Special Report – Students To Universities: “We Have A Drug Problem” 13/05/2014 by Julia Fraser for Intellectual Property Watch 6 Comments Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)BASEL — Students from around the world are gathering momentum to challenge their universities’ licensing policies and research and development systems. That was one of the messages emerging from the annual meeting of Universities Allied for Essential Medicines (UAEM) Europe. Important research behind many patented drugs that treat some of today’s most destructive diseases originates at universities. But close ties with the pharmaceutical industry has led to profit-driven research, overlooking key areas such as neglected diseases primarily affecting poor populations, and the commercialisation of research at unaffordable prices, the students say. Students demonstrating in Basel© UAEM In a time of austerity and growing pressure to become self-financing, universities risk losing sight of their social mission. These students want to change that, and they believe they have the power to do so. The UAEM Europe meeting in Basel, Switzerland, on 25-27 April gathered some 200 students from 22 countries. For the first time, UAEM Europe invited some their counterparts from lower and middle-income countries (LMICs). This is a “truly global movement,” said Lukas Fendel, executive director of UAEM Europe, and the global issue of access to medicines cannot be addressed by “bracketing” the different regions. UAEM was started by a group of students at Yale University in 2001, in reaction to the high prices Bristol Myers Squib was charging for the AIDS drug stavudine, originally developed at Yale. With help from Médecins Sans Frontières (MSF, Doctors Without Borders) and the Consumer Project on Technology (now called Knowledge Ecology International), the students launched a campaign and eventually convinced Yale and BMS to allow generic production of stavudine, leading to a dramatic drop in its price. The movement has grown big across US universities, it then spread to Canada, Europe, and now has a presence in universities in Brazil, India, South Africa and Nepal. This year’s conference gathered UAEM members and interested new students for a series of motivational speeches, panel discussions and workshops presented by leading global health advocates and university directors. Discussions at the “symbolic” city of Basel, where leading European pharmaceutical companies are based, centred on what universities and students can do to address the issue of access to essential medicines and healthcare. Shortcomings in R&D Systems Some 10 million people die every year because they don’t get adequate access to medicines and medical devices, said Bryan Collinsworth, executive director of UAEM North America, in an introductory speech for new students at the conference. This is not just a problem in the developing world, where a third of people do not have access, he said, but even in Europe “access to essential medicines in the public sector is generally below 60 percent.” Rachel Kiddell-Monroe, UAEM senior advisor and former president of the Board of UAEM North America, identified some defining global health trends in the context of the weekend’s debates. These included: epidemiological shifts from the rise in non-communicable diseases worldwide; “astronomical” prices of new medicines; global economic crisis, which has had repercussions in developed countries as well developing countries; and the corporatisation of universities. Fendel also pointed to recent public outrage over “immorally high” costs of hepatitis C medicines and cancer treatments. Universities develop many of the drugs that are on the market today. For example, the latest hepatitis C drug sofosbuvir marketed by Gilead and whose exorbitant price has attracted worldwide criticism, was originally developed by Emory University in the US, explained Collinsworth. © UAEM Of the 21 drugs with the highest therapeutic impact, 15 were developed using public funding. Universities then licence their discoveries for a royalty through profit-driven university technology transfer offices to the highest-bidding pharmaceutical companies who then develop and commercialise the drugs for whatever revenue they choose, he said. Because of this practice, universities can sometimes find themselves on the “wrong” side of infringement cases, fighting to protect their pharmaceutical partner’s IP rights, as the University of Utah is doing in the Myriad case (IPW, Public Health, 18 February 2013). Close ties with the pharmaceutical industry also means that companies often direct research at universities towards more profitable discoveries rather at the expense of global health needs such as treatments for neglected diseases. Panellists Highlight Key Issues in R&D At a public panel discussion on 26 April titled, “Making medicines for people… not for profit,” UAEM invited expert speakers to discuss “why our R&D system is deeply troubled and what concepts exist to make it better.” Eva Ombaka, member of Health Action International, ReAct, and the Sustainable Health Care Foundation, said there is a second category of “neglected diseases” aside from those that lack interest for investment in research. There are also cases where the drugs are available, but disease remains neglected as a consequence of the combination of poor, remote living conditions and inadequate health care systems leading to lack of access. Rohit Malpani, director of policy for Médecins Sans Frontières (MSF) Access Campaign, added that although R&D for neglected diseases has improved, there is “still