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3. Institute a Licensing System

The most troubling aspect of the current spate of gene patenting is the risks that the right afforded by patents “to exclude others” poses to medicine. To avoid the worst potential problems, we need a compulsory licensing system, and Congress should hold hearings as soon as possible to figure out how it should be implemented.

Changing licensing rules would go far to insure that in the future researchers will be guaranteed the right not just to view the genome but also to use the information it contains to develop vital products. Under a compulsory licensing plan, patent holders could still receive compensation, but would no longer retain the right to exclude others from research that could improve public health. Congress needs to spell out new rules in this regard, specifying guidelines for licensing fees and perhaps adopting a sliding scale of payments for public sector vs. commercial research.

Without new licensing rules we risk replaying the sorry history of antitrust actions and patent tangles. A century ago, broad patents tied both the automotive and aviation industries in knots during their first decades. The costly and debilitating tangle of lawsuits only ended with the creation of so-called patent pools that cross-licensed everything and divvied up the royalties. The patent pools-later used in the semiconductor industry-can successfully end the worst of the wrangling. But they also tend to consolidate entrenched oligopolies and present stiff barriers to entry in the field.

If at all possible, in the case of the human genome we need to try to avoid acrimonious after-the-fact kinds of settlements. A new, transparent licensing system will help companies navigate what’s likely to be an unusually complex terrain of patent claims and ensure they have access to what they need to create new drugs.

4. Establish a Zoning Commission

The management of the human genome is a vital matter of public policy. It is not something that should be left to powerful business players, lawyers or scientists to resolve alone. We need a body made up of stakeholders from the public and private sectors, scientists and laypeople alike, to serve as a kind of genomic zoning board.

In the first decade of recombinant DNA research, the National Institutes of Health (NIH) established a body called the Recombinant DNA Advisory Committee (known as “the Rack”) to determine policy about what safeguards were needed for certain kinds of previously untried recombinant DNA research. Although the practice of gene patenting also presents many unknowns, there has been little analysis of its economic, social or scientific impact. There isn’t even an official body within the NIH to deal with the issue. It is naive to think that a laissez-faire policy can be effective. We badly need a standard-setting group that can help shape policy in this emerging area.

Why think of it as a “zoning board?” Because zoning regulations represent a good example of how community standards can be established and enforced to shape the rules governing private property. We would do well to remember the lesson of Central Park in New York City. At the time it was proposed, the idea of setting aside 700 acres of prime real estate in one of the world’s most vibrant cities was controversial to say the least. The land seemed too valuable to turn into a park, but time has shown that, for most Manhattan residents, the value of Central Park far exceeds the monetary worth of the property.

Just as zoning can add value to a community by balancing the needs of the private and public sectors, we need a public policy body tasked with balancing and nurturing the partnerships between the private and public sectors that have brought us to this stage in our understanding of the human genome.

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Tagged: Biomedicine

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