[Ip-health] CORRECTED VERSION Re: TWN Info: Countries reaffirm need for high-level commitment on antimicrobial resistance

Chee Yoke Ling yokeling at twnetwork.org
Mon May 30 06:06:11 PDT 2016

CORRECTED VERSION TWN Info Service on Health, IP and UN Sust. Dev.
30 May 2016*
Third World Network
www.twn.my* <http://www.twn.my>

Countries reaffirm need for high-level commitment on antimicrobial resistance

Geneva, 30 May (Mirza Alas) – Actions and challenges to implement the Global Action Plan on Antimicrobial Resistance gained attention at the 69th session of the World Health Assembly (WHA) that took place on 23-28 May.

Representatives from over 190 countries came to the World Health Organization’s headquarters in Geneva once again to participate in the annual meeting of the highest governing body of the World Health Organization (WHO). Over 3500 persons, including observers, participated at the week-long meeting.

There were long days with evening sessions to advance on more than 60 agenda topics.  This 69th WHA represents a year since countries adopted the Global Action Plan (GAP) on Antimicrobial Resistance (AMR) and was thus an opportunity to assess progress, challenges and the way forward.

Under agenda item 14.4 on AMR (documents A69/24 and A69/24 Add 1) WHO Member States were provided with a short report on the progress of implementation of the GAP by regions, and the plans for a High Level Meeting at the side of the United Nations General Assembly in New York this coming September. There was also a document titled: “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” for discussion 

Countries noted the report of the implementation of the GAP and many of the Member States provided information on their respective national action plans (NAPs) implementation. Many countries acknowledged that much work still needs to be done and pointed out the importance of creating awareness of resistance at the national level as well as the urgent need for high-level political commitment on the issue that many hope can be addressed at the High Level Meeting in New York.

Countries also emphasized the need for inter-sectoral collaboration and the inclusion of not only ministries of health but also agriculture, environment and finance as well as the need for strong leadership from WHO and the importance of collaboration with the Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE).

Developing countries stressed the need for financial and technical assistance as well as for capacity building.  Access to vaccines and medicines were highlighted as key elements to ensure the successful implementation of the GAP.    

Under the proposed options for a stewardship framework developing countries asserted the need to ensure that issues of access are balanced with appropriate use and scientific knowledge of the pursuit of the “One Health approach.”

Brazil in particular emphasized that the One Health approach could not be taken as a one-size fits all approach and that access and affordability must be at the forefront. Brazil also reaffirmed the importance of flexibilities of the Trade-related Aspects of Intellectual Property Rights Agreement (TRIPS) as a tool for countries to ensure access.

India called for policy coherence and that the principles of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) are fully applied (affordability, effectiveness, efficiency, equity and de-linkage).

With regard to the High Level Meeting on AMR, India requested the WHO Director-General to recommend that AMR be addressed as a global development issue, that awareness must be created and to ensure that any stewardship framework integrates sustainable and equitable access (to antibiotics and other related medicines and diagnostics).

Iran requested that a consultative meeting be conducted by WHO to clarify expectations around the UN High Level Meeting. 

 Zimbabwe on behalf of the African region asked the secretariat to prepare a document on how prioritization of antibiotics could work and the repercussions that this could present.  

Developed countries reaffirmed AMR as a global health security issue and their commitment to the High Level Meeting.

The United Kingdom noted that the Fleming fund, with £195 million, has been established to build capacity for low and middle-income countries, and called for engagement with other UN bodies such as FAO but also the World Trade Organization.

The United States stressed that AMR threatens health and economic potential at all levels and supported the global development and stewardship framework, noting that the framework should explore innovative arrangements and bring the private sector to the table.  It also expressed concerns over the UN High Level Panel on Access to Medicines convened by the UN General-Secretary and asked to delete any reference to it in the text of the possible framework. 

[A letter from 6 major industry associations to Senator Orrin Hatch, chair of the US Senate Committee on Finance, dated 18 February 2016 expressed strong criticism over the UN High Level Panel on Access to Medicines. The Panel formed in November 2015 is tasked to analyse and make recommendations to “remedy the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies”. 

