Info Service on Health Issues (May15/11)
Global antibiotics plan adopted with “kick start” on implementation
(An earlier version of this article was published in SUNS #8028 Wednesday 27 May 2015.)
Geneva, 28 May (K.M. Gopakumar and Mirza Alas) – The World Health Assembly adopted the Global Action Plan on Antimicrobial Resistance (GAP) on 25 May through a resolution which also kick starts a work programme on the implementation of GAP.
The GAP was adopted through a resolution, after a series of informal consultations among Member States especially between the United Kingdom and India. Even though many developing countries pointed out the gaps in GAP, especially in relation to access to existing and new anti-microbial agents and diagnostic kits as well as financial and technological resources to develop and implement national action plans in line with GAP. During the discussions on antimicrobial resistance (AMR) on 21-22 May there was consensus for the adoption of GAP (http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_20-en.pdf).
The draft resolution for the adoption of GAP also contained concrete work programmes for the establishment of the surveillance and monitoring mechanisms. However, there was no concrete work programme to address the key concerns of developing countries related to access to existing and new antimicrobial agents and financial resources for the implementation of GAP.
The developing countries demanded to reflect their concerns in the resolution leading to informal consultations on the afternoon of 22 May and the morning of 23 May, resulting in a consensus.
The important changes brought in the resolution (A68/A/CONF./1Rev.1.) are as follows:
In Operational Paragraph (OP) 2(2) the scope of resource mobilisation now explicitly mentions domestic, bilateral and multilateral channels. OP2(2) requests Member States: “to mobilize human and financial resources through domestic, bilateral and multilateral channels in order to implement plans and strategies in line with the global action plan”. The original version stated: “to mobilise human and financial resources in order to implement plans and strategies to strengthen the containment of antimicrobial resistance”.
In OP2(3) the following words were added: “and with standards and guidelines established by relevant intergovernmental bodies”. It reads: “to have in place, by the Seventieth World Health Assembly (2017), national action plans on antimicrobial resistance that are aligned with the global action plan on antimicrobial resistance and with standards and guidelines established by relevant intergovernmental bodies; …”
In OP4 a new additional paragraph was added: “1bis. to ensure that all relevant parts of the Organization, at headquarters, regional and country levels, are actively engaged and coordinated in promoting work on containing antimicrobial resistance, including through the tracking of resource flows for research and development on antimicrobial resistance in the new global health research and development observatory; …”
According to observers this is a clear direction from the Member States to the Secretariat to act in coordination with different divisions of the WHO. Currently, GAP is anchored at the health security division of WHO, which looks at the issue of AMR from a narrow perspective. However, the effective response to AMR needs coordinated actions from other divisions of the WHO such as health systems, medicines, research and development, which currently are under the Health Systems and Innovation cluster.
OP4(4) reads: “to work with the Strategic and Technical Advisory Group on antimicrobial resistance, Member States, FAO (Food and Agriculture Organization) and OIE (World Organization for Animal Health), and relevant partners to develop a framework for monitoring and evaluation in line with principle five of the global action plan”.
[Principle Five of GAP reads: “Incremental targets for implementation: Member States are at very different stages in terms of developing and implementing national plans to combat antimicrobial resistance. To enable all countries to make the most progress towards implementing the global action plan on antimicrobial resistance, flexibility will be built into the monitoring and reporting arrangements in order to allow each country to determine the priority actions that it needs to take in order to attain each of the five strategic objectives and to implement the actions in a stepwise manner that meets both local needs and global priorities”.]
This new OP4(4) replaced the original version OP4(3) which read: “Strategic and Technical Advisory Group on antimicrobial resistance, Members States, FAO and OIE, and other relevant partners to develop a framework for monitoring and evaluation, including the identification of measurable indicators of implementation and effectiveness …”
OP4(5) reads: “to develop and implement, in consultation with Member States and relevant partners, an integrated global programme for surveillance of antimicrobial resistance across all sectors in line with the global action plan”.
The original version of OP4(4) read: “to develop and implement, in consultation with Member States and relevant stakeholders, a global programme for surveillance of antimicrobial resistance in human health, including surveillance and reporting standards, and tools, case definitions, external quality assessment schemes, and to establish a network of WHO Collaborating Centres to support surveillance antimicrobial resistance and external quality assessment in each WHO region”.
The part of the original version dealing with WHO collaborating centres is included as a separate OP6 which reads: “to establish a network of WHO Collaborating Centres to support surveillance of antimicrobial resistance and quality assessment in each WHO region”. Similarly in OP4(5) the term “stake holders” has been replaced with “partners”.
The most important change in OP4(5) and OP4(6) clearly rules out external quality assessment. Third World Network learned from the negotiators that many developing countries were not ready to accept the external quality assessment primarily due to its intrusive nature.
