[Ip-health] Shreerupa Mitra-Jha: Landmark resolutions at WHA but old problems persist

Manon Ress manon.ress at keionline.org
Fri Jun 5 12:49:22 PDT 2015


quote:
“The WHO EML is often used as a benchmark for priority-setting and
procurement decisions. As countries wrestle with affordability issues, they
should be encouraged to seek WHO technical assistance in using lawful
pathways to ensure that these treatments are widely available by regulating
or eliminating monopolies-including through the granting of compulsory
licences,” said Thiru Balasubramanium of Knowledge Ecology International
(KEI).
end of quote
--

http://www.governancenow.com/news/regular-story/india-steers-world-health-assembly-vision-landmark-event-concludes

Landmark resolutions at WHA but old problems persist

Shreerupa Mitra-Jha | May 28, 2015
Photo: Shreerupa Mitra-Jha

The World Health Assembly (WHA) concluded its 68th session in Geneva on May
26 with Union Minister for Health and Family Welfare JP Nadda, the
president for this year’s assembly, saying ‘thank you’ to delegates in
seven languages: merci, gracias, obrigado, shukran, spasiba, xie xie and
thank you very much.

The concluding session with its thin attendance from the member states,
NGOs and journalists stood out against the inaugural session—an event
bustling with activity and the Salle de Assembly bursting at seams. Did it
indicate that the people were disappointed with the outcomes? No, just that
the participants, exhausted after negotiations, shouting and strategizing
couldn’t wait to leave the premises at the first opportunity.

Politicians, not known to be left behind in hyperbole, didn’t disappoint in
their speeches both at the inaugural and the concluding sessions.

Margaret Chan, the Director General (DG) of the World Health Organization
(WHO) called this year’s Health Assembly a “landmark” event. She said at
the concluding session, "You can be proud of the outcome of this Health
Assembly. This Health Assembly has produced some landmark resolutions and
decisions that are very important for global health and development for a
long time to come. And, of course, for the future of the WHO.”

“The 68th WHA will be remembered by posterity for these crucial decisions
which will shape our collective efforts in the years to come,” said the
Indian health minister at the concluding session.

Michael Malabag, Minister of Health of Papua New Guinea and Chairman of
Committee B (WHA has two Committees: A and B with certain thematic debates
under each of them), gave the audience a laugh when he said that the
President of WHA kept referring to him as Dr. Michael Malabag, when he is
not a doctor, and the media in his country is fine with it as long as he
doesn’t go back home and start practising.

As usual, the range of resolutions adopted at the Assembly were wide: a new
resolution on a global action plan (GAP) for combating anti-microbial
resistance, resolutions on WHO’s reforms for response in emergency
situations, a resolution on poliomyelitis, yellow fever mapping and
vaccination for travellers, a resolution on global vaccine action plan
(GVAP), the impact of air pollution on health, framework for non-State
actors, communicable diseases (dengue and malaria), 2014 Ebola virus
disease outbreak and follow-up to the special session of the Executive
Board (EB) on Ebola, implementation of international health regulations
(IHR), programme budget for 2016-2017, health in post-2015 development
agenda, among others. These draft resolutions were debated under Committee
A.

Most resolutions under Committee B were of administrative and budgetary in
nature. They included financial reports and audited financial statements,
status of collection of assessed contributions, scale of assessments for
2016 and ‘17, reports of the external auditor, appointment of external
auditor, WHO staff pension committee, salaries of staff in upgraded posts,
amendment to the staff regulations and rules, etc. There was also a
resolution on health conditions in the occupied Palestinian territories,
including east Jerusalem, and in the occupied Syrian Golan.

Some debates, on health systems and non communicable diseases (NCDs), were
shifted from Committee A to B during the course of the week, including
strengthening emergency and essential surgical care and anesthesia as a
component of universal health coverage, WHO global code of practice on
international recruitment of health personnel,
sub-standard/spurious/falsely-labelled/ falsified/counterfeit medical
products (SSFFC), global strategy and plan of action on public health,
innovation, and intellectual property (GSPOA), maternal, infant and young
child nutrition, global burden of epilepsy and need for a coordinated
action at the country level to address its health, social and public
knowledge implications, etc.

Sweeping changes
Notwithstanding the importance of the adopted resolutions, the volume of
the texts agreed upon in the WHA necessitates that we focus on some of the
more salient resolutions and its implications for the global health regime,
to ensure that we emerge from this diplomatic maelstrom unscathed.

The focus of this year’s Health Assembly, understandably, was on Ebola and
health-related emergency response, after the poor and delayed response of
the WHO under its present leadership during the Ebola outbreak. Amid cries
for her resignation, Chan promised to make “landmark” reforms for
preparedness in dealing with future health-related emergency situations.

