Challenges, complexities over COVID vaccines

Conventionally, vaccines have always been thoroughly tested across the population for several years. But the time is different now as governments and institutions were forced to squeeze the timeline.
For representational purposes (Photo | Vinay Madapu, EPS)
For representational purposes (Photo | Vinay Madapu, EPS)

India has started its Covid-19 vaccine rollout and approximately one million people have already received the shots.

The pandemic triggered a global race to come up with a vaccine. Authorities have approved the ‘Covishield’ and ‘Covaxin’ while other companies are also in the race for developing and manufacturing vaccines.

Conventionally, vaccines have always been thoroughly tested across the population for several years.

But the time is different now as governments and institutions were forced to squeeze the timeline from years to months.

This does keep the possibility of harmful side-effects and other questions open.

Are we ready to protect our citizens lawfully? Can the government force citizens to get vaccinated? Since the law can serve as both an enabler and a barrier, the answers should be dealt prudently. The Centre has recently rejected the demand by vaccine makers for indemnification thus assenting with the basic fairness principle that the manufacturers should pay for the injuries their products cause. As per the order, the Company shall be liable for all adversities as per CDSCO/Drugs and Cosmetics (D&C) Act/DGCI Policy/approval, as per reports.

Also, in the amended (D&C) Act, the compensation rules are defined for the clinical trial phase only, where the sponsor (company or institution) is mandated to provide financial compensation for the clinical trial-related injury or death. But, it also needed to keep in mind that the same will put the vaccine producing companies to the dais to response to the media about serious hostile events and investing time in addressing the legal issues rather than focusing on mass production. The unprecedented times are, thus, calling for an unprecedented critical assessment of rights, liabilities and processes. 

The government may enforce compulsory vaccination as it is to infectious disease and can be interpreted as an obligation for the sake of public health. The colonial-era has witnessed how the Epidemic Diseases Act of 1897 was first enacted to tackle bubonic plague in Mumbai. The Compulsory Vaccination Act of 1892 came into the picture to deal with the smallpox epidemic. At present, the power has been vested to the State through the National Disaster Management Act, 2005 to form nodal agency/authority to mandate compulsory vaccination. However, an FAQ released by the Ministry of Health and Family Welfare (MoHFW) states that vaccination for Covid-19 is ‘voluntary’. 

Another grappling issue in India has been easing out the Intellectual Property (IP) rights related to the vaccines.  The economy is global now and disruptions in one country or one part of the world tend to affect others. The pandemic has created a need for better research for detecting infections, vaccines and treatment. However, rich and developed countries are riding on a wave of ‘vaccine nationalism’, and backing their right to protect their vaccines and drugs as their intellectual property.

India and South Africa, however, have strongly defended their stance that the World Trade Organization (WTO) should waive off all IP rights to ensure that not only the wealthiest countries will be able to access and afford the vaccines, medicines, and other new technologies needed to control the pandemic.
According to a joint submission, without special measures, rich countries will benefit from new technologies, while poor nations will continue to be devastated. It was also submitted that IP rights such as patents have been obstructing affordable Covid-19 medical products and a temporary ban would allow multiple makers to start production sooner, instead of having manufacturing concentrated in the hands of a small number of patent holders.

Importance should also be given whether Indian manufacturers can claim against the foreign countries if widespread harmful effects were seen? If not, then do the financial benefits of small patent holders get justified? Though one is seeking ban temporarily, it can’t be neglected that IP protection laws strengthen incentives to provide for innovation and investment in products such as vaccines which are, by definition, unpredictable, risky, and expensive to develop. Strong IP protection also protects the public from counterfeit and adulterated drugs and from stockpiling medicines in developing countries. 

As PM Modi said, in his Mann Ki Baat, that for building a new India we require sabka saath sabka vishwas. A multi-stakeholder policy framework is the need of the hour to balance the safety of our citizens as well as for boosting innovation. It will be better if the white paper on vaccines is shared with citizens giving them access to raise questions, demand transparency and ensure that all data and information are made available in the public domain. It is in our interest that the above challenges are dealt with wisely as a remedy should never be worse than the disease.

Tishya Pandey Technology, Media and Telecom (TMT) Lawyer

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