Why is there no open-source vaccine against Covid-19?

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.

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.

Most of the arguments refer to patenting and its usefulness, even in times of a global pandemic. A patent is an exclusively granted right protecting an invention (e.g., a new product or process). Since a protected “invention cannot be commercially made, used, distributed, imported, or sold by others without the patent owner’s consent”, patent owners get temporal monopolies (20+ years) that allow exploiting their inventions. A patent for a vaccine, thus, creates artificial scarcity ensuring the (increase of its) value. In addition to the substance of the vaccine itself (‘substance patent’), processes to produce the substance are usually patented, too (‘process patent’) – either by the patent holder of the substance patent or others that license their process patent to the patent holder of the substance. The patent holder decides who is allowed to manufacture how much of a vaccine through licensing mechanisms. The main reason for granting patent rights is to materially reward inventors to foster creativity and innovation, while compelling them to make their innovations publicly available. Does this line of reasoning also hold in times of a global health crisis?

Argument 1: Protecting intellectual property through patenting is the best way to ensure that future innovations will be developed.

In October 2020, India and South Africa asked for a waiver to suspend the patent rights on Covid-19 vaccines for some time. They argue that this would help to overcome the shortage of delivered vaccines, reduce its price, and balance the inequality of vaccine shares around the globe. However, the EU, the US (although thinking about it), and Britain argued that this step would undermine the most important mechanism ensuring innovation at pharmaceutical companies. According to WTO representatives of these wealthy countries, we need to keep on incentivizing the drug makers to innovate to be prepared for mutations in the future. They should leverage the principle of re-financing their research through profits from existing vaccines and acquire funding from investors by promising future profits.

However, this argument can be challenged – at least to some degree and particularly in the case of the Covid-19 vaccines. First, re-financing of research and development through the exploitation of existing patents only represents one part of the drug development story. In the case of the Covid-19 vaccines, for example, states have invested around €86 billion to support and materially incentivize their efficient development. Incentives were already provided during the development process and, thus, prior to a fixed commitment by the developers that this promising vaccine will work afterwards. Acknowledging that the development of the vaccines was publicly funded to a large degree, critics argue that pharmaceutical companies should not exploit their patent rights for profit – the vaccine should be treated as a public good. According to Human Rights Watch, “[g]overnments should urgently band together, [leverage their regulatory power], be transparent, and cooperate to share the benefits of the scientific research they fund to help humanity”. One idea for this governmental intervention proposed by South Africa and India (and supported by the WHO) would be to force IP holders to waive IP rights for the time of the pandemic. While the public debate around this idea mainly circles around the lift of patent protection, the proposed waiver would actually “cover almost all of the intellectual property rights such as copyright and related rights, industrial design, patent, undisclosed information and their enforcement that can be obstacles to the response of COVID-19 pandemic.”

Argument 2: Waiving or infringing patent rights is not helpful because manufacturers lack the know-how to produce patent-free vaccines.

Moderna, which received millions of public funds (mainly from the U.S. and inter-governmental organizations such as the CEPI), agreed to not enforce their patent rights during the pandemic. This sounds like really good news when it comes to organize access to the vaccines in developing countries, foster mass production all over the globe, and thus, lower the prices per dose. However, producing a vaccine requires more knowledge than is shared via a patent. Rather, producing a vaccine requires combining different patents (e.g., patents protecting a vaccine development technology, certain molecules, or compounds). Thus, a medication or vaccine is usually tied to a bunch of patent rights (either licensed from others or owned by the same patent holder who developed the vaccine). However, IP legislation does not only protect inventions through patenting but also through copyrights and the legal mechanism of trade secrets. Both play a huge role when it comes to producing vaccines, too. Copyrights, for example, protect the tools (e.g., due to their software and computational algorithms) that are needed to produce the mRNA for the vaccine. Trade secrets “include clinical trial data (e.g., which candidates work and don’t work and how different patient populations react to them), a biological database, or cell lines used for production.” According to Ellen t’Hoen, co-founder of the WHO’s Medicines Patent Pool and the director of a nonprofit organization called ‘Medicines Law & Policy’ that campaigns for greater access to medicines, the composition of vaccines is far more complex than of ‘usual’ medication products. Some vaccines are cultivated with the help of living organisms. So the manufacturers need to have detailed know-how about cultivation processes and cell lines. And this know-how is usually kept secret – protected by trade secrets. It is the combination of patents, copyrights, and trade secrets that ensures a competitive advantage. Besides waiving patent and copyrights, these secrets would also need to be disclosed to boost vaccine development.^[1]

