[Ip-health] UNITAID Civil Society Delegations communique - Board special session on Patent Pool - 5th February 2010

[Jessica Hamer]

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UNITAID ? Executive Board Special Session on Patent Pool

5th February 2010, WHO, Geneva, Switzerland

Civil Society Delegations Communiqu=E9


Outline of this Communiqu=E9:
Introduction (Reminder)
Background: UNITAID Board Special Session on Patent Pool
What were the Civil Society delegates? key issues at the UNITAID special
Board session on Patent Pool?
What were the outcomes of the February 5th UNITAID Board meeting on Patent
Pool?
Next steps for the Civil Society delegations

Introduction (Reminder)

What is UNITAID and what are the UNITAID Civil Society delegations?
UNITAID is an international drug-purchasing facility, intervening for
market impact to scale up access to prevention and treatment products of
HIV and AIDS, TB and malaria in developing countries. UNITAID raises money
through a combination of taxes on airline tickets and long-term government
funding.  UNITAID is also a vehicle to encourage follow-on innovation, to
ensure medicines are available in formulations and combinations that are
best suited to the target populations and treatment conditions in
developing countries.

The UNITAID Board has 10 seats, including a seat for communities affected
by HIV, TB or malaria, and another seat for NGOs involved in the global
fight against these diseases. The Communities and NGO delegates to the
UNITAID Board form the Civil Society delegations. Three stakeholder groups
facilitate the engagement of Civil Society with the UNITAID Civil Society
delegations: 1) Advisory Group (a group of Northern and Southern experts
with particular knowledge of issues relating to access to medicines), 2)
Communities? Support Team (a small group of local community
treatment/access activists) and 3) Contact Group (a broad group of
interested parties who receive regular information on the delegations?
activities). Please contact the delegations? Liaison Officer for more
information on engaging with these groups.

This communiqu=E9 is to report back about the activities of the Civil
Society delegates at the recent UNITAID Board Special Session on Patent
Pool (5th February). This is part of the transparency and accountability
mechanism set up by Communities and NGOs who follow UNITAID closely. A
process of document review with the delegation?s Advisory Group was also
conducted prior to this meeting, and utilised in the development of the
delegations? talking points (see annex I).

Background: UNITAID Board Special Session on Patent Pool

The Patent Pool Implementation Plan (
http://www.unitaid.eu/images/meetings/ForWebsite_UNITAID_Patent_Pool_Implem=
entation_Plan_-_Executive_Summary.pdf
) was presented and discussed at the December 2009 UNITAID 11th Executive
Board meeting. A resolution was passed allowing the Secretariat to proceed
with the next steps of establishing a separate legal entity for the Patent
Pool. Further analysis of the Patent Pool?s governance structure was
requested, and was to be presented at the Board special session on
February 5th 2010.

The Civil Society delegations held an open teleconference (with an
invitation circulated to the delegations? three stakeholder groups, and
others who have engaged with the delegations) on 29th January 2009 to
discuss issues of the Patent Pool with broader civil society. Please
contact the Liaison Officer for details of this conference call. Please
also see annex II for two emails circulated to civil society on the Patent
Pool, before and after the December Board meeting discussions? of the
Patent Pool Implementation Plan.

What were the Civil Society delegates? key issues at the UNITAID special
Board session on Patent Pool?

Both the Communities and NGO delegates to the Board see the Patent Pool as
a key deliverable of UNITAID to reduce ARV prices, to remove patent
barriers against price reductions, and to facilitate development of needed
new formulations.

The key goal for the Communities and NGO delegations with regard to the
Patent Pool is to ensure that UNITAID does not miss this window of
opportunity to effectively implement the Patent Pool, generate licenses,
and increase the market availability of generic versions of recent or
missing ARVs.

The civil society constituents who attended the January 29th
teleconference were very supportive of the delegates? position. The
delegations are organising a further conference call on Thursday 25th
February, at 2pm UK time, to keep the constituency discussion on the
Patent Pool strategy open, and to avail themselves of the best
intelligence possible (please contact the Liaison Officer if you are
interested in participating in this).


What were the outcomes of the February 5th UNITAID Board meeting on Patent
Pool?

Key issues discussed at this meeting, input of the Civil Society
delegations, and outcomes, are outlined below:

Legal analysis for the establishment and governance of a legal entity for
the Patent Pool and relationship between Patent Pool and UNITAID

The presented option for the establishment of the Patent Pool was an
independent Swiss foundation. The option of hosting the Patent Pool at
UNITAID/WHO was stated to be inappropriate given the quasi-commercial
nature of the Pool, as the WHO is an intergovernmental organisation. This
will expose the WHO to potential litigation, which would have to be
mitigated by insurance at an unknown cost, and would be complicated by
WHO?s benefits from UN immunities and privileges. WHO may also have to be
involved in litigation to enforce the terms of any licenses which were
agreed, if necessary, and this too was felt not to be appropriate for the
WHO.

