27 декабря, 2021

Reorganization of the discipline of scientific hospitalization and care institutes

Italian Government

Decreto Legislativo   n.200 — Official Gazette n.304 of — In force

Reorganization of the discipline of scientific hospitalization and care institutes

Chapter I

               THE PRESIDENT OF THE REPUBLIC
 
  Having regard to Articles 76 and 87, fifth paragraph, of the Constitution;
  Having regard to the Law , No.129, delegating to the Government for
the reorganization of the discipline of the Institutes  di  hospitalization  e  care  a
scientific character referred to in the legislative decree of 16 October  2003,
n. 288;
  Vista  la  law  23  August  1988,  n.  400   bearing   discipline
of the activity  di  Government  e  sorting  della   Presidency   of
Council of Ministers;
  Having regard to the legislative decree  16  October  2003,  n.  288,  bearing
reordering of  discipline  degli  Institutes  di  hospitalization  e  care  a
scientific character, pursuant to Article 42, paragraph 1, of the law
16 January 2003, n. 3;
  Having regard to the preliminary   resolution  del  Council  dei  ministers,
adopted at the meeting of ;
  Having reached the agreement of the Standing Conference for the reports  between
the State, regions and autonomous provinces of Trento and Bolzano in the
session of , rep.acts n. 255/CSR of ;
  Having obtained the opinion of the competent Commissions of the _- Room  of
deputies on date and of the Senate  della  Republic  in
data ;
  Having regard to the deliberations of the Council of Ministers,  adopted  in
meeting of ;
  On the proposal  del  Minister  della  health,  di  concert  with  i
Ministers of Economy e  of  finances,  of the university  e  of
research and public administration;
 
                              E m a n a
                  the following legislative decree:
 
                             Art.1
 
                      Amendments to Article 1
          of Legislative Decree 16 October 2003, n. 288

 
  1. Article 1 of Legislative Decree 16 October 2003,  n.  288
the following changes are made:
    a) in paragraph 1 after le  words:  ‘a  character  scientific» 
inserted the following: ‘hereinafter IRCCS’  e  after  le  words:  ‘are
institutions’ the following are inserted: ‘the National Health Service’;
    b) in paragraph 1 is added, at the end,  the  next  period:  ‘The
IRCCS, in order to integrate i  Tasks  di  care  e  support  gia’
svolti,  promote  also’  innovation   e   the   transfer
technology.  Le  activities  are  turns  in the field   of   areas
themes  Internationally  recognized,   held   account   della
classification  of  diseases   second   categories   integrated diagnostics
major (MDC) (MDC); from  Ministry
of health with categories referable to disciplinary specializations
not directly  linked  alle  MDC  o  per  le  quali  there are
special national coordination programmes, also with  Reference
to age classes;’
  2.In Article 1, after paragraph 1, the following are inserted:
    ‘1-bis. The IRCCS communicate, by the Ministry
of health and to the region concerned, the affiliation ad  a  o  plus
thematic areas listed in Annex 1, integral part  del  present
decree, on the basis of disciplinary specialization  object  of
respective scientific recognition.
    1-ter. At the end of the communication referred to in paragraph  1-bis,  with
decree of the Minister of Health, after consulting the competent region  for
territory, assessed the consistency of the required thematic area with  the
discipline of recognition of origin, are identified  the area
or the thematic areas of relevance valid until the next confirmation
of the scientific character. If at the end of the evaluation,  emerge
profiles of discrepancy between the requested thematic area and the  discipline
di  recognition  di  provenance,  the   Minister   della   health,
jointly with the relevant region  per  territory,  locate
the area  thematic  di  afference,  motivating   any    Decision
Different from communication’.

