Radical proposal to speed development of stem cell therapiesThe proliferation of patents in the emerging stem cell field may impede scientists from developing new treatments, says Merrill Goozner of the Center for Science in the Public Interest in the open access journal PLoS Medicine.
Patent restrictions on the use of stem cells, says Goozner, can discourage researchers from pursuing a particular line of inquiry and can slow the pace of research.
Funders of stem cell research, such as the newly created California Institute for Regenerative Medicine (CIRM), which is authorized to spend $3bn to support human stem cell research, could become the catalyst for "cutting through this patent thicket."
Goozner argues that CIRM could require that all grant recipients agree to donate the exclusive license to any insights, materials and technologies they patent to a common, open source patent pool administered by a new, non-profit organization. "A patent pool serves as a one-stop shop where investigators can obtain no-cost or low-cost licenses for subsequent research."
Such patent pools have been successfully used in other high tech industries, such as consumer electronics, to facilitate development of new technologies that require either common standards or rest on a common base of basic research.
While open source patent pools should stimulate innovation in human stem cell research, there is still a major stumbling block to ensuring that the resulting stem cell therapies are affordable to the public. Once the research has identified a potentially useful product, it can be costly to carry out the clinical trials needed to bring the product to market, so it is typically the private sector that funds these trials.
"The private sector's price for taking these late stage risks," says Goozner, "is exclusive rights to the technology. Its reward, if successful, is the right to charge whatever the healthcare marketplace will bear."
Goozner proposes a radical alternative to the "exclusive rights/high prices" model used by conventional markets: "A government body such as CIRM could establish a major prize for the companies and institutions that collaborate to produce a successful stem cell therapy." Governments could finance this prize using tax-exempt bonds; the bonds could be repaid by a surcharge on each use of the new therapy as it rapidly diffuses through the health care system.
By combining a patent pool with a shared prize system for developing stem cell therapies, says Goozner, the California state stem cell program can point the way to a new medical innovation system for the 21st century.
Citation: Goozner M (2006) Innovation in biomedicine: Can stem cell research lead the way to affordability? PLoS Med 3(5): e126.
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