There was consensus that the relationship between UNITAID and the Patent
Pool should be close and well defined. It was agreed that this close
relationship would be maintained through:

Mission of the Patent Pool being closely aligned with UNITAID
Contract between Patent Pool and UNITAID (relating to UNITAID?s funding of
the Patent Pool)
UNITAID observer seat on Patent Pool Board
Elements of UNITAID?s constitution/strategy should be reflected in the
contract and statutes of the Patent Pool.

The NGOs delegation stressed the importance of upholding the principles of
UNITAID but that there was an urgency of moving forward with the Patent
Pool to maintain the momentum and keep the pressure on the rights holders.
The biggest risk here, by far, is to miss the political window of
opportunity, and end up with nothing at all. For the UNITAID Board to
attempt to micromanage the Patent Pool could damage the process of
establishing and running the Pool, and could push the initiative outside
the current political space.

The civil society delegations? joined the rest of the Board in supporting
the Secretariat?s proposal that the Patent Pool be set up as a Swiss
Foundation. NGOs emphasised the importance of establishing the entity
quickly, increasing access to medicines for those who need them.

Outcome: The establishment of a Patent Pool as a Swiss foundation was
approved. Due to late arrival of the draft resolution on the eve of the
Board meeting, formal approval was allowed to be postponed by 2 weeks.


Concerns raised

Concerns were raised about issues related to the Patent Pool and access to
medicines especially that the Patent Pool should consider provisions to
address the following:

Technology transfer
Local production
Royalties will not be paid for frivolous or non existent patents
Ever-greening will not take place
Licenses must be on a non-exclusive and non-discriminatory basis
Patent Pool will not undermine the provisions for access to medicines
under TRIPS
Patent Pool must be for all developing countries (i.e. must include all
lower and middle income countries)
Transparency


The civil society delegates fully support the sentiments behind these
concerns.

The civil society delegates feel very strongly that the need to seize the
opportunity offered by the current build-up in Patent Pool momentum should
be maintained, and that the drafting of the MOU and statutes to address
board concerns should be progressed quickly.

Outcome:
An annex was added to the resolution stating that the above issues (and
others) would be reflected in the funding contract between UNITAID and the
Patent Pool Foundation.


4. Next steps for the Civil Society delegations

A teleconference with constituents will be hosted by the Civil Society
delegations on Thursday 25th February, 2pm UK time. Please contact the
Liaison Officer (JHamer@oxfam.org.uk) if you would like to participate in
this call, for more details.





For any further information, or if you have any feedback for the
Delegations, please contact UNITAID Civil Society delegations? Liaison
Officer, Jessica Hamer, on JHamer@oxfam.org.uk

A leaflet on Civil Society and UNITAID is also available on the following
url:
http://www.oxfam.org.uk/resources/policy/health/civil-society-unitaid.html


_____________________________


Annex I: UNITAID Civil Society delegations? ?talking points? for UNITAID
Board Special Session on Patent Pool (5th February 2010)


1.      Emphasise the need for the Patent Pool to move quickly because we
need ARVs for children that are not available now and we need affordable
second line combinations.
We have reasonable assurance about the relationship of UNITAID and the
Patent Pool entity in terms of: the Patent Pool?s clear mission, (the MOU,
the statutes which we hope will reflect the Patent Pool mission and
UNITAID mission and values) and the criteria for the advisory experts
which includes accountability to patients.

Additional talking points:

The MoU and the statutes should include a statement on transparency e.g.
of the terms of the conditions of the licenses once they are finalised and
the start and end point of negotiations
Strong statement about accountability to patients
The statutes should reflect the points included in the mission (Patent
Pool for low and middle income countries) and the points in the
implementation plan on IP e.g. Patent Pool is an additional measure for
access to medicines and that it should not stop countries to use their
national laws and TRIPS flexibilities.

Annex II: Emails circulated to civil society re: Patent Pool

First email, circulated 13/12/09:


Dear colleagues

Thank you for including us in your letter to the UNITAID board criticising
or warning against the adoption of Patent Pool strategy. Here are few
points of clarification on how we see the Patent Pool:

On content:
The Patent Pool has been supported by many many CSOs from the south and
the north since it was discussed first at IGWG and then at UNITAID
In 2008 UNITAID decided to establish a Patent Pool and this was made
public. Many CS organisations have campaigned and voiced their support.
Very few talked about some technical issues about MICs. Yet nobody voiced
opposition nor ?conditionalities? since 2008 till 2 days ago
The PP should not and, as in the current plan, is not to undermine or
threaten any of the public health mechanisms that are available including
the use of TRIPS flexibilities nor national IP laws in any country.
The Patent Pool is one mechanism that aims to increase access to one class
of medicines (ARVs). It does not and should not replace any other
mechanisms currently existing or planned or even dreamt about.
This is not a perfect solution and it carries some risks but given the
current situation on medicines, all potential mechanisms-even if risky-
are worth trying. If they do not work or if they cause harm-then they can
be stopped.

