This article has been written by Meera Shah.

Introduction

In order to safeguard the intellectual creativity and acumen of an individual, any invention of which the creator makes full disclosure should be protected so that it cannot be wrongly stolen by other individuals in order to make illegal personal gains for themselves. Intellectual Property Rights are essential rights with incentives for economic growth and a boost to undertake endeavours that promote the quality of human life. As the world has been battling against the COVID-19 pandemic, various pharmaceutical companies and research laboratories have been successful in developing a vaccine against it but now the goal is to make the vaccine available for the maximum number of individuals across the globe. 

In order to ensure a mass scale production of the vaccine at affordable rates, several developing countries, such as India and South Africa in October, have approached the World Trade Organisation and proposed for a waiver of the patent rights on the vaccines among other COVID essential equipment, so that the domestic manufactures of the nations could produce the vaccine. However, this waiver has been opposed by some developed economies. This has necessitated for us to strike a balance between protection of patent rights of the manufacturers on one hand and making the vaccines available especially for the developing and the poor nations and thereby saving their lives on the other.

Issue at hand

Raising concerns about the availability of vaccines at affordable prices and sufficient quantities and meeting up with the global demand for vaccines, developing nations like India and South Africa have proposed for waiver of patent rights on the vaccines, drugs and other COVID essential protective equipment. This waiver has also been supported by most other developing nations and lately by developed nations such as the US and members of the European Parliament which was largely appreciated however on the other hand nations like the UK, Germany, Japan as well as vaccine developers, such as Novovax and Pfizer, have opposed the proposal.

They were of the opinion that intellectual property rights were not obstructing the global supply chains of vaccines and doing away with them could lead to serious and harmful implications. An important precedent to this issue was related to the HIV/AIDS drugs TriAvir, which could not be afforded by the Sub-Saharan African nations. Hence, by issuing compulsory licensing, Canada had allowed one of the Canadian Pharmaceutical companies to produce a generic version of the drug and had exported it to the African nations, helping them to procure drugs at cheaper prices. 

To sum up, the crux of the issue is to safeguard the IP rights of the manufacturers, do adequate justice to the billions of dollars invested by them in the research and manufacturing of the vaccine, not unnecessarily undermine the monetary credits or otherwise, of the inventors of the vaccine and on other hand, safeguarding the lives of trillions of people across the globe by scaling up the mass vaccination drive and thereby overcoming this pandemic and its disastrous effect.

Importance of mass vaccination

Vaccination provides protection not only to the individual who is vaccinated but also to the individuals who are not. The major aim of mass vaccinating the population is to achieve herd immunity. Herd immunity is the concept wherein if a sufficient proportion of the population is vaccinated against the bacteria/virus, it makes people less vulnerable to contracting the disease. And even in case, it is further contracted, it makes them less infectious and eventually decreases the probability of others being infected by it. For example, in the United States, after vaccinating a significant amount of the population with the pneumococcal vaccine, the probability of contracting of disease among the non vaccinated masses, came down by nearly 70%.

Also, one of the epidemiological models based on the Ebola virus suggested that mass vaccination could reduce the chances of further outbreaks of the virus. Hence, mass vaccination would be a promising move at fighting against this pandemic and quickly eradicate its effects. And the more we delay or cause hindrances in this mass vaccination drive, the more lives and livelihoods we will end up claiming.

Acts and legislations

The TRIPS agreement, which was negotiated in the year 1994, required all its signatory-nations to enact domestic laws which would assure minimum standards of IP protection to the creators of the inventory products and safeguard the monetary benefits and credits of their inventions in multiple countries.

As per the WTO agreement on TRIPS (Trade-Related Aspects of Intellectual Property Rights), Article 8 and Article 7  are broadly focussed upon amending laws and regulations and bringing in measures that protect public health and assure greater socio-economic welfare. Further, as per Article 27(2) of the TRIPS Agreement, the patentability of inventions might be excluded if it is necessary to protect public health.

