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The Health of Regulation for Medical Innovation

Posted by: Mark Marich on October 07, 2009 Source: Policy Dialogue on Entrepreneurship

PDE staff attended a Capitol Hill briefing on “Incentives for Innovation: Protecting America’s Greatest Innovators” sponsored by the Council for American Medical Innovation. Our report of the event follows:

The third and final briefing of a series entitled "Recovery Through Discovery" focused on how government policies and regulation play a key role in healthcare-related innovation. In her welcoming message at the Oct. 5th meeting, Debra Lappin, President of the Council for American Medical Innovation, underscored how medical innovation is not only important to the individual health of citizens, but also to the health of the U.S. economy as a whole and the preservation of American competitiveness in the global marketplace.

Greg Simon, the Senior Vice President of Worldwide Policy at Pfizer Inc., described how the "innovation life cycle" of emerging medical technologies includes government, private industry, doctors, and patients. Simon also stressed that effective regulation, including strong patents, ensures the transfer of technology through the entire cycle.  Kelly Slone, the Director of Federal Life Science Policy at National Venture Capital Association (NVCA), also echoed the need for strong patents from the perspective of the VC community.

Marc Boutin, the Executive Vice President and Chief Operation Officer of the National Health Council, shared his view on patents as a representative of the patient advocacy community. He emphasized the fact that the current U.S. patent process does not take into account the "value to society" provided by a new treatment. To change this, Boutin suggested the creation of "periods of exclusivity" (similar to the framework for the development of generic drugs) for treatments relating to areas such as pediatrics or rare conditions. This would provide companies with the necessary incentives to invest in much-needed treatments which remain unprofitable under the current system.

The related topic of "personalized medicine" also played prominently within the discussion. This technology could allow a patient's treatment to be specifically curtailed to his or her genetic profile, thus eliminating unnecessary treatments, improving delivery of care, and reducing costs. In order to accelerate the development of such diagnostics, Boutin suggested that the FDA could design specific policies that would incentivize their development.

The NVCA’s Kelly Slone explained that personalized medicine is also of high interest to venture capitalists, but the lack of a regulatory framework inhibits investment in this area. At this time, the FDA does not have any established policy of how to approve the "biomarker" technology that is key to personalized medicine. Slone noted that this opportunity is a good example of an innovative medical technology that is currently not being invested in because of regulatory gaps.

Overall, the event highlighted areas where cooperation between different groups and agencies, particularly with the FDA, can promote the successful commercialization of technology.

[Reported by Marianne Sierocinski]

Category:  Technology Transfer  Tags:  medical innovation

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