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Are Patents Impeding Medical Care and Innovation? (Part 3)

PatentPart 3 brings about the final perspective on this hopefully interesting series. Obrinski, Logan, and N-Maranid discuss how, in their opinion, medical patents skew biomedical research toward problems of the rich world. Readers are encouraged to first read Part 1 and Part 2 to gain a more complete understanding of the issues that surround medical patients.

James Orbinski’s, Sarah Harland Logan’s, and Sevil N-Marandi’s Viewpoint: Patents Skew Biomedical Research Toward Problems of the Rich World
If patents represent a bargain between the claimant to intellectual property (IP) and the state, and on balance should benefit society, a key question in this age of globalization is “which society?” The United Kingdom’s Royal Society, an independent academy of science, rightly argues that “uses of intellectual property that benefit people in one part of the world but conspicuously fail to benefit others, or even act to their detriment, are not what the [patent] system is supposed to be about” [40].

For developing countries, patents can impede medical care by pricing medicines and other health care technologies (HCTs) out of the reach of patients or their health care systems. Pharmaceutical companies have little interest in pricing drugs for developing country markets because they are seeking to maximize global not national profits, and do not want to set a low price precedent that would increase demand in wealthy countries for similar low prices [41]. For those with a purchasing power less than what is needed to meet minimal needs—i.e., most of the 3.8 billion people who live on less than US$2 per day [42]—access to HCTs is little more than a discomforting dream. Further, if a treatment is too expensive, other factors that can affect medicines availability, such as drug distribution systems and rational drug use policies, become moot. Indeed, it was only when generic competition lowered the price of antiretroviral therapy for HIV—from more than US$15,000 per patient per year in 2001 to less than US$99 in 2007—that the policy debate shifted from whether such therapy was possible in resource-poor settings to how to strengthen health infrastructure to provide comprehensive HIV health care for people in such settings [43, 44].

To increase access to existing HCTs, governments can make use of fully legal safety provisions of the World Trade Organization’s Trade in Intellectual Property Rights Agreement (TRIPS). These provisions include compulsory licensing, which allows a government to force a drug company to license its patent to a local generic producer who must pay a royalty to the patent holder. But a government is allowed to issue a compulsory license only after price negotiations with the patent holder have failed. Nevertheless, compulsory licensing remains a valuable tool, as memorably shown in 2001 when South Africa issued compulsory licenses to produce selected anttiretroviral drugs. Although 39 pharmaceutical companies attempted to sue South Africa’s government for allegedly infringing on their patent rights, they ultimately chose to withdraw this lawsuit in the face of immense public pressure [45]. The confrontation led the World Trade Organization to issue its November 2001 Doha Declaration, which affirmed that “the TRIPS Agreement does not and should not prevent members from taking measures to protect public health” [46].

Current patent laws also skew biomedical research to products that yield high profits rather than to global priority health needs in both developed and developing countries. Currently, malaria, pneumonia, diarrhea, and tuberculosis, which together account for 21% of the global disease burden, receive 0.31% of all public and private funds devoted to heath research [47],[48]. More than 1 billion people—the overwhelming majority of whom are in the developing world—suffer from neglected tropical diseases, those for which there are inadequate or nonexistent treatments and a paucity of research and development [49]. Of the 1,556 new pharmaceutical compounds that appeared on the market between 1975 and 2004, just twenty of these drugs—1.3%—were for tropical diseases and tuberculosis [50].

The international debate around patents has been largely framed in terms of “protection for” versus “access to” IP. If the framing of the debate shifts to a focus on research and development, this is likely to strengthen the leverage of developing countries to change the dynamics of IP negotiations in trade agreements [51]. Entirely shifting the debate from IP rights to the R&D gap may help tackle the fundamental problem of a monopoly-based innovation and access system. One example is nonexclusive licensing practices, such as those used by the not-for-profit Drugs for Neglected Diseases Initiative. The initiative finances R&D up front and offers the outcome of its research on a nonexclusive basis to generic producers, allowing for technology transfer and competition among multiple producers [51].

Furthermore, universities currently hold important patents on many life-saving drugs, including the antiretroviral drugs stavudine (Yale University), abacavir (University of Minnesota), lamivudine (Emory University), and enfuvirtide (Duke University) [52]. In recognition of these university patents, Universities Allied for Essential Medicines proposes that “when a university licenses a promising new drug candidate to a pharmaceutical company, it should require that the company allow the drug to be made available in poor countries at the lowest possible cost” [53]. Another alternative to overcoming current patent barriers is the use of patent pools, as proposed by the WHO, Médecins Sans Frontières, and UNITAID [54],[55]. Here, a number of patents held by different entities, such as companies, universities, or research institutes, are pooled and made available to others for production or further development—of, for example, pediatric formulations or fixed-dose formulations. The patent holders receive royalties that are paid by those who use the patents. The pool manages the licenses, the negotiations with patent holders, and the receipt and payment of royalties.

Other innovative policy proposals, such as the Heath Impact Fund (a strategy to create a publicly funded “pot of gold” that would attract the private sector to create R&D innovations that effectively address priority global heath needs) [56], should be implemented. However, using patents as the financial incentive to encourage the pharmaceutical industry to develop drugs for the world’s poor is of limited use where the market is nonexistent because neither governments nor patients can afford the end product [57]. Instead, framing the issue around global R&D, as opposed to international IP rights, will aid in developing public–private partnerships and a set of novel policy alternatives that support approaches to addressing the public health needs of developing nations [58].

The patent system as it affects access to and innovation for HCTs is broken. The system must be reformed so that public goods—such as genuine innovation and access to HCTs—are not sacrificed on the altar of private gain. This reform must prioritize the public good, use innovative policy tools to harness the private sector where it is possible to do so, and create public R&D capacity where market forces and actors are likely to continue to fail.

Material adapted by CFisher from:

Gold ER, Kaplan W, Orbinski J, Harland-Logan S, N-Marandi S, (2010). Are Patents Impeding Medical Care and Innovation?. PLoS Med 7(1): e1000208. doi:10.1371/journal.pmed.1000208

References
Please see the original open access article for the extensive reference list. Numbered references in this current article match the references in the original article.

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