[Ip-health] English translation: Submission to WHO/IGWG by Bolivia

[James Packard Love]

This is David Serafino's  unofficial translation of the 28 February
Bolivia submission to the WHO Intergovernmental Working Group.   Jamie

(The original in spanish is here:   http://www.keionline.org/misc-
docs/bolivia28feb07igwg.pdf)


The Permanent Mission
of the Republic of Bolivia
Geneva

MBNU- 203-50

The Permanent Mission of Bolivia to the United Nations and Other
International Organizations in Geneva offers its cordial salutations
to the Secretariat of the World Health Organization - Inter-
Governmental Working Group on Public Health, Innovation, and
Intellectual Property.  Regarding the deadline to present reactions
to the =93Elements of the World Strategy and Plan of Action: Progress
to Date=94 we submit the document entitled =93Bolivia Proposal=94 with
comments on procedural issues as well as on substantive aspects of
the Plan.

The Government of Bolivia, by means of this Permanent Mission, would
like to present the following proposals:
=95=09Extend the deadline to present comments on the document and/or
submit proposals until 15 May 2007.
=95=09Extend the deadline to conclude the work of the Inter-Governmental
Group for at least one more year.
=95=09Deepen the treatment of the issues regarding the =93Improvement of
distribution and access to medicines=94, Patent Pools, and new prize
and remuneration mechanisms as incentives to innovation.
=95=09To improve the level of discussion and attempt to reach a consensus
on the issues under consideration, regional discussions should be
organized, in the case of America by means of the Pan-American Health
Organization.

The Permanent Mission of Bolivia to the United Nations and Other
International Organizations in Geneva takes this opportunity to
reiterate to the World Health Organization - Inter-Governmental
Working Group on Public Health, Innovation, and Intellectual Property
- assurances of its highest regards.

Geneva 28 February 2007




World Health Organization
- Inter-Governmental Working Group on Public Health,
Innovation and Intellectual Property =96
Geneva.-
Appendix Cited
World Health Organization:
Intergovernmental Work Group on Public Health, Innovation, and
Intellectual Property (IGWG)

Bolivia Proposal

The present proposal consists of a first point related to questions
concerning the Work Group=92s procedure with some concrete
requirements, and of a second point which details the position
regarding substantive issues.  Nevertheless, Bolivia considers that
all the recommendations presented in the Commission Report on
Intellectual Property Rights, Innovation, and Public Health (CIPIH)
should be analyzed and incorporated into the Global Strategy and Plan
of Action.  For reasons of time, we consider it fundamental to
incorporate into the work plan the issues of Improvement in
Distribution and Access, Agreement on Research and Development,
evaluation of Patent Pools and some proposals on possible mechanisms
of Prizes and Rewards as incentives to innovation.


1.  Procedural Proposal

The Global Plan of Action of the Intergovernmental Work Group on
Public Health, Innovation, and Intellectual Property (IGWG) should be
driven by the Member States of the World Health Organization.  In
order to adequately comply with the General Assembly mandate and to
achieve the results expected by the Group, Member States must have
the opportunity to submit new proposals following detailed revision
and exchange of different suggestions from the rest of the Members.
To this end, we request that the deadline to present and/or reach a
consensus on proposals be extended from 28 February, at minimum,
until 15 May 2007.

Also, more opportunities to discuss the IGWG work plan are
necessary.  We request that the Secretariat facilitate the
organization of informal meetings and of regional work groups, for
example in the framework of the Pan-American Health Organization
(PAHO).  In the same vein, the Secretariat should propitiate informal
discussions on specific issues with the participation of stakeholders
and experts in the field, for example the priority-setting, financing
mechanisms, or the use of flexibilities in the Trade-Related Aspects
of Intellectual Property Rights.  Bolivia proposes an informal
meeting in March of 2007.

It is unlikely that the work of the IGWG can be completed by fall
2007.   The issues to be discussed are important, and an unfinished
and rushed product will not serve the interests of the WHO Member
States.   We request that the deadline to conclude the work of the
IGWG be extended for at least one year to permit serious negotiation
on the priority issues.


