1. Nathan Trayner 1,2 ; John Prensner 1,2 ; Heather Ames 1,2 ; Ashwin Vasan 1,2 1.MD Candidate, University of Michigan Medical School 2.Universities Allied for Essential Medicines, University of Michigan Chapter Access to medicines in the developing world: Current challenges and role of universities and medical education Introduction M ore than ever, medical students are participating in international health field work during their degree programs 1 (Fig. 1). For these students, working in poor settings with drastic health inequalities can have important effects on their lives and career choices 2. These experiences leave students yearning for a better understanding of the political and social mechanisms which foster and sustain global health inequalities. E ducational opportunities that adequately address global health are challenging for US medical schools, given the existing size of the required curriculum and the diversity of student interest. In the place of curriculum-based pedagogy, many medical schools, including the University of Michigan, sponsor student-led organizations interested in multi-disciplinary issues related to global health. One area of interest that has proven of immediate relevance and concern to medical students is access to medicines in poor countries and the role of universities in this dynamic. U niversities Allied for Essential Medicines (UAEM) is a national student-led organization that since 2005 at the University of Michigan has developed a strategy to educate medical students and faculty as well as students and faculty campus-wide, about two issues of critical importance to global health inequality and how universities themselves can serve as a solution: The Access Gap to essential medicines The Research Gap and “Neglected Diseases” References 1.Association of American Medical Colleges’ Medical School Graduation Questionnaire All Schools Report, 1978 to 2004. Data for 1993 were not accessible. 2.Ramsey et al. Career Influence of International Health Experience During Medical School. Fam Med 2004;36(6):412-6. 3.The Selection and Use of Essential Medicines. Report of the WHO Expert Committee, 2002, including the 12th Model List of Essential Medicines. WHO Technical Report Series No.914. 4.Equitable Access to Essential Medicines: A Framework for Collective Action. WHO Policy Perspectives in Medicine. March 2004. 5.de Joncheere K. WHO European Regional Office 6.Untangling the Web of Price Reduction. Médecins Sans Frontières. http://www.accessmed-msf.org. January 2005. 7.Love J. An Essential Health Care Patent Pool. Presentation at the 14 th Annual AIDS Conference, Barcelona. July 2002. http://www.cptech.org/slides/jameslove-barcelona.ppt 8.Building a global strategy for policy change in neglected disease research. DNDi submission to the WHO IGWG, November 2006. 9.Trouiller et al. Drug Development for Neglected Diseases: a deficient market and public-health policy failure. The Lancet. Vol 359. June 2002. 10.Pecoul, PLoS Med. 2004 (image modified by Trayner N) 11.Chaifetz et. Al. Closing the access gap for health innovations: an open licensing proposal for universities. Globalization and Health 2007, 3:1 12.Forrest S. Research at the University of Michigan A Report to the Regents. January 2007. The Access Gap The Research Gap The Role of Universities UAEM Educational Strategies Medical schools and their students have an important role to play in encouraging wider engagement of their universities in the development of fair licensing of university research and to increasing attention and funding for neglected disease research UAEM’s strategy, led by its student members, is to generate widespread consensus and support for these principles amongst the students, faculty, and staff at the University of Michigan. Some techniques employed have been: E ssential medicines (Fig. 2) are those that are needed to meet the priority health care needs of the population. As such, these drugs should be available: Figure 1. Percentage of Medical School Graduates Participating in an elective International Health- Related Clinical Experience 1 Figure 3 4 Access to Essential Medicines Ibuprofen Epinephrine Praziquantel Amoxicillin Azithromycin Doxycycline Rifampicin Lamivudine Stavudine Efavirenz Lopinavir+Ritonavir Artemether+Lumefantrine Essential Medicines Include: 5 Figure 2 3 1. Rational selection 4. Reliable health and supply systems 2. Affordable prices 3. Sustainable financing ACCESS A ccess to essential medicines is impacted multifactorially 5 (Fig. 4). Affordable pricing is just one issue related to access, yet high drug prices are an important hurdle in low- and middle income countries. Drug pricing itself