Following its US sister organization, the European Association for BioIndustries (EuropaBio) has recently drafted bioethical guidelines for its member companies. EuropaBio expects that clearer ethical boundaries will enhance the public acceptance of the biotechnology industry and its products. The formulated Core Ethical Values, however, suffer from the same ambiguity as the existing national and international bioethical regulation, lacking concrete steps forward.

The first step to formulate a unified standpoint on the issue of corporate bioethics in Europe has recently been taken. At its first conference in Amsterdam, April 1997, EuropaBio presented its draft Core Ethical Values, a binding document for all its members. EuropaBio was launched in September 1996 through a merger between the Senior Advisory Group on Biotechnology (SAGB) and the European Secretariat for National BioIndustry Associations (ESNBA). It represents 11 national biotechnology associations and some 600 companies, amongst them most of Europe's multinational operating enterprises such as Novartis, Unilever, and Hoffmann­La Roche.

Bioethics against sales resistance
EuropBio's initiative is driven by its realization that the lack of public acceptance for many products generated by means of modern biotechnology is not necessarily due to lack of information, but rather due to moral concerns. This was confirmed by a 1996 study recently published in Nature, which investigated the perception of the European population regarding biotechnology applications. It concluded that policy debates about biotechnology have normally been framed in terms of potential risks to the environment and public health. However, these concerns, as well as regulatory initiatives to avoid such harm, were found to be less significant than moral acceptability in shaping public opinion on biotechnology. Therefore, clear and predictable ethical boundaries are expected to become a strategic requirement for the biotechnology industry's further development, not only in Europe, but all over the world. By giving itself an ethical framework, the biotechnology industry hopes to generate a more biotechnology­friendly climate in general and to strengthen its position in arguments with critics, such as consumers and environmental organizations.

The value of Core Ethical Values
The first draft of EuropaBio's Core Ethical Values starts by emphasizing the benefits of biotechnology for humans in general through its positive impact on health care, agriculture, food and environment (see box). The Core Ethical Values "are intended to provide guidance to our industry where no legal requirements exist or where industry wishes to go beyond any legal requirement." They fit into the aim of EuropaBio to encourage dialogue with those having ethical concerns about the use of biotechnology. Although this document is intended as a basis for further discussion rather than as a final code, most of its self­imposed obligations circumvent the ethical issues they supposedly address. Instead, concrete commitments are only made for applications of biotechnology that have already been put into legislation or are forbidden, as in the case of biological weapons and human cloning. For instance, the ban on the use of biotechnology for the production of weapons is already covered by the legally binding Biological Weapons Convention. The Core Ethical Values document does not make any effort to cover the loopholes in this Convention. For example, the acceptance of research for defence purposes, which has proven to open the door for the development of biological weapons, is not addressed in the document.
Another example is cloning to reproduce human beings. This is opposed by the Core Ethical Values document, but it remains unclear if this also holds true for research purposes. Also, the document states that EuropaBio prohibits its members from altering the genes of human germ line cells or embryos until the medical, ethical and social issues have been discussed and put into legislation. This is an empty commitment because it only subscribes to the current situation in Europe: in some European countries labaratory research on human germ line cells and embryos is forbidden, whereas in other countries this is performed on a legal basis.
Critics of the biotechnology industry are sceptical as to how far the Core Ethical Values can be seen as a real commitment. The environmental organization Friends of the Earth has stated that some main fields of moral concerns about the implications of modern biotechnologies, such as the export of genetically modified organisms to developing countries or the patenting of human genes and genetic material originating from the Southern hemisphere, are being neglected.
Another Northern non­governmental organization, Genetic Resources Action International (GRAIN), has demanded that transparent product information and informed consumer choice have to be taken seriously. So far, biotechnology industry still opposes a strict labelling and separate treatment of genetically modified products. Newspapers reported that members of EuropaBio asked the US President to oppose the European Novel Food legislation, because the labelling and separation measures mentioned therein were seen as a trade barrier. Benny Härlin, international coordinator of genetic engineering issues for Greenpeace, has pointed out that the Core Ethical Values lack the precautionary principle which would allow prompt detection of any adverse effects not currently foreseeable. The absence of this approach with regard to biotechnology is even more remarkable, since many of the biotechnology industry companies also belong to the chemical industry, which has learned to handle risk assessment as an inevitable tool of public acceptance. Risk assessment based on safety studies including long­term effects has been common practice in the chemical industry for a long time.

