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UN High-Level Panel on Access to Medicines
Submission by Kevin Outterson, Boston University
28 Feb 2016
1. Impact on remedying policy incoherence
A number of initiatives are underway to address the crisis of antibiotic
resistance. Some focus on innovation – creating new antibiotics to replace those
lost to resistance (Chatham House 2015, AMR Review 2015a). Others focus on
conservation - reducing the need for antibiotics through infection control,
vaccines, clean food and water, and antibiotic stewardship (US National Action
Plan 2015). Access to antibiotics is a third area that is important but frequently
overlooked. More than 455,000 children under 5 die from susceptible bacteria
that could be treated with existing drugs (Laxminarayan 2016).
The first policy incoherence is that all three of these goals – access, conservation,
& innovation – undermine the others and therefore must be pursued in a
coordinated fashion.
Hoffman SJ, Ou erson K. J Law Med & Ethics
2015;43(2 Supp):6-11
Second, antibiotic resistance spans both human and animal health. Many
emerging infectious diseases have zoonotic origins and low-value use of
UN High-Level Panel on Access to Medicines
Submission by Kevin Outterson, Boston University
28 Feb 2016
antibiotics in agriculture drives resistance, but antibiotics also play an important
role in animal health in the food supply. Any solution will require tradeoffs and
coordination between these two sectors (AMR Review 2015b).
2. Impact on public health
In high-income countries, significant declines in infectious disease mortality predated the introduction of antibiotics. Most of the declines in that period can be
attributed to public health interventions, including clean water, clean food,
infection control, and environmental control of waste. Nevertheless, the
introduction of antibiotics was a signal event in the battle against infectious
disease: antibiotics are perhaps the single most valuable drug class in human
history. Much of modern medicine depends on it (Teillant 2015).
In many low- and middle-income countries, investment in public health
infrastructure lags, resulting in a much higher burden of infectious disease. In
these settings, antibiotics perform an additional function: compensating for the
weaknesses in public health infrastructure (Laxminarayan 2015).
Therefore, preserving antibiotic effectiveness is a foundation for medical care,
population health, and as a key interim tool while public health infrastructure is
being improved around the world. Knowing that antibiotics are at risk should
prompt additional investments in public health.
3. Impact on human rights
The unwarranted death of 455,000 children under five is a major violation of
human rights.
4. Implementation
Conservation & Access: Solutions to the antibiotic access crisis do not require
waiting for a new drug to arrive; existing treatments are effective. Nor are
patents a major barrier; most of these drugs are off patent. In addition, the WHO
Global Action Plan serves as a model for conservation and access efforts. Most
of this foundational work is completed; we can focus on implementation
immediately, although much work remains in coordination between human and
agricultural uses.
UN High-Level Panel on Access to Medicines
Submission by Kevin Outterson, Boston University
28 Feb 2016
Innovation: Despite our best efforts on conservation, new drugs will eventually
be required, but they must be brought to the market with guaranteed global
access and with incentives in place to support conservation. Access,
conservation and innovation must be simultaneously addressed, across both
human medicine and agriculture.
Political and civil society mobilization on antibiotic resistance has never been
higher. Many stakeholder are currently involved – and more every day –
including efforts at IMI/DRIVE-AB, BARDA, PACCARB, AMR Review, Chatham
House, Center for Global Development, World Bank, European Investment Bank,
Medical Research Council, G7, G20, WHO, DNDi, CDC, ECDC, NIH, Longitude
Prize, ReACT, CDDEP, Wellcome Trust, Pew Charitable Trusts, the Bill & Melinda
Gates Foundation, and others. Some key points about this process:
First, antibiotics suffer from a particular form of neglect, which is quite different
from Chagas, human African trypanosomiasis, Ebola and other neglected
diseases. Most diseases treated by antibiotics are globally prevalent. Highincome markets, if properly functioning, should be sufficient to drive innovation.
If so, some of the goals of the High-Level Panel might be met by articulating and
supporting delinkage innovation reforms already in various stages of
development (KEI/MSF 2016, AMR Review 2015a, DRIVE-AB 2016, Chatham
House 2015, Love 2009, CEWG 2012), with the proviso that leadership is
required to ensure that the fruits of that innovation are fully available at generic
costs of production to low-income populations.
