WHO Joint Tropical Disease Program Issues Report On Research Fairness

The World Health Organisation’s Special Programme for Research and Training in Tropical Diseases (TDR) has published the first report on research fairness under a new initiative. The report includes an analysis of how TDR manages intellectual property rights in a positive way.

The Research Fairness Initiative (RFI) was developed by the Council on Health Research for Development (COHRED). It is a “first attempt at creating a systematic global evidence-based assessment of fairness in the field of global health.”

The TDR Research Fairness Initiative report 2018 is available here. TDR is a joint initiative of WHO, UNICEF, the UN Development Programme, and the World Bank.

“The RFI provides a framework that allows an organization to take a step back and challenge itself to think about how its processes and approaches affect its partners,” the foreward to the report says. How do we select research priorities so they are in line with the needs of the country? Does our application process favour male applicants over women? How should benefits be shared and are contributions properly acknowledged? It is vital that we all continually ask ourselves questions like these.”

The RFI measures fairness in five areas: benefit-sharing, ethics, finance management, legal contracting, and capacity building.

The report includes an analysis of TDR’s treatment of intellectual property, innovation, and data ownership. On data ownership it states:

“Rules around sharing ownership of data, data storage, access to data and other collected information are contentious issues within the research arena that could place researchers and institutions from LMICs at a disadvantage. Traditionally, policies surrounding data ownership and use have been preferential towards research sponsors, high-income countries and those with access to legal support. Many LMICs do not have the necessary national legislation in place to sort through these issues, leading many to lose intellectual property rights or opportunities to publish.”

“TDR relinquishes its intellectual property right to any data or results collected from the projects funded by its research partnerships in its TSA, under the condition that the information is used for the purpose of promoting progress in science, technology and public health. Within the general conditions, there are also stated conditions that funded institutions should share the results of the project with TDR. Neither the grantee nor TDR are expected to keep the results confidential, unless otherwise discussed or if used for industrial or commercial purposes.”

“Institutions and investigators are expected to publish in an appropriate form (generally a peer-reviewed journal or monograph) based on the research that is undertaken through the WHO TSA. The publication should be in accordance with WHO’s policy on open access and must indicate that financial support was received from WHO/TDR.”

The report’s section on intellectual property rights states:

“Unfair intellectual property (IP) sharing is a major issue in research, which has the potential to affect individuals, institutions and countries in a negative manner. IP rights and the processes associated with technology transfer have the potential to reduce benefits that could have been realized had adequate IP rights been established.

At TDR, IP is covered under the WHO TSA agreement which is signed by all grantees. The manner in which technology transfer is handled is exactly the same as materials transfers, which is outlined in detail in topic 9. Additionally, TDR relinquishes its IP rights to its partners. The LOA separately asserts that all rights to the results of the work that is performed under the agreement shall lie with the Institution or Principal Investigator of the study. However, simultaneously, the Institution and/or Principal Investigator agrees to grant WHO an irrevocable and unconditional perpetual, royalty-free, world-wide, non-exclusive, sub- licensable license to utilize the same results in any manner or for any purpose WHO may deem appropriate. As previously mentioned, TDR and WHO must also receive acknowledgement for funding the study in any publication and all publications must comply with WHO’s open access policy.”

“If there are any issues with regard to IP or specifications within contracts for grantees and our partners, the WHO Legal Department will step in to resolve the issue. The conditions of the TSAs and LOAs are outlined by the WHO Legal Department, and as such, they would intervene in the event of a conflict.”

“TDR works closely with the WHO legal team on all the contracts it issues. WHO, and therefore TDR, relinquishes all IP rights to its partners and there are no plans to alter this position in the future.”