Injury compensation

Vaccine injury compensation programmes (VICPs) are no-fault schemes established to compensate individuals who experience a vaccine-related injury due to the inherent risks of vaccination. These programmes do not require injured parties or their legal representatives to prove negligence or fault by the vaccine provider, the health care system or the manufacturer before compensation. They serve to waive the need for accessing compensation through litigation. As of 2010, compensation schemes for vaccine-related injuries had been identified and characterized in only 19 WHO Member States,⁵ none of which were low- or middle-income countries. With improved global capacity for vaccine safety surveillance, including more reporting and investigation of “adverse events following immunization” (AEFI) in low- and middle-income countries, WHO Member States are identifying and documenting reactions, with scientific evidence of causal associations with vaccination. This has led to increased interest and discussion of the need for national no-fault compensation policies for vaccine injuries.

GACVS was presented with the results of a global survey of the status of no-fault VICPs in WHO Member States, the main objective of which was to update the inventory of such programmes, evaluate current practices and update the characteristics of programmes. Further details of VICPs in China and USA were also presented and discussed. The survey identified 25 jurisdictions with no-fault VICPs, including 2 low- and lower–middle-income countries, although most countries with these programmes are categorized as high-income countries, mainly in the European Region, with 5 in the Western Pacific Region and 2 each in North America and the South East Asia Region. There is currently no such programme in Latin America or in the African or Eastern Mediterranean regions of WHO.

The no-fault VICPs in most jurisdictions are implemented and funded at central or federal government level. The eligibility criteria for vaccine injury compensation varied considerably among the schemes evaluated. Most programmes cover injuries arising from vaccines that are registered in the country and are recommended by the authorities for routine use in children, pregnant women and adults (e.g. influenza vaccines) and for special indications. In most programmes, a claim process is initiated once injured parties or their legal representatives file for compensation with a special administrative body. All the no-fault VICPs reviewed require proof of a causal association between vaccination and injury. Once a final decision has been reached, claimants are compensated with a lump sum of money; monetary compensation calculated from medical care costs and expenses, loss of earnings or earning capacity; and/or non-monetary compensation calculated on the basis of pain and suffering, emotional distress, permanent impairment or loss of function. In most jurisdictions, claimants have the right to seek damages either through civil litigation or from a compensation scheme but not both.

GACVS acknowledged that, as countries continue to extend the use of vaccines and strengthen their safety surveillance and investigative capacity, occasional severe vaccine-associated reactions will continue to be identified. No-fault VICPs are considered a measure to maintain confidence in immunization programmes, as they increase the adequacy and fairness of compensation by providing clear criteria and processes to access compensation for vaccine injuries. GACVS encourages and will support WHO in developing guiding principles for countries ready to develop VICPs.

⁵ Looker C, Kelly H. No-fault compensation following adverse events attributed to vaccination: a review of international programmes. Bull World Health Organization 2011;89:371–378.

Full report of GACVS meeting of 5-6 December 2018, published in the WHO Weekly Epidemiological Record on 25 January 2019