Convention on human rights and biomedicine
So far EuropaBio's Core Ethical Values do not differ much from the Convention on Human Rights and Biomedicine, which was adopted by the Council of Europe in 1996. This Convention aimed at unifying the ethical guidelines of most European countries with an emphasis on the moral implications resulting from research activities in the field of biomedicine and genetic engineering. The Convention's positive standpoint on research involving people who are unable to express their informed consent, such as disabled newborns or coma patients, has provoked protest. According to the Convention, research could be allowed even in cases where the patient will not have any direct benefit from it. On this issue as well, EuropaBio's restrictions do not extend existing ethical regulations. EuropaBio appears to be unwilling to take measures that could have adverse effects on research activities. Consequently the Core Ethical Values do not include an accommodation to the existing criticism of the Convention on Human Rights and Biomedicine.
 

EuropaBio's Core Ethical Values The following elements are included in EuropaBio's Core Ethical Values:  No use of cloning to reproduce human beings; Animal welfare needs to be respected and their use in research to be reduced; No use of biotechnology for weapon production; The privacy of medical information, including genetic information, has to be protected; No alteration of genes of human sperm, eggs or germ line cells. No interventions on genes of human embryos until their consequences are publicly discussed and put into legislation; Clinical trials need to be based on prior informed consent. For individuals who are unable to give this consent, it may be obtained by the legal representative according to existing legislative requirements Transparent product information is needed to promote informed consumer choice; The conservation of genetic and biological diversity needs to be supported; Transfer of technology between developed and developing countries, respecting their cultural heritages, needs to be stimulated. Source: website http://www.europa­bio.be/

Competitive advantage of bioethics
The release of EuropaBio's Core Ethical Values is a reaction to activities by the US partner organization. In 1996, the US American Biotechnology Industry Organization (BIO) launched a committee on bioethics as well. The fields of concern of the two biotechnology lobby organizations are the same, as are their bioethical positions. Like EuropaBio, BIO opposes cloning for the reproduction of human beings, but allows cloning of human parts for research purposes. It also demands the protection of medical and genetic privacy to prevent genetic discrimination. The interconnectedness of the European and US lobby organizations is further illustrated by the fact that many companies are members of both organizations.
It is the intention of the biotechnology industry that these commitments will enhance the credibility of the biotechnology sector as a whole. However, the idea that ethical codes can contribute to this is based on the assumption that consumers have knowledge of the product and that there is an alternative available. It would also require clear labelling for consumer products produced with modern biotechnology. Labelling is, however, still under discussion in the European Union. The Core Ethical Values lack concrete steps forward in this discussion.

Southern complications
Whilst it is doubtful whether these prerequisites for informed consumer choice are really met in the industrialized world, the situation in developing countries is even more complicated. The European and US biotechnology organizations failed to consider how their ethical standards would be applicable to developing countries. Therefore, enterprises operating on a worldwide scale may see their own ethical values being challenged by ethical consideration arising from the use of biotechnology in developing countries. Even if an internationally operating company bases its activities on sound moral ground, it might become vulnerable to criticism if it applies either double standards or one single approach to the employment of biotechnologies. A European company which applies lower ethical standards in a developing country than at home would not be trustworthy. On the other hand, products that have been approved in the European context have to be reassessed using local ethical values before they are used in a developing country.
At present, EuropaBio's effort to unify the biotechnology industry's views on ethical issues can be seen as an adjustment of marketing strategies rather than a first step towards a novel set of ethical guidelines. Moreover, to change the Core Ethical Values into a substantial commitment, EuropaBio would have to go beyond the existing regulation and make sure that its members apply these standards as minimal standards worldwide. In return, it could require that within Europe the same standards should be applied by non­members too. It can be assumed that in the long run the biotechnology industry's credibility will only increase if this first version of Core Ethical Values develops into a stronger ethical Code of Conduct, further specified to the needs of all the different societies that are influenced by the industry's activity.
Volker Lehmann

Overtoom 447 L, 1054 KG Amsterdam,
the Netherlands. E­mail rli@xs4all.nl

Sources
Several documents of EuropaBio

Nature (1997), "Europe ambivalent on biotechnology." No.387, 26 June 1997, pp. 845­847.

Personal communication with E. Tambuyzer, (EuropaBio Ethics Task Force), A.R. Martinez (GRAIN), D. Leskien (Friends of the Earth, Europe) and B. Härlin (Greenpeace International).