COVID-19 vaccines: Are IPRs real barriers to manufacture?

Update in June 2021: A more comprehensive version of this blog entry was published by the Manchester Journal of International Economic Law for its September issue in 2021 (link) More of my publications can be found here.
The article is co-authored by me and Leah Samson.

1. An Introduction to the debate of Covid-19 vaccines distribution

In less than a year since the WHO’s declaration of COVID-19 as a global pandemic, thirteen vaccines against COVID-19 have been approved in at least one jurisdiction. This is a truly tremendous achievement if we compare it with the considerable time of between 10 to 15 years to develop a new vaccine from scratch for most diseases.

However, new challenges have arisen, mostly surrounding the global distribution and access to these vaccines, particularly for low and middle-income countries. The patent system has been accused of standing in the way of global vaccination supplies. In early October 2020, an initiative, led by India and South Africa, has called for a temporary waiver of intellectual property rights (IPRs) in relation to the ‘prevention, containment or treatment of COVID-19 … until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity.’^[1]

It occurs to me that the proposal is built on a premise that once the patent system and other forms of IPRs are dismantled, COVID-19 vaccines will be made cheaper and quicker. This is simply not true as researchers pointed out that second-generation vaccines do not lead to the same price reduction as normally seen with generic drugs because the main cost drivers for vaccine development are fixed.[2]  When the world is facing difficulties and uncertainty, it seems easy to point the finger at patents, turning it into a scapegoat.

2.     Understanding the manufacture of COVID-19 vaccines

Vaccines are biological products, produced with help from a microorganism and involve the manipulation of genetic material and living animal, bacterial, or yeast cell cultures. Compared to small molecule drugs which have generics, there is no such thing as generic vaccines, only so-called bio-similars (highly similar in terms of structure, function, and clinical effect to the innovator product).[3]

In fact, before the approval of COVID-19 vaccines, in May 2020, a group of Imperial College’s researchers foresaw that normal supply chain routes and distribution networks may face disruption, particularly because not a single of 200 vaccine manufacturing facilities worldwide was ready to produce a COVID-19 vaccine (at that time).[4]

Roadblocks of the inoculation program have nothing to do with IPRs but lie in manufacturing, supply chain, and transportation. The export restrictions imposed by the EU and the US have also worsened the situation. Poor countries are also far from blameless. The Indian government’s decision to temporarily ban exports of AstraZeneca’s vaccine, which is being manufactured by the Serum Institute of India, hit other poorer countries badly.

Likewise, a report of the UK Parliament identified that one of the main roadblocks that slow COVID-19 vaccine manufacture is the final ‘fill and finish’ stage, i.e., putting the vaccine into containers for distribution, which can be understood as the ‘bottling’ of a product.

The challenges to vaccine manufacture are real and enormous and for that reason, cooperation, not polarisation, must be needed to free the world from the pandemic and give back the normal life that many of us have missed.

3.     Eroding patent protection does more harm than good.

The inherent sophistication of vaccine manufacture has turned the patent system into a low hanging fruit where it is easy to be (wrongfully and factually) blamed. Vaccine development is a highly risky, uncertain, and capital-intensive business. It has an average of 94% chance of failure, meaning that only 6% of vaccine candidates have proved successful.[5] In the meanwhile, the estimated cost per approved new vaccine varies between $1.2 billion and $8.4 billion.[6]

Because of the innate vulnerability of the vaccine industry due to the uncertain outcomes of clinical trials, changes in epidemiology and in many other aspects, IPRs including the patent system have long been regarded as a guarantee of return on research and development (R&D) investment, only if the vaccine is proved successful. Without a reliable patent system, there is no incentive to invest.

There is no clear-cut evidence that taking an antagonistic approach toward IPRs will speed up vaccine production. Even where there is no IP protection and any companies would be free to make COVID-19 vaccines, whether would an additional generic company embark on a highly risky and research-intensive business without certain outcomes? The answer is probably no.

Furthermore, dismantling patent protection might lead to substantial risks. First of all, if patented vaccines are in the public domain and are not properly allocated, the ripple effect of the tragedy of common goods will soon be felt. The quality of vaccines might be compromised, efficacy and safety might be weakened. Secondly, removing IP rules can cause an increase in counterfeit products. While patents and other forms of IPRs are generally viewed as an incentive to fuel innovation, it is little known that they also serve to suppress counterfeiting. Consequently, dismantling the IP system can result in more spread of pharmaceutical crime.

4.     Conclusion

Although the patent system is nowhere from being perfect and has its flaws, it is overly simplistic and unfair to shift the blame to patent protection and the global pharmaceutical companies for vaccine distribution. While it is true that ‘no one is safe until everyone is safe’, instead of trying to bring the whole IP system down, we should look into the vaccine situation from a more holistic view to identify the root cause of the problem and then act accordingly.

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^[1] Communication from India and South Africa, ‘Waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19’ (WTO, Council for TRIPS, 2 October 2020), IP/C/W/669.

[2] A Nguyen and N Schwalbe, ‘Apples and oranges? Can second generation vaccines become as low cost as generic medicines?’ (2019) 37 Vaccine 2910, 2911.

[3] ibid, at 2911.

[4] S West et al., ‘Is the world ready to produce a billion doses of a COVID-19 vaccine?’ (Imperial College London, News on 6 May 2020) https://www.imperial.ac.uk/news/197321/is-world-ready-produce-billion-doses/ accessed 5 April 2021.

[5] D Gouglas et al., ‘Estimating the cost of vaccine development against epidemic infectious diseases: a cost minimisation study’ (2018) 6 Lancet Global Health e1386, 1386.

[6] ibid, at e1386.