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© 2007 American Public Health Association
DOI: 10.2105/AJPH.2005.077453
HEALTH POLICY AND ETHICS |
The author is with the Medical College of Wisconsin, Milwaukee.
Correspondence: Requests for reprints should be sent to Thomas May, Center for the Study of Bioethics, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI 53226 (e-mail: tmay{at}mcw.edu).
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ABSTRACT |
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The Bioshield Initiative seeks to stimulate development of new drugs and vaccines to prevent and treat diseases caused by biological agents likely to be used by terrorists, and recent proposals have sought to expand patent protections in this context. To the extent that patent protections are needed as part of the incentive structure for new drug and vaccine development, it may be better to strengthen patent protections on nonterror-related drugs and vaccines to avoid production capacity problems, as well as follow-up research and development problems. However, at the same time, both practical and ethical considerations argue that the good that might be achieved through expanded patent protections come at costs that make this strategy unacceptable.
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INTRODUCTION |
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FORMULATED IN RESPONSE TO the threat of bioterrorism, the Bioshield Initiative seeks to stimulate development of new drugs and vaccines to prevent and treat diseases caused by biological agents likely to be used by terrorists. It does so by attempting to change the financial incentive structure for new drug and vaccine development. The need for such change stems from widespread recognition that drugs that combat infectious diseases in particular are not often financially lucrative (this is especially true for vaccines), leading the pharmaceutical industry to focus research efforts on more potentially lucrative drugs for chronic diseases. In its original formulation, Bioshield sought to address incentive problems in the drug discovery process through the funding of research, expedited approval by the Food and Drug Administration, and provision of "guaranteed markets" for products developed under the Bioshield Initiative. These steps are important because each of the above areas has contributed to what the Institute of Medicine describes as a "growing exodus" of companies from infectious disease research and production, particularly vaccines.1
Recently, legislators have begun to push for expansion of the Bioshield Initiative to further increase incentives for bioterror-related biomedical research. One idea for expansion, "wild-card exclusivity," is what I focus on in this article. Because bioterror (indeed, infectious disease in general) drug and vaccine development is largely unprofitable, wildcard exclusivity would reward investment in such drug and vaccine development by extending patents on other, more profitable drugs (rather than the bioterror-related drug or vaccine). This idea is being pushed by Sen Joseph Lieberman (ID, Conn), who believes such incentives are necessary to entice drug companies to invest in bioterror-related drug and vaccine development, a "riskier and less profitable business than traditional pharmaceuticals."2 The prospect of extended patents on high-profit drugs like Viagra or Lipitor, proponents argue, would provide greater incentive for bioterror-related drug and vaccine development than do stronger patents for bioterror-related drugs and vaccines themselves (for which "artificial markets" must be created).
Use of extended patents has been successfully employed to increase incentives for pharmaceutical research in the past. This history, however, will be of limited use for evaluating the type of wildcard exclusivity proposed for Bioshield, because this proposal is disanalogous in several important respects to previous programs using extended patents as pharmaceutical incentives. First, past successful uses of patent extensions to increase pharmaceutical research have largely revolved around expanding research to include more populations. For example, consider the patent extensions tied to licensing drugs for pediatric use provided through the 1997 Food and Drug Administration Modernization Act and the 2002 Best Pharmaceuticals for Children Act. These incentive programs extended exclusivity rights for product lines of certain drugs to encourage the development of data for potential pediatric use of the drug.3 The problem such incentives were designed to address is that few drugs that undergo clinical trials for adult use have been approved for children.4 Proposed wildcard exclusivity under Bioshield, however, would be meant to encourage the development of different drugs altogether (not simply to expand the use of an existing drug) and would do so through expanded exclusivity on drugs other than the drugs for which incentives are needed. As I will discuss, this calls for careful consideration of the indirect effects of patent protections of the type proposed that may cause wider problems concerning access to medications and public health.
Nonetheless, the idea of wild-card exclusivity is not without merit, although for reasons other than those normally cited by proponents. Patent protections have long been recognized as an important component of the scientific research incentive structure. Indeed, the 1980 Bayh–Dole Act was specifically designed to provide incentives for the development and use of scientific discoveries through patents. To the extent that patent protections are needed as part of the incentive structure for new drug and vaccine development, it may be better to strengthen patent protections on nonterror-related drugs and vaccines to avoid production capacity problems, as well as follow-up research and development problems. However, both practical and ethical considerations argue that the good that might be achieved through wildcard exclusivity comes at costs that make this strategy unacceptable.
