[Ip-health] TWN News: WHO - Critical issues still unresolved in antimicrobial resistance draft action plan

K.M. Gopakumar kumargopakm at gmail.com
Wed Jan 28 03:03:10 PST 2015


*Title :* TWN Health Info: WHO - Critical issues still unresolved in
antimicrobial resistance draft action plan
*Date :* 28 January 2015

*Contents:*

TWN Info Service on Health Issues (Jan15/04)
28 January 2015
Third World Network
www.twn.my

_______________________________________________________________________________________

*WHO: Critical issues still unresolved in antimicrobial resistance draft
action plan*

Geneva, 28 January (Mirza Alas) – Several critical issues remain unresolved
in a draft global plan to put in place a sustained public health response
to antimicrobial resistance.

The severe state of antimicrobial resistance with no effective antibiotics
in sight and its alarming impact on public health worldwide has prompted
World Health Organization Director General Dr. Margaret Chan to warn that
inaction would mean “the end of modern medicine as we know it”.

However, several health experts and practitioners say that the draft Global
Action Plan (GAP) on Antimicrobial Resistance prepared by the WHO
Secretariat, following several consultations with Member States and the
wider health community and civil society groups, still needs considerable
improvement.

The critical issues are: access to current and new antibiotics, research
and development of new antibiotics and diagnostic tools, rational use of
antimcrobial medicines, regulation of promotion and marketing of medicines,
as well as financial and technical assistance for developing countries for
the implementation of GAP.

The draft GAP is high on the agenda at the 136th Executive Board (EB) that
is meeting from 26 January to 3 February at the WHO headquarters in Geneva.
It will be discussed today (28 January) under Agenda item 8.1 (For the text
of the draft plan please see:
http://apps.who.int/gb/ebwha/pdf_files/EB136/B136_20-en.pdf).

Stressing the importance of the issue, DG Dr. Margaret Chan in her opening
remarks at the EB session on 26 January had highlighted some of the dangers
of antimicrobial resistance.

She stressed that, “Resistance to antimicrobial medicines is happening in
all parts of the world for an increasingly broad range of pathogens. The
consequences for human health are severe, especially with so few
replacement products in the pipeline. The world is moving towards a
post-antibiotic era in which many common infectious diseases may once again
kill.  In the absence of effective antibiotics, some of the most advanced
interventions available to modern medicine, like organ transplantations,
hip and joint replacements, cancer chemotherapy, and care of pre-term
infants, could become too dangerous to perform. The consequences can be
succinctly expressed: the end of modern medicine as we know it.”

In light of the severity of antimicrobial resistance, political momentum to
act culminated in a decision of the 67th World Health Assembly in 2014 to
mandate WHO to prepare the GAP. Resolution WHA67.25 requested the Director
General (DG) “to develop a draft global action plan to combat antimicrobial
resistance, including antibiotic resistance, which addresses the need to
ensure that all countries, especially low- and middle- income countries,
have the capacity to combat antimicrobial resistance and …”(
http://www.twn.my/title2/health.info/2014/hi140506.htm)

The Secretariat prepared the draft GAP based on the inputs from various
consultations that it either organized or participated in, including the
WHO Strategic Technical Advisory Group (STAG) on antimicrobial resistance,
regional and country meetings, high-level technical, political and
interagency discussions and a web-based consultation. In late October 2013
a Member State consultation was organized to obtain feedback from Member
States on the initial draft of GAP (
http://www.twn.my/title2/health.info/2014/hi141003.htm).

The latest version of GAP tabled for the EB discussion contains four parts:
an introduction outlining the issue, the scope, the challenge, and a
proposal for the way forward. The last part includes a table with actions
outlined for Member States, the Secretariat and for international and
national partners underpinned by the main objectives explained below.

The draft GAP frames the overall goal as:  “to ensure, for as long as
possible, continuity of successful treatment and prevention of infectious
diseases with effective and safe medicines that are quality-assured, used
in a responsible way, and accessible to all who need them.”  Together with
this main goal GAP also contains the following five guiding principles:

   1. Whole-of-society engagement
   2. Prevention first
   3. Access not excess
   4. Sustainability
   5. Incremental targets for implementation.

 These principles draw the main lines of the plan ensuring the engagement
of all actors, guaranteeing prevention as an important strategy and cost
effectiveness. The third principle aims to ensure “equitable access and
appropriate use”. The last two principles looked at sustaining actions in
systems and practices and builds on the fact that countries are at
different stages in designing and implementing antimicrobial action plans
and therefore some flexibilities need to be built in for those countries.

Moreover, the draft GAP also outlines the following five objectives that
are meant to support the actions needed to address antimicrobial resistance:

   - Improve awareness and understanding of antimicrobial resistance
   through effective communication, education and training;
   - Strengthen the knowledge and evidence base through surveillance and
   research;
   - Reduce the incidence of infection through effective sanitation,
   hygiene and infection prevention measures;
   - Optimize the use of antimicrobial agents in human and animal health;
   - Develop the economic case for sustainable investment that takes
   account of the needs of all countries, and increase investment in new
   medicines, diagnostic tools, vaccines and other interventions.

 The draft GAP addresses many of the considerations put forward by Member
States and civil society organizations. For instance, it provides a good
perspective on the complexities of antimicrobial resistance and the need
for creating awareness at all levels of society and incorporating this
component in professional education and training. The plan also
incorporates actions for other UN agencies to work on that will complement
the work of the WHO.

