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 Public Debate and Regulation of Biotechnology in Europe
By
Peter Commandeur, Pierre-Benoit Joly, Les Levidow, Beatix Tappeser, Fabio Terragni
 
Keywords:  Public acceptance; Intellectual property rights; Ethical aspects; Labelling; Biosafety/Foodsafety; European Union (EU); United Kingdom; Italy; Germany; France.
Correct citation: Commandeur, P., Joly, P.-B., Levidow, L., Tappeser B. and Terragni, F. (1996), "Public Debate and Regulation of Biotechnology in Europe." Biotechnology and Development Monitor, No. 26, p. 2-9.

The public debate on regulation of biotechnology in Europe is both wide and intense. Interest groups at national and European levels have succeeded in getting ecological, ethical and social considerations on the agendas of the various legislative bodies involved. Because of the many concerns which are being taken into account, European regulation is developing slowly, in the meantime leaving an uncertain environment for the biotechnology industry. The outcome, however, will be an internationally unprecedented set of new regulations.

Despite the evolving European integration, huge differences exist in the intensity of the public debate on biotechnology. In Italy, for example, biotechnology is hardly considered as controversial, and the ‘public’ debate is confined to small circles of scientists and industrialists while the Catholic Church is involved as far as human applications are concerned. In Germany, on the other hand, environmental groups, consumer organizations, religious groups, and farmers’ organizations actively participate in an intense public debate on biotechnology, especially regarding biosafety. German groups also have a considerable influence in the debates at the European level.

Public acceptance and ethics
Like other peoples around the world, Europeans tend to accept biotechnology in medical applications more easily than biotechnology in the field of agriculture or food processing. Nevertheless, especially in Germany, concerns exist that genetic engineering will lead to eugenetics (i.e. the genetic improvement of the human race), and that genetic data may be misused for commercial purposes. Particularly, the women’s movement and disabled people’s interest groups fear the social impact of biotechnology will be divergent from solidarity and human rights. In Germany any form of research on human embryos, which are available from for example in vitro fertilization, is prohibited.
The European Bioethics Convention is negotiated within the Council of Europe (an organization consisting of most European democratic states), with the aim to come to general ethical guidelines on research, genetic screening and testing. The discussions in this Convention are developing slowly, however. The most controversial issues are research or practices on people unable to express their consent (e.g. the incapacitated, young children), and research on human embryos. Although member states only have to adopt the guidelines of the Convention after ratification of the Convention, it is felt as a basic ethical framework for future research throughout Europe.
Concerns about public acceptance resulted in several European countries in ‘consensus conferences’, which have been organized to broaden the debate on biotechnology, and increase peoples’ knowledge of biotechnology. During these conferences, a panel of ‘lay’ people is informed by different specialists in the field of biotechnology. Thereafter the panel discusses its main ideas with a wider audience, and presents a report in a final discussion before the media. Although similar initiatives are also organized in the USA, for example by Hoban and Kendall (see Monitor No. 24), the process goes beyond a better assessment of the acceptability of biotechnological products on the market: the ‘lay’ panels are to come to an informed opinion on the technical and regulatory aspects of biotechnology, which could form an important input for a debate on regulation. In the case of a conference on human genome mapping in Denmark, for example, the Danish parliament subsequently discussed the recommendations made by the ‘lay’ panel, which resulted in regulation prohibiting the use of information gained from genome mapping for insurance and employment purposes.