                                 Art.2
 
                      Amendments to Article 4
          of Legislative Decree 16 October 2003, n. 288

 
  1. Article 4 of Legislative Decree 16 October 2003, n.  288,
paragraph 3 is replaced by   following:  ‘3.  The  college  trade union
of IRCCS Foundations and untransformed IRCCS hard  in  Carica
three years and is composed, without prejudice to Article 16 of the law  31
December 2009, n. 196, da  three  members,  di  which  one  designated  by
President of the Regional Council, one by the Minister  economics  e
of finance and one by the Minister of Health’.

                               Art.3
 
                      Amendments to Article 6
          of Legislative Decree 16 October 2003, n. 288

 
  1. Article 6 of Legislative Decree 16 October 2003, n.  288,
the following changes are made:
    (a) the heading is   superseded  from  following:  ‘Provisions  in
Matter of organisation and requirements of the organs’;
    (b) the following shall be added after paragraph 1:
      ‘1-bis.The institutions referred to in paragraph 1, by 31 March  2023
adjust  gli  statutes  o   i   Regulations   di   organization   e
functioning in accordance with policy guidelines  sanitary  e
in respect  autonomy  regional,  in  mode  da  ensure  IL
Coordination of the Director’s activities  general  e  those  del
director  scientific  e  al  end  di   ensure   the integration
of the activity  welfare  e  of the activity  di  training  with
the activity  di  search  per  enhance  efficacy  in   areas
issues of affiliation. The statutes or regulations of organization
and operation also provide that the director  scientific  is
supported by the administrative structure of the IRCCS, and that  all  i
members of the governing bodies hold a diploma of
degree referred to in the previous legal system al  decree  ministerial  3
November 1999 n.509, or master’s degree  e  di
proven  experience  e   competence   in   field   administrative,
economic, financial, medical or biomedical, ensuring absence  di
conflicts of interest.
      1-ter. For the purposes of  which  al  comma  1-bis,  le  Regions
shall assign to the Director-General, at the time of appointment, additional
specific  objectives  functional  al  fitting   between   activities   of
assistance and research, as well as the realization of the  plan
three-year research lines defined for the Institute e  approved
by the Ministry of Health.’

