EUROPEAN ASSOCIATION FOR BIOINDUSTRIES (EUROPABIO) PRESS RELEASE

DOCUMENT DATE: JUNE 26, 1997

EUROPEAN BIO-INDUSTRY INVITES PUBLIC COMMENT ON

BIO-TECHNOLOGY ETHICS

Amsterdam - EuropaBio, the industry association representing some 600 companies actively engaged in biotechnology in Europe, will invite public comment here today on a draft statement of its members' ``core ethical values'' as its first annual Congress comes to a close.

Prof. Jurgen Drews, EuropaBio Chairman and International President of R&D for Hoffman-La Roche Ltd., stresses that this statement is just the first step in a permanent process through which EuropaBio intends to engage in open dialogue on ethical questions raised by the use of modern biotechnologies.

Most notable in this draft is the commitment not to undertake reproductive human cloning. Says Drews, ``we intend to make clear that EuropaBio members cannot and should not, as a special interest group, try to decide for society whether human cloning - or anything else - is ethically acceptable or not. Rather, we believe our responsibility is to inform the ethical debate and respect the consensus. Today, the consensus on human cloning is a clear ``no.'' Who can say wliat it will be years from now ?''

Other issues addressed by EuropaBio's core Ethical Values include animal welfare, protection of medical information, alteration of human sperm, eggs and embryos, consumer information for food products, and conservation of genetic diversity.

Following a period of comment, revision and final adoption, commitment to these ethical values will be one of the mainstream issues for our members, says EuropaBio Secretary General Andrew Dickson. ``We will also then have to be keep current with societal consensus. To help us do that we are right now putting in place a panel of independent advisors from different disciplines and different European countries.''

Comments on the current draft may be sent directly to EuropaBio by post (Avenue de l'Armee 6, B-1040 Brussels), fax (32 2 735 4960) or e-mail (mail+europa-bio.be). ``Everybody's view is important to us,'' stresses Dickson. ``And because transparency is our first ethical principle, we will be open about the views we receive.''

FULL TEXT OF DRAFT STATEMENT

ETHICAL CONSENSUS KEY FOR GROVVTH OF BIO-TECHNOLOGY, SAY EUROPEAN INDUSTRY LEADERS

Amsterdam - Clear and predictable ethical boundaries, based if possible on societal consensus, have become a strategic requirement for continued bio-industry development,'' argues Dr. Erik Tambuyzer, Chairman of EuropaBio's Ethics Task Force and senior executive in Europe for Genzyme Corporation.

``But these boundaries will inevitably shift over time, as we open up new technological capabilities with possible new ethical issues embedded in them'' says Tambuyzer. So a snap-shot of the ethical consensus today may well be unreliable as a navigational tool a few years from now. This means that Europe's bio-industry has to build a permanent process which continuously gives us the degree of clarity we need to invest for the future. It has to become part of our business model.'' Last January, well before Dolly, EuropaBio's Task Force set out to do just that. Predictably perhaps, they discovered that listening was far more valuable than talking.

The intentions of a non-member company, which already publicises its services on the Internet, and means to construct a laboratory in a country where cloning is not illegal, proves the need for ethical boundaries. Never mind formal opposition to human cloning from the European Commission's bio-ethics advisory group and European bio-industry. Never mind Bill Clinton's recent decision to outlaw human cloning for now in the U.S. Investors were found for this new company. Suppose they one day succeed. What's the rest of the world going to do ? Demand proof of succeed natural conception as a condition of entry, employment or citizenship

It may be tempting to dismiss them as nothing more than opportunists with a flair for headlines. But this venture dramatises the sorts of head-on collisions between science and society that are turning ethics, philosophy and theology into hard-core business issues in the fast growing world of bio-industry.

Small wonder then that EuropaBio's first annual Congress, having begun with a forecast of ten-fold growth over the next decade given broad societal support, ends here today with a hard look at ethical limits, and how to set them.

Of immediate concern, for example, is what can be done with new medical information. Recently, the UK insurance industry backed away from a previously announced-decision to weigh genetic traits in its medical insurance decisions, which had set it on a collision course with other parts of Europe. But the questions remain contentious and unresolved. Who should have the right to know whether somebody carries a genetic predisposition to cancer, or cardiovascular disease ? Even more important, who should be prevented from finding out, or from using this knowledge if they do ? Uncertainty on these questions could easily lead people to refuse to submit to such testing in the first place, thereby denying themselves potentially life- saving information.

Or take the growing interest in using animal organs for human transplants, much of which is focused on pigs because they carry fewer harmful viruses. How will society judge the balance of human and animal welfare for this and other new human health-care possibilities involving animals?

``Our original idea was to agree an ethical code of conduct for our members,'' says Tambuyzer, ``and then tell the world. But we quickly realised we would just be looking in the n-drror of our own interests. That would not have taken us forward from a business point of view, and could easily have backfired. So we changed course and are now building what I would call an institutionalised industry listening system at European level. It is the only way we are going to get a reliable indicator of society's attitudes on the important ethical questions.''

