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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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At this year’s Global Congress on Intellectual Property and the Public Interest, which takes place October 25th-29th 2021, Konstantin Hondros and myself presented a working paper titled “Tinkering and Repurposing: How Open Source Vaccine Initiatives Alternatively Organize for Novelty“.

While the innovation brought forward by biotech and pharmaceutical companies was exceptional, many countries still lack access to vaccines. Public debates arose discussing alternative ways of handling IP in vaccine R&D beyond the prettified standards of the western dominated pharmaceutical industry.

Building upon literature on organizational isomorphism (DiMaggio & Powell, 1983) and literature about the emergence of novelty in organizations (Cattani, Ferriani, & Lanza, 2017), we argue that the westernized pharmaceutical industry – mainly in response to regulative standards – has developed highly isomorph organizational practices that might make the entering of outsiders, who apply alternative approaches to vaccine R&D (e.g., open source approaches), quite difficult. Puzzled by the question of how alternative ways of fostering novelty can be embraced and gain legitimacy in organizational fields deeply relying on isomorphism, we ask: how do open source vaccince R&D initiatives alternatively organize for novelty?

Source: PPT Presentation by Milena Leybold

We compare two empirical cases that both build on an open source practice: Vaccinuum and RaDVaC (Rapid Deployment Vaccine Collaborative). Vaccinuum (formerly OpenVax) was initially focused in developing a vaccine against SARS-CoV-2  and is now trying to discover an “Ultra-Broad Spectrum Open Source Vaccine for SARS-CoV-2 Variants and Future Epidemics” through processes of repurposing of already existing, “widely-available, approved, licensed, widely-accepted, non-exclusively manufactured, off- patent, live attenuated vaccines“.

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The Covid-19 pandemic is, without doubt, one of the biggest societal challenges of our times. Since its outbreak in December 2019, more than 3 million people died due to or with a Covid-19 infection. The pandemic hits the world with disastrous side effects such as economies suffering from recurrent or constant lockdowns, children who can’t go to school, or rising case numbers of mentally ill people. The most promising solution to stop the pandemic: vaccination.

In December 2020, the first person got vaccinated with the officially authorized Pfizer/BioNTech mRNA vaccine “COMIRNATY” in UK and Russia started mass vaccination with the vaccine “Sputnik V”. Shortly after, other big pharmaceutical companies such as Moderna, Astrazeneca, Sinovac, or Johnson & Johnson managed to get marketing authorizations for their vaccines. However, the vaccination campaigns proceed slower than expected: the demand for vaccines exceeds the production capacities of the pharma companies. Further, vaccines are not globally distributed at comparable rates. Unequal access to vaccines is not just a matter of injustice but imbalances also increase the risk of mutations developing in non-vaccinated countries.

Overview of vaccination rates by April 28th, 2021 (the darker the more people got vaccinated)
Source: https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html

In January 2021, WHO Director-General Tedros Adhanom Ghebreyesus described the imbalance of vaccine distribution as “a catastrophic moral failure” and asked countries of the Global North to lift intellectual property protections so that countries around the world could produce vaccines. Similarly, the People’s Vaccine Alliance proposes offering the Covid-19 vaccine as a common good:

Our best chance of all staying safe is to ensure a COVID-19 vaccine is available for all as a global common good. This will only be possible with a transformation in how vaccines are produced and distributed — pharmaceutical corporations must allow the COVID-19 vaccines to be produced as widely as possible by sharing their knowledge free from patents.
Instead they are protecting their monopolies and putting up barriers to restrict production and drive up prices, leaving us all in danger. No one company can produce enough for the whole world. So long as vaccine solutions are kept under lock and key, there won’t be enough to go around. We need a People’s Vaccine, not a profit vaccine.

https://peoplesvaccine.org

This raises the question of this blog post: wouldn’t it be possible to organize the development of an open source vaccine that could be produced and distributed all over the world? Fortunately, media articles and governmental statements provide us with a rich bunch of arguments, why this is not an option. Let’s have a look at those.

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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.
January 2022
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