The European Union is currently offering very limited protection to COVID-19 vaccine makers against the legal risks that may arise from side-effects of these vaccine shots, according to European officials, with this move hindering the sealing of deals, contrasting with U.S. policy.
As vaccines continue to be developed at record speed during the pandemic, there is a greater chance that unexpected side-effects may arise or else the vaccine is not totally effective.
The financial coverage of these liabilities is a prominent topic of discussion during talks between medical scientists and governments, with the latter often being keen to secure these vaccine shots in advance.
An EU official claimed that EU governments “are ready to financially cover certain of the companies’ risks”, yet the strict rules imposed by the EU on liability still remained.
At the moment, these liability rules consider vaccine makers and other manufacturers to be totally liable for their products that are on sale in the European Union, apart from those extremely rare cases when they did not push them into circulation themselves.
These rare cases can be when doses are stolen and are therefore not provided by the original company willingly.
The EU’s top court increased the burden on drugmakers significantly in 2017, ruling that vaccine users were entitled to compensations if they could prove that a vaccine had caused some form of negative side-effect to them, even when there was no scientific consensus on the matter.
During the pandemic, the EU has continuously worked towards reducing the legal burden for vaccine makers, with this being crucial to convincing drugmakers to invest in risky vaccines, according to an EU internal document which is dated May 7.
However, offers made to vaccine makers have not always been what they expected.
EU officials that are involved in these delicate negotiations told Reuters in July that liability issues were the main stumbling blocks during the talks between United States drugmakers Johnson & Johnson and Pfizer, with these developing a potential COVID-19 vaccine with German biotech company BioNtech.
Whilst the EU later claimed that negotiations with Johnson & Johnson are at their latter stages, no deal had been reached.
When asked by Reuters to comment on whether such liability issues hindered talks with vaccine makers, a European Commission spokesperson refused to comment.
The supply agreement that the EU agreed earlier in August over a potential COVID-19 vaccine developed by AstraZeneca and the University of Oxford, offers only partial liability coverage.
The vaccine developed by AstraZeneca and the University of Oxford remains the only one to have a deal agreed between the vaccine makers and Brussels.
A European Commission official claimed that “Advance purchase agreements provide for member states to indemnify the manufacturer for certain liabilities incurred”.
The EU’s stance on liabilities could be the reason as to why the bloc is behind the United States when it comes to developing a potential COVID-19 vaccine.
The U.S. system shifts liability for vaccine fully to the government, thus protecting vaccine makers from any possible legal harm.
U.S. Congress has put aside $30 billion (€25.39 billion) this year in order to fight COVID-19 and find a vaccine, whilst the EU has formed an emergency fund that is expected to reach around €2 billion (€2.36 billion), something very minimal when compared to the U.S.