DDL 770 - Text of the Bill - Provisions on vaccine prevention

DDL 770 - Text of the Bill - Provisions on vaccine prevention

Bill 770 of initiative of Senators Patuanelli, Romeo, Sileri, Castellone and Fregolent communicated to the presidency on August 7, 2018.


The decree-law 7 June 2017, n. 73, converted, with modifications, by law 31 July 2017, n. 119, containing "Urgent provisions on vaccine prevention, infectious diseases and disputes relating to the administration of drugs", established in article 1, paragraphs 1 and 1-bis, that for minors aged between zero and sixteen years and for all unaccompanied foreign minors, vaccinations are mandatory and free of charge, based on the specific indications of the national vaccination calendar for each birth cohort: antipolyomyelitis; anti-diphtheria; anti-tetanus; anti-hepatitis B; cough suppressant; anti-Haemophilus influenzae type b; measles; Rubella; mumps; varicella.

Article 1, paragraph 1-quater, also provides that the autonomous regions and provinces of Trento and Bolzano ensure the free and active supply of vaccinations: anti-meningococcal B; anti-meningococcal C; pneumococcal vaccines; rotavirus.

Article 3, paragraph 3, of the aforementioned decree-law (the so-called "Lorenzin" decree) specifically prescribed that for educational services for children and kindergartens, including non-equal private ones, the submission of documentation proving that mandatory vaccinations are carried out is an access requirement. For the other degrees of education and for the regional professional training centers, the presentation of the aforementioned documentation does not constitute a requirement for access to the school or center or to the exams.

This provision is aimed at removing the provisions on vaccine prevention.

Article 1 sets out the aims of the bill: to ensure the protection of public health by promoting vaccinations in compliance with the recommendations of international health organizations; ensure full and uniform delivery of vaccination services throughout the country; ensure the implementation and updating of the national vaccination registry.

Article 2 provides that the national vaccination prevention plan (PNPV), with a five-year duration, identifies and periodically updates the specific minimum quality standards of vaccination activities, the objectives to be achieved throughout the national territory.

Article 3 contains measures for the implementation of the national vaccine prevention plan.

Article 4 regulates the functioning of the national vaccination registry, which contains the data relating to the vaccinated subjects and to be subjected to vaccination, to the subjects who omit or differ the vaccinations provided for by the PNPV, in relation to specific documented clinical conditions, attested by the doctor general practitioner or the free choice of pediatrician, as well as the doses and times of administration of the vaccinations carried out and any undesirable effects that flow into the national pharmacovigilance network. The national vaccination registry makes available to the regions and autonomous provinces of Trento and Bolzano, at central level, information relating to vaccinations carried out in a region or in an autonomous province other than that of residence as well as vaccinations carried out by the patient who has moved from an autonomous region or province to another autonomous region or province.

Article 5 contains interventions in the event of health emergencies or impairment of group immunity. The adoption of extraordinary intervention plans is also envisaged if significant deviations from the objectives set by the PNPV are identified as part of the monitoring of vaccination coverage carried out on a half-yearly basis by the Ministry of Health, such as to generate the risk of compromising the group immunity. These plans include, where necessary, the obligation to carry out one or more vaccinations for certain birth cohorts or for health professionals, in order to achieve and maintain safety vaccination coverage. Failure to comply with the obligations imposed by the extraordinary intervention plans entails the imposition of a pecuniary administrative sanction from € 100 to € 500.

Extraordinary intervention plans are expected to: temporarily, on a national, regional or local basis, in relation to the data contained in the national vaccination registry, the frequency of educational institutions of the national education system, private non-equal schools, educational services for children and regional vocational training centers after one or more vaccinations have been administered; request the school managers of the educational institutions of the national education system and of private non-equal schools as well as those responsible for regional vocational training centers and children's education services to take all appropriate measures to protect the health of non-vaccinated students , also ensuring that these subjects are included in classes in which only vaccinated or immunized minors are present.

In the event that health emergencies or specific epidemic episodes occur, the power to activate the Crisis Unit remains established, already provided for in article 4-ter of the aforementioned decree-law 7 June 2017, n. 73, and that of the health authority to adopt urgent interventions pursuant to article 117 of the legislative decree 31 March 1998, n. 112.

Article 6 contains financial provisions.

Article 7 contains repeals and final rules. The aforementioned decree-law of 7 June 2017, no. 73, regarding vaccination prevention, starting from the date of entry into force of the first national vaccination prevention plan referred to in article 2 of this provision, with the exception of paragraph 3 of article 4-bis (charges deriving from national register of vaccines) and articles 4-ter (Crisis unit), 5-bis (Disputes regarding the recognition of damage from vaccines and the administration of drugs), 5-ter (Definition of refreshment procedures for injured parties from transfusions or from infected blood products or from compulsory vaccinations) and 5-quater (Indemnities in favor of subjects damaged by irreversible complications from vaccinations).

