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PROLOGUEAssuring Access To Affordable Drugs And VaccinesSecuring affordable access to needed medications remains an enduring challenge for policymakers in both the United States and the developing world. Two critical pieces of this conundrum—ensuring the availability of drugs and vaccines tailored to the local disease burden and enabling people to afford the purchase price of their medications—bedevil the developed and developing worlds in different ways. The "patent rents" system, the bedrock compact between policymakers and pharmaceutical companies, encourages robust research and development (R&D) investment based on an expectation that drug producers can recoup their costs in bringing a product to market. This system assures users in the United States and other rich countries of the availability of cutting-edge drugs and vaccines, but it does so at premium prices that are beyond the reach of many. For residents of the developing world, a perceived lack of profit potential in many cases dissuades drug companies from investing R&D dollars in interventions suited to local health needs. The result can be slow progress on eradication of long-standing disease-causing pathogens that exact tolls in morbidity and mortality on a scale that, were they to befall Western countries, would be deemed a crisis. A robust policy literature has proposed alternative models for ensuring access to critical medications without dampening research investment and innovation. For the developing-world context, in particular, such discussion has helped propel public/private partnership strategies whereby rich donor countries, nongovernmental organizations (NGOs), and industry work together to put in place "push-pull mechanisms" to defray the economic uncertainty for pharmaceutical companies investing in diseases of the developing world. One such collaborative model described by Ernst Berndt and John Hurvitz in Health Affairs (May/June 2005) is advance purchase commitments. On the other hand, comprehensive solutions to the "high-price problem" in the United States remain largely elusive. The papers that follow carry forward this discussion. First, Dana Goldman and colleagues consider the U.S. context by proposing a drug-licensing model allowing individuals to purchase unlimited access to prescribed medications on a yearly basis. Next, Kevin Outterson and Aaron Kesselheim offer pharmaceutical companies a model for fair recompense of their R&D investment in developing countries through a market-based licensing arrangement with generic producers. A Perspective by Amie Batson and Julie Milstien follows, considering such additional concerns as market viability in poor countries.
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