Compulsory licensing has been one of the measures adopted by the governments during public health emergencies in which they permit other manufacturers to produce the patented product without the consent of the patentee. In 2001, the WTO had signed the Doha Declaration, which further emphasized and clarified laws associated with compulsory licensing in the TRIPS agreement, which could be enforced by the respective governments during public health emergencies. Section 92 of the Indian Patents Act, 1970 deals with the provision of compulsory licensing in India.  So, upon the consensus of the member nations of the WTO agreement, many steps are taken in light of these articles to deal with global pandemics like COVID-19.

Although safeguarding human lives becomes a priority in these trying times, however, we need to evidently prove if waiving the IP restrictions is indeed beneficial and necessary to the cause of making vaccines available at a quicker pace. An inconclusive unproved moral demand cannot be a reason to compromise the profitability of these manufacturing firms, if in reality it cannot scale up the vaccine distribution drive.

Intellectual property rights and the vaccines

Vaccine and vaccine-related technologies can be protected using various IP Rights: 

• Patents: Patents usually protect the formulation of the vaccines, which includes the medical components involved in them. They also protect the vaccine administering devices, which may include injections or capsules used to release the product in specific areas of the body. Also, the clinical test data of the vaccines which are submitted to the regulating authorities to get the approval of their vaccines, are not disclosed and protected by patents.
• Trademark: Trademarks help in protecting the brand name of the organisation/company and the associated products and services provided by them. It prohibits any third party to supply products or services under their name.
• Trade Secrets: Trade secrets form the backbone of any company or organization. Trade secrets are a protection given to the knowledge which the inventors would not want to publish or codify and is kept confidential with them. Such information cannot be found on patent applications or in clinical trials information submitted to the regulating authorities. When speaking in relation to the vaccine, this information is usually related to the know-how and all the details of the steps involved in the manufacturing process of the vaccine. Mere waiver of the patent rights would not be beneficial for the production of the vaccines unless the trade secrets are also shared with the manufacturing companies.

Importance of upholding intellectual property rights for vaccines

• Firstly, IP Rights act as an encouraging factor for the various organizations /pharmaceutical companies to invest in Research and Development and also secure the profits that they can make out of those inventions.

• The patent holders can regulate the vaccine production and distribution by way of voluntary licensing or leasing out licenses to third parties as well as collaborating with other manufacturers or adopting a public-private partnership model to boost up vaccine production. If such agreements are executed in a diligent and responsible manner, they can act as pacers to the mass vaccination drive.
• Upholding patent rights would assure the quality, safety and effectiveness of the vaccine. Waiving of patent rights can lead to the production of sub-standard quality vaccines and might weaken public trust in the administration of the vaccine.