Labelling
The central issue of labelling is not food safety, but offering a free choice to consumers to buy genetically modified products or not. If the food safety is not guaranteed, a food product is not allowed on the market, and labelling not applicable.
Labelling of products generated with the use of genetically modified organisms is a controversial issue in Europe. A recent dispute about marketing approval of a genetically modified herbicide-resistant oilseed rape from the Belgian company Plant Genetic Systems (PGS) demonstrates the difference in opinions. In its marketing application, PGS has already undertaken to label the seed as tolerant to the herbicide glufosinate-ammonium (active compound of the herbicide Basta). The European Commission (DGXI) proposed that PGS be required to add the phrase ‘modified’, as agreed by a qualified majority of member states. This proposal was a compromise between no specific labelling and labelling as ‘genetically modified’. Subsequently, after a prolonged dispute among Commissioners, a majority outvoted the DGXI stance, resulting in the counter-proposal that required only the label which PGS itself had originally undertaken. This arrangement was finally accepted by a qualified majority of member states, and the Council of Ministers granted market approval in early February 1996. The first marketing authorization of this oilseed rape specifies that the seed may not be used for human or animal consumption. However, a second authorization is already pending for it to be used for human and animal food.
This oilseed rape is the first genetically engineered crop which has received authorization for large-scale marketing in the European Union (EU) (see box ). It is therefore the precursor in the debate on labelling of Novel Food and Novel Food Ingredients which is currently under discussion in the European Parliament. In January 1996, its Environmental Committee debated for the first time the proposal of the Council of Ministers for a Novel Food Regulation. One of the amendments that have been proposed is on social assessment, including the statement that "a product should not get authorization if it results in a burden for society or groups of society which cannot be compensated and which is not acceptable."
In 1995, the Informal Consultation Group, consisting of representatives from the biotechnology industry and consumer and environmental organizations in the Netherlands, has reached an informal agreement about labelling of foods produced with the aid of genetic engineering. The industry will inform consumer organizations in an early stage about market introduction of new genetically modified food products, and consult them about needed consumer information. Industry’s interest in early consultation is to avoid an overall rejection of genetically engineered products by these organizations, resulting in public campaigns against these companies or their products.
The Group is provisionally taking as its basis the wording ‘produced with the aid of modern biotechnology’. The discussion unveiled another problem inherent to labelling, i.e. what to label. The Group agreed on the general principle to label those foods and ingredients that are themselves, or contain, genetically modified organisms. It agreed that no label is needed for processing aids which do not occur in the final products or only in inactivated form without giving the finished product new properties (such as enzymes); additives derived from genetically modified organisms which are identical to existing ones (such as aspartame); ingredients which because of their small quantity or inactivity are not subject to declaration under existing labelling regulations; and products of animals fed with transgenetic crops.
Finally, the Group identified a third group of products, on which no agreement has been reached yet. This group contains ingredients made out of modified organisms but chemically identical to existing ones (such as sugar, oil or starch from herbicide-tolerant crops) and processing aids which occur in the final product in active form or give the product new properties. Several practical problems were raised during the discussions, such as the difficulty to label unpacked products, the nonexistence of separate raw material flows for chemically identical ingredients, the impossibility to control the origin of chemical identical ingredients, and the danger of an "overkill" of labelling, since most of the ingredients are used in small quantities by many manufacturers a highly processed form.
Meanwhile, the first genetically modified products have arrived at the supermarket in a few member countries. In the UK, imported tomato puree from genetically engineered US tomatoes is on the market, voluntarily labelled with "made with genetically modified tomatoes". The relevant UK advisory committee has publicly recommended that market approval should not be provided for the unprocessed tomato.

