[Ip-health] APN+ concerns on the Patent Pool Implementation Plan

[Kajal Bhardwaj]

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[ Picked text/plain from multipart/alternative ]




Asia Pacific Network of
People Living with HIV/AIDS (APN+)

51/2, 3rd
Floor, Ruam Rudee Building
III

Soi Ruam Rudee, Ploenchit Road,
Lumpini,

Pathumwan, Bangkok, 10330 Thailand

Tel: +662 255
7477-78, Fax: +662 255 7479

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10th December, 2009



UNITAID Executive Board

World
Health Organization

20, avenue Appia

CH-1211 Geneva 27

Switzerland



Dear UNITAID
Executive Board,



I write to you on behalf of the Asia-Pacific Network of People living with =
HIV
(APN+). APN+ is the network of PLHIV living in Asia Pacific region. It was
established in 1994 at a meeting in Kuala
  Lumpur by 42 PLHIV from eight countries. Among our key
objectives is to provide a collective voice for PLHIV in the region and to =
support
better access to treatment and care.

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APN+ is deeply
concerned about the Implementation Plan for the UNITAID Patent Pool. We
apologise for writing to you so close to the Board meeting; however we did =
not
have any opportunity prior to this to convey our concerns or be consulted o=
n
the actual plan for setting up the Pool.

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We understand that
on 14-15 December 2009, the UNITAID Executive Board will take the important
decision on the Patent Pool after careful and detailed scrutiny of the Pate=
nt
Pool Implementation Plan. We are also aware that the objective of such a Pa=
tent
Pool is to address the lack of affordable medicines for a disease predomina=
ntly
affecting millions of poor people in the developing world.=C2=A0

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In this regard, we put
down our main concerns:

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WILL ALL DEVELOPING COUNTRIES BE COVERED BY THE POOL? UNDER WHAT CONDITIONS=
?

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We are extremely
concerned that the UNITIAD Patent Pool should not exclude any developing co=
untries; it should further not impose additional conditions or requirements=
 on governments of
these countries to take actions to ensure that their country is included in=
 the
Pool.

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This issue is
critical; we know this because from the 29 countries from where APN+ member=
s
are drawn, 15 are classified as middle income countries. These are:

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China, Fiji, India, Indonesia, Iran, Malaysia, Mongolia,
Pakistan, Papua New Guinea, Philippines, Samoa, Sri Lanka, Thailand, East T=
imor,
Vanuatu

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In this regard, we
appreciate the recent statement of the UNITAID Board Chairperson that, =E2=
=80=9Cthe Patent Pool plan aims to enable both
low- and middle-income countries to benefit from the work of the Patent Poo=
l.=E2=80=9D=C2=A0

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However, our
concerns in this matter have increased since MSF has put out a press releas=
e
that states: =E2=80=9CInternational
medical humanitarian organisation M=C3=A9decins Sans Fronti=C3=A8res (MSF) =
is concerned
that a number of pharmaceutical companies are seeking to exclude developing
countries categorised as =E2=80=98middle-income=E2=80=99 from benefiting fr=
om medicines made
under licence from the Pool.=C2=A0If they are successful, people living wit=
h
HIV/AIDS will be made to pay the price.=E2=80=9D[1]

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Further, an article
in the Lancet reporting an interview with UNITAID confirms that, =E2=80=9C=
=E2=80=9Ca big sticking point=E2=80=9D for stakeholders, is
the scope of the patent pool in terms of countries. Patent owners seek to m=
ake
profits from sales to middle-income countries and would like restrictions o=
n
generic sales to these countries, while generic manufacturers are keen that
such countries are included in the pool to increase the volume of their sal=
es. One option under discussion is an opt-out
clause for patent owners specifying certain countries. UNITAID is keen for
stakeholders to define the terms of the patent pool themselves, given what
experience and concerns each party =E2=80=9Cbrings to the table.=E2=80=9D[2=
]

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We trust that based
on the statement of the UNITAID Board Chairperson, this opt-out clause will=
 now
be removed from the Patent Pool Implementation Plan. We are also compelled =
to
state once again that the Pool should not create additional requirements on
governments of developing countries to convince patent owners to put their
patents in the Pool. This is the reason we ask under what conditions will a=
ll
developing countries be included in the Pool. We must avoid a situation whe=
re
patent-owners can blame governments of developing countries for not creatin=
g
the conditions necessary for them to be part of the Pool.

