[Ip-health] 9 November 2016 - WTO TRIPS Council - WHO's intervention on the Report of the UN High-Level Panel on Access to Medicines

Thiru Balasubramaniam thiru at keionline.org
Thu Nov 10 01:08:30 PST 2016


Submitted by thiru <http://keionline.org/user/6> on 10. November 2016 -

On Wednesday, 9 November 2016, the World Health Organization (WHO)
delivered the following statement to the World Trade Organization's (WTO)
TRIPS Council's discussions of the United Nations Secretary-General's High
Level Panel Report on Access to Medicines.


8-9 NOVEMBER 2016



Thank you very much for giving WHO the opportunity to share our feedback on
the Report of the High-Level Panel on Access to Medicines.

In 2016, the UN Secretary General convened the High-Level Panel on Access
to Medicines “to review and assess proposals and recommend solutions for
remedying the policy incoherence between the justifiable rights of
inventors, international human rights law, trade rules and public health in
the context of health technologies.” WHO was not part of the Secretariat to
the Panel, but the Organization had the opportunity to participate in
discussions through membership in the Expert Advisory Group, and made two
submissions to the Panel, one jointly with UNIDO focusing on local

The HLP issued its report on 14 September 2016, and its conclusions are
sobering. “Millions of people continue to suffer and die from treatable
conditions,” the report observes, “because of a lack of access to health
technologies.” Pharmaceutical research still focuses disproportionately on
the treatment of diseases that are common in the developed world,
neglecting those that primarily afflict the world’s poor.

The report thus echoes conclusions of previous reports done under the
auspices of the WHO, which draw attention to disparities in the R&D system
and lack of access to essential medicines.

I will go through the different recommendations, in particular those that
are directly addressed to WHO and share with you information on relevant
WHO activities and future plans:

Let me start with the recommendations on intellectual property laws and
access to health technologies:

The Report reiterates many recommendations that can be found in in the WHO
Global Strategy and plan of action on public health, innovation and
intellectual property. Many of its recommendations are in line with a
number of WHO resolutions, including those that encourage WTO Members to
make full use of TRIPS flexibilities. Consistent with its mandate, WHO will
continue to provide support to its Member States—upon request, and in
coordination with other intergovernmental organizations—on implementing and
using TRIPS flexibilities to facilitate access to essential medicines.

The Panel recommends that UNCTAD, UNDP, WHO, WIPO, and WTO should cooperate
with other relevant bodies with the requisite expertise to support
governments to apply patentability criteria that are sensitive to public
health concerns. We welcome that recommendation; indeed, we are already
working closely with our UN partners. Most recently, we have joined with
WTO, WIPO and UNCTAD to provide advice to the South African government as
it rethinks its intellectual property policy. In 2007, ICTSD, UNCTAD, and
WHO published draft guidelines on how to bring a public-health perspective
to bear on the examination of pharmaceutical patents. We will continue to
work closely with our partner agencies and entities that have relevant
expertise, including national or regional patent offices.

I will now turn to the recommendations with respect to publicly funded
research. Here too, we applaud the recommendations of the Panel that public
funding should be better-targeted to support public health needs. We also
agree that the fruits of that publicly financed research should be made as
widely available as possible.

WHO shares the view of the Panel that new incentives for R&D of health
technologies are needed.

The Report positively acknowledges two recent major WHO initiatives:

   - the Global Antibiotic Research and Development Partnership a joint
   venture of WHO and the Drugs for Neglected Diseases initiative, which we
   presented yesterday, as well as
   - the R&D Blueprint, a global strategy and preparedness plan that
   fosters R&D activities with respect to pathogens with pandemic potential.
   The aim of the Blueprint is to accelerate the development of effective
   tests, vaccines and medicines to save lives, prevent large scale epidemics
   and minimize socio-economic disruption of an outbreak.

The Panel furthermore urges the UN Secretary-General to 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 the cost of R&D from end prices to promote access.
The Panel thus reiterates the main recommendation of the WHO Consultative
Expert Working Group on Research and Development: Financing and
Coordination (CEWG). The Panel is optimistic that an R&D treaty has
“increasingly gathered support” since it was first proposed by the CEWG. An
R&D treaty has indeed earned strong support from civil society
organizations, and may be again discussed in the coming months in WHO
Governing Bodies’ meetings.

In the framework of the follow-up of the CEWG, WHO member states have taken
action to improve priority-setting and coordination of R&D activities. They
have requested the WHO Secretariat to establish a Global Health R&D
Observatory to provide data on R&D activities and allow the identification
of R&D gaps. Once gaps are identified, priority-setting will be undertaken
by a new, independent WHO Committee on R&D Coordination that will be
established in the first quarter of 2017. The Observatory and the new R&D
Coordination Committee will be discussed by the upcoming Executive Board
meeting in January 2017.

Under the chapter on governance, accountability and transparency the Panel
calls on governments to review the situation of access to health
technologies in their countries in light of human rights principles and to
strengthen the national level policy and institutional coherence between
the different policies by establishing national inter-ministerial bodies.
The latter reiterates a recommendation of the WHO Global Strategy.

With respect to Multilateral organizations, the Panel recommends setting up
an independent review body to assess progress on health technology
innovation and access under the 2030 SDG agenda. The Panel also recommends
establishing an inter-agency taskforce to work towards increasing coherence
among international organizations. WHO jointly with WIPO and WTO has
already established a trilateral working group on questions pertaining to
access to medicines, leading to increased coherence and collaboration among
the three organizations. An informal all-agency discussion on trade,
health, and intellectual property policies is planned for December 2016 in

With respect to R&D, production, pricing and distribution of health
technologies, we welcome the call of the Panel for more transparency of
production and R&D costs, including contributions of the public sector. The
Panel also calls for an expansion of the WHO Global Price Reporting
Mechanism, which has already been expanded to include hepatitis C. WHO will
consider expanding the GPRM to include more patented essential medicines.
However, it is not practically feasible to establish a database of all
prices worldwide of all patented and generic medicines in the public and
private sector and given that many prices currently are not transparently
available; it may not be meaningful. WHO has already moved forward on
assessing the production cost of essential medicines which will allow
procurement agencies to better assess their performance and contribute to
the overall objective of transparency.

The WHO supports the Panel’s recommendation to require the disclosure of
unidentified data from all completed and discontinued clinical trials,
regardless whether the results are positive, negative, neutral, or
inconclusive. The WHO’s Clinical Trials Registry Platform is one of the
international instruments facilitating such disclosure.

With respect to the recommendation on Patent information, we again fully
support the move toward more transparency. WHO has published a number of
patent reports—including on Hepatitis C. In enhancing transparency,
however, it is important to draw on the experience of other organizations
that work in this area in order to meet the needs of particular users.
Efforts should be made to build on existing databases, in particular the
one managed by the Medicines Patent Pool, to avoid duplication of effort
and ideally create a one-stop shop for the public-health community.

I would like to end my intervention by reiterating WHO’s commitment to
continue to work at the intersection of public health, trade and
intellectual property, in collaboration with all relevant partners.

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