Biosafety regulation
In the 1986 OECD safety guidelines for the release of genetically modified organisms (GMOs) some key principles were presented for safe, small-scale field trials with genetically modified plants and micro-organisms, and suggestions were made how to implement these principles. These recommendations have influenced national policies of many OECD member states. Examples are the ‘case-by-case’ and ‘step-by-step’ principle, implying that each case should be considered separately and that a large scale release should form the last stage of a process during which experience with a GMO is gradually obtained. Although member states have all used these similar principles in setting-up risk analyses and risk management, different interpretations have resulted, as is manifest in current biosafety regulations in Europe.
The regulatory framework for biosafety regarding GMOs in the EU member states consists of the EC Directives for Contained Use (90/219) and the Deliberate Release (90/220) that were published in 1990, and which all member states must implement. Harmonization of procedures and criteria for biosafety assessments were the main aim of the Directives, in the context of ‘completing the [EU] internal market.’ The EU regulation on deliberate release is ‘process-based’ legislation, because it requires a consent of national authorities for any transgenic organism prior to release. The European biotechnology industry accepted in principle the need for such legislation, as a means to allay public suspicion and overcome divergent national regulations.
Harmonization of member states’ policy with respect to deliberate releases has been difficult to achieve. Firstly, this is because differences in the understanding of ‘risk’ exist in national biosafety regulations. According to the Directive, member states must evaluate the risks of each proposed release. However, strong differences exist in the conceptualization of risk. For example, in the UK ecological uncertainty about long-term environmental harm, somewhat analogous to the introduction of non-indigenous organisms, forms part of the risk assessment. By contrast, French regulators adopted a concept of risk which focuses more on the biotechnology, whereby risk of the GMO arises in the first place from uncharacterized or imprecise insertion of DNA material.
Secondly, harmonization is problematic because of differences in opinion concerning the environmental impacts that should be taken into consideration. The Directive prescribes that member states must undertake all appropriate measures ‘to avoid adverse effects on human health and the environment.’ Since this general requirement does not clarify the extent of causal chains deemed relevant, this issue has become contentious at the commercial stage of GMOs in the EU. Potential effects that would result from agricultural practices in using the transgenic organism are often labelled as ‘secondary’ or ‘indirect’. Some member states, such as Denmark, Sweden, Finland and Austria, have publicly argued that such effects be included within the risk assessment. Perhaps not coincidentally, their national legislation linked biotechnology with broader criteria, like for example sustainable agriculture, socio-economic consequences or ethics. Others member states, such as the UK and the Netherlands, consider only direct ecological effects of the GMO.
The statutory relevance of secondary effects provoked disagreement, particularly over the PGS application for glufosinate-tolerant oilseed rape (as cited above). PGS acknowledged that unintended transfer of genes from the oilseed rape to weeds (gene flow) could potentially generate glufosinate-resistant weeds. But most member states interpreted the Directive to state that potential secondary effects, such as farmers losing the option of using the herbicide Basta, or an increase of the overall usage of herbicides, were irrelevant for decision making. Similarly, for market approval of transgenic maize including a Bt gene, member states disagreed over the statutory relevance of the prospect that its use could generate pest resistance, and thus undermine the effectiveness of Bt as a microbial insecticide.

The following summary gives more details of biosafety regulation in some European countries:

The European Union 

15 Countries form the European Union (EU): Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom. 
The EU consists of three pillars: (1) Community policies (such as agriculture, R&D, transport); (2) Common foreign and security policy; and (3) Justice and home affairs. The EU operates through the Council, the European Parliament and the European Commission. The tasks of these bodies differ between the pillars. With respect to the community policies, the tasks are as follows: 
 
Council  European Parliament  European Commission 
Competence 
  • Highest decision making authority that has the power to adopt, amend or ignore a proposal of the Commission 
  • Legislative power which ranges from consultation to decision making in cooperation with the Council, depending on the area 
  • Power of the budget 
  • Supervision of the executive 
  • Guardian of the treaty 
  • Initiation of legislation 
  • Executive body 
Members 
  • Consists of representatives of member states, usually ministers 
  •  Democratically elected body of 626 members. Members are elected by direct European elections every five years 
  • Headed by 20 independent Commissioners appointed by member states 
 

UK
In the late 1980s, Britain had a wide ranging risk debate on GMO releases, that included ethical and socio-economic aspects. In response, the British Department of the Environment (DoE) announced ‘precautionary controls’ in the Environmental Protection Act of 1990. This stringent Act required a prior risk assessment and consent for each GMO release, and prohibited any release which posed ‘a risk’ of harm, including the long-term potential for harm. Regulators emphasized the genetic novelty of GMOs as a source of uncertainty about risk. DoE established an Advisory Committee on Releases to the Environment (ACRE), which included ecological expertise and an implicit public-interest representation, e.g. the Green Alliance. Through ACRE, responsibility has been shared by other ministries, the industry, an environmental lobby and the academic scientists. The main task of ACRE was to advise the government on the release of ‘novel organisms’, i.e. both GMOs and non-indigenous organisms. In this way, the procedure accommodated also ecological concerns.
Industry regarded biosafety controls as helpful for enforcing a collective self-discipline among biotechnologists as well as protecting their public image. Although it doubted the potentially negative ecological effects, it accepted the challenge of demonstrating that the inserted genes would not inadvertently confer a selective advantage once released. In the early 1990s, the ‘over-regulation’ in the UK was generally blamed for deterring private innovation and investment. Partly in response, DoE adopted ‘risk-based regulation’ in 1993, aiming ‘to make the regulatory burdens on applicants commensurate with the degree of risk involved in their release’. The practice, however, is more the reverse: the regulatory burden still exists, but helps clarify whether there is a risk, or helps to defer such uncertainty by imposing confinement measures on the transgenic material. In such ways, regulators guide applicants in designing and justifying their proposed releases as safe, e.g. as a ‘low-risk release’. For each release so far, applicants have argued that the potentially harmful effects are small or negligible because the GMO will be kept in reproductive isolation, the GMO is harmless, or both.
A marketing application by PGS for glufosinate-tolerant oilseed rape, meant that controversy has shifted to the potential agricultural effects of large-scale commercial use. NGOs criticized the PGS risk assessment for excluding the herbicide implications. As regards ‘the agricultural environment’, the DoE and ACRE focused their discussion more narrowly: they judged that the spread of glufosinate-resistance genes could not disrupt existing weed-control methods, which generally rely upon glyphosate (the active compound of the herbicide Roundup). Nevertheless, several ACRE members expressed their unease about broader effects of the product, e.g. on crop rotation and overall herbicide usage. Anticipating subsequent transgenic products, some ACRE members publicly signalled the long-term prospects that oilseed rape may inadvertently acquire resistance to several herbicides, with implications for volunteer weeds. The National Farmers’ Union proposed that this issue should be considered within the statutory regulation. So far, no ministry has accepted responsibility for preventing such problems.