Since Moderna, for example, did not yet disclose any information on manufacturing processes (incl. cell lines, etc.), the vaccine production remains exclusively in their hands. In November 2020, an opinion published by the Wall Street Journal summarizes the problem of manufacturers lacking know-how as follows: “It’s not clear developing countries even have the ability to manufacture large-scale, complex technologies like Moderna’s mRNA vaccine or Eli Lilly’s monoclonal antibody cocktail—let alone distribute them.” Ellen t’Hoen, however, argues that at least production capacities in developing countries would be available but exploiting them requires “the sharing of knowhow and the technology by those who have it in their hands”. 

Historically, knowledge and technology was transferred to developing countries such as India – despite similar concerns of them lacking ability to apply those (e.g., Tamiflu, Hepatitis medication, or Gilead’s Remdesivir in India). So, the question remaining is why is it not possible to also disclose trade secrets during the times of global pandemic crisis. Reto Hilty, Director of the Max Planck Institute for Innovation and Competition explains that IP rights related to the Covid vaccines, in particular vaccines based on the mRNA technology, “also have other, very promising areas of application, namely in cancer therapy“. He argues that waiving basic IP rights for such promising areas during a pandemic crisis can be dangerous. We could lose the pharmaceutical companies’ commitment to invest in these future technologies. Thus, in line with Argument 1, he assumes that the patent system is the main driver to ensure future inventions that might underestimate the power of an innovator’s intrinsic motivation to help in these times of crises. Are there only profit-oriented initiatives out there? 

No. The Open Source Pharma Foundation (OSPF), for example, is a non-profit organization that aims “to develop affordable new therapies in areas of great health need, by using open source principles derived from the software industry”. The foundation features four projects responding to the Covid-19 pandemic. One of them is called “OpenVax” a venture led by OSPF in collaboration with the Harvard Medical School and the Government of India’s National Institute for Research in Tuberculosis. OpenVax is close “to launching multiple Phase 3 COVID-19 vaccine trials”. In August 2020, it started to raise funding ($10 million) from the U.S government and private investors, e.g. through crowdfunding. However, the initiative seems to have gotten stuck – a phenomenon that small R&D initiatives seemingly often face before starting into the cost-intense Phase 3 trials. Some scientists from the University of Finland claim that the main challenge is to get funding for this costly and risky phase – which leads us to the third a final argument discussed in this blog post.

Argument 3: Supporting small teams of scientists who aim for developing a patent-free vaccine is too risky.

Kalle Saksela, virologist at the University of Helsinki, claims that their vaccine development initiative was not supported by the Finish government because of not being “an entity with broad enough shoulders to take on the risk.” Considering the billions of Euros that governments spent on vaccine development by companies such as Moderna or Astrazeneca before knowing whether the vaccine would receive a marketing authorization eventually, makes this point difficult to understand.^[2] However, while the risk during drug development might be solidarized, big pharmaceutical companies take most of the risk of vaccination damages after successful approvals. When a vaccine is a common good, the issue of liability after a marketing authorization needs to be organized differently.

We are organization scholars. Thinking about how liability could be better shared so that smaller developer teams could contribute to the development of a patent-free vaccine that is then produced by many manufacturers around the world is, thus, a question of organization to us. Inter-governmental and inter-organizational collaborations (incl. Big Pharma) are probably key to the alternative organization of liability. Governments need to collaborate to support developers and to share liability of potential vaccination damages (not related to faults in manufacturing, but even after the third round of clinical trials). 

