[Ip-health] Draft text on neglected tropical diseases favours industry

Gopa Kumar kumargopakm at gmail.com
Thu May 23 23:04:12 PDT 2013


*Draft text on neglected tropical diseases favours industry
*
*Geneva, 23 May (K. M. Gopakumar)* - Concerns have surfaced that the draft
resolution on neglected tropical diseases at the ongoing World Health
Assembly (WHA) session promotes the interests of pharmaceutical
multinational corporations.

The central role given to partnerships with industry that focus on
medicines' donation, could undermine a long-term systemic solution to the
South's struggle to address the burden of those diseases.

The WHA will consider a report and the annexed resolution on Friday, 24 May
at Committee A. The draft text was approved by the 132th session of the WHO
Executive Board and contains nine preambular paragraphs and three
operational paragraphs. Its primary objective is to obtain political
endorsement of WHO's Roadmap titled "Accelerating Work to overcome the
Global Impact of Neglected Tropical Diseases" and the "London Declaration
on Neglected Tropical Diseases".

(Available at:
http://www.who.int/neglected_diseases/NTD_RoadMap_2012_Fullversion.pdf, and
http://unitingtocombatntds.org/downloads/press/ntd_event_london_declaration_on_ntds.pdf
)

According to the report of the Secretariat on neglected tropical diseases
(NTD) (A66/20), "in 2011, WHO and its Strategic and Technical Advisory
Group for Neglected Tropical Diseases drew up the roadmap to accelerate
work on neglected tropical diseases".

It sets targets for the eradication of dracunculiasis (by 2015) and yaws
(by 2020). It also sets six targets for the elimination of five NTD by
2015, and 10 elimination targets either globally or in selected
geographical areas for nine NTD by 2020. Further, the roadmap also has
targets for intensified control of dengue, Buruli ulcer, cutaneous
leishmaniasis, selected zoonoses and helminthiases.

The roadmap recommends five public health measures for the prevention,
control, elimination, and eradication of NTD: preventive chemotherapy;
intensified case-management; effective vector control; the provision of
safe drinking-water, basic sanitation and hygiene; and involvement of
veterinary public health. The sixth area of intervention proposed by the
roadmap is in the area of capacity strengthening.

The purpose of the roadmap is to guide implementation of the policies and
strategies set out in the "Global Plan to combat neglected tropical
diseases 2008-2015" and developed in the document "Working to overcome the
global impact of neglected tropical diseases".

Following the publication of the roadmap, in 2012, a conference attended by
the heads of global health organisations, donors, politicians and
pharmaceutical industry leaders endorsed the London Declaration on
Neglected Tropical Diseases.

The Declaration has the following elements: (a) to sustain, expand and
extend programmes that ensure the necessary supply of medicines and other
interventions; (b) to advance research and development through partnerships
and provision of funding to find next-generation treatments and
interventions; (c) to enhance collaboration and coordination at national
and international levels; (d) to enable adequate funding with countries
endemic for the neglected tropical diseases to implement programmes
necessary to achieve these goals, supported by strong and committed health
systems at the national level; and (e) to provide technical support, tools
and resources to countries endemic for these diseases to evaluate and
monitor those programmes.

Preambular paragraph 3 (PP3) of the resolution notes "the WHO's roadmap to
accelerate the work to overcome the global impact of neglected tropical
diseases and the subsequent London Declaration on Neglected Tropical
Diseases endorsed by a community of partners."

Further, operational paragraph 1(2) urges WHO Member States "to expand and
implement interventions against neglected tropical diseases in order to
reach the targets agreed by WHO and its partners in the London Declaration
on Neglected Tropical Diseases and set out in WHO's roadmap for
accelerating work to overcome the global impact of neglected tropical
diseases ..."

Thus, the main purpose of the resolution is to legitimise and mainstream
WHO's partnership approach to overcome the global impact of NTD.

Both the roadmap and the declaration use the partnership as the vehicle of
programme implementation, with the pharmaceutical MNCs as one of the
leading partners. The resolution aims to obtain the political endorsement
from Member States and to legitimise such partnership.

