brand logo

Covid-19 vaccines: Indemnification vs. accountability 

28 Jan 2022

BY Dr. Dharshana Kasthurirathna  Ford Pinto, a subcompact car that went on sale in the early 1970s in the US, had a technical issue in its gas tank, which officially caused 27 burn deaths (although according to some estimates, this number is significantly higher). Ford Motor had to face more than 100 lawsuits throughout the US and was forced to pay damages and eventually recall the car from the market. It was later revealed that a mere $ 11 improvement on the gas tank, per vehicle, could have prevented the fatal flaw (The Ford Pinto. Moral Issues in Business. Eighth Edition. W.H. Shaw and V.E. Barry. Pages 83-86). This particular example and countless other cases brought against powerful industrial players demonstrate the power of litigation in ensuring product safety. A market economy can only function in a healthy manner, without exploiting and misleading the general public, if only there is a free and fair legal system that holds the business interests accountable in ensuring the safety of their products and services. Otherwise, the sheer wealth and political influence of these industries can easily overrun individual rights and freedoms to cause immense harm to the society, in the pursuit of increasing the shareholder value.  Enter 2020 and the entire world is overrun with the Covid-19 pandemic scare. At the height of the pandemic, the US, China and other leading nations, the World Health Organisation (WHO) and the pharmaceutical industry rushed to the rescue with the introduction of a novel army of vaccines in the battle against Covid-19. Though it may be well intentioned, the issue of legal indemnification to protect the pharmaceutical industry against any liability of damages was one of the major aspects that was looked into, early in this process. In November 2020, just before the vaccines were made available to the public, the WHO published a draft document (Briefing note: Additional Information On Indemnification For Covax Advance Market Commitment [AMC] Participants) on how the Covid-19 Vaccines Global Access (Covax) facility will handle the issue of indemnification, or liability protection for the manufacturers from any potential adverse events that these novel vaccines may cause in people who receive them.  The Covax facility is a mechanism through which the WHO, vaccine manufacturing pharmaceutical companies, and organisations like the Bill and Melinda Gates Foundation and the Global Alliance for Vaccines and Immunisation (GAVI) joined hands to provide Covid-19 vaccines to all nations. The document clearly indicates that there is a risk of unforeseen serious adverse events and the manufacturers should be protected from any potential legal actions should they occur, in order to encourage them to fast track the vaccine production and dissemination. The justification for this is claimed to be that in a global emergency, some of the legal checks and balances that may be there in a normal market economy have to be overlooked, for the greater good.  The draft document, which appears to be a blueprint for the subsequent agreements that were to be signed among individual nations and the Covax facility, further recognised that there should be a mechanism to compensate individuals who may be potentially vaccine damaged, even though the exact mechanism is not elaborated on. Interestingly, the document suggests that a levy should be added to the vaccine cost or funds should be allocated by the member nations themselves to fund such compensation. What this suggests is that it is the general public of the member nations, and not the manufacturers, that may be bearing the cost of compensation for any potential vaccine injuries, for which they themselves may have taken legal action! This is not the first time the vaccine industry has passed the liability of damages back to the general public. In 1986, the US Senate passed the “National Childhood Vaccine Injury Act”, supposedly to protect the industry from relentless legal battles that it had to face at the time against numerous parents claiming that the diphtheria, pertussis/whooping cough and tetanus (DPT) vaccine damaged their children. The Act set up the “Office of the Special Masters of the US Court of Federal Claims”, popularly known as the “vaccine court” (the National Vaccine Injury Compensation Programme The Act protected the pharmaceutical companies and relieved them from any liability against potential damages. Instead, the petitions at the Court had to be filed against the US government, based on the justification that the Government mandates of these childhood vaccines made the government, not the industry, responsible for any potential harm a vaccine might cause.  As of October 2019, the so-called “vaccine court” had paid $ 4.2 billion in damages, albeit all of which is ultimately paid by the US taxpayer, as it is the taxpayer who ultimately bears government expenses. The industry has not paid a single cent out of this $ 4.2 billion. It has to be noted that the number of vaccines administered as well as the market value of the childhood vaccine programme has increased exponentially since the Act was passed, and one cannot help but wonder whether “medical necessity” is the only factor that affected that exponential growth. The criticality of vaccines in public health has always been the justification for the protected and special status that these products have enjoyed over the years, and the recent indemnification of Covid-19 vaccines is a mere globalisation and generalisation of the same trend. That said, it is hard to ignore the unintended consequences that this kind of protected status these products may have. Vaccines, after all, are very profitable products with almost guaranteed markets, with the full backing of almost all governments. In the case of Covid-19 vaccines, many governments have opted for questionable policies that essentially limit the travelling and liberties of those who refuse to get vaccinated, creating an environment of mandatory vaccination without actually mandating them.  