The Austrian Bioethics Commission

by Alexander Unkart

The fact that biotechnology is a contentious issue in Austria hardly makes the country and its people unique. So it should come as no surprise that Austria followed the path of other countries by establishing a federal advisory panel on biotechnology that will celebrate its fourth birthday this June.

{access view=guest}Access to the full article is free, but requires you to register. Registration is simple and quick - all we need is your name and a valid e-mail address. We appreciate your interest in bridges.{/access} {access view=!guest} an independent Bioethics Commission to advise the government on the ethical considerations associated with scientific developments in medicine and biology. The mandate of this panel was to examine the social, natural science, and legal issues that might arise.

The Bioethics Commission is expected to provide practical suggestions, recommend changes in law, and offer expert opinions on topics that are brought to its attention. It is also expected to shine a spotlight on the social significance of the latest scientific developments in biotechnology. In addition, its mandate includes producing evaluations to assist the political leaders in their decision making. And last, but not least, a special concern of the commission is to keep the general public informed of developments in the field of biotechnology. It meets at least once every three months, but can be convened at any time by either the Federal Chancellor or the commission chairman.

The commission is comprised of 19 experts in medicine, microbiology, sociology, philosophy, theology, and the law. The medical experts are generally drawn from the fields of reproductive medicine, gynecology, psychiatry, oncology, and pathology. Members are appointed for two-year terms and can be reappointed twice. The panel is currently chaired by Johannes C. Huber, head of the Department of Gynecological Endocrinology and Reproductive Medicine at the General Hospital of Vienna. His deputy is Günther Pöltner, a professor at the University of Vienna's Institute of Philosophy.

"The Bioethics Commission has had mixed successes so far," said Dr. Robert Gmeiner, secretary general of the Bioethics Commission. "In regards to its specific task of keeping the general public informed about bioethical problems, the Commission has found it difficult to spark these discussions in Austria on a broad level, although these issues affect us all. But they tend to affect us at different times in our lives. Take, for instance, the case of a couple that wishes to have a child. They would tend to be more interested in the topic of reproductive medicine at that particular point in time."

A snapshot look at two commission actions regarding issues related to biotechnology illustrates the commission's work.

Protection for Biotechnological Inventions: The first case concerns a request for an opinion regarding a directive of the European Union on legal protection for biotechnological inventions [Directive 98/44/EC of July 6, 1998]. With this directive, the EU intended to foster European competitiveness relative to the U.S. and Japan by instituting effective and well-regulated protection for biotechnological inventions to encourage investment in the field of biotechnology. From the time the EU made its initial proposal on this subject, it took ten years and considerable political discussion before the directive was issued in 1998. The directive prohibited patents on humans, animals, and even on parts of the human body and methods for human cloning. However, under certain circumstances, it did allow patents on elements isolated from the human body including the sequence or partial sequence of a gene. The latter led to protests that the directive permitted biotech companies to receive a "patent on life." Austria failed to promulgate and amend the laws, regulations, and administrative provisions needed to comply with the directive by the target date of July 30, 2000.

The Bioethics Commission tackled the issue and offered its opinion in March 2002. By that time, only five of the 15 European Union member states had taken the necessary actions to enforce the directive.

The commission's unanimous opinion was that Austrian enforcement of the directive was important from an ethical point of view. This opinion was based on the grounds that the directive fine-tunes the European patent law and enables legal certainty on a topic where uncertainty had been the rule. Additionally, the directive provides, for the first time, ethical boundaries for patenting living organisms. However, as of March 23, 2005, the directive still has not been enforced in Austria.

Promotion of Stem Cell Research: The second case addresses the issue of whether stem cell research should be promoted with European Community funding. The origin of this case was the proposal for the 6th Framework Program (FP6 - The Sixth Framework Program of the European Community for Research, Technological Development and Demonstration Activities Contributing to the Creation of the European Research Area and to Innovation, 2002 to 2006) which included funding for stem cell research. "As far as I know, there is currently no embryonic stem cell research conducted in Austria. All political parties are opposed to it. Also, the Catholic Church does a lot of lobbying to prevent it. The reasons given are the protection of human life and human dignity, and skepticism over whether this really leads to progress," said Dr. Gmeiner.

Not surprisingly, the Austrian Bioethics Commission was unanimous in its decision that reproductive cloning and the production of embryos for scientific research, including alterations of the human genome, should not be promoted with EU money. However, in the same case, the commission could not agree on whether research with already existing human embryonic stem cell lines should be promoted. Eleven commission members determined that, under certain conditions, this type of research should be promoted, while eight members could find no justification for the majority's opinion. One month after the commission's decision, Austria was the only EU country to vote against the 6th Framework Program, and thus forced the enactment of amendments to the initial proposal.

Interestingly enough, there is still no Austrian law regulating stem cell research. "There are attempts to look to Switzerland, which has straightforward regulations governing stem cell research," Gmeiner said. "There is a Stem Cell Research Act, and there are plans for a separate Embryo Research Act and a Human Research Act, the latter relating to research on humans in general, such as in clinical trials."

The Bioethics Commission anticipates working on interesting cases in the near future. Dr. Gmeiner believes that, during the Austrian EU presidency in the first half of 2006, "the Bioethics Commission will have a stronger focus on European issues. The 7th Framework Program will be completed during this time. Since the issue of stem cell research, for example, was not resolved the last time, it will probably now be Austria's responsibility to achieve an European consensus. It will be an interesting time," Gmeiner concludes.