is also a dynamic, multifactorial process (Fig. 5 ) Figure 4 5 Factors affecting access C ompetition is the single most important contributing factor to the price of medicines. Barriers to competition include exclusive patent and licensing rights which prevent the importation and/or production of generic versions of these drugs. When developing countries have been able to generically produce essential drugs, prices have been drastically reduced 6 (Fig. 6). Lower prices have allowed countries like Brazil and Thailand, to offer universal treatment for HIV/AIDS 7. Figure 6 6 Effect of Generic Production on the cost of Anti-Retroviral Theraphy (ART) F rom 1975 to 2004, 1556 new drugs were approved for market 8. Of those, only 21 were for neglected diseases (see Fig. 7). And two-thirds showed little to no therapeutic gain over existing treatments 9. Neglected Diseases (ND): Have a shortage of safe, effective treatments Fall outside the world pharmaceutical market Lack attention from global R&D Affect 1 billion people annually, mostly in poor, tropical areas Are often disabling, disfiguring, stigmatizing Neglected Diseases Include: African trypanosomiasis Kala-azar (visceral leishmaniasis) Schistosomiasis Lymphatic filariasis Trachoma Buruli Ulcer Figure 7 T he failure to produce new, effective treatments for neglected diseases is the result of multiple research gaps within the drug development pipeline 10 (Fig. 8). Addressing each gap is critical to any strategy address neglected disease treatment and prevention. Figure 8 The Drug Development Pipeline and Gaps affecting Neglected Diseases 10 Addressing the Research Gap: U niversities generate important research has led, directly or indirectly, to the production of drugs and tools for combating diseases that predominately effect poor countries. GIVE EXAMPLE (reference) Universities, therefore, occupy a natural and unique position to conduct research on neglected diseases that lie outside the purview of for-profit companies by actively encouraging, supporting, and funding researchers to work on such diseases (Fig. 10). Addressing the Access Gap: M odern universities are centers for scholarship and research devoted to the public good. While universities do not mass-produce drugs, they do license drugs and technologies to pharmaceutical companies and biotechnology firms for production or further development. Figure 9 11 Schematic diagram of the Equitable Access License mechanism. U niversities are thus in an ideal position to insist that licensing terms for all university- developed products, particularly those that Figure 10 8 C urrently, one-third of the world’s population lacks access to these essential medicines (Fig. 3). In many African and Asian countries, up to half of people lack adequate access 4. Factors Affecting the Price of Medicines Inefficient Distribution Inefficient Procurement Competition Production Costs Figure 5 With assured quality information At an affordable price At all times In adequate amounts In appropriate dosage forms 3 address priority health conditions in the poorest nations, support access and include language that requires companies to make these technologies readily available those most in need (Fig. 9). By employing an Equitable Access License for relevant products, universities can exert their important social influence by improving the availability of essential drugs and technologies that they generate 11. Meetings w/ faculty and staff at all levels and at all schools of the University, encouraging public signatories to the UAEM Philadelphia Consensus Statement found at http://www.essentialmedicine.org/cs/ Educational meetings and “teach-in” targeted at students Public lectures and speaker series addressing the principle issues related to access to medicines and university research Medical School faculty and administration can provide important intellectual and material support to these efforts, providing forums for these events and encouraging discussion of these issues within the general medical school curriculum. In this way, University of Students and Faculty at a UAEM “Teach-In” Michigan has been a leader, addressing global access to essential medicines within the 1 st year Infectious Disease & Microbiology course and providing financial resources for UAEM events. In addition, Medical School faculty are critical to building support for equitable licensing and for increase ND research. The Medical School generates X% of University research at Michigan and receives 41% funding given to the university 12. The public support of senior medical school officials is necessary for these reforms to take hold throughout the University. Conclusion