The EuropaBio system now under construction will be a network built around a panel of independent advisors, each involved in other similar bodies at national or European level, or in particular disciplines such as ethics, animal welfare, law or theology. EuropaBio hopes to announce its membership by October 1997. Advisors' expenses will be reimbursed, but they will receive no other payment.

``We are not trying to duplicate or supplant other bio-ethics fora,'' stresses Andrew Dickson, Secretary General of EuropaBio. ``We are trying to benefit from other work by linking it to a process directly connected to our members in Europe. And we believe that our work will also be helpful for their efforts. It will be in effect an open network, where a view expressed in one place can be heard in many.''

Because EuropaBio's ultimate goal is to anticipate and address future issues, not just react to media-grabbing events, one of industry's primary roles in the process will be to paint panelists a picture of future scientific possibilities. As an example Tambuyzer cites the idea of removing the key BSE gene from cows, making it impossible for them to catch 'mad cow disease'.

``Is that good or bad?'' he muses. ``It would certainly solve a real problem. But could it lead to a single race of super-cows and the disappearance of other breeds ? Or could we make any breed BSE free ? Industry needs that debate to begin now, before anybody commits major resources to the idea. Our system should make sure not only that it begins, but that it keeps pace with developments and that all points of view are both heard and disseminated.''

Asked whether the EuropaBio ethics panel won't just be a front for the bio-industry lobby, Andrew Dickson is adamant. ``If that happens, it will fail - and deserve to fail - and we simply cannot afford to have that happen. We are much more concerned that the panel's views are seen to be completely independent and credible. Its work needs to be transparent and accessible. So the panel's first task will be to decide their own procedures for making sure that it is.''

Does Dickson think European attitudes on key bio-issues will differ from attitudes elsewhere in the world ? ``We must expect that in some cases they will,'' he replies. ``But isolating ourselves from the rest of the world in some sort of ethical cocoon won't work. Europe's strategy must be to listen to others and to defend and export our own carefully considered conclusions. That's the best way to minimise differences and maximise Europe's influence on global bio-ethics.'' Achieving both is critical, points out Dickson, because the growing globalisation of trade in bio- products and services will carry the attendant risk of 'ethical dumping'.

``One of our primary objectives in seeking clear and predictable ethical boundaries at European and eventually multilateral level is to be able to make a clear distinction in the future between responsible bio-companies and others. Support for our ethics system, and a commitment to respect its conclusions and recommendations, will therefore be a mainstream issue for EuropaBio members.''

EUROPABIO's DRAFT CORE ETHICAL VALUES

EuropaBio, the European Association for BioIndustries, represents sonw 600 European companies and 11 national associations involved in the research, development, testing manufacturing, sales and distribution of biotechnology products and services in the fields of healthcare, agriculture, food and the environment.

One of EuropaBio's aims is to encourage, through dialogue and consensus, better mutual understanding of ethical concerns, including any cultural or religious aspects, related to biotechnology, possible environmental impact, the adequacy of regulations and, ultimately, to improve the quality of life.

All members of EuropaBio share these Core Ethical Values. They are intended to provide guidance to our industry where no legal requirements exist or where industry wishes to go beyond any legal requirement.

Because biotechnology is innovative and advancing rapidly, these Core Ethical Values may be expanded over time to address new issues that arise in the future.

General principles

We are committed to realising the potential of biotechnology for the benefit of humankind.

We use biotechnology with full respect for the rights of individuals.

We will communicate and share information about biotechnology and its derived products, their benefits, and their potential risks in an open fashion.

We will engage in a dialogue with those who may be concerned about ethical and societal implications of biotechnology.

We place priority on health, safety, and environmental protection in the manufacture and use of all our products and services.

We oppose the use of cloning to reproduce human beings and will not undertake it.

We respect animal welfare by working to reduce their use in research and any disproportionate suffering to them.

We oppose the use of biotechnology to make any weapons and will not develop products for that purpose.

Healthcare

We support the protection of the privacy of medical information, including genetic information (e.g. by anonymisation of research samples), as well as the availability of any necessary professional counselling.

We oppose the use or disclosure of medical information, including prognostic genetic information, to promote intolerance or stigmatisation.

We do not alter the genes of human sperm, eggs or germ line cells. Nor will we undertake interventions on the genes of human embryos until the medical, ethical, and societal issues that may arise from this kind of therapy have been publicly discussed, clarified and resolved and, if applicable, put into legislation.

We will obtain the informed consent of all individuals participating in our clinical trials, genetic tests or undergoing medical treatment. When the individual is physically or mentally unable to give his consent, it may be obtained from his legal representatives) within the confines of existing legislative requirements.

We respect the codes of ethics of the healthcare professionals who prescribe, dispense, and use our products or make use of our services.

Agriculture, Food and Environment

We support transparent product information to promote informed consumer choice.

We promote efficient and sustainable agriculture.

We develop improved agricultural products which enhance the world's food supply.

We support the conservation of genetic and biological diversity.

We support the transfer of technology between developed and developing countries respecting their cultural heritage.

For more information

Andrew Dickson
Secretary General EuropaBio

Tel 32 2 735 0313

Fax 32 2 735 4960

e-mail: mail + europa-bio.be


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