Article 7 maintains the repeals already provided for by the Lorenzin decree and in particular:

  1. Article 47 of the Presidential Decree of 22 December 1967, n. 1518, for which school directors and heads of public or private education institutions were required, upon admission to school or exams, to ascertain whether vaccinations and compulsory revaccinations had been practiced to pupils, requesting the presentation by the interested party of the relative certification, proving the execution of the aforementioned vaccinations and revaccinations;
  2. the second paragraph of article 3 of law no. 4 (administrative sanction of mandatory polio vaccination);
  3. the second paragraph of article 3 of Law no. 20 (administrative sanction for compulsory tetanus vaccination);
  4. article 7, paragraph 2, of law 27 May 1991, no. 165 (administrative sanction for mandatory vaccination against viral hepatitis B).

Bill

Art. 1. (Purpose)

1. The purpose of this law is:

  1. to ensure the protection of public health through the promotion of vaccinations with the aim of achieving and maintaining safety vaccination coverage, also for the purpose of protecting the subjects for whom vaccinations are contraindicated due to particular documented clinical situations, in compliance with the recommendations of international health bodies on the prophylaxis, control, elimination and eradication of diseases preventable by vaccination;
  2. to guarantee the full and uniform provision of vaccination services on the national territory to ensure equity and equal access to them, recognizing that education and information on vaccine prevention constitute an essential level of assistance (LEA) as priority interventions in the fight against reluctance to vaccines and to optimize vaccination coverage;
  3. to guarantee the implementation and, consequently, the constant updating of the national vaccination registry in a rapid and certain time.

Art. 2. (National vaccination prevention plan)

1. The national vaccination prevention plan (PNPV) identifies and periodically updates the specific minimum quality standards of vaccination activities, the objectives to be achieved throughout the national territory and the methods for verifying their achievement.

2. The PNPV is adopted, in compliance with the guidelines contained in the national prevention plan, on the proposal of the Minister of Health, after consulting the Higher Institute of Health, with an agreement at the Permanent Conference for relations between the State, the regions and the autonomous provinces of Trento and Bolzano, pursuant to article 8, paragraph 6, of law no. 5, and has a five-year duration.

Art. 3. (Measures for the implementation of the national vaccine prevention plan)

1. A portion of the National Health Fund, pursuant to article 1, paragraph 34, of law no. 23, is bound to the effective pursuit of the objectives set by the PNPV and to the realization of the following purposes:

  1. updating, adaptation and maintenance of regional information systems for the government and the exercise of vaccination activities, with particular reference to those that feed the national vaccination registry, referred to in article 4 of this law;
  2. promotion of the vaccinations envisaged by the PNPV and removal of the factors that hinder the achievement of adequate vaccination coverage through:

1) the maintenance of adequate structural and functional standards of vaccination services;

2) the availability of suitable channels and information materials on vaccinations and on diseases preventable by vaccinations, on the results obtained by vaccination prevention programs and on the adverse events associated with vaccinations;

3) the analysis of vaccine refusal or hesitation behaviors and their causes and the consequent implementation of targeted actions of active vaccination offer;

4) the implementation of communication and information, promotion and listening interventions aimed at the general care of patients and health professionals through the structures of the National Health Service, also making use of the opportunities offered by the programs school and job placement;

5) the active involvement of citizens in the promotion of vaccination programs and in surveillance activities, in particular in those on adverse events;

c) promotion of voluntary and conscious adherence to the vaccinations envisaged by the PNPV through communication plans inspired by the principles of transparency and independence of information sources, in order to consolidate trust in the National Health Service with regard to vaccine prevention and his reputation.

2. The Standing Committee for the verification of the delivery of the essential levels of assistance, referred to in Article 9 of the agreement of 23 March 2005 at the Permanent Conference between the State, the regions and the autonomous provinces of Trento and Bolzano , published in the ordinary Supplement n.83 to the Official Journal n. 105 of 7 May 2005, verifies the compliance with the vaccination prevention objectives referred to in the PNPV every six months, in the manner indicated in the PNPV pursuant to article 2, paragraph 1, of this law.

3. If, from the certification of the quarterly accounting flows (CET), the failure to comply with the vaccination prevention objectives referred to in the PNPV is found, the Minister of Health sets aside, up to the adjustment, the share of the National Health Fund referred to in paragraph 1 of the this article due for the year following the one in which the defaults were noted.

