ORDER NO. 178
YEAR 2024
ITALIAN REPUBLIC
IN THE NAME OF THE ITALIAN PEOPLE
THE CONSTITUTIONAL COURT
composed of:
President: Augusto Antonio BARBERA;
Judges: Giulio PROSPERETTI, Giovanni AMOROSO, Francesco VIGANÒ, Luca ANTONINI, Stefano PETITTI, Angelo BUSCEMA, Emanuela NAVARRETTA, Maria Rosaria SAN GIORGIO, Filippo PATRONI GRIFFI, Marco DALBERTI, Giovanni PITRUZZELLA, Antonella SCIARRONE ALIBRANDI,
has rendered the following
ORDER
in the proceedings concerning the constitutional legitimacy of Article 5 of the Puglia Regional Law No. 21 of 31 July 2023 ("Colon al sicuro. Research project for the early diagnosis of colon cancer through blood tests”), brought by the President of the Council of Ministers with an appeal notified on 2 October 2023, filed with the Registry on 4 October 2023, registered under No. 29 of the 2023 appeals register and published in the Official Gazette of the Republic No. 42, first special series, of the year 2023.
Having considered the notice of appearance of the Puglia Region;
having heard, at the Chamber hearing of 15 October 2024, Judge Giulio Prosperetti, Rapporteur;
having deliberated at the Chamber hearing of 15 October 2024.
Considering that, by appeal of 4 October 2023 (Reg. Ric. No. 29 of 2023), the President of the Council of Ministers, represented and defended by the Attorney General of the State, has raised questions of constitutional legitimacy concerning Article 5 of Puglia Regional Law No. 21 of 31 July 2023 ("Colon al sicuro. Research project for the early diagnosis of colon cancer through blood tests”), in reference to Articles 81, third paragraph, and 117, third paragraph, of the Constitution, the latter for violation of fundamental principles in the matter of "coordination of public finance”;
that the aforementioned Puglia Regional Law No. 21 of 2023, consisting of five articles, aims at the implementation of a research project for the early diagnosis of colon cancer through blood tests;
that, in particular, Article 5, entitled "Financial provision”, provides that: "[t]he costs for the implementation of the research project are estimated at €396,000, to be divided into two annual installments, and paid to the relevant health authority of the competent center, following the readjustment of Table L) of the Regional Government Decree of 4 August 2021, No. 1346, or by a separate Regional Government Decree and advance payment on the allocation to the health authorities of the resources for the 2023 financial year, within the framework of the delegated project activities, to be adopted in any case within sixty days from the date of entry into force of this Law”;
that, according to the appellant, the aforementioned regional provision presents issues of constitutional illegitimacy "in relation to the violation of the principle of harmonization of public budgets and coordination of public finance pursuant to Article 117, third paragraph, of the Constitution, since, by introducing a further level of health assistance with respect to the essential levels of health care benefits (LEA), and placing it on the regional health service, it violates the regulations concerning plans for recovery from the financial deficit in the health sector, to which the Puglia Region is subject, and the consequent prohibition of non-mandatory expenditure”;
that the challenged provision would conflict with the national legislation defining the essential levels of assistance (LEA);
that, in this regard, the State’s defense first refers to Article 1, paragraph 7, of Legislative Decree No. 502 of 30 December 1992 (Reorganisation of the regulations on health matters, pursuant to Article 1 of Law No. 421 of 23 October 1992), which states that the National Health Service (SSN) is responsible for "the types of assistance, services and health care benefits that present, for specific clinical conditions or risks, scientific evidence of a significant benefit in terms of health, at the individual or collective level, in relation to the resources used”, further providing that "excluded from the levels of assistance provided by the National Health Service are the types of assistance, services and health care benefits that: a) do not meet care needs protected in accordance with the guiding principles of the National Health Service referred to in paragraph 2; b) do not satisfy the principle of effectiveness and appropriateness, or whose effectiveness is not demonstrable on the basis of the available scientific evidence or are used for subjects whose clinical conditions do not correspond to the recommended indications; c) in the presence of other forms of assistance aimed at satisfying the same needs, do not satisfy the principle of cost-effectiveness in the use of resources, or do not guarantee efficient use of resources in terms of methods of organization and provision of assistance”;
that the definition and updating of the LEAs referred to in the aforementioned Article 1, paragraph 7, of Legislative Decree No. 502 of 1992, were last carried out by the Prime Ministerial Decree of 12 January 2017 (Definition and updating of essential levels of assistance, pursuant to Article 1, paragraph 7, of Legislative Decree No. 502 of 30 December 1992);