The NTD roadmap clearly acknowledges the role of pharmaceutical MNCs and
depends upon the drug donations from pharmaceutical MNCs to provide
treatment. The roadmap contains the following references to the
pharmaceutical industry.

Regarding the success of the roadmap, it states: "The roadmap's destination
can be reached only if two established, interconnected routes are followed.
The first route is to continue to provide guidance and technical insight to
policy makers and programme managers in governments seeking to prevent,
control, eliminate and eradicate the NTDs that are endemic in their
countries."

The second interconnected route, according to the roadmap: "The other route
is to continue to encourage the community of partners - including donors,
pharmaceutical companies, agencies, non-governmental organisations (NGOs),
philanthropists and universities - to maintain and increase their
commitments to overcoming NTDs".

Further, the roadmap states that the international experts who serve on the
Strategic and Technical Advisory Group for NTD which approved the roadmap
clearly recognises the role of the pharmaceutical MNCs and states:

* In addition to donors, agencies, NGOs and others, positive outcomes from
working with the pharmaceutical companies have helped millions of people to
receive free regular treatment for Chagas disease, human African
trypanosomiasis, fascioliasis and other food-borne trematodiases, leprosy,
lymphatic filariasis, onchocerciasis, schistosomiasis, soil-transmitted
helminthiases and trachoma.

* WHO/NTD has established an effective, transparent and respected
relationship with a number of pharmaceutical companies and has contributed
to mobilising much needed resources as part of the industry's corporate
social responsibility.

* Expertise has been acquired in the complex process of procurement,
quality assurance and improved access to medicines, again reflecting the
important relationship between WHO/NTD and the pharmaceutical companies.

The roadmap further anchors the drug donation program as one of the
important modes of providing access to medicines (WHO had entered into such
an Agreement with the pharmaceutical MNCs). The roadmap states that recent
renewal of these agreements would ensure donations of medicines and
financial support until the end of 2017.

According to the roadmap, the following pharmaceutical companies are the
major donors of medicines: GlaxoSmithKline (Albendazole), Gilead
(AmBisome), Pfizer (Azithromycine), Eisai Co. Ltd (DEC), Sanofi
(Eflornithine), Merck & Co (Ivermectin), Novartis (Rifampacin, clofazimine
and dapsone), Johnson & Johnson (Mebendazole), Sanofi (Melarsprol), Bayer
(Pentamidine), Sanofi (Pentamidine), Merck KGaA (Praziquantel), Bayer
(Suramin), and Novartis (Triclabendazole).

Thus, there are 11 companies listed in the roadmap. Except for Gilead, all
others seem to provide the medicines as donation and Gilead provides it
through a WHO concessional price.

In 2012, as a follow-up to the publication of the roadmap, the partnership
was launched through a conference in London which adopted the declaration.
According to the WHO website, "the Roadmap that lays out the vision for
ending the misery caused by neglected tropical diseases has inspired public
and private partners to unite in the fight against some of the most
devastating diseases".

The London Conference witnessed "Major pharmaceutical companies, the Bill &
Melinda Gates Foundation, the governments of the United States, United
Kingdom and United Arab Emirates and the World Bank announced measures to
support WHO in sustaining progress achieved as well as give a push to
accelerate the control, elimination and eradication of these diseases".

As per the WHO website, the major measures that came out of the conference
include: "sustaining or expanding current medicine donation programmes to
meet demand through 2020; providing more than US$785 million to support
elimination efforts; strengthening drug distribution and implementation
programmes; sharing expertise and compounds to promote research and
development of new medicines."

Apart from the Bill & Melinda Gates Foundation and the World Bank, the
following pharmaceutical MNCs also endorsed the declaration: Abbott, Astra
Zeneca, Bayer, Becton Dickinson, Bristol Mayors Squibb, Gilead, Glaxo
SmithKline, Johnson and Johnson, Merck, Novartis , Pfizer and Sanofi.

According to the roadmap, its purpose is to guide implementation of the
policies and strategies set out in the "Global Plan to combat neglected
tropical diseases 2008-2015." (
whqlibdoc.who.int/hq/2007/who_cds_ntd_2007.3_eng.pdf)

However, the roadmap diluted the implementation plan contained in the
Global Plan in order to make it palatable for the pharmaceutical MNCs.

