Pain Policy in Italy

Legge 38

A new law “Policies to guarantee access to palliative care and pain medicine” - impact and perspectives

More information about services and aspects of palliative care of law 38 available on the website of the Italian Ministry of Health.

A short summary on Legge 38 you can find in this PDF.


  • Two integrated networks: palliative and pain medicine
  • Selection of involved professionals
  • Formation and education
  • Funding of informational campaigns
  • Institution of government-level overseeing
  • Explicitly provides for the special needs of pediatric patients

Art. 1

This law grants citizens the legal access rights to palliative care and pain medicine

Art. 2 - Definitions

Palliative Care
Interventions for patients and families in the presence of progressive disease with negative prognosis, not amenable to specific treatment.

Pain Medicine
Diagnostics and therapeutics aimed at suppressing or controlling pain of any etiology.

Person who suffers of chronic pain could evolve in illness and/or pain.

Art. 3 – Responsibilities

National Health Service
Palliative care and pain medicine are priority objectives; implementation is required for access to complementary funding by the government.

Ministry of Health
Defines guidelines for publicity, development and coordination of regional policies.

State-Regions Committee

  • Status of Implementation of the law
  • Appropriateness of interventions
  • Adequacy of available resources with respect to performance

Art. 4

€ 350.000 for information campaigns

Art. 5 State – Regions Committee

  • Institutional Accreditation Criteria
  • Staff Accreditation Criteria
  • System coordination
  • Reimbursement control
  • Care homogeneity

Art. 6 – “Pain-free Hospital & Territory

€ 2.450.000 for staff education

Art. 7 Pain as vital sign: Regular assessment in patients’ medical records.

Pain management is the patient’s right, and the caring physician’s duty.
Law requirements: written records of treatments and outcomes.

Art. 8 Educational Activities

  • Medical school masters and post graduated masters (by the Ministry of Education and Research);
  • CME for physicians and other staff;
  • Compulsory internships/rotations (where applicable);
  • Special education for volunteers and charities/NGOs.

Art 9 and 11 Process Control

National Commission monitors and reports to Parliament about:

  • Network development
  • Performance and Efficiency
  • Education
  • Public information
  • Research
  • Budget
  • Technical reports by experts

Ministry of Health -> National Commission -> Subcommissions 

                                   -> Palliative Care -> National Experts
Subcommissions     -> Pain Medicine -> National Experts
                                   -> Pediatric Care -> National Experts

Art. 10 . Simplification of prescription rules

No more special logs for oral or transdermal opioid formulations. Easier access to analgesics for acute and chronic outpatients. 
Encouraging some of Europe’s most reluctant prescribers

Art. 12

Budget for services: Ministry and State-Regions Permanent Conference:
More or equal € 100 million/year taken from National Health Fund

This law has been so important and well done that it has been taken as a model to make the following declaration of Montreal:

“Access to pain management is a fundamental human right”

Resolution of the Regional Council of the region Marche

Pain relief acute-primary care net (´Ospedale-territorio senya dolore´) - Piloting a new care model

Lucia Di Furia, Luigi Nardi, Alfredo Fogliardi, Fabio Izzicupo, Claudio Caputi, Vincenzo Firetto, Fulvio Borromei, Edoardo Berselli.

The project aims to developing a care model which is able to guarantee, within the hospitals of the Marche Region, both a systematic and uniform detection of pain by the health professional involved (ability to methodically detect pain, ability to understand the level of pain) and consequently,  when necessary, the administration of the appropriate and efficacious analgesic treatment. The health professionals observe and document the level of pain of the patient, as the V vital parameter, using a standardised tool, validated to evaluate the intensity of pain.

In order to do this the project involves a methodological-managed and clinical-care study to be piloted in a so called “Area Vasta”, a well-defined area, which is representative of the critical points and the opportunities of our local healthcare system. Following evaluation of the pilot project, the necessary modifications will be made, before extending the operating system in the entire regional area. The re-organisation and systematization of the current offer of services could guarantee easier access to the current health services, in particular reinforcing the pool of services for adults (and children) in the area.

A new organisational model embedded in the area, will be developed. The level of care will be divided into three complementary sectors: the reference pain treatment centres (HUB), the outpatient analgesic treatment centre (SPOKE), and the GP surgeries.

The project “Ospedale-Territorio senza Dolore” aims at improving the quality of life of patients who need any kind of treatment and who are in pain; the project gets its realisation in controlling pain, which is often associated to other symptoms. It includes the take-off of procedure pain management protocols for adults and children within the hospital.

The need to safeguard both adult and children patients forces the Region to define a project which will identify an organisational pathway able to improve pain relief treatment both in acute and especially in primary care.