Seize this opportunity to institutionalize accountability

The Drug Controller General of India gave emergency use authorization (EUA) for COVID-19 vaccines moderna and by johnson and johnson, in late June and early August 2021, respectively. In addition, India has an opportunity to receive 50 to 100 million doses of Pfizer-BioNtech’s mRNA-based vaccine. COVAX MACHINERY Before the end of 2021, the Coalition for Epidemic Preparedness Innovation (CEPI), co-led by Gavi and the World Health Organization.

what does that involve

Despite two vaccines being granted an EUA and a third (Pfizer-BioNtech) eligible for approval, uncertainty remains over supply and availability. One of the primary reasons for this is the indecision of the Government of India to request compensation from these manufacturers. Indemnity translates to protection from legal proceedings and liabilities against claims from people who may experience rare and serious adverse events after vaccination (AEFI).

COVID-19 vaccines are given EUA by regulatory authorities after a thorough review of their safety and efficacy. However, even if vaccines meet safety standards, as an immuno-biological substance, a vaccine may be associated with rare and serious AEFIs, some of which – such as vaccine-induced immune thrombotic thrombocytopenia (VITT) and myocarditis – are known. Other long-term effects may only be known over a period of time.

There is a need to increase the supply of vaccine in India and to have a continuous supply. The country’s COVID-19 vaccination campaign is performing poorly, and in the seven-and-a-half months since the campaign began, only 11% of the total population has been fully vaccinated, and 35.5% received a single dose. One reason for this is insufficient supply, which has consistently been lower than projected vaccine availability. The situation persists despite some regulatory amendments enacted by the government to increase availability, including: Fast-track authorization of COVID-19 vaccines approved by regulatory authorities in the United States, United Kingdom, Japan and Europe, and they include the world Health Organization (WHO) Emergency Use List; Waive the requirements for bridging tests; and eliminating mandatory batch testing for vaccines manufactured abroad. While these steps have given the EUA two additional vaccines, there is a lack of clarity on a definite timeline regarding their availability in India. A major bottleneck is the demand for compensation from manufacturers. The main argument of manufacturers is that they have been indemnified in their country of origin and supplied vaccines to other countries only when indemnified. Vaccines under the COVAX program provide an effective waiver of compensation through a separate mechanism that has been established.

existing provisions

The idea of ​​not paying compensation is to hold vaccine manufacturers accountable. The manufacturers of the three vaccines (Covishield, Covaxin, and Sputnik V) currently being administered in India have not been compensated. There seem to be two major considerations that are delaying the government’s decision on compensation. First, the supply from these manufacturers is likely to be a very small proportion of the total vaccine availability in the country. Second, it is likely that once foreign manufacturers are compensated, manufacturers currently supplying vaccines may make similar demands, citing the fair play rule.

What do the current rules and regulations suggest? The rules governing clinical trials in India specify that compensation should be given in case of injury or death of a test subject. However, a uniform compensation mechanism does not exist in the country for AEFIs reported under the government’s routine immunization program or for any other vaccine-related injury; Manufacturers have legal responsibility for any vaccine-related injury under existing Indian regulations. Therefore, if manufacturers are to be compensated for any COVID-19 vaccine, there should be an alternative mechanism for people to make a legal claim for compensation. This would essentially mean that the government would have to accept the responsibility of providing compensation for any such proven injury or damage. Second, compensation for instances of intentional acts, fraud or negligence should not be treated as blanket protection. Third, if foreign vaccine manufacturers are compensated, manufacturers of vaccines currently in use may demand similar protections.

However on a broader scale, the stand and reluctance of these manufacturers to supply COVID-19 vaccines to any country unless indemnified is very harsh. However, beyond compensation, India has mechanisms in place in the existing legal framework to ensure protection and legal remedies for any damages. First, the Drug Controller General of India is empowered to take action against companies violating the Drugs and Cosmetics Act, 1940 while granting the registration certificate. Second, any person seeking compensation after experiencing AEFI can directly file a petition in consumer courts and high courts. Third, the recent amendments to the Consumer Protection Act, 1986 do not permit individuals but allow regulatory bodies to initiate class action suits (cases representing groups of people who have suffered from similar harm) on the basis of individual complaints. Huh.

opportunity in crisis

Requests for compensation should be made relevant in the larger public interest. For citizens, as long as mechanisms are in place to deal with and compensate potential damages, it makes little difference if they come from the government or the manufacturer. Furthermore, even in cases where manufacturers bear legal liability, governments and regulators cannot shirk their responsibility to protect public health.

Therefore, India should examine safeguards established by countries that have provided indemnity to manufacturers, such as the US. Countermeasures Injury Compensation Program (CICP) and similar schemes in the UK, Canada, the European Union and Singapore. COVAX has reduced the compensation burden to protect vaccine manufacturers and distributors.

This discourse clearly needs a recalculation and provides a valuable opportunity for the Indian government to institutionalize legal safeguards against vaccine injuries and, possibly, on a larger scale, to improve overall patient and health care security in the country. Is. Such institutional mechanisms need to be supplemented with dedicated funding from the government. Such systems can be applied to any licensed vaccines in India.

One of the features of India’s response to the COVID-19 pandemic is the delay in decisions until a point of crisis emerges. Situations like the Novel Coronavirus pandemic demand proactive and decisive problem-solving rather than burying our heads in the sand, hoping that the problem will disappear. However, the debate over compensation has far-reaching consequences. This should be seen as an opportunity, more than just the quantity of vaccines, to review legal provisions and create long-term mechanisms for vaccine harm protection and to make health services safe and accountable. It is high time to decide whether to compensate (or not) the COVID-19 vaccine makers before the situation turns into another crisis and then a decision is taken. The approach should be to protect the interests of citizens and convert this into an opportunity to bridge the vaccine ‘license to availability gap’, increase vaccine availability and establish institutional mechanisms.

Virag Gupta is an Advocate in the Supreme Court of India. Dr. Chandrakant Laharia, a physician-epidemiologist, a public policy and health systems expert and also co-authored Until we win: India’s fight against the COVID-19 pandemic. Views expressed are personal