The Global Plan identified an urgent need for diagnostic tools, medicines
and pesticides and development of more effective medicines and insecticides
are the key challenges. It clearly states: "Current control strategies for
some NTDs that belong to the tool-deficient category rely on imperfect
tools. Diagnostic tools, medicines and pesticides are costly and difficult
to manage. Using the currently available tools, sustainable control or
elimination of the diseases remains an unattainable objective. This reality
points to an urgent need to develop simple and safe control tools that can
be integrated into health systems in resource-limited settings".

However, the task of development of new tools is identified within the
public-private partnership, while the Global Plan clearly puts WHO in the
leading role: "WHO should play a leadership role in the introduction of
innovative tools and in making them available and accessible to populations
in need".

Further, it identified access to innovation as one of the strategic areas
for action: "access to innovation is an integral part of control activities
because it allows adaptation of NTD control strategies. ‘Access to
innovation' refers to a process that facilitates and expedites the
development of new key tools, and ensures their quick implementation at
field level".

The roadmap is completely silent on the innovation of new products. The
five areas identified for intervention do not include access and innovation.

The London Declaration states that one of the commitments is to "advance
research and development through partnerships and provision of funding to
find next-generation treatments and interventions".

However, the Declaration is silent on the R&D model to be followed in this
area. Since the publication of the WHO Report of the Commission on
Intellectual Property, Public Health and Innovation (CIPIH), there is ample
evidence existing within WHO that the mainstream approaches to R&D based on
the intellectual property protection model does not work in the area of NTD.

The Global Strategy and Plan of Action on Public Health, Innovation and
Intellectual Property adopted by Member States clearly acknowledges the
need for alternative models based on de-linking of the cost of R&D from the
prices of medicines through an open innovation approach. However, the
London Declaration is silent on this.

It is also not clear from the documents viz. roadmap, Declaration and draft
resolution, whether the medicine needs are to be met exclusively through
drug donation or whether procurement on a commercial basis is also carried
out under the initiative. If there is commercial procurement, whether the
non-partners, including generic companies, are allowed to participate in
the procurement program.

Operational paragraph 2.3 of the draft resolution calls upon WHO's
international partners, including intergovernmental, international and
non-governmental organisations, financing bodies, academic and research
institutions, civil society and the private sector "to encourage
initiatives for the discovery and development of new diagnostics, medicines
and pesticides, and to support operational research to increase the
efficiency and cost-effectiveness of interventions, taking into account the
global strategy and plan of action on public health, innovation and
intellectual property".

The 132nd session of the Executive Board of WHO while approving the draft
resolution for WHA consideration, added the following words: "taking into
account the global strategy and plan of action on public health, innovation
and intellectual property". However, it is clearly silent on the principles
of open innovation and de-linking of cost of R&D as a guiding principle.

The Report of the Consultative Expert Working Group on R&D Coordination and
Finance (CEWG) recommended certain guiding principles for R&D. The Report
recommends an "open knowledge innovation" approach to R&D. It further
defines this approach and states: "We characterise these as ‘open knowledge
innovation', and define this as research and innovation that generates the
knowledge which is free to use without legal or contractual restrictions".

Similarly, operational paragraph 3(4) requests the WHO Director-General to
encourage and support initiatives to discover and obtain new diagnostic
tools, medicines and insecticides, and to support operational research to
increase the efficacy and cost effective intervention". The resolution is
not requesting the WHO D-G to advocate open knowledge innovation to achieve
the objectives of de-linking of the cost of R&D from the price of the
product.

Stressing the need for R&D to develop new tools including diagnostics,
Bernard Pecoul, Executive Director of Drugs for Neglected Diseases
initiative (DNDi), one of the signatories of the declaration, wrote in PLoS
NTD (a journal): "Although tools exist to control, or in some cases even
eliminate, NTDs, for many of these diseases the tools and implementation
strategies available are sub-optimal, incomplete, or inadequate to sustain
elimination efforts. Consequently, substantial investments in R&D are
urgently needed to develop new-generation control tools and strategies for
their improved use and implementation."

