely on the basis of responses to a questionnaire sent out by the World Intellectual Property Organisation and without formal consultations with anyone set to be affected. NGOs, however, had their hands on a draft seven months earlier, in April. GRAIN, at that time ICDA Seeds Campaign, immediately issued an Information Release explaining what the directive was about and providing a point-by-point assessment of the draft law. The Information Release, "Patenting Life to Become Legal in the EEC", was circulated widely to public interest groups and was the first layperson's guide to the European Commission's proposal. (See box on the main points of the directive.)

Two months later, in June 1988, 70 people representing 50 NGOs and development agencies from 12 European countries met in Humlebaek, Denmark, for the first meeting of the Seeds Action Network in Europe. The meeting was co-organised by GRAIN and the North-South Coalition Denmark. At that meeting, a workshop was held on patenting life and the participants resolved to launch co-ordinated efforts to defeat the European directive. Just weeks after the directive was finally published, GRAIN and the Rainbow Fraction in the European Parliament (the Greens, then known as GRAEL) agreed precipitously to co-organise a public hearing in the European Parliament. That conference was held on 7-8 February 1989 and resulted in the real launch of the NGO campaign. The conference was a success in that 200 people came and debated all the points of view — something the Commission did not bother to do when drawing up its proposal. Speakers included NGOs, the biotech industry, seed companies, animal welfare activists, legal experts, Third World representatives, farmers' organisations, etc., and.... the drafters of the directive themselves. At the closing of the meeting, NGOs met for a strategy session and formalised their agreement to mount strong public action against the directive. Their final statement reads: "We accept a major role in the development of public discussion and policy related to biotechnology and the patenting of life. We therefore commit ourselves to carry our concerns back to the NGOs and networks with which we are engaged and start a broad campaign against the patenting of life at the local, national and international levels."

The next six years were exhausting, but NGOs stuck firm to their commitment. Popular education efforts on patenting life and the EC directive in particular mushroomed. This included countless conferences and seminars, publications, and lots of educational materials. Initially the whole issue was to some extent limited to NGOs working on genetic resources and biotechnology. By the turn of the 1990s, however, big environmental groups like Greenpeace and Friends of the Earth started getting involved and the scope of people trying to stop the directive broadened through persistent information work.

The European Parliament moves

What was happening in the Parliament all this time? Both a lot of scuttle and a lot of dead air. Especially due to incessant activities of the Green Group in the Parliament, the directive survived hot committee debates, three readings in the plenary and various amendments before it got finally blocked last May 1994. Throughout the process, the Parliament and Commission constantly clashed. From the very beginning, the Parliament had a lot of hesitations about the Directive. It presented over 40 amendments to the text and took a strong stand on a number of issues. These included the question of a farmers' exemption (the right of farmers to freely re-use and exchange patented seed, which the Parliament wanted to see guaranteed) the patenting of human materials and the patenting of medical treatments (both of which the Parliament wanted to stop).

The Commission, however, didn't budge and ignored on several occasions the proposals and requests from the Parliament. For example, after the signing of the Convention on Biological Diversity, the Parliament sent the directive back and requested an assessment of whether and to what extent this directive would support and not run counter to the objectives of the Biodiversity Convention. The Convention holds that parties make sure their intellectual property rights laws meet this requirement, but the European Commission didn't bother to address this question. This arrogance, and non-responsiveness to legimate concerns, is what in the end backfired.

In the process, however, the institutional ballgame had changed when the Maastricht treaty was signed late 1993. Among other things, this gave the European Parliament more legislative power. The directive now became a joint Council/Parliament directive, subject to new rules of "co-decision".

The only legal way out of the blockages was for the two parties to enter into direct negotiations through a representative Conciliation Committee. The conciliation procedure went on for several months before closing on 23 January 1995 with the adoption of an "agreed" text. However, rather than a balanced compromise, the "agreement" was one where hard-liners won and the patent pushers got virtually everything they wanted. It still allowed for patenting of human genes and germline therapy, and there was no derogation for farmers to reproduce patented livestock, despite the Parliament's insistence. It was a bad agreement, which laid the basis for the plenary to scrap it altogether just over a month later.

