[Ip-health] Response to Questions and Comments on the Medicines Patent Pool-Gilead Licence

Medicines Patent Pool office at medicinespatentpool.org
Wed Jul 27 05:47:56 PDT 2011

[Re-sending, re-formatted for ip-health]

Dear IP-Health readers,

We have read with great interest the large number of comments received,
and/or circulated on list-servs on the recent licences between the
Medicines Patent Pool and Gilead from various organizations, including
communities of people living with HIV.

The licences allow for the production of the HIV medicines tenofovir,
emtricitabine, cobicistat, and elvitegravir as well as a combination of
these products in a single pill, known as the “Quad.” Details on the
licences, as well as the ful text of the agreement itself, are available
on the Medicines Patent pool website at: www.medicinespatentpool.org.

Published commentaries have reflected different perspectives on the
licences.  Some groups have welcomed the improvements over current
voluntary licensing practices.  Many have also focused on the shortcomings
of the licences, most of which were identified in the Pool’s Questions and
Answers that accompanied the announcement of the licenses.  Others have
looked at the options that are available to countries to obtain access to
affordable HIV medicines, in light of the agreement.  We share the
concerns expressed by many groups and agree that there is room for
improvement.  And we are committed to working with civil society groups to
continue to advocate for access-friendly licensing as a key mechanism to
remove barriers to access, promote generic competition and make HIV
medicines more affordable.

We believe it is important to mention the context in which the Medicines
Patent Pool operates and its mandate in order to place discussions on the
licences in perspective.  The Medicines Patent Pool negotiates voluntary
licences with patent holders aiming to create the largest possible
benefits for the largest number of people. It is, however, not in a
position to dictate terms and conditions to the licensors.  In its
exchanges with patent holders, the Pool regularly makes the case for
removing restrictions from licences, for including all low- and
middle-income countries, for enhanced transparency and for ensuring that
public health considerations guide the formulation of terms and conditions
of the licences.

In this first set of licences with a pharmaceutical company, it has been
possible to make significant improvements on previous licensing practices
in some key areas.  These include, for example:

-       the partial expansion of geographical scope, beyond that of any
other licence for HIV medicines to date (actual coverage ranges between
87.6% of people living with HIV in low- and middle-income countries for
tenofovir to 82.7% for elvitegravir);

-       the inclusion of late-stage pipeline products so that the
development of generic versions can begin immediately upon approval by the
necessary regulatory authorities;

-       the expansion of the field of use for tenofovir to hepatitis B;

-       special provisions for paediatric formulations that waive
royalties and enable sales beyond the territory of the licence;

-       provisions that allow licensees to supply countries that make use
of key TRIPS flexibilities, such as the issuance of compulsory licences;

-       provisions enabling licensees to terminate the license
unilaterally at any point in time for any reason;

-       the right of licensees to pick and choose the products for which
it wants a license (unbundling);

-       explicit waiver of any data exclusivity rights by Gilead and
future licensees; and

-       the transfer of know-how without strings attached (inclusion of
know-how transfer often results in no termination provisions, which is not
the case in these licences).

Another key improvement has been the publication, on the Pool’s website,
of the detailed terms and conditions of the licences.  This is considered
to be almost unprecedented in the pharmaceutical field for a licence
involving a commercial company, as voluntary licences are generally kept
confidential.  This has even been the case for licences on HIV medicines
issued or obtained by public organizations (a key exception is the NIH
licence with the Pool, which is also publicly available).

Making the licences public has sparked significant debate on the optimal
terms and conditions of voluntary licences. We welcome this debate. It
builds upon extensive input received from many groups while establishing
the Pool and regular ongoing dialogues with a wide range of stakeholders
and civil society groups.  It will help to keep the areas of greatest
priority to the public health community in the forefront of negotiations,
and create focus on where the Pool should continue to work to improve on
existing licensing practices.  It will also help to ensure that the
present licences represent a floor and not a ceiling for future licences.

We are also aware, however, that it has not been possible for the time
being to remove some restrictions.  These include, in particular, the
exclusion of certain countries from the geographical scope of the
licences, the restrictions on the sourcing of API and the restrictions on
the country of manufacture.  In at least these key areas, we must continue
working together to ensure that better terms and conditions can be
obtained in the future.

This is why it is important to bear in mind that in addition to the Pool,
other complementarymechanisms will continue to play a central role in
enhancing access.  The Medicines Patent Pool must be viewed in the context
of the range of different policy options available to governments and
other actors to promote access to HIV medicines.  On its own, the Pool
will not be able to remove all barriers to access.  It can make a key
difference in some areas and ensure that its licences do not hinder the
implementation of other important access mechanisms.

We are grateful to organisations that have long been advocating for patent
holders to licence to the Pool and recognize that their support has been
key in obtaining the gains that have been achieved so far. Advocating now
for greater inclusion and less restrictions in the Pool licences is
important and we welcome the comments, suggestions and concerns expressed
by a wide range of stakeholders.

We are pleased that out of 10 patent holders targeted by the Pool, 7 have
entered into formal negotiations with the Pool and/or have licensed to the
Pool. Continued support from various stakeholders is essential to ensure
we can obtain the best possibleresults in future licences.

We look forward to continuing to actively engage with civil society groups
around the world.

Ellen ‘t Hoen,
Executive Director
Medicines Patent Pool

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