Law 25 February 1992, n. 210 (in the Official Gazette no. 55 of 6 March) - Compensation for subjects damaged by irreversible complications due to compulsory vaccinations, transfusions and administration of blood products
1. Anyone who has reported, due to mandatory vaccinations by law or by order of an Italian health authority, injuries or infirmities, from which a permanent impairment of psycho-physical integrity has derived, has the right to compensation by the State, under the conditions and in the ways established by this law (1).
2. The compensation referred to in paragraph 1 is also due to subjects who are infected with HIV infections following the administration of blood and its derivatives, as well as to health professionals who, on the occasion and during the service, have reported permanent damage to the consequent psychophysical integrity. an infection contracted following contact with blood and its derivatives from subjects affected by HIV infection.
3. The benefits referred to in this law also belong to those who present irreversible damage from post-transfusion hepatitis (4).
4. The benefits referred to in this law are for unvaccinated persons who have reported, following and as a result of contact with the vaccinated person, the damages referred to in paragraph 1; to people who, for work reasons or on behalf of their office or to be able to access a foreign state, have undergone vaccinations which, although not mandatory, are necessary; risk subjects operating in hospitals that have undergone vaccinations, even if not mandatory (2) (3).
(1) With judgment of 23-26 February 1998, n. 27 (Official Gazette no. 4 of 1998 March 9 - Special series), the Constitutional Court declared the constitutional illegitimacy of art. 1, paragraph 1, in the part in which it does not provide for the right to compensation, under the conditions established therein, of those who have undergone polio vaccination during the period of validity of the Law of 30 July 1959, n. 695 (Measures to make polio vaccination integral). The same Court, with judgment 9-16 October 2000, n. 423 (Official Gazette 18 October 2000, n. 43 - Special series), declared, among other things, the illegitimacy of art. 1, paragraph 1, in the part in which it does not provide for the right to compensation, under the conditions established therein, of those who have undergone vaccination against hepatitis B, since 1983. See also art. 3, Law 14 October 1999, n. 362 and art. 1, Law 29 October 2005, n. 229.
(2) The indemnity referred to in this article consists of a check, reversible for fifteen years, determined to the extent indicated in table B attached to the Law of 29 April 1976, n. 177. The compensation is cumulative with any other remuneration for any reason received and is revalued annually on the basis of the programmed inflation rate (art. 1, l. 25 July 1997, n. 238), for 1997.
(3) The subjects referred to in this article are exempt from participating in the healthcare expenditure pursuant to paragraphs 14 and 15 of art. 8, l. December 24, 1993, n. 537, as well as the payment of the fixed fee per recipe referred to in paragraph 16-ter of the same article 8, limited to the health services necessary for the diagnosis and treatment of the pathologies provided for by this law, for 1997.
(4) The Constitutional Court, with judgment of 20-26 November 2002, n. 476 (Gazz. Uff. 4 December 2002, n. 48 - First special series), has declared the illegitimacy of this paragraph, in the part in which it does not foresee that the benefits provided by the law are also due to health care workers who, on the occasion of the service and during the same, have reported permanent damage to the psycho-physical integrity resulting from an infection contracted following contact with blood and its derivatives from subjects suffering from hepatitis.
1. The indemnity referred to in article 1, paragraph 1, consists of a check, reversible for fifteen years, determined to the extent indicated in table B attached to the Law of 29 April 1976, n. 177, as modified by article 8 of the Law of 2 May 1984, n. 111. The compensation is cumulative with any other compensation for any reason received and is revalued annually on the basis of the programmed inflation rate (1).
2. The indemnity referred to in paragraph 1, is supplemented by the special supplementary indemnity referred to in Law 27 May 1959, n. 324, and subsequent modifications, foreseen for the first functional qualification of civil employees of the State, and starts from the first day of the month following the month of submission of the application pursuant to article 3. The aforementioned supplementary sum can be combined with the indemnity special supplement or other similar indemnity linked to the change in the cost of living. The persons referred to in paragraph 1 of article 1, even if the compensation has already been granted, are paid, on request, for the period between the occurrence of the harmful event and the obtaining of the expected compensation from this law, a one-time check equal to 30 per cent of the indemnity due pursuant to paragraph 1 and the first sentence of this paragraph for each year, with the exclusion of legal interest and monetary revaluation.
3. If death has arisen due to the vaccinations or pathologies provided for in this law, the beneficiary can choose between the reversible check referred to in paragraph 1 and a one-time check of 150 million lire. For the purposes of this law, the following dependents are considered entitled in order: the spouse, children, parents, siblings, older siblings unable to work. The benefits referred to in this paragraph are also due in the event that the income of the deceased person is not the only sustenance of the family.
4. If the person has died at a minor age, compensation is due to the parents or to those who exercise parental responsibility.
5. The subjects referred to in article 1 are exempted from participation in the health expenditure referred to in paragraphs 14 and 15 of article 8 of the Law of 24 December 1993, n. 537, and subsequent amendments, as well as the payment of the fixed fee per recipe referred to in paragraph 16-ter of the same article 8 of the aforementioned Law no. 537 of 1993, introduced by article 1 of Law 24 December 1994, n. 724, limited to the health services necessary for the diagnosis and treatment of the pathologies foreseen by this law.
6. The benefits referred to in this law are also due to the spouse who is infected by one of the subjects referred to in article 1, as well as to the child infected during gestation.
7. In addition to the benefits provided for in this article, injured parties who contract more than one disease each of which has achieved a distinct disabling outcome are granted additional compensation, established by the Minister of Health with its own decree, to an extent not exceeding 50 per cent of that provided for in paragraphs 1 and 2 (2).