Art. 4. (National vaccination registry)

1. Without prejudice to the effects produced by article 4-bis of the decree-law 7 June 2017, n. 73, converted, with modifications, by law 31 July 2017, n. 119, the national vaccine registry assumes, from the date of entry into force of this law, the name of "national vaccine registry" and its operation is governed by the decree of the Minister of Health that established it, pursuant to referred to in article 4-bis of the decree-law 7 June 2017, n. 73, in agreement with the Permanent Conference for relations between the State, the regions and the autonomous provinces of Trento and Bolzano. The national vaccination registry contains data relating to the vaccinated subjects and to be subjected to vaccination, to the subjects who omit or differ from the vaccinations provided for by the PNPV, in relation to specific documented clinical conditions, attested by the general practitioner or the doctor of free choice, as well as the doses and times of administration of the vaccinations carried out and any unwanted effects, which flow into the national network of pharmacovigilance referred to in the decree of the Minister of Health 30 April 2015, published in the Official Journal n. 143 of 23 June 2015.

2. The national vaccination registry also contains 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 no. 6 of 8 January 1991, or, as from the date of entry into force of the regulation governing its operation, those collected through the infectious disease reporting system of the Ministry of Health (PREMAL), referred to in point A1.25 .3 of annex A of the decree of the President of the Council of Ministers 2017 March 109, published in the Official Gazette no. 12 of 2017 May XNUMX.

3. The data referred to in paragraphs 2 and 3 of this article are used to guarantee, in the context of monitoring vaccination programs on the national territory, the verification of vaccination coverage in relation to the current national vaccination calendar and the development of indicators to national, regional and company level, also for comparative purposes.

4. The data contained in the national vaccination registry are also used by the Ministry of Health for the performance of the administrative functions and duties concerning the collection and exchange of information with European and international bodies and the preparation of reports to be submitted to the Chambers and other national reports or relationships.

5. The regions and the autonomous provinces of Trento and Bolzano have the obligation to bring the data referred to in this article into the national vaccine registry, in compliance with the procedures and times established in the ministerial decree referred to in paragraph 1. The information transmitted is subject to verification of completeness and quality and the provision of data in compliance with the aforementioned methods and timescales is included in the obligations to which the regions and autonomous provinces of Trento and Bolzano are required for access to supplementary financing by the State, pursuant to the aforementioned agreement sanctioned by the Permanent Conference for relations between the State, the regions and the autonomous provinces of Trento and Bolzano in the session of 23 March 2005.

6. The national vaccination registry, with the modalities referred to in the decree of the Minister of Health establishing the same pursuant to article 4-bis, paragraph 1, of the decree-law 7 June 2017, n. 73, converted, with modifications, by law 31 July 2017, n. 119, makes available to the regions and autonomous provinces of Trento and Bolzano, at central level, information relating to vaccinations carried out in a region or in an autonomous province other than that of residence as well as vaccinations carried out by the patient who has been transferred from an autonomous region or province to another autonomous region or province.

Art. 5. (Interventions in case of health emergencies or compromise of group immunity)

1. If, in the context of the monitoring of vaccination coverage carried out on a half-yearly basis by the Ministry of Health, significant deviations from the objectives set by the PNPV are identified such as to generate the risk of compromising group immunity, on the proposal of the Minister of health after deliberation by the Council of Ministers, after hearing the Higher Institute of Health and the Permanent Conference for relations between the State, the regions and the autonomous provinces of Trento and Bolzano, by decree of the President of the Republic, are adopted extraordinary intervention plans, which include, where necessary, the obligation to carry out one or more vaccinations for certain birth cohorts or for health professionals, in order to achieve and maintain vaccination safety coverage.

2. The local health authorities that are territorially competent invite the subjects required to carry out the vaccinations, on the basis of the extraordinary intervention plans, providing any useful information on the same, also regarding the free vaccinations provided therein and involving the doctor in the information activity. of general medicine and the pediatrician of free choice, and verify the fulfillment of the measures contained in the aforementioned plans.

3. Failure to comply with the obligations imposed by the extraordinary intervention plans, in the presence of the conditions referred to in paragraph 1 of this article, entails the imposition of a pecuniary administrative sanction from € 100 to € 500. For the assessment, the dispute and the imposition of the administrative sanction referred to in the first sentence shall apply, insofar as compatible, the provisions contained in Chapter I, sections I and II, of the law 24 November 1981, n.689. 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.

