May 27, 2016 - According to a new report, by 2050, some 10 million lives could be lost a year due to antimicrobial resistance. This is an issue which has been central to this year’s World Health Assembly, and is of global consequence. Delegates gathered for the occasion noted a report by the World Health Organization secretariat on the global action plan on antimicrobial resistance adopted last year and options to develop a global stewardship framework to try to limit the use of antibiotics and develop new ones.
The 69th World Health Assembly is taking place from 23-28 May.
Last year, the World Health Assembly adopted a global action plan on antimicrobial resistance. The resolution adopting the action plan also requested WHO to develop, “in consultation with member states and relevant partners,” options for establishing a global development and stewardship framework, according to the WHO report [pdf] noted by WHA delegates today.
Options for this stewardship framework are further detailed in this document [pdf].
The stewardship framework is expected to support the development, control, distribution and appropriate use of new antimicrobial medicines, diagnostic tools and vaccines, while preserving existing antimicrobial medicines, and promoting affordable access to existing and new antimicrobial medicines and diagnostic tools, according to the WHO.
Several options are detailed in the document, as to which form the framework should take, such as a non-legally-binding recommendation, a resolution of the WHA, such as the Pandemic Influenza Preparedness Framework, or a convention, such as the WHO Framework Convention on Tobacco Control.
According to the document, the WHO intends “to revise WHO’s list of critically important antimicrobials for human medicine and is currently identifying which antibiotics should be included in the WHO Model List of Essential Medicines.”
The De-Linkage Connection
Parallels can be drawn between antibiotics and the area of neglected diseases and emerging pathogens with pandemic potential, all facing market failure, said the document.
“The Consultative Expert Working Group on Research and Development (CEWG) has provided a detailed assessment of the gap in research and development and assessed different strategies for bridging it,” it said.
In particular, de-linking the cost of investment in research and development from price and sales volume would remove pressure on pharmaceutical companies, but this principle of de-linkage would require a sustainable financing mechanism, which does not currently exists, the document said.
The document also underlined that antimicrobials are the most frequently reported category of falsified and substandard medicines and vaccines that are tracked in the WHO medical products database.
Since the launch of the global action plan, the WHO has launched a Global Antimicrobial Resistance Surveillance System. WHO is also collaborating with the UN Food and Agriculture Organization (FAO), and the World Organization for Animal Health (OIE), and the three organisations have developed a guidance manual on developing national action plans for antimicrobial resistance.
Also, in December 2015, the UN General Assembly decided to hold a high-level meeting on antimicrobial resistance in 2016. However, options and modalities for the conduct of the high-level meeting and potential deliverables are not yet finalised, according to the document.
Delegates Support UN High-Level Meeting on AMR
During the WHA yesterday afternoon and this morning, a large number of delegates took the floor on the subject, most of them detailing what local initiatives have been deployed to follow and implement the global action plan.
Most of the countries delivering statements on antimicrobial resistance insisted on the importance and urgency of the issue, and supported the UN High-Level Meeting on AMR set to be organised at the time of the annual General Assembly in New York in September.
Some developing countries, such as Egypt, and India, underlined the need for fair access to antimicrobial medicines and essential medicines in developing countries. Some also called for increased support by the WHO both in technical and financial assistance to implement the global action plan.
India asked that the principles of the CEWG be fully applied in the potential framework.
Zimbabwe for the African Region said the burden of disease in countries should be taken into account. In the context of the potential review of antibiotics in the WHO Essential Medicines List, the delegate asked that the WHO prepare a document for the next Executive Board in January detailing how the WHO intends to prioritise antibiotics and which repercussions it could have on public health systems.
Iran underlined the fact that counterfeit medicines are a leading cause of antimicrobial resistance, and cited the importance of WHO’s work on “substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC)” medical products.
Several developing and developed countries underlined the importance of the work undertaken by WHO in collaboration with FAO and OIE.
US Requests Deletion of Mention of Secretary-General’s High-Level Panel
The United States also supported the framework and offered some recommendations. In particular, they said it would be essential to bring the private sector to the table as their input, cooperation, and action are critical for a sustainable framework.
The document outlining options for the stewardship framework noted that developing options of the establishment of a possible global framework will require taking account of the outcomes of the United Nations Secretary-General’s High-Level Panel on Access to Medicines.
The US remarked that the High Level Panel report has not been released and that “the US government and other member states have publicly conveyed deep concerns about the panel’s establishment and mandate.” The US requested “deletion of all references of the High-Level Panel from the secretariat’s report or inclusion of any concepts from the High-Level Panel in the development of the framework until the assembly has had time to consider its relevant recommendations.”
It appeared afterward that the reference to the High-Level Panel on Access to Medicines remained in the text, at least for now.
New Report Underlines Urgency, Sets Recommendations
Separately, a new report [pdf] on antimicrobial resistance, issued in May, sets out the United Kingdom Review on Antimicrobial Resistance’s final recommendations to tackle AMR in a global way.
The Review on Antimicrobial Resistance was chaired by Jim O’Neill, international economist, and it was sponsored by the UK government and the Wellcome Trust. The report caused a fair amount of discussion at the WHA.
According to the report, by 2050, some 10 million lives could be lost a year due to antimicrobial resistance. Today, the report said, drug resistance kills some 700,000 people a year.
The O’Neill report gives a series of ten recommendations which would be expected to curb the problem. For instance, the report recommends to: Improve global surveillance of drug resistance and antimicrobial consumption in humans and animals; promote new, rapid diagnostics to cut unnecessary use of antibiotics; and promote the development and use of vaccines and alternatives.
The establishment of a Global Innovation Fund for early-stage and non-commercial research, and better incentives to promote investment for new drugs and improving existing ones are also part of the recommendations.
However, warns the Review, “none of this will succeed without building a global coalition for action on AMR.” This global coalition should be established via the G20 and the United Nations, according to the report.
The cost of taking global action on AMR is broadly estimated to be up to US$40 billion over a 10-year period, says the report, US$16 billion of which would be used to overhaul the antibiotics and tuberculosis research and development pipeline “using new market incentives such as market entry rewards.”
The costs have been modelled on reaching 15 new antibiotics per decade, “of which at least four would be breakthrough products targeting the bacterial species of greatest concern.”