Under the list of commitments of the declaration, DNDi is to get access to
the compound libraries of Abbott, AstraZeneca, Novartis, Pfizer,
GlaxoSmithKline and Eisai to develop new medicines.

However, one source told the author that "there should be initiatives from
the WHO Secretariat and Member States to ensure that these commitments from
the pharmaceutical companies are met in transparent, timely manner".

Thus, the NTD initiative and the resolution are widely viewed as a
pharmaceutical MNCs agenda to neutralise the implementation of the CEWG
recommendations.

Some experts also point out that the draft NTD resolution failed to make
the linkage with other existing initiatives within the WHO like the
Tropical Drug Research (TDR), the Special Programme for Research and
Training in Tropical Disease jointly set up by the United Nations
Children's Fund (UNICEF), the United Nations Development Programme (UNDP),
the World Bank and WHO in 1975.

Similarly, the roadmap identifies safe water and sanitation for
intervention. The Global Plan to combat neglected tropical diseases
2008-2015 identified pro-poor polices as a key principle for intervention.
It states: "The fight against NTDs should form an integral part of pro-poor
policies. The introduction of basic public health measures, such as access
to clean water and sanitation as well as health education, would
significantly reduce the burden of a number of NTDs and other infectious
diseases".

The political declaration adopted at the Rio Conference on Social
Determinants of Health clearly states: "Based on the experiences shared at
this Conference, we express our political will to make health equity a
national, regional and global goal and to address current challenges, such
as eradicating hunger and poverty, ensuring food and nutritional security,
access to safe drinking water and sanitation, employment and decent work
and social protection, protecting environments and delivering equitable
economic growth, through resolute action on social determinants of health
across all sectors and at all levels."

However, the roadmap, the Declaration and the draft resolution are silent
on the social determinants aspects of the intervention. The resolution does
not establish any linkage between the social determinants aspects of NTDs.

Another important missing link is the linkage of the NTD resolution with
the Global Strategy and Plan of Action on Public Health, Innovation and
Intellectual Property (GSPOA).

The aim of the GSPOA is "to promote new thinking on innovation and access
to medicines and, based on the recommendations of the report of the
Commission on Intellectual Property Rights, Innovation and Public Health,
provide a medium-term framework for securing an enhanced and sustainable
basis for needs-driven essential health research and development relevant
to diseases that disproportionately affect developing countries, proposing
clear objectives and priorities for research and development, and
estimating funding needs in this area."

Element 5.3 of the GSPOA clearly mentions the de-linking of the costs of
research and development and the price of health products.

Further, the monitoring matrices identified the following action on Element
5.3: "explore and, where appropriate, promote a range of incentive schemes
for research and development, including addressing, where appropriate, the
de-linking of the costs of research and development and the price of health
products, for example, through the award of prizes, with the objective of
addressing diseases that disproportionately affect developing countries."
It also identifies WHO as one of the stakeholders in implementing Element
5.3.

The resolution provides only lip service mentioning in the preamble without
any corresponding operational paragraphs except in Op 2.3. Preambular
paragraph 4 of the draft resolution acknowledges "the linkage between, and
mutual supportiveness of, control and elimination of neglected tropical
diseases and the global strategy and plan of action on public health,
innovation and intellectual property".

The resolution is silent on the various elements of GSPOA such as
prioritising R&D needs, promoting research and development, building and
improving innovative capacity, building innovative capacity, transfer of
technology, application and management of intellectual property to
contribute to innovation and promote public health, improving delivery and
access, and promoting sustainable financing mechanisms.

Thus, the more one examines the NTD draft resolution, the agenda of
pharmaceutical MNCs becomes more and more clear. The critical question at
this juncture is whether the peoples of the South should be given a more
comprehensive package to address the burden of NTDs instead of short-term
solutions like drug donation. While the drug donations would help to
address the problem in the short run, it does not yield results in the long
term.

However, it does serve the long-term interests of pharmaceutical MNCs to
prevent the implementation of new R&D models which address both innovation
and access while meeting the unmet R&D needs of developing countries in
NTDs.

Observers wonder if Member States will remove the veil and see the real
agenda Friday when discussion begins.



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