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 The European Commission has confidential liability clauses in
contracts signed with AstraZeneca and Sanofi and is negotiating
similar conditions with other firms for the advance purchase of
their potential vaccines.
Sue Middleton, President of the Executive Board of Vaccines Europe
which represents top vaccine makers, told a European Parliament
hearing that in case of unexpected adverse events, which could
include unpredicted side-effects, she understood that there was
indemnification.
"The Commission or the member states would essentially indemnify the
companies against the cost of legal action that followed those
claims," she said, adding that these events were rare and that she
had not seen all contracts signed so far.
A spokesman for the European Commission said advance purchase deals
"provide for Member States to indemnify the manufacturer for certain
liabilities incurred under specific and strict conditions", but
"liability still remains with the companies".
Officials have said partial legal protection offered by the EU
hampered advance purchase deals in past months and prompted vaccine
makers to ask for more.
Middleton called for no-fault compensation in all 27 EU states for
COVID-19 vaccines which would speed up resolution of legal disputes.
Such a system is in place in 11 countries, but its application to
COVID-19 vaccine cases is not always clear, she said.
Consumer organisations and lawmakers insist that companies should be
liable for all potential side-effects.
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ROLLING REVIEW
No COVID-19 vaccine has yet been authorised in Europe, with clinical trials
underway. But contacts between vaccine makers and regulators are ongoing to
speed up possible authorisations.
The World Health Organisation lists 38 candidate vaccines in late-stage trials,
including from China and Russia. Another 149 are in pre-clinical evaluation.
"As of early September the EMA has been in contact with developers of 38
potential COVID-19 vaccines," Fergus Sweeney, head of clinical studies and
manufacturing task force at the European Medicines Agency, told EU lawmakers.
Under a faster "rolling review", vaccine makers can share data with EMA on their
trials as they happen, so that shots could be authorised more quickly when all
data is available.
No rolling review has yet began on vaccines, Sweeney said, adding the agency was
expecting that to begin in the coming weeks. EMA must authorise vaccines before
they can be used in the EU.
(Reporting by Francesco Guarascio; Editing by Gareth Jones, Jason Neely and
Alexander Smith)
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