Pharma official: COVID-19 vaccines will need no-fault compensation systems

In the context of COVID-19 vaccines, Luppi said this means that individuals who suffer serious vaccine-related injury, disability, or death can secure prompt compensation for their injuries without having to incur the cost, delay and uncertainty of the judicial process. [PopTika/Shutterstock]

Billions of people across the world will be vaccinated in a very short period of time once a COVID-19 vaccine is available, inevitably resulting in some side-effects that may or may not be linked to the vaccine. For this reason, countries should adopt no-fault compensation systems, a senior pharma official told EURACTIV in an interview.

“No-fault compensation systems (NFC) and vaccines confidence go together,” said Nicoletta Luppi, senior vice president and managing director of MSD Italia, a multinational pharmaceutical company.

“Vaccine confidence is about trust individuals have in the safety and efficacy of a vaccine, but also in the systems that is delivering them. A trusted system is also system that provides the right level of protection and compensation in case of vaccine-related injuries,” she told EURACTIV.

The date of a possible vaccine against COVID-19 is not yet known. However, governments and the pharma industry have already started the discussion on how to handle possible side-effects of COVID-19 vaccines, which will have to be administered to billions of people worldwide in a short period of time.

This could lead to massive lawsuits against manufacturers and distributors, but also against healthcare professionals and public health authorities.

“Such litigation is normally costly and time-consuming, often taking many years for resolution, during which claimants remain uncompensated and assertions concerning the safety of vaccines remain unresolved,” she said.

NFC systems are based on the principle that injured parties can be compensated without having to prove that the opposing party is at fault for the injury, or that the vaccine is defective  -although the victims have to prove a causal link between the use of the vaccine and the injury.

In the context of COVID-19 vaccines, Luppi said this means that individuals who suffer serious vaccine-related injury, disability, or death can secure prompt compensation for their injuries without having to incur the cost, delay and uncertainty of the judicial process.

“Once the COVID19 vaccines will be made available, it is millions, if not billions, of individuals that will be vaccinated in a very short period of time. It is unavoidable that a number of individuals will experience medical events in temporal proximity to vaccination that are unrelated to the vaccinations,” she emphasised.

Currently, eleven EU member states have some compensation systems in place but they differ from each other in the funding sources or the level of compensation.

“Countries with no-fault compensations systems in place should share their experience with other countries and how they consider these systems are protecting vaccine confidence […] This may help other countries to assess the value of such mechanism and potentially seek for EU support in their establishment,” she said.

Luppi emphasized that in an NFC, the vaccine developers remain liable in case of deliberate fault impacting the vaccine safety and quality or if the Good Manufacturing Practices were not followed. [Photo by MSD]

Side-effects not related to a vaccine

Luppi, who is also a board member of Vaccines Europe, stressed that there will also be cases of people who will get vaccinated and have side-effects due to another disease and not to the vaccine.

“In 2018, more than 17 million new cases of cancer were diagnosed worldwide, or approximately 46,575 diagnoses every day. It is inevitable, based on these numbers, that people will be diagnosed with cancer on the day of vaccination and in the days that follow,” she said.

This, according to Luppi, will have a disastrous effect on the trust in the vaccine as a wave of lawsuits will follow.

“This type of temporal association will cause some to believe incorrectly that the vaccine caused their injury, and some of these individuals will file lawsuits. Even in the absence of reliable evidence that the vaccine caused harm, one well-publicised case of a serious medical problem can start a wave of product liability claims,” she said.

“This will fuel safety concerns about the vaccines, result in additional claims, and undermine vaccine confidence,” she added.

Last but not least, Luppi emphasised that in an NFC, the vaccine developers still remain liable in case of deliberate fault impacting the vaccine safety and quality or if the Good Manufacturing Practices were not followed. 

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