*Some concerns and shortcomings *

However, draft GAP is either silent or soft on certain critical issues that
are important to address antimicrobial resistance in a comprehensive
manner, especially in the developing country context.

The strategic objectives do not give sufficient recognition to equitable
and affordable access to existing and new antibiotics especially for
developing countries and poor and vulnerable sections of society.  Instead
of giving due concern to affordable access, the draft GAP in formulating
the principle of “access not excess” can inadvertently convey a meaning
that affordable access may lead to excess and therefore needs to be checked.

Another important concern of is GAP’s silence on the question of financial
and technical assistance to developing countries for operationalizing the
action plan. Paragraph 50 of the draft GAP states: “Member States are urged
to develop their own national action plans on antimicrobial resistance
within the next two years of the endorsement of the draft action plan by
the Health Assembly that are in line with the global action plan”.
However, GAP does not provide any indication on how developing countries
are expected to obtain resources to implement national plans national
strategies and surveillance systems.

The issue of research and development (R&D) of new antibiotics is still not
really addressed in the current draft. Objective 5 mentions how most
pharmaceutical companies have stopped researching on new antibiotics and
how “the cost of investment in research and development may need to be
de-linked from the volume of sales.” However, under the actions of this
Objective Member States are encouraged in the “strengthening existing and
creating new public-private partnerships for encouraging research and
development of new antimicrobials agents and diagnostics.”

Furthermore the Secretariat is to “explore with Member States,
intergovernmental organizations, industry associations and other
stakeholders, options for the establishment of a new partnership or
partnerships”.

While “delinking” is raised, the emphasis and recommendation is on creation
of new public-private partnerships. There is no mention, as a way forward,
the new R&D model based on delinking of cost of R&D from the price of a
product as proposed by WHO’s own Consultative Expert Working Group on
Research and Development: Financing and Coordination.

The draft GAP continues to remain weak on the crucial aspect of regulation
of promotion and marketing of antibiotics.

Paragraph 42 states that “industry’s spending on promoting products is
greater than governmental investment in promoting rational use of
antimicrobial medicines or providing objective information”. However, the
indicated actions under Objective 4 do not include any regulation of
unethical promotion of medicines. This is despite the fact that in recent
years pharmaceutical transnational corporations such as Glaxo Smithkline
(GSK) and Novartis faced or are facing prosecution/investigations in the
USA, Japan, China and Poland for unethical promotion of medicines.

Furthermore, the WHO Global Strategy on the Containment of Antimicrobial
Resistance (
http://www.who.int/drugresistance/WHO_Global_Strategy_English.pdf) clearly
calls for the adherence to national and international codes of practices on
promotional activities. Even this clear language on codes of practices (not
regulation) is missing in the draft GAP.

Instead, the indicated actions in the draft GP are: identification and
elimination of economic incentives in all sectors that encourage
inappropriate use of antimicrobial agents and introduction of incentives to
optimize the use.  Further, the draft GAP proposes “effective and
enforceable regulation and governance to ensure appropriate licensing,
distribution, use and quality assurance of antimicrobial medicines in human
and animal health, including a regulatory framework for preservation of new
antibiotics”.

The soft approach on unethical promotion of medicines including antibiotics
could be due to the approach of GAP for implementation through a
partnership model and the creation of new public private partnership for
R&D.

Another area of concern is that the current language in the draft GAP,
particularly paragraph 17, makes a problematic reference to
Substandard/Spurious/Falsely labeled/Falsified/Counterfeit (SSFFC)
medicines as one of the causes of antimicrobial resistance.

The problem of lack of active ingredients or inadequate dosage is a problem
of quality, safety and efficacy (QSE) of a medicine. Paragraph 44 of the
draft GAP cites the prevalence of substandard medicines for both human and
veterinary use as a cause for developing antimicrobial resistance.
Accordingly an indicated action identified for the Secretariat under
Objective is to “Provide support to Member States in the development and
enforcement of relevant regulations that will prevent
substandard/spurious/falsely -labelled/falsified/ counterfeit antimicrobial
medical products reaching patients”.

However, the word ‘counterfeit’ refers to a particular type of intellectual
property (IP) infringement and links the issue of QSE with such
infringement. The pharmaceutical transnational corporations conflate the
issue of QSE of medicines with IP rights such as counterfeit in order to
push for IP enforcement.  The issue of quality of antimicrobial medicines
should be addressed through measures that are appropriate to national
circumstance without linking it to IP.

In addition, the draft GAP should also address affordable access to QSE
medicines and rational use of drugs, instead of linking to the question of
SSFFC as in the draft now. To date there is no shared understanding on the
term SSFFC. A Member State-driven process is discussing the issue of SSFFC (
http://apps.who.int/gb/ebwha/pdf_files/EB136/B136_29-en.pdf) and the
outcome of that process should not be pre-judged. Therefore, the GAP should
remove any reference to SSFFC.

Another problematic area could be the indicated action Member States action
under Objective 5. It suggests: “Collaborating in the investigation of
natural resources of biodiversity and bio repositories as sources for the
development of new antibiotics”.  However, the document does not mention
the obligations under the Convention of Biological Diversity and its Nagoya
Protocol that create an obligation to fairly and equitably share the
benefit of such research as a condition to access bio resources.

According to an observer at the ongoing EB session, the draft GAP follows a
health security approach rather than a health system approach.+

(With inputs from K M Gopakumar and edited by Chee Yoke Ling)




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