[Ip-health] TWN Info: World Health Assembly to discuss UN high level report on access to medicines

Mirza Alas mirzalas at gmail.com
Thu Feb 2 05:23:25 PST 2017

*Title :* TWN Info: World Health Assembly to discuss UN high level report
on access to medicines
*Date :* 2017-02-02 <2017%200202>



TWN Info Service on UN Sustainable Development, IP and Health
2 February 2017
Third World Network

*World Health Assembly to discuss UN high level report on access to

London, 2 February (Sangeeta Shashikant*) – The forthcoming 70th World
Health Assembly (WHA) will discuss access to medicines including the United
Nations Secretary General’s High Level Panel Report on Access to Medicines
(UNHLP report).

The inclusion of this agenda item has been a topic for debate and the 140th
meeting of the Executive Board of the World Health Organization (WHO)
finally agreed to accordingly amend an existing agenda item on shortage of
medicines of the 70th WHA that will convene in May this year.

The Executive Board is composed of 34 WHO members on a rotation basis,
primarily mandated to facilitate the work of the WHA. It met at the WHO
headquarters in Geneva from 23 to 31 January 2017.

The Board’s move follows a proposal by Eritrea on behalf of the Africa
Group to have on the agenda of the WHA a stand-alone agenda item on access
to medicines to give WHO Members an opportunity to deliberate on the
problems Member States face on access to medicines.

However, Eritrea’s proposal was not agreeable to the Chairman of the
Executive Board, Ray Busuttil from Malta who instead proposed re-naming
agenda item 14.3 of the WHA from “Addressing the global shortage of
medicines and vaccines” to “Addressing the global shortage and access to
medicines and vaccines”.

The agenda item debate was essentially about the UNHLP report which was not
listed as a separate agenda item on the Board’s programme of work mainly
because its recommendations are not acceptable to some developed countries,
in particular the United States.

The Director-General of WHO, Dr. Margaret Chan, intervened to clarify that
the Secretariat’s paper on shortage of medicines will be expanded to cover
all issues concerning access to medicines, including comments made on the
UNHLP report during the Executive Board meeting, the adopted Global
Strategy and Plant of Action on Public Health, Innovation and Intellectual
Property (GSPOA), and the Follow-up to the report of the Consultative
Expert Working Group on Research and Development: Financing and
Coordination (CEWG).

Dr. Chan also said that the document would provide a platform to WHO
Members to make interventions again. “I really want my Member States to
take a comprehensive view of what can be acted on and what needs further
discussion”, she said, further adding, “What are some of the things not
done because of the lack of resources and no consensus. It’s time we bring
the issues together”.

Brazil, given the floor after the adoption of the Chairman’s proposal, said
that it would have liked to support the original proposal of the African
region prior to the decision of the Board, adding it will take the matter
up during the WHA along side 193 of WHO’s Members. It called the Chairman’s
proposal a “second best option” as the topic of shortage of medicines and
access to medicines are not related. Brazil highlighted that it will result
in a “skewed treatment” of access to medicines issues, if the subject is
associated with shortage of medicines as “we might end up with a discussion
on fair pricing which would be a pity”.

During the course of its proceedings, the Executive Board also heard
multiple calls from WHO Members for in-depth discussions on the
recommendations of the UNHLP report.

On 12 September 2016, eleven WHO Member States of the South-East Asia
Region supported by Brazil, Iran and South Africa requested to place an
item entitled “Report of the UN Secretary-General’s High-Level Panel on
Access to Medicines” on the agenda of the 140th Executive Board session.
However, the WHO Secretariat and five Officers of the Board (which includes
the US) rejected this request without providing any valid reason.

At the start of the Board meeting, India again highlighted its concern over
the non-inclusion of a specific agenda item on the UNHLP report.

India pointed out that “The report of the High Level Panel addresses some
of the long-standing problems facing medical innovation and access to
medicines. The UN Secretary General has welcomed the report and called for
broader discussions on its findings and recommendations. The recent (UN
General Assembly) resolution on Global Health and Foreign Policy also
encourages Member States and relevant UN agencies to discuss the report.”

It stressed that a number of international bodies, such as the UN General
Assembly (UNGA), the World Trade Organization Council for Trade-Related
Aspects of Intellectual Property Rights (TRIPS), and UNAIDS have initiated
discussions on the report” and thus “[i]t would be simply inconceivable and
inexcusable that WHO, which has a constitutional mandate to set and
coordinate global R&D efforts and which is the main UN agency that should
be at the forefront of the access to medicines agenda, does not discuss and
take appropriate follow-up actions on the UN High Level Panel report” .

