5.1 How would the answers above change if the adverse drugs reactions concern a vaccine?
Adverse events from vaccines involve the same considerations made in terms of responsibility, whether contractual, tort or criminal of those involved, i.e., manufacturers, health professionals and the State.
The system for communicating adverse reactions to vaccines is in fact the same, always set up by AIFA, and therefore the National Pharmacovigilance Network (RNF).
Alternatively, the report of a suspected adverse reaction can be communicated to the Marketing Authorisation Holder (MAH) of the vaccine/drug suspected of causing the adverse reaction.
Therefore, except for the indemnities referred to in the next answer, which introduces a different form of compensation, the remaining rules discussed above for adverse drugs reaction also apply in the case of adverse reactions resulting from a vaccine.
5.2 Is any public indemnity/compensation provided in the case of both compulsory and not compulsory vaccination?
Italian legislation provides for a mechanism of indemnification by the state for individuals who are 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.
This indemnity is the result of a principle of social solidarity and, therefore, different from the compensation that could be claimed from the injured party due to contractual or tort liability.
Law n. 210 of 1992generally provides for indemnity only for mandatory vaccines. However, following an interpretation provided by the Constitutional Court, this form of compensation is also provided for certain types of vaccines which, although not compulsory, are strongly recommended by the state as being carried out in the interest of the community.
Individuals injured by compulsory vaccination, who are already beneficiaries of indemnity under Law 210/92, may submit directly to the Ministry of Health an application under Law 229/05 to obtain further compensation equal to six, five or four times the amount attributed by Law 210/92, depending on the category ascribed.
The beneficiaries of Law 229/05 may also obtain a one-off allowance equal to 50% of the further compensation provided by Law 229/05 for the period between the occurrence of the harmful event and the obtaining of compensation.
The Ministry of Health is entirely responsible for the preliminary investigation of the files and the payment of the benefits provided for by Law 229/05. The Ministerial Decree of 21 October 2009, published in the Official Gazette no. 9 of 13 January 2010, supplemented the regulations on the benefits to which persons injured by vaccinations are entitled, identifying the criteria necessary for the formation of the ranking list for the payment of benefits. The ranking list is issued by a directorial decree and expires every six months.
From the date of the report of a suspected adverse reaction to the vaccine, the injured party has three years elapse to file a claim for indemnity under Laws 210(1992 and 229/2005. Once three years have elapsed, it is no longer possible to file a claim due to the limitation period.
Social Media cookies collect information about you sharing information from our website via social media tools, or analytics to understand your browsing between social media tools or our Social Media campaigns and our own websites. We do this to optimise the mix of channels to provide you with our content. Details concerning the tools in use are in our privacy policy.