[Ip-health] Medical R&D that Works for the Developing World

[Sarah Rimmington]

Essential Action's Global Access to Medicines Bulletin
Issue No. 4, April 28, 2008
Medical R&D that Works for the Developing World

To subscribe to the Global Access to Medicines Bulletin go to:
http://salsa.democracyinaction.org/o/1678/t/5144/signUp.jsp?key=3D2959

Can the world settle on a medical research and development (R&D) system
that develops medicines and other products to meet priority health needs
and makes those products available on an affordable basis? Developing a
strategy to meet these twin goals is the task of World Health
Organization (WHO) negotiations[1] that enter their final phase today in
Geneva.

The WHO Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property (IGWG) is finishing talks to create a global
strategy and plan of action[2] to spur medical R&D focused on the health
needs of developing countries, and to ensure that poor populations get
access to important pharmaceuticals and other medical technologies.

WHO member states authorized the creation[3] of the IGWG in 2006. IGWG
has held web-based public hearings[4] and two official negotiating
sessions[5], involving government representatives from more than 100
countries. Delegates are scheduled to finalize a global strategy and
plan of action by May 3 at the conclusion of the final week of
negotiations. This plan will be presented to the World Health Assembly,
made up of all WHO member states, in mid-May.

Advancing Innovation and Access to Medicines
IGWG=92s core mandate[6] challenges participants to come up with a
strategy that advances both innovation and access (=93I plus A=94), rather
than treating these two public health imperatives as contradictory
objectives that must be counterbalanced to each other.

The shortcomings of the current R&D model are numerous, but two key
outcomes have a particularly harmful impact on developing countries,
which comprise 80 percent of the world=92s population but amount to only
13% of the global market for medical products. New products are
frequently priced so high as to deny access to poor people globally, and
especially to huge numbers in developing countries who must pay for them
out of pocket. Also, too little investment in R&D is directed at
products that target the priority health needs of people in developing
countries. These countries=92 buying power is too limited to induce
investments responsive to their particular needs.

Although people in developing countries get sick and die from the same
diseases as people in rich countries, they also have some specialized
R&D needs. The current R&D system -- which rewards innovators with
marketing monopolies -- does a poor job of generating investment in new
treatments for neglected diseases, which are conditions that
disproportionately affect developing countries, where buying power is
limited. It is also the case that the products that treat diseases that
occur in all countries whether rich or poor (such as cancer and heart
disease) are often not appropriate for conditions in developing
countries. For example, not enough R&D is invested in creating products
that do not require refrigeration, an important feature for products to
be used in countries with warm climates and unreliable electricity.

An abundance of I plus A proposals
The IGWG is exploring several ideas and proposals focused on advancing
both innovation and access. Some ideas could be immediately operational.
Others will require more follow-up exploration and negotiation.
Proposals under consideration include:

=95 Establishment of a system to incentivize private R&D priority setting
based on identified health needs, rather than market demand for a product.
=95 Systems to reward innovators financially by means other than
patent-based marketing monopolies. Instead of enabling drug companies to
charge high drug prices and protection from competition, one promising
model would offer prizes to the developers of new medicines, with the
prize amount based upon the health impact of the product.[7]
=95 Special incentives for R&D in diseases specific to poor countries, or
open and collaborative approaches, modeled on the Human Genome Project,
that involve the widespread sharing of information.
=95 Management of the fruits of publicly funded R&D to ensure that they
are affordable and available in developing countries, and priced
reasonably in rich countries.
=95 Agreement that all countries should have to contribute to global R&D,
or at least participate in the R&D system, but that there should be
differential obligations based on degrees of wealth. In other words, the
burden on Guatemala should be less than that on the United States.
=95 Provision of technical assistance by the WHO to developing countries
that promotes the use of existing flexibilities in international trade
rules, to expand access to new and existing patented treatments where
there are price barriers.

Optimism about negotiations despite challenges
Significant issues remain on the agenda for this week=92s discussions.
Some developing country delegations and public health experts expect
continued resistance from rich countries -- home to the major
pharmaceutical and biotech companies -- to some of the fundamental
issues under consideration This includes disagreement over language that
encourages taking a pro-public health approach to patent and related
rules, resistance to R&D incentive systems designed to replace patent
monopolies, as well as a move to limit the scope of diseases for which
solutions are being devised to a narrow set of health problems.

Despite the challenges ahead, public health advocates are optimistic.
Member state delegates have already agreed on a considerable portion of
the framework, and several observers from the public health community
are pleased with the overall tone of the discussions to date.

=93We are getting a sense that countries are pushing WHO to be more active
in resolving the access to medicines crisis, and take a pro-health
approach to intellectual property,=94 said Michel Lotrowska of Doctors
Without Borders/M=E9decins sans Fronti=E8res upon the conclusion of the
November, 2007 negotiating session. =93And governments are taking steps to
address the fundamental reasons why investment into innovation for
diseases of the poor is lacking.=94[8]

Web links:
[1] http://www.who.int/phi/en/ and
http://www.keionline.org/index.php?option=3Dcom_content&task=3Dview&id=3D3&=
Itemid=3D1
[2]
https://salsa.democracyinaction.org/o/1678/images/IGWG2_Strat_POA_07_08.pdf
[3] https://salsa.democracyinaction.org/o/1678/images/wha59-24.pdf
[4] http://www.who.int/phi/public_hearings/en/
[5] http://www.who.int/gb/phi/
[6] http://www.who.int/intellectualproperty/en/
[7]
http://www.keionline.org/index.php?option=3Dcom_content&task=3Dview&id=3D4&=
Itemid=3D1
[8] http://www.ip-watch.org/weblog/index.php?p=3D820


Essential Action is a public health and corporate accountability group
located in Washington, DC. Essential Action's Access to Medicines
Project has worked on global access to medicines issues for more than a
decade. For more information on our work go to
www.essentialaction.org/access/

Published by Essential Action's Access to Medicines Project
P.O. Box 19405, Washington, DC, 20036, USA
Tel: (1) (202) 387-8030
www.essentialaction.org/access/
Editors: Sarah Rimmington srimmington@esssentialinformation.org
Robert Weissman rob@essential.org

To subscribe to the Global Access to Medicines Bulletin go to:
http://salsa.democracyinaction.org/o/1678/t/5144/signUp.jsp?key=3D2959

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/