Europeans Put Ethics Issues At Top of Biotech Agenda

Industry pitted against those opposed to genetic manipulation

Businessmen worldwide see biotechnology, or genetic engineering, as a lucrative area for industrial growth. But the processes by which living organisms -- including human cells -- can be modified to develop commercial products is also one of the most sensitive ethical issues of today.

Just how sensitive was made clear earlier this month in the European Parliament, where public concerns about where the industry may be headed butted squarely up against the bid by companies to win Europe-wide patents for genetic-engineering processes and modified genes.

After a passionate debate, advocates of an expanding industry came off second best in a head-on clash with those opposed to any altering of human life.

The Parliament rejected a measure March 1 that would have granted Europe-wide legal protection to patents on genetically engineered life forms, bringing to at least a temporary halt seven years of attempts by the pharmaceutical, food, and farm-chemical industries to win more freedom for their activities.

What Robin Jenkins of Britain's Genetics Forum -- a group of scientists opposed to genetic manipulation -- sees as ''a most welcome boost for ethics in the application of science,'' has been condemned by European business leaders.

Daniel Rahier, secretary-general of the Senior Advisory Group on Biotechnology, which represents European biotech companies, calls the vote ''a very bad signal for European industry''.

Mr. Rahier warns that it leaves the field open for the United States and Japan to consolidate their already considerable lead in biotechnology.

The United States is the world leader, with a turnover of $8 billion, projected to climb to an estimated $52 billion by the year 2000, according to the European Commission. The industry in Europe is worth only $3 billion.

On the face of it, genetic engineering presents humanity with a beguiling prospect.

The basic substance of cells consists of deoxyribonucleic acid, or DNA. By isolating parts of DNA, rearranging and transferring them from one cell to another, scientists can alter the genetic identity of a seed, a plant, or an animal. So far, the process has been used to breed fruits and vegetables that stay fresh for long periods, and grains that are resistant to disease and severe climates.

Another aim of genetic engineers is fine control of animal breeding so that pigs, sheep, or cattle can be produced with specific characteristics.

Acute problems arise, however, when scientists begin to consider applying this to human beings, or at least certain human characteristics.

As a German member of the European Parliament (MEP) said before this month's vote, ''I am apprehensive about legislating in an area that impinges on human life itself.''

The Parliament's vote halted the bid by the Brussels Commission (the European Union's executive) to push through a law to give protection to genetically engineered products in the EU's 15 member-states. The bill would have allowed European companies to obtain patents on biotechnology processes and opened up the possibility of manufacturers securing Europe-wide patent protection on modified human genes.

At present the European Patent Office can issue a protective order on a biotechnology process, but such patents can be challenged in the national courts of any EU country.

Before the vote, joint committees of the European Parliament and the Brussels Commission had produced a compromise patenting formula which aimed to provide safeguards against abuses. The compromise described genetic manipulation of the human fetus as being ''not at the present time ethically acceptable.''

Members of the conservationist Green Party argued that the phrase, ''not at the present time,'' left the door open to future experimentation. They were supported by the Socialist Party -- the Parliament's largest grouping.

Evelyne Gebhart, a German Socialist, said it was ''wrong to suggest'' that the genetic manipulation of human beings ''could be acceptable at some future time.''

''Human life is sacred. It is wrong to attempt to change it,'' said Roberto Mezzaroma of Italy's Forza Europa group.

Some British members argued that genetic manipulation of animals was an abuse of the creatures' rights, especially if they suffered during experimentation.

In the end, the vote was a decisive 240 to 188 against the Brussels directive.

Martin Bangemann, the European commissioner for industry, indicated last week that the Brussels Commission could come up with a new proposal as early as June.

Mr. Jenkins says the measure deserved. ''The directive would have allowed a discovery to be equated with an invention ... to protect the means of production rather than the product itself. That would be like a car manufacturer preventing other people from copying not his latest models, but the factories used to make them,'' he says.

Critics of the Parliament's move argue that by hewing to a strong ethical line, Parliament has done a major disservice to European industry. They say investment will not flow into European industry unless investors are reasonably certain that discoveries are protected. The lead time to develop a single drug is between seven and 10 years, and the development cost of a drug can go well over $100 million, they say.

But permitting a company to patent a biotechnology process can cause acute problems of commercial competition.

David Dickson of the London-based science magazine, Nature, says that if a research organization that is the first to discover a new gene can obtain a patent, it can determine the terms under which other scientists work with that gene. He draws a comparison with Bill Gates and his Microsoft computer software empire.

''No-one disputes the right of Gates to profit from the inventiveness of his program-writers,'' Mr. Dickson says. ''What is in dispute is the way he has built his control over key operating systems into a powerful lever for determining both the nature and price of computer products around the world.''

''The key issue in genetic engineering,'' Dickson says, ''is whether industry is prepared to give issues such as equity and human dignity their proper place.''

When asked to choose between commercial imperatives and ethical concerns, members of the European Parliament opted for the latter and rejected a measure that would have protected genetic patents Europe-wide.

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