                               Art.4
 
                      Amendments to Article 8
          of Legislative Decree 16 October 2003, n. 288

 
  1. Article 8 of Legislative Decree 16 October 2003, n.  288,
the following changes are made:
    (a) the following shall be inserted after paragraph 3:
      3-bis. IRCCS research networks are networks  di  Excellency
which, in the thematic areas referred to in Annex 1 of this document  decree
legislative,  pursue   purpose   di   research   mainly
translational, promote the advancement of knowledge, experiment
innovation models in the different sectors of the thematic area,  also
for  enhance  la  capacity  operational  del   Service   health
national and regional networks, and are open  alla  collaboration
with other bodies of the National Health Service, with  universities
and public research institutions, with networks  o  groups  di  search,  also
international,  as well as ‘  with  partner  scientific   e   industrial
national and international;
      3-ter.The IRCCS research networks are set up at the __- sensi
of Article 36 of the Code  civil  by   act  public,  e  lo
statute indicates the legal representative, the scientific coordinator,
the modalities of operation of the shareholders’ meeting  e  those  for
share instrumentation e  le  skills  scientific  between  i
participants.
      3-quarter. Without prejudice to the possibility of accessing networks  in
area  thematic  coincident  with  that  del  recognition   of
qualification of IRCCS, for the purpose of participation in a network of  area
thematic different from  a  that  di  recognition,  gli  IRCCS
document possession of  following  requirements,  that  the  Ministry
of Health validates:
       a) specific research activity both with regard to the  Number
of publications that al  number  dei  trials,  turning point  in the last
three-year period relating to the thematic area of  network,  in  respect
dei  parameters  bibliometrics   Internationally   recognized   e
anyway to an extent not less than 5 percent  degli  indicators  e
assessment thresholds referred to in Annex 3, paragraph 1, letter b);
        (b) disbursement  of the activity  welfare  deducible  da
current information flows, carried out in the thematic area of the network, in
measure equal to at least 10 per  hundred  respect  a  that  Overall
of the Institute;
        c) instrumental resources and platforms from  share  as well as
the specific knowledge and skills related to the thematic area
of the network aimed at  enhancement  of  capacity  operational
of the other IRCCS.
      3-quinquies.  Le  networks  di   research   degli   IRCCS   carry out
the research activity on the basis of a four-year program,
articulated in integrative trajectories with respect to the lines of  search
of singles  Institutes,  in  consistency  with  the  program  di  research
health, referred to in the article  12-bis  del  decree  legislative  30
December 1992, No.502;
      3-sexies. For the purposes of the financing referred to in paragraph 1,  second
period,  of the article  10,  nei  limits  ed  in  consistency  with   the
four-year programming referred to in paragraph  3-d,  gli  IRCCS
that participate in the network with recognition in different thematic area
da  that  della  network,  guarantee  the  respect   dei   following
parameters:
        a) assistance activity deducible from the flows  information
current, carried out in the thematic area of the network, equal to 20 per  one hundred
of the total institute;
        b) research activity carried out in the thematic area of  network
equal to 20 percent of the total IRCCS network, with a minimum of 10 percent of indicators and thresholds of  evaluation  di
referred to in Annex 3, paragraph 1, point (b);
        c)   indexes   bibliometrics   relative   impact    of
publications in the thematic area of the network equal to the national average
of the area itself.
      3-septies.The possession of the requisites referred to in al  comma  3-sexies
can be proven by the IRCCS by means of a substitutive declaration
of the deed of notoriety rendered pursuant to the article  47  del  decree
of the President of the Republic of 28 December 2000, n.  445.  Ai  sensi
of article 71 of the aforementioned decree n. 445  del  2000,  the  Ministry
of health carries out random checks on the veracity’  of
statements made;
    (b) the following shall be inserted after paragraph 5:
      ‘5-bis. The Institutes, in compliance with the law 31 May  2022,
n. 62, ensure that research and care activity conforms  ai
the principles of fairness, transparency, fairness,  Responsibility,
Recognized reliability and completeness  a  level  international.
They publish all i  data  e  le  sources  della  search  in  way
truthful and objective,  al  end  di  allow  la  verification  e  la
reproducibility, with specific reference to the maintenance of  Data
used.To this end, to ensure the  evaluation  of the scientific activity
, also with regard to the effects  di  the latter  on
health of  population,  use  indicators  di  efficacy  ed
efficiency of the quality of the activity of  search  recognized  a
level  international.   The   Institutes   adopt   e   update
periodically a code of conduct for the integrity of  research.
The staff in service at the IRCCS is required to adhere to  a
code of conduct governing behavioural requirements  times
to the correct use of resources and compliance with  rules  di  fair
competition.
      5-ter.Subject to   quantum  expected  from the article  65  del
decreto legislativo 10 febbraio 2005, n. 30,  gli  IRCCS  promote,
In compliance with the relevant provisions, the development of start  up  e  spin  off  innovative  in  matter  di  Research
Biomedical and Biotechnology.
      5-quarter.  The  staff  degli  IRCCS  e   the   personnel   in
agreement with the IRCCS is required to respect  la  discipline  delle
incompatibilities  between  lo  unfolding  of  activities  tied   al
employment relationship with IRCCS  e  lo  unfolding  of the activity  a
favor  di  spin-off  e  start  up,  second  quantum  expected  from
current legislation  e  dai  Regulations  respectively  adopted  da
each IRCCS on incompatibility, cumulation  di  uses  e
discipline of extra-institutional assignments  a  title  burdensome  o
free also with regard to the phase of  transfer  technology
of research results, as provided for in the   legislation
in force and regulations adopted by the IRCCS on the subject.
      5-quinquies.  The  IRCCS  di  law  public  promote  the
participation of researchers in spin-offs and established start-ups  for
the development of research products  degli  same  Institutes.  Con
regulation  internal  gli   IRCCS   define    le   modalities   di
staff participation, alternating institutional work and in
start-up and spin-off.To the determination of the   remuneration  del  foresaid
staff is provided in respect  della  bargaining  collective
national reference work and according to the principles of  Legislative Decree No 165 of 30 March 2001.
      5-sexies. IRCCS under public law, in order to  transfer
the results of  search  in  scope  industrial,  also  by
contracts of  collaboration  industrial,  di  license,  as well as ‘  la
creation of spin-offs and start-ups, identify the partner  industrial
according to the following criteria and modalities:
        (a) in compliance with the _- in force  provisions  in  matter  di
intellectual property,  adopt  apposito  regulation,  face  a
regulating procedures  ed  i  criteria  per  the identification  dei
partner  industrial  with  adequate  skills  technology  e   di
research, with a view to adopting the Register of Industrial Partners,  di
followed Albo, as well as the modalities and criteria  per  la  stipulation  degli
agreements and the operation, maintenance and updating of the Register;
        b) preparation and updating  periodical  of the Register
are  carried out  by   procedure  di   evidence   publish,   in
implementation of the principle of transparency and publicity;
        c) inclusion in the Register referred to in letter b) subordinated
to the signing of a specific confidentiality agreement;
        (d) for _- IRCCS  public,  per  le  purpose  di  which  al
present  comma  with  special  procedure  selective  locate   i
subjects in possession  degli  eligible  requirements  di  qualification  e
technological skills for the conclusion of the agreement.If  none
of subjects  members  to the list  sia  in  possession  dei  requirements
required, the public IRCCS can proceed to further procedure  di
public evidence for updating the Register.

