Law 119/2017: Conversion into law, with amendments, of the decree-law 7 June 2017, n. 73, containing urgent provisions on vaccine prevention

Law 31 July 2017, n. 119 (in the Official Gazette n.182 of 5 August 2017) - Urgent provisions on vaccine prevention, infectious diseases and disputes related to the administration of drugs

Warning: The coordinated text published here was drawn up by the Ministry of Justice pursuant to article 11, paragraph 1, of the consolidated text of the provisions on the promulgation of laws, on the issue of decrees of the President of the Republic and on the official publications of the Italian Republic , approved with Presidential Decree 28 December 1985, n. 1092, as well as art. 10, paragraphs 2 and 3, of the same consolidated text, for the sole purpose of facilitating the reading of both the provisions of the decree-law, integrated with the changes made by the conversion law, and those modified or referred to in the decree, transcribed in the notes. The value and effectiveness of the legislative acts reported here remain unchanged.

Changes made by the conversion law are printed in italic (and bold) characters
In accordance with art. 15, paragraph 5, of the law of 23 August 1988, n. 400 (Discipline of Government activity and regulations of the Presidency of the Council of Ministers), the changes made by the conversion law are effective from the day following that of its publication.

Art 1. - Vaccine provisions
1. In order to ensure the protection of public health and the maintenance of adequate epidemiological safety conditions in terms of prophylaxis and vaccination coverage, as well as to guarantee the achievement of the priority objectives of the 2017/2019 National Vaccine Prevention Plan, pursuant to the agreement sanctioned by the Permanent Conference for relations between the State, the regions and the autonomous provinces of Trento and Bolzano on 19 January 2017, published in the Official Journal Officer n. 41 of 18 February 2017, and compliance with the obligations assumed at European and international level, for minors aged between zero and sixteen and for all unaccompanied foreign minors The following vaccinations are mandatory and free, based on the specific indications of the national vaccination calendar for each birth cohort:
a) anti-polio;
b) anti-diphtheria;
c) anti-tetanus;
d) anti-hepatitis B;
e) anti-pertussis;
f) anti-Haemophilus influenzae type b;

1-bis. For the same purposes referred to in paragraph l, for minors between the ages of zero and sixteen and for all unaccompanied foreign minors they are also compulsory and free, based on the specific indications of the national vaccination calendar relating to each cohort of birth, the following vaccinations:
a) anti-measles;
b) anti-rubella;
c) anti-mumps;
d) anti-chickenpox.

1-ter. Based on the verification of epidemiological data, of any adverse reactions reported in implementation of the current provisions of the law and of the vaccination coverage achieved as well as of any adverse events reported in implementation of the current provisions of law, carried out by the Commission for monitoring the implementation of the decree of the President of the Council of Ministers defining and updating the essential levels of assistance, established by decree of the Minister of Health of 19 January 2017, the Minister of Health, with a decree to be adopted after three years from the date of entry into force of the conversion law of this decree and subsequently every three years, after consultation with the Higher Health Council, the Italian Medicines Agency (AlFA), the Higher Institute of Health and the Permanent Conference for relations between the State, the regions and the Provinces autonomous of Trento and Bolzano and subject to the opinion of the competent Pa Regulatory, may order the cessation of the obligation for one or more of the vaccinations referred to in paragraph l-bis. In the event of failure to submit the decree schemes to the Chambers, the Minister of Health shall send the Chambers a report containing the reasons for the non-submission as well as the epidemiological data and those on vaccination coverage.

1-quater. For the same purposes referred to in paragraph 1, for minors aged between zero and sixteen, the regions and autonomous provinces of Trento and Bolzano ensure the active and free offer, based on the specific indications of the national vaccination calendar. relative to each cohort of birth, of the following vaccinations:
a) anti-meningococcal B;
b) anti-meningococcal C;
c) anti-pneumococcal;
d) anti-rotavirus.

1-d. Within ten days from the date of entry into force of the conversion law of this decree and subsequently every six months, the Ministry of Health, after consulting the Higher Institute of Health, provides operational indications for the implementation of paragraph l-quater, also on the basis of the verification of epidemiological data and the vaccination coverage achieved, carried out by the Commission for monitoring the implementation of the decree of the President of the Council of Ministers defining and updating the essential levels of assistance, established by decree of the Minister of Health 19 January 2017 .

