| Drug Resistance and Global Health Update | May 2008 | ||
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Dear Colleague: This is the second issue of CGD's monthly e-newsletter devoted to news and information about global drug resistance, with special attention to resistance in the developing world. In this issue, the first of our periodic guest columnists, Professor Kevin Outterson, provides a summary of key legal challenges to antimicrobial conservation. I will use this space for updates on the latest activities of the Drug Resistance Working Group, and invite your suggestions and ideas about our work. The Working Group is currently using its tripartite framework of resistance drivers – technology, behavior, and health systems – to understand what actions can make a real difference in fighting resistance. Our goal is to produce recommendations that go beyond the oft-repeated and never-realized good public health practice to give companies, donors, and regulators the knowledge and means to think and act differently where resistance is concerned. Building on CGD's unique approach to policy change, we have also created a detailed outreach and dissemination strategy to raise awareness of this critical problem and see our recommendations taken forward. Thanks for subscribing to this newsletter. As always, we welcome your comments and suggestions on our program of work, which can be directed to [email protected]. Best Wishes, Rachel Nugent Guest Columnist - Kevin OuttersonAntimicrobial Conservation & Competition Law* There is no longer any doubt that antimicrobial resistance poses an increasing threat to global human health. While much better surveillance is needed, estimates indicate significant and growing problems worldwide. Both supply and demand strategies are necessary to address this critical challenge. The supply-side response focuses on creation of new antimicrobials; in contrast, a demand-side approach seeks to reduce resistance pressure through conservation, public health, infection control, and vaccination. Conservation is particularly important, as it lies at the heart of the economic conceptualization of antimicrobials as a potentially exhaustible resource, akin to a fishery or public woodlot. To date, the global policy discourse has largely focused on supply-side incentives to stimulate new innovation, but without a complementary effort on the demand side we risk continually playing catch up with the science. To effectively tackle drug resistance in a sustainable fashion, we must also make existing products last longer, in part through collaboration with pharmaceutical manufacturers to ensure that their products are used appropriately and responsibly. From a socially optimal standpoint, patent-holding firms should be legally able to cooperate in limiting the marketing, sale and utilization of important drugs for the purposes of antimicrobial conservation. For example, only two firms hold US patents on commercially significant FDA-approved drugs in the class of antimicrobials known as fluoroquinolones. Resistance to fluoroquinolones can spread between drugs within the class as well as across diseases. The class itself is a form of common property, at least in the aspect of resistance. The classic economic response would be private group coordination, which could be effective in this case given the relatively small number of sophisticated actors. The class owners could jointly endeavor to conserve this precious resource. However, competition law threatens exactly this form of joint coordination amongst competitors. The US Federal Trade Commission and Department of Justice have issued guidelines suggesting that in narrow circumstances health care joint ventures that would otherwise be anticompetitive might be permitted, and European Union authorities have demonstrated similar flexibility when pro-competitive effects can be demonstrated. But existing law does not clearly permit the type of joint coordination that might be required amongst firms holding antimicrobial patents. The pharmaceutical industry has received significant attention from competition authorities with regard to its patent policies, which underscores the need for clarification from enforcement agencies. This problem is particularly acute when drugs in a class begin to go off patent, adding to the group coordination problem. Moreover resistance may be transmitted across borders, which necessarily involves the competition laws of more than one state. Given these legal hurdles, it is small wonder that manufacturers rarely engage in active conservation efforts; this is further reinforced by their economic disincentives to do so. Greater flexibility in the application of competition laws may be needed to permit joint coordination of conservation strategies by firms marketing a class of antibiotics. Strengthening the legal framework for engaging in such conservation activities may also open the door to exploring economic incentives that might actively encourage firms to do so, potentially through policies to compensate patent-holders for conservation efforts. Kevin Outterson *These and other findings on the "Markets for Infections: Mismatched Incentives for Hospitals, Patients and Drug Companies" at Harvard's Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics on June 13. The accompanying working paper will be available through the Social Science Research Network. Drug Resistance News
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