When the factor of legal indemnification of manufacturers is added on top of that, it can easily create a platform for exploitation, where free market principles of the right to choose and legal liability are thrown out of the window, allowing a free reign for the pharmaceutical giants. After all, the threat of litigation and fines is one of the key incentives for any industry to make their products safer, and the automobile industry is a prominent example of this.  What the Ford Pinto example shows is that, to make a product more safe, there is an additional cost to the manufacturer. It may be a minute cost per unit, yet multiplied over millions or billions of units, that may add up to quite a large sum over the years. Every cent counts in any cutthroat industry, and the shareholder value is the ultimate performance indicator for any company. This is why having a functioning legal framework is critical to ensure the safety of the public. While regulators are supposed to be the gatekeepers when it comes to vaccines and pharmaceutical products, there has been some alarming evidence of “regulatory capture”, where the industry essentially takes over or absorbs the regulatory authorities.  For instance, the Food and Drug Administration (FDA), in the US, plays a pivotal role in drug approvals, presenting evidence to the agency’s advisory panels and influencing or making approval decisions. Their staff is free to move to jobs in the pharmaceutical industry, and many do. In a 2016 study in The British Medical Journal, researchers examined the job histories of 55 FDA staff who had conducted drug reviews over a nine-year period in the haematology-oncology field. They found that 15 of the 26 employees who left the agency later worked or consulted for the biopharmaceutical industry (FDA’s revolving door: Companies often hire agency staffers who managed their successful drug reviews). The existence of such a revolving door between the industry and the regulators, raises the question as to whether the public can depend on the regulators to protect their interests, which is what the regulators are supposed to do. In countries like Sri Lanka where corruption is rampant and most of the Government institutions are highly politicised, the issue of regulatory capture may be even more prevalent.  How does all this affect Sri Lanka, a country with a trembling economy that may be a tiny fraction of the budget of a single pharmaceutical giant? According to the Government website that publishes Cabinet of Ministers’ decisions, the Cabinet has given approval, back in January 2021, to sign an indemnification agreement with the Covax facility, as with the case of many other nations, relieving the vaccine manufacturers of any liability of potential adverse events. Interestingly, the Health Ministry asks the recipients of vaccines to sign a consent form indicating that they are aware of the rare yet potential adverse events and they were made aware of these events prior to taking the Covid-19 vaccines, supposedly to protect the Government entities from any potential legal action by anyone who thinks they had a serious adverse reaction.  Thus, it seems, everyone is “passing the buck” to the consumer, who is often coerced by veiled threats of Government health officials, Ministers, and sometimes their own employers to get vaccinated. The “consent” that they provided is given under duress and it is questionable as to whether it can be considered as genuine consent at all. The issue becomes even more tricky when considering that the manufacturers do not bear any liability and the WHO too has accepted that there could be unforeseen serious adverse events that may affect at least some individuals that receive these vaccines.  At the very least, the Government should have the transparency to make the agreement that they entered with the Covax facility available to the public. Further, there should be a rigorous legal and ethical discussion on issues such as indemnification of the manufactures as well as the issue of informed consent, which is currently virtually absent among the medical and academic community, although some members of the legal community have raised some of these issues.  If the Government lacks transparency on these issues, the possibility of using the Right to Information Act to disclose critical public information such as these agreements can be looked into. After all, it is the public that pays for these products and they have every right to know the agreements under which their Government is purchasing these products, what the rights and freedoms that they have in deciding whether to receive them or not.  (The writer is a senior lecturer in computer science and software engineering)  The views and opinions expressed in this article are those of the writer, and do not necessarily reflect those of this publication.


More News..