that the aforementioned Prime Ministerial Decree, in Annex 1, concerning the essential level of assistance called "Collective Prevention and Public Health”, only includes – within the area of intervention Programme/Activity F8 "Oncological screenings defined by the State-Regions Agreement of 23 March 2005 and the National Prevention Plan 2014-2018” – the "Screening for colorectal cancer: Recommendations of the Ministry of Health prepared in implementation of Article 2 bis of Law 138/2004 and the National Prevention Plan 2014-2018”;
that the aforementioned ministerial recommendations identify, as a first-level screening test, the search for occult blood in faeces (SOF) and rectosigmoidoscopy;
that, according to the appellant, "[t]he research project for the early diagnosis of colon cancer through blood tests provided for by the regional law under examination therefore introduces, in substance, a further level of health assistance that does not fall within the regulatory framework of the Prime Ministerial Decree of 12 January 2017 defining the essential levels of assistance and, consequently, cannot be guaranteed by the National Health Service”;
that the appellant continues by stating that "[a]ny screening activities additional to those provided for by the national legislation, such as those contemplated in the research project, should be borne by the Regional Health Service” but, since the Puglia Region is subject to the regulations on recovery from the deficit, binding pursuant to Article 2, paragraphs 80 and 95, of Law No. 191 of 23 December 2009, containing "Provisions for the preparation of the State’s annual and multi-year budget (2010 Finance Law)”, and to the prohibition of non-mandatory expenditure, pursuant to Article 1, paragraph 174, of Law No. 311 of 30 December 2004, containing "Provisions for the preparation of the State’s annual and multi-year budget (2005 Finance Law)”, it cannot guarantee further levels of assistance either with resources from the undistributed share of the National Health Fund, or with its own resources, being able to carry out "only interventions aimed at recovering the health deficit in compliance with and within the limits of the provision of mandatory LEAs”;
that, in this regard, the appellant refers to the constitutional jurisprudence which "has repeatedly reiterated the binding nature of the plans for recovery from the health deficit (ex plurimis judgments No. 172 of 2018, No. 278 of 2014) and that the constraints on containing public health expenditure constitute an expression of a fundamental principle of coordination of public finance (judgment No. 190 of 2022 in reference to judgment No. 161 of 2022)”;
that, again according to the appellant, "[t]he project provided for by the law under examination could not be financed in the manner indicated by the challenged Article 5 even as research activity” since, the financing of the Regional Health Service being parameterised to the needs deriving from the provision of LEAs under conditions of efficiency and appropriateness, "the costs for the implementation of the research project referred to in Article 5 of the challenged regional law could in no way be financed with the Regional Health Fund”;
that, in this regard, the Attorney General of the State observes that the national legislation on the financing of research projects in the health sector "provides for a separation of the resources allocated to LEAs from those allocated to research, so that the share of the national standard health requirement allocated by CIPESS decisions does not include resources to finance research activities, which will have to find their corresponding coverage in resources allocated for that purpose”;
that the State’s defense points out that the challenged regional legislative intervention also takes place "at a time when, for the year 2023, a significant management deficit is looming (-€171,207 million – linear projection to the end of 2023 = -€342,416 million)”, with the consequence that "the implementation of other expenditure, in a condition of contingent resources, also raises the problem of the appropriateness of the coverage of "necessary” expenditure (Article 81, third paragraph, of the Constitution), given that the use of resources for "non-essential” benefits would correspondingly reduce the resources for essential ones”;
that, in conclusion, according to the appellant, the regional law under examination, in establishing the "Colon al sicuro” research project with the assumption, pursuant to the challenged Article 5 of Puglia Regional Law No. 21 of 2023, of additional health costs to the mandatory ones on the regional budget, conflicts, on the one hand, with Article 117, third paragraph, of the Constitution, in the matter of "coordination of public finance”, with reference to the commitments to recover the health deficit undertaken by the Region for the containment of public expenditure and the prohibition of non-mandatory expenditure (pursuant to Article 1, paragraph 174, of Law No. 311 of 2004) and, on the other hand, "with Article 81, third paragraph, of the Constitution in terms of the appropriateness of the coverage of necessary expenditure, given that the use of resources for non-essential benefits would correspondingly reduce the resources for essential ones”;
