Introduction
COVID 19 changed the entire world. It made the entire world standstill because various forms of lockdowns were enforced by almost all countries of the world. From March 24th to August, India, the world’s largest democracy, went into a complete lockdown. The months long lockdown have been unsuccessful in completely eliminating the pandemic and one might expect that the vaccine could just do the trick and put a stop at this pandemic forever, but COVID 19 vaccines have a lot of complications in all arenas. The focus is going to be on the legal aspect of COVID Vaccines.
Obstacles Imposed by the Vaccines
Since the emergence of COVID 19 was unforeseen, it came as a shocking surprise to the entire mankind. A pandemic brings its own set of challenges along with it. The development of vaccines can be a lengthy and cumbersome process. “I’ve never seen one take less than about 20 years” says Barney Graham, deputy director of the Vaccine Research Center at the US National Institute of Allergy and Infectious Diseases.[1] Nobody can give a straitjacket formula to determine exactly how long it takes. “The fastest vaccine we previously developed was for mumps, and that took four years to develop. And typically it takes 10 to 15 years to develop a vaccine. So 12 to 18 months would be record-breaking” says Dr. Seema Yasmin, director of the Stanford Health Communication Initiative.[2] One of the reasons behind the long duration of the development of a vaccine can be the fact that every vaccine has to go through three stages of trials before it is deemed to be safe for use. The first phase is tested on approximately 100 healthy volunteers, followed by the second phase, which is tested on a large group of people and finally, the third phase is tested on tens of thousands of people. [3] Once it is approved by the concerned authorities, there arises the issue of side effects. It is common knowledge that any drug has a potential risk of side effects. This very small and unusual chance of side effects generally causes a wave of fear among the masses. It is feared that these side effects could incur monetary losses and more importantly, significant damage to the health and wellbeing of the people. In cases like these, they are left with no choice but to undergo the arduous process of litigation. With this threat upon us, it becomes essential to look into the past in order to comprehend the mechanism and the grounds behind a legal suit. Before their troops were preparing to fight in Iraq and the possibility of enemy forces using smallpox as a chemical weapon was looming large, the United States began a vaccination programme for their forces in Iraq and the result was some troops experiencing side effects.[4] In these situations, it is crucial to demonstrate that using all the fair, logical and empirical evidence available at the time, the side effects were a direct consequence of the vaccine. Information is available on the potential side effects and the time period in which they can appear available and used. Taking the instance of the Rubella vaccine, if the recipient developed chronic arthritis in the span of seven to forty two days, it is called a direct injury due to the vaccine, following which, the investigation panel works to find out the compensation depending on the amount of days of missed work and total financial costs.[5] In India, fear of side effects resulting from the COVID vaccine has gained some attention in the mainstream media when a Covishield Vaccine volunteer alleged side effects a week ago and demanded compensation from the Serum Institute of India for 5 crore (SII ). [6] The SII has collaborated with Oxford in order to manufacture the vaccine. This lawsuit was termed frivolous and malicious and was countered with a suit for defamation, with damages amounting to 100 crores. The Indian Council for Medical Research (ICMR) dismissed the allegations and labelled the condition established by the litigant as irrelevant to the vaccine. Thus, nullifying the first condition to be fulfilled, which is that the side effect should be a direct consequence of the vaccine and must be verified by the scientists. In order to create convenience for consumers and reduce the problem of pendency of courts, most countries have come up with compensation systems.
