Italy Covid Vaccine NFCS
Introduction
Italy had an existing no-fault compensation scheme for vaccines created in 1992 (through the passing of Law no. 210/92), and which incorporated COVID-19 vaccines from 2022.
This scheme was created under national legislation.
Applications for no-fault compensation are filed with Local Health Authorities (Aziende Sanitarie Locali). Since 2001, competence for the compensation procedure has been transferred from the Ministry of Health to Regions, with the sole exception of Sicily, where the state retains powers over compensation claims filed by residents.
The funding for the scheme comes from the Italian Government.
Vaccines covered
Originally, this NFCS covered nationally approved mandatory vaccines only (with the exception of particular groups of claimants, such as certain hospital workers who have undergone vaccinations, even if not mandatory), but subsequent Constitutional Court decisions have expanded the scope of the law to include other vaccines which are not compulsory but recommended by the state. COVID-19 vaccines were included in the scheme following the passing of the Law-Decree no. 4 of 27 January 2022, amending Law no. 210/92.
The scheme includes vaccines approved for emergency use and standard approvals.
Injuries covered
Under this NFCS only eligible injuries are covered. Eligible injuries are injuries causing a permanent mental or physical impairment.
Charges for making a claim
There is no charge for making a claim under this scheme.
Claimants
Under this scheme the following categories of individuals are permitted to make a claim:
- Injured vaccine recipient;
- Specified surviving family members in case of death of the vaccine recipient (in the following order: spouse, children, parents, siblings under the age of 18, siblings over the age of 18);
- Non-vaccinated people who have been permanently impaired as a result of contact with a vaccinated person.
Under this scheme the claimant is allowed to nominate a legal representative to make their claim.
In addition to vaccination-related injuries, note that the scheme also provides compensation for individuals who have been irreversibly damaged by hepatitis or HIV infection resulting from transfusion or administration of blood products, and to other related categories of claimants.
Losses covered
This scheme pays the following:
| Live vaccine recipient | Dependants of vaccine recipient | Estate of a deceased vaccine recipient |
| Compensation payments are for general categories and are not broken down into economic and non-economic losses. | No Compensation is provided specifically for dependants | Compensation payments are for general categories and are not broken down into economic and non-economic losses. |
Payments consist of a mixture of periodic payments and/or a lump sum payment (in case of death following vaccination).
The availability of funeral expenses is not specified under this NFCS.
Compensation under this scheme calculated on an individual basis using tariffs/guidelines to assist with quantification.
Loss of earnings are not paid under this scheme.
The maximum amount of compensation that can be awarded under this scheme depends on the quantum determined by tariffs, which are set out in Table B of Law no. 177/76. In case of death of the vaccine recipient, the surviving claimant is entitled to a pre-determined lump sum of € 77,468.53 (either in a single instalment or in the form of a pension over a period of 15 years).
Time limits for claims
The scheme does not set a time limit between vaccination and the adverse event occurring.
A claim under the scheme must be brought within 3 years from the moment the vaccine recipient becomes aware of the injury, or within 10 years from death in case of death of the vaccine recipient.
Evaluating claims – standard of proof required
The decision on causation in individual cases is made by committees of experts (‘Commissioni Mediche Ospedaliere’ or ‘CMO’), which are made up of at least three medical officers. The specific standard of evidence adopted by the committees is not further detailed in the NFCS legislation.
Appeals and the right to litigate
The right to litigate is not affected by use of the scheme - A claimant has a free choice to use the scheme or to litigate.
There is an external review process to review CMO’s decisions. A request for review needs to be filed with the Ministry of Health witin 30 days from notification of the CMO's decision, or from the moment the claiman has full knowledge of the decision. In addition, the Ministry of Health's decision can be reviewed by the competent Employment Tribunal (in this case, a request for review needs to be filed within one year from communication of the Ministry of Health's decision).
Useful information and links
It is not known whether annual reports including data on claims & financial performance (claim numbers, payments, claim processing timeframes, administrative costs, etc) are available for this scheme.
NFCS information on the Ministry of Health website (in Italian):
Links to legislation (in Italian):
https://www.trovanorme.salute.gov.it/norme/dettaglioAtto?id=13249 (Law no. 210/92)
https://www.gazzettaufficiale.it/eli/id/2022/01/27/22G00008/sg (Law Decree no. 4/2022)
http://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:legge:1976-04-29;177!vig=2023-02-10 (Law no. 177/76)