                               Art. 5
 
                      Amendments to Article 11
          of Legislative Decree 16 October 2003, n.288

 
  1. In Article 11, paragraph 3, del  decree  legislative  16  October
2003, n.  288,  after  the  third  period  e’  inserted  the  following:
«The appointment of the scientific director of the IRCCS  public  incompatibilities
incompatibility with any other public employment relationship  e
private, except   the activity  di  search  preclinical,  clinical,
translational and training,  exercised  in interest  exclusive
of the Institute, without further compensation.’.

                                 Art.6
 
                      Amendments to Article 12
          of Legislative Decree 16 October 2003, n. 288

 
  1. In Article 12 of Legislative Decree No 288 of 16 October 2003,
after paragraph 2, the following are added at the end:
    ‘2-bis. The IRCCS of  law  private,  al  end  di  ensure
integration  of the activity  welfare  e  activity   di
training with  the activity  di  search,  within  the  31  March  2023
adapt their acts of organization  in  mode  da  ensure  IL
Coordination of the Director’s activities  general  e  those  del
Scientific Director.
    2-ter.Acts of organization must also be ‘  predict  that
the scientific director, is in possession of the proven requirements
professionalism and  competence,  also  managerial,  Related   alla
specificity  dei  same  Institutes,   insuring   absence   di
conflict of interest.
    2-quarter. Without prejudice to the juridical-administrative autonomy  di
referred to in paragraph 1, IRCCS under private law shall send  annually  al
Ministry of Health the planning of research activities  e
the related report, the annual financial statements  with  the
related certification of an independent auditing firm, the
sectional research report, a separate financial statement  per  i  public funds
, as well as financial statements of non  economic
and economic.They send to the Ministry of  health  each  act  di
edit  della  person  legal,  di  revision  della  Endowment
organic and ownership of health accreditation.
    2-d. The  Ministry  della  health,  in the exercise  of
supervisory functions referred to in Article 1(2) may verify
at any time the maintenance of the requirements and standards for the
recognition of scientific character.’.