Italy
In Italy no biosafety regulation existed before it was induced by the EU Directives. Previously, the Italian government made use of other laws, such as in 1987 when it received the first application for field testings by the US company Advanced Genetic Science. This company had developed the genetically modified bacterium Ice-minus, which protects crops against frost damage. The release was not carried out in California because of public opposition there. The application was denied by the Italian Ministry of Health by, as an ad hoc measure, applying regulations concerning pesticides.
The establishment of regulation was preceded by a narrow debate among researchers, responsible authorities and some environmental NGOs. Probably the only instances where a public debate on biosafety issues took place was during two national meetings in Rome in 1990 and 1991, attended by no more than 30 people. These were organized by the Gruppo di Attenzione sulle Biotecnologie (GAB) to urge the Italian government to implement the Directives.
In March 1993, eighteen months after the scheduled deadline mentioned in the Directive, the Italian parliament approved Italian regulation, which closely followed the EU Directives. The Ministry of Health is the competent authority, while other ministries are involved through the established inter-ministry coordinating commission. Furthermore, an advisory committee for both the confined use and deliberate release of GMOs was established, which includes representatives from public research, the European Commission, and ASSOBIOTEC (the biotechnology industry association), as well as an independent expert. Contrary to the situation in the UK, and to the representation of the industrial lobby group, NGOs have not been involved. The disciplinary composition of the committee shows a dominant representation of medicine, while only one ecologist is included.
Based on the documentation delivered by the applicant, the risks for human health and the environment are evaluated by experts appointed by the inter-ministry commission. These experts also take into account the risk assessments of other EU member states. Applications are dealt with on a case-by-case basis, and lack a unique set of evaluation criteria. If the appointed experts are not unanimous, the advisory committee may be consulted, although this consultation is neither obligatory nor binding. So far the committee has met only twice.
The Italian scientific community seems basically positive about the level of protection ensured by the regulation. Environmentalists, on the other hand, point to the lack of monitoring by the government. Although inspection and monitoring is provided for in the existing regulation, it is hardly taking place. Scientific research on biosafety risks is not well developed in Italy, and the government does not fund research projects in this field. Funded by the European Commission, two research teams have been working on risk assessment at the Universities of Padua and Florence.
Another shortcoming of the Italian regulation is the lack of any provision concerning public access to information. The EU Directive considered the possibility for member states to consult the public, but this option has been dropped by Italian regulators. The inter-ministry commission may provide for the consultation of public interest groups or the public in general on any aspect of release, but it has not actually done so. So far, no applications for deliberate release has met serious public opposition.

