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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Platform rule No. x, own drawing

In a recent blog post, Amy Thomas from the CREATe center at the University of Glasgow suggests that contractual provisions can have – not least detrimental – effects for creativity on digital platforms. She points to uncertainty of users generating content (UGC) on platforms as their creations are regulated by a complex and often confusing “combination of legal, technical and contractual features,“ and particularly issues rising from the multiple (contractual) terms and conditions every platform develops, the T&Cs. Platforms do not disclose properly what they are allowed to do with users’ creativity and related intellectual property (IP), and hide behind legalese contract provisions. Thomas concludes that the complex regulatory “tapestry” eventually leads to an imbalance between platforms and users, perceived regulatory uncertainty of users and even “legal mandates to change the law without the legislative process.“ Instead of fostering creativity, platforms’ regulatory environments put “users in a confusing, and potentially vulnerable, position.“

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We, that is Sigrid Quack, Konstantin Hondros, Katharina Zangerle and I, proudly present the article “Between Anxiety and Hope? How Actors Experience Regulatory Uncertainty in Creative Processes in Music and Pharmy”, which has recently been published in “Research in the Sociology of Organizations” (RSO) as part of a volume on “Organizing Creativity in the Innovation Journey”. Check out the abstract below:

Uncertainty about Intellectual Property Regulations (IPR) is prevalent in today’s knowledge-based and creative industries. While prior literature indicates that regulatory uncertainty affects creative processes, studies that systematically analyze the effects of IPR on the experiencing of involved actors in creative processes across fields are rare. We ask how core professional actor groups including creators, legal professionals and managers involved in creative processes experience regulatory uncertainty in the fields of music and pharma. By studying practices of engaging with, circumventing and avoiding regulatory uncertainty about IPR, we show how creative processes in both the music and pharma fields are entrenched with emotional-cognitive experiences such as anxiety, indifference and hope that vary by professional group. Our findings point toward managers and legal professionals observing, exposing and cultivating emotions by ascribing experiences to other actor groups. We conclude that comparing regulation-related emotions of involved actors across fields helps to develop a deeper understanding of the dynamics of creative processes.

In case you or your institution does not have access to RSO please do not hesitate to contact me so I can send you a copy of our article.

(Image, CC0)

This post is provided by Konstantin Hondros, post-doctoral researcher at University of Duisburg-Essen in the DFG-funded research project “Organizing Creativity under Regulatory Uncertainty: Alternative Approaches to Intellectual Property”.

Though “alternative” (both as an adjective and a noun) has widespread meaning in contemporary society, it is not generally clear, what constitutes and conveys something to be (an) “alternative”. This blogpost’s goal is to offer a more nuanced understanding of the concept and ask how this can guide the use of “alternative” as an analytical lens. To begin with, I give an etymological account, then I look at “alternatives” in philosophy and its significance for epistemology, finally, I describe how social sciences make use of “alternative” in an evaluative manner. While from a philosophical perspective, “alternative” is rather a logical operator, in the social sciences “alternative” evaluates institutions, practices, or beliefs. This evaluative use can be either positive and empowering, ambivalent and skeptical, or even negative and destabilizing. I argue that it is this umbrella-term’s multi-facetted and evaluative nature that makes it analytically fruitful for social sciences.

I thus develop the concept of alternative mainly for practical reasons. Our recently kicked-off DFG-funded project Organizing Creativity under Regulatory Uncertainty: Alternative Approaches to Intellectual Property pursues “alternatives” empirically. We take a closer look at how creative processes unfold when intellectual property (IP) is approached “alternatively” and what obstacles and uncertainties these processes encounter. We compare alternatives to the IP-regulations copyright and patent law with case studies from the music economy and the pharmaceutical industries. Differentiating “ alternatives” will inform our methodological and analytical proceeding as it will give as clearer picture of what we are actually dealing with empirically.