2. The immunization following a natural disease, proven by the notification made by the attending physician, pursuant to article 1 of the decree of the Minister of Health 15 December 1990, published in the Official Gazette no. 6 of January 1, 8, or from the results of the serological analysis, exempts from the obligation of the relative vaccination. Consequently, the immunized subject fulfills the vaccination obligation referred to in this article, normally and in any case within the limits of the availability of the National Health Service, with vaccines in one-component or combined formulation in which the antigen for the infectious disease is absent for which immunization exists.

2-bis. For the purpose referred to in paragraph 2, the centralized purchasing procedures referred to in article 9, paragraph 3, of the decree-law of 24 April 2014, no. 66, converted, with amendments, by law 23 June 2014, n. 89, and article 1, paragraph 548, of the law of 28 December 2015, n. 208, with reference to the purchase of compulsory vaccines, also concern vaccines in one-component formulation.

2-ter. Annually, ALFA publishes on its website data relating to the availability of vaccines in one-component and partially combined formulations.

3. Except as provided in paragraph 2, the vaccinations referred to in paragraph l and paragraph 1-bis may be omitted or deferred only in the event of ascertained danger to health, in relation to specific documented clinical conditions, certified by the general practitioner or by the free choice pediatrician.

3-bis. The ALFA, without new or greater burdens on public finance, provides, availing itself of the technical-scientific Commission, integrated for this purpose by independent experts who are not in situations of conflict of interest, and in collaboration with the Higher Institute of health, to prepare and transmit to the Ministry of Health an annual report on the results of the pharmacovigilance system and on the data of adverse events for which an association with vaccination has been confirmed. The Minister of Health sends the aforementioned report to the Chambers.

4. In the event of non-compliance with the vaccination obligation pursuant to In this article, parents exercising parental responsibility, guardians or foster subjects are summoned by the local health authority that is territorially competent for an interview in order to provide further information on vaccinations and to request that they be carried out. In case of failure to carry out the vaccinations referred to in paragraphs 1 and 1-bis, to parents with parental responsibility, to guardians or to the foster subjects pursuant to the law of 4 May 1983, n. 184 a pecuniary administrative sanction of euro is imposed hundred to euro five hundred. They do not incur the sanction referred to in according to period of this paragraph parents exercising parental responsibility, guardians and the foster subjects that, following a dispute by the local health authority that is territorially competent, within the term indicated in the act of contestation, they provide the child with the vaccine or the first dose of the vaccination cycle, provided that the completion of the cycle
provided for each compulsory vaccination takes place in compliance with the times established by the vaccination schedule in relation to age. For the assessment, the contestation and the imposition of the administrative sanction, the provisions contained in chapter I, sections I and II, of the law 24 November 1981, n. 689, and subsequent amendments. The competent bodies based on the legislation of the regions or autonomous provinces provide for the assessment, dispute and imposition referred to in the previous period.

5. (Deleted)

6. It is, however, without prejudice to the adoption by the health authority of emergency interventions pursuant to article 117 of the legislative decree 31 March 1998, n. 112, and subsequent amendments.

6-bis. The vaccines indicated in the national vaccination calendar are subject to the mandatory negotiation of the ALFA, pursuant to article 48, paragraph 33, of the decree-law of 30 September 2003, n. 269, converted, with modifications, by the law 24 November 2003, n. 326.

6-ter. The Commission for monitoring the implementation of the decree of the President of the Council of Ministers defining and updating the essential levels of assistance, established by decree of the Minister of Health 19 January 2017, verifies compliance with the objectives of the national vaccination calendar and launches measures of competence designed to ensure the full and uniform provision of the essential levels of assistance provided for cases of failure, delay or incorrect application. In the presence of specific conditions of high risk for public health, the Government exercises the substitute powers, pursuant to article 120, second paragraph, of the Constitution and according to the procedures referred to in article 8 of the law of 5 June 2003, n. 131.

Art. 2 - Communication and information initiatives on vaccinations
As of July 2017, 7, the Ministry of Health promotes institutional communication and information initiatives to illustrate and promote knowledge of the provisions of this decree, pursuant to the law of June 2000, 150, no. XNUMX, and to promote voluntary and conscious adherence to the vaccinations provided for in the National Vaccine Prevention Plan, as well as to spread the culture of vaccinations in the population and among health professionals, without new or greater burdens on public finance, to be carried out also with the collaboration of general practitioners, free-choice pediatricians and pharmacists from local pharmacies, after consulting their respective ordinances and trade associations.