The final countdown

Last 16 February 1995, NGOs were alerted that the final vote on the compromise text would take place in Brussels on 1 March. This was it, after seven years. We knew that all the odds were stacked up against us and in favour of the directive's adoption. After all, a compromise had formally been reached, the Parliament seemed ready to let the whole thing go and Council was planning to do no more than rubber-stamp the directive into existence a week later. What happened in the final two weeks is now history.

NGOs reared into action to give it one last try to inform the deputies about profound social opposition to the directive. (Of course, the industry did the same from their side to get the legislation approved.) MEPs were bombarded with letters and phone calls from all angles. As an international initiative, GRAIN circulated an open letter that was signed, in one week, by over a hundred agencies representing well over three million people all over the world. Some of the signatories included Dr. Geoffrey Hawtin, Director General of the International Plant Genetic Resources Institute of the Consultative Group on International Agricultural Research, Dr. M.S. Swaminathan of the M.S. Swaminathan Research Foundation and president of WWF-India, and Dr. Marcio de Miranda Santos, Director General of the Genetic Resources and Biotechnology National Research Centre of the Brazilian Corporation for Agricultural Research. The letter was delivered to all MEPs the day before the vote.

In the meantime, two developments were very encouraging and had a decisive impact. On 21 February, the European Patent Office tabled a landmark decision in favour of opposition plaintiff Greenpeace International regarding a patent on genetically engineered herbicide resistant rapeseed. The original patent, granted in 1990 to Plant Genetic Systems (Belgium) and Biogen (USA), has now been limited in its scope by the deletion of six claims. The EPO's Technical Board of Appeal has ruled that the patent may cover the genetically engineered plant "cells" but cannot extend to a whole plant, its seeds and any future generations of plants grown from the cells. Although the text of the Board's reasoning had yet to be published and made available, the EPO finally seemed to interpret the European Patent Convention's article 53b, which prohibits the patenting of plant and animal "varieties", as prohibiting patents on plants and animals per se.

Also, the Austrian Parliament had moved and bound their government's position against the directive. The fact that yet another European Union government was going to slate a "no" to the directive, if the Council were to vote on it, had an important impact on many Europarliamentarians. In Italy the mood was also turning against this piece of legislation when, on the 23rd of February, 85 members of the Italian Parliament signed a resolution instructing their government to "promote urgent initiatives toward the European Union and other international organisations in order that the principle of patenting life forms — self-reproducing animals and plants — be refused." The resolution was signed by representatives of every single political group in the Italian Parliament except the Fascists — a daunting feat in the Italian political culture. If formalised, this would align the Italian government with countries such as Austria, Denmark, Luxembourg and Spain who already had expressed formal reservations about the European directive

NGO lobby efforts built up as the 1st of March came closer. The day before the vote, Greenpeace hung a huge banner — and several people — from a passarelle linking two Parliament buildings over a major thoroughfare in Brussels proclaiming "European Parliament: Reject Patents on Life!". The audacious action really stirred up the Parliament, the media and everyone who gathered to watch. The morning of the vote itself, the Financial Times ran a news item "MEPs urged to vote against 'patents on life'", reporting on the letter GRAIN had circulated and the events at the EPO and Italian Parliament. Every MEP had a copy by 08:00 that morning. Then the real countdown started, as described in our accompanying editorial. Nervous NGOs wearing T-shirts that read "VOTE NO! TO PATENTS ON LIFE" mingled with MEPs as the hours passed and final speeches about the directive filled the air. Then the came the vote itself. When the president read out the verdict, no one in the room believed her. "Four hundred and fifty-one votes expressed: 188 in favour, 240 against, 23 abstentions." After a moment of stupor, the Greens jumped up and cheered, lots of people were clapping from other political groups and NGOs exploded with disbelief and joy. It was over. The directive was dead.

