GREENPEACE BRIEFING ON THE AMENDED PROPOSAL FOR A EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE ON THE LEGAL PROTECTION OF BIOTECHNOLOGICAL INVENTIONS (COM (97) 446 final)

INDUSTRY GREED OVERRIDES MORAL AND ETHICAL CONCERNS

1. Introduction

National governments are due to come to a common position on the proposal for a directive on the legal protection of biotechnological inventions this year. Greenpeace considers the European Commission amended position is untenable and does not reflect concerns of broad cross-section of society.

In 1995, after seven years of debate, the European Parliament rejected a proposal for a directive on the legal protection of biotechnological inventions on moral grounds. However, in 1996 the Commission introduced another proposal which was almost identical to that thrown out by the Parliament. It allows for patents on plant varieties, animals, human cells and genes. The new proposal was considered by the Parliament in July 1997 and made 66 amendments to the Commission's text. During this process the Parliament succumbed to intense pressure from industry and abandoned many of the moral principles which underlay its rejection in 1995. Profit and greed has been allowed to become the driving force.

The Commission has considered the Parliament's amendments and produced an amended proposal (COM (97) 446 final) to be considered by the Council. Under the amended proposal:

* Plant varieties will become patentable.

* Animals genetically engineered to have physical disabilities will become patentable.

* Human genes and cells will become patentable.

* No proof is required of the consent of people, here or in Third World countries, who donate material which is then patented by a company.

* Enormous scope is given to patent holders in the monopoly they can claim, a scope which would not be allowable in the United States.

* Confusion rather than harmonisation of regulations will result as the proposed Directive is in direct conflict with the European Patent Convention.

* Treatments for diseases which are not profitable to companies may not be developed.

* The Parliament's (albeit) weak amendments have even not been fully incorporated.

Greenpeace believes EU member states must not accept the Commission's amended proposal.

2. Plant varieties will become patentable

In direct contravention of the European Patent Convention, of which all European Union countries are members, plant varieties are patentable under the Commission's proposals. Although Article 4 (1) of the Commission's amended proposal states that plant varieties are not patentable, this is rendered meaningless by the following sentence. Under part 2 of Article 4, if the technique to be patented is applied to more than one variety, any varieties developed from it become patentable. Lawyers will simply draft patent applications to exploit this loophole.

However, this loophole is in complete contradiction to the European Patent Office's interpretation of the exclusion of plant varieties from patent protection. In a ruling from the highest board of the European Patent Office, it was stated that the exclusion to patentability of plant varieties could not be avoided by claiming many plants which would include plant varieties (OJEPO 1995, T356/93). The large agrochemical companies now genetically engineering crops did not like this decision as it might restrict their profits, so they have pressured the Commission and Parliament into helping create a legal loophole.

The exemption of plant varieties from patent protection is to protect the interests of plant breeders who do not use genetic engineering but rely on traditional breeding methods. Plant breeders can only claim plant variety rights which do not give the extensive monopoly protection that patents do. Having plant varieties that are patented will either restrict the access of plant breeders to plant material or make it very expensive if they have to buy licences to it from other companies. This situation could threaten plant breeders livelihoods and could cost jobs.

3. Animals will become patentable

Allowing the patenting of animals reduces animals to objects to be used as industrial machinery with no obligations towards them. Under Article 6 (2d) of the Commission's amended proposal, the only situation in which animals are not patentable is if their suffering as a result of genetic modification does not result in `substantial medical benefit to man or animal..' Animals engineered to have physical handicaps or deformities would be patentable for any purpose if they were not considered to be suffering. For example, a genetically engineered hairless mouse could be developed to test hair care products or cosmetics (the pharmaceutical company Upjohn has already done this). Scientists in America have transferred a firefly gene into a mouse so its ears glow. British scientists have created a frog embryo without a head and this technology will now be applied to other species. Under the Commission's proposal all these could be patented because it could be argued that having no hair, no head or ears that glow does not cause suffering. Unless the patenting of animals is completely prohibited, there will always be cases like these which greedy companies will try to fiddle through the system.

4. Claiming to be God - human genes and cells and those of all organisms will become patentable

Under Article 5(2) of the Commission's amended proposal, human genes and cells become patentable as do those of all other organisms. In order for companies to claim living material as an invention all a company has to do is to use some kind of technical procedure. Taking blood with a syringe and needle is a technical process and so is using a machine to identify its components. However, this is no justification for man to claim to have invented, and thus patent, parts of organisms which already exist in nature.

If patents are allowed on basic elements of humans and other organisms, industry place themselves as the creators and designers of life. Patents on cells and genes mean the company holding the patent decides how the genes or cells are used, how much is charged for their use and who can have access to them. This is a frightening prospect and fundamentally immoral.

5. The green light to steal genetic material

The Commission's amended proposal contains no requirement for companies to prove that they have acquired genetic material with the consent either of the individual donor concerned in the case of human material or, in the case of plants and animals, the country of origin. Although Recital 16(f) plays lip service to the need for consent, there is no Article in the proposal that would make this real although the European Parliament proposed relevant amendments in this area.