Germany
Biosafety regulation in Germany distinguishes four risk levels concerning GMOs, from ‘no’ risk to ‘high’ risk for people and/or environment. Some experiments with GMOs, such as laboratory research of ‘no’ or ‘low’ risk and controlled production facilities of ‘no’ risk, only require notification. The categorization of the risk is made by the applicants themselves. 80 to 90 Per cent of all research and production facilities remain in the ‘no-risk’ category, while high-risk activities have not been registered yet.
The opposition against deliberate release experiments has always been strong in Germany. From the first release with transgenic petunias in 1989/90 onwards, different environmental groups have expressed serious ecological concerns about the predictability and the ability to control the spread of new plant or traits in the environment. Especially because of the required public hearings during the application procedures, which were felt burdensome and time-consuming, only four other release experiments were applied for before the regulation was amended. The amendment took place after intense pressure by industry and research associations, including a large publicity campaign in a main German newspaper emphasizing the benefits of biotechnology and its importance for German economic competitiveness. The amendment abolished the public hearings and only allowed written reactions.
After the amendment of the biosafety regulation the number of applications jumped to 18 in one year (1994). Before January 1996, 25 release experiments took place, of which 24 were with transgenic plants. Another 12 experiments are waiting for approval. Consumer and environmental organizations state that the underlying arguments for the deregulation in Germany and elsewhere, namely that GMOs have no chance to survive in the environment and that isolated DNA is rapidly degraded, are not supported by current studies.
The end of public hearings did not result in the decrease of public resistance. On the contrary, the increasing number of field tests led to a range of public actions in the test areas. An information campaign directed at farmers led them to withdraw their consent to use their fields for release experiments. Protests also included open-air camps on the fields preventing sowing, while in other cases the transgenic crops were destroyed by unknown people. The main force behind these actions is concern about ecology, human and animal health aspects, socio-economic impacts and ethics.

France
The positive attitude towards biotechnology of the French government resulted in the creation of the Commission pour le génie biomoléculaire (CGB) by the Ministry of Agriculture as early as 1984. The mission of CGB is to give its opinion prior to governmental approval of the deliberate release of GMOs. The Commission does not consider GMOs to include an inherent risk. Risk assessment is conducted on a case-by-case basis taking into consideration the impacts of the specific GMO in the specific environment. CGBs attitude is a very pragmatic one, as is shown by its current position towards marketing authorization. It intends to give provisory marketing authorization to GMOs for 5 years, in which period the impact of the GMO on its environment will be monitored. In this way CGB hopes to get a more realistic evaluation of risks of transgenic plants in a quasi-normal situation, on which it could define the conditions of its use. Some people strongly criticize this official position stressing that once the transgenic plants are commercialized there is no way back.
This pragmatic attitude mainly explains why France is the country in Europe where the highest number of field trials has been conducted: 138 trials between 1986 and 1993. These field tests hardly evoked public protests, with a few exceptions such as a conflict in 1988 around the unauthorized release of transgenic micro-organisms by a research team in Dijon. Specialists do debate risk, such as on the introduction of herbicide-tolerant oilseed rape and the risk of gene flow to weeds or increased herbicide use following such introduction. The nature of these debates is more of a technical than of a political nature, and NGOs are hardly participating in them.

