SA could protect vaccine firms from lawsuits
'If we are going to rely on emergency use approval, it is very likely that there will be the same expectation for South Africa.'
This picture taken on 23 November 2020 shows a bottle labelled ‘Vaccine Covid-19’ next to US pharmaceutical company Pfizer and German biotechnology company BioNTech logos. Picture: Joel Saget/AFP
With the United Kingdom (UK) having granted the Pfizer/BioNTech an indemnity to roll out vaccines to its citizens, South Africa was likely to follow a similar process – should the procurement be based on emergency use, according to an expert.
The UK indemnity protects Pfizer/BioNTech from any legal action associated with the vaccine – making it difficult for patients to file lawsuits in the event of complications, with the National Health Service (NHS) staff providing the vaccine, also protected.
Public health lawyer Safura Abdool Karim yesterday said public medication procured based on emergency use compelled governments to “to grant this type of indemnity to the company” in order to roll out the vaccine faster.
“Normally, a health regulator would monitor the product after it entered the market for long-term adverse effects.
“That has not happened. A company might be reluctant to roll out a product and be liable for unintended adverse consequences, outside of what they could monitor in a brief trial,” said Karim.
“In South Africa, it would depend a lot on regulatory approvals that are given. If we are going to rely on emergency use approval, it is very likely that there will be the same expectation for South Africa.
“However, if we were to roll out a vaccine in a year or two from now, where there has been long-term adverse consequence monitoring, it is possible that government would be justified for not granting that exemption.”
Karim said there were less legal risks for international pharmaceutical giants like Pfizer/BioNTech in South Africa, compared to other countries.
“The liability that Pfizer/Biontech would carry in countries like the US and UK, is much higher that the liability they would carry here.
“This is due to the way our laws work, with the cap here taking into account medical costs that you would suffer as a result of that adverse consequence effect.
“The risk of these companies facing lawsuits in the US and UK is very large in quantum – much smaller in South Africa. In the UK they introduced liability exemptions for healthcare workers in dealing with Covid-19 – not just the vaccine.”
Karim found non-disclosure agreements signed by government officials during meetings with manufacturers “normal”.
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