What happened? Everything was stacked in favour of the directive! An analysis of the voting shows that the majority of the Socialist Group had abandoned the directive's rapporteur — who comes from their ranks — and voted massively against the directive. But there were also "no's" from the Conservatives and Christian Democrats. Enough Parliamentarians realised at the last moment that this directive was too much biased towards industrial interests alone and did not take into account the growing social and ethical concern over this piece of legislation. It was a vote of Conscience over Capital, as we call it in our editorial.

In the days and weeks following the vote, there was a lot of efforts to put the EP's ruling in a bad light. Industry sources and several newspapers and weeklies aired frustration and blamed the Parliament for its "emotional" and "irresponsible" decision. None of their arguments make much sense. The typical threat that now the biotech industry will massively move to the USA and Japan does not stand for obvious reasons. The rules of the directive would have applied to any company, anywhere in the world, wanting to obtain a patent in Europe. Shifting your physical location doesn't solve that problem. Also, blaming the European Parliament for creating a legal vacuum is more based on frustration than on a real assessment of the situation. All countries of the European Union (except for Finland, which is expected to sign this year) have signed the European Patent Convention, which is clear on what can be patented and what not: nothing which is contrary to public order or morality and no plant and animal varieties. In a sense, if adopted, the directive would have created more legal uncertainty because it tried to undress these restrictions by squeezing in human materials, medical treatments, and plant and animals. Some in the pharmaceutical industries seem to confirm this by calling the rejection of the directive "the lesser of two evils", worried that the final compromise text provided for too many ambiguities and too little clarity.

This was the first time the European Parliament used its newly acquired post-Maastricht power to block a bad piece of legislation. Within the European Commission and some member state governments, voices are growing that this power should now be tuned down again, devolving the Parliament to its largely decorative, consultative and powerless function of before. This is moving back in history. After finally achieving some traces of democracy at the European level, those in real power want to tone it down again after their first lost battle. If anything, the European Parliament can be proud of its decision and should stand for the achievements obtained.

Where from here?

Without downplaying the importance of this historical decision, it is important to realise that we won a battle, but not necessarily the war. The burying of the directive basically stopped an intent to force a very far-reaching and European Union-wide interpretation of what can be patented. But patent practices at the national level and at the European Patent Office continue. The importance of the decision of the European Parliament lies in its message: patenting in the field of life sciences bears major social, political and ethical implications, and both legislators and the courts should not fly forward.

This message is backed up by developments at the national and EPO levels. At least five governments (Denmark, Austria, Italy, Spain and Luxembourg) had substantive problems with the EU proposal. Parliamentarians in these and other countries are questioning the patenting of life as such. Also, in an uprecedented move, the 93rd Conference of the Interparliamentary Union adopted a resolution on the first of April calling for a total ban on the patenting of human genes. Although this resolution is not legally binding, the Union brings together parliamentarians from 135 different countries and sends an important signal to the world. And, most significant perhaps, the EPO seems to be indicating that patents should not extend to seeds and plants. All this could — and should — be the beginning of a re-questioning of the use of the patent system to protect innovations in the field of life forms, and the beginning of the development of "rights" regimes that take into account all aspects (not only the economic ones) and all innovators (not only the big industry).

In Europe, the next step is to get national legislation in place that clearly limits the scope of life patenting, especially in those countries where governments and parliaments already have indicated their problems with this system. This could be the first step towards much broader rights regimes with an holistic approach to innovation, including all actors and all concerns. At some point, we will need European-wide interpretation on how this should look, and perhaps even a renegotiated European Patent Convention. But the first signals on a fresh look at innovation should come from the national levels.

But then, the decision of the European Parliament should also send a strong signal beyond the European borders. Especially in discussions on patenting in the Third World, policy makers are often told to look at the situation in the "most advanced" countries, and use their legislation as a model. The EP decision is already having its impact on discussions in India and Brazil (see "sprouting up" in this Seedling). Well, here we have a whole group of "advanced" countries that tell the rest of the world: be careful with patents on life and go slow, there are a lot of implications that were only now starting to be aware of.