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This post is provided by Suela Simoni, Student Assistant at Innsbruck University

While the concept of “open source” emerged as a radically open and transparent way of developing software, it is increasingly applied in other contexts as well. In pharmaceutical open source projects, for example, anyone can contribute at any time to the project, methods and data are in the public domain, and data is released as soon as it is acquired. However, compared to the software industry, open source approaches struggle to take ground in the pharma industry. As of December 2021 there has not been a single molecule worldwide, which has been discovered, developed, and brought to market completely open source. There are a few examples of patent-free molecules that have been going through clinical trials: one is the Praziquantel and the second one is the Fexinidazole. Since only a part of the process has been done openly in these cases, they cannot be considered to be completely ‘open source’. Using the example of the initiative “Open Source Malaria” and outlining the challenges they face, I will discuss why developing drugs and vaccines based on open source principles represents a difficult endeavor.

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Building upon a case study of the Medicines Patent Pool, this blogpost aims to set the Medicines Patent Pool/Merck License for Molnupiravir in a processual context.

About the License Agreement

Recently, on October 27, 2021, the Merck & Co., Inc. Kenilworth NJ USA (MSD) and the Medicines Patent Pool (MPP) jointly announced the signing of a license agreement for Molnupiravir. Molnupiravir is an “an investigational oral antiviral medicine“ against Covid-19 that has shown promising results in Phase 3 clinical trials. The drug is currently under review by the European Medicines Agency (EMA). The voluntary license and technology transfer agreement for Molunpiravir allows generic manufacturers from anywhere in the world to produce the drug and supply it to 105 low-and middle income countries (the “territory”). Manufacturers can license royalty free for the time of the pandemic

While the medical non-governmental organization Médecins Sans Frontières (MSF) criticizes the agreement for excluding “half of the world’s population and important upper-middle-income countries (UMICs) with robust manufacturing capacity, such as Brazil and China”, other medicine policy experts such as James Love or Peter Maybarduk celebrate the agreement as an “impressive achievement” or a “starting point and an example” to increasing access to Covid-19 therapies in LMICs. James Love commented that the “licensed area is large enough (more than half the world’s population) to induce efficient generic entry and economies of scale”. 

To understand the impacts of this license agreement, we take a closer look on the patent pool mechanism that is leveraged here. 

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The Book

Governance across borders: transnational fields and transversal themes. Leonhard Dobusch, Philip Mader and Sigrid Quack (eds.), 2013, epubli publishers.
May 2022
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All texts on governance across borders are licensed under a Creative Commons Attribution-Share Alike 3.0 Germany License.