                                 Art.7
 
                      Amendments to Article 13
          of Legislative Decree 16 October 2003, n. 288

 
  1. Article 13 of Legislative Decree No 288 of 16 October 2003,
is amended as follows:
    (a) paragraph 1 is replaced by the following:
      ‘1.  Done  hello  le  provisions  di  which  to the article   1,
the establishment of new  Institutes  di  hospitalization  e  care  a  character
scientific must be consistent and compatible with the  Programming
Health of the Region  concerned  e  with  la  discipline  European
concerning  gli  organisms  di  search;  it  e’  subordinate   al
recognition of requirements  di  which  al  comma  3  ed  takes place  with
reference to one or more of the thematic areas referred to in the annex  1  del
this decree, and only to the principals in which the same activity is’
carried out.Polythematic institutes are recognized with reference to
plus integrated biomedical thematic areas»;
    b) the following amendments are made to paragraph 3:
      1. in point (c), after the words ‘level  technological  of
equipment,’ shall be added,  in  end,  le  following:  «adequacy
of the organizational structure with respect to the purposes of  search  ed
economic, financial and patrimonial equilibrium, as well as at least 35
per cent of researchers with an employment contract according to
the national collective labour agreement  della  health  public
and/or private. For the purpose of calculating this percentage does not  si  calculate
staff dedicated to health care as well as’  the  personal
seconded  in  via  exclusive  in  base  alle  conventions  with   le
University;
      2)  alla  letter  d),  after  le  words  «Service   health
national’, are added finally,  le  following  ‘of  Complexity
of the services provided,  of  features  structural,  del
volume and type  of  activities  e  del  path  welfare
as well as’  della  qualification  di  center  di   reference   clinical   —
welfare  a  level  regional  o  supraregional  per   the area
thematic to which it belongs;
      3) to the letter  e),  are  additions  finally  after  le  words:
‘specific assigned discipline’ are inserted le  following  ‘according to
internationally recognised bibliometric systems’;
      4. point (f) shall be replaced by the following:  ‘f)  demonstrated
ability to network with the research institutes of the same
reference area, to collaborate with other public and private bodies
as well as’  di  prove  the  number  of  Experimentation  clinics
multicentre and the number of participations in Community tenders.’.
    (c) the following shall be added at the end of paragraph 3:
      3-bis.Without prejudice to the provisions of paragraph 3,  ai  purposes
of recognition of the qualification of IRCCS, in the Annex  2,  part
integral del  present  decree  legislative,  e’  identified  for
each thematic area listed in the Annex  1  del  present  decree
as well as for each national territorial macro area, the basin  minimum
of users on a territorial basis, which allows an adequate activity of
research to guarantee innovative paths  di  care  e  access  a
new drugs and the identification of their centers  di  reference
regional or supraregional.
      3-ter. The Ministry of  health,  ai  Ends  of the examination  of
applications for recognition of scientific character, verification  la
compatibility  of the instance   with   the   requirement   national   di
performance  di  excellence  that  require  technologies  advanced  e
innovative drugs, as well as with the need  national  di  research
health, and verifies the existence of the minimum catchment area  for
MDC,  how  defined  al  comma  3-bis,   e   of   characteristics
epidemiological   della   population   insistent    in the area    di
reference.  A  such  Fini,  si  keeps  account   del   number   delle
experiments  clinics  no  profit  annually   pipelines   in
related subject areas, number of patients  enlisted,  as well as
of the number of patients affected by  pathologies  attributable  alla
same area.
      3-quarter.In case of request  di  transfer  di  headquarters  da
part of an IRCCS within the same municipality,  alle
structures    different    from     those     afferents     alla     network
of emergency-urgency, not  si  apply  le  provisions  di  cui
in article 8-ter, paragraph 3,  del  decree  legislative  30  December
1992, No 502.
      3-d. For the purpose of verifying the possession of the   requirements
referred to in paragraph 3, Annex 3 identifies the  indicators  e
high assessment thresholds, including for branch sites  of the IRCCS
IRCCS in order to ensure that they are equipped with high-level operational capacities
, contribute to the results of the research activity of the IRCCS headquarters.
      3-sexies.For the purposes of the recognition of new IRCCS, in the context of
allocation of needs  sanitary  national  standard,  can’  be
tied a share for research funding  degli  themselves
IRCCS, in compliance with the planning of activities and volumes
of the same Institutes.
      3-septies. Regions in  which  insist  different  locations  di  a
same IRCCS adopt specific agreements to define  a  floor  di
development  valid  per  le  different  locations  of the Institute   also   with
reference to a system of  accreditation  e  di  convention
uniform, regulating the implementation of diagnostic pathways  e
patient care, recruitment plans and regulating the  coverage
of budget losses o  di  imbalances  financial,  also  relative
to the research activity.

