South Africa published draft regulations to establish a new fund that will protect pharmaceutical companies from all liability arising from the use of Covid-19 vaccines.
This will address a key demand made by Johnson & Johnson (J&J) and other suppliers.
The regulations on the Covid-19 Vaccine Injury No-Fault Compensation Scheme, released by the department of health on Thursday, propose the establishment of a panel led by a retired judge and other experts to adjudicate vaccine-related claims.
The finance minister will issue regulations setting out how much compensation will be paid.
Claims may not be filed in court until they have been processed by the panel, but its rulings may be appealed.
Government has faced widespread criticism for being slow to procure vaccines, with almost 300 000 healthcare workers inoculated with the J&J shot so far in a study targeting up to 500 000 workers.
On Wednesday, Health Minister Dr Zweli Mkhize told parliamentarians delays were partly attributable to manufacturers making “unreasonable demands” on government to ensure their interests were safeguarded.
The regulations clearly state that government will bear liability for all vaccine-related claims and the manufacturers will be granted indemnity under procurement agreements.
The country worst-hit by the pandemic in Africa in terms of the Covid-19 infections and deaths is counting on the single-dose J&J and double-shot Pfizer vaccines to ramp up immunisations after a slow start.
It has signed deals with the two firms for a combined 61 million doses, enough to vaccinate 46 million people out of its population of about 60 million.
“As government we have found ourselves in a precarious position of having to choose between saving our citizens’ lives and risking putting the country’s assets into private companies’ hands,” Mkhize told a parliamentary committee about vaccine negotiations on Wednesday.
He added that procurement efforts were now largely concluded.
Mkhize did not give a value for the non-refundable payments, which are in the spotlight after South Africa paused use of the J&J vaccine on Tuesday to investigate a potential link to rare blood clots – following the lead of US regulators.
Mkhize reiterated on Wednesday the pause was likely to be short-lived.
J&J and Pfizer did not immediately respond to requests for comment.
Mkhize said Pfizer initially wanted “sole discretion to determine additional terms and guarantees for us to fulfil indemnity obligations” but had backed down after “intense negotiations”.
He said J&J was holding out for a letter from the trade minister expressing support for its investment in local pharmaceutical company Aspen, which will be making J&J doses under licence.
Opinion among ordinary South Africans appears divided over whether the country was right to pause use of the J&J vaccine.
“I think it’s a little bit premature given the fact that we have had no local reports in terms of the blood clots, but ... what happens in the US tends to influence what happens in the rest of the world,” Johannesburg resident Ntokozo Mhlongo told Reuters TV.
Mkhize said officials were still expecting the first batch of commercial doses from J&J later this month and they were not considering terminating their contract.
The suspension was the latest setback for South Africa’s immunisation efforts, after it ditched plans to kick-start vaccinations with Oxford-AstraZeneca’s shot in February.
A trial showed that vaccine had greatly reduced efficacy against the dominant local Covid-19 variant.
Regulator SA Health Products Regulatory Authority said on Wednesday it had found no major safety concerns with the J&J shot after reviewing data from the research study that started in February.
It said further data were being obtained from J&J and the US Food and Drug Administration and that reviewing that could take a few days.
Mkhize said South Africa was paying $10 (R140) per dose for the J&J and Pfizer vaccines and talks were continuing over the Russian and Chinese shots.
Comments on the new rules can be submitted by April 19. – Additional reporting by Reuters