[The signatories were the Biotechnology Innovation Organization (BIO), National Association of Manufacturers (NAM), National Foreign Trade Council (NFTC), the Pharmaceutical Research and Manufacturers of America (PhRMA), the US Chamber of Commerce (the Chamber), and the United States Council for International Business (USCIB) 

[The letter claimed that, “the UNHLP process will not provide for an informed, balanced, and inclusive dialogue that adequately incorporates the perspectives of innovators.”  The US lobbies also criticised work done by the WHO on its Framework for Engagement with Non-State Actors (FENSA) as well as in the UN's global Technology Facilitation Mechanism.

[According to a 6 April 2016 report in South-North Development Monitor-SUNS, “the American business lobbies are on a warpath because the panel includes a range of people with different backgrounds and experiences and it might adopt a genuine inquiry into the policy incoherence that is responsible for denying humanitarian remedies … Casting aspersions on the selection process of the panel, the business lobbies raised vicious charges that the panel will not be able to assess ‘the complex issues impacting the development and deployment of health-related technologies.’ For the full article, see US business launches campaign against UNHLP.]

Italy emphasized that the pharmaceutical sector and regulatory agencies should be included in the debate and that the G7 and G20 initiatives on AMR can strengthen WHO’s initiatives.

Sweden remarked that the UN High Level Meeting will be a unique opportunity for political level support and that all sectors need to be involved and be part of the 2030 Agenda on Sustainable Development (and its Sustainable Development Goals).

After Member State interventions, Mr. Keiji Fukuda, WHO Assistant Director-General and Special Representative for Antimicrobial Resistance, emphasized that the challenge is clear and that AMR will have a direct impact on agriculture and food production, noting the concerns on development, access and the relationship with Sustainable Development Goals.

Fukuda said that the challenge is to keep the impact on health central in this response. It is clear we also have to engage with other stakeholders, ministries of health, trade, industry and pharma and create a multisectoral response.

On the One Health approach, he said that this is done for good reason as the connections between the sectors are close. WHO works closely with FAO and OIE and Member States have repeatedly mentioned working with those two organizations. Fukuda recognized that there is a need to be coordinating with other initiatives such as Codex Alimentarius.

On how to move forward he stressed three essential elements:

·      GAP is the technical blueprint, and covers many of the issues talked about at the WHA discussion, including preservation, access, prevention, etc. We have the key action and countries to develop and implement NAPs.

·      Moving ahead with the options for the global development and stewardship framework – many inputs for countries are needed now. At this point several countries believe a process is needed to take this forward and to take it to the WHO Executive Board and report back.

·      Need for high-level political engagement – the New York meeting is critical for high level engagement needed so we can move ahead and the meeting should be the start 

On the UN High Level Panel on Access to Medicines, Fukuda acknowledged the point made by the US that the outcome of the panel was not yet known.

Fukuda told Third World Network (TWN) separately that the New York  meeting will be an opportunity to get political commitment to reaffirm the importance of the GAP adopted by the WHA last year.

(TWN also learnt from a source that, discussions on the framework of stewardship will likely start in the coming months and probably after the UN High Level Meeting in New York.)

Meanwhile negotiations will begin in New York this June on an outcome document and it will be important that missions in Geneva are able to coordinate with their counterparts in New York for an outcome that provides strength and traction for the full implementation of the GAP and to ensure that developing countries can get the financial and technical resources they will need to truly tackle this global problem. As can be seen from the WHA discussion, most developing countries are keen that access remains at the forefront of any political declaration.

Below a summary of selected interventions by Member States and their groupings:

Thailand on behalf of the South East Asian Region (SEARO) expressed its support to the High Level Meeting at the at UN and said that a global political commitment will lead to sustainable multi-sectorial commitment but resources are needed to tackle the challenge.

Antibiotic prioritization and the capacity of different countries have to be taken into account. There is a real need for an effective global mechanism and tools to make sure that every Member State can walk the talk of addressing AMR. The role of pharma in the stewardship framework, especially in rational use, needs to be revisited, Thailand said, adding that promotional activities by pharma influence prescriber behavior.