Companies may reap huge profits from genetic material freely given by individuals. Countries may have their genetic resources plundered by gene hunters and have no influence on how they are used or benefit from them. It will be the weakest and poorest people who will be most vulnerable to exploitation. Companies are already prospecting for genes among indigenous peoples in less developed countries and scouring the rain forests for genes with profit potential in the North. Not even ensuring that local people or their governments have been consulted and given permissions goes against basic considerations of human rights and any ethical foreign policy.

6. Massive scope will give companies a licence to print money

The scope of the monopolies that would be given under the Commission's amended proposal are huge and would not be allowed in the United States where they would be considered anti-competitive. Article 5 (3) only requires that the function of a full or partial gene sequence be disclosed in the patent, it does not require the use to which the gene will be put to be disclosed. Asking for this information alone means that the patent would give rights to claim licence fees from anyone who later found a practical use for the invention. In the United States, all patents have to have `utility', that is the industrial use must be disclosed and the scope of the invention is restricted to that use. This is to ensure that companies are not given excessive rewards and competition is not stifled.

7. Confusion will be created not harmonisation

One of the claimed intentions of the proposed Directive is to harmonise patent law in the field of biotechnology throughout the European Union and to `clarify the _ uncertainty' (Recital 8a). However, all the EU Member States are signatories to the European Patent Convention (EPC), a non-EU agreement which also includes non-EU nations. Companies obtain Europe wide patents under the EPC. The European Patent Office, which administers the EPC, is already granting patents in the field of biotechnology many of which have proved hugely contentious.

An EU Directive cannot resolve conflict and controversy at the EPO because the EPO is not an EU body and the Directive will not change the EPO. Because the Commission's proposal is direct conflict with the EPC and case law relating to its interpretation, particularly in respect of plant varieties, no clarity will be achieved. If the EPO were somehow to take a signal from an EU Directive, they would be subject to challenge under the terms of the EPC.

8. Only profitable suffering to be relieved

There are three aspects of the Commission's proposal which will result in innovation in medical treatments being discouraged, especially for illnesses affecting relatively few people,:

* the huge scope of the monopoly awarded will discouraged other research (see under 6. above)

* there is no compulsory cross-licensing in the field of medicines - companies holding a patent may prevent others developing a life-saving drug which uses their patent even though they do not intend to do so themselves.

* allowing patents on genes and cells, the most basic knowledge of molecular biology, will reduce openness of scientists. They will have to be more secretive in order to get patents for their discoveries and this will hamper the free exchange of knowledge and ideas which has been the cornerstone of science.

If this Directive is passed, European citizens should be warned only to contract common illnesses if they wish to benefit from the claimed promises of biotechnology. Uncommon illnesses will not promise sufficient profit for pharmaceutical companies to be interested.

9. Ignoring societies concern

Animal welfare groups, development and AID organisation, scientists, farmers organisation, indigenous people rights and environment organisation and many others groups and organisations raised fundamental concerns about the patentability of life. The Commission ignored these concerns in its amended proposal.

The Commission's amended proposal claims to have taken all but one of the Parliament's amendments into account. However, there have been some subtle but crucial changes that mean even the weak position of the Parliament is further watered down:

* the Parliament asked for the industrial application of identified genes to be disclosed - this has been ignored

* the Parliament wanted animals with physical handicaps not to be patentable unless there was considerable medical benefit - this has been ignored

* the Parliament wanted a new ethical committee to be formed to evaluate the morality of granting certain patents and the implication was that this should be accountable and open. The Commission has simply placed the unaccountable, secretive Group of Advisors on the Ethical Implications of Biotechnology into this role.

* the Parliament wanted evidence that the consent of the people or countries of origin had been obtained before patents on genes and living material was granted. This was to try and prevent blatant exploitation taking place - the Commission have completely disregarded this, apparently seeing the role of the EU as protecting the strong against the weak.

10. Conclusions

The Commission's proposed Directive demonstrates just how greedy big businesses have become. In their drive for more profits the biotech industries are pushing society to be more corrupt and immoral. If the Directive is accepted in its present form, private interests will be able to claim they have invented life and control the design of new organisms. Companies will be able to choose who benefits from potential new treatments, deciding on the basis of how lucrative their illness and suffering is likely to be. Industry will be able to steal genetic material from people in Europe and abroad and profit from their plunders under the protection of the European Union.

None of this is about honest reward for innovation, it is about greed and power. The environment, animal welfare and human health are being sacrificed through the desire of the new biotechnology industry to grab monopolies, stifle competition and threaten the jobs of those in traditional businesses. The companies involved in pushing for patents are the same ones seeking to introduce genetically engineered foods no wants and which carry long-term irreversible risks to human health and the environment. Not only are companies like Ciba Geigy (now Novartis) seeking to make Europe accept genetically engineered corn which contains an antibiotic resistance gene against the wishes of most European citizens, but they wish to have a monopoly reward in the form of a patent for this `invention'. They are showing no respect for the public interest or the wishes of European citizens, Europe should not reward them by giving patents on life.