By Nuala Moran

BioWorld International Correspondent

SAN DIEGO ¿ Biotechnology is a source of profound change in our lives, raising many dilemmas in areas such as genetic testing, stem cell research and human cloning, and many of its leaders say the industry needs to create an open and two-way communication with the public on the bioethical implications of its products.

The problem for biotechnology as a global industry is that while the issues that cause concern are the same from country to country, there are no cross-border political groups to foster harmonization in bioethics and related legislation, according to Erik Tambuyer, vice president for corporate affairs, Europe, at Cambridge, Mass.-based Genzyme Corp. and chairman of the bioethics committee of Europabio, the pan-European industry body that represents some 800 companies.

Speaking on how the ethical and public policy issues associated with genomics are raising unique ethical challenges for the industry, Tambuyer told delegates, ¿We wanted to develop standard policies on bioethics in Europe, but the world is not homogenous, certainly not for ethical issues. So the question is, How can the industry arrive at a common position on issues?¿¿ Although it recognizes the need to agree on core ethical values, it was difficult for Europabio to formulate them because it is comprised of people from the industry, not ethicists.

Despite these difficulties, Europabio has drawn up a list of core ethical values to which all members agree to adhere, Tambuyer said. These include promoting dialogue with the public; participating in discussions on the responsible use of new technologies; providing information for stakeholders, including employees; a commitment to use biotechnology to improve the quality of life; supporting the conservation of biological diversity; and opposing the use of biotechnology to produce biological weapons.

The process of formulating these values has shifted the stance of many of the companies involved. There is now a more balanced position on issues where the industry was previously being forced into a defensive stance because of poor public perception of the industry. ¿For example, the industry now recognizes that there is no need to control gene databases or tissue banks to use them effectively,¿ he said.

When Europabio first began to draw up its bioethics policy, Tambuyer was struck by the fact that most people it consulted from outside the industry thought the industry did not care about the ethical implications of its work. ¿The outside world is gradually starting to notice that the biotechnology-based industry is concerned about societal and ethical issues, and is willing to actively participate in the ongoing dialogue regarding these areas,¿ he noted.

Robert Cook-Deagan, director of the national cancer policy board at the National Academy of Sciences, said that in some areas, the industry has been really successful in leading the debate to get the ethical framework in place before the technology is available. ¿For example, in the area of genetic testing, the issues of genetic privacy and discrimination and informed consent were anticipated in advance.¿

The next big bioethics debate for which the industry must prepare is on fairness in the field of DNA patents. Of 25,000 issued patents based on DNA, most of the valuable territory is owned by five organizations: the U.S. government; the University of California; Incyte Genomics, of Palo Alto, Calif.; Chiron Inc., of Emeryville, Calif.; and GlaxoSmithKline plc, of London.

Increased life expectancy in the developed world is directly attributable to developments in science. But in sub-Saharan Africa, life expectancy is going down. ¿So there is a problem of fairness underlying the very valuable products that will come out of DNA patents,¿ Cook-Deagon said.

¿You have got a very serious problem in biotechnology: Your products save lives; the stakes are very high. That translates into people caring about the outcome, and wanting access,¿ he said.

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