[Ip-health] KEI Statement on UNITAID Decision to Approve Creation of a Patent Pool for AIDS medicines

[James Love]

http://keionline.org/dec14unitaid


KEI Statement on UNITAID Decision to Approve Creation of a Patent Pool
for AIDS medicines
By James Love
Created 15 Dec 2009 - 1:22am

On Monday, December 14, the UNITAID board passed a resolution to
establish a Patent Pool for AIDS medicines. The decision caped a
dramatic debate on the proposal, which had been before UNITAID since
2006, and had been discussed in other fora since 2002 [1]. The following
is a statement by KEI and background on the UNITAID patent pool
proposal, including a copy of the UNITAID press release.

Statement of James Love, Director of KEI, on the UNITAID Patent Pool:

   "The decision by UNITAID creates an opportunity to scale up efforts
to promote access to newer AIDS drugs in developing countries. UNITAID
will invest in the creation of a new licensing agency for patents on
AIDS medicines, with a broad geographic scope. The pool will be
voluntary, and its success or failure will depend upon the actions of
owners of patents, but also the governments and civil society that
influence patent owners.

   "The decision of December 14 was essential to authorize the creation
of the legal entity that will manage and implement the patent pool, and
it sets into motion a series of subsequent actions and policy decisions.
In the more than 7 years the patent pool for AIDS has been debated, a
number of persons, governments and other organizations (both non-profit
and for-profit) have played an important role. The UNITAID press release
notes the role of MSF and KEI in proposing the patent pool to UNITAID in
2006, and many others played key roles in advancing the patent pool
concept, including the NGO representatives from the public health and
patient communities to the UNITAID board, and the broader community of
activists, experts and company and government officials who were
supportive of this effort, many of whom submitted comments to the
UNITAID board during the years when the proposal was under
consideration.

   "KEI, operating then as CPTech, first proposed "An Essential Health
Care Patent Pool" at the XIV International AIDS Conference in Barcelona,
Spain, on July 8, 2002 [1], modeled after the Manufacturers Aircraft
Association (MAA) that was created in the United States in 1917, to
facilitate access to patents on aircraft. The MAA was created in order
to fight a conventional war, and the patent pool for medicines was
proposed to help fight a war against AIDS and other diseases. Over
several years, various versions of the patent pool were presented,
including proposals to the African Union, CARICOM, UK Commission for
Africa, to the WHO and UNITAIDS, and to many national governments and at
countless intergovernmental, academic or NGO meetings, to the point
where the "new idea" was sometimes described as an "old idea."

   "MSF's leadership in moving the pool forward was quite important,
beginning in 2006 with a series of presentations and collaborations
involving UNITAID. On the KEI staff, many people have worked on the
patent pool concept, including Manon Ress, Terry Gardiner, Jon Merz and
David Serafino, who worked on early research and design issues for
patent pools, as well as Michelle Childs, who led the KEI collaboration
with MSF involving UNITAID, and Judit Rius Sanjaun, who headed the
cluster that produced the Essential Medical Inventions Licensing Agency
[2] proposal, which remains an important plan for how to implement a
pool, including model licenses for patents and data. KEI worked with a
large number and diverse group of experts and stakeholders to develop
the EMILA proposal and the UNITAID submissions, and benefited much from
the collaborations with the many others who have worked so hard on the
UNITAID patent pool initiative. There is simply no fair way to
adequately note everyone's contributions.

   "The UNITAID decision will launch a new phase of the implementation,
and it will be a challenge for the patent pool to acquire rights from
patent owners. Recently there has been greater awareness that decisions
about geographic coverage of the market will be very important. Many
pharmaceutical companies and some donors have tried to limit the patent
pool to only very low income and smaller market countries. Some NGOs
have expressed concern that UNITAID would allow patent owners to exclude
some markets.

   "On December 14, UNITAID was clear that the patent pool would include
all developing countries, but this decision does not answer the
practical issue of responding to offers to license that are more
limited. It is the view of KEI that UNITAID should ask for rights in all
developing countries, but accept whatever the patent owner offers.
Others want UNITAID to make a non-negotiable offer for all developing
countries. If KEI thought a non-negotiable offer for all developing
countries would be successful, we would endorse such an approach. We do
not, without significant changes in the way the pool is structured.

   "KEI believes it would be a mistake for UNITAID to negotiate against
itself, and limit its initial requests to only some countries, and we
think that any classification of developing countries will be
counterproductive. But KEI endorses an approach that would allow patent
owners to license only in the countries where they are willing to make
offers. To the degree that this will result in exclusions of countries
with large markets or higher incomes, as it certain will, other measures
will have to used to expand access to the patents. These will include
actual or potential compulsory licensing actions in the countries that
are excluded, something the UNITAID board clearly endorsed, as well as
consideration of new incentives to license to the pool, which UNITAID
also will consider. In regard to incentives, KEI is a strong supporter
of the so called "donor proposal" as was submitted to the WHO by
Bangladesh, Barbados, Bolivia and Suriname, that would combine donor
funded prize funds with licensing to the patent pool. KEI believes it is
possible to have inclusive coverage of all important patents for AIDS
and other diseases addressed by UNITAID to all developing countries, if
the donor proposal is implemented and supported by the United State and
European governments to the degree that developing countries are no
longer subject to pressure and trade sanctions on medical patent issues.

