South Africa Covid Vaccine NFCS

South Africa has a national scheme, see below, and is a member of the AVAT NFCS.

Introduction

South Africa introduced a no-fault compensation scheme for COVID-19 vaccines in 2021 through the National Department of Health Regulations No. 376 of 22 April 2021.

In addition to the 2021 Regulations, Directions on the establishment of a COVID-19 vaccine injury no-fault compensation scheme have been published in 2022 (see the National Department of Health Directions 1987 of 4 April 2022).

This scheme was created under national legislation, and its statutory basis is the Disaster Management Act 2002 (Act no. 57 of 2002).

The scheme is administered by the National Department of Health – see Regulations no. 376/2021, 90(1) and Directions no. 1987/2021, 3.1.

The funding for the scheme comes from Central Government and Donations – see Regulations no. 376/2021, 91(1):

‘The funds of the Scheme consist of -

(a) funds appropriated by an Act of Parliament to the vote of Health or from contingencies in terms of appropriation legislation or the Public Finance Management Act; and

(b) funds donated to the Scheme.’

Vaccines Covered

The vaccines covered by this NFCS are those COVID-19 vaccines specified in Schedule 1 to the Directions no. 1987/2021, which are procured and distributed by the National Government (see Directions no. 1987/2021, 1.4).

Schedule 1 to the Directions lists as covered vaccines (‘applicable vaccines’ in the Schedule) the following COVID-19 vaccines approved by the South African Health Products Regulatory Authority (SAHPRA):

Comirnaty and Pfizer-BioNTech COVID-19 vaccine;
Johnson & Johnson’s Janssen COVID-19 vaccine (JNJ-78436735)

that were donated to the National Department of Health, obtained by the Government of South Africa in terms of the COVAX facility, or which were procured by the Government of the Republic of South Africa through the National Department of Health in terms of specified previous agreements with Pfizer and Janssen Pharmaceutica (see Schedule 1, Directions no. 1987/2022).

To be covered by the NFCS, vaccines should be procured and distributed by the Government (see Directions no. 1987/2022, 1.4).

They should also have been administered at facilities in the Republic where COVID-19 vaccines are officially administered (Regulations no. 376/2021, 93(4)(c)).

Injuries Covered

Under this NFCS only eligible injuries are covered. Eligible injuries are ‘severe injuries’ resulting in permanent or significant injury, serious harm to a person's health, other serious damage or death as specified in directions issued in terms of subregulation (4)(a) – Regulations no. 376/2021, 93(3).

Charges for making a claim

It is not specified whether there is a charge for making a claim under this scheme.

Claimants

Under this scheme the following categories of individuals are permitted to make a claim:

‘A person who has suffered harm, loss or damage caused by a vaccine
injury ...’
‘...A dependant of a deceased person, who has suffered harm, loss or
damage caused by the death of the deceased person whose death was caused by a vaccine injury ...’

See Regulations no. 376/2021, 93(1) and (2) and also Directions 1987/2022, 6.

Under this scheme the claimant is allowed to nominate a legal representative to make their claim (see Directions 1987/2022, 14.3.2). There is no specific funding for legal representation, however the Directions state that the Scheme Administrator should support claimants if they decide to formally lodge a claim (see Directions 1987/2022, Schedule 3).

Losses covered

This scheme pays the following:

Live vaccine recipient

Dependents of vaccine recipient

Estate of a deceased vaccine recipient

Compensation payments are for general categories and are not broken down into economic and non-economic losses.

No Compensation is specifically provided to the estate of the vaccine recipient.

Dependants are eligible for compensation only in the event the vaccinee is deceased.

Payments consist of a mixture of periodic payments and/or a lump sum payment.

A Death Benefit of R150,000 is available under this NFCS. This is to be divided between all dependants identified by the Adjudication Panel or the Appeals Panel within two months of the final determination of the claim.