                                 Art.8
 
                      Amendments to Article 15
          of Legislative Decree 16 October 2003, n. 288

 
  1. In Article 15, paragraph 1, of the _- decree  legislative  16  October
2003, n. 288, the words «two years» are  replaced  from  following:
‘four years’.

                               Art.9
 
                      Amendments to Article 16
          of Legislative Decree 16 October 2003, n. 288

 
  1. Article 16 of Legislative Decree of 16 October 2003,  n.  288,
is replaced by the following:
    ‘Art. 16 (Supervision). — 1. IRCCS under public law  send
annually   al   Ministry   della   health    la    programming
of the research activity and related reporting, the  Financial statements
of the financial year  annual,  the  budget  sectional   della   search,   i
financial statements of non-economic activity ed  economic,  le
eventual  modifications  alla  person  legal,  le  revisions   to
organic endowment or ownership of health accreditation.
    2.The Ministry of Health, in the exercise  of  functions  di
vigilance referred to in the article  1,  comma  2,  can’  ask  data  e
information on maintaining requirements and the  Standard
for recognition of scientific character.
    3. The boards of directors of  Foundations  IRCCS  e  gli
organs  degli  IRCCS  not  transformed  may  be  loose  with
provision of the Minister of Health,  adopted  d’intesa  with  il
Minister for Economy and Finance  e  with  the  President  of
region, when:
      (a) serious irregularities are found; in administration,  i.e.
gravity  e  reiterate  violations  of  provisions   di   law   o
statutes;
      (b) the income statement closes with a loss  top  al  20
per cent of assets for two successive financial years;
      (c) vi  e’  impossibility  di  operation  degli  organs  di
administration and management.
    4.By decree  di  dissolution  the  Minister  della  health,
in agreement with the  President  della  region  concerned,  nomination  a
Commissioner  extraordinary,  with   the   task   di   remove   le
irregularity  e  heal  la  situation  di  liabilities,  sino  to
reconstitution of ordinary administrative bodies.’

Chapter II

                         Art.10
 
                       Relevant provisions
               of health research personnel

 
  1. Without prejudice to the resources referred to in Law 27  December  2017,  n.
205, paragraph 424, as well as the constraints of paragraph 428 of the same law,
the duration of the second contractual period of  work  subordinate  a
fixed time of health research personnel, of which  di  which
in Article 1(422) to (434) of  cited  law  n.  205  del
2017, can be reduced  respect  all’arco  thunderstorm  dei  five
years, in case of positive evaluation according to the established discipline
by paragraph 427 of law no.205/2017, also al  end  of the eventual
permanent classification in the roles of the Service  health
national (SSN) and in compliance with the provisions of paragraph 2.
  2. Within ninety  days  from  data  di  entry  in  vigor  del
this legislative decree, pursuant to paragraph 423 of  law  n.
205  del  2017,  gli  IRCCS  redefine   gli  acts  corporate   di
organization with a specific e  autonomous  section  per  le
search functions and define reserved dimensions,  da  allocate   al
health research staff, recruited with  contract  di  Work
fixed-term subordinate. The IRCCS  within  one hundred and twenty  days
from the date of entry in  vigor  del  present  decree  legislative
in the field  dei  places  della  Endowment  organic  del   staff,
define the number of posts allocated to the _- activities  di  Research
For the permanent classification of research staff
Health.
  3.Without prejudice to the provisions in relation to mobility towards
the universities, by Article 26 of Decree-Law 6  November  2021,
n. 152, converted, with amendments, by the law of 29 December  2021,
n. 233 and the implementing decree of the Minister of University e  della
research n. 367, to the end  di  favor  lo  exchange  di
professional experience in  system  della  search,  the  staff
of IRCCS under public law employed  in  activities  di  research
translational, preclinical and clinical, compatibly with  le  resources
for the period of validity of the employment relationship a  time
determined, can be seconded or seconded to another IRCCS of
public law or  ente  public  di  search  in  respect  of
provisions in force in the field of civil service.

