Written by Shobha Shukla, Bobby Ramakant and Sandeep Pandey
Think about this: Should a government come up with laws to protect a corporation against liability lawsuits, or should it come up with laws to regulate corporations and empower citizens so that corporations can be held to account for any kind of abuses or exploitation?
A statement made by one of India’s vaccine makers reminds us that the Constitutional duty of our democratically elected government is to protect its citizens, not corporations. Governments must keep people before profits and regulate corporations so that these companies conduct businesses with respect to human rights and the planet.
According to a news report Adar Poonawalla, the Chief Executive Officer of Serum Institute of India, had said that manufacturers of vaccines against the coronavirus disease (Covid-19) must be protected against liability in case there are any claims, including against serious adverse reactions, made against their shots during a pandemic. “We need to have the government indemnify manufacturers, especially vaccine manufacturers, against all lawsuits. In fact, COVAX and other countries have already started talking about that,” he said. “This is especially important only during a pandemic to indemnify vaccine manufacturers against lawsuits for severe adverse effects or any other frivolous claims which may come about because that adds to the fear (about vaccines)”.
Adar Poonawalla needs to be reminded that India, along with other governments, is negotiating a UN legally binding global treaty on human rights and business. It is the governments that needs to hold abusive corporations legally and financially liable. It is the responsibility of institutions, like Medical Research Councils, Drug Controller Generals, and other regulatory bodies like US FDA and other national FDAs or their equivalents, to ensure that scientific studies are being conducted with utmost scientific integrity and ethics.
Elaborate protocols have been laid out (with due diligence and scientific integrity) to conduct any scientific research study (also referred to as a clinical trial) to find if a vaccine or a drug is safe and effective for human beings, if there are any side effects (on different populations/ age-groups etc), and also to find answers to a range of other safety, efficacy and effectiveness related issues. It is also important to note that clinical trials have had a badly tainted history of ethical and human rights violations, with human beings treated as ‘guinea pigs’ (such as studies done forcibly on prisoners of war, decades back).
While it is important for science to proceed ahead, there is no doubt that ethics cannot be compromised at any stage. For instance, communities that participate in a clinical study ‘for larger good’ should be fully protected, compensated, provided best standards of care, and be the first ones to be offered access to the product-under study (if and when found safe and effective). Every adverse side effect they report must be attended to with dignity and respect, and not brushed off. But a news published on 1 December 2020 says that “Serum Institute of India is threatening to file for damages against a trial volunteer who went public about a severe adverse event he suffered while he was part of the COVID vaccine trial.” The news further stated that the Indian Council of Medical Research, Drug Controller General of India and the Ministry of Health and Family Welfare have been “conspicuously silent” on this.
Last month some COVID-19 vaccine manufacturers released some information on initial early-stage results of ongoing studies in the form of press releases, forcing scientists to demand more transparency in the sharing of scientific information for scrutiny and review before creating a (undue) hype. Is it not alarming to learn that some corporate executives of these agencies had sold millions of dollars’ worth of their shares when share prices had gone up soon after the press release went out?
What Adar Poonawala is suggesting is ominous as it reminds us of several instances in this country when the governments have clearly tried to protect the interests of the corporate at the cost of the people. The Chief of Union Carbide, Warren Anderson, was let go off by the Madhya Pradesh government in December 1984 under pressure from the United States after the fatal accident in the company’s plant in India and put on a filght from Bhopal to Delhi to eventually escape from the country never to return to face trial in Indian courts. The compensation eventually paid was inadequate and punishment given to Indian officials of Union Carbide too little. Then again, the Civil Liability for Nuclear Damage Act, 2010, puts all the burden of compensation (in case of an accident in a nuclear facility) on the operator which would be the public sector unit, Nulcear Power Corporation of India Limited, clearly shielding the suppliers who would be foreign multinational giants, unless it is a very obvious case of an act of omission by an employee of the supplier done with the intent to cause damage, which would not be easy to establish. In 2003, the Centre for Science and Environment (CSE) revealed high levels of pesticides and insecticides in Pepsi and Coca Cola sold in India. The government formed a parliamentary committee headed by Sharad Pawar, then Agriculture Minister, which verified the CSE findings but didn’t recommend any action against the soft drink manufacturers. Interestingly, since then these soft drinks are banned in the Parliament’s canteen. Health Ministry has now notified standards for pesticides in carbonated water and soft drinks. Rajasthan High Court had directed the two soft drink giants to mention on each bottle that the drink did not contain pesticide residue or that it is safe. The companies chose not to comply with the order. When the matter was taken to Supreme Court by the petitioner Sunil Mittal, the court while supporting the idea, in principle, lef the matter of mandating a declaration that the level of pesticides was within permissible limits to the Food Safety and Standards Authority of India, which is yet to enforce the decision. Public policy has increasingly been dominated by private corporations as India adopted neo-liberal economic policies in the early ‘90s.
Moreover, we the people, need to think why do we have to deal with almost 8 crores COVID-19 cases worldwide (over 1 crore in India)? Why did the government dither in taking appropriate infection control measures (including ban on international travels) when the World Health Organization had declared a Public Health Emergency of International Concern on 30 January 2020? Infection control and disease control is the government’s responsibility. Who is responsible for preventable diseases to become the leading causes of deaths of our population?
Shobha Shukla and Bobby Ramakant are with Citizen News Service and Sandeep Pandey is Vice President of Socialist Party (India).
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