The government’s plans to exempt coronavirus vaccine manufacturers Johnson & Johnson (J&J) and Pfizer from liability for any harm caused by their products has raised the ire of local stakeholders.
Both companies have required the government to establish a no-fault compensation fund by April 30 in their negotiations with SA. The government has ordered 31-million doses of J&J’s single-shot vaccine and 30-million doses of Pfizer’s double-shot regimen. The scheme limits claims for severe side-effects from Covid-19 vaccines to the fund or the government.
The government has been accused of rushing its plans, as stakeholders complained on Monday that a five-day public comment period is inadequate for such far-reaching proposals.
The health department released draft regulations to the Disaster Management Act setting out the government’s proposals for the fund on April 15, and gave interested parties until April 19 to comment.
“It is a matter of national importance and we shouldn’t be rushed and bullied by the global pharmaceutical industry,” said Health Justice Initiative (HJI) founder Fatima Hassan. “We were given less than five days — including over a weekend — to make comment on a scheme that will potentially cover over 40-million people,” she said, referring to the government’s plans to inoculate that number of people by early 2022.
In its formal submission, the HJI said the regulations establishing the fund lack crucial details, including its cost and how the claims process will work. Nor is it clear what would happen to the fund if the state of disaster was lifted.
The plan to fully indemnify vaccine manufacturers and bar anyone from taking legal action against a vaccine manufacture even for negligence or conduct outside SA is an “unjustified restriction” on the rights of people living in SA, it said.
Asking the public to comment at short notice on a vaccine injury scheme without a complete rationale for its need undermines public trust and has the potential to fuel vaccine hesitancy, it said.
Rob Hutchinson, MD of lobby group DearSA, said the government’s proposals pose a big risk to taxpayers, as the liability for serious harm caused by Covid-19 vaccines would shift from the private sector to the state. Pharmaceutical companies have taken the same stance worldwide, shifting liability for claims from vaccine manufacturers to the taxpayer, in exchange for a “favourable place on the procurement ladder”, he said.
The brief public comment period was “a gross violation of the right to just administrative action”, and DearSA had written to co-operative governance & traditional affairs minister Nkosazana Dlamini-Zuma, asking her to extend the public comment period by three weeks, he said. The Disaster Management Act is in her portfolio.
In a written reply to parliamentary questions by IFP MP Magdalena Hlengwa, health minister Zweli Mkhize said a contingent liability of about R250m will be set aside for the fund for the first year, which is expected to cover administration costs and payouts for an estimated 800 to 2,000 successful claims.
The national immunisation safety expert committee will develop a vaccine-injury table to provide an objective point of departure for assessing compensation claims, and claimants will have to demonstrate a causal link between vaccination and injury, he said.
The committee consists of experts appointed by the minister.
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