[Ip-health] Countries reaffirm need for high-level commitment on antimicrobial resistance

K.M. Gopakumar kumargopakm at gmail.com
Mon May 30 05:37:21 PDT 2016


*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

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

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 an 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 ฃ195 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

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.

On the framework of stewardship, he said that discussions will likely start
in the coming months and probably after the UN High Level Meeting in New
York. Fukuda stressed that this meeting will be an opportunity to get
political commitment to reaffirm the importance of the GAP adopted by the
WHA last year and ensure that issues of access remain at the forefront of
any political declaration.

Negotiations will begin in New York this June on an outcome document and it
will be important that missions in Geneva are able to communicate with
their counter parts (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, he said further.

Below a summary of selected interventions by Member States and their

*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

*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 ฃ195 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 36 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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