a fundamental imbalance between medicines developed for those in developing countries and for those in the rich world.” Malpani pointed to other neglected areas of research including healthcare that is adapted and suitable to developing country settings, such as heat-stable vaccines. He also mentioned antibiotics, which is a worldwide problem irrespective of development status. Zafar Mirza, head of the Department of Public Health, Innovation and IP at the WHO, identified a “new generation of problems.” These include the “absolutely unaffordable” new medicines, “exponential” growing demand of medicines, and drug safety in developing countries where there is limited regulatory environment. Mirza also said that “anybody, especially students who are really championing” access to medicines should “read, internalise and pursue into their implementation” the documents of key milestones in the global health agenda. These include the WHO Commission on Intellectual Property Rights, Innovation and Public Health; the Doha Declaration; the World Intellectual Property Organization Development Agenda; and WHO’s Consultative Expert Working Group on Research and Development (CEWG). Dominique Junod-Moser, legal officer for DNDi, whose licensing contracts offer some guidance to UAEM, highlighted key important policies of DNDi. These are that IP issues are always discussed and negotiated with their partners, DNDi absorbs the risks of research so that this is not reflected in outcome product prices, and they encourage open publication of research. However, she said public-private partnerships cannot be the only solution. There must also be coordination, leadership from endemic countries, open innovation and pooled funding, she said. To move things forward, Mirza emphasised the need for political consensus. “Most of the problems with health systems in developing countries are well known, solutions are well known, but they don’t get implemented” for lack of political will, and it’s “not a problem of resources,” he said. However, Malpani added that “it’s not that simple,” as pharmaceutical companies have a strong influence on governments. He also criticised “new models” of R&D as “emphasising the existing system” instead of promoting the development new approaches. The Role of Universities and Students Throughout the conference, students were reminded that they are the “future” of global health. “The most important element for students to take home,” Collinsworth told Intellectual Property Watch, “is the power they have as students and as a rising generation of leaders to actually impact how research is conducted, how it meets the global health needs and how medicines are made accessible to patients who need them.” As constituents of universities, they have to power of challenging old practices, and universities “should be responsive to that,” he said. The essential pillars of UAEM’s work are “access, innovation and empowerment.” UAEM aims to “mobilise universities to become active stewards of a better R&D system,” said Fendel. They are campaigning for innovative R&D models that yield affordable products aligned with global health needs, including public-private partnerships such as DNDi, open source discovery, crowd funding and prizes for medically necessary inventions, added Collinsworth. Looking at the long term, students not only learn the skills for advocacy at their universities, but there is a “broader theory of change that becomes part of anyone who has been involved with UAEM,” said Fendel. “Students will carry these concepts and ideas into professional contexts, and into society.” More concretely, one of the founding activities of UAEM is to campaign for the adoption of global access licensing (GAL) policies at their universities. “Universities have a lot of leverage” when it comes to setting the terms in licensing contracts with pharmaceutical companies, said Collinsworth. Universities should include terms requesting the sublicensing of products to generic companies to make generic versions in LMICs at a lower cost. Recently, several universities have “global access licensing policies as a reaction to very persistent and long time UAEM advocacy,” said Fendel. And significantly, none of the universities who have adopted a GAL policy in the US have reported a decrease in licensing volume or revenue, reported Collinsworth. Students at universities in lower- and middle-income countries also have a role in “shaping access policies as their universities start scaling up research,” he said. Collinsworth and Sara Crager from the University of California, Los Angeles recently published a paper that discusses university licensing strategies, which is available here. Access-Driven Research and Transparency The public panel’s second part addressed “How can universities be game changers in our broken medical research system?” Speaking on the panel, Kiddell-Monroe emphasised that universities should consider their social mission to society as a whole, and prioritise research on “real world issues.” Universities “as agents of change,” should support new models, be transparent about patenting and licensing, and make sure research is open and available to all, she said. Albrecht Jahn, head of the research group “Global Health Policies and Systems” at the Institute of Public Health, University of Heidelberg (Germany), agreed that what is “relevant for universities is the concept of open access and open innovation.” Universities should move away from the counterproductive trend towards patenting everything, which encourages secrecy, he said, adding a call for more research into defining