Who is liable for serious vaccine side effects? That, says a report in The Times, s an unanswered question hovering over negotiations between government and vaccine manufacturers.
Details of bilateral negotiations remain a closely guarded secret, subject to non-disclosure agreements (NDAs). The issue of liability is among those.
According to The Times, Health Minister Zweli Mkhize named liability as one of several issues that had been addressed: “There are certain issues of liability that are non-negotiable — it’s either you accept the conditions or you don’t get a vaccine, but we can’t go into specifics (because of NDAs)”
Mkhize’s comments echo those of Health deputy director-general Anban Pillay: “There’s an indemnity clause in place which requires you to accept liability for the product,” he said. “Here we are being told ‘we did this in record time, the clinical trials were in a short period of time, this is the best we could do, we are not prepared to accept the liability around these vaccines’. So we are having to manage that as well.”
Biovac, a local vaccine distribution company, said the liability issue was related to the absence of long-term clinical trial results for Covid-19 vaccines. Biovac CEO Morena Makhoana said, “For now, most developers know how it performs in the short term, but the long term is unknown, hence they typically require a no-compensation agreement,” he said.
According to The Times, a local health expert said manufacturers may be pushing for a liability arrangement similar to that in place in the US. It was a “no-fault” system that could provide compensation for those saying a vaccine adverse reaction, even in cases where a direct link between the reaction and the vaccine could not be proved. In this way the public had recourse to compensation and governments could proceed with urgent vaccine programmes with a minimum of delay.
Full report in The Times