Unascertained side effects of a vaccine and the lack of damages law

Vaccines for Covid-19 are in the works at an unprecedented speed, thanks to new technology, urgency and speedy approvals. Trials that usually take years have been reduced to mere months.
 

However, the temporary halt in AstraZeneca’s vaccine trials, in which one participant developed symptoms consistent with transverse myelitis, has fuelled scepticism. To address this, Health Minister Harsh Vardhan offered to become the first person to be vaccinated.
 

With countries despairing as economies grapple with the pandemic, governments are queuing up to sign contracts with vaccine makers, many of whom are asking for indemnification against future product liability claims.
 

Such indemnification clauses are significant. They provide exemptions that would protect firms from lawsuits filed if there are problems with their vaccines. While vaccines are vital to safeguard public health, there have been instances when unknown side effects crop up, also known as adverse effects following immunisation (AEFI).
 

While the mechanism for compensating people who have had AEFI during a clinical trial is present, there is no such formal system for compensation when a vaccine is in the market.
 

“The Covid-19 vaccine has to be administered to over 1.3 billion people, maybe even twice. Even if a fraction of these undergo unascertained side effects, the recourse they have to receive compensation remains extremely weak,” says Zulfiquar Memon, managing partner, MZM Legal.

There are multiple laws that deal with vaccines and immunisation directly or indirectly. The most relevant here is the Drugs and Cosmetics Act, but even this only deals with issues such as vaccines being spurious, mislabelled, adulterated, etcetera. It does not deal with problems in the underlying formulation.

Other laws that could address this, such as tort and consumer protection laws, offer little protection because it is very difficult to establish cause and effect, especially when one is up against giant corporations that have their own research teams, say lawyers. “You need money, experts and the ability to make a case saying this was so obvious and clear that you should have known it,” says Kartik Ganapathy, partner, IndusLaw.
 

“Under criminal law, the degree of proof becomes even higher,” points out Arya Tripathi, principal associate, PSA Legal. Add to that the expenses of a long-drawn litigation. “When it comes to fighting big pharma, there is no way that they won’t appeal. You’re looking at a case with a litigation cycle of about 8-10 years,” she says.
 

One needn’t look too far back. Johnson & Johnson was accused of selling faulty hip implants (which, like vaccines, were deemed to be under the definition of drugs for legal purposes) to over 4,700 Indians between 2004 and 2010.
 

In other countries, such as the US, it agreed on settlements amounting to $4 billion. However, in India, nothing came out of the initial suits filed by patients in consumer courts. The government only intervened in 2017, facing public pressure.
 

After many legal battles, the firm agreed to pay an interim compensation to only 67 people, who approached the committee, Rs 25 lakh each. No patient was directly heard, and many were left out of the process. The case, even today, is still ongoing.

Vaccine compensation programmes exist in over 19 nations. They can benefit ordinary citizens as well as pharmaceutical firms. In the US, before 1987, firms were pricing vaccines keeping worst-case scenarios in mind. Their inability to predict exposure to lawsuits resulted in closure of small vaccine makers, reduced innovation and raised prices of doses. Legislations ensuring just compensation helped improve public trust, ensured access to justice and brought certainty for firms.
 

“Nearly all developed countries have compensation programmes, which protect the public by providing them recourse in the case of side effects due to a vaccine. These programmes, when run well, can be very helpful in encouraging confidence in vaccines since the onus of ensuring safety then falls on both firms and regulators,” says Ramanan Laxminarayan, founder and director of the Center for Disease Dynamics, Economics & Policy in the US.
 

Many such countries follow the “no fault” system, where the state recognises that many vaccine injuries are not attributable to any one party, where despite the best of care, some unforeseen event may happen and the patient must be compensated.

“In India, too, we definitely need the legal system to respond so that there is just compensation under the Drugs Act.

Something similar to the compensation scheme for clinical trials may be considered. This may be a greater issue with vaccines than drugs, since vaccines are given to healthy individuals,” says Murali Neelakantan, former global counsel for Cipla and Glenmark. He says that pharma companies, with the government, must follow “pharmacovigilance”, a term used for the practice of identifying side effects of drugs after they’ve been licensed and approved.
 

While details, onus of payment and structure of such a compensation mechanism are debated among experts, many believe that in principle, acceptance of a formal compensation mechanism must not be delayed further. Covid-19 offers the perfect opportunity to do so.