Second, for antibiotics in particular, coordination with diagnostics and vaccines
are key. Most antibiotics are taken in a cloud of diagnostic uncertainty, which
leads to significant waste and clinical failure. The best infection is the one that
did not occur due to vaccination. The MSF Fair Shot campaign and the Longitude
Prize should be amongst the most important near-term policy objectives for any
global effort against resistant bacteria.
Third, the High-Level Panel should call for a global antibacterial threat
assessment, building on the recent US CDC effort (CDC 2013) (and the ECDC
effort currently underway), but with the world in mind. This threat assessment
can be used to set research priorities, but more importantly it should guide
priority setting at other research institutions like NIH and Wellcome Trust.
Governments will increase funding for basic research on bacteria in the next few
UN High-Level Panel on Access to Medicines
Submission by Kevin Outterson, Boston University
28 Feb 2016
years. University labs are eager to get to work. A global threat assessment could
help focus more than a billion dollars in research efforts over the next decade.
Fourth, the High-Level Panel can help design a sustainable financing mechanism
for antibiotic-resistant bacteria. Three models include revisions to the flawed
priority review voucher system (Outterson & McDonnell 2016), contractual
funding for big science such as CERN and the International Space Station
(DRIVE-AB 2016), and an antibiotic user fee (Hollis & Ziana 2013, 2014;
Outterson & Hollis 2016). Resistance is a battle fought over decades; bacterial
evolution will not resign the field. Our efforts must be similarly relentless and
sustainable.
References:
AMR Review. Securing new drugs for future generations: the pipeline of
antibiotics. May 2015.
AMR Review. Antimicrobials in agriculture and the environment: reducing
unnecessary use and waste. Dec. 2015.
CDC. Antimicrobial resistance threats in the United States, 2013.
Chatham House (Clift C, Gopinathan U, Morel C, Outterson K, Rottingen JA, So AD,
eds.). Towards a new global business model for antibiotics: delinking revenues
from sales. May 2015.
Consultative Expert Working Group on Research and Development. Research
and development to meet health needs in developing countries: Strengthening
global financing and coordination. Geneva, Switzerland: World Health
Organization; 2012.
Driving Re-investment in Antibiotics and Advocating for Their Responsible Use
(DRIVE-AB). Research project funded by the Innovative Medicines Initiative.
Interim report will be discussed at a policy meeting in Amsterdam on June 1-3,
2016.
UN High-Level Panel on Access to Medicines
Submission by Kevin Outterson, Boston University
28 Feb 2016
Hoffman SJ, Outterson K. What will it take to address the global threat of
antibiotic resistance? J Law Med Ethics. 2015;43(Supp 2):6-11.
Hollis A, Ziana A. Preserving antibiotics, rationally.
2013;369(26):2474-2476.
New Engl J Med.
Hollis A, Ziana A. The path of least resistance: paying for antibiotics in nonhuman uses. Health Policy 2014;118:264-270.
Knowledge Ecology International, Médecins Sans Frontières/Doctors Without
Borders, et al. Joint submission to UN High-Level Panel on Access to Medicines
(pending, Feb. 2016).
Laxminarayan R. Economics of antibiotic resistance. Presentation at the Latsis
Symposium. July 2015, at slides 4-6 (adapted from Armstrong, Conn, et al. 1999).
Laxminarayan R, Matsoso P, Pant S, Brower C, Rottingen JA, Klugman K, Davies S.
Access to effective antimicrobials: a worldwide challenge. Lancet 2016; 387:
168–75.
Love J, Hubbard T. Prizes for innovation of new medicines and vaccines. Ann
Health Law. 2009;18(2):155–86, 8 p.
Outterson K, McDonnell A. Transferable regulatory exclusivities for antibiotic
innovation: design issues for antibiotic vouchers. Health Aff. 2016 (in press).
Outterson K, Hollis A. Antibiotic user fees as a global funding mechanism.
Informal discussion paper for WHO brainstorming session (1 Feb. 2016).
Teillant A, et al. Potential burden of antibiotic resistance on surgery and cancer
chemotherapy antibiotic prophylaxis in the USA: a literature review and
modeling study. Lancet Infect Dis. 2015;15(12):1429-1437.
US National Action Plan on Combatting Antibiotic-Resistant Bacteria. March
2015.