Global Access to Medicines Bulletin: Medical R&D that works for the developing world

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 now entering their final phase today in Geneva.

The latest issue of Essential Action’s Global Access to Medicines Bulletin discusses these WHO negotiations, explaining what’s at stake and what’s on the table. The text of the bulletin follows on the continuation of this post.

An .rtf version of the bulletin is available here.

Essential Action’s
Global Access to Medicines Bulletin
Issue No. 4, April 28, 2008

Medical R&D that works for the developing world

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’s core mandate[6] challenges participants to come up with a strategy that advances both innovation and access (“I plus A”), 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’s 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’ 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:

• Establishment of a system to incentivize private R&D priority setting based on identified health needs, rather than market demand for a product.
• 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]
• 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.
• 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.
• 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.
• 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’s 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.

“We 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,” said Michel Lotrowska of Doctors Without Borders/Médecins sans Frontières upon the conclusion of the November, 2007 negotiating session. “And governments are taking steps to address the fundamental reasons why investment into innovation for diseases of the poor is lacking.”[8]

Web links:
[1] http://www.who.int/phi/en/ and http://www.keionline.org/index.php?option=com_content&task=view&id=3&Itemid=1
[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=com_content&task=view&id=4&Itemid=1
[8] http://www.ip-watch.org/weblog/index.php?p=820

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 [email protected]
Robert Weissman [email protected]

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