The regulations on the government's proposed Covid-19 vaccine injury no-fault compensation scheme were posted on the Department of Co-operative Governance & Traditional Affairs website on Friday afternoon (17 April), giving members of the public “until 19 April” 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 founder Fatima Hassan. Rob Hutchinson, MD of NPO DearSA, said the brief public comment period was “a gross violation of the right to just administrative action,” and DearSA had written to Minister Nkosazana Dlamini-Zuma asking her to extend the public comment period by three weeks, he said.
The COVID-19 Vaccine Injury Compensation Fund is to be established in terms of regulations added to the Disaster Management Act. Interested parties have until 19 April to comment, reports BusinessLIVE .
The draft regulations say the fund is intended to offer eligible people “expeditious and easy access to compensation” for injury caused by COVID-19 vaccines, but do not specify which entity will administer claims and pay-outs.
They make provision for the department to either do this job in-house – which it could do via the Compensation Commission for Occupational Diseases – or outsource it to a service provider, such as an insurance administrator.
The draft regulations say the fund will compensate people for severe vaccine side-effects that cause permanent or significant injury, serious harm to a person’s health, or death.
Claims are restricted to vaccines approved by the SA Health Products Regulatory Authority, and procured by the government. The regulations make provision for the Health Minister to appoint an adjudication panel and an appeal panel to deal with claims, as well as a governance and oversight committee headed by a retired judge.
Government intends to gazette the finalised regulations for the NFC fund, or Vaccine Adverse Events Compensation Scheme, by 22 April, well ahead of COVID-19 vaccine manufacturers Johnson & Johnson’s and Pfizer’s stipulated end April deadline, says a Daily Maverick report. A NFC fund – a standard condition, also approved by the World Health Organisation – effectively would indemnify vaccine manufacturers, but still allow anyone adversely affected by COVID-19 vaccines to claim recompense.
That’s why this fund would be “mainly government funded”, Health Minister Zweli Mkhize told MPs. “We intend for the NFC fund to be independent, have credibility and skill that is required. We have finalised the process to identify a seasoned retired judge to chair this scheme,” said Mkhize before announcing retired Chief Justice Sandile Ngcobo as the fund’s chairperson.
“We believe that his extensive experience as a jurist, including having headed the highest court in our land, the Constitutional Court, and his recent experience to health-related complexities as the Health Market Inquiry chair makes him an ideal candidate to oversee that all claims and process followed by the NFC fund uphold the principle of fairness, transparency, equity and protect the constitutional rights of all our citizens.”
Despite imposing Monday (19 April) as the deadline for input on proposals for a “COVID-19 vaccine injury no-fault compensation scheme”, they were only officially published on Friday afternoon, reports Legalbrief Policy Watch.
Adding a new chapter to the disaster management regulations, the document concerned provides a framework within which Mkhize is required to issue directives prescribing all related processes and procedures, including those to be followed when claiming. In consultation with the Minister of Finance, he is also required to issue a directive specifying the “amounts and structure of compensation” to be provided. This is noting that the scheme will be limited to covering vaccine-related “severe … permanent or significant injury”, “serious harm to a person’s health”, “other damage” or death.
Completely indemnifying vaccine manufacturers from being held liable for any vaccine-related injury whatsoever, the draft regulations make it clear that any claim for damage through a court process may only be brought against the national government or a provincial government. This is regardless of whether the injury concerned is said to have been caused by the conduct of an organ of state, service provider, health establishment or facility, or the person who performed the authorised function entailed.
Described in the document as “an essential part of the COVID-19 vaccination rollout”, the scheme’s purpose is to provide for “expeditious and easy access to compensation for persons who suffer vaccine injury” when inoculated against the virus. To that end, the draft regulations cover the procedures to be followed by the Ministers of Health and Finance in establishing and managing the fund and scheme – the administration of which may involve the appointment of a service provider with “the necessary expertise and capacity to perform … these functions efficiently, effectively, competently and fairly”.
This is noting provisions in the 1999 Public Finance Management Act regarding financial accounting in such circumstances, as well as legislation dealing, among other things, with conditions of employment. They also prescribe criteria to be met in identifying and appointing people to serve on various structures, as well as the terms and conditions of their appointment. In that regard, it is envisaged that separate claims adjudication and appeals panels will be established, along with a governance and oversight committee.
In terms of the proposed new regulations, the Minister is responsible for issuing directives prescribing, among other things, the policy underpinning the scheme; the claims system (including persons eligible to claim, the types of claims that may be made, injuries to be covered, and specific vaccines to which compensation for injury may apply); related reporting requirements; and the appeals process.
The government has been accused of rushing its plans for establishing a no-fault compensation fund for severe side-effects from COVID-19 vaccines, as stakeholders complained that a five-day public comment period was inadequate for such far-reaching proposals, reports BusinessLIVE.
“It is a matter of national importance and we shouldn’t be rushed and bullied by the global pharmaceutical industry” said Health Justice Initiative 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 40m people,” she said, referring to the government’s plans to inoculate that number of people by early 2022.
Rob Hutchinson, MD of NPO DearSA, said the government’s proposals posed a significant risk to taxpayers, as the liability for serious harm caused by COVID-19 vaccines was shifted from the private sector to the state. Pharmaceutical companies had 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 and traditional affairs minister Nkosazana Dlamini-Zuma, asking her to extend the public comment period by three weeks, he said.
The regulations have been gazetted in terms of the Disaster Management Act, which falls under her portfolio.
The fund will have R250m at its disposal in its first year, according to Mkhize, who said the figure was based on an estimated caseload of between 800 and 2 000 successful claims. It also includes the provision for administrative costs, says a News24 report.
According to Mkhize's reply to a written response to a parliamentary question from IFP MP Magdalena Duduzile Hlengwa, the types and categories of injuries to be covered would be kept simple and limited to severe harm at the ‘launch of the programme’.
The existing National Immunisation Safety Expert Committee (Nisec) of the Department of Health – a non-statutory, standing, ministerial-appointed, advisory committee of independent experts – follows a globally used structured and systematic causality assessment process to classify cases in terms of causality.
“Nisec will develop and maintain a vaccine injury table to be used to provide an objective point of departure for assessing an application for compensation. The standard of proof for compensation must be a causal link between vaccination and injury,” he said.
Full BusinessLIVE report (Restricted access)
Full Daily Maverick report (Open access)
Full Legalbrief Policy Watch report (Restricted access)