India also said that “If the EB140 does not discuss the report, WHO risks
losing its leadership on such a vital global health issue. This would be a
serious setback to its credibility and integrity, particularly when it is
trying to justify an increase in its programme budget,” adding that “We
believe that an informed discussion, with an open mind, on the UN
High-Level Panel will allow Member States to consider potential innovative
approaches to address some of the persistent challenges to access to
medicines and provide appropriate directions to WHO to carry forward its
work on health innovation and access.”

However, India’s request as a non-Executive Board Member fell on deaf ears,
although other non-Members, Iran and Brazil supported it. Brazil said that
it is “inadmissible” that an organisation dedicated to health refuses to
discuss such a report.

Busuttil, the Board Chairman, offered a weak explanation. He said the
Bureau (of the Executive Board) was of the view that sufficient items on
medicines were already on the agenda and the UNHLP report could be
considered one of those. He added that the report generated divergent views
and so the chances of reaching any substantial conclusions on a way forward
seemed elusive, thus it was decided to retain the decision to discuss the
topic under existing agenda items.  Member States can then express their
opinion on the report, he said, and those opinions can be collated and for
a possible way forward to consensus and constructive discussions.

Civil society organizations (CSO) have also advocated through multiple
letters to Dr. Chan, Chair Busuttil and Executive Members for WHO to
convene discussions on the UNHLP recommendations.

During the Executive Board session itself, a letter addressed to Board
Members signed by 26 CSOs, urged WHO to facilitate the implementation of
the UNHLP recommendations. The CSO letter argued that “WHO is the primary
global agency with responsibility for global health and it should see the
UNHLP work and its recommendations as an opportunity to revive and
facilitate WHO’s work on innovation and access.”

The letter also echoed the words of the eminent jurist and UNHLP member
Michael Kirby: “… unless the UNHLP’s recommendations impinge on our hearts
and minds, a vital opportunity may be lost, perhaps forever,” and that the
WHO “cannot shirk that responsibility or surrender it to others –
trilateral or otherwise. It thus has the primary responsibility to lead for
attainment of Sustainable Development Goal 3. WHO must find its own voice
and powerfully support action on the UNHLP (report)”.

(“Trilateral” refers to cooperation among the WHO, WTO and WIPO.)

Although the UNHLP report was not reflected as a specific agenda item of
the Executive Board’s programme of work, discussion on the report was taken
up during the agenda items on GSPOA and the CEWG.

Malta on behalf of the European Union said it was committed to increasing
access to affordable medicines and finding solutions to the world’s public
health challenges and inequities based on a human rights approach, adding
that these challenges apply to all countries in all regions. It said that
the current innovation process has delivered consistent progress in global
public health, but it also recognized the challenges of high costs of
medicines for the sustainability of health systems.

It agreed with the UNHLP report’s acknowledgement that there are many
reasons why people do not get healthcare, referring to numerous factors
including exclusive marketing rights. It added that the EU favored a more
comprehensive and balanced approach, further stating that the challenge is
to strike the right balance between the need to ensure incentives for
continued innovation, to promote and finance research for new medicines, to
ensure medicines are affordable to those in need, to promote human rights
and ensure the sustainability of health systems. “We believe these goals
are not contradictory and must be pursued jointly”, it further said.

Malta referred to the agreement among EU health ministers to explore
obstacles for deploying existing medicines and to consider new solutions to
address market failure. It noted that the UNHLP Report is a “new element”
in global discussions of a complex issue. It further remarked that the EU
is ready to engage in a constructive manner within the context of GSPOA,
but also recommended WHO to continue the useful trilateral cooperation with
WTO and WIPO on these issues.

The Netherlands said it was more than ready to discuss the follow up and
implementation of the UNHLP recommendations in an open and constructive
manner. “After all the challenges described apply to all countries from all
regions”, it added, “The proliferation of high cost medicines and rising
drugs are increasing pressure on public health spending also in our
countries.” It stressed on the need to discuss the profit margins of the
pharmaceutical industry vis-à-vis other business sectors, and the
conditions under which public money is put in the development of new
medicines, as is often the case in European R&D programme. It also said it
would continue efforts to prevent TRIPS Plus provisions in free trade
agreements that are negotiated and to provide for safeguards against the
abuse of intellectual property (IP) measures and procedures for enforcing
IP rights.

However the Netherlands particularly highlighted a fair price initiative
that it is being undertaken with WHO.

Colombia said that recommendations of the UNHLP report give viable
alternatives to access to medicines and called for it to be listed on the
agenda for further discussion.

Thailand highlighted that there were two UN High Level reports before the
Executive Board and “We need to treat them fairly” referring to the UN
High-Level Commission on Health Employment and Economic Growth which was
added to the agenda of the Board and the UNHLP report that was not.

“The majority of the report is acceptable”, and the Board should consider
both with the same treatment, Thailand added, further calling for a
decision point and to emerge with a 5-year action plan.  “We are not saying
that every recommendation has to have action but we need to consult
widely,” Thailand said, adding that we may not want to act on some

Algeria on behalf of the Africa Group said that access to medicines is a
problem that affects developed nations as well as developing and puts
intolerable pressures on governments due to budgetary pressures.