the best models of global governance. Marcel Tanner, director of the Swiss Tropical and Public Health Institute, said universities should put emphasis on translational science, and “basic research in the downstream question of access.” They should also have a “fundamental strategy, not this side effect discussion” of technology transfer. Scientific findings must also be “validated in different contexts to see if they hold true and can be applied.” David Hammerstein, policy advisor to the Transatlantic Consumer Dialogue (TACD) and former Member of the European Parliament, said, “We live in a modern myth that science is separate from society…. We shouldn’t split research on the one side, and leave access to politicians.” He reiterated the role of universities in “transparency enforcement”, especially when it comes to publishing clinical trials for new medicines and their effects on health, which is often “hidden under the guise of ‘commercial confidentiality’.” Additionally, he criticised the fact that universities have to pay for subscriptions to academic journals to which they are contributors, and copyright laws that act as a barrier to open use of databases for text and data mining for research. “This panel is very relevant to that in that we are very much beginning a conversation about an entirely new approach to medicinal research that doesn’t rely on patents and high prices,” said Collinsworth. “Universities as public interest non-for-profit institutions, can really be pioneers in new models of research” and students can advocate for universities to test out these new approaches. Developments at UAEM “UAEM has seen rapid expansion in Europe over the past few years. The conference will be a crucial moment to channel this momentum and streamline local campaigns,” Fendel told Intellectual Property Watch. An aspect of the conference was also for students to share and learn from ongoing projects at each other’s university chapters. There was a strong feeling that affordability and access to medicines is now also hitting home in European countries. Speakers throughout the conference made reference to the newest unaffordable IP-restricted cancer treatments, causing the government of Greece to consider the use of compulsory licences for expensive pharmaceuticals, and the UK’s National Institute for Health and Care Excellence – which decides which new drugs can be used by the National Health Service – to turn down the expensive new breast cancer drug Kadcyla. The conference organisers “reached out especially to countries affected by austerity and European countries with access problems such as eastern Europe,” said Fendel. “Those students and contexts could be especially receptive to ideas that we have as they are experiencing their own crisis,” he added. For the first time, the European conference also invited students from middle-income countries, including students from Brazil and India. Walter Britto Gaspar, a student in Rio de Janeiro, Brazil, said they are working on South-South coordination. There has been a patent pre-grant opposition filed in India against Gilead’s hepatitis C drug sofosbuvir, and the students are working together to identify how they can use the same arguments for an opposition in Brazil, he said. “South Africa and Brazil are experiencing law reforms in this area. This is another interaction” that could be important, he added, as “India has a great history of public health.” Unlike their European counterparts who are looking for more involvement from law students, in Brazil they are trying to recruit more medical students for the movement. This is “really important,” said Gaspar, as when reading patenting contracts and other documents, “the legal part I can read fine, but when it gets to what the drug does, it could be in Japanese.” Avnish Deshmukh, from UAEM India, said that they have just opened a new chapter in India. They are focussing on raising awareness, he said, as “these issues are so important yet people don’t know about them.” “The issues are increasingly the same in that many high income countries are now facing serious concerns about the prices of new medicines. And in many middle-income countries they are starting to develop independent research capacity, not only for generic drugs but also for new health technology,” said Collinsworth. Chapters Students also presented ongoing projects at the UAEM chapters. These include “drug biographies,” where students are researching the contributions of public research to the development of specific medicines, which would “be a strong argument in favour of making these drugs more affordable and accessible,” said Fendel. They are also working with ASTP Proton, Europe’s largest organisation of university patenting professionals, to get them to accept global access licensing policies and host on their website an example text of GAL. For this, they are getting external input from DNDi whose licensing language can be used to prepare a template. Other projects include TED talks like educational videos on UAEM’s issues, an Access 2 Medicines Week campaign, and university report cards to rank universities on their impact on global health, measuring innovation, access and empowerment. More about their projects is available here. Julia Fraser is an intern at Intellectual Property Watch. She is currently training to be a solicitor and will start work at an international law firm in London in 2015. She has a BSc Honours in Biology from Edinburgh University where she developed an interest in public health related intellectual property issues. 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