COMMENT | Public confidence is crucial for the success of Malaysia’s Covid-19 immunisation programme. To build public confidence in the vaccine, we must answer the question of “what happens if there’s an adverse event from the vaccine?”. We would like to explain the situation and propose a framework to manage liability arising from the rare occasions of an adverse event.
For a start, we would like to firmly state that the currently available data for the Pfizer/BioNTech vaccine shows a strong safety profile. The risk of a serious adverse event from a vaccine is extremely low. Among 20 million people worldwide already vaccinated so far with the Pfizer/BioNtech vaccine, the overall adverse event rate reported was approximately 0.02 percent . That is much safer than the effects of actually getting Covid-19.
Side effects from a vaccine are called an “adverse event following immunisation” or AEFI. In many cases, the side effects are expected and predictable, such as some injection site redness, some fevers or some muscle pain. The safety profile of the Pfizer/BioNTech Vaccine was characterised mostly by short-term and mild-to-moderate pain at the injection site, fatigue and headache.
Reported injection site reactions like pain, redness, and swelling are resolved within seven days, while systemic reactions like fevers are resolved within one to two days. In a three-month trial of 40,000 participants, six deaths were reported, but most were cardiovascular events unrelated to the vaccine. In short, the Pfizer/BioNTech vaccine has a strong safety profile, leading to its approval in Malaysia.
Medical product liability happens when a person is harmed from a defective medical product and was not warned beforehand about the potential side effects. In Malaysia, there is no specific law that governs adverse events from vaccines or medicines. Therefore, product liability is broadly based on legal principles relating to contract law, tort law and relevant statutory provisions.
The civil remedies available to a patient would be legal action based on the tort of negligence or contract. It can be against any party in the chain of distribution of the drug including the manufacturers, distributors, retailers or even the healthcare provider. The relevant statutes in Malaysia would be the Sales of Goods Act 1957, Consumer Protection Act 1999 and the Contracts Act 1950.
The patient could obtain remedies including compensation, right to replace defective product or a refund under the Consumer Protection Act 1999. Patients can sue for pain and suffering and out-of-pocket expenses under the law of tort. Criminal sanctions against side effects from drugs may attract liability under the Poisons Act 1952 (and its Regulations) or the Sale of Drugs Act 1952. Criminal prosecutions is unlikely due to difficulty in securing a successful conviction.\
The Malaysian government has not disclosed the terms of the agreements to purchase vaccines from the various manufacturers and we are therefore not able to comment conclusively on product liability. Nevertheless, from the publicly available information, it is clear that Pfizer has insisted that as a condition of vaccine supply, governments must give a full indemnity to it. This is the case in the United Kingdom and Singapore.
If the same terms are applied to Malaysia, then the party who gives the indemnity (in other words, the Malaysian government) will likely be primarily and independently liable if any adverse effect occurs from the vaccine. Therefore, in any case, where any damages are awarded, this will have to be paid by the Malaysian government.
Vaccine manufacturers generally do not want to be financially accountable for any consequences from vaccine adverse events, especially during pandemics. This is broadly the position of the International Federation of Pharmaceutical Manufacturers Association, an industry group, which has publicly called for protection against lawsuits associated with vaccine-related adverse events.
It is true that concerns about litigation and liability had previously delayed availability of vaccines, even when other parts of emergency response had been accelerated. For instance, during the H1N1 influenza pandemic in 2009, the World Health Organisation (WHO) accelerated the process of authorising treatment approvals, but product liability concerns hampered the process of approvals.
In another example, the United States government enacted the 2005 Public Readiness and Emergency Preparedness Act (PREP) to exclude tort claims from products that help control a public health crisis, providing immunity to vaccine manufacturers from lawsuits (with some exceptions).
However, we share four examples of vaccine liability solutions that Malaysia can learn from across the world. One, the Vaccine Damage Payment Act 1979 in the UK allowed financial remuneration from its national fund to provide compensation to those injured by specified vaccines. Two, the Singapore government announced the Vaccine Injury Financial Assistance Programme for Covid-19 Vaccination in January 2021. The programme will provide financial assistance for affected persons in the rare event of serious side effects.
Three, the US Department of Health and Human Services (HHS) specified that the Covid-19 vaccination is covered by the Countermeasures Injury Compensation Programme (CICP). People injured by Covid-19 vaccines must file claims with a fund administered by HHS. The CICP is a payer of last resort, with insurers, workers’ societies or other third-party payers being earlier payers. Four, the Philippines is considering a Vaccine Indemnification Fund Act for Covid-19 vaccines to provide liability coverage for their population.
We welcome the decision of the Malaysian government to provide free vaccines for non-citizens. Vaccine liability for non-citizens may need to be extended within an appropriate framework. As Malaysia develops our own vaccine liability programme, we must understand that there is no "one-size-fits-all" solution globally.
It may not be feasible for some countries to offer pharmaceutical companies an indemnity deal as it may be constitutionally or financially impossible. Other countries may refuse due to basic fairness, believing that manufacturers should be responsible for the injuries caused by their product. This is especially true for low- and middle-income countries which have to weigh between refusing or providing liability protection to manufacturers, and its subsequent impact on contracts and supplies.
We recommend the following three options. One, Malaysia can adapt the no-fault vaccine injury compensation programmes (VICPs) implemented in WHO-member states, as reported in the Global Advisory Committee on Vaccine Safety (GACVS) in 2018. Adapting compensation systems for routine immunisations for public health emergencies will show the government’s commitment towards the Covid-19 immunisation plan.
While different systems vary in terms of elements of compensation and funding mechanisms, we can adapt the policies related to funding, proving injury and distributing compensation involving multiple parties. For example, we can set up a bespoke Covid-19 vaccine compensation programme. The programme could be co-financed by a mixture of public and private funds (for example, led by insurers), to achieve effective immunisation rollout while providing a fair and equitable remedy and reduce overall costs to society.
Two, Malaysia can adapt the Singapore model and completely assume the financial costs of any serious adverse events from the vaccine. The list of serious adverse events that are covered, the mechanism of approval and the ministry which will pay are details that can be decided by a relevant committee. Given serious adverse events are rare, the overall cost should be manageable and represents a good investment for public confidence.
A third option is the Covax Facility’s no-fault-compensation scheme for indemnification and liability. The scheme proposed by Covax aims to set up a compensation fund for vaccine recipients in participating countries who might suffer any side effects from Covid-19 vaccines.
The scheme proposes a new mechanism to pay a lump sum based on the severity of harm to victims from Covid-19 vaccines-associated side effects. The proposed mechanism would be funded by earmarking funds from high-income countries or by charging taxes on pharmaceutical companies.
There are reasonable solutions to the problem, and Malaysia must have a full and honest conversation about how to manage adverse events, no matter how unlikely they might be. All the solutions described above are not mutually exclusive. However, implementing them requires political will and courage. Covid-19 vaccination is a collective national effort, and we must do all we can to increase public confidence in the vaccine by providing appropriate liability protections.
YEE HUI FANG is a pharmacist currently pursuing a MSc in public health. Also contributing are Sharmini Navaratnam (a medico-legal practitioner) and Khor Swee Kheng (a physician specialising in health systems and policies).
The views expressed here are those of the author/contributor and do not necessarily represent the views of Malaysiakini.