Stimulation programmes in the European Union*
  • Forecasting and Assessment in Science and Technology (FAST): initiated in 1978, it was the first EU programme that included biotechnology. Its purpose was to identify options and priorities for long term R&D. FAST’s first report (1982), laid down a proposal for the basic principles of an integrated European biotechnology policy. It presented a model of a "European biosociety", in which an ecological modernization of the West should be combined with the needs and interests of developing countries. FAST has had an important influence on the initiation of European biotechnology programmes in the 1980s. The FAST activities, in later years operating under the name MONITOR, have been ended in September 1995.
Generally oriented research programmes
  • Biomolecular Engineering Programme (BEP): was established in 1982 as the first biotechnology programme. The aim of the programme was to research the application of biotechnology in the agrofood industry and agriculture. For a four-year period, BEP was promised a budget of US$ 20 million (15 million ECU). Compared to individual government budgets, this was low. In 1982-1983 the total public budget for biotechnology R&D of all member states was US$ 200 million, of the USA US$ 335 million and of Japan US$ 80 million. 
  • Biotechnology Action Programme (BAP): implemented in 1985, this continuation and extension of BEP had a four-year budget of US$ 74 million (75 million ECU). Just as BEP, it was established to stimulate a European research network between universities, other publicly funded institutes and industry. In addition, BAP included more research areas such as enzyme engineering and bioinformatics. BAP has proved to be unable to stimulate the research network due to the lack of funding, the lack of information available, and the possible conflict of interests between the public and private sector on confidentiality rules. Only 6 per cent of the actors engaged in the programmes originated from the industry, and most projects were carried out in single research institutes and not through transnational cooperation. 
  • Biotechnology Research for Innovation, Development and Growth in Europe (BRIDGE): running from 1990-1994 with a total budget of US$ 123 million (100 million ECU), it was the follow-up of BAP. Although BRIDGE continued the same activities as BAP, BRIDGE was more oriented towards industrial applications.
  • BIOTECH 1: this US$ 229 million (189 million ECU) two year programme started in 1992-1994 as a supplement to BRIDGE. It included some new research areas, such as the conservation of genetic resources.
  • BIOTECH 2 : with a budget of US$ 681 million (552 million ECU), this programme is the follow-up on BIOTECH 1 and BRIDGE. It runs from 1994 to 1998.
Focused research programmes`
  • Agro-industrial research: Between 1987 and 1994, four agro-industrial research programmes with a total budget of US$ 589 million (493 million ECU) were initiated. Their common aim was to stimulate research in the field of plant genetic engineering, animal production and health, processing of new biological materials from agriculture, forestry and fisheries, and food safety.
  • Agro-Industrial Research and Fisheries (AIR): running from 1994-1998, it is the follow-up of the four agro-industrial research programmes. It has a budget of US$ 844 million (684 million ECU). 
  • BIOMED 1: In the biomedical field, during the 1980s only human genome research was conducted. However, with the expansion of the Community’s authority new possibilities have opened up. Public health and health research now belong to the tasks of the European Commission. In 1990, the first BIOMED programme was implemented, with a budget of US$ 166 million (135 million ECU) from 1990-1994. The main task of BIOMED 1 was to support network building and training in the field of human genome research, disease prevention, care and health systems, cancer, cardiovascular, mental and neurological diseases.
  • BIOMED 2: since public health is considered a new market which offers novel possibilities for increasing the European competence in biotechnology, the budget of US$ 415 million (336 million ECU) for BIOMED 2 (1994-1998) is significantly higher than the budget of BIOMED 1. The goal of BIOMED 2 is to improve the partnership between basic and applied research in order to achieve a faster transformation of innovation into practice. The main difference with BIOMED 1 is the substantial support of research activities. New priority areas are socio-economic important neurological diseases, pharmaceutical research and biomedical technology and engineering. 
Elisabeth Bongert 

Post-graduate, Department of Social Sciences, Frankfurt University, Loogestieg 17, D-20249 Hamburg. Phone (+49) 40 470964; Fax (+49) 40 4605266 

* See for an analysis of the EU programmes until 1990 Monitor No.2, 1990; see for an anlysis of EU cooperation with third countries article page 12. 

source: Several reports of the EU Commission (1977-1994).

Plant variety protection
Regulation of intellectual property of biotechnological products is complex in Europe. The main public debate on intellectual property rights (IPR) takes place at EU level, especially surrounding the (so far unsuccessful) introduction of a new EU patent Directive. The EU has been more successful in regulating plant breeders’ rights at EU level. In June 1994, the Council of Ministers of the European Union adopted the Regulation on Community Plant Variety Rights, which is compatible to the International Union for the Protection of New Varieties of Plants (UPOV) 1991 Act. Since April 1995, a breeder can choose to have new varieties protected either at national or community level. By a single decision of the Community Plant Variety Office, a plant breeder may acquire direct and uniform protection throughout the entire Union. In this respect the development goes parallel with the creation of the internal EU market which ensures the free circulation of people, goods, services and money on the territory of the Union.
The Community Regulation does not affect existing national plant variety protection systems, which exist in all EU member countries except Greece and Luxembourg. Most national plant breeders’ rights regulation is in accordance with UPOV 1978, although most of the member states are in a process to align their national laws with UPOV 1991. There is no intention to proceed to an overall harmonization of national legislation on plant variety rights.
The Community Regulation includes a ‘farmers’ privilege’ for certain agricultural crops such as cereals (except for maize), some fodder crops, oil seeds and potatoes. Hybrid and synthetic varieties are excluded from this privilege, but here the farmers’ privilege is less relevant. The farmers’ privilege allows farmers to save seed for their own use, but prevents marketing. In return for the privilege, farmers have to remunerate breeders. The level of remuneration is, up to now, left to contractual arrangements between (future) holders of the Community plant variety and farmers, since an attempt by European breeders’ and farmers’ organizations to come to a specific percentage of the royalty usually charged for the licensed production of seed of a protected variety, failed.
Not all European farmers, however, will have to compensate breeders for seed saving: ‘small-scale farmers’ are excluded from this requirement. A farmer is considered ‘small’ if he or she does not cultivate more than about 20 ha. of cereals or oilseeds, or about 5 ha. of potatoes (irrespective of the other crops grown).
Legal protection against infringement of variety protection must be pursued before national courts. Also the farmers’ privilege is a question of private law, and therefore breeders themselves are responsible to monitor compliance. Since control of individual farmers will be a costly and time consuming activity, breeders might have much to gain from a commitment by farmers’ organizations to the enforcement of the principle of remuneration in return for low remuneration rates.
The new Regulation on Plant Variety Rights can be considered a compromise between the interests of breeders and farmers, but also of Northern and Southern European states (see also Monitor No. 17). In Southern Europe seed saving is more common than in the Northern member states, and without an exemption for small farmers the Regulation could have had a significant effect on South-European agriculture. Between April and September 1995, the Community Plant Variety Office had already received 2900 applications. This high number might illustrate the benefits it includes for most breeders. These are, besides less administrative procedures and costs, the UPOV 1991 type of protection which, among others, prevents not only cultivation but also marketing of the final product in countries in which the protection applies.

