[Ip-health] Medicines Patent Pool and UNITAID response to the ITPC letter of 10 October
kmara at medicinespatentpool.org
Tue Nov 1 04:45:10 PDT 2011
Please find below the response of the Medicines Patent Pool and UNITAID to
the ITPC Letter of 10 October.
A detailed response by the Medicines Patent Pool to the technical concerns
raised in the ITPC letter may be found on the Pool's website here:
Additional information on the Pool- Gilead licences is available from our
Q&A, now available in Spanish and in French, and from a document answering
frequently asked technical questions on the implications of the licences.
The Q&A is here:
The FAQ is here:
Geneva, 26 October, 2011
Dear Signatories of the ITPC Letter,
Thank you for your letter of 10 October 2011, following on from the
meeting that took place in Geneva on 2 October 2011 between UNITAID, the
Medicines Patent Pool and several representatives from civil society
We would like to assure you of our ongoing commitment to a meaningful
engagement with civil society groups. We take comments of civil society
groups very seriously and welcome your continued contributions through
constructive discussions regarding the scope and implementation of the
We are disappointed to note that following on from our recent meeting, you
continue to feel that the agreement between the Pool and Gilead Sciences
does not substantially increase affordable access to medicines for people
living with HIV. As you know, we share some of the concerns you have
raised regarding the terms of the Gilead license. We therefore
acknowledge the need to continue working to improve the terms of this and
future licenses, in accordance with the Pool's mandate. However, we
remain confident that the Gilead license represents a significant step
forward in promoting access to affordable HIV medicines in the developing
world and should not be substantially revised or terminated.
In addition, we also disagree with the analysis presented in your letter
regarding some of the broader implications of the Gilead-Patent Pool
license. A detailed note prepared by the Pool addressing the substantive
concerns regarding the broader implications of the license is attached to
this note. [available online here:
We have and will continue to welcome inputs from a wide variety of
stakeholders. We recognize the need for the Pool to broaden its
stakeholder engagement and consult a larger constituency of civil society
representatives. As we work with you and others to put in place measures
to ensure broader consultation and greater transparency, the Medicines
Patent Pool will continue in its core work of negotiating voluntary
licenses from a public health and enhanced-access perspective.
With reference to your question of why the Pool signed the license with
Gilead, there are a number of key features that represent important
achievements in enhancing access. These can be summarized as follows:
expansion of the geographical scope of the license with respect to
existing licenses, resulting in the broadest geographical coverage of any
license to date (all PLHIV in low-income countries and over 75% in
middle-income countries); inclusion of new molecules in development;
expansion of the tenofovir part of the license to benefit hepatitis B
patients; provisions enabling licensees to supply any country issuing a
compulsory license; waiver of data exclusivity provisions; special
provisions for pediatric formulations (royalty free); reduction in
royalties from 5% to 3% for tenofovir; inclusion of termination
provisions; unbundling of products allowing the licensees to pick and
choose the licenses they need; full transparency of the license through
its publication on the Medicines Patent Pool¹s website, which is
unprecedented. Many of these features are explained in more detail in the
Q&A published on the Pool¹s website.
The above features of the license represent improvements on licenses that
Gilead had in place before. In addition, some positive features already
in the previous licenses also remain in place, such as the absence of
no-challenge clauses, the transfer of know-how, ability to develop
combination products and others. Nevertheless, some of the challenges of
the previous Gilead licenses are still present, i.e., limitations on the
sale of active pharmaceutical ingredient to licensees based in India and
the fact that not all low-and middle-income countries have been included
in the scope. These are areas in which the Pool did not manage to
overcome differences with Gilead, and were openly discussed
by the Pool since the first publication of the license in July 2011.
Nevertheless, the range of improvements led the Pool Board to decide to
sign the agreement.
It is important to remember that the Pool is a voluntary mechanism, which
represents but one tool among many that can improve access to HIV
medicines. The Pool does not replace other mechanisms, nor does it address
all the IP-related access challenges faced today. A core mandate of the
Pool is to ensure that its work does not hamper the ability of others to
utilize alternative mechanisms, such as the use of TRIPS flexibilities,
and we strongly feel that we have abided by this mandate.
When deciding to sign the license, the Medicines Patent Pool Board worked
on the basis of an assessment framework that included analysis of:
(1) whether the license represented a significant improvement on the
pre-existing situation for as many countries as possible;
(2) whether it met the requirements of the memorandum of understanding
(MOU) signed with UNITAID and the Statutes of the Medicines Patent Pool;
(3) whether it allowed countries making use of TRIPS flexibilities (e.g.
compulsory licenses) to benefit from the availability of generic suppliers.
The Board also benefitted from the advice from an ad hoc Expert Advisory
Group that was convened for the purposes of reviewing the license.
The recent uptake of the Pool license by two companies including one major
generic manufacturer is an important step forward and evidence that
generic companies are interested in making use of some of the
flexibilities licenses negotiated by the Pool.
The involvement of civil society organizations has been significant in the
development of the Pool by UNITAID. The UNITAID NGO and Communities
delegations played a major role in the two-year discussions within the
UNITAID Board that led to the establishment and definition of the mode of
operation of the Pool. Since the Pool became an independent institution
in November 2010, regular briefings and discussions have continued with
the UNITAID Civil Society delegations.
The Pool acknowledges however the need to enhance and formalize its
consultative processes to enable input from a wider range of civil society
stakeholders. While the UNITAID civil society delegations will continue
to be a key counterpart, given UNITAID¹s role as funder of the Pool, it is
important that more systematic consultative processes be developed with
civil society institutions around the globe. The Pool will therefore
engage with various
civil society organizations and networks to develop a process that is
appropriate to its size and mandate.
The Pool will expand its Expert Advisory Group to include more people from
the communities of people living with HIV. In addition, the Pool will
increase transparency with respect to the Board¹s decision-making process
and assessment framework for taking decisions concerning any licenses
negotiated by the Pool.
We look forward to further discussions with you and other stakeholders on
how we can work to strengthen the Pool¹s consultative process towards our
common goal of enhancing access to affordable HIV medicines in developing
Ellen Œt Hoen Denis Broun
Executive Director Executive Director
Medicines Patent Pool UNITAID
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