Juxtaposition with Other Jurisdictions
While India does not have a set mechanism in place in order to combat this issue, other countries of the world do. It becomes necessary to examine them, so that India can come up with its own system in place. The United States of America has two systems in place to deal with the compensation claims. The first one being the National Vaccine Injury Compensation Program (NVICP). It is a specially designed mechanism to deal with all the claims arising out of vaccination side effects. The second one is the Countermeasures Injury Compensation Program (CICP)[7]. It mainly deals with claims of injuries against the usage bio or chemical weapons. Since there are not many instances of the usage of bio or chemical weapons, the CICP has disposed until now only 500 cases while NVICP has disposed more than 20000 cases. One of the key limitations of these mechanisms is that they will not file a new suit for any form of injury if the victim accepts the settlement. Much like the United States of America, the United Kingdom also has no fault liability when it comes to coverage for side effects from a vaccine. The UK government recently announced that compensation would be given to anyone who may be adversely affected by the COVID 19 vaccines.[8] The policy is called the Vaccine Damage Payment Scheme (VDPS), which pays a one-time payment of up to 120,000 pounds if there is a permanent disability or death caused. Under the scheme, severe disability means a disability level of more than 60 percent. VDPS was established in 1979. It protects victims of side effects caused by common vaccines, such as those against measles, influenza, smallpox and tetanus. The H1N1 swine flu vaccine was also briefly added to the list in 2009. In New Zealand, there is no independent regulatory body to handle vaccine accidents. Instead, the broad Accident Compensation Company, which is a statutory corporation that provides no-fault compensation for any serious injury and death caused by accident, covers the claims of injury from vaccinations. This scheme is funded by a variety of sources, including levies on employers, workers and owners of motor vehicles, government support and returns on investment. The Accident Liability Company has 9 months to make a decision in the event of the incident being serious enough to be covered. Vaccine injuries were previously considered “medical misadventures” there. This was taken in practice to mean a “medical error” or “medical mishap”[9]. Although both forms of accident were eligible for compensation, the distinction required the Accident Compensation Corporation to investigate whether a vaccine injury was caused by an error or was an adverse outcome of a correctly delivered vaccine.
Conclusion
After due analysis of the mechanism employed by different countries in the rare case of the causation of adverse side effects by vaccines, we can create a versatile system for a country in order to reduce the burden of conventional litigation. This will also help solve the long pendency in courts and in this way, we can empower people who cannot afford the costs which litigation entails. India is one of the few developing countries that lack a centralised compensation system entirely. It is high time to implement such a platform, especially at this stage of the pandemic where vaccines are about to be inoculated to the world.
References
Covid-19 vaccine trial in India: Covishield volunteer alleges side effects, mint (2020), https://www.livemint.com/science/health/covid-19-vaccine-trial-in-india-covishield-volunteer-alleges-side-effects-seeks-compensation-of-rs-5-crore-11606696030577.html
Nicholas M. Pace, Lloyd Dixon & Bethany Saunders-Medina, The Compensation System for Potential Side Effects Is an Important Part of a COVID-19 Vaccine Campaign RAND Corporation (2020), https://www.rand.org/blog/2020/12/the-compensation-system-for-potential-side-effects.html
Britain to cover COVID-19 vaccine side-effects under damages scheme, Reuters (2020), https://www.reuters.comRandy G. Mungwira et al., Global landscape analysis of no-fault compensation programmes for vaccine injuries: A review and survey of implementing countries PLOS ONE, https://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0233334
No-fault compensation following adverse events attributed to vaccination: a review of international programmes, World Health Organization (2011), https://www.who.int/bulletin/volumes/89/5/10-081901/en/
Nadimpally S;Banerjee S;Venkatachalam D;Bhagianadh D; An idea whose time has come: Compensation for vaccine-related injuries and death in India Indian journal of medical ethics, https://pubmed.ncbi.nlm.nih.gov/28512074/
[1] Why does it take so long to develop a vaccine? (2020) https://science.thewire.in/health/coronavirus-vaccines-clinical-trials/
[2] Why creating a COVID 19 vaccine is taking so long? (2020) https://www.wired.com/story/why-creating-a-covid-19-vaccine-is-taking-so-long/
[3] Peter Brookes, Here’s why development of vaccine takes so long? (2020) https://www.heritage.org/public-health/commentary/heres-why-development-vaccine-takes-so-long
[4] Michael McCarthy, US Military prepares for Iraq to use chemical and biological weapons (2003) https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(03)12621-9/fulltext
[5] Institute of Medicine (US) Immunization Safety Review Committee; Stratton K, Gable A, Shetty P, et al., editors. Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism. Washington (DC): National Academies Press (US); 2001. Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism. https://www.ncbi.nlm.nih.gov/books/NBK223375/
[6] Covid-19 vaccine trial in India: Covishield volunteer alleges side effects, Live mint (2020)
[7] Nicholas M. Pace, Lloyd Dixon & Bethany Saunders-Medina, The Compensation System for Potential Side Effects Is an Important Part of a COVID-19 Vaccine Campaign RAND Corporation (2020)
[8] Britain to cover COVID-19 vaccine side-effects under damages scheme, Reuters (2020)
[9] No-fault compensation following adverse events attributed to vaccination: a review of international programmes, World Health Organization (2011),
https://www.who.int/bulletin/volumes/89/5/10-081901/en/
Written By:
Simran Bherwani
Simran is a First year law student at NLUJ