Compensation under this scheme is calculated on an individual basis using tariffs/guidelines to assist with quantification. The quantum of compensation in the event of permanent disability is calculated by multiplying the Death Benefit amount by the specific harm factor depending on the severity of the disability.

The following harm factors are specified in Schedule 6 of the Directions:-

Harm Factor	Impairment following vaccination
0	No compensation will be paid if the impairment is below 5%
0.13	Impairment equal to or greater than 5% but below 10%
0.26	Impairment equal to or greater than 10% but below 20%
0.44	Impairment equal to or greater than 20% but below 30%
0.61	Impairment equal to or greater than 30% but below 40%
0.79	Impairment equal to or greater than 40% but below 50%
0.96	Impairment equal to or greater than 50% but below 60%
1.14	Impairment equal to or greater than 60% but below 70%
1.31	Impairment equal to or greater than 70% but below 80%
1.49	Impairment equal to or greater than 80% but below 90%
1.75	Impairment equal to or greater than 90%

In the event of temporary vaccine injury (in excess of 25% impairment), there is a temporary disability benefit of R5000 per month of disability up to a maximum of 6 months, with a minimum claim of one month. In order to be eligible for this benefit, a claimant should not be receiving a benefit for the same injury under COIDA.

A person may claim for both temporary and permanent disability where applicable.

Time limits for claims

The scheme does not set a time limit between vaccination and the adverse event occurring.

According to the Directions 1987/2022, 11, the following time limits apply:

An adverse event following immunisation (AEFI) must be reported to the National Immunisation Safety Expert Committee (NISEC) within 30 days of the onset of the AEFI. NISEC is a non-statutory, standing advisory committee of independent experts appointed by the Minister of Health (see Directions, 1.17). Note that reporting an AEFI is not a claim for compensation, but a prerequisite for an investigation into causality which may result in a claim (see Directions, Schedule 3);
A claim for compensation must be filed within 30 days after the claimant or duly authorised person has been informed, in writing, of the outcome of the NISEC causality assessment by the NFCS Administrator.

Claims cannot be filed for vaccinations administered before 17 May 2021 or procured under the terms of an agreement entered into after 5 April 2022 – see Directions, 10.1 and 10.2.

The NFCS will not cease to operate or cease to be of force and effect merely because the State of National Disaster comes to an end (See Regulations, 101, on the duration and termination of the Scheme).

Evaluating claims – standard of proof required

NISEC must make an initial recommendation as to whether the claimant's reported vaccine injury meets the requirements of being causally linked to the applicable vaccine (Directions, 13.1.1).

When NISEC makes a determination of causality between a covered vaccine and an injury, it must inform the Department of Health, and the Department must then notify the Scheme Administrator within 28 days of the NISEC determination.

The Scheme Administrator must inform the eligible person, or the dependant, or parent or legal guardian in the case of a child, of the NISEC determination and assist with the lodging of a compensation claim. (Directions, 14.1 and 14.2).

The assessment on causality is made by NISEC (Directions, 14.5.3). To determine causality, NISEC shall apply the WHO Methodology for Causality Assessment of AEFI as may be published from time to time by the WHO (Directions, 14.5.4). The assessment on eligibility and quantum is made by the Adjudication Panel (see Directions, 15).

Appeals and the right to litigate

Court litigation and NFCS are mutually exclusive - see Regulations 376/2021, 96(1).

There is an internal review process to review the NFCS’s decisions - see Regulations 376/2021, 100 and Directions 1987/2022, 16.

Useful information and links

It is not known whether the scheme produces an annual report including data on claims & financial performance (claim numbers, payments, claim processing timeframes, administrative costs, etc).

Links to legislation:

https://www.gov.za/documents/disaster-management-act (Disaster Management Act 2002)

https://www.gov.za/sites/default/files/gcis_document/202204/46196gon1987.pdf (Directions no. 1987 of 4 April 2022)

https://www.gov.za/sites/default/files/gcis_document/202104/44485gon376.pdf (Regulations no. 376 of 22 April 2021)