2.  Proposal on Substantive Issues

The two central issues of the IGWG=92s work are, on one side, the
importance of access to medicines, vaccines, and other health
technologies; on the other side, the need to stimulate innovation in
new drugs for illnesses and conditions which primarily affect poor
people living in developing nations.

In this vein, Bolivia initially proposes a thorough analysis of the
following issues, reserving the right to present additional proposals
or revisions, and pertinent complementary materials.

Improvement of Distribution and Access

The Right to Health is a fundamental principle in compliance with
international agreements such as the International Covenant on
Economic, Social and Cultural Rights, resolution WHA 57.14 of the
57th World Health Assembly, specifically in taking advantage of
flexibilities provided in the Trade-Related Aspects of Intellectual
Property agreements and promoting that bilateral agreements take into
account the Doha Ministerial Declaration regarding the agreements on
TRIPS and Public Health so that they do not constitute barriers to
access to medicines, for which it is necessary to establish the
necessary policies to make these flexibilities viable.

The flexibilities established in Doha, such as compulsory licensing
and parallel trade, are mechanisms that permit the State access to
medicines, even though they are protected by patents.  These
mechanisms set a basis for access and are not negotiable under
different free trade agreements.  Also, independent of the national
or international pharmaceutical industry=92s commercial interests, the
exclusivity of new molecules which can be considered essential
medicines constitutes a non-negotiable principle in the attempt to
guarantee and protect the right to health and, consequently, access
to essential medicines for the entire population.

Patent Pools

With regard to the issue of ensuring access, recommendations from the
Commission on Intellectual Property Rights, Innovation and Public
Health (CIPIH) have focused on the need to increase voluntary and non-
voluntary licensing of patents to generic drug manufactures, in order
to ensure that a competitive market exists for generic products of
acceptable quality.

To achieve these goals, the IGWG should recommend the creation of new
systems for the collective management of intellectual property
rights, such as patent pools.   Patent pools could be a mechanism to
enhance the capacity of governments to manage the voluntary or non-
voluntary licensing of patents for essential medicines.  These
mechanisms could include the use of best practices in issues such as
competition law, transparency, and adequate remuneration for patent
owners, and ensuring that licensed products meet appropriate
standards for quality. By creating pools that are regional,
individual member states will be protected from uninformed and
unreasonable pressures that are frequently targeted at countries
using TRIPS flexibilities.


Treaty/Agreement/Norms in Research and Development
Resolution WHA59.24 indicates that the IGWG was created in order
=93draw up a global strategy and plan of action.=94   It is expected that
the strategy and plan of action is asked to secure =93a firmer and more
sustainable basis for needs-driven, essential health research and
development relevant to diseases that disproportionately affect
developing countries, proposing clear objectives and priorities for
research and development, and estimating funding needs in this area.=94

The IGWG needs to create a process to achieve this objective.  The
WHO Secretariat should provide the IGWG with a work plan for priority-
setting and estimating funding.  The Member States should be directly
involved in discussion about the methods of funding and the types of
incentives to private industry that are consistent with the IGWG
objectives of ensuring access to inventions.

The long run objective should be some type of multilateral or
regional agreement to provide sustainable funding for priority
research and development that addresses important health needs of
developing countries.

It will be important to debate and consider the nature of the
obligations on Member States to support such research.  This could
include legally binding obligations or non-binding, voluntary
agreements or norms.

Funding for priority research and development could be tied to a
country=92s GDP, level of development, health care budget, or set as a
fraction of health care or development aid, or the financing could
come from new instruments such as the UNITAID airline tax or taxes on
currency transactions.  A meeting of the IGWG members to discuss this
topic would be timely.

There should also be consideration of the possible incentives to
participate in such obligations or to accept voluntary norms.  One
possible incentive would be to reward countries that meet such norms,
lowering expectations in terms of enforcing high levels of
intellectual property protection.


De-Linking Prices from Research and Development Incentives

A growing number of economists, health experts and private sector
companies are examining the benefits of changing the nature of
private R&D incentives so they are no longer linked to drug prices.
We note in particular work on prizes by Tim Hubbard, James Love,
Aidan Hollis, Thomas Pogge, and Joseph Stiglitz.

We suggest that the IGWG evaluate the plausibility of creating a new
system of prizes to reward development of essential medicines.  These
prizes should reward inventions that improve health care outcomes.