On process
We represent all NGOs and Communities Living with the 3 diseases- a
difficult task - including those who have expressed great support of
Patent Pool since it was proposed at IGWG and then at UNITAID.
Guys: we know each other. Some of us have worked together for
years/decades so it is not difficult for any of you to contact your
NGOs/Community rep and raise your concern. Yet we get your concerns as
part of your letters to the whole board.  This means we deal with your
concerns as a board rather than we represent your concerns as part of the
CS delegations (NGOs and Community delegations). Some of you sent us
15-page document opposing the idea of Patent Pool-2 days before the board
decision. Please remember that since the Patent Pool came to UNITAID
attention-2 years ago- we only heard support from CS.
We produce communiqu=E9s after board meetings which we post on major
listserves so that as many CS as possible read what happened at the
meetings from CS reps point of views. (official UNITAID documents are on
UNITAID website). We invite people to comment/respond so anyone can tell
us what they think about the issues discussed at the board. Thus people
can raise concerns to be taken on next board meeting or even
beforehand/after the board.
We know that the UNITAID secretariat conducted wide consultation with
stakeholders including wide groups of CS in a number of countries
including in India and at the Implementers meeting in Nairobi where CS had
the opportunity to voice concerns

Finally let us remember that all of us share the same goal of getting
everyone (especially poor and marginalised people) to achieve his or her
right of access to vital medicines. We recognise that the Patent Pool will
add crucial capacity to produce new HIV medicines formulations that are
unavailable in developing country markets where need is high. The pool
complements other mechanisms related to IP flexibilities including those
in national laws of countries including India.


We will try our best to represent all views of the wide CSOs at the board
and we will, as usual, report our perspective on the board discussions and
decisions in the communiqu=E9 that we usually send after the board meeting.

Let us take this opportunity to welcome your continual engagement with
UNITAID?s issues via more involvement with CS representatives on the
board. The contact group and advisory group have always been open to you
and remain so. We hope that we will work together to ensure that UNITAID
delivers on its mandate to intervene in the market in order to expand
access to prevention and treatment for HIV, TB and malaria.


Yours sincerely

Esther, Nelson, Kim, Mohga


Second email, circulated 22/01/10:


Dear colleagues, (please share with others as appropriate)

Further to our previous e-mail before the UNITAID board meeting, we would
like to update you on the progress of implementation of the UNITAID Patent
Pool.

As you know, the board has made a decision to set up the pool (Resolution
EB211/2009/R5, posted on UNITAID web site). There will be a special board
session on the 5th of February to clarify and/or resolve some remaining
issues raised by board members. These issues are:

1.      Structure and Governance issues: This is the main issue to be
resolved at the meeting including a decision on the location/hosting of
the licensing agency and the legal structure and governance. WHO has
advised that neither UNITAID or WHO cannot run the agency but UNITAID
board members are concerned to ensure that sufficient control is
maintained to ensure that the pool keeps its focus on the mandate set by
the board.  We hope to achieve resolution on these issues during the board
session.
2.      Middle Income Countries: At the board meeting we emphasised that
the Patent Pool should be open to all developing countries, as mandated by
the UNITAID constitution.  It should be noted that when UNITAID was set up
we worked hard to ensure that the UNITAID constitution and other key
documents included MICs, together with the best language possible on IP
and the use of TRIPS flexibilities in relation to public health.
3.      TRIPS flexibilities and IP in national laws: We raised this issue
and were assured - as confirmed now in the language of the resolution -
that the Patent Pool will not inhibit in any way countries? abilities to
use TRIPS flexibilities or affect their IP laws.
4.      Sustainability of the pool: Whether the Patent Pool can sustain
itself without UNITAID funding. We think that UNITAID funding of the
operations of the Patent Pool legal entity is a cost-effective way to
ensure low prices.
5.      Local production: The Patent Pool should not negatively affect
local production of quality medicines.
6.      Licensing arrangements and royalties? management are important
aspects of the Pool, which remain to be worked out in the next stages of
the implementation plan in 2010.

We are aware of the letters sent by the UNITAID board chair to you and we
hope that they have provided reassurance on the issues you have raised.

As we said before, we welcome your input on this and other issues related
to UNITAID. We also welcome you joining the contact group, and/or the
advisory group (AG). Members of the AG spend more time engaging with us
and giving us input into UNITAID?s policies and programmes. These
consultative pathways were initiated in order to stimulate wider CS
engagement on UNITAID issues.

Once the agenda has been circulated to us, we will be sharing it with you.
We shall also be holding a teleconference before the board meeting in
order to hear civil society views on the issues and the agenda., and hope
that you will be able to join in. We encourage you to share your questions
and comments prior to the February 5th session with your respective
government delegations to the UNITAID board.

Best wishes for 2010


Esther, Nelson, Kim, Mohga

Jessica Hamer
Liaison officer, Civil Society Delegations to UNITAID Board
Telephone:    +44 (0)1865 473508
Email:              JHamer@oxfam.org.uk
Skype:             'jessica.hamer'

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