Patents: European Patent Convention
The differences in views surrounding the Regulation on Plant Variety Protection are in magnitude incomparable with the continuing disputes around the proposals for an EU Directive on the legal protection of biotechnological inventions. In March 1995 the European Parliament voted against the common position of the Council of the EU. In December 1995, a new proposal was presented, which is again the subject of heated debate. Since the outcome of this debate will be the framework to which member states are obliged to adjust their patent laws, national governments did not take much initiatives to adapt their national IPR laws, although new jurisprudence has emerged in some countries.
Currently, no patent law exists at the level of the European Union. In Europe, patent law is reserved to national legislation and to the European Patent Convention (EPC) of 1973, of which the contracting parties are not identical to the members of the EU. The European patent is "a bundle of national patents valid in the countries specified by an applicant", but patent requirements are laid down in the EPC. Biotechnology industry is not satisfied that within EPC each nation has been treating biotechnology patents slightly differently, and the European Patent Office (EPO) has been deciding on biotechnological patent applications on a case-by-case basis, without providing clear limits of what is patentable.
The EPC excludes animal varieties, plant varieties and essentially biological processes for the production of plants or animals from patentability.
Microbiological processes or the products thereof are patentable. Although the European Patent Office (EPO) used to apply a very strict interpretation of the concept ‘plant variety’, the current scope of their patents is unclear since Greenpeace successfully challenged a patent already granted to the Belgium company Plant Genetic Systems. By a decision in February 1995, the patent was limited to the process of genetic modification of plants and the plant cells produced by that method, but no longer covered the seeds and plants that were produced using the patented process.
The vague boundaries of what EPO judges patentable in respect to animals might be clarified by the jurisprudence which will result from the final decision on a challenged patent on the ‘onco-mouse’ granted to the US Harvard University. Due to genetic modification, the onco-mouse quickly develops cancer and therefore can be used as a model for human cancer research. After a first denial in the 1980s, EPO granted a patent in 1991. Before this positive decision, however, the invention passed an ethical screening, which is uncommon in the process of patent assessment. Only because EPO decided that the possible benefits to human welfare outweighed the suffering of the animals, was the patent granted. Several organizations have challenged the patent on ethical grounds even since. According to them, it is immoral to create animals "made to suffer", and these groups tone down the onco-mouse’s importance for human welfare by emphasizing that it is a relatively poor model for human cancer. The ethical examination of patents on animals, is one of the elements that has been adopted in the EU Directive on biotechnological inventions.