1-bis. To family counseling centers as per law no. 29, is entrusted with the task of disseminating information relating to the provisions of this decree.

2. The Ministry of Health and the Ministry of Education, University and Research, for the 2017/2018 school year, also initiate training initiatives for teaching and educational staff as well as for the education of pupils and pupils, students and students on the issues of health prevention and in particular vaccinations, also with the involvement of parents' associations and trade associations of the health professions.

3. For the purposes referred to in paragraph 2, the expense of two hundred thousand euros for the year 2017 is authorized.

4. The administrative pecuniary sanctions referred to in article 1, paragraph 4, are paid to a specific chapter of the revenue of the State budget. Fifty percent of the amount thus acquired is reallocated, for the years 2017 and 2018, to each of the estimates of the Ministry of Health and the Ministry of Education, University and Research, for the purposes of referred to in paragraph 2.

Art. 3 - Vaccination requirements for enrollment in educational services for children, institutions of the national education system, regional vocational training centers and private non-peer schools
1. The school directors of the institutions of the national education system and the heads of the educational services for children, of the regional vocational training centers and of the private non-equal schools are required, upon enrolling the minor aged between zero and sixteen and the unaccompanied foreign minor, to ask parents who exercise parental responsibility, to guardians or to the foster subjects the presentation of suitable documentation proving that vaccinations are carried out compulsory indicated in Article 1, paragraphs 1 and 1-bis, or the exemption, omission or postponement of the same in relation to the provisions of article 1, paragraphs 2 and 3, or the presentation of the formal vaccination request to the local health authority that is territorially competent, which will carry out the vaccinations mandatory according to the vaccination schedule foreseen in relation to age, by the end of the school year, o the conclusion of the annual calendar of childhood education services and courses for regional vocational training centers. The submission of the documentation referred to in the first period must be completed within the deadline for registration. The documentation proving that vaccinations are carried out can be replaced by the declaration made pursuant to the decree of the President of the Republic of 28 December 2000, no. 445; in this case, the documentation proving that vaccinations are carried out must be submitted by 10 July of each year. Without prejudice to the provisions of article 5, for cases in which the registration procedure takes place ex officio, the documentation referred to in the first sentence of this paragraph must be submitted by 10 July of each year, without prior presentation of a declaration made pursuant to the aforementioned decree of the President of the Republic no. 445 of 2000.

2. Failure to submit the documentation referred to in paragraph 1 within the set deadlines is reported, within the following ten days, by the school managers of the institutions of the national education system and by the managers of the educational services for children, of the professional training centers. regional and private non-peer schools, to the local health company which, if the same or other health company has not already activated itself in order to violate the same vaccination obligation, provides for the fulfillment of competence and, if necessary, to those referred to in Article l, paragraph 4.

3. For educational services for children and kindergartens, including non-equal private ones, the presentation of the documentation referred to in paragraph 1 is an access requirement. For the other degrees of education and for regional vocational training centers, the presentation of the documentation referred to in paragraph 1 does not constitute a requirement for access to the school, center or exams.

3-bis. Within three months from the date of entry into force of the law of conversion of this decree, school, health and socio-health operators present a declaration to schools and health companies in which they serve, made pursuant to the decree of the President of the Republic December 28, 2000, no. 445, proving your vaccination situation.

Art. 3-bis - Simplification measures of vaccination requirements for enrollment in the institutions of the national education system, childcare education services, regional vocational training centers and private non-equal schools, starting from the year 2019
1. Starting from the 2019/2020 school year as well as from the beginning of the calendar of childhood education services and courses for the 2019/2020 regional professional training centers, school managers of the institutions of the national education system and the heads of the educational services for children, the regional vocational training centers and the private non-equal schools are required to send the list of students enrolled for the school year or the subsequent calendar aged between zero and sixteen and unaccompanied foreign minors.

2. The territorially competent local health companies will return, by June 10, the lists referred to in paragraph 1, completing them with the indication of the subjects who are not in compliance with the vaccination obligations, who do not fall under the conditions of exemption, omission or postponement of vaccinations in relation to the provisions of article 1, paragraphs 2 and 3, and which have not submitted a formal vaccination request to the competent local health company.