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REASONS FOR IMPLEMENTING WILDCARD EXCLUSIVITY |
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Increasing patent protection can decrease production capacity. The 2004 flu vaccine shortage created by contamination at the manufacturing plant of vaccine maker Chiron illustrates this problem. Although related to profitability rather than patents, the Government Accountability Office found that the limited number of vaccine manufacturers (there are only 3 approved for the US market) was a significant contributing factor to the crisis.5 Greater diversification in manufacturing enhances alternatives for production. It would be wise not to limit alternatives for production, especially for bioterrorism defense–related drugs and vaccines, because more-limited alternatives make production more vulnerable to disruption. Patents, by their nature, inhibit such diversification. This provides a reason, in the context of bioterrorism defense, not to strengthen patents on the drugs and vaccines developed under Bioshield itself.
The original Bioshield legislation attempted to address potential production problems arising from a lack of diversification of manufacturers through clauses that explicitly recognize the government’s right to override patents in emergency circumstances. These clauses, however, hardly resolve the problem in question. For many drugs, and particularly for vaccines, the production process is such that significant time is required to "ramp up" production. This was apparent in the flu vaccine shortage last fall: because vaccine production is a year-round process that requires equipment and supplies well beyond simple permission to manufacture (e.g., arranging for the acquisition of eggs to be used in the manufacturing process long in advance of the production process itself), the ability to fill the gap created by Chiron through alternative manufacturers was extremely limited. There is a danger, then, of putting all of one’s eggs in one basket through patent protections.
Furthermore, it has long been recognized that strong patents can result in underuse of potential products and inhibit further research by creating what has been dubbed a "tragedy of the anticommons."6 Because patents impose transaction costs, require overcoming strategic behaviors, and incorporate the cognitive biases of participants, use of patented materials and ideas is slowed. In theory, it is thought that these problems should be resolvable through market-related incentives to contract and license. However, 25 years after the Bayh–Dole Act seeking to enhance incentives through patents, there remains considerable ambivalence about its effects on scientific innovation. Patents, although providing incentives, also have indirect effects on the transfer of materials and knowledge that can inhibit follow-up research.
To some extent, wildcard exclusivity could address the problems just described by offering expanded patent protections on drugs other than those developed for bioterrorism protection. This, in turn, could increase both follow-up research and (coupled with the "guaranteed market," which Bioshield creates) emergency production capacity through the diversification of manufacturers. Such diversification, in light of the production capacity problems experienced in the flu vaccine shortage, would be consistent with the fundamental aims of Bioshield. Considered purely within the context of bioterrorism protection, then, wildcard exclusivity has considerable merit.
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REASONS AGAINST IMPLEMENTING WILDCARD EXCLUSIVITY |
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Despite the goods that might be achieved through wildcard exclusivity, the increased bioterror protection that wildcard exclusivity might provide comes at considerable economic, ethical, and political costs. Ironically, these costs relate to the very feature of wildcard exclusivity that is normally used to justify the idea: that strengthened patents for other drugs with larger (natural) markets would be more lucrative for pharmaceutical companies and, thus, provide greater incentive to develop less marketable drugs. The flip side of this incentive (indeed, the feature that would make wildcard exclusivity lucrative) is that wildcard patents would inhibit reduced prices for widely used chronic disease drugs by limiting market-driven competition.
In a social context in which prescription drug prices are one of the most significant factors associated with skyrocketing health care costs, the economic implications are considerable. Already, many states have attempted to get around the high prescription drug prices that patents contribute to by purchasing prescription drugs from Canada. At root, by attempting to strengthen bioterrorism defense in a way that imposes additional burdens on the broader health care system, wildcard exclusivity suffers from the same flaw present in the original Bioshield Initiative: that is, it sacrifices basic health care system needs to promote a narrow bioterror-defense initiative.7 This approach neglects the fundamental importance of a strong basic health care system for bioterror defense.
From an ethical standpoint, the higher costs of prescription medications associated with strengthened patent protections pose burdens to developing countries. In a March 2004 editorial, Donald Kennedy describes the high costs of prescription drugs, particularly for developing countries, as creating pressures "either for big pharma to lower prices or for others to breach intellectual property protections so that drugs can be made for less."8 This poses an ethical dilemma for the United States: although the incentives created by wild-card exclusivity may mean that we in the United States are better protected because of the incentives provided through an expanded Bioshield program, this increased protection comes at a cost to developing countries. In terms of moral considerations of distributive justice, this cost is significant: developing countries are already economically disadvantaged and are far less able to bear the burdens of these costs than are we in the United States. Increasing bioterrorism protections through wildcard exclusivity, then, would amount to increasing protection for the most well-off populations (ourselves) at a considerable cost to the least well-off populations.
