From What We Know to What We Do: Now is the Time for Governments to Fix a Failing System for Drug Development

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Kristine Husøy Onarheim and Johanne Helene Iversen from Universities Allied for Essential Medicines write about the broken system for drug development, and how governments are given an opportunity to address it.

The member states of the World Health Organization (WHO) will meet at the World Health Assembly later this month to discuss WHO’s follow-up of the report of the Consultative Expert Working Group (CEWG) on Research and Development: Financing and Coordination, and the follow-up report issued by the WHO Secretariat after an open-ended member state meeting in November last year.

It has long been recognized that “Market mechanisms, and also publicly-funded research, collectively result in far too little investment in research and development on diseases that mainly affect developing countries. This means that poor people suffer and die because there are no effective health technologies like medicines, vaccines or diagnostics”. Discussions on how to ensure innovation of and access to medical technology addressing diseases disproportionally affecting the poor dates back decades, and several commissions and working groups have been set down by the WHO on request from member states to examine the problem and possible solutions. Most of them have not been able to deliver a sustainable package addressing the profound market failures, until now.

Biomedical research is complex, and it is not easy to predict where we will be when looking ten years ahead. Nobody would have prioritized drugs for HIV/AIDS in 1980, but during the 1990s it became and still is a major research area, both due to the extent of the disease burden and the financial incentives for drug development. However, the world’s poor lack purchasing power and thus diseases primarily affecting them and not their richer counterparts, provide little incentive for the pharmaceutical industry to address their needs. The lack of new drugs or access to the existing ones makes it even harder to break the cycle of poverty. As R&D are high-risk, resource demanding processes, finding the right solutions that both incentivize research that are aligned with health needs and make end products available, are not easy tasks.

The CEWG took on the challenge and ended up recommending the following  as suitable solutions: Global Framework on Research and Development, Open approaches to research and development and innovation, Pooled funds, Direct grants to companies, Milestone prizes and end prizes and Patent pools. These tools cannot easily be tested and compared in randomized-controlled trials, as they all address broad and complex processes, deeply embedded in the current market economy. Still, based on the CEWG criteria; potential public health impact, efficiency/cost-effectiveness, technical feasibility, intellectual property management, degree of delinking, access promotion, transparent and accountable governance arrangements and capacity building in low- and middle-income countries, these are the most promising solutions we have.

Based on the recommendations, the WHO member states conducted national and regional discussions before meeting again in November 2012 to discuss further progress. The report of their meeting recognizes that the current system for drug development does not address the needs of the world’s poor and the urgency to address the medical research and development needs of low- and middle income countries. However, the operative points are not living up to the sustainable package approach suggested in the original recommendations. The draft resolution on the table proposes to postpone further discussions on the feasibility of a R&D Convention until 2016. Open Knowledge Innovation Mechanisms are not being promoted as a solution that can be implemented within the current R&D system and most importantly, sustainable financing mechanisms are not discussed. We find it difficult to see effective implementation of any of the recommendations, also within the tabled resolution, without additional funding.  Last, but not least, we have concerns regarding the process leading to consensus at the November meeting. Even though all member states were invited to participate, the final draft was passed behind closed doors, around 2 am the last day of negotiations, with no translators and less than 25 of the 194 member states present.  This makes us question not only the outcome of this process in particular, but also the overall decision-making procedures in global governance.

Will member states take on necessary leadership?

Though different concerns impact member states decision making within and between countries, we see few good arguments for not taking action. We do understand that the solutions suggested will demand time and resources from all countries, but underline that the solutions can potentially yield high gains in health. We need sustainable solutions in striving towards global health equity. This includes a major transformation of the health R&D system, with strengthened research coordination, improved financing mechanisms and monitoring of R&D priorities. The fragmented approaches that have been tried until now will not alone foster sustainable change.

The last years illustrate many success stories in global health. The reduction in child mortality is one of the examples of how action at national and global level together has enabled us to make health progress. In year 2000, we saw a possibility to act based on knowledge on effective interventions, and the international community responded. Though the challenges we face in drug development and delivery differ greatly, there are valuable lessons learned from the effect of global commitment and cooperation. Member states have been provided an opportunity to take responsibility and be true to their quest of improved population health. Take it.

Kristine Husøy Onarheim is co-founder of Universities Allied for Essential Medicines in Norway, and has been advocating for access to medicines since 2009. She is a final year medical student and global health researcher at the University of Bergen, and is currently a visiting graduate student at Harvard School of Public Health.

 Johanne Helene Iversen is co-founder of Universities Allied for Essential Medicines in Norway, and was previously in charge of international affairs and global health issues in the Norwegian Medical Students Association (2011-2012). She is a final year medical student at University of Bergen, and currently a visiting graduate student at Harvard School of Public Health.

Competing interests: Universities Allied for Essential Medicines is an international student organization advocating for improved access to essential medicines www.uaem.org

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