Home > IP Topics Index > Putting Intellectual Property to Work: Experiences from Around the World > Pragmatic and Principled: DNDi’s Approach to IP Management > Editor's Summary, Implications and Best Practices

The Drugs for Neglected Diseases Initiative (DNDi) was set up to address the imbalance in access to critically needed medicines, by giving patients in developing countries the opportunity to be the direct beneficiaries of new products of drug R&D for diseases that do not represent a viable drug market. DNDi’s mission is to develop safe, effective, and affordable new drugs for patients suffering from neglected diseases and to ensure equitable access to these. By 2014, it aims to develop and make available six to eight such field-relevant treatments.

This chapter presents one organization’s efforts to bring to light and address a grave imbalance that persists in pharmaceutical research throughout the world. As the authors of this chapter note, a tiny fraction (1.3%) of the drugs that came to market from 1975 to 2004 were for the tropical diseases (such as human African trypanosomiasis, Chagas’ disease, leishmaniasis, helminthic infections, schistosomiasis, onchocerciasis, malaria and tuberculosis) that together make up 12% of the global disease burden and kill more than 35,000 people a day. The drugs that do exist are either inaccessible to patients or unbearably costly, both to the individuals suffering from these diseases and government agencies responsible for their care. DNDi believes that drug research can, however, exist in the public domain, and that patented products do not always benefit those who need them most.

As clearly articulated in its IP Policy statement, DNDi is committed to managing intellectual property in a manner that pragmatically and effectively advances its mission of providing the most vulnerable populations in developing countries with equitable access to critically needed medicines. Perhaps this is most clearly stated in the preamble of the DNDi IP policy statement:

The DNDi IP approach will be pragmatic, and decisions regarding the possible acquisition of patents, ownership, and licensing terms will be made on a case-by-case basis. DNDi will put the needs of neglected patients first and will negotiate to obtain the best possible conditions for them. The DNDi’s decisions regarding IP will contribute to ensuring access and encouraging further innovations.

The authors relate two of DNDi’s successful campaigns to negotiate terms that allowed them to get important drugs to the world’s most needy at minimal cost. In the first case, DNDi approached French pharmaceutical giant sanofi-aventis in 2003 to develop artesunate-amodiaquine, a fixed-dose combination therapy for chloroquine-resistant malaria. The negotiation process eventually led to a contract with very favorable terms for DND i; the drug was made available for production by any generic manufacturer with no payment owed to either sanofi-aventis or DNDi, and sanofi-aventis agreed to supply the drug at cost to the public sector, NGOs, and international organizations. In the second instance, DNDi successfully collaborated with the University of California, San Francisco’s (UCSF) business development office to support research leading to treatments for the lethal human African sleeping sickness. While conventional wisdom holds that a university should always seek the largest possible return on research investment, DNDi was able to convince university officials of the seriousness of their mission, and a compromise was reached that advances the project of bringing new treatments to those suffering from this deadly and largely neglected disease.

In pursuing their humanitarian mission, to use best, pragmatic practices for IP management to bring critical drugs to those not served by the standard drug R&D market, DNDi has learned that it is crucial to thoroughly familiarize all parties with the organization’s aims and guiding principles. By the end of contract negotiations with UCSF, for example, decision makers expressed great personal satisfaction at helping to advance DND i’s work. Through similar efforts DNDi hopes, by 2014, to have developed and make available six to eight field-relevant treatments, in a small but significant move to redress the imbalance in pharmaceutical research funding and help those around the world who are most in need of new drugs and yet least able to afford them.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• Strengthening a nation’s IP regime will facilitate the mission of organizations, such as DNDi. Established IP systems are an important factor which donors of patented technology consider as they decide whether, or not, to participate in product development partnership. In this context, strengthening means to build transparent and enforceable IP systems that include all the flexibilities offered by TRIPS.

For Senior Management (university president, R&D manager, etc)

• Due to the imbalance in global health research, health R&D priorities might need to be shifted to better reflect the global disease burden.
• Working with organizations such as DNDi can significantly accelerate access to drugs that are vital to the needs of the poor in developing countries. However, for this to happen, all involved should have capacity in IP management.
• Although generic medicines (by definition) are not covered by patents, obtaining permission from a patent holder to market a generic, that is, to structure market segmentation, will require sophisticated skills and knowledge in IP management.

For Scientists

• Be conscious of the imbalance in global health research and consider ways that your own research might be relevant to fighting the world’s neglected diseases.
• If the opportunity arises for participation in development of a drug for a neglected disease, look upon this as an opportunity to build R&D networks, for the express purpose of improving public health. Also, understand any IP implications related to such projects.

For Technology Transfer Officers

• Proceed with caution when trying to use pre-formulated contracts. Although there are benefits from using someone else’s draft contracts as a basis for negotiation, make sure your key “must have” points are explicit.
• Work with organizations such as DNDi to advance their public interest mission. Understand any IP issues, constraints and/or obligations and ensure that they are strictly adhered to by your institution.