3. In the ten days following the acquisition of the lists referred to in paragraph 2, the managers of the institutions of the national education system and the heads of the educational services for children, of the regional vocational training centers and of the non-peer private schools invite the parents exercising parental responsibility, guardians or carers of minors indicated in the aforementioned lists to file, by 10 July, the documentation proving the vaccinations or the exemption, omission or postponement of the same, in relation to the provisions of article 1, paragraphs 2 and 3, or the presentation of the formal request for vaccination to the local health authority with territorial jurisdiction.

4. By 20 July, the school managers of the institutions of the national education system and the heads of the educational services for children, of the regional professional training centers and of the private non-equal schools shall transmit the documentation referred to in paragraph 3 received, or communicate any non-filing, to the local health company which, if the same or other health company has not already activated itself in order to violate the same vaccination obligation, will carry out the fulfilments of competence and, if the conditions are met, to that of which Article 1, paragraph 4.

5. For educational services for children and kindergartens, including non-equal private ones, failure to submit the documentation referred to in paragraph 3 within the terms provided for will result in forfeiture of enrollment. For the other degrees of education and for the regional professional training centers, failure to submit the documentation referred to in paragraph 3 within the set deadlines does not determine the forfeiture of enrollment or prevent participation in the exams.

Art. 4 - Further fulfillments of school and educational institutions
1. Minors who are in the conditions referred to in Article 1, paragraph 3, are normally included in classes in which there are only vaccinated or immunized minors, without prejudice to the number of classes determined according to the provisions in force and the limits of which article 1, paragraph 201, of the law of 13 July 2015, no. 107, and article 19, paragraph 7, of the decree-law 6 July 2011, n. 98, converted, with modifications, by law 15 July 2011, n. 111. 2. The school managers of the institutions of the national education system and the heads of the regional vocational training centers and private non-equal schools shall communicate to the local health company, by 31 October of each year, the classes in which they are present most ' of two minor not vaccinated.

Art. 4-bis - National vaccines registry
1. In order to monitor the implementation of vaccination programs on the national territory, by decree of the Minister of Health, in agreement with the Permanent Conference for relations between the State, the regions and the autonomous provinces of Trento and Bolzano, it is established at the Ministry of Health, also through the reuse of computer systems or part of them already made by other health administrations, the national vaccines registry, in which the vaccinated subjects are registered and to be vaccinated, the subjects referred to in the 'article 1, paragraphs 2 and 3, of this decree, as well as the doses and times of administration of the vaccinations carried out and any unwanted effects.

2. The national vaccine registry referred to in paragraph 1 collects the data of the existing regional registries, the data relating to the notifications made by the attending physician, pursuant to article 1 of the decree of the Minister of Health 15 December 1990, published in the Official Gazette. Officer n. 6 of 8 January 1991, as well as the data concerning any undesirable effects of vaccinations that flow into the national pharmacovigilance network referred to in the decree of the Minister of Health 30 April 2015, published in the Official Journal n. 143 of 23 June 2015, in implementation of article 1, paragraph 344, of law 24 December 2012, n. 228.

3. The charges deriving from this article, quantified as 300.000 euros for the year 2018 and 10.000 euros starting from the year 2019, are provided for by means of a corresponding reduction in the expense authorization provided by article 1, paragraph 1, letter a) , of the decree-law 29 March 2004, n. 81, converted, with modifications, by law 26 May 2004, n. 138.

4. Without prejudice to the provisions of paragraph 3, the Ministry of Health shall provide for the activities referred to in this article with the resources available under current legislation.

Art. 4-ter - Crisis unit
1. To achieve the objectives of prevention and management of health emergencies in the field of infectious diseases, within three months from the date of entry into force of the conversion law of this decree, the Minister of Health, with his own decree, without new or major charges for public finance, integrates the objectives and composition of the Permanent Crisis Unit referred to in the decree of the same Minister of March 27, 2015 in order to make them functional to the coordination needs between all the institutional subjects competent in the field of disease prevention infectious as well as directing with respect to the actions to be taken in conditions of risk or alarm. Participation in the Crisis Unit is free of charge and the members are not paid tokens, fees or other emoluments, however denominated.