(1) See also art. 3, paragraph 145, Law 24 December 2003, n. 350.
(2) Article thus replaced by art. 7, dl 25 October 1996, n. 548, conv. in l. December 20, 1996, n. 641.
1. The subjects interested in obtaining the compensation referred to in Article 1, paragraph 1, submit the relevant applications to the USL, addressed to the Ministry of Health within the peremptory term of three years in the case of vaccinations or post-transfusion hepatitis or ten years in cases of HIV infections. The terms start from the moment in which, on the basis of the documentation referred to in paragraphs 2 and 3, the claimant is aware of the damage. The USL shall, within ninety days from the date of submission of the applications, investigate the applications themselves and acquire the judgment referred to in article 4, on the basis of the directives of the Ministry of Health, which guarantee the right to confidentiality also through appropriate organizational methods (1).
1-bis. Anyone who, in the exercise of their functions, becomes aware of cases of people damaged by irreversible complications due to compulsory vaccinations, transfusions and administration of blood products, is required to respect professional secrecy and to adopt, within of its competences, all the necessary measures to protect the privacy of the person concerned (2).
2. Attached to the application is the documentary evidence: the date of the vaccination, the data relating to the vaccine, the clinical manifestations following the vaccination and the extent of the injuries or infirmities from which the permanent impairment of the subject is derived.
3. For HIV infections, the application must be accompanied by documentation proving the date of the transfusion or the administration of blood products with the indication of the data relating to the transfusion event or the blood product, as well as the date of the HIV infection. .
4. The document proving: the date of the vaccination, the data relating to the vaccine, the clinical manifestations following the vaccination and the death are attached to the application for compensation pursuant to Article 2, paragraph 3. For HIV infections, the documentation enclosing the date of the transfusion or the administration of blood products with the indication of the data relating to the transfusion event or the blood product, as well as the date of death, is attached to the application.
5. The doctor who carries out the vaccination referred to in Article 1 fills in an information sheet which indicates any side effects deriving from the vaccinations themselves.
6. The doctor who carries out transfusions or administers blood products compiles an information sheet of the data relating to the transfusion or administration.
7. For those who, at the date of entry into force of this law, have already suffered the impairment provided for in article 1, the term referred to in paragraph 1 of this article starts from the date of entry into force of the law (3).
(1) Paragraph, lastly, thus replaced by art. 1, l. July 25, 1997, n. 238.
(2) Paragraph added by art. 1, l. July 25, 1997, n. 238.
(3) The Constitutional Court, with sentence no. 18, declared the constitutional illegitimacy of this paragraph in the part in which it excludes, for the period included between the occurrence of the event before the entry into force of the aforementioned law and the obtaining of the performance determined in accordance with the same law, the right outside the hypothesis of art. 1996 of the civil code to a fair compensation paid by the State for the impairments and by those who have provided direct personal assistance to the first.
1. The medical judgment on the causal link between vaccination, transfusion, the administration of blood products, contact with blood and derivatives during service activities and impairment of psycho-physical integrity or death is expressed by the medical-hospital commission referred to in article 165 of the consolidated text approved by decree of the President of the Republic 29 December 1973, n. 1092.
2. The medical-hospital commission draws up a report of the tests carried out and makes a diagnostic judgment on the infirmities and injuries found.
3. The medical-hospital commission expresses its opinion on the causal link between infirmities or injuries and vaccination, transfusion, the administration of blood products, contact with blood and derivatives during service activities.
4. The report expresses the assessment of the classification of injuries and infirmities according to table A annexed to the consolidated text approved by decree of the President of the Republic 23 December 1978, n. 915, as replaced by table A attached to the decree of the President of the Republic 30 December 1981, n. 834.
1. An appeal to the Minister of Health is allowed against the judgment of the commission referred to in Article 4. The appeal is submitted within thirty days of notification or full knowledge of the judgment itself.
2. Within three months from the presentation of the appeal, the Minister of Health, having heard the medico-legal office, decides on the appeal itself with an act which is communicated to the applicant within thirty days.
3. The appellant has the right to bring the action before the competent ordinary judge within one year from the communication of the decision on the appeal or, failing that, from the expiry of the deadline for the communication.
1. In the event of aggravation of infirmities or injuries, the interested party can submit a request for revision to the Minister of Health, through the territorially competent USL within six months from the date of knowledge of the event (1).
2. For the judgment on the aggravation, the procedure referred to in articles 3 and 4 is observed.
(1) Paragraph thus modified by art. 7, dl 25 October 1996, n. 548, conv. in l. December 20, 1996, n. 641.
1. For the purpose of preventing complications caused by vaccinations, the local health units prepare and implement, within six months from the date of entry into force of this law, information projects aimed at the population and in particular to donors and recipients of human biological materials, to people to be vaccinated and to people in contact.
2. The projects referred to in paragraph 1 ensure correct information on the use of vaccines, on possible risks and complications, on methods of prevention and are primarily aimed at parents, schools and communities in general.
3. The regions, through the local health units, take care of the collection of cognitive data on vaccine complications, also in order to adapt the information projects and prevention methods to these data.
1. The compensation provided for in this law is paid by the Ministry of Health.
2. The burden resulting from the application of this law, valued at 19 billion lire for the year 1992 and 10 billion lire from 1993, is provided by reducing the appropriation entered in chapter 4550 of the estimate of the Ministry of Health for the year 1992 and corresponding chapters for the following years.
3. The Minister of the Treasury is authorized to make the necessary changes in the balance sheet with his own decrees.