4. In the presence of the conditions referred to in paragraph 1 of this article, in order to protect the health status of the subjects who cannot be vaccinated for specific documented clinical conditions, certified by the general practitioner or pediatrician of free choice, the extraordinary plans of intervention referred to in the same paragraph 1 may:

  1. a) to subordinate, on a temporary basis, on a national, regional or local basis, in relation to the data contained in the national vaccination registry, the attendance of the educational institutions of the national education system, private non-equal schools, educational services for the childhood and regional vocational training centers upon the administration of one or more vaccinations;
  2. b) request the school managers of the educational institutions of the national education system and non-equal private schools as well as the heads of the regional vocational training centers and of the educational services for children to take all appropriate measures to protect the health of the members not vaccinated, also ensuring that these subjects are included in classes in which only vaccinated or immunized minors are present, without prejudice to the number of classes determined according to the current provisions and the limits referred to in article 1, paragraph 201, of the law of 13 July 2015 , n. 107, and article 19, paragraph 7, of the decree-law of 6 July 2011, no. 98, converted, with modifications, by law 15 July 2011 n. 111.

5. In the presence of the conditions referred to in paragraph 1, in implementation of article 7, paragraph 2, of the law of 23 December 1978, no. 833, by decree of the Minister of Health, after consulting the Italian Medicines Agency, the regions and the autonomous provinces of Trento and Bolzano, integration is arranged, also through the use of the military pharmaceutical chemical plant, based in Florence, the production of vaccines that may not be available and the storage of adequate stocks.

6. In the event that there are health emergencies or specific episodes of epidemics, the power to activate the Crisis Unit remains, pursuant to article 4-ter of the decree-law 7 June 2017, n. 73, converted, with amendments, by law 31 July 2017, no. 119, and that of the health authority to adopt urgent interventions pursuant to article 117 of the legislative decree 31 March 1998, n. 112.

7. In order to facilitate the supply of vaccines for human use by aggregators, the Italian Medicines Agency, in agreement with the technical table of aggregators referred to in the decree of the President of the Council of Ministers November 14, 2014, published in the Official Gazette no. 15 of 20 January 2015, publishes the results of the centralized purchasing procedures referred to in Article 9, paragraph 3 of the aforementioned decree-law of 14 April 2014, no. 66, and article 1, paragraph 548, of law no. 28, including information relating to quantities purchased and payment times, of supplies of vaccines for human use.

Art. 6. (Financial provisions)

1. The charges deriving from the implementation of this law are provided for by means of a corresponding reduction in the allocation of the Fund for structural interventions of economic policy pursuant to article 10, paragraph 5, of the decree-law of 29 November 2004, no. 282, converted, with modifications, by law 27 December 2004, n. 307, as well as by means of a corresponding reduction in the authorization of expenditure 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.

2. For the complete realization and evolutionary management of the national vaccination registry, the allocation referred to in article 4-bis, paragraph 3, of decree-law 7 June 2017, n.73, converted, with modifications, by law 31 July 2017, n. 119, increased by € 185.000 for the year 2018 and € 80.000 per year starting from the year 2019.

3. In order to collect the data to be included in the national vaccine registry uniformly throughout the national territory, including through the reuse of computer systems or parts of them already implemented by other health administrations, € 2.000.000 has been allocated. 2018 for 500.000 and € 2019 per year starting from XNUMX, distributed between the regions and the autonomous provinces of Trento and Bolzano on the basis of criteria determined by decree of the Minister of Health, to be issued within sixty days from the date of entry into force of this law, after hearing the Permanent Conference for relations between the State, the regions and the autonomous provinces of Trento and Bolzano.

4. The charges deriving from paragraphs 2 and 3, equal to a total of € 2.185.000 for the year 2018 and € 580.000 per year starting from the year 2019, are made using the resources of the fund referred to in article 36, paragraph 14. , of the law 27 December 1997, n. 449, merged into the sources of financing of the ordinary budget of the Italian Medicines Agency.

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

Art. 7. (Repeals and final rules)

1. The decree-law 7 June 2017, n. 73, converted, with modifications, by law 31 July 2017, n. 119, is repealed from the date of entry into force of the first national vaccine prevention plan referred to in article 2 of this law, with the exception of paragraph 3 of article 4-bis and of articles 4-ter, 5-bis , 5-ter, 5-quater.

2. In article 5-quater of the decree-law 7 June 2017, n. 73, converted, with modifications, by law 31 July 2017, n. 119, the words: «because of the vaccinations indicated in article 1» are replaced by the following: «because of the vaccinations foreseen in the National Vaccination Prevention Plan».

3. The following provisions are repealed:

  1. article 47 of the decree of the President of the Republic 22 December 1967, n. 1518, and subsequent modifications;
  2. the second paragraph of article 3 of law no. 4;
  3. the second paragraph of article 3 of Law no. 20;
  4. article 7, paragraph 2, of law 27 May 1991, no. 165.

Source:

www.senato.it/service/PDF/PDFServer/DF/339498.pdf