Clinton, Blair to Back Access to Genetic Code

President Clinton and British Prime Minister Tony Blair are expected to issue a joint statement today declaring that the soon-to-be-deciphered human genetic code should be freely available to the public and not end up the private property of a few corporations.

Leaders of the two nations, which are at the forefront of the deciphering effort, are expected to sign documents embracing a principle long held by academic researchers but recently attacked by biotech firms seeking to patent and profit from the code.

“Raw fundamental data on the human genome, including the human DNA sequence and its variations, should be made freely available to scientists everywhere,” says a draft of the joint statement obtained by the Los Angeles Times. “Unencumbered access to this information will promote discoveries that will reduce the burden of disease, improve health around the world and enhance the quality of life for all humankind.”

Rather than making outright changes in policies or procedures, Clinton and Blair were adding their prestige to one approach to genetic research. White House aides and outside observers said the statement’s most important effect might be to raise the public profile of a debate that has been conducted in the arcane languages of patent law and science.

“In effect, what these leaders are saying is, ‘This is a real issue which deserves real public policy attention, and not just something to be treated as a technical question,’ ” said University of Michigan law professor Rebecca Eisenberg.

More immediately, the document seems likely to fuel competition between the publicly funded gene decoding effort and that of an aggressive private-sector rival, Celera Genomics of Rockville, Md.

Last week, leaders of the public effort rejected Celera’s demands for up to five years of exclusive rights to the code in return for collaborating to speed the project.

Company executives struck back by accusing the government of distorting their position and seeking a damaging alliance with a competitor. They have since apologized for some of their charges.

The fact that Clinton and Blair chose to address the issue illustrates the increasingly fast pace of events involving genetics--and its vast differences from other great scientific and technological enterprises of the last half-century.

As the two make clear in their statement, cracking the code--the biochemical instructions carried in a person’s cells--is widely considered a feat of the same magnitude as smashing the atom or putting a man on the moon.

Like its predecessors, the code-cracking effort began as a large, expensive and very public undertaking--the 15-year, $3-billion Human Genome Project--and its results were universally expected to belong to the public in the same way as the atom bomb and the moon shot.

But advances in technology during the early 1990s and a growing entrepreneurial outlook changed all that. In short order, a new breed of biotech company emerged that sought to crack portions of the code and patent them. The trend culminated in 1998 with the formation of Celera, which announced that it would beat the public effort to the entire code.

Fearful that the rush to privatize the code could damage research and innovation, a group of leading scientists and policymakers issued a call in 1996 for broad public access to the code in what came to be known as the Bermuda agreement. Aides said Clinton and Blair had effectively adopted the agreement.

“We applaud the decision by scientists working on the Human Genome Project to release raw fundamental information about the human DNA sequence and its variants rapidly into the public domain and we commend other scientists around the world to adopt this policy,” the statement says.

Observers noted that despite calling for broad public access, the statement also endorses the idea of some kinds of patents on genetic material and appears to dodge the thorniest patent policy issues.

“My one hesitation is that the statement doesn’t foreclose someone getting exclusive rights to a gene fragment or a variation, which means there can still be a problem,” said Stanford University law professor John H. Barton.

Negotiations toward a possible collaboration between Celera and the Human Genome Project apparently broke down over company demands for exclusive rights to distribute the code.

In a strongly worded letter last week, project leaders charged the company with trying to establish “a monopoly on commercial uses of the human genome.” Company executives, after initially accusing the genome project of seeking to scuttle the negotiations, then suggested that it was scheming to damage Celera’s business.

The executives said the genome project would work with a nonprofit group made up of major drug companies and Britain’s charitable Wellcome Trust to finish deciphering the genome before Celera with the help of one of Celera’s chief rivals, Incyte Pharmaceuticals.

This month, the group, called the SNP Consortium, agreed to underwrite a new approach to identifying as many as 1 million of the genetic variations using a method that would also help the publicly funded Human Genome Project close gaps in its detailed map of the genome. Celera suggested that this was simply a way for the genome project to beat Celera and throw business to rival Incyte.

However, SNP Consortium CEO Arthur Holden said Monday that Celera had been given an opportunity to bid and had not done so.