Severe side-effects after COVID-19 vaccine: What are your legal options?
India is looking forward to launching a massive COVID-19 vaccination drive with two vaccines that have been granted emergency use authorization (EUA). As the coronavirus pandemic continues to rage on, authorities had to accelerate development and regulatory processes for the vaccine. In this context, what happens if you experience an adverse event following immunization (AEFI)? Are there any legal avenues to explore?
Covishield and COVAXIN have been granted EUA in India. Covishield has been developed by AstraZeneca and Oxford University, and manufactured by Pune-based Serum Institute of India, while COVAXIN has been developed indigenously by the Hyderabad-based Bharat Biotech. Notably, COVAXIN has been granted EUA "as an abundant precaution, in clinical trial mode." The compensation mechanisms for both vaccines will be different, lawyers told Business Standard.
Legal experts say the recipients of COVAXIN will qualify as trial volunteers as the government has said that the vaccine's use will be an extension of Phase III trials. The vaccine recipients will hence be eligible for compensation in case of a vaccine injury in accordance with the New Drugs and Clinical Trial Rules, 2019, Kartik Ganapathy, partner, IndusLaw told Business Standard.
"In its simplest expression, this compensation includes meeting medical costs (medical management), as well as compensation for loss of livelihood (financial compensation)," Ganapathy said. An ethics committee will be set up if AEFI occurs, however, the compensation amount may be meager, lawyers said.
Covishield has been granted permission in Form CT-23 (permission for manufacture for sale and distribution), said Murali Neelakantan, principal lawyer, Amicus, and former global counsel for Cipla and Glenmark. "This means that those who get the SII vaccine will not be trial volunteers and not have the protection of the New Drugs Rules, 2019, including care and compensation," Neelakantan added.
Traditionally, there are few legal options for recipients experiencing adverse side-effects once a drug like Covishield is rolled out. Recipients usually approach courts on the grounds that the drug was spurious, mislabelled, adulterated, or had manufacturing defects—issues addressed by The Drugs and Cosmetics Act. Experts told Business Standard that recipients can approach the court under the Law of Torts or the Consumer Protection Act.
However, experts warned that any litigation against big pharmaceutical companies could prove to be long-drawn and expensive. A case such as this would also require higher proof of causation and effect. Notably, the words "emergency use" are not mentioned in statutes, the report stated. A lawyer, wishing to remain anonymous, told the publication, "Everyone is running away from liability."