Patents: EU Directive
The original aim of the EU patent directive is to state clearly the limits of the living material patentable, and to harmonize national patent laws within the EU. This clarification and harmonization of EU member states’ patent laws may take years since the EU Directive on the Legal Protection of Biotechnological Inventions was rejected by the European Parliament in March 1995. As distinct from the EPC, an EU Directive would be a regulatory framework to which national patent legislation of EU member states would have to be adapted. The main reason the Parliament did not agree, is that it wants a ban on patents on all human body parts. The Council of Ministers and the European Commission only want to exclude human body parts ‘as such’, leaving the door open for patents on cells, genes and proteins isolated from the body.
The rejection of the EU Directive came as a surprise for many, especially since compromises on several controversial issues were included in the final proposal. Nevertheless the vote was clear: 240 votes to 188, with 23 abstentions. The compromises reached make the Directive a unique piece of patent legislation in international context. For example, the patent law includes a farmers’ privilege to guarantee the freedom of farmers to reproduce both patented animals and patented plants for their own use. Transgenic animals could be patented, but only if their use for human well-being would outweigh their suffering. This is the same criteria under which the onco-mouse is patented by the EPO. Additionally, plants would be patentable, but plant varieties would remain excluded.
Proponents of a far reaching biotechnology patent law state that "social and political issues were allowed to overwhelm the original legal and economic agenda. What began as patent legislation came to be about farmers’ privileges and animal "rights" and questions of the value and dignity of human life" (Sussan Hassler, Bio/Technology). Opponents, on the other hand, conclude that "for once ethical considerations won over economic interests" (Florianne Koechlin, No Patents On Life). According to Science, the biotechnology industry is not very disappointed about the rejection of the patent Directive since, in their opinion, the Directive was too ambiguous to be very effective in serving their interests.
In December 1995, the European Commission presented a new draft which specifically excludes patents on germ-line gene-therapy (therapy that would change the genetic information of an individual and of further generations), which includes an ethical examination, and which distinguishes more clearly between invention and discovery, with the latter excluded from patentability. The controversial section on the patenting of human genes, however, remains unchanged.
The new draft could in principle be adopted at the end of 1997 at the earliest, but it is far more likely that it will take longer. Because of the delay in common EU legislation and the unclear boundaries of the EPC, companies are likely to look for other ways to obtain legal protection of their biotechnological products and processes. One way is by searching for indirect protection such as patents on essential processes or parts of the organism (cells, genes, etc.). Through these patens, companies can also exercise control over the final product. Another way is to circumvent the EPO, and file patents at the national patent offices in Europe. The British Patent Office, for example, has granted patents on animals expressing growth-enhancing genes. If a renewed emphasis on national patent law evolves, then this will be a development opposite to the often noticed phenomena in the EU that (national debate) on regulation is surpassed by decisions at the Union level. Lobbies of environmental, consumer, farmer, religious, social and biotechnology interests groups are directed at the EPC and the European Directive, while for the time being, national regulation might become more important.
1 Peter Commandeur
2 Pierre-Benoit Joly
3 Les Levidow
4 Beatix Tappeser
5 Fabio Terragni
 

  1. Editor Biotechnology and Development Monitor
  2. Research Director INRA/SERD, P.O. Box 47, 38040 Grenoble Cedex, France. Fax (+33) 76 825455; E-mail joly@grenoble.inra.fr
  3. Centre for Technology Strategy, Open University, Milton Keynes MK7 6AA, UK. Fax (+44) 1908 652175; E-mail l.levidow@open.ac.uk
  4. Öko-Institut e.V., P.O. Box 6226, D-79038 Freiburg, Germany. Fax (+49) 761 475437.
  5. GAB, Via Andegari 18, 20121 Milano, Italy. Fax (+39) 2 8690099.
sources
Claire O’Brian (1995), "European Parliament Axes Patent Policy" Science, Vol.267, 10 March 1995, pp.1417-1418.

Susan Hassler (1995), "European Patent Legislation: A missed opportunity". Bio/Technology, Vol. 13, April 1995, p. 305.

Bernhard Jank (1995), "Biotechnology in European Society." Trends in Biotechnology, Vol.13, No.2, pp.42/43.

Emma Johnson (1996), "Oncomouse Patent in Limbo: But does it matter?" Bio/Technology, Vol. 14, January 1996, pp.20/21.

Les Levidow, Susan Carr, Rene von Schomberg and David Wield (1996), "Bounding the Risk Assessment of a Herbicide-tolerant Crop." In: Ad van Dommelen (ed.), Coping with Deliberate Release: The limits of risk assessment. Tilburg: International Centre for Human and Public Affairs, pp.81-102.

Mailout, Friends of the Earth Europe Biotechnology Programme, several issues.

Jürgen Tiedje (1995), Possible Effects of Recent Developments in Plant-Related Intellectual Property Protection in Europe. Paper presented at the Seminar "Effects of Intellectual Property Rights on Agriculture in Developing Countries." Bogota, March 1995.

Science & Public Policy. Issue on harmonization difficulties of Directive 90/220 (forthcoming).



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