OP4(7) reads: “to develop, in consultation with Member States and relevant partners, options for establishing a global development and stewardship framework to support the development, control, distribution and appropriate use of new antimicrobial medicines, diagnostic tools, vaccines and other interventions, while preserving existing antimicrobial medicines, and promoting affordable access to existing and new antimicrobial medicines and diagnostic tools, taking into account the needs of all countries, and in line with the global action plan on antimicrobial resistance, and to report to the sixty-ninth World Health Assembly; …”
The original version numbered as OP 4(5) read: “to explore with Member States and relevant stake holders, options for elaborating a global development and stewardship framework that aims to support the development, control, distribution and appropriate use of new antimicrobial medicine, diagnostic tools, vaccines, and other interventions, while preserving existing antimicrobial medicines, taking into account the needs of all countries and in line with global action plan on antimicrobial resistance.”
The important change is that instead of a vague word “explore” the resolution now clearly directs the WHO Secretariat to develop a global development and stewardship framework. Further, the framework clearly includes the promotion of affordable access to new and existing antimicrobial medicines and diagnostic tools. Further, it also requests the Director-General to submit a report to the 69th WHA in May 2016.
Further, an additional paragraph has been introduced as OP4(8) and it reads: “to work with the United Nations Secretary-General and bodies in the United Nations system to identify the best mechanism(s) to realize the investment needed to implement the global action plan on antimicrobial resistance, particularly with regard to the needs of developing countries”.
This clearly refers to the actions mentioned in Objective 5 of the GAP, which was missing in the original version of the resolution. However, this paragraph does not mention any explicit reporting requirement to WHO governing bodies i.e. the Executive Board and WHA.
In addition, the resolution requests the Director-General in OP4(9) “to elaborate, in consultation with the United Nations Secretary-General, options for the conduct of a high-level meeting in 2016, in the margins of the United Nations General Assembly, including potential deliverables, and to report to the sixty-ninth World Health Assembly through the 138th Executive Board; …”
Similarly, OP4(10) requests the Director-General to provide support and technical assistance to countries, with a specific focus on low and middle income countries . The original version used “developing countries” instead of low and middle income countries.
The changes in the preamble are as follows.
An additional preamble paragraph 3bis was introduced to reflect the developmental concerns around AMR. It reads: “Aware that the health and economic consequences of antimicrobial resistance constitute a heavy and growing burden on high-, middle- and low-income countries, requiring urgent action at national, regional and global levels, particularly in view of the limited development of new antimicrobial agents”.
Preambular paragraph 6 was amended to include universal access and diagnostic tools. It reads: “Noting that despite sustained efforts over a number of decades by Member States, the Secretariat and partners, most developing countries are still facing a multitude of challenges in improving affordability and universal access to quality, safe and effective antimicrobial medicines and diagnostic tools”.
In preamble paragraph 7 the term “financial” has been added to include financial assistance along with technical assistance. It reads: “Recognizing that, although substantial investments have already been made to tackle antimicrobial resistance, significantly more resources need to be mobilized to support effective action at national, regional and global levels, including through the provision of technical and financial assistance, particularly to low- and middle-income countries”.
The Director-General Dr. Margaret Chan lauded the GAP adoption as a great achievement, a historical step and a landmark event. She reminded the Member States that this was the first step and assured them that WHO would work closely with the FAO, OIE, the academic sector and civil society organizations for the implementation of the plan.
The United Kingdom and Sweden were the countries tasked to steer the informal consultation process into a consensus on the text.
Sweden opened the agenda item noting that they had reached a consensus and the current text was strong and balanced for all countries and all regions. Sweden thanked all the 16 co-sponsor countries and presented the resolution for adoption.
Ghana on behalf of the WHO African Region (AFRO) endorsed the GAP and the amended resolution and commended the leadership of Sweden and the UK. Ghana also emphasized on the need to ensure the development of mechanisms to support countries to develop regulations.
Sri Lanka emphasized the importance of availability of existing and new antibiotics and diagnostic tools in order to ensure appropriate use.
India supported the draft resolution with the amendments that now reflect clear priorities. It noted that it was necessary to have a comprehensive and holistic strategy that reflected the developmental challenges and which would be incomplete without adequate resources for low- and middle- income countries. It also emphasized the need to ensure access to existing and new antibiotics.
South Africa supported the adoption and urged Member States to start the work on implementation.
The Republic of Korea, the Philippines, Mexico and the Democratic Republic of Congo also spoke in favor of the adoption of the resolution and the GAP.
The United Kingdom expressed its delight on the adoption of the plan and said that it was an important first step. The UK pledged 3 million pounds in funds and in kind for the WHO to implement the plan by assisting developing countries in preparing national action plans. This would help the WHO to move from words into action, according to the UK. Reference was also made to the earlier creation of the Fleming fund of 195 million pounds for surveillance networks and strengthening of laboratory capacity in countries were there is limited capacity.
Meanwhile, a press release issued by the Welcome Trust states: “The Wellcome Trust will collaborate with the UK Government, the Bill and Melinda Gates Foundation, the Institut Pasteur International Network and other partners over the next five years to build laboratory capacity, surveillance networks and response capacity in low- and middle-income countries” (http://www.wellcome.ac.uk/News/Media-office/Press-releases/2015/WTP058933.htm). It is thus not yet clear if the Fleming fund would be a public private partnership.+