Vaccine Damage

Bulletin of the World Health Organization

Published online 21 March 2011

No-fault compensation following adverse events attributed to vaccination: a review of international programmes

Clare Looker a & Heath Kelly a

a. Victorian Infectious Diseases Reference Laboratory, Locked Bag 815, Carlton South, Vic., 3053, Australia.

Correspondence to Clare Looker (e-mail:

(Submitted: 10 August 2010 – Revised version received: 01 February 2011 – Accepted: 03 February 2011 – Published online: 21 March 2011.)

Bulletin of the World Health Organization 2011;89:371-378. doi: 10.2471/BLT.10.081901

Arguments for schemes

Arguments supporting vaccine-injury compensation include political and economic pressures, litigation threats, increasing confidence in population-based vaccine programmes and ensuring sustainability of vaccine supply. However, compensation schemes are also based on underlying principles of fairness and justice.

If there is no formal compensation scheme, the only source of compensation is through the courts, usually under the law of tort. Tort law requires a claimant to prove that he or she has suffered a wrong due to another person’s negligence or deliberate harm. The problem with this process, in the case of vaccination, is that there is often no clearly negligent party. A court-based approach to compensation can be inequitable and unpredictable, resulting in high monetary awards for some, while those who do not seek legal recourse receive nothing.

In the USA, before 1987, those injured by vaccines had no choice but to take their chances in the court system and seek recovery for their injuries directly from the manufacturer.34 Without a compensation system, it became difficult for vaccine manufacturers to predict their exposure to lawsuits. Accordingly, manufacturers and their insurers increased prices based on worst-case estimates.35 This led to exponential price rises, vaccine shortages and a reduction in vaccine research. Furthermore, several small vaccine manufacturers left the market.35

A vaccine-injury compensation scheme removes the uncertainty of tort liability for manufacturers and provides a more fair, efficient and stable approach for injured parties. Litigation is an expensive and restricted avenue that is inaccessible for many vaccine recipients. Furthermore, compensation schemes avoid the polarization of drug companies against vaccine recipients through litigation and the associated negative media coverage.36

Many countries that have implemented compensation schemes have done so as an expression of community solidarity.4 Ethicist Michelle Mello argues that solidarity means members of a community do not bear the risks of vaccination alone.37 Vaccine injuries can be severe and complex, and are often suffered by children who require a lifetime of care and may not qualify for other benefits under accident insurance schemes.3 In a vaccination programme, the injured and uninjured pay unequal shares of the social cost of producing the social good of herd immunity.37 Mello argues that, in line with principles of fairness and solidarity, mechanisms are needed to prevent the uninjured (unintentionally) “free-riding” on the injured... © John Fletcher 2012