Arguments against waiver of patent rights

1. People in favour of the waiver point out the  HIV  therapies in the 2000s which were produced in abundance by the generic manufacturers and had brought down its price, making it affordable for the low-income countries. However, what gets missed out is that vaccines are complex biologics and as they are difficult to replicate it is not easy to produce a generic version of them. So any manufacturer of the vaccine attempting to create a new version of the vaccine would have to make it run through a clinical trial and successfully demonstrate that the vaccine is safe and effective. Active cooperation from the end of the patent company would be essential even after sharing out of the trade secrets and altogether setting up a new manufacturing unit would attract a lot of time and monetary resources. 
2. Undeniable is the fact that vaccine patent waiver would help in magnifying long term supply, but that comes with a number of safety and policy measures. A waiver might boost up the quantity, but more importantly, it is necessary to maintain the quality and standards of the vaccines. Also, the key barriers to magnifying the supply of vaccines are not just patent rights. Factors such as technical expertise of the manufacturers, limited availability of the raw materials and concrete supply chains with good infrastructure, sound networking and the right type of storage capacity etc are also crucial and in a way greater cause of obstruction. And merely a waiver cannot soundly address these issues.
3. The Germany based Biotech company has developed novel mRNA technology which has been the basis of formulation of the Pfizer vaccine. It is a novel technique and has not been previously used in manufacturing of any other types of drugs or medications. Hence many nations might not have the know-how of this technique, the infrastructure, raw materials or technical expertise to adopt it.
4. Compared to other types of small molecule medicines, vaccines involve a higher level of ‘know how’, relatively more complex and procedural, which are not disclosed either in the patent applications or in the clinical trials information submitted to the regulating authorities. This ‘know-how’ become essential components of trade secrets. These trade secrets can be selectively licensed to other manufacturers by setting up technology transfer hubs. The model of technology transfer hubs are such that the technology is transferred from the patent holder through a licensed agreement to a licensee (pharmaceutical company or industry) which may grant partial or absolute rights as per the agreement to the patentee. Here, the inventor continues to hold up the intellectual property rights and conditionally transferred rights allow the potential organisations to use the technology. So, in the case of the vaccine, the trade secrets are shared in such technology transfer hubs. This can be a positive step in boosting up vaccine manufacturing capacity and at the same time keeping up with the quality standards of the vaccine. As per one of the recent announcements by the World Health Organisation, the member nations are planning to establish a COVID-19 mRNA vaccine technology transfer hub in order to scale up vaccine production. Also, such sharing of technology and know-how of the vaccines might encourage innovations from the generic manufacturers and this can also bring down the prices of the vaccines.
5. The currently existing flexibilities in TRIPS agreement relating to the public health emergencies might be sufficient to deal with the patent issue associated with the vaccines. This includes voluntarily sharing of trade secrets, leasing out licenses to third parties or entering into collaborations or partnerships with other manufacturers or governments. These can be wisely executed and a further waiver or greater flexibility might not be required at the moment. E.g. AstraZeneca along with Novovax has partnered with Serum Institute Of India (SII) to produce a net of 3 billion doses of  Covishield vaccine and supply it across 145 countries as part of their  Covovax pledge for equitable distribution of the vaccines especially aiding the lower-income countries.
6. One of the critics also pointed out that the waiver could undermine innovations and the incentives to research more on novel alternatives, which could help in combating COVID-19. Patents are crucial assurers of economic returns or profits of the risks taken in innovation and the investments made in researching manufacturing and conducting clinical trials.
7.  It is a slow-paced process and there is uncertainty in the effects of the waiving of the patent rights. The need of the hour is mass vaccination and keeping time as a priority, we need to adopt methods that hold a greater probability of success and closest to our ends of achieving the target of mass vaccination.
8. If we take into consideration the case of India, there have been a lot of administrative inefficiencies in the production, procurement and distribution of the vaccines. India is known to be the largest producer of vaccines, despite that, the country faces a scarcity of vaccines. The scarcity was obvious due to the highly populated states of India of around 1.38 billion people but there have been other factors as well that have grabbed the issue. Factors such as greater exports of vaccines to the other nations, deficiencies in planning and supply of vaccines across the nation, the surge in demand of vaccines due to initial lack of orders by the government which has lately pressurised the manufactures to increase their capacity many folds in a short span of time, which is unlikely, and this have had an impact on the pricing structure of the vaccines in the nation and consequently hardships for the common people.
9. Another important point is that the limited raw materials available would further get constrained and depleted if it ends up in the hands of the manufacturers who are incapable of producing safe and effective vaccines. Vaccine manufacturing is a complex process with many nuances and nitty-gritties involved. The slightest negligence on the part of vaccine manufacturers could risk the lives of humans who would be subjected to its clinical trials and end up doing more harm than good.
10. Vaccines scarcity often gets widened due to careless handling of supply chains due to inadequate infrastructure for transportation, disconnects between foreign and national supply chains, poor maintenance and insufficient storage units for vaccines in their appropriate conditioned temperatures as well as deploying the vaccines into use within  their shelf lives are more important considerations to be mindful about.  Also, the medical staff employed in the vaccination drive should be sufficiently trained. These many times ignored minutes, make a huge lot of net difference and can smoothen the vaccination drive.

