December 5, 2022

The National Recovery and Resilience Plan, Mission No. 6, “Health”: Current status

The Italian version of this article has been published on October 17, 2022 on AboutPharma.com, within our bi-monthly column about Clinical Trials Regulation EU 536/2014 and its implementation in Italy.

In recent months, implementation of the measures contained in Mission No. 6 of the National Recovery and Resilience Plan (“NRRP”), which allocates over 15 billion euro to the health sector, has come to the fore with the adoption of a series of actions that outline more specifically the contents of the two macro-areas of intervention, the “components” of the mission. The first is dedicated to the reorganization of community medicine and telemedicine, and the second focuses on innovation and research and the modernization of National Health Service technology and equipment.

With regard to the first component, the guidelines published on May 24 containing the “Digital model for the implementation of home care” and Ministerial Decree No. 77/2022, which establishes models and standards for development of home care, provide precise indications regarding the new structure taking shape. The focus is on construction of a care network that stands as an alternative to hospitals. The network is to be developed at a local level so that it is accessible to all citizens; it should be designed to encourage the use of digital tools and provide care for patients in their own homes.

The second component of Mission No. 6, covering reorganization of regulations governing Scientific Institutes for Research, Hospitalization, and Health Care (“Istituti di Ricovero e Cura a Carattere Scientifico,” or “IRCCS”) was finally published on August 3. Within six months of taking effect, that law will empower the government to adopt one or more legislative decrees to revise and update the regulatory structure and legal framework for such institutions.

Under that second component, on July 11, 2022, the guidelines for the implementation of the Electronic Health Record (“EHR”) were published in the Official Gazette. These guidelines provide a consistent strategy for developing the EHR throughout the country.

Lastly, the signing of institutional development contracts by the Ministry of Health and the individual Regions and Autonomous Provinces for implementation of the NRRP measures is of particular importance, as these are agreements that regulate the commitments of the individual territorial entities and establish an operating procedure for each of the planned actions.

Below we will look specifically at what has been done in recent months and what steps need to be taken in the immediate future to ensure that deadlines and goals are met.

Component I: Proximity networks, facilities, and telemedicine for territorial health care

The actions envisaged under Component I are intended to strengthen health and care services by strengthening existing structures and creating new territorial centers promoting home care and the use of telemedicine, as well as more effective integration between social and health services.

With regard to territorial reorganization and assistance, Ministry of Health Decree No. 77 of May 23, 2022 established structural and organizational standards for the provision of healthcare services in various areas, starting with the health districts. A health district is an organizational/functional subsection of a local health authority with an estimated population of about 100,000. A minimum number of facilities (such as community homes and community hospitals) is guaranteed for each individual district. The decree provides detail about the composition of these and the roles filled and services provided. The focus is on implementing telemedicine tools to meet the minimum requirements and service standards established in the “National indications for the provision of telemedicine services” approved by the State-Regions Conference on December 17, 2020.

With an eye to enhancing home care with new digital tools, in accordance with the principle of the home as the first place of care, the guidelines in the Ministry of Health Decree of April 29, 2022 established the implementation of various telemedicine services (such as teleconsultation and telehealth) in the home setting, starting with service access methods and patient responsibility and going on to cover roles and responsibilities.

Implementation of the above is now the responsibility of the individual Regions and Autonomous Provinces, and Ministerial Decree No. 77/2022 also provides that within six months of the entry into force of the decree, i.e., by January 2023, each entity must adopt a general document governing territorial assistance planning that is consistent with the guidelines outlined by the government. Regions that fail to comply risk losing 2 to 3% of the supplementary financing from the National Health Fund.

Component II: Innovation, research, and digitalization of the National Health Service (“NHS”)

The measures in this component focus on updating and modernizing NHS technological and digital structures, completing and disseminating the Electronic Health Record, and enhancing and strengthening scientific research conducted within the National Health Service.

Among the main actions, on July 11, the guidelines for implementation of the Electronic Health Record, as set forth in the ministerial decree of May 20, 2022, were published in the Official Gazette to provide a consistent strategy for development of the EHR across the nation. There are four main directives: (i) guaranteeing consistent and uniform digital health services; (ii) standardizing content in terms of data and coding; (iii) strengthening architecture to improve interoperability of the EHR; and (iv) strengthening oversight of EHR implementation. The EHR guidelines are indispensable for achieving the objectives of the NRRP, which include a goal of widespread use (at least 85%) of the EHR by GPs by 2025 and its full adoption throughout the country by 2026. As provided in Article 21 of Decree-Law No. 4/2022, the Regions and Autonomous Provinces were to formulate ad hoc adaptation plans within three months of publication of the guidelines on July 11; these are still lacking to date.

Also key is the recent publication in the Official Gazette of Law No. 129 of August 3, 2022 that delegates the government to handle the reorganization of regulations for Scientific Institutes for Research, Hospitalization, and Health Care (IRCCS)—structures of primary importance in the field of biomedical research—which will rewrite Legislative Decree No. 288/2003. The law consists of a single article. Within six months of taking effect, it gives the government the power to adopt one or more legislative decrees for the “reorganization” of IRCCS using guidelines and criteria indicated therein. The aim is to strengthen the relationship between research, innovation, and health care by revising and updating the regulatory and legal frameworks of the IRCCS, as well as the research policies under the purview of the Ministry of Health. The reform also aims to facilitate exchange of knowledge between IRCCS and other NHS facilities.

Key points of the underlying act include strengthening the role of IRCCS as nationally and internationally important institutions of excellence, revised criteria for recognizing, revoking, or confirming the scientific character of IRCCS, streamlined processes for patent registration and product manufacture and marketing, as well as new regulations on protection of intellectual property and relations with companies involved in research.

Institutional development contracts

Finally, one month ahead of the roadmap outlined by the NRRP, in May 2022 all the national development contracts (contratti nazionali di sviluppo, “CIS”) were signed by the Ministry of Health and the Italian Regions and Autonomous Provinces. They are available on the ministry’s website at this link.

CIS are contracts that, pursuant to Article 56 of Law Decree 77/2021, require the Regions and Autonomous Provinces to implement the NRRP measures according to the operating procedures attached to the individual agreements. These plans detail the methods and timeframes for various actions, from establishment of new territorial garrisons to modernization of technological and digital systems.

As part of the activities that the territorial authorities shall carry out to implement the CIS signed at the regional level, the National Agency for Inward Investment and Economic Development, known as Invitalia, has been appointed to provide economic, technical, and financial support to administrations, as well as to serve as the central purchasing body and contracting hub. A number of calls for tenders—totaling more than EUR 3.2 billion—were launched in July for numerous (as many as 1,189) infrastructure actions to strengthen territorial social-health centers and improve the seismic resistance of existing properties. Information is available on the Invitalia website; the deadline for submitting bids was September 14.

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