                                Art.11
 
Provisions on benefits of  high  specialty  dispensed
  IRCCS in favour of extra-regional patients

  1. In order to ensure equitable access  di  all  i  citizens
to high-specialty services  dispensed  dagli  IRCCS,  second
principles  di  appropriateness   e   di   optimization   of the offer
assistance of the Service  sanitary  national,  le  regions  e  le
Autonomous provinces of Trento e  di  Bolzano  provide  the purchase,
from these institutions, of health services  di  high  specialties
falling within the thematic areas of the individual IRCCS to be paid in favor
of citizens residing in regions other than those where they insist  Le
structures, in line with regional and national programming  e
with the constraints dictated by the current legislation on the subject  purchase
of health services from private  accredited,  also  using
the derogation provided for in Article 1,  comma  574,  letter  b),  della
legge 28 dicembre 2015, n.208, including the further  expenditure
referred to in Article 1, paragraph 496, of Law 30  December  2020,  n.
178.
  2. Starting from the year 2023, within the framework of health needs
standard is identified for the same year a  bottom  pari  a  euro
40,000,000, to be revalued annually by  del  Ministry  of
health on the basis of the care needs met, intended
to remuneration for the services referred to in paragraph  1  e  distributed
between regions and autonomous provinces in accordance with le  services
of high speciality falling within the thematic areas of the individual IRCCS
detected within the flows  informative.  Such  allotment  integrates
the agreement for the regulation of the services rendered by the _- IRCCS  For
The high mobility specialty of the reference year.On-site  di
final balance the regions and autonomous provinces, by  le  structures
having offices in their territory, are responsible for controls
of appropriateness, preparatory to financial regulation  e  alla
possible reassessment of requirements.  Sono  recipients  di  such
fund all structures that subscribe to the  agreements  contractual
pursuant to Legislative Decree no. 502 of 30 December 1992.
  3. The benefits referred to in subparagraph   1,  dispensed  dagli  IRCCS,  are
regulated through  gli  ordinary  mechanisms  della  matrix  of
health mobility, as part of the allocation of health needs
national standard, with the sole exception of the additional expenditure referred to in
in article 1, paragraph 496, of the law  30  December  2020,  n.  178,
remunerated at the time of distribution of the same sums submitted  alle
rules referred to in the relevant implementing decree.

                                Art.12
 
                  Final and transitional provisions

 
  1. By decree of the Minister of  health,  heard  la  Conference
State-regions,  are  updated  periodically,  e  anyway  by
twelve months from the date of entry into force of this decree, in
compliance with scientific developments, annexes 1, 2,  e  3  of
this decree, as well as the requirements of  which  ai  paragraphs  3-quarter  e
3-sexies of article 8 of the legislative decree of 16 October 2003,  N.
288, introduced by Article 4 of this decree.
  2.The provisions of Article 2 shall apply: a  start
from the first renewal of the Board of Statutory Auditors.
  3. IRCCS thematic networks already established on the date of  entry  In
force of this decree shall be adapted by   alle
provisions  di  which  to the article  4,  from  comma  3-bis  al  comma
3-septies of this decree.
  4. Articles 7 and 8 shall apply  decorsi
one hundred and eighty days from the date  di  entry  in  vigor  del  present
decree and also apply to instances not yet defined  a  that
date. The same  provisions  si  apply  alla  before  confirmation
after the date of entry into force of  present  decree  for
the Institutes already recognized and in any case not before  di  twelve  months
from the date of entry into force of this decree.