Not having the obligation to pay for the risks would also increase the motivation to engage in co-developing a new medical treatment or vaccine. We have already seen some inter-organizational and -governmental collaborations popping up during the current pandemic, such as the WHO-backed initiative “Access to COVID-19 Tools (ACT) Accelerator” Technology that aims to catalyze global efforts to develop, produce, and distribute Covid-19 medication and vaccines. The initiative includes the Covid-19 Vaccine Global Access (COVAX) initiative that should ensure a fair distribution of vaccines around the globe. Unfortunately, these inter-organizational efforts partly lack funding and have missed their goals so far. Providing a good overview about what has been promised by the current players on the Covid-19 vaccine market, IAM Media reports that not one “vaccine rights holder has committed to sharing its patent, data and know-how openly through the WHO’s Covid-19 Technology Access Pool.” The collaborations lost traction.^[3]

Concluding remarks

Besides these three arguments, there are also strategic considerations with regards to protective governmental behavior. Instead of waiving IP rights to countries of the Global South, wealthy countries, such as the U.S., argue that they need to protect as much as they can. Countries like China should not ‘steal’ any IP and have it for the future.^[4] The former deputy director of the National Economic Council argues for using other inter-governmental mechanisms (such as the Quad^[5]) instead of lifting protections and points to the danger of “setting a precedent of sharing technology”. Mechanisms like these require trust, and therefore, time. Particularly the latter is an issue during a pandemic. And while governments think about how to organize their vaccine campaigns with the doses they have bought for their countries and how they could support the Global South, China developed its own vaccines and donated millions of doses to 69 developing countries.

We can’t judge the effects of waiving IP rights in the context of vaccine development and production, yet. If there is a need to keep on relying on the IP protection system due to political issues, mechanisms such as patent pooling and publicly funded voluntary licensing models (including knowledge transfer) could be an option. However, as the Covid-19 pandemic taught us, stable inter-organizational and inter-governmental collaborations need to be set up constantly for the case of a global pandemic and maybe hard to get to whilst being in the middle of a crisis already.^[6]

Developing open source vaccines seemingly depends on a system change in the pharmaceutical industry, its use of IP regulation, its liability, and its funding mechanisms. Hereby, the Covid-19 pandemic might be more than a single occasion to question the status quo. It could become the point of departure for this system change, a context for experimenting with alternative forms of vaccine development and production and a motivation to take the first steps to sustainably prepare for global pandemics in the future.

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This blogpost was co-authored by Milena Leybold and Leonhard Dobusch.

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^[1] As an alternative to accelerating regulative governmental power, the  Peng! Collective aims to motivate employees of Biontech to leak these secrets: https://pen.gg/campaign/biontech-leaks/  

^[2] On a side note: Astrazeneca promised not to make profits from the vaccine during the pandemic but is in power to define when the pandemic is over. Moderna claimed not to enforce their patent rights during the pandemic that is, unfortunately, only helpful to some degree (s. Argument 2).

^[3] See also: https://khn.org/news/rather-than-give-away-its-covid-vaccine-oxford-makes-a-deal-with-drugmaker/

^[4] Media has reported several instances of hacking attacks from China, Russia, Iran, and North Korea to gain vaccine related IP. See e.g., https://www.theguardian.com/world/2020/nov/22/hackers-try-to-steal-covid-vaccine-secrets-in-intellectual-property-war

^[5] The Quad is a group formed by U.S., India, Japan and Australia seeking to lower the influence of China (https://www.cnbc.com/2021/03/26/covid-vaccine-updates-white-house-mulls-lifting-intellectual-property-shield.html).

^[6] See https://medicinespatentpool.org, for a pooling mechanism that is based on voluntary licensing in the context of HIV, Hepatitis C, and Tuberculosis.