Compensating harms from vaccination is one of the topical matters that arose during the COVID-19 pandemic. Some countries have created or extended no-fault compensation schemes for vaccination harm (hereinafter, “NFCS” or “scheme”) to offset injuries arising from new vaccines. NFCSs are politically desirable to incentivise vaccination development by waiving the liability of manufacturers and may play a role in responding to known and emerging infectious diseases threats by enhancing public confidence and promoting uptake.
From a constitutional perspective, the matter lies at the heart of the problem of state intervention in the personal sphere for collective goals. The importance of vaccination is twofold. It protects the individual, but it also prevents the outbreak of contagious diseases in the communities by developing immunisation among the population. For this reason, there is a fundamental public interest in the preventive action of individuals. This distinctive feature casts a specific light on the reciprocal relationship between the individual and the community. When healthy individuals receive vaccination, electively or compelled by law, the occurrence of serious adverse events, rare as they may be, raises distributive justice concerns. Is it fair that the individual bears the full risk of severe (albeit rare) side effects while the community gets the full benefit of vaccination? This thesis argues that setting the constitutional balance between individual and public health requires a fair compensation to offset vaccine harm and socialise the relevant risk.
Legal systems share a common difficulty in providing an effective remedy to vaccination harm. The latter can occur following different causation paths. The vaccine can present a defect due to its manufacturing and/or testing, its design, contamination or adulteration, as well as its labelling. When relying on the product liability regime, the major obstacles concern the proof of defectiveness and the causal link between the vaccine and the injury complained of. In contrast, a non-defective vaccine can still cause an injury if it is improperly administered in the wrong dosage or when there is a contraindication for the receiver. Suing the healthcare professional who administered the vaccination for medical malpractice is often not a strong litigation strategy. Moreover, non-defective vaccines properly administered can nevertheless produce idiosyncratic reactions in individual cases. For these reasons, civil litigation can be extremely burdensome for injured individuals having to commence legal action and pursue protracted and complex legal processes against the tortfeasor. NFCSs do not depend on proof of defectiveness or fault and, as such, guarantee a more reliable and effective remedy that is driven by justice.
This dissertation explores how different legal systems address these issues by comparing the regulations on compensation for vaccine-induced harm across Italy, Australia and Germany. The thesis questions the extent of state liability under NFCSs vis-à-vis the goal of ensuring equity in vaccination. These schemes affect the distribution of the risks associated with immunisation in different ways depending on their legal design. The question to be answered is whether they inject equity into the legal system by providing accessible, transparent, timely and adequate compensation. Specifically, the dissertation focuses on key features of these schemes. The eligibility requirements shape the reach of the policy. The scope of the scheme determines the vaccines covered and the type of injuries for which economic relief is granted. The causation assessment is a subsequent controversial element which has a significant impact on the effectiveness of the right to compensation.
Further, some systemic considerations are relevant when assessing the overall equity of these schemes. One aspect concerns the interaction, within each legal system, of the scheme with other existing social security measures, which might affect the amount of the compensation that injured individuals will receive. Furthermore, the potential interaction of these schemes with the wider civil litigation system not only affects the individual procedural position, but has broader political and legal repercussions. Designing the scheme as an exclusive remedy means waiving vaccine manufacturers from liability. This provides a strong incentive to research and development. At the same time, as an administrative remedy – insofar as it effectively avoids the complexities of civil litigation and is easy to navigate – it can tackle inequalities, enhance transparency in public-private negotiations and consistently improve the fair supply of and access to vaccines, especially in situations of an emergency requiring prompt public health response. The application for compensation under the scheme could be cumulable with the action for civil damages and/or with other social security benefits. However, this feature of the scheme might differ when considering a new pharmaceutical product developed under emergency conditions compared to a well-known vaccine routinely administered according to national immunisation schedules. The liability concerns are present with regard to both types of vaccine. Yet, in the first scenario manufacturers face an increased level of uncertainty due to pressing public health needs limiting the possibility to perform standard exhaustive trials. In this case, it could be argued that compensation for harm is a necessary condition for approval to make up for the compression of the clinical trial phase.
When evaluating whether these schemes can be regarded as an equaliser, it is also necessary to consider the relevant procedure. While an adversarial procedure might safeguard the claimant's position, an administrative one can ensure easier access to remedy. However, the need for legal representation (if any) and the impossibility to recover legal costs might annul the equalising function that these schemes allegedly perform. If the scheme cannot be easily navigated by laypeople, the substantial length and complexity of the administrative procedure can be just another cause of distress for claimants and might substantially marginalise some subsets of the population.
In sum, by providing a thorough analysis of the scope and limitations of existing NFCSs, this legal investigation will shed light on whether injured parties have effective access to foreseeable treatment as well as adequate social and economic support.
