Aligning pharmaceutical innovation with medical need

C Nathan - Nature Medicine, 2007 - nature.com
Nature Medicine, 2007nature.com
How can we make vaccines and medicines for major diseases that have been largely
ignored? How can we get vaccines and medicines to populations that cannot afford them? A
fundamental solution to these problems requires aligning three basic processes—
innovation, incentive and access—so that they become mutually reinforcing. The present
patent system provides incentives for innovation by enforcing product monopolies that
permit sales at prices far above production cost. Industry has little financial incentive to …
How can we make vaccines and medicines for major diseases that have been largely ignored? How can we get vaccines and medicines to populations that cannot afford them? A fundamental solution to these problems requires aligning three basic processes—innovation, incentive and access—so that they become mutually reinforcing. The present patent system provides incentives for innovation by enforcing product monopolies that permit sales at prices far above production cost. Industry has little financial incentive to develop products for diseases that mainly afflict the poor, and the poor cannot afford products that industry develops for wealthier customers. Two reforms could correct these disparities and benefit all stakeholders. First, open-access drug companies—fee-for-service sites within drug companies for collaborations among academics and biotechnology and pharmaceutical professionals, funded by users and government—would bring new ideas and expertise to the development of drugs independent of market drivers. Second, a patent track that rewards innovation in proportion to its impact on the global burden of disease would provide an incentive for pricing near the cost of production and commit government and business to improving health care delivery. Allying open access and traditional drug companies and offering a credit-assignment patent track alongside the monopolyenforcement track would increase the number and accessibility of medical interventions, industry’s therapeutic and geographic opportunities, and global health. We must reform how we make and distribute vaccines and drugs. This call is coming from diverse quarters: business school professors, economists, jurists and pharmaceutical executives. They write:“The global system of drug development and marketing is broken...” 1;“The system is ill-adapted to develop products of great social need...” 2;“In developing countries, life-saving medicines are priced beyond the reach of most people, a morally offensive outcome” 3; the “flow of new drugs has slowed to a trickle...” 4. Something is wrong when President Clinton had to devote much of his energies to negotiating price reductions so AIDS drugs could reach just a few of the children who need them5. The issues come into focus if we discuss them with reference to three categories of diseases6 and three economic concepts. Type I diseases, such as cancer, afflict people everywhere, not only in economically developed countries but also in less developed countries. Type II diseases, such as tuberculosis, strike everywhere but are far more prevalent in less developed countries. Type III diseases, such as filariasis, are encountered almost exclusively in less developed countries. The three economic concepts as used here are ‘innovation’, drug and vaccine research and development and the manufacture of resulting products;‘incentive’, financial returns adequate to sustain production and new research and development (R&D) while attracting investment; and ‘access’, the impact of price and health care infrastructure on the ability of populations to use medical products.
The current system for commercial drug development (Fig. 1a) provides incentives for innovation for treatments of type I diseases by providing rewards through patentbased monopoly pricing. This system offers in adequate monetary incentive for commercial innovation for diseases of types II and III. Médecins Sans Frontières (MSF) brought this forcefully to the fore in 1999:“Among the 1223 new chemical entities commercialized from
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