Algeria stressed the difficulties faced by doctors and patients due to lack
of access to medicines that are readily available but are too expensive. It
noted that the UNHLP gives an opportunity to address this issue and that
the conclusions of the report were very important and needed to be
considered as soon as possible.

India requested WHO to adequately respond to the UNHLP since the report is
directly relevant to the GSPOA and the follow up to the CEWG.

India highlighted a number of UNHLP recommendations that merited immediate
consideration, such as countries making full use of TRIPS flexibilities;
using licensing agreements that ensure public health returns for
publicly-funded research; creating new incentives for R&D beyond patent
monopolies; coordinating and sustainably financing R&D through innovative
models; de-linking the costs of R&D from the price of medicines;
negotiating a binding R&D Convention or Agreement based on de-linkage and
other principles promoting public health, and ensuring transparency,
accountability and governance in the R&D process; governments should
require manufacturers and distributors of health technologies to disclose
to drug regulatory and procurement authorities information pertaining to
the costs of R&D, production, marketing and distribution of health
technology being procured or given marketing approval with each expense
category separated; and any public funding received in the development of
the health technology including tax credits, subsidies and grants.

The UNHLP report recommends inter alia that building on the current
discussions at the WHO the UN Secretary-General should initiate a process
for governments to negotiate global agreements on the coordination,
financing and development of health technologies, including a binding R&D
convention that delinks costs of R&D from end prices to promote access to
good health for all.

India emphasized that without comprehensively addressing the issue of
access to medicines and vaccines guided by the principles of affordability
and equity, we would not be able to achieve the Sustainable Development
Goals and Universal Health Coverage.

India proposed a web-based consultation with Member States before the 70th
WHA, on the UNHLP recommendations and the convening of an open-ended
meeting of Member States by the 70th WHA to discuss the recommendations and
other relevant recommendations in the CEWG report.

Iceland speaking also on behalf of Norway said that there was a need for a
public health approach to intellectual property.

Brazil stressed that the UNHLP report was convened by the Secretary-General
of the UN and has a broad constituency, adding that that the UNHLP report
relates to several agenda items  of the WHO that were discussed, GSPOA,
Sustainable Development Goal alignment process with health targets, and
shortage of medicines. It pointed out that the development of the report
included an advisory group of experts which was enlarged to appease some
Member States.

Brazil further said “We aren’t seeking an endorsement of the content of the
report” or for it to become an official document of the WHO, adding that,
“certain issues that are in there we would like to be in a position to find
a venue within WHO to have a discussion. (That) is basically it”.

Iran stressed that access to medicines a right and intellectual property
impedes access to affordable drugs. It said that there is a need to
seriously consider the UNHLP recommendations and to make them a reality. It
urged the convening of an open-ended meeting to discuss the recommendations
of the UNHLP.

South Africa said that the UNHLP report is an opportunity to improve access
to medicines. It called for consideration of the report adding that it did
not expect all the recommendations to be adopted. It further said that
discussing the report may help find solutions to current problems.

The US, Japan and Switzerland were the few countries that opposed taking
forward the UNHLP report.

The US said that the report had a narrow mandate and does not address
critical facets of the complex problem of promoting innovation and access
to medicines. It added that the panel was unable to find consensus on key
recommendations with two of the panelists which had the most extensive
experience in managing R&D portfolio warning that the report’s
recommendations could result in serious negative unintended consequences
for R&D.

The US countered that the UNHLP was not a Member State-driven process and
had no mandate from the UN General Assembly, adding that the report’s
criticism of US policy on management of IP for research in the public
sector was “misguided”.

Japan and Switzerland offered arguments similar to the US, arguing that the
UNHLP report does not recognize the central role of IP in biomedical
research and development.

A source closely following developments around the UNHLP observed in
relation to the US statement that the arguments put forward by the US were
flawed. “The UNHLP report is the UN Secretary General’s report which was
undertaken through an extensive transparent, inclusive and participatory
process. To appease the US, the advisory group to the panel of experts was
expanded to include industry representatives and the panel also includes
industry representatives. Several members of the panel offered additional
commentaries to the main high level report, and it is unreasonable to
object to discuss the recommendations of the report based on the views of
two panelists.

“The critique of the UNHLP report on US policy on management of IP is
accurate as the introduction of the 1980 Bayh-Dole Act in the United States
allows universities and public research institutions to patent the results
of federally-funded research and license private enterprises to develop
them. This results in limiting access to the results of the research and
taxpayers paying twice for the benefits of publicly-funded research.”

(*With inputs from Mirza Alas and the WHO Watch team of the People's Health

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