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First published online July 1, 2010

Medicine for Tomorrow: Some Alternative Proposals to Promote Socially Beneficial Research and Development in Pharmaceuticals

Abstract

The current models of pharmaceutical drug discovery display significant inefficiencies. One inefficiency is the widespread prevalence of me-too drugs. Second, some patents can act as barriers to knowledge, by slowing down the pace of new discoveries. Third, there are higher costs for the public, who end up paying double costs — subsidizing or funding research and development (R & D) that leads to new discoveries on the one hand, and, on the other, paying the social costs of restricted access to knowledge when the discoveries are privatized. Fourth, when the market returns are the sole guide to R & D of new drugs, diseases that are prevalent in markets with weaker buying power are neglected. Thus, policymakers need to identify a new, more cost-effective and innovative productive system for R & D. Policymakers are faced with very complex choices in designing their regulations. They want to promote access to medicines, to lower costs and to encourage research. Politically, they have to balance pressure from the industry with increasingly forceful demands from health advocacy groups. The article looks at four different sorts of policies that may be used to address some of the inadequacies in the current system, especially with regard to the management of R & D: promoting prizes over patents; directing innovation toward socially beneficial outputs by adopting some form of value-based pricing; publicly funding clinical trials to reduce conflicts of interest while reducing costs; and actively managing frontier technologies to maximize positive social spillovers.

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References and Notes

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3. We do not review here the well-established reasons for the role of government in the public sector, associated with market failures (externalities) and distributional concerns.
4. Some companies appear to be less concerned by this possibility. For example, Schering-Plough (which merged with Merck in March 2009) predicted in its last R & D update that perhaps seven of the drugs in its pipeline could become blockbusters in the near future.
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8. This said, the threat of generic competition for new drugs may also begin to diminish, given that the development of generics will be impeded by the imposition of the TRIPS agreement in several countries with thriving generic industries. Diminished generic competition is certainly going to have serious deleterious consequences for global health, even as it makes profit margins more secure for large R & D-based pharmaceutical firms.
9. For a less-than-sanguine view of this process from an anti-trust viewpoint, see Shapiro10 and Hemphill11.
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19. This problem exists in any imperfectly competitive market. But the problem is particularly acute in the case of pharmaceuticals, because there is so little price sensitivity. A me-too drug that is identical to existing drugs might be able to receive close to the existing market price.
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22. Such a system can also be used to replace the patent system with a prize system. A prize system has the advantage of rewarding the innovator for his innovation without inducing distortions in the marketing of the drug; a well-designed system can also reduce the risk facing the innovator, thereby lowering the total compensation required to elicit a given level of research effort.
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28. The recent court decision invalidating the Myriad patents may curtail some of this kind of socially inefficient expenditure.
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30. The standard commons problem is that free access to the commons results in overusage, such as overgrazing or overfishing.
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33. Needless to say, there are other issues that we have not addressed here, which are also important in promoting global health outcomes, notably remedying some of the excesses of the TRIPS agreement and bilateral trade agreements.

Biographies

Is a professor at Columbia University, the winner of the 2001 Nobel Memorial Prize in Economics, and a lead author of the 1995 IPCC report, which shared the 2007 Nobel Peace Prize. He was chairman of the US Council of Economic Advisors under President Clinton, and chief economist and senior vice president of the World Bank for 1997–2000. He received the John Bates Clark Medal, awarded biennially to the American economist under 40 who has made the most significant contribution to the subject. He is a member of the National Academy of Sciences and a corresponding Fellow of the British Academy and the Royal Society.
Is an assistant professor of Economics at the University of Massachusetts Boston. He has been a research fellow at the Committee on Global Thought at Columbia University and is currently a fellow at the Roosevelt Institute. Among his interests is the development of an effective and fair global intellectual property regime. He has published in specialist economics journals such as the Journal of Development Economics and Economics Letters, as well as in policy-oriented journals such as Health Affairs.

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Article first published online: July 1, 2010
Issue published: July 2010

Keywords

  1. innovation
  2. generic medicine
  3. TRIPS
  4. prizes
  5. patents
  6. value-based pricing

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Uris Hall, Room 814, Columbia University, 3022 Broadway, New York, NY 10027, USA E-mail: [email protected]

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