By Suzanne Perry
BRUSSELS - The European Union will face another showdown next week in its nearly 10-year quest to agree rules on patents for genetic engineering and other techniques involving living material.
The European Parliament, which in 1995 vetoed a text that had been agreed by EU countries, will review a new proposal at its monthly session in Strasbourg -- in the midst of heavy lobbying by industry, environmental, medical and other groups.
The biotechnology industry is urging deputies not to fiddle too much with the proposal, saying it will help European companies protect their investments in the research and development that allows them to develop medical breakthroughs.
But critics charge that the text gives industry too much control over the "raw material of life" by allowing patents to cover human body parts such as gene sequences.
They also want stricter limits on patents for genetically engineered animals and greater freedom for farmers who use genetically modified seeds and livestock.
Those sorts of ethical questions have dogged from the start an initiative that aims to help boost Europe's biotechnology industry by giving it a clear legal framework that provides an incentive to invest in new medical products and techniques.
The European Commission, which first proposed rules in 1988, argues that Europe's companies lag behind their U.S. counterparts in a huge and growing market partly because of uncertainty over patent rights, a notion the industry endorses.
The European Federation of Pharmaceutical Industries' Associations (EFPIA) released figures on Monday showing that Europe won only 11 patents for health products involving genetic engineering in 1995, compared with the U.S.'s 122.
"In industry, if you're preparing to make big investments, you have to know where you are (legally)," Brian Yorke, head of corporate intellectual property for Novartis International, told reporters.
The Commission's first legislative effort, however, was rejected by the parliament, which has veto rights over the proposal, after a heated debate over ethical considerations.
Deputies were especially unhappy because the text did not completely ban patents for human body parts such as genes and cells, leaving the door open to patents for elements that had been isolated from the body.
Pharmaceutical companies say that is critical to the development of drugs based on body products such as human growth hormone for treating dwarfism or interferons for cancer.
But critics warn of the growing commercialisation of the body, citing a growing number of U.S. patents for gene sequences -- the specific gene makeup -- and a patent granted to a U.S. company for procedures using blood cells from umbilical cords.
In a new proposal issued in 1995, the Commission inserted language aimed at ensuring that patents can be awarded only for true inventions and not for discoveries of natural substances.
But opponents say the new language is barely an improvement over the original and they are not happy with an attempt by the parliament's legal affairs committee to refine it.
The panel proposed language last week that would ban patents for the human body or "the simple discovery of one of its elements including the sequence or partial sequence of a gene."
However, it allows patents for such elements if a technique is used to isolate them from the body and an "industrial application" is cited.
Opponents say that is fudging the traditional line in patent law between a "discovery" and an "invention," giving companies commercial rights over a natural entity.
That's like saying, "I invent a telescope, therefore all the stars I now discover with this telescope also fall under the patent," said Thomas Schweiger, head of the Brussels office of the environmental group Global 2000.
In a letter to Eurodeputies, staff members at the Regional Genetic Service at St Mary's Hospital in Manchester, England, warned against allowins a single company to "completely control all future research and medical development leading from the isolation of a specific gene."
But EFPIA president Rolf Krebs, chief executive officer of Boehringer Ingelheim Corp, said patents actually promote research because inventors are required to publish their work. "A patent just prevents others from commercialising (the invention)," he told reporters.
He warned that the industry would be at risk if the legal affairs committee's language was weakened any further.
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