Zimbabwe on behalf of African Region (AFRO) said the threat of AMR should be viewed as a development issue. WHO should support implementation especially to the development of national actions plans, including training of health workers, surveillance, building regulatory capacities that are currently weak, and also capacity in laboratories that is now inadequate. The agricultural sector remains an important sector, stressed AFRO. It supported convening the High Level Meeting in New York to increase awareness and political commitment.

Zimbabwe also said that further discussions are needed on the three elements of the Global Stewardship Framework. The principle of access to new and existing antibiotics and diagnostics needs to be reflected, and burden of disease should be taken on board so as not to exacerbate the problem of shortage of medicines 

It requested the Secretariat to prepare a document on how prioritization of antibiotics could work and the repercussions.

Iraq said that WHO has a role in supporting countries, capacity building and joint monitoring and should be involved in formulating action plans.

Kenya aligned with the statement of AFRO and acknowledged the burden that AMR imposes. It also reiterated the need for political, financial and technical support from WHO and other partners. The fight against AMR calls for an inter-sectoral approach, thus Kenya is addressing it together with its ministries of agriculture and health. In addition, a technical working group in Kenya is drafting a national action plan.

Kenya took note of the stewardship framework, stressing that it is important to ensure the involvement of Member States and relevant stakeholder in such a framework.  It also called for development and implementation of surveillance systems and fostering of collaboration and information sharing.

South Africa aligned with AFRO and noted that the global development and stewardship framework was recommended with the aim of stewardship and access to antibiotics and therefore it is important to balance the issues of access, appropriate use, scientific knowledge and the elements of the One Health approach, agriculture and environment 

It called for focus on unnecessary use, and the need to review the WHO essential medicines list. It cited restricted use of second line antimicrobials and limited use in cases where failure of the first line of antibiotics has been confirmed.  

Brazil said AMR deserves serious consideration. In Brazil mandatory prescriptions of antibiotics have been put in place but this is not the case in all countries. It said that action is needed to not duplicate the gaps in AMR, adding that the One Health approach is not a one-size fits all approach and there is need to work within the framework and mandate. Brazil also stressed the need for access and affordability where antibiotics are required, together with innovation, saying further that TRIPs flexibilities should be affirmed as a tool to allow early access to antibiotics in the market.

Egypt reaffirmed its commitment and inquired about the fair access to antibiotics and essential medicines for developing countries in the light of resistance. It also stressed the need for the WHO Essential Medicines List to be regularly updated. There is need to support capacity building in microbiology laboratories and WHO to support developing countries for technology capacity and financial support.

India noted the report of the Secretariat on the options for establishing a global development and stewardship framework on AMR. Promoting affordable access has been discussed in paragraphs 28-31. While appreciating the options delineated to promote affordable access, India said concrete action is expected through the AMR framework in consonance with the mandate given by WHA resolution 68.7. In this context it is important that the principles of the CEWG are fully applied and that policy coherence is reflected in WHO’s action. 

India looks forward to the high-level meeting on AMR in New York in September 2016. This meeting will certainly heighten attention of all countries for prevention and containment of AMR, it said, adding that the success of the GAP hinges on its effective implementation by all countries. However, for many countries AMR is also a formidable development challenge, said India, and it requested the Director-General to make the following recommendations to the High Level Meeting:

·      Recognize and address AMR as a global development issue;

·      Focus on awareness on AMR including through the launch of an AMR logo;

·      Integrate sustainable and equitable access in the global development and stewardship framework.

Iran remarked on the importance to ensure that patients have access to high quality antibiotics. It requested the secretariat to hold a consultative meeting to clarify expectations around the UN High Level Meeting.  It also highlighted the need to consider incentives such as research grants and data sharing between countries. Iran said that a key strategy is international monitoring of antibiotics to ensure access to quality antibiotics, adding also international awards for doctors who properly prescribe antibiotics.

The Netherlands speaking on behalf of the European Union (EU) said that the GAP references well the One Health approach. It noted more concrete progress towards a global framework (including making a list of priorities in antibiotics) and remarkably good collaboration with FAO and OIE, adding that there is need for active preparation and coordination of Member States.

The United Kingdom supported the Netherlands’ statement on behalf of the EU, and indicated that it was happy with the report, and that more should be done and more can be done at the UN General assembly High Level Meeting. Development of NAPs was welcomed and it said countries should start to develop them and publish them by September if possible. The UK called for building on commitments including in the G20.