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In this regard, we
would also like to point out that including all developing countries in the
Pool is important not just from the point of view of access to the medicine=
s in
the pool but also for production of these medicines. For many of the countr=
ies
in the Asia-Pacific region, local manufacturing is the key to ensuring acce=
ss
to treatment in those countries. Thus, the Pool should avoid creating a sys=
tem
that relies only on the import of generic medicines and must take concrete
steps to ensure local production as well.=C2=A0=C2=A0
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Countries in the Asia-Pacific region have seen the
impact of allowing companies to pick and choose countries for their volunta=
ry
licences. We bring to your attention Gilead's voluntary licence for tenofov=
ir that has excluded key
countries in Asia. For some that have been
included like Thailand,
Gilead has also used the VLs as an opportunity to prevent local production =
in Thailand by not
offering the VL to the Thai GPO and only offering it to Indian generic
companies. This means that Thailand
has to import generic tenofovir from India
and cannot make it within the country.

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WILL THE POOL UNDERMINE THE USE OF PUBLIC HEALTH SAFEGUARDS?


The governments and
positive networks of many of the APN+ members are struggling with the
implementation of the TRIPS regime and its impact on access to medicines.

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Again we express our
appreciation for the statement of the UNITAID Board Chair that the Patent P=
ool,
=E2=80=9Cin no way means to replace or override=E2=80=9D
the Doha Declaration and that it is an =E2=80=9Cadditional
tool,=E2=80=9D for increasing access to HIV treatment. However, the experie=
nce for
countries in using TRIPS flexibilities has shown that those whose interests=
 lie
in the promotion of an inequitable patent system will use every possible av=
enue
to put pressure on developing country governments to prevent the use of the=
se
flexibilities.

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Our concern remains that patent-owners,
associations of multinational pharmaceutical companies and even the governm=
ents
of some developed countries will use the existence of the Patent Pool to op=
pose
the use of safeguards like compulsory licensing,
pre-grant oppositions, and patent revocations. We look forward to hearing f=
rom
the Board what specific safeguards will be included in the Patent Pool
Implementation Plan to prevent this misuse by patent owners.

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The experience of Thailand in
trying to negotiate with patent owners would be a useful guide in this rega=
rd.
These negotiations got extended to two years. One of the measures the UNITA=
ID Patent
Pool could take is to have strict time restrictions on negotiations.=C2=A0 =
The other could be to ensure absolute and
complete transparency so that we, as civil society and patients waiting for=
 the
drugs and our governments know exactly where we stand in these negotiations=
.

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We hope you will
appreciate our concerns in this regard as many of us have experienced first
hand the result of the manipulation of multinational pharmaceutical compani=
es
through greater enforcement of their patents or voluntary licensing to keep
crucial medicines out of the reach of patients. Voluntary licensing in our
experience has had limited benefits for a limited time for a limited number=
 of
people. We appreciate that the UNITAID Patent Pool will attempt to correct =
some
of these issues with voluntary licences and in doing so, we hope that they =
will
rely on some of our experience in this regard.

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What is being
considered by the UNITAID Executive Board is the investment of several mill=
ions
of dollars to create a mechanism to ensure greater access to treatment. Thi=
s
investment will be wasted if the actual functioning of the Pool is unable t=
o
escape or improve on some of the worst aspects of the TRIPS regime.



>From APN+ we request that the UNITAID Board examine critically what the imp=
act
of the Patent Pool will be on the use of TRIPS flexibilities by developing
countries and to ensure that it does not inadvertently legitimise the actio=
ns
of the multinational pharmaceutical industry to use patent monopolies to
control our access to treatment. Thus, we still believe that the UNITIAD Bo=
ard
has to consider carefully the questions and concerns we have raised in this
letter.=C2=A0

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Sincerely yours,

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Shiba Phurailatpam

Regional Coordinator

On behalf of APN+

Tel: +66 (0) 2255-7477

Fax: +66 (0) 2255-7479

Email: shiba@apnplus.org


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[1] MSF, UNITAID
Patent Pool: Key Developing Countries at Risk of Being Excluded, 8 December=
 2009

[2] Kelly Morris,
HIV drug patents in the spotlight, The Lancet Infectious Diseases, Volume 9=
,
Issue 11, November 2009