Arguments for the waiver of patent rights

• Holding up of the patent rights can create a monopolistic market of the vaccines making it an expensive and non-affordable affair for many of the low-income countries. Also, the distribution patterns of the companies are commercially biased towards capitally dominating nations, leaving the developing countries at the mercy of the rich and powerful.
• The developing nations argue that manufacturing vaccines by limited pharmaceutical companies and then exporting the vaccines by them across other nations might be a lengthy and time-consuming process, rather an expansion of the manufacturing units would ensure faster scaling of production.
• As per the reports by Reuters, Pfizer was agreeing to manufacture Pfizer in India, if it had the flexibility over imposing price of its choice and also receiving permits from the government to export those vaccine to other parts of the world. This would not be an unreasonable demand as vaccine development would require a considerable amount of skills and monetary investment, but at the same time it might turn out to be an exploitative proposal for the Indians.
• Obtaining licenses might not be an affordable alternative for many of the nations. Instead issuing of compulsory licensing by the government can help amplify the production schemes of generic vaccines or otherwise (if possible as no generic version of the COVID-19 vaccine has been produced till date) at lower prices by the manufacturing nations. These vaccines can be imported by the poor countries lacking the infrastructure and financial capacity of producing the vaccine.
•  As per one of the reports by World Health Organisation, out of 700 million vaccine doses that have been administered globally, wealthier nations have got 87 % of them as contrasted to the share of the lower-income countries being just 0.2 % of them. Such grave is the disparity and inequity in distribution of the vaccines. It would not be fair to be deprived of a vaccine due to one’s skin colour or socio-economic status of the nation. This thereby supports a vaccine waiver.

Conclusion

The need of the hour for the policymakers is to focus on how to easily transfer vaccine technologies and also ensure equitable distribution of these vaccines. Also, a waiver is foreseen to be more effective over technologies that are easy to transfer and safe to replicate, which is not the case with vaccines. Ineffective distribution can further disrupt supply chains and lead to waste of time and resources. 

Global access to vaccines is indeed a moral imperative of the time. Scaling up of the manufacturers is ideal to increase vaccine production. One may easily transfer the IP rights, but transfer of technology and skills is practically more challenging. Hence in my view transfer of IP rights may be more a symbolic move rather than a substantive one in addressing this issue. Patent waiver is just one of the complex steps among many for the third party to successfully manufacture a vaccine. There are many complexities following it.  This time-consuming affair might not end up serving the purpose of mass vaccination and in the process many more lives and livelihoods might be lost.

References

1) Leroy Leo, Novovax criticizes vaccine patent waiver proposal, the Mint, 7th May 2021.

2) Shivangi Mittal, Why the Trips Waiver is unlikely to solve India’s Covid-19 vaccine shortage, The Print,7th May ,2021.. https://www.msn.com/en-in/news/newsindia/why-the-trips-waiver-is-unlikely-to-solve-indias-covid-19-vaccine-shortage/ar-BB1gsmqQ

3) Stevens H, K Debackere, M Goldman, RT Mahoney, P Stevens & I Huys, Vaccines: Accelerating Innovation and Access. Global Challenges Report, WIPO,Geneva,2017. www.wipo.int/globalchallenges

4) Norman Baylor. https://www.statnews.com/2021/05/06/waiver-of-patent-rights-on-covid-19-vaccines-in-near-term-may-be-more-symbolic-than-substantive

5) Lisa Larrimore Quellete, Waving Covid 19 vaccine patents, Stanford law blog. https://law.stanford.edu/2021/05/04/stanfords-lisa-ouellette-on-waiving-covid-19-vaccine-patents/

6) Establishment of a COVID-19 mRNA vaccine  technology transfer hub to scale up global manufacturing,WHO, 16th April ,2021.https://www.who.int/news-room/articles-detail/establishment-of-a-covid-19-mrna-vaccine-technology-transfer-hub-to-scale-up-global-manufacturing 

7) Damian Garde, Helen Branswell ,Matthew Herper ,Waiver of patent rights on Covid-19 vaccines ,in near term ,may be more symbolic than substantive, STAT ,May 6 ,2021. https://www.statnews.com/2021/05/06/waiver-of-patent-rights-on-covid-19-vaccines-in-near-term-may-be-more-symbolic-than-substantive/

8) Holly Ellyatt, India is home  to the world’s biggest producer of Covid vaccine but it  is  facing a major internal shortage, CNBC newspaper ,5th May ,2021. https://www.cnbc.com/2021/05/05/why-covid-vaccine-producer-india-faces-major-shortage-of-doses.html

9) Agnes Lenagh, The Importance of technology transfer ,UNeMed,Dec 18,2012. https://www.unemed.com/blog/the-importance-of-technology-transfer

10) Jake Verzosa, Low –income countries have received just 0.2 per cent of all COVID -19 shots given,UN News ,9th April 2021. https://news.un.org/en/story/2021/04/1089392

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