It further said that it has plans to address current market failures and mentioned the commitment of £195 million in the Fleming fund to build laboratory capacity for low and middle-income countries. The global development and stewardship framework will support the work of other governing bodies; however there is a need to define its scope.  The UK also stressed engagement with other UN bodies such as FAO, WTO as the framework moves forward.

Germany welcomed the support provided by WHO for countries to develop NAPs. It will contribute euros 1.3 million for implementation of the GAP, but each Member State has to contribute by developing their own NAP. Germany strongly supported the leadership of the WHO and encouraged discussions to be taken up to a higher political level at the UN High Level Meeting in New York. It is supporting the initiative of WHO-DNDi with euros 500,000 this year, and encouraged other countries to also contribute.

The United States said the tripartite collaboration (of WHO, FAO and OIE) is critical for the One Health approach and that AMR threatens health and economic potential at all levels. It supported the global development and stewardship framework; highlighted innovative arrangements and bringing the private sector to the table as their actions are critical. Human, animal, environment, food and industry sectors should be involved, said the US.

It also said that like the WHO Essential Medicines List, the OIE could have a list of antibiotics for animal use for the framework. Proper manufacturing and proper use in human and animals was noted by the US.

It asked for deletion of any reference to the UN High Level Panel on Access to Medicines due to its concerns with this panel.

Sweden noted that the WHA discussion was a good start and that the UN High Level Meeting (in New York) will be a unique opportunity for political level. All sectors need to be involved and be part of the 2030 Agenda for Sustainable Development. It requested the Director-General to continue engaging with the UN for a strong outcome of the High Level Meeting and to report to the 140th session of the WHO Executive Board on the progress made and proposals of how to take the process forward. Sweden has itself adopted a strategy to combat AMR.

Italy said the One Health approach is the pillar of Italy’s national health service. Veterinary and food chains sectors are fairly advanced. There are critical problems over prescription by doctors, self-prescription by patients and trade in fake medicines. The pharmaceutical sector and regulatory agencies should be included in the debate, it said, adding that G7 and G20 initiatives on AMR can strengthen WHO’s initiatives.

Japan said AMR is a threat to global health security and that WHO should continue to engage with the UN Secretary-General regarding the High Level Meeting. WHO should also continue working on the Global Development and Stewardship Framework, and the modalities of the framework should be based on each country’s context. 

Medicus Mundi International – International Organisation for Cooperation in Health Care (MMI) made a statement on its own behalf and that of 20 other civil society organisations (CSO) including many members of the Antibiotic Resistance Coalition.

MMI said that the extensive misuse of antimicrobials in humans and animals have raised levels of resistance posing a global health threat that jeopardizes treatment of infections across the world. Public leadership is needed to enact new needs-driven research and development models, with open research and transparent data which support rational use and equitable access to antibiotics.
It stressed the importance to ensure coherence across parallel processes addressing innovation and access the CEWG on R&D, the R&D Blueprint for Emergencies and the UN High Level Panel on Access to Medicines.
The CSO statement urged WHO to apply the CEWG principles of affordability, effectiveness, efficiency, equity and de-linkage to any initiative based on publicly-funded R&D. It pointed out that the pharmaceutical companies distort de-linkage to mean an assured return for industry irrespective of the value of the innovation in promoting public health goals.
Proposals should also address innovation of vaccines and diagnostics, said MMI, adding that securing access for everyone in need is as vital as conserving therapies. Price should not be used as an instrument to ration use for humans, it said.
The CSO statement also stressed that strengthening of public health and agricultural systems across all countries is a key requirement. Resource-limited settings need support to strengthen infection prevention and control. Sustained investments to address AMR across sectors must become a collective commitment.
With resistance now evident to last line antimicrobials it is urgent that Member States and WHO act decisively, said MMI. “We urge WHO to take a leadership role both here as well as in New York as preparations for upcoming UN High-Level Meeting on AMR continue. We ask that WHO, Member States, and other intergovernmental agencies ensure that AMR becomes a remarkable example of intersectoral coordination that puts the public interest at the center of its discussion.” 
(With inputs from, and edited, by Chee Yoke Ling)


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