DNDi publishes model contracts as new examples of how principles that secure access to medicines can be operationalized in R&D collaboration agreements
12 Apr 2023 — A new article published today by the Oxford University Press Journal of Intellectual Property Law and Practice shows how fair deals on medical research that ensure equitable access to life-saving medicines can be signed with pharmaceutical companies.
Entitled ‘Striking fair deals for equitable access to medicines’ and authored by researchers from the not-for-profit medical research organization Drugs for Neglected Diseases initiative (DNDi), the article details examples of robust access clauses built into collaboration and licensing agreements DNDi has signed with public and private partners, including with pharmaceutical companies.
The publication can provide policy makers and global health experts with useful insights, in light of debates rekindled by the COVID-19 pandemic on ensuring that medicines and vaccines developed with public funding guarantee equitable access. This question is also at the core of the ongoing and difficult global negotiations on a future treaty for pandemic preparedness and response.
‘This is a tremendously valuable resource for those engaged in negotiating and drafting intellectual property licenses that are designed to promote critical innovation while maintaining sharp focus on making new treatments affordable and accessible,’ said Professor Frederick Abbott, Edward Ball Eminent Scholar Professor of Law at the Florida State University College of Law, who was not involved in the writing of the article.
The paper’s authors explain how DNDi managed to secure non-exclusive, permanent, irrevocable rights to the drugs it jointly develops with its partners for neglected diseases, with the aim of making them accessible to all patients and ensuring all knowledge generated through the research and development (R&D) process is publicly shared. DNDi has now published online model licensing contracts based on its 20-year experience in concluding collaborative deals with industrial partners, which can serve as examples of how to operationalize these ambitions within R&D collaboration agreements.
‘DNDi’s mission is to address the needs of people affected by “neglected” diseases,’ said Professor Abbott. ‘The carefully designed licensing terms and conditions developed by DNDi are nevertheless of great value to everyone involved in publicly oriented drug development and distribution. They reflect years of experience in the real world of creating productive collaborations among partners with diverse interests. They show that innovation and access are complementary objectives.’
DNDi includes in its agreements a definition of ‘affordability’ that is aiming at ‘the lowest sustainable price.’ The non-profit also secures via these agreements all the intellectual property rights it needs to license commercialization partner(s) to deliver affordable treatments to neglected patients.
‘All of the agreements that DNDi has signed with its industrial partners include clauses that ensure that the medicines we develop together will be affordable and accessible for all of those who need them – while also ensuring that the collaboration is economically sustainable for the partners,’ said Michelle Childs, Policy Advocacy Director at DNDi and co-author of the article.
Triggered by widespread failures to ensure equitable access to COVID-19 health tools, global health experts hope that ongoing negotiations at the World Health Organization to shape a future global pandemic preparedness and response treaty will result in norms and binding rules that ensure access to the fruits of publicly funded pharmaceutical R&D.
‘Country negotiators are struggling to find the appropriate language to ensure global equity in future pandemics. Including access conditions on public R&D funding as part of the agreement is a key way of operationalizing equity. DNDi publication of its licensing model contracts can provide insights on how conditions can be applied in R&D collaborations,’ said Childs.
Since its creation 20 years ago, DNDi has established partnerships with dozens of public and private partners, including medical research institutions and pharmaceutical companies, to successfully develop and deliver 12 affordable and accessible treatments for six deadly diseases affecting neglected populations.
The templates of DNDi collaboration and licensing agreements are publicly available at dndi.org/licensing
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit medical research organization that discovers, develops, and delivers safe, effective, and affordable treatments for neglected people. DNDi is developing medicines for sleeping sickness, leishmaniasis, Chagas disease, river blindness, mycetoma, dengue, paediatric HIV, advanced HIV disease, cryptococcal meningitis, and hepatitis C. Its research priorities include children’s health, gender equity and gender-responsive R&D, and diseases impacted by climate change. Since its creation in 2003, DNDi has joined with public and private partners across the globe to deliver twelve new treatments, saving millions of lives. dndi.org
Source : DNDi
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