In her opening remarks at this year’s WHA, Chan said, “The world was
ill-prepared to respond to an outbreak that was so widespread, so severe,
so sustained, and so complex. WHO was overwhelmed, as were all other
responders”. So, she stated, that as the chief she is making some
“fundamental” changes to the global health body. She declared, rather
unabashedly, at the end of the WHA that “this was one of the most, if not
the most important WHA.”

Consequently, there were five major areas of reform in emergency
operations—a single new programme for health emergencies, uniting all
outbreak and emergency resources across the three levels of the
Organization—country, regional and headquarters level; plans for a global
health emergency workforce drawn from the global outbreak alert and
response network, the global health cluster, foreign medical teams, and
others;  performance metrics for the emergency programme; developing new
business processes to facilitate a rapid and effective response including,
developing streamlined administrative and managerial procedures for
logistics, procurement, and emergency staff recruitment; a $100 million
contingency fund, financed by flexible voluntary contributions, to sustain
immediate response for a period of three months which can be stretched to a
maximum of six months.

The new emergency programme under the DG’s direct supervision will have
performance matrix of what needs to be done in the first 24, 48 and 72
hours and will also have a roster of experienced emergency coordinators
from across the entire organization who can be deployed quickly to lead
field operations and national disaster teams who in turn can be swiftly
stationed in the areas of emergency operations.

India committed $2.1 million voluntary contributions to the global health
body towards the new WHO contingency fund, the pooled fund for
implementation of R&D demonstration projects and for the member state
mechanism on SSFFC medical products.

The emergency programme was debated for long hours on May 19 and May 20 and
finally reached consensus on May 23. However, even though the new emergency
programme has been adopted, operationalizing it will be a major challenge.

Dwindling pennies
Consider this: most of the international responders for the Ebola outbreak
were drawn from China, African Union and Cuba. India, for one, had not
responded much to the Ebola crisis.

Ebola has run into a huge financial stalemate even though the outbreak had
reached the shores of powerful western nations. “There is no reason why
Ebola can’t be beaten but financing is becoming the most essential glaring
reason for failure,” said Bruce Aylward, WHO Assistant Director-General for
Emergencies, at a press conference on May 26.

WHO is currently facing a funding gap to the tune of $100 million for Ebola
response. “Money is falling faster than cases,” said Aylward. “Last week it
was 11 days that I stopped deploying international staff in Sierra Leone.
That is how tight financing was,” he added. WHO will submit, what it calls
a “bare bones” budget, to the Secretary General’s Office, who will “go out
and beat the drum again to get that financed”.

Apart from that, the World Food Program’s (WFP’s) special operations that
is underpinning the response right now, needs $50 million to “to keep those
helicopters in the air and to keep those operations working,” said Aylwards.

“The failures such as they were of WHO’s response to Ebola are a large part
a consequence of a funding freeze which has been operating with increasing
strangle-ment over the last 20 to 30 years,” said David Legge of the
People’s Health Movement (PHM). To understand this statement one would have
to study WHO’s funding mechanisms. There are two sources of funding for the
WHO: assessed contributions i.e., mandatory contributions of member states
and voluntary contributions that is further divided into the two types of
specified or earmarked contributions and core account, flexible
contributions.

Over the last 20 years the proportion of WHO’s budget which is met through
mandatory, assessed contributions has fallen from 75 percent to 20 percent.
This is a consequence of continuous new functions being added to the
organization and a continuing freeze on assessed contributions. The
remaining 80 percent is met by voluntary donations – the top four voluntary
donors of 2014 were the US, followed by Bill and Melinda Gates Foundation,
the UK and Canada.

The total fund break-up for 2014 for the global health organization was as
follows: voluntary contributions (core) was $133 million, voluntary
contributions (specified) was $1,869 million, which adds up to a total of
$2,002 million. 51 percent of the revenue for voluntary funds were by
member states, two percent by the private sector, seven percent by NGOs and
14 percent by foundations.

Staff and other personnel costs were the largest category of expenses and
represented 41 percent of the total expenses incurred in the programme
budget for 2014 down from 43 percent in 2013.

“[Of] these voluntary contributions, 93 percent are tightly earmarked. They
are not earmarked for things that the donors are not currently supporting.
And guess what, emergency interventions were not being supported in the
last two years,” said Legge.

“Ebola and so many other failures and inefficiencies of WHO are consequent
upon donor freeze–the freeze in assessed contributions,” said the health
activist.

In 2014, Bill and Melinda Gates Foundation had contributed $256.5 million
as voluntary funds of which $253.6 million was specified voluntary funds
and nearly $2 million for R&D. Compare this to India’s voluntary
contributions in 2014: $2.67 million of which $2.58 million was specified
while $35,000 was for R&D.

