Pharma ‘must not dodge liability for harm in COVID-19 vaccine trials’

An EU consumer body has urged the European Commission to keep compensation measures in place for people who might be harmed in COVID-19 vaccine trials, responding to reports that the drug industry is lobbying to reduce liability.

In a letter to the Commissioner for Health and Food Safety Stella Kyriakides, the BEUC says that even though the need for a coronavirus vaccine is urgent, access “must go hand in hand with adequate consumer compensation in case of harm.”

With dozens of vaccines starting human testing at breakneck speed as the COVID-19 crisis continues, there are concerns that unexpected side effects could occur, and that more people could be exposed to that risk than usual as the lead candidates start large-scale trials.

Last month, there were reports that the pharma industry was lobbying to relax liability rules for coronavirus vaccines across the board, arguing that given the unprecedented situation it was not fair for companies to shoulder the risk of hefty damages payments if a vaccine is shown to cause side effects years down the line.

AstraZeneca for instance told Reuters in July that it has already been granted protection from future claims in most countries with which it had signed supply agreements for its COVID-19 shot AZD1222. AZ has agreements in place to supply more than 2 billion doses of the vaccine to the US, UK, other countries in Europe and elsewhere.

Meanwhile, the European Commission has said it will offer partial protection against liability for coronavirus vaccine developers, in contract to the US where laws are already in place that exempt products used in public health emergencies from tort (civil wrong) liability claims.

The EU has insisted that strict liability rules remain in place however, and there are reports that even that level of protection is hampering the bloc’s ability to secure access deals to some vaccines, including shots in development at Johnson & Johnson and Pfizer/BioNTech.

The BEUC is adamant that relaxing consumer protections even in such exceptional circumstances is a bad idea.

“This raises serious concerns about the extent to which citizens will be protected, and on the possibility that pharmaceutical companies end up making economic profits from the sale of their products without also being held accountable when things go wrong,” says its letter to Kyriakides, signed by BEUC director general Monique Goyens.

The Brussels-based consumer group says while it recognises that governments may choose to bear some portion of the liability risks associated with COVID-19 vaccines, the risks must be shared between EU member states and the drug industry.

BEUC wants any agreements between the industry and EU to be open to public scrutiny, and the process for securing compensation to be “quick and effective.” It also wants drugmakers to be required to carry out rigorous follow-up of patients who receive vaccines and report adverse events quickly to the authorities when seen.