that, by document filed on 2 November 2023, the Puglia Region entered an appearance, arguing the inadmissibility and/or unfoundedness of the questions raised by the appellant;
that, during the proceedings, the challenged Article 5 of Puglia Regional Law No. 21 of 2023 was replaced by Article 9, entitled "Amendment to Article 5 of Regional Law 21/2023”, of Puglia Regional Law No. 34 of 30 November 2023 (Adjustment and variation to the budget forecast for the 2023 financial year and the 2023-2025 multi-year period), in force since 30 November 2023, in the following terms: "1. The expenditure arising from this regional law shall be met by the allocation, in the autonomous regional budget, within mission 13, programme 7, heading 1, of a financial allocation for the 2023 financial year, in terms of commitment and cash, of €198,000 and, for the 2024 financial year, in terms of commitment, of €198,000”;
that the Attorney General of the State, by note of 10 February 2024, filed on 12 February following, requested the adjournment of the hearing on the appeal, set for the public hearing of 6 March 2024;
that the application stated that the Puglia Regional Council, given that the appellant had argued the inadequacy of the subsequent provision to overcome the objections of constitutional illegitimacy, as it continued to provide for the financing of the project in question within the "health protection” mission of the regional budget, had approved a new amending provision of Article 5, according to which the aforementioned financing was charged to "mission 12, programme 2, heading 1” of the same budget;
that, therefore, the application for adjournment was motivated by the need to await the promulgation of the new regional provision and the possible decision to withdraw the appeal by the President of the Council of Ministers, following the amendment of the challenged provision in satisfactory terms;
that, by Presidential Decree of 14 February 2024, the hearing on the appeal was adjourned to a new role;
that the aforementioned further amendment to the challenged Article 5 of Puglia Regional Law No. 21 of 2023 was therefore made by Article 2, entitled "Amendment to Article 5 of Regional Law 21/2023”, of Puglia Regional Law No. 2 of 16 February 2024, concerning "Amendments to Regional Law No. 31 of 15 July 2014 (Reorganisation of the Puglia and Basilicata Experimental Zooprophylactic Institute (IZSPB), in implementation of Legislative Decree No. 270 of 30 June 1993, as amended by Legislative Decree No. 106 of 28 June 2012) and various provisions on health matters”, in the following terms: "1. In paragraph 1 of Article 5 of Regional Law No. 21 of 31 July 2023 ("Colon al sicuro. Research project for the early diagnosis of colon cancer through blood tests”), as amended by Article 9 of Regional Law No. 34 of 30 November 2023 (Adjustment and variation to the budget forecast for the 2023 financial year and the 2023-2025 multi-year period), the words: "mission 13, programme 7, heading 1,” shall be replaced by the following: "mission 12, programme 2, heading 1,””;
that the President of the Council of Ministers, following a decision of the Council of Ministers of 6 May 2024, withdrew the appeal by document filed on 10 May 2024, as "[t]he subsequent amendment allows the objections of illegitimacy concerning the financial provision under challenge to be considered overcome and the Puglia Region has certified that the challenged provision has not been applied in the meantime”;
that, following a decision of the Regional Government of 28 May 2024, No. 673, the Puglia Region, on 31 May following, filed a document accepting the withdrawal of the appeal;
that, by Presidential Decree of 29 May 2024, the hearing of the proceedings was adjourned to the Chamber hearing of 15 October 2024;
that, shortly before the hearing, the regional defense, in implementation of the provisions on this point in the aforementioned decision of the Regional Government No. 673 of 2024, on 17 September 2024 filed a "[d]eclaration of acceptance of the withdrawal of the appeal”.
Considering that the President of the Council of Ministers, following a decision of the Council of Ministers of 6 May 2024, withdrew the appeal, by document filed on 10 May 2024;
that the withdrawal was accepted by the Puglia Region;
that, pursuant to Article 25 of the Supplementary Rules for proceedings before the Constitutional Court, in proceedings concerning constitutional legitimacy in the principal manner, the withdrawal of the appeal, accepted by the party appearing, determines the extinction of the proceedings.
Having considered Article 26, second paragraph, of Law No. 87 of 11 March 1953, and Articles 24, paragraph 1, and 25 of the Supplementary Rules for proceedings before the Constitutional Court.
for these reasons
THE CONSTITUTIONAL COURT
declares the proceedings extinct.
So decided in Rome, at the seat of the Constitutional Court, Palazzo della Consulta, on 15 October 2024.
Signed:
Augusto Antonio BARBERA, President
Giulio PROSPERETTI, Rapporteur
Roberto MILANA, Registrar
Filed with the Registry on 8 November 2024