The global health body’s priorities are hugely donor-driven, including, its
R&D and its emergency focus.

The freeze was partly brought about citing the inefficiencies of the WHO
but even after five years of some effective reform, member states have
carried on with the freeze tradition.

The DG recently sought five percent increase in assessed contributions
which would mark a symbolic lift of the freeze.  However, Belgium and the
UK both spoke firmly against this proposed increase while Germany supported
it.

“It’s a trivial amount of money, actually. Just looking at the UK
figures–UK contributes $24 million a year and 5 percent of that is $1.25
million. Last year they saved $13 million in terms of their exchange losses
and gains in terms of their contribution to WHO. And their voluntary
contributions are $65 million a year. And they are refusing to pay 1.25
million, which the DG is asking [for]. Belgium contributes $4.65 million in
assessed contributions, its exchange rate saving was 700,000 and five
percent for Belgium is $230,000,” Legge said.

There was a big debate on increased assessment fund as part of the
programme budget discussion but ended with the agreement that the budget
increase will go forward but it will be voluntarily funded not from
assessed contributions.

“In terms of WHO’s emergency programme this was a recurring theme as well
that the financing of it is highly dependent on voluntary contributions and
that now needs to be a rebalancing of that with a much bigger proportion
funded from assessed contributions,” Aylward told this reporter.

“The DG makes clear though that she welcomes anyone who voluntarily
increases their assessed contributions,” he added.

So where does that leave emergency funding for outbreaks that tend to be
concentrated in the creases of fragile health systems of low income
countries? There will be a financing dialogue between member states in
November where, hopefully, better sense prevails and assessed contributions
are pushed—crucial for the WHO to deliver on its mandates.

The budget discussions were tied to another important and highly
contentious resolution on Framework of engagement with non-State actors
(FENSA). The debate aimed to determine the rules of engagement between WHO
and non-State actors (NSAs)—comprising academia, non-governmental
organizations, philanthropic foundations, and the private sector.

The draft resolution was not accepted by India and it proposed many
amendments. The concern is that if private organisations enter into
legitimate relation with the WHO it may lead to major conflict of
interests, like big pharmas on the board to decide drug prices or junk food
industries on the board of policies for containing NCDs. India proposed
that "WHO shall not collaborate with private sector entities in the
generation of evidence, in knowledge management, in information gathering
and in research." The proposal was challenged by the US and the UK.

India also proposed a ceiling of $50,000 from NGOs, above which the amount
would go to the core voluntary fund. The rationale is that the WHO should
not be constricted by donor priorities in its ability to mobilize resources.

There was no consensus reached on FENSA and so it was adopted with the
agreement to form an open ended inter-governmental meeting, no later than
October this year, to finalise the draft framework to be submitted to the
69th WHA through the 138th Executive Board meeting in January next year.

Accessing Excess Antibiotics
The other important resolution that captured much news space globally was
the resolution on GAP for AMR. Pathogens are getting increasingly resistant
to drugs, affecting treatment for tuberculosis, malaria, influenza,
HIV/AIDS, gonorrhea, and common infections such as pneumonia and urinary
tract infections, affecting the developed and developing countries alike.
AMR can develop in human and animal health as well as through food and
agriculture sectors.

Chan has famously warned of a “post antibiotic era” where common cold may
once again kill due to the overuse and misuse of microbial agents.

Resistant microorganisms (including bacteria, fungi, viruses and parasites)
are able to withstand attack by antimicrobial drugs, such as antibacterial
drugs (e.g., antibiotics), antifungals, antivirals, and anti-malarials, so
that standard treatments become ineffective and infections persist,
increasing the risk of spread. For instance, in 2013, there were about
4,80,000 new cases of multidrug-resistant tuberculosis (MDR-TB). Also,
extensively drug-resistant tuberculosis (XDR-TB) has been identified in 100
countries.

While the GAP on AMR may seem a benign albeit urgent resolution to adopt,
the adoption was delayed at the behest of India, who wanted more time for
deliberations before the final agreeent. Consequently, a drafting group was
formed who had closed-door discussions on the issue before a final
consensus was achieved.

The issue of anti-microbial resistance (AMR) should be seen holistically as
a “development challenge” instead of narrowly interpreting it as a health
security challenge, India said at a Committee A meeting before asking for
more time. “Emphasis should be on raising awareness, infection prevention,
promoting rational use of antibiotics and addressing the needs of
developing countries in strengthening access to health care facilities,
promoting availability and affordability of existing and new antibiotics,
diagnostics and vaccines,” India stated.

