Against ‘Grave Challenge To Achievements Of 20th Century’, UN Agrees Political Declaration On Antibiotic Resistance

NEW YORK — The membership of the United Nations today agreed a political declaration on antimicrobial resistance, elevating the global fight against overuse and misuse of antibiotics – and lack of new antibiotics – to the highest political level. The declaration struck by world leaders at the UN General Assembly in New York includes mention of separating medicine prices from the cost of research and development, and calls on the UN secretary-general to create an interagency coordination group. Now – as framed by many governments, intergovernmental organisations and nongovernmental representatives – attention moves to implementation of actions aimed at staving off this threat to humanity itself.

The declaration on antimicrobial resistance (AMR) is available here [pdf].

The AMR issue cuts across public health, agriculture, animal health, trade and even security policy, and key element of the way forward involves efforts to coordinate between various sectors. This was the fourth time a health issue has been taken up by the UN General Assembly (following HIV, noncommunicable diseases, and Ebola). The UN High Level Meeting on Antimicrobial Resistance took place on 21 September.

“Antimicrobial resistance poses a fundamental threat to human health, development, and security,” World Health Organization Director General Margaret Chan said (see press release [pdf] from the event). “The commitments made today must now be translated into swift, effective, lifesaving actions across the human, animal and environmental health sectors. We are running out of time.”

“Common and life-threatening infections like pneumonia, gonorrhoea, and post-operative infections, as well as HIV, tuberculosis and malaria are increasingly becoming untreatable because of AMR,” the release stated. “Left unchecked, AMR is predicted to have significant social, health security, and economic repercussions that will seriously undermine the development of countries.”

Among the many actions in the political declaration is reinforcement of the principle of “delinkage” of research and development costs from the price of resulting medicines.

It also called on the World Health Organization, the UN Food and Agriculture Organization and the World Organization for Animal Health to “finalize a global development and stewardship framework,” as requested by the World Health Assembly.

Other actions target greater awareness, enhanced capacity-building, improved monitoring and surveillance, strengthening health systems, and especially greater funding from a range of sources.

The declaration gives guidance at the international level, and the focus moves now to implementation at the national level around the world as nations committed to carry out action plans.

The declaration also reinforces progress made on the issue at the WHO in recent years, including the global action plan on antimicrobial resistance.

As described by the release, leaders called on WHO, FAO and OIE, in collaboration with development banks such the World Bank other relevant stakeholders, to coordinate their planning and actions and to report back to the UN General Assembly in September 2018. The declaration calls on the secretary general to establish an ad hoc interagency coordination group, “co-chaired by the Executive Office of the Secretary-General and the World Health Organization, drawing, where necessary, on expertise from relevant stakeholders, to provide practical guidance for approaches needed to ensure sustained effective global action to address antimicrobial resistance.”

Several states praised Mexico for its role in helping to bring about the agreement. Developing countries insisted on retaining the elements related to delinkage, according to an observer.

R&D and Delinkage

On R&D and delinkage, the declaration under item 10 includes calls to:

“(b) Underline that basic and applied innovative research and development, including in areas such as microbiology, epidemiology, traditional and herbal medicine and social and behavioural sciences, as appropriate, are needed in order to better understand antimicrobial resistance and to support research and development on quality, safe, efficacious and affordable antimicrobial medicines, especially new antibiotics and alternative therapies, vaccines and diagnostics;

(c ) Underline also that all research and development efforts should be needs-driven, evidence-based and guided by principles of affordability, effectiveness and efficiency and equity, and should be considered as a shared responsibility: in this regard, we acknowledge the importance of delinking the cost of investment in research and development on antimicrobial resistance from the price and volume of sales so as to facilitate equitable and affordable access to new medicines, diagnostic tools, vaccines and other results to be gained through research and development, and welcome innovation and research and development models that deliver effective solutions to the challenges presented by antimicrobial resistance, including those promoting investment in research and development; all relevant stakeholders, including Governments, industry, non-governmental organizations and academics, should continue to explore ways to support innovation models that address the unique set of challenges presented by antimicrobial resistance, including the importance of the appropriate and rational use of antimicrobial medicines, while promoting access to affordable medicines;

(d) Underline that affordability and access to existing and new antimicrobial medicines, vaccines and diagnostics should be a global priority and should take into account the needs of all countries, in line with the World Health Organization global strategy and plan of action on public health, innovation and intellectual property [WHA62/2009/REC/1, resolution 62.16], and taking into consideration its internationally agreed follow-up processes;”

The declaration also involves industry in its vision. Item 12 (e ) states:

“Support a multisectoral One Health approach to address antimicrobial resistance, including through public health-driven capacity-building activities and innovative public-private partnerships and incentives and funding initiatives, together with relevant stakeholders in civil society, industry, small- and medium-sized enterprises, research institutes and academia, to promote access to quality, safe efficacious and affordable new medicines and vaccines, especially antibiotics, as well as alternative therapies and medicines to treatment with antimicrobials, and other combined therapies, vaccines and diagnostic tests;”

Some Government Views

In statements today, governments repeatedly emphasised their commitment and detailed progress and challenges at the country level.

Germany said that fighting AMR will be a priority when Germany takes over chair of G20 in December.

On R&D for new medicines, India mentioned the newly released report of the UN Secretary General’s High Level Panel on Access to Medicines. “As highlighted by the report, the existing imbalance between IPR and public health is leaving people behind,” India said. “Therefore, we must prioritise incentivizing investment in R&D for health technology innovation.”

Zimbabwe also mentioned the report of the High-Level Panel, as well as citing the importance of flexibilities to patents under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Numerous governments mentioned the landmark “O’Neill” report from the UK that sparked action with its alarming statistics and clear delineation of the problem of AMR.

Australia mentioned a multi-million dollar fund. Another speaker mentioned a new index for companies on AMR.

Reactions

Two panels of experts were held during the daylong meeting, and highlights of the panels will be captured in an Intellectual Property Watch story to follow.

In one immediate reaction, Médecins Sans Frontières issued a response to the declaration, calling it “an important political step.”

“In addition to recognising that all countries must do much more to better use existing antibiotics by strengthening health systems, human resources for health and laboratory capacity, this declaration also highlights the need to improve access to existing medical tools, including by reducing the price of existing vaccines to prevent infections, as well as the need for research and development of new products that are patient-focused, affordable and appropriately available to all who need them,” MSF said.

The Drugs for Neglected Disease initiative (DNDi) issued a release welcoming the declaration.

“Today’s UN declaration another encouraging sign that governments have elevated the debate on biomedical innovation and access to medicines, diagnostics and vaccines to the highest political levels,” it said.