EUROPEAN PATENTS STEP CLOSER

October 1997

EUROPEAN PATENTS STEP CLOSER

The campaign against the proposed European Union Biotech Patents Directive came to a head on 16 July when the European Parliament (EP) passed the first reading of the Commission's proposals to allow patents on plants, animals and parts of humans. Despite a flurry of last minute lobbying by NGOs the vote resulted in a two thirds majority in favour of the Directive, including 66 amendments out of over 250 forwarded.

De Clercq, Chair of the legal affairs committee, highlighted the heated controversy caused by the proposals saying it was, " the largest lobby campaign in the history of the EU". Indeed, against the economic might of transnational pharmaceutical companies, an impressive array of groups representing a broad spectrum of civil society, from women's groups to scientists, had come together all under the basic issue of no patents on life. The failure of the EP to heed their concerns raises questions about its integrity as a representative body of European opinion.

Yet industry had clearly won votes on two counts. Firstly by striking at the hearts of Members of the European Parliament (MEP's) with the slogan "No patent No cure", borne on the yellow T-shirts of an army of disabled people on wheelchairs, recruited from patient groups and highly visible in the parliament. Secondly by pushing the routine economic rhetoric of, jobs, growth and competitiveness, which featured prominently during the pre-vote debate. Disappointing for those opposed to the directive was that most MEP's were taken in by these hollow arguments and failed to grasp the seriousness of sanctioning monopoly control of the world's genetic heritage, by powerful transnational interests.

By definition, life and the gene pool generated through evolution, cannot be invented. However, the EP side-stepped this reality by adopting article 2 which states, "Biological material which is isolated from its natural environment or processed by means of a technical process may be the subject of an invention even if it already occurred in nature". This amounts to a radical redefinition of patent law, broadening the concept from invention to include mere discovery. Hence opening the door to the widespread patenting of biological material which may even include entire species.

The extent of the losses incurred by those opposing the directive can best be exemplified by the rejection of an amendment forwarded by the Green group of the EP to prohibit development and patenting of genetic weapons. Amongst the wreckage of defeat are a few conciliatory seeds to be built upon during the coming process of adoption which could be complete in early 1998. Even these are already under attack by the Commission who has gone against its word by watering down a number of amendments through rewording the current draft.

The Single Market Council, due to debate the Commission's proposals on November 27, will need to agree a common position before resubmission to the EP. The second reading in the parliament must take place within three months and the outcome of this debate will decide whether the Council finally accepts the proposals, or as happened last time the issue goes to the arduous process of conciliation.

The new draft excludes patents on human reproductive cloning, as well as processes for modifying the germ line genetic identity of humans beings. To mollify ongoing concerns about such aspects of new biotechnologies, the directive now includes provision for an ethics committee. However the committee will have no powers to change the directive, and in any case has been appointed by the Commission, so is likely merely to add a veneer of acceptability. All such measures were predictable, and as is characteristic with the proposals, even clear cut issues are worded ambiguously leaving room for interpretation and loopholes. Importantly, exclusions will not apply to human DNA, body parts and even certain types of chimera (half-human, half-animal) — all are patentable with few restrictions.

Given that the directive looks increasingly unlikely to exclude patents on genes, it was useful to achieve the inclusion of an amendment safeguarding against biopiracy. In the case of human genetic materials it requires, "voluntary and informed agreement of the person of origin" as well as submission of their contact details. Criteria would also apply to plants and animals including the need to prove, "that the material was used in accordance with the legal access and export provisions in force in the place of origin". This would give countries in the South a chance to protect their citizens and biodiversity against the increasing problem of genetic exploitation, primarily by Northern concerns.

This window of opportunity was immediately rejected by the Commission on two counts; firstly claiming that it goes beyond the obligations of member states under the Convention on Biological Diversity (CBD). This assertion makes clear that the Commission is keen to avoid setting any positive precedents which seek to limit biopiracy by going beyond existing conventions. It is also based on false premises as the terms of the CBD on access to biological resources are not set, still being subject to negotiation.