Art. 5 - Transitional provisions and finals
1. For the 2017/2018 school year and for the calendar of childhood education services and courses for the 2017/2018 regional professional training centers, the documentation referred to in Article 3, paragraph 1, must be submitted by 10 September 2017, to educational services and kindergartens, including private unequal ones, and by 31 October 2017 at the institutions of the national education system and regional vocational training centers. The documentation proving the execution of compulsory vaccinations can be replaced by the declaration made pursuant to the decree of the President of the Republic of 28 December 2000, n. 445; in this case, the documentation proving that the mandatory vaccinations have been carried out must be submitted by 10 March 2018.

1-bis. In order to facilitate the vaccination requirements introduced by this decree, the regions and autonomous provinces of Trento and Bolzano can provide that the free booking of the vaccinations referred to in Article 1, without new or greater burdens on public finance, can take place at affiliated pharmacies open to the public through the Unified Reservation Center (CUP System) referred to in Legislative Decree 3 October 2009, n. 153, and to the implementing decree of the Minister of Health 8 July 2011, published in the Official Gazette no. 229 of 1 October 2011, as well as within the scope of the purposes referred to in article 11 of the law of 18 June 2009, no. 69.

Art. 5-bis - Disputes regarding the recognition of vaccine damage and the administration of drugs
1. In proceedings relating to disputes concerning applications for the recognition of vaccination compensation pursuant to Law no. 25, and to any other dispute aimed at recognizing the damage from vaccination, as well as in proceedings relating to disputes concerning applications for authorization to administer alleged drugs not subject to experimentation at least in phase 1992 and to be economically charged to the Health Service national or public health bodies or structures, the ALFA is required.

2. The provisions of this article are applied exclusively in the judgments introduced at first instance starting from the thirtieth day following that of the publication of the law converting this decree in the Official Journal. 3. From the provisions referred to in this article, new or greater charges for public finance must not arise.

Art. 5-ter - Definition of refreshment procedures for subjects damaged by transfusion or by infected blood products or by mandatory vaccinations
1. In order to define the procedures aimed at the refreshment of subjects damaged by transfusions with infected blood, by administration of infected blood products or by mandatory vaccinations, the Ministry of Health, for the needs of the Directorate-General for the supervision of institutions and the safety of care , is authorized to make use of a contingent of up to twenty units of personnel belonging to area III of the Ministries compartment in command position pursuant to article 17, paragraph 14, of law no. 15, to be identified primarily among those with legal-administrative and economic-accounting professionalism.

2. The implementation of paragraph 1, within the maximum limit of € 359.000 for the year 2017 and € 1.076.000 for the year 2018, is carried out by means of a corresponding reduction in the expenditure authorization referred to in article 2, paragraph 361, of the law 24 December 2007, n. 244. The Minister of Economy and Finance is authorized to make the necessary changes in the budget by his own decrees.

Art. 5-quater - Compensation in favor of subjects damaged by irreversible complications from vaccinations
1. The provisions of Law no. 25, apply to all subjects who, due to the vaccinations indicated in article 1992, have suffered injuries or infirmities from which a permanent impairment of psycho-physical integrity has derived.

Art. 6 - Repeals
1. From the date of entry into force of this decree, the following are repealed:
a) Article 47 of the Decree of the President of the Republic 22 December 1967, n. 1518, and subsequent modifications;
b) the second paragraph of article 3 of Law no. 4;

6-bis) the second paragraph of article 3 of Law no. 20;
c) article 7, paragraph 2, of law 27 May 1991, no. 165.

Art. 7 - Financial provisions
1. The charges deriving from article 2, paragraph 3, equal to two hundred thousand euros for the year 2017, are provided for by means of a corresponding reduction of the expense authorization referred to in article l of the law of 18 December 1997, n. 440.

2. From the implementation of this decree, with the exception of the provisions of article 2, paragraph 3, there must be no new or greater burden on public finances.

3. The Minister of Economy and Finance is authorized to make the necessary changes in the budget by his own decrees.

Art. 7-bis - Safeguard clause
1. The provisions of this decree are applicable in the regions with special statute and in the autonomous provinces of Trento and Bolzano compatibly with the respective statutes and the relative implementation rules, also with reference to the constitutional law 18 October 2001, n. 3.

Art. 8 - Entry into force
1. This decree comes into force on the day following that of its publication in the Official Gazette of the Italian Republic and will be presented to the Chambers for conversion into law.

Source: http://www.gazzettaufficiale.it/eli/id/2017/08/5/17G00132/sg

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