EU faces another showdown over biotech patents
RTw 07.07.97 18:28
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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. REUTER