                                Art.13
 
                      Financial provisions

 
  1. The implementation of this decree must not result in new o
increased burdens on public finances.
  2.  Le   administrations   concerned   provide   ai   related
fulfillment  in the field   of   resources   human,   instrumental   and
financial available under current legislation.

                               Art.14
 
                          Entry into force

 
  1. This Decree shall enter into force on .
  This decree, bearing the seal of the State, will be inserted
in  Collection  official  degli  acts  regulations  della  Repubblica
italiana. It is the obligation of anyone who is responsible to observe it and to do it
observe.
    Given in Rome, addi’
 
                             MATTARELLA
 
                        Meloni, President of the Council  dei
                             ministers
 
                        Schillaci, Minister of Health
 
                        Giorgetti, Minister  economics  e
                              finance
 
                        Bernini, Minister of Universities  e
                              of the search
 
                        Zangrillo, Minister for  la  publish
                            administration
Seen, the Keeper of the Seals: Nordio

                          &_ —            Annex 1
 
                              &_ —      Annex 2
 

                                  — Annex 3
 
Indicators  e  thresholds  di  evaluation  per  the  recognition   del
                         scientific character

 
    1.For verification purposes  del  possession  dei  requirements  per  the
recognition of the scientific character referred to in the article  13  del
decreto legislativo 16  October  2003,  n.  288  are  identified  i
following indicators and assessment thresholds:
      a) for letter d) of paragraph 3, la  qualification  di  Center  di
regional or supraregional reference for individual area  thematic  di
referred to in the Annex  1  e’  per  at least  1.5  million  di  inhabitants,  ad
exception for regions with fewer inhabitants,  e  must
have the best case mix index (where applicable)  di  at least  IL
10% compared to that of the national average, and in any case to the exclusion
of the rehabilitation thematic area.
      (b) for points (e) and (f) of the _- comma  3,  are  identified  i
next   standard   di   benchmarking   obtainable   dai    systems
international bibliometrics (SCOPUS, Incites) referred to:
        1.Normalized Impact Factor (NFI) produced in the year with the
thresholds of 500 points/year for all subject areas except
Paediatrics, Hematology and Immunology, Geriatrics, Diseases  infectious,
for which la  threshold  e’  di  700  points/year,  e  of  areas  di
Neurology, Oncology  e  Cardiology-Pulmonology  per  le  quali  the
threshold is set at 900 NFI points/year;
        2. ‘Field Weight Citation’ of publications  major  of
25% compared to the best average between the national and European ones;
        3.  ‘%  International  Collaboration»   of   publications
25% higher than the best average between the national and
european;
        4.’% National Collaboration’  of  publications  Higher
by 25% compared to the best average between the national and European ones.
    2. For IRCCS branch offices, for the purpose of verifying that
they contribute with high-level operational capabilities  level  The following indicators and assessment thresholds are identified at -_r>       a) for letter d) of paragraph 3, if  la  headquarters  secondary
carries out welfare activities, the qualification of Reference Center
territorial;
      b)  per  le  letters  e)  ed  f)  del  comma   3,   the   volume
of the activity of  search  pari  ad  at least  the  25%  respect  alla
scientific production of the main office as well as standards  di
benchmarking  obtainable  dai  systems  bibliometrics  international
(SCOPUS, Incites) referred to in paragraph 3d above.

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