1. Are COVID-19 vaccinations obligatory in your jurisdiction? Are you expecting any legislative changes to enable mandatory vaccines for all or certain people (e.g. healthcare professionals, public servants, school children, the elderly, frequent travellers)?
The Government does not currently intend to impose mandatory vaccinations. During the course of the campaign, citizen adherence will be measured in order to evaluate whether to impose any obligation.
According to the Vaccine Strategic Plan approved by parliament on 2 December 2020, vaccines will be offered free of charge to the entire population, according to an order of priority, which considers the risk of disease, types of vaccine and their availability. The vaccination campaign began with the inoculations of the following groups:
- Health and social care workers;
- Residents and staff of residential care facilities for the elderly;
- Persons of advanced age.
2. How would any COVID-19 vaccine be paid for in your jurisdiction (is it reimbursed from the public health system)?
The COVID-19 vaccine is provided at no charge to everyone and costs will be borne solely by the state.
It is not possible to vaccinate privately for a fee because the vaccines currently available will only be used in the facilities defined by the Vaccine Plan and will not be available in pharmacies or on the private market.
3. What legal regime(s) and regulations govern vaccine compensation in your jurisdiction? Is there specific legislation enacted or anticipated in relation to a COVID-19 vaccine or will it be covered under existing legislation?
Italian legislation provides for a mechanism of indemnification by the state for individuals who have undergone compulsory vaccination. The regulation is set forth in Law n. 210 of 1992. The law provides that anyone who has suffered, due to compulsory vaccinations by law or by order of an Italian health authority, injury or disability, which resulted in a permanent impairment of mental and physical integrity, is entitled to receive an indemnity from the state.
The indemnity provided for by Law 210/92 is a measure of social solidarity that does not prevent the damaged party from seeking damage compensation in case of culpable or intentional responsibility from the Public Authority or any other subject involved such as the manufacturer or healthcare professionals, as established by the Civil Code in Article 2043 on tort liability.
Given that COVID-19 vaccinations are not currently mandatory, the compensation scheme described above should not apply.
However, it is worth considering that, over the years, the Constitutional Court has ruled on the obligation of the state to recognise the indemnity also in some cases (e.g. vaccination for Hepatitis A), in which the vaccine, although not mandatory, is strongly recommended by the state. From the court decisions, it is not possible to draw a principle of general application for all cases in which the vaccine is recommended by the state, but it is possible that the court will rule on the subject of indemnity in a case concerning COVID-19 vaccines.
4. Who is covered/eligible for compensation (please cover compulsory and non-compulsory vaccination)?
In the case of compulsory vaccinations, the subjects mentioned in Law 210 of 1992 will be eligible for indemnification. The law refers to:
- the damage suffered by a subject due to compulsory vaccination by law or order of a health authority;
- unvaccinated subjects who have suffered a permanent impairment as a result of contact with a vaccinated person;
- subjects who for reasons of work or assignment of their office, or in order to access a foreign country, have undergone vaccinations that, although not mandatory, were necessary;
- subjects at risk who are working in hospital health facilities who have undergone vaccinations even if vaccinations are not compulsory for them;
- the spouse infected by one of the subjects mentioned above;
- the child infected during gestation by a mother who has been recognised as having the right to indemnity.
With respect to both compulsory and non-compulsory vaccinations, those individuals who can demonstrate that they suffered an injury as a result of the vaccination will instead be eligible for compensation
5. What damages are compensated, e.g. death, injury, disability, pain, mental suffering of a close person, economic damage (please cover compulsory and non-compulsory vaccination)?
The indemnity paid in case of damage from compulsory vaccination under Law 210 of 1992 is an all-inclusive sum that is paid out for the purpose of social solidarity.
Both in the cases of compulsory and non-compulsory vaccinations, material and non-material damage can be compensated. Such damages include compensation of any medical-related expense conducted to assist and treat the damaged party as well as of any expense incurred as a consequence of the vaccination. In addition, compensation may cover non-material damages suffered by the damaged party and, in case of death, also by the family members of the affected person.
6. What are the necessary conditions for a person to make a claim for compensation, including burden of proof (please cover compulsory and non-compulsory vaccination)?
In order to receive indemnity pursuant to Law 210 of 1992 for compulsory vaccinations, the claimant must submit a request to the Local Health Authority within the peremptory term of three years from the moment in which the person entitled becomes aware of the damage.
Documentation must be attached to the application proving the date of vaccination, the data relating to the vaccine, the clinical manifestations resulting from vaccinations and the extent of injury or disability of the subject.
In all other cases in which compensation for damages is requested (for both compulsory and non-compulsory vaccinations), the injured party must provide proof of damages, of the defect in the product or the error committed by the health professional, and of the causal link between the defect or error and the damage.
7. Who would be liable to pay the compensation, e.g. the state, the manufacturer of the vaccine (please cover compulsory and non-compulsory vaccination)?
The state is liable to pay the indemnity in relation to damages resulting from compulsory vaccinations.
In relation to both cases of compulsory and non-compulsory vaccination, the manufacturer, the importer, the healthcare providers and all those involved in the distribution of the product could be found liable.
The manufacturer or importer of the vaccine can be held liable if the damage is due to a defect in the product.
Healthcare providers can be held liable if the damage caused resulted from a breach of their legal obligations, such as proper disclosure and assessment of the patient's condition in relation to potential adverse effects of the administered product.
Liability could also be incurred by those acting as distributors or warehouse keepers if the product was damaged while under their responsibility.
8. Is there a de minimis threshold or a cap on compensation?
No cap on compensation is provided in relation to the compensation for damages caused by vaccines. However, the indemnity referred to in Law 210/1992 for compulsory vaccinations is calculated on the basis of the amounts contemplated in a table attached to the law, which could be considered a minimum threshold of indemnity.
9. Is compensation based on tariffs or individual assessment?
The indemnities paid pursuant to Law 210 of 1992 are based on tariffs. Each hypothesis of proper compensation for damages, both in case of compulsory and non-compulsory vaccination, is instead based on a specific evaluation of the case. In particular, the validity of the evidence adduced by the injured party in order to demonstrate the quantification of the damage will be evaluated.
10. Can a claimant obtain additional compensation beyond payment made by the compensation system?
In the Italian legal framework, the prohibition of compensatio lucri cum damno operates, which expresses the concept whereby the compensation is aimed at restoring the status quo ante, so that the compensation cannot represent an occasion of profit for the damaged party.
Therefore, the amount paid as indemnity should in principle be deducted from the amount awarded as compensation for damages. However, the application of this principle cannot result in an advantage for the damaging party, who cannot take advantage of the circumstance that a part of the damage has already been covered by the indemnity. Therefore, it will have to be assessed on a case-by-case basis whether or not the principle can operate. For instance, the Supreme Court has held that the principle can operate when the damaging party is an entity of the national health system since in this scenario the advantage gained by the damaging party actually represents an advantage for the entire health system.
11. Are you aware of any future legal developments in your jurisdiction with regard to compensation of COVID-19 vaccines?
At present, no reforms regarding compensation for damages from COVID-19 are expected.
Originally published 2 June 2021
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.