   "UNITAID and all supporters of the UNITAID patent pool have been
clear that the pool should not tolerate discriminatory licensing as
regards to generic producers. The pool should and we predict will follow
an open licensing model, offering access to patents and other
intellectual property on a non-discriminatory basis to qualified
manufactures of products.

   "None of the forward looking challenges will be easy. UNITAID is
blessed with a talented and courageous staff and enlightened and
innovative board of directors, and we look forward to working with both
going forward.

   "A number of NGOs have recently raised important criticisms about the
patent pool and the process, and as the pool moves forward it is
important to expand the transparency of the patent pool initiative, and
to ensure that all patient and public health groups, generic drug
producers, academic experts, governments and other concerned about,
interested in and impacted by the pool will have the effective
opportunity to review, comment and influence outcomes, including the
many policy decisions will be made in the next 12 months.

   "KEI will publish a number of technical notes on the patent pool in
coming months, and will also explore the use of patent pools and other
collective management approaches to intellectual property for areas
outside of the treatment AIDS or access to anti-retroviral drugs.

The following is the UNITAID press release on the pool:


UNITAID EXECUTIVE BOARD APPROVES BREAKTHROUGH PLAN TO MAKE AIDS
TREATMENT MORE WIDELY AVAILABLE AT LOWER COST

PATENT POOL COULD SAVE OVER ONE BILLION DOLLARS A YEAR

Geneva, 14 December 2009 =E2=80=94 Today UNITAID's Executive Board made a
landmark decision to establish a Patent Pool for AIDS medicines. The
pool, scheduled to start operating in mid-2010, aims to make newer
medicines available in patient-adapted form, at lower prices, for low-
and middle-income countries. UNITAID has committed to provide start-up
funds of up to US$ 4 million over the next year. Expected savings exceed
one billion dollars a year, which will make more medicines available for
more people.

=E2=80=9CThis is an historic day,=E2=80=9D said Philippe Douste-Blazy, Chai=
r of
UNITAID's Executive Board. =E2=80=9CUNITAID has now put in place a mechanis=
m
that will make medical advances work for the poor, while compensating
companies for sharing their technology.=E2=80=9D

The Patent Pool will allow generic companies to make lower cost versions
of widely patented new medicines by creating a common space for patent
holders to license their technology in exchange for royalties. This will
spur competition and further bring down the price of vital new and
effective medicines, giving hope to millions of patients. Companies with
which UNITAID has had consultations include Gilead, Tibotec, Merck and
Sequoia.

UNITAID has identified 19 products from nine companies for potential
inclusion into the pool. The pool will facilitate the development of
fixed-dose combinations (FDCs). For some years now clinical evidence has
revealed that these combinations are the best way for patients to access
safe, effective treatment. Until now, patents have created barriers to
developing FDCs combining newer and more effective drugs from different
companies. Today, with the first concrete step in the realisation of the
Patent Pool, the door is open for new FDCs to enter the market.

=E2=80=9CFDCs are especially important in the treatment of children, who ma=
ke up
10% of current treatment needs,=E2=80=9D said Jorge Bermudez, UNITAID Execu=
tive
Secretary. =E2=80=9CThe Patent Pool will greatly help us accomplish our mis=
sion
of scaling up treatment access, particularly for specific target groups
otherwise neglected by the market =E2=80=93 that is, children and people wh=
o
fail on older therapies.=E2=80=9D

The idea of a Patent Pool has been in discussion for a number of years.
In 2006, Knowledge Ecology International and M=C3=A9decins Sans Fronti=C3=
=A8res
proposed it to UNITAID. Today UNITAID has become the first international
body to translate this idea into reality.

=E2=80=9CToday is a good day for people living with HIV/AIDS in developing
countries,=E2=80=9D said Nelson Otwoma, the HIV/AIDS community representati=
ve on
UNITAID's Executive Board. =E2=80=9CWhen my son was a baby we had to break
pieces of adult tablets for him - treating him was guess work. The Pool
gives me hope that we'll have better medicines to treat children in the
future.=E2=80=9D

=E2=80=9CWe=E2=80=99ve had enormous interest from companies and political s=
upport from
numerous constituencies around the globe,=E2=80=9D said Ellen =E2=80=98t Ho=
en, in charge
of the Patent Pool for UNITAID. =E2=80=9CWe're now ready to move to the nex=
t
phase - reaching agreements with companies to get the drugs out.=E2=80=9D

Contact: Daniela Bagozzi, UNITAID Communication, Te. +41 22 791 45 44;
Mob. +41 79 475 54 90; Email bagozzid@who.int [3]
Ellen 't Hoen, UNITAID Patent Pool, Tel. +41 22 791 18 20; Mob. +41 79
509 06 79; Email thoene@who.int [4]

www.unitaid.eu/en/The-Medicines-Patent-Pool-Initiative.html [5]

www.unitaid.eu


--
James Love, Director, Knowledge Ecology International
http://www.keionline.org | http://www.twitter.com/jamie_love
Wk: +1.202.332.2670 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.=
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