This latter consideration is more than an ethical one; it also has significant political ramifications that relate to the very foundation of Bioshield itself. To the extent that higher drug prices inhibit the ability of developing countries to address health problems, economic and social conditions that may, at least partly, give rise to terrorism are exacerbated. It has been well established that health is a major factor contributing to a country’s economic prosperity.9 Poor health undermines the productivity of a country’s workforce and diverts resources away from other social problems that require resources, including education and basic security (such as police).10 These conditions, in turn, contribute to the feelings of rage, frustration, and helplessness that can give rise to the terrorist mindset.11
Feelings of helplessness, frustration, and rage that result from chronic poverty create an environment that increases a population’s receptivity to radicalized social and political structures—social structures based on ideologies susceptible to harboring terrorist groups.12 In many cases, scholars have linked these feelings of rage, frustration, and hopelessness to economic disparities partly attributable to poor health.13 As the World Health Organization Commission on Macroeconomics and Health has observed: "the linkages of health to poverty reduction and to long-term economic growth are powerful, much stronger than is generally understood."9 Higher drug prices can only exacerbate the economic and social effects of poor health in developing countries. In attempting to provide incentives for bioterror-related drug and vaccine development, we may actually increase the conditions that give rise to terrorism more broadly, indirectly undermining the foundational goals of Bioshield itself. Indeed, this is also true in a more direct sense: given the nature of the global threat posed by infectious disease spread, the strength of foreign health care systems is as important as the strength of the domestic health care system.14
Although increased incentives are an important component of bioterror-related drug and vaccine development, this goal itself must be balanced in terms of broader considerations related to the basic domestic and foreign health care infrastructure and both biological and biological terrorism defense in general. Although wildcard exclusivity would likely enhance drug and vaccine development and production, it would do so at significant costs that ultimately undermine the fundamental goals of such development and production. Indeed, it may be more prudent to focus resources on basic infrastructure needs rather than bioterror-related drug and vaccine development, even within the narrow context of effective bioterrorism defense. To the extent that enhancing incentives for drug and vaccine development remains a priority, however, it may be wise to focus on creating incentives through funding and market outlets, which have fewer indirect costs.
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Footnotes |
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Peer Reviewed
Human Participant Protection
Institutional review board approval was not required for this article.
Accepted for publication December 2, 2005.
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References |
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1. Institute of Medicine, Financing Vaccines in the 21st Century. Washington, DC: National Academies Press; 2004.
2. Lueck S. "Bioshield" drug-patent plan draws fire. Wall Street Journal. April 1, 2005:A4.
3. Grieve J, Tordoff J, Reith D, Norris P. Effect of the pediatric exclusivity provision on children’s access to medicines. Br J Clin Pharmacol. 2005;59: 730–735.[CrossRef][Web of Science][Medline]
4. Shirkey S. Editorial comment: therapeutic orphans. Pediatrics. 1999;104: 583–584.
5. US Government Accountability Office. Flu Vaccine: Recent Supply Shortages Underscore Ongoing Challenges. State of Janet Heinrich, Director, Health Care/Public Health Issues. Testimony before the House of Representatives Subcommittee on Health and the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce. November 18, 2004. Washington, DC: US Government Accountability Office; 2005.
6. Heller M, Eisenberg R. Can patents deter innovation? The anticommons in biomedical research. Science. 1998; 280:698.
7. May T, Silverman R. Bioterrorism defense priorities. Science. 2003;301:17.[Abstract]
8. Kennedy D. Drug discovery. Science. 2004;303:1729.[Abstract]
9. World Health Organization. Report of the Commission on Macroeconomics and Health, executive summary, p. 1. Available at: http://www3.who.int/whosis/cmh/cmh_report/report.cfm?path=cmh,cmh_report&language=english. Accessed December 2001.
10. Price-Smith A. The Health of Nations. Cambridge, Mass: MIT Press; 2002.
11. Easley C, Allen C. Exploring the roots of terrorism. In: Levy B, Sidel V, eds. Terrorism and Public Health. Oxford, England: Oxford University Press; 2003:339–342.
12. See Benjamin D, Simon S. The Age of Sacred Terror. New York, NY: Random House; 2003:173–182.
13. See Easley and Allen, pp. 339–342 and Horton R, Health Wars. New York, NY: New Review of Books; 2003.
14. May T. Isolation is not the answer. Nature. 2004;429:603.[CrossRef][Medline]
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