- South Africa's vaccine injury fund will be headed up by retired chief justice Sandile Ngcobo who led the Competition Commission's investigation into the private health sector.
- South Africa is too wealthy to qualify for the World Health Organisation's Covax vaccine injury fund and had to establish its own fund to make bilateral deals for Covid-19 jabs.
- You can claim from the fund if you had a severe side-effect as a result of a Covid-19 jab bought and distributed by the South African government.
South Africa has secured enough vaccine doses to vaccinate 46 million people against Covid-19 - but the agreements to get shots into the country come with a catch.
In order to secure jabs, vaccine manufacturers require the government to exempt them at least partly from liability and potential lawsuits in the case of any severe side-effects the shots may cause.
The solution: a no-fault compensation fund.
Research has shown these types of schemes can have tangible benefits, such as fairly repaying people who are injured after they got vaccinated for the public good. They could also improve the public's trust in vaccine programmes, found a 2020 study, PLoS ONE, which analysed 23 schemes worldwide.
But the study also found some drawbacks of compensation schemes, including that people have to wait long for payouts and many of these funds have strict rules when it comes to proving a vaccine and a severe event are linked.
Speaking to Parliament on 14 April, Health Minister Zweli Mkhize said one of the conditions in the agreement with Johnson & Johnson (of which the country has secured 31 million doses) was that the regulations for the fund be published by 30 April.
Mkhize added a similar condition had also been put forth by Pfizer - from which South Africa has procured 30 million doses.
On 15 April, the regulations for the Covid-19 Vaccine Injury Compensation Scheme were published and opened up for public comment. The document gave the public five days (so until 19 April) to give their input on the funding scheme. This was a shorter period than normal because the Johnson & Johnson vaccines are expected to arrive this week.
One submission, from the Health Policy Initiative (HPI), criticised the regulations because they "contain minimal details and information on the specifics and cost of the proposed mechanism".
"This makes it difficult to comment on the mechanics of the fund, as mostly, it is still to be developed in the future," the HPI argued.
The organisation also pointed out although the compensation scheme had funding implications, the regulations were vague about how the scheme would be funded, "what financial contribution the public or others will actually make" and "whether said vaccine manufacturers will contribute to the fund or whether they are given special exemption … potentially leaving the entire financial burden of maintaining the fund to the state, and in turn, the public".
So what exactly is this fund?
If someone is harmed as a result of their vaccination, they can submit a claim to this compensation scheme, which will then pay them for the injury sustained. Each claim will be assessed by a panel of experts who will determine if the injury was caused by the vaccine itself.
Common side-effects associated with Covid-19 vaccines include pain at the injection site, fever, fatigue, headache, muscle pain, chills and diarrhoea. The fund is designed to cover more rare and severe occurrences.So far, this list only includes severe allergic reactions which are extremely uncommon. There are concerns about a possible link between the AstraZeneca vaccine and unusual blood clots, which is being listed as a rare side-effect in Europe, but it is unclear if this is being caused by the vaccine as yet. Similar claims are also being investigated regarding the Johnson & Johnson jab.
The idea is that South Africa's system will allow people to get access to financial compensation without having to go to court, which could potentially draw out the process. If a person is not satisfied with their award from the fund, they can then choose to file a claim through the legal system.
Importantly though, the funding scheme protects anyone involved from taking responsibility for the injury that occurred - so there is no blame assigned in the "no-fault" scheme and people cannot file a claim against the vaccine manufacturer or the government without having claimed from the fund first.
The exact amount of money that will be available through the fund is not entirely clear, but on Monday, Business Day reported R250 million would be allocated to the fund for the first year, based on the expectation that 800 to 2 000 successful claims would be paid out. Bhekisisa could not confirm this information.
Retired chief justice Sandile Ngcobo is in charge of overseeing the fund and ensuring all claims are dealt with fairly. Ngcobo headed up the Competition Commission's health market inquiry into the private health sector.
Why do we have the fund?
Internationally, the deals to get Covid-19 vaccines directly from pharmaceutical companies included provisions which protected the companies from claims made against them as a result of side-effects of their jabs, National Treasury told Bhekisisa in a written response to its queries.
But until last week, the legal responsibility for vaccine injuries that occur in South Africa's public and private sectors lay with the manufacturer that supplied the jabs.
This no-fault compensation fund is the government's response to having to take on some of the liability for potential serious adverse effects of the Covid-19 vaccines.
These funds usually cover a range of vaccines.
South Africa's fund is one of only two in the world that only covers injuries from Covid-19 vaccines. The other is the fund the World Health Organisation established for jabs secured through the international procurement mechanism Covax, but South Africa is not one of the 92 countries and territories that qualify to use it because the country is too wealthy.
The specifics of deals made directly with pharmaceutical companies are kept mum due to strict secrecy rules, but Treasury said the health department had not signed any agreements that completely waived companies' liability.
