More than 10,000 Australians so far requested compensation for COVID vaccine injuries under the country’s vaccine injury compensation scheme. What types of compensation programs exist in other countries?
By Michael Nevradakis, Ph.D.
The claims come as part of an Australian government program allowing individuals to be compensated for lost income after being hospitalized for “rare but significant” side effects resulting from the vaccination.
As originally conceived, compensation through the program was available to people who incurred A$5,000 or more in vaccine injury-related medical costs. However, the government enacted a reduction in the compensation threshold, permitting claims for the cost of vaccine injuries beginning at A$1,000.
The 10,000-plus compensation claims were submitted as almost 79,000 adverse side effects after COVID vaccines were reported to the country’s Therapeutic Goods Administration, as of mid-November.
No-fault vaccine liability: what is it?
Australia’s vaccine injury compensation program is an example of a “no-fault compensation program.”
This refers to a measure put in place by public health authorities, private insurance companies, manufacturers, and/or other stakeholders to compensate individuals harmed by vaccines. Such programs allow a person who has sustained a vaccine injury to be compensated financially, without having to attribute fault or error to a specific manufacturer or individual.
No-fault compensation schemes are one of three options used by various countries to handle vaccine injury claims.
The other two options include allowing vaccine-injured people to sue private-sector actors, such as vaccine manufacturers or their insurers, or to place the full financial burden on the patient.
A 2020 study found 25 countries with a no-fault program in place, with 15 of these programs administered at the government level.
In some countries, such programs are administered at the provincial level or at multiple levels of government, while two countries (Sweden and Finland) were identified by the study as having no-fault programs fully administered by the insurance sector.
The exact nature of such no-fault schemes, however, can differ significantly from one country to another. As explained in the 2020 study:
- In Sweden and Finland, pharmaceutical companies who market their products in these jurisdictions provide insurance contributions which fund those countries’ no-fault programs.
- Similarly, Norway’s no-fault program is funded by a special insurance organization known as the Drug Liability Association.
- Latvia’s Treatment Risk Fund is funded through contributions from medical institutions, acting as professional indemnity insurance.
- In China and South Korea, there are two separate programs, covering those vaccines in each country’s national immunization program (NIP) and those not included in the respective country’s NIP. Each government funds injury claims for NIP vaccines, while pharmaceutical companies or those holding a drug’s market authorization are responsible for funding injury claims regarding non-NIP vaccines.
- The U.S. no-fault Vaccine Injury Compensation Program is funded by a flat-rate tax of 75 cents for each disease covered in each vaccine dose.
- New Zealand has set up an Accident Compensation Corporation, which acts as a general compensation fund for accidents stemming from vaccinations, and treatment injuries. The program is funded through general tax contributions and levies on employee wages, businesses, vehicle licenses and fuel sales.
Not all no-fault programs compensate for injuries arising from all vaccines. For instance, according to the 2020 study:
- Only five (Japan, France, Italy, Hungary, and Slovenia) of the 23 programs specifically examined by the study covered injuries arising from mandatory vaccines or vaccines recommended by law — of particular significance in a world where more and more countries are attempting to implement COVID vaccine mandates.
- Just over half (57%) of the programs examined provide compensation for injuries arising from registered and recommended vaccines for children, pregnant women or adults and for special indication, such as occupation or travel, within the jurisdiction. This latter point is also significant in an era where many COVID vaccine mandates are being imposed on specific occupations or as a means of being “allowed” to travel.
Different no-fault programs also have differing rules with regard to when claims can be filed.
Referring again to the 2020 study, in certain countries, claims have to be filed within a certain number of years of vaccination or, in some cases, of the initial onset of vaccine injury symptoms. This ranges from 20 years (Norway), to six years (UK, for adults), to three years (U.S. and several other countries).
In some other countries, the maximum interval varies by province (China), or there is no specific deadline for filing a claim (including Sweden, Germany, New Zealand and Japan for NIP vaccines).
As seen with the example of Australia above, no-fault programs also set compensation thresholds. This is true in all no-fault countries examined by the 2020 study.
Thresholds of eligibility also exist, which may include injuries resulting in financial loss or permanent or significant injury (such as a medical disability), serious health damage or death, severe injuries surpassing normal post-vaccination reactions or other degrees of injury.