The adoption of the AMR means, among other things, all member states are
expected to have in place, within two years of the endorsement of the draft
action plan by the Health Assembly, national action plans on AMR aligned
with the global action plan. The national actions should include developing
a national surveillance system for antimicrobial resistance to collect data
on resistance by bacteria to various medicines, and as well as surveillance
in the animal health and agriculture sectors, effective regulation and
governance for the licensing, distribution, prescription, dispensing and
use of medicines in human and animal health, improve laboratory capacity to
identify pathogens and their antimicrobial susceptibility in order to guide
optimal use by doctors of antibiotics etc.

All of this requires considerable financial and technological investment—a
burden that low and middle income countries may not have the immediate
capacity to carry out. Consider the case of point-of-care diagnostic tools.
Often, there is an over-prescription or misuse of, for instance,
antibiotics especially in rural areas because of the unavailability of
diagnostic tools to find out whether antibiotics are required at all. The
availability of such diagnostic tools especially in least developed
countries will be a challenge that the more developed countries will have
to undertake. Kenya, for instance, raised the question of financial and
technical assistance for diagnostic tools in agriculture.

Developing countries and health activists have been concerned about
resources for implementing AMR plans, particularly, affordable, point of
care diagnostics to inform health practitioners and veterinarians of the
susceptibility of pathogens to available antibiotics. They have argued that
the draft in its current form emphasizes surveillance but doesn’t mention
any financial commitment crucial for developing countries to implement the
national plans.

India also pointed out that there is not only a need to accelerate R&D for
new antibiotics, since no new class of antibiotics has been developed in
the last 30 years, but also for the global health body to ensure the
affordability of new antibiotics.

Currently, most major pharmaceutical companies have stopped research in
development of new antibiotics; a situation described by WHO’s consultative
expert working group (CEWG) on Research and Development, as a “serious
market failure”.

“It would be terrible if the present antibiotics don’t work anymore and
when new ones are developed, the patients in developing countries cannot
have access to these, because they are patented and thus have high prices,”
said Martin Khor, Director of the South Centre, an inter-governmental body
of developing countries based in Geneva.

India had earlier in an EB meeting in January this year called for
de-linking the cost of investment in R&D from the volume of sale. In the
same meeting, they had also indicated the role of pharmaceutical industries
in unethical marketing practices that may lead to overdose in
antibiotics--which the draft GAP on AMR does not address.

India also co-sponsored a related resolution on GSPOA that saw heated
debates in the Health Assembly. However, it was adopted with the consensus
“to promote new thinking in innovation and access to medicines, which would
encourage needs-driven research rather than purely market-driven research
to target diseases which disproportionately affect people in developing
countries”.

In May 2015, WHO announced the inclusion of 16 cancer drugs on the WHO
Model List of Essential Medicines (EML) including such costly treatments as
trastuzumab and imatinib.

“The WHO EML is often used as a benchmark for priority-setting and
procurement decisions. As countries wrestle with affordability issues, they
should be encouraged to seek WHO technical assistance in using lawful
pathways to ensure that these treatments are widely available by regulating
or eliminating monopolies-including through the granting of compulsory
licences,” said Thiru Balasubramanium of Knowledge Ecology International
(KEI).

“The first question addressed would be on how to achieve better
transparency of the true cost of R&D of cancer drugs (for example - on
small molecule and biosimilars, clinical trials and the disclosure of
public funds). The second question would focus on how we should implement
effective mechanisms delinking the cost of R&D from the price of cancer
treatments, and providing life saving medicines to cancer patients in all
countries. Without delinkage, we will never achieve universal health
coverage and resilient health systems will remain but a distant hope,” he
told the WHA.

Consensus was reached on the wording of the proposed AMR resolution, and it
was re-submitted to the Committee that approved it without further
amendment on May 23. Some concerns of India and other developing countries
have been included in the amended text that highlights the challenges that
poorer parts of the world face in “improving affordability and universal
access to quality, safe and effective antimicrobial medicines and
diagnostic tools”. The WHO under the amended AMR resolution will attempt to
contain AMR “including through the tracking of resource flows for research
and development on antimicrobial resistance in the new global health
research and development observatory”.

Also, the GAP resolves to promote “affordable access to existing and new
antimicrobial medicines and diagnostic tools”, taking into account the
needs of all countries, and in line with the GAP on AMR, “and to report to
the sixty-ninth World Health Assembly”. The amended text also purports to
provide support and technical assistance to countries, “with a specific
focus on low and middle income countries”.

Given that WHO is the only legitimate body playing the watch dog for the
global public health regime, one hopes that narrow concerns will eventually
be trumped by the pursuit of the greater common good.

- See more at:
http://www.governancenow.com/news/regular-story/india-steers-world-health-assembly-vision-landmark-event-concludes#sthash.NyYitH03.dpuf


-- 
Manon Ress, Ph.D.
Knowledge Ecology International, KEI
manon.ress at keionline.org, tel.: +1 202 332 2670
www.keionline.org
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