June 06, 2016

Rohit Malpani, director of policy and analysis at Doctors Without Borders/Médecins Sans Frontières’ (MSF) Access Campaign, delivered the following remarks at Meeting the Challenge of Antimicrobial Resistance, an event hosted by the United Nations’ Every Woman Every Child movement.

Thanks for providing Medecins Sans Frontieres the invitation to speak. MSF is an independent humanitarian organization providing impartial medical assistance in more than 70 countries to people affected by wars, natural disasters, disease outbreaks and economic exclusion.

Drug-resistant infections are a looming challenge for our work. We see them in the war-wounded people we treat in Jordan, in newborns in Niger, and in people in our burn unit in Iraq. Our medical staff is increasingly seeing people with infections that can only be treated with the last lines of antibiotics. There are many challenges to address in tackling antimicrobial resistance and MSF welcomes the AMR Review’s broad, global approach.

The report confirms what MSF has long voiced – that the current system of pharmaceutical research and development, based on monopolies and high prices, often does not develop and deliver the drugs, vaccines and diagnostics we need. And when new medical tools are developed, they are often unaffordable or not suitable for the people and contexts which need them the most.

MSF would like to make five observations.

First, although we welcome efforts to foster new investments and approaches to research and development for unmet needs, these measures will not have any impact unless governments and the World Health Organization assume the central role in identifying gaps, guiding priority-setting and ultimately managing new research and development funding within the already agreed WHO norms to ensure access. We wish the report could have issued a clear recommendation supporting such a mechanism for priority-setting. This matters to MSF, since only governments can ensure that the needs of neglected and vulnerable patients are not left behind. The report highlighted the need for new drugs and diagnostics to address tuberculosis, yet we cannot be confident that despite the significant morbidity and mortality associated with the disease, that it will be appropriately prioritized. This is due to the fact that TB is especially prevalent in low- and middle-income countries. If we introduce a system of priority-setting based on who can pay the most or exert the most influence, or simply leave it to companies to decide, we will reinforce the failures of the current system of research and development, not correct them.

Second, even as we acknowledge efforts in the report to highlight the importance of access, urgent action that goes beyond the report’s recommendations of voluntary action, and in particular government action, is required to expand access to existing drugs and vaccines. Today, more people are dying for lack of access to appropriate drugs and vaccines, not from drug resistance. The pneumococcal vaccine, or PCV, which is sold by only Pfizer and GlaxoSmithKline, is one example of an unaffordable vaccine. Even in the poorest countries, PCV accounts for approximately 45 percent of the total cost to vaccinate a child.

Why does PCV matter?

PCV protects against pneumococcal disease, which kills about one million children each year. It is estimated that universal coverage of PCV could result in a 47 percent reduction in antibiotic use in people with pneumococcal infection. Today, just under a third of people globally are protected with PCV. To maximize the potential of this vaccine, we need dramatic price reductions and competition.

Third, while MSF welcomes the efforts of the report to identify and propose alternative models of research and development, the report at times does not propose models that truly safeguard affordable access for new medical tools. In particular, the report does not always fully support de-linking, or separating, the cost of research and development from sales volumes and – most importantly – the end product price.  De-linkage is often limited to stewardship, particular diseases or only applied to low and middle income countries.

This means that even though new drugs may be conserved, they may not be affordable for all people. Companies could be paid at least twice – via market entry rewards of approximately one billion dollars, and a second time through an opportunity to sell new drugs at higher prices. The report proposes slightly different models to develop new diagnostics and vaccines, yet as with GAVI’s advanced market commitment, the proposed subsidies are neither efficient nor safeguard sustainable access.

One example where the report supports de-linkage in its entirety is a mention of a new model of TB drug development that MSF has championed, the 3Ps Project, also known as Push, Pull and Pool.  The 3Ps demonstrates how to implement de-linkage, including the licensing of intellectual property in exchange for financial rewards, to deliver effective, short-course, less toxic and affordable combination treatments for all forms of TB.

Fourth, we stress the importance of policy coherence. We note that alongside the UN Special Session on Antimicrobial Resistance, the WHO continues to advance government-led efforts on R&D through the Consultative Expert Working Group, and the UN General Assembly may consider a new report being written by a UN High Level Panel on Access to Medicines, which was commissioned by the UN Secretary General. The High Level Panel seeks to recommend solutions to the broader research and development crises of unaffordable prices and a lack of innovation to address priority health needs worldwide. The three-decade long gap in development of new, effective antibiotics is just one example of how the current system falls short of addressing global public health needs. We hope Missions in New York connects the dots between these three processes.

Finally, we are concerned that global health security drives our fight against antimicrobial resistance.  While such a framing may be an effective means to call governments to action, it can lead governments to focus on solutions that seek only to protect their own people, rather than ensuring affordable, effective and appropriate medical interventions for people in all countries who lack access to effective care today.

We welcome the report for building attention to this urgent problem, and we hope that government action, at the UN Special Session in September and beyond, will ensure political commitment to make urgent changes to introduce a global R&D framework that puts patients’ needs first.

Thank you.

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