The provisions did, however, require the government to provide "substantial" indemnity to claims that resulted from adverse effects, it added.
South Africa's finance management laws do not ordinarily allow for agreements that totally suspend indemnity for companies that enter into deals with the state. Exceptions can only be made if the minister involved (in this case the health minister) and finance minister both agree to it.
Who is eligible to access the fund?
The short answer: We do not yet know exactly who will qualify to access compensation from the fund.
Here is what we do know - you are entitled to submit a claim if:
- The injury was caused by a Covid-19 vaccine registered, or approved, by the SA Health Products Regulatory Authority (Sahpra).
- The vaccine was procured and distributed by the national government.
- You received the jab at a government-listed vaccination site.
Both the health and finance ministers are tasked with determining the finer details of who is eligible to access compensation, which injuries - and vaccines - will be covered, the time period of injuries that the fund will cover, and the procedures of applying to the fund.
The fund is meant to provide compensation for "severe injuries resulting in permanent or significant injury, serious harm to a person's health, other damage or death" - provided that these injuries were caused by the vaccine.
A serious adverse response or reaction was defined as any condition caused by a medication that required hospitalisation, prolonged hospitalisation, caused persistent or significant disability, was a birth defect, was life-threatening or resulted in death, according to the Medicines and Related Substances Act.
All existing vaccine injury schemes covered vaccine injuries that resulted in disability, health damage or death, the PLoS ONE study found.
The SAHPRA provides oversight and regulates the quality, safety and efficacy of medicine and medical devices in the country. This means it is in charge of continuously monitoring the safety of medical interventions in South Africa and reviewing reports of adverse reactions that may occur.
It recently reviewed reports of unusual blood clots in people who received the Johnson & Johnson Covid-19 vaccine. This was part of checks and balances introduced along with vaccines to continuously monitor the jabs for any rare or severe side-effects. A simultaneous review is still being conducted by the US Food and Drug Administration.
On Saturday, the SAHPRA recommended the pause of the Sisonke study, through which the J&J vaccine is being rolled out to 500 000 health workers, should be lifted, provided certain conditions were met, such as "screening and monitoring of participants who are at high risk" of the rare type of blood clotting disorder that was associated with the vaccine.
Such reviews were done to "assess the benefit-risk ratio of the medicines", said Florah Matlala who oversees pharmacovigilance at the SAHPRA.
"Based on the outcomes of such assessments, different regulatory decisions are made which include professional insert amendment, restricting access through prescribers or up-scheduling."
Matlala said the SAHPRA's role was, however, more focused on ensuring the safety of the intervention and did not extend to liability issues.
Pharmaceutical liability cases must typically be dealt with through the Consumer Ombudsman and the legal system - something which the compensation fund minimises the need for.
The head of the health department's National Health Insurance office, Nicholas Crisp, said the department's team at the National Immunisation Safety Expert Committee, which is in charge of monitoring adverse events of vaccines administered in the country, might eventually form part of the monitoring body for claims with the fund too, but this had not been finalised.
How will the fund work?
The regulations published on 15 April leave the finer details of the fund's management up to directives from the department or committees it appoints.
The document gives the department the right to decide on whether to appoint a private company or government entity to administer the fund.
It also gives people the options to approach the courts to sue a national or provincial government department, but only after applying for a claim with the fund.
This was also the case for 65% of existing schemes globally, the PLOS ONE study found.
In South Africa, people who were unhappy with the fund's decisions could only go through the court system once an appeal to the fund was also resolved, according to the regulations. Vaccine manufacturers may not be sued.
How much compensation will people who claim from the fund be entitled to?
If South Africa bases its fund on the US' vaccine injury fund, for example, Crisp said the payout for vaccine injuries would be a set rate that was calculated based on the degree of disability you experienced as a result.
Claims for death as a result of a vaccine would then, in principle, be a once-off payment while an ongoing disability such as, say, paraplegia for argument's sake, might be paid out in monthly installments.
The specifics of the payout system in South Africa will still be determined. In the US, however, the vaccine injury fund covers medical expenses, income lost as a result of a vaccine injury, and a capped fee for pain and suffering.
Lawyers could claim fees from the fund too, according to the US Health Resources and Services Administration’s (HRSA) website.
In the US, manufacturers paid 75 cents (or R10) excise tax on each dose of vaccines covered by the scheme, and this money was used to pay people who were awarded compensation, said the HRSA.
This tax is calculated based on how many diseases each vaccine prevents. So, the MMR vaccine will be taxed $2.25 (R32) because it prevents measles, mumps and rubella.
Crisp said a body such as the SA Social Security Agency (Sassa) might be used to compensate people monthly, but the government was also considering other fund models, including private insurers.The fund hinges on the Disaster Management Act, which, (for now) will end in May, but ideally the fund could become a permanent feature that can eventually mediate claims for all vaccine injuries in South Africa.