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Over at Elephant in the Lab, Paul Börsting and Maximilian Heimstädt blogged about “Wikipedia as Science Communication” and provide a neat step-by-step guide for researchers who want to improve their field’s coverage in the world’s most important encyclopedia:

Instagram, TikTok, Clubhouse: Today, researchers who want to share their work with non-academic audiences can choose between a vast array of digital platforms. Some of them vanish as quickly as they appear. Others attract an audience that is looking  for something other than scientific content. This blogpost is a plea for researchers to consider one of the most important and yet oftentimes neglected digital platforms when thinking about science communication: Wikipedia. Occupying a stable position among the most accessed websites, it has become the most popular encyclopedia worldwide. However, when considering various alternatives for digital science communication, many scholars think of Wikipedia as just  another profile page on the web, complimenting their institutional website. However, they are missing the point. The great but underappreciated advantage of Wikipedia is that it allows researchers to communicate research results and scientific expertise in exactly the place where people look for it: in topical Wikipedia articles. In this way, Wikipedia provides one of the most straightforward and effective means to share knowledge and to leverage research findings towards societal impact. Engaging with the vibrant  community of co-editors on Wikipedia is also not a one-way street but in turn can broaden one’s horizon and potentially inspire future research.

Check it out!

This post is provided by Jasmin Schmitz, Research Assistant at the Käte Hamburger Kolleg / Centre for Global Cooperation Research

When the then novel Covid-19-virus broke out in December 2019, it soon spread globally posing a challenge to health governance all across the globe. Internal containment measures were put in place to domestically stop the virus through lockdown or social distancing; internationally borders were closed, and travel restrictions were put in place to stop the ongoing spread at the borders. When first news broke that vaccine-trials were showing promising results, this seemed like the salvation from ever increasing new infections. Already during the first wave of Covid outbreaks trends of nation-focused policies could be observed. While there are certainly cases of cross-border cooperation, they tend to remain the exception. The WHO tried to install a global distribution mechanism through COVAX yet the initiative did not succeed in gaining global influence; Vaccine nationalism became is predominant mode of governance. The access to the shot has become highly dependent on where one lives. The inequality in access to vaccines has sparked discussion surrounding intellectual property as well as the involvement of public financing in the developmental stage of the pharmaceutical. So, more than half a year since the roll-out of the immunization campaign started, it is time to take a look at the distribution of vaccines globally and why they should not be viewed as the sole solution to the pandemic.

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Over at the Käte Hamburger Kolleg / Centre for Global Cooperation Research, we have recently launched Cooperadio – The Global Cooperation Podcast. In its most recent episode on “Patents, Profits & Pandemics”, I had the honor and pleasure to host intellectual property scholar Susan Sell, who echoes a growing consensus that our intellectual property regime, that is so essential for 21st century intellectual monopoly capitalism, is hampering global health outcomes – not just in the current pandemic.

Together, we addressed questions such as the following:

  • While in regions like Europe and North America national vaccination campaigns have been picking up speed over the past months, the less well-off majority of the world has seen little to no vaccine supplies.
  • Why does it have to be like that?
  • Is there a moral obligation to make health innovations easily available globally?
  • What about the intellectual property rights of the researchers and creators of these innovations, should they not profit from their work?

Check it out!

(sigrid)

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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Five years have passed since universities, universities of applied sciences and research institutions in Germany initiated terminating their contracts with the world’s largest scientific publisher, Elsevier (see also “‘The Garbage Strike Test’ Put to A Test in Germany: Already One Month Without Elsevier”). There are now almost 200 institutions that no longer have a contract and thus no direct access to Elsevier journals. The reason for this wave of cancellations was a combination of exorbitant price (increases) and the publisher’s refusal to switch to new open access publishing models.

However, it is precisely such new, quasi Germany-wide Open Access agreements that have been signed with the two next largest scientific publishing houses, Wiley (2019) and Springer Nature (2020), as part of „Project DEAL“. These agreements provide for all participating universities and research institutions to be granted access to the publishers‘ journals (archives) and for all articles written by their researchers to be freely and permanently accessible on the Internet worldwide. In turn, Publish & Read fees are charged for each published article. The contracts have been published in full on the web, including conditions (see contract with SpringerNature and contract with Wiley).

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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.
December 2021
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