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Ethical considerations can become an integral part of the European regulation of biotechnology.

October 08, 2002

A new report, published as part of a project sponsored by the Danish action plan for bio-technology and ethics, concludes that the European Union ought to include ethical principles in the regulation of biotechnology. Until now the regulation of biotechnology in the European Union has primarily been con-cerned with trade, security and environmental issues. However, the new report provides the groundwork for a substantial discussion of ethical issues when the European Union de-bates the use of biotechnology regardless whether the issue at hand is stem cell research or genetically modified crops.

The two authors of the report are: the Rector of the University of Copenhagen, Professor of Law, and member of the European Group on Ethics, Dr. Linda Nielsen; and Berit A. Faber, Head of Secretariat of the Danish Ethical Council. The two authors are experts in the legal and ethical aspects of the application of biotechnology. Among other things they compare how ethical principles are applied in the medical sector in contrast to their application in the plants and foods sector.

"When it comes to regulating the application of genetic technologies to food products we are in a vacuum in Europe. This is very different from the situation in the medical field where we have a long tradition for bringing ethical concerns to bear on government regulations" say Berit A. Faber and Linda Nielsen.

The Ethics Tool Box

The report emphasises that the inclusion of ethical principles in legislative regulation, especially at the EU level, faces many challenges and it is impossible to single out any one right solution to the problem. Instead the report suggests and analyses a number of tools that can be used to incorporate ethical principles in regulative measures. The report contains several recommendations. For example, that the European Union ought to include ethical evaluations in connection with the implementation of biotechnologies, that criteria and guidelines should be articulated to serve as a basis for ethical evaluations, and that the future decision making process concerning the application of biotechnologies should be an open process that secures real influence and co-determination for the general population in the European Union.

Bio-democracy

Especially the last point, the involvement of the populations of the different EU Member States, is crucial for the future regulation of biotechnology.

"We suggest a two pronged strategy for the inclusion of ethical principles, legislation and dialogue" say Linda Nielsen and Berit A. Faber. " Regulation through legislation can`t stand alone, we have to make sure that the future EU regulation is based on an open dialogue and transparent decision making procedures.
The arrival of the new biotechnologies marks a shift away from the information society towards a bio-society. Bio-ethics combined with an open dialogue that involve ordinary citizens and lay people are important tools that should ensure that the bio-society is also a bio-democracy when the time comes for us to decide how to best use the new technologies".

The report recommends a number of specific models for an informed debate. These include "consensus-conferences", "future studies panels", "value workshops" and "ethics councils", models that have all been tried out in Denmark.

In addition the report discusses a number of pos-sible models for regulation that could be adopted by the EU.

European strategies for biotechnology

The report is a contribution to the efforts to implement the EU decision of 2002 to the effect that methods as well as a timetable should be developed for the inclusion of ethical and social considerations in the decision making that pertains to the application of biotechnology.
The report sets the agenda at a European workshop to be held in Copenhagen on October 8th and 9th. The participants in the workshop are relevant government officials from the EU Member States as well as representatives from the EU Commission.
The purpose of the workshop is to discuss how the EU can better incorporate ethical considerations into future decisions about the application of biotechnology. The Danish EU chairmanship is pushing to get a resolution on biotechnology and ethics in place for the council meeting on November 26. The resolution should provide a framework for the way the European Union will address biotechnological developments in the years to come.

BioTIK National Consumer Agency