Alessandra Tomasi received her B.A. from Cornell University and is now a first year medical student.
A major barrier in medical access worldwide is the high price of drugs. Especially in developing nations, millions of people do not have access to the pharmaceuticals they need because they, or at times even their government, cannot afford them. A significant contributing factor to this obstacle lies in patent law and distribution [1, 4]. Laboratory advancements that are translated into new drugs, vaccines, and other tools for pathogenic prevention and treatment are afforded a seal of exclusive rights, thereby eliminating any form of open competition that could drive prices down to more affordable levels . Such high prices result in life-saving drugs that are too expensive for many in need, leaving millions of people around the world unable to afford medicine for treatable conditions .
When pharmaceutical companies develop a new drug, they are awarded a patent, which grants the group exclusive rights to make, use, and distribute the medication on their own terms for 20 years [1, 2]. The most widely acknowledged function of a patent is thus its role as a financial incentive, making it possible for innovators to obtain sufficient returns for their research . This incentive, though lucrative and advantageous to developed nations, according to the WHO, poses a threat to the advancement of those that are instead less industrialized. That is, whereas developed countries that have vast capacities for innovation benefit from such a system, developing nations that lack such technological resources and infrastructure are unable to keep up and sustain their own growth . These populations therefore remain in reinforced cycles of poverty, with little access to vital medications.
The unequal access to pharmaceuticals due to monopolies over drug development has been the subject of numerous negotiations and debates in key international forums, including the World Trade Organization, the World Health Organization, and the World Intellectual Property Organization [3, 4]. These discussions draw on several facets of public policy, including international trade law, intellectual property law, health law, and human rights and ethics . According to the World International Intellectual Property Organization (WIPO), fiscal and commercial incentives provided by the patent system do not ensure the development of new products in certain areas, especially with respect to neglected diseases that plague countries of poverty . As a result, policymakers must continuously seek a balance between the rights of patent owners and the overall public need. Since drug research and development is an incredibly expensive process that requires vast and long-term investment, the patent system exists to offer scientists a means for pursuing innovation. At the same time, however, accessibility to society remains an issue.
Current pharmaceutical ownership and licensing policies thus pose threats to health crises in developing nations, in that they prevent access to essential medicines by providing incentives for drug development based almost exclusively on market-based needs . Drug companies have little incentive to spend millions to develop necessary drugs and bring them to the markets most in need, if these markets cannot in turn provide monetary gain [4, 5]. Consequently, while a patent system should guarantee that innovations be beneficial to the public as a whole, the vast majority of drug research and development is instead focused on diseases that more commonly affect people in developed countries— thereby neglecting the diseases that primarily affect people in developing nations .
South Africa provides a powerful example of an especially ill-structured patent system. Currently under fire by many activist groups for its adverse structure, according to the Doctors Without Borders Access Campaign, the nation has incorporated such lenient patent laws that private pharmaceutical companies benefit financially while leaving patients unable to pay the excessive pricing on drugs . South Africa’s current system, in fact, allows any minimal change in a specific drug— even one that provides no actual improvement to the existing medication— to be easily re-patented for an additional 20 years following its original stamp, thereby furthering its monopolized distribution and pricing. Rather than strengthen the health care system, therefore, South Africa's patent system reinforces a cycle where necessary medications remain out of reach for most . This is especially a concern today, given this year's rapidly proliferating drug-resistant tuberculosis bacteria: one of the few drugs that is actually known to successfully treat this strain— Linezolid— is marketed at such a high price due to patent protection, that thousands of South African citizens dependent on their nation's health care remain unable to purchase the drug necessary to treat the rampant disease .
Law should be used to accelerate medical treatment, not inhibit it. The artificially high prices imposed by South Africa's current system reflect a gaping hole in the process of drug development and distribution that unfortunately extends across several nations worldwide. Overall, it appears that in terms of pharmaceutical availability, either no product exists, or not enough do at reasonable enough prices for patients to actually afford them. These circumstances thus call for innovations in the patent system itself. How, though, does one stimulate innovation, particularly in the developing world, such that nations and communities in need of drugs no longer rely solely on pharmaceuticals derived from external and thus expensive research? As summarized by the Science and Technology Advisor for Africa's New Partnership for Africa's Development (NEPAD), “scientific and technological capacity for health cannot be reduced to equipment, funding, and number of health scientists and technicians” . That is to say, the capacity for a nation to build its own innovation lies in a carefully mapped arrangement of policies, skills, and communication, a pursuit that begins with the careful re-organization of patent law.
1. Elliott R, Bonin MH. Patents, International Trade Law, and Access to Essential Medicines. & Médecins Sans Frontières Canada, May 2002.
2. Reisman J, Physicians and Surgeons as Inventors: Reconciling Medical Process Patents and Medical Ethics, 10 HIGH TECH. L. J. 355, Section II.C (1995)
3. Commission on Intellectual Property Rights, Innovation and Public Health. World Health Organization. Library Cataloguing-in-Publication Data. May 2005.
4. Medcins Sans Frontières. MSF welcomes Brazil Parliamentary Committee recommendation to reform patent law. October 2013.
5. World Intellectual Property Organization, Public Health and Patents. March 2009.
6. Twagirumukiza, M. Drugs and Diagnostic Innovation in the Developing World: A Review and Call For Debate. The Science Advisory Board, 2011.
7. Medcins Sans Frontières. Fix the Patent Laws: A grassroots campaign in South Africa could change all that. October 2013.