Just over half (52%) of the programs studied also provided compensation for claims regarding vaccine defects or immunization errors, while in the remaining countries, these types of claims are covered separately, through civil litigation or medical malpractice indemnity.
The 2020 study also noted that in almost all no-fault jurisdictions, such programs are non-judicial in nature and are instead administrative in scope, typically involving panels of medical experts who review each individual vaccine injury claim.
In a minority of countries, the administrative program is combined with a legal approach and the involvement of legal experts, while in Finland and Sweden, compensation decisions are made based on civil liability (tort) laws.
The standard of proof the claimant is required to demonstrate is generally similar across most no-fault programs, according to the 2020 study. These programs tend to employ a “balance of probabilities” approach that weighs whether it is “more likely than not” that the vaccination led to the injury in question.
This approach takes into consideration such factors as the time interval since vaccination, and existing medical evidence establishing a connection between the vaccine and that type of injury.
A country-by-country look
The above provides a general overview of how no-fault compensation programs work. However, it is also worth examining the specific rules in place in major countries and blocs of nations around the world.
In 1986, the U.S. Congress passed the National Childhood Vaccine Injury Act of 1986, often simply referred to as the Vaccine Act. Under this act, a no-fault program for administering vaccine claims, known as the National Vaccine Injury Compensation Program (VICP) was established.
Through this program, any individual claiming a vaccine injury (or a parent or guardian of a child) can file a petition with the U.S.Court of Federal Claims. The petition is reviewed by the U.S. Department of Health and Human Services (HHS), which makes a preliminary recommendation.
The U.S. Department of Justice (DOJ) then prepares a legal report, which includes the medical recommendation, and submits it to the court. The court then appoints a special master, who may convene a hearing, and who decides whether the petitioner should be compensated, and if so, what the level of compensation will be.
This compensation is then disbursed to the petitioner through HHS. Petitioners may also appeal a decision that isn’t in their favor, and by rejecting the decision of the court, may then file a lawsuit in civil court against the vaccine maker and/or the healthcare provider who administered the vaccine.
VICP, however, does not encompass all vaccines. It covers vaccines that are routinely administered to children and to pregnant women, and that are subject to the previously-mentioned 75-cent excise tax.
To date, more than 8,400 VICP claims have been settled, out of more than 24,000 petitions, with a total of $4.6 billion issued in settlements.
Compensation has also been issued. However, most such settlements were reached following negotiations instead of a hearing, with no admission on the part of HHS that vaccines were ultimately responsible for the injuries in question.
A different category of vaccines, including, at present, the existing COVID-19 vaccines, are covered under what is known as the Countermeasures Injury Compensation Program (CICP).
This program was established under the aegis of the Public Readiness and Emergency Preparedness (PREP) Act of 2005. The PREP act was developed to coordinate the response to a “public health emergency.” The law is scheduled to remain in place until 2024.
CICP specifically focuses on countermeasures, that is, “a vaccination, medication, device or other item recommended to diagnose, prevent or treat a declared pandemic, epidemic or security threat.”
Under CICP, a different claims process exists as compared to the VICP. The process for claimants is more cumbersome, and individuals have only one year after the administration of the vaccine to file a claim. Injuries whose symptoms materialize later in life, for instance, would presumably not be covered under this process.
Moreover, the likelihood of success, if past precedent is any indication, is slim. As previously reported by The Defender:
“The program’s parsimonious administrators have compensated under 4% of petitioners to date — and not a single COVID vaccine injury — despite the fact that physicians, families and injured vaccine recipients have reported more than 600,000 COVID vaccine injuries.”
Notably, vaccines with full FDA approval but which are not placed on a vaccination schedule for children or pregnant women are subject to ordinary product liability laws, while vaccines administered under an Emergency Use Authorization are protected from legal liability.
Furthermore, a 2011 Supreme Court decision, Bruesewitz v. Wyeth, held that the Vaccine Act preempts claims made under state-designed defect laws, against vaccines covered by the Act. The decision stated that ““[The Vaccine Act] reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.”
Until the 1980s, a series of successful lawsuits against vaccine makers was seen as resulting in increasing vaccine hesitancy and declining vaccination rates, as indicated in a 1985 National Research Council publication, released just one year before the passage of the Vaccine Act.