Their second reason referred to the supply of personal details to the patent office by individuals subject to patent application. This the Commission said, would contravene a 1994 directive on privacy, an unlikely scenario as the issue at stake here is one of informed consent (by way of the patent office, which in any case is bound by the directive to confidentiality). The amendment was already shaky on these grounds as it would have enabled one person of a genetically distinct ethnic group to sign away patent rights for the whole community. The deletion of this amendment will go one step further, enabling bioprospectors to acquire patents on genetically unique people without their knowledge or consent. There is still a chance for interested parties to put pressure on the Council to maintain the article.

Similarly an amendment attempting to broaden farmer's privilege has been scrapped. The Commission's original proposal limited farmer's privilege to re-sow their own harvested seed, to a list of 23 species. The amendment would have broadened the right to use and resell seed irrespective of the list, whilst maintaining exclusions on hybrids or for commercial plant breeding purposes. This would have had two consequences clearly unacceptable to the Commission. First it would have created a difference in the rules between existing Community Plant Variety Rights (CPVR 1994) and patent rights. A weak argument given that implementation of the directive would severely weaken traditional plant breeders rights in favour of biotechnologies.

Perhaps more significantly it could have allowed farmers access to use genetically manipulated (GM) seed such as soya and oil seed rape. This posed a clear threat to industry who have gone to great pains to restrict unlicensed use of GM seed, as seen with the rigorous contract accompanying Monsanto's Roundup Ready Soya.

It has yet to be seen how member states react to the proposals in December. For NGO's, now is the time to get the arguments across to EU national governments where in most cases the Ministry of Economy is picking up the negotiating baton. Whatever transpires at Council level will eventually return to the EP which is likely to be displeased at having their voted amendments thrown out by the Commission.

International implications

European developments to tighten up IPR's have been mirrored on the international stage with the US flexing its economic muscle to pressure Southern countries into implementing IPR laws quickly and in line with its interests (see Sprouting up). This goes contrary to both the spirit and letter of the GATT TRIPS agreement which gives undeveloped countries a buffer period for implementing IPRs until the year 2000, extended to 2005 for least developed nations.

NGO's are watching developments in Europe closely as the legislation that develops here looks certain to have international repercussions, with more countries moving towards US style patent regimes. Central for many is the impact that current trends will have when part of the TRIPS agreement comes up for review in 1999.

During the original Uruguay round negotiations, European countries sided with the South in pushing for the TRIPS option for the exemption on patenting of plants and animals. This was a pragmatic move as the existing European Patents Convention (EPC) is limited in scope and undefined on the issue of life patents. Hence Europe risked non compliance with the GATT which implied at least accusations from the US and at worst discipline from the WTO.

The arrival of the Patents Directive explicitly allowing patenting of plants and animals, would remove Europe's interest in maintaining the TRIPS exemption. The extent to which Europe will adopt the US line beyond the directive remains to be seen, but it is possible that we see Europe playing, if not a role reversal, at least a passive position during the review, either of which would help the US push life patents on the South.

The patents directive may have passed the first hurdle more intact than reason would have allowed, but the stages it still has to go through give time for the NGO alliances initiated in recent months to grow and develop into a potent force. That the Commission has stooped to foul play at every stage not only reconfirms suspicions that they are being leaned on by industry and the US, but also damages the integrity of their position. Having been beguiled into passing the worst aspects of the directive, the EP displays extraordinary impotence, which the Commission is merely playing on by rewriting the script the way industry demands.

The proposed life patents directive remains as potentially dangerous as ever, in handing over the wholesale monopoly ownership of life to corporate control. Now that amendments have failed to reduce its negative impact, NGOs would do well to push for complete rejection of the directive; both through the governments of EU member states and the Commission itself. The concern stimulated by the prospect of European life patenting has seen a heartening array of inspired groups coming together to campaign against the directive. The momentum has already spread far beyond the walls of the EU as people recognise the profound implications at stake. The coming months are sure to see this movement increase to a level which policy makers can no longer ignore.