18 December

HEALTHCARE

New Competition Law Published in the Official Gazette: Suspension of Accreditation and Agreements with the NHS, New Rules for Plasma

18/12/2024

The new competition law has been published in the Official Gazette, introducing significant changes in the healthcare sector. Article 36 provides for the suspension, until December 31, 2026, of provisions related to institutional accreditation and contractual agreements with the National Health Service (NHS). This measure applies to requests for new facilities as well as the launch of new activities within existing structures. The suspension aims to allow a comprehensive review of the accreditation system and contractual agreements, pending the outcomes of the National Accreditation System Development Working Group (Trac), which will be submitted for approval by the State-Regions Conference.

Another significant update is introduced in Article 38, which amends the current regulations on the processing of Italian plasma derived from donations by unpaid volunteers. The change allows for the commercialization of blood plasma processed in a free-market regime, removing current restrictions that exclude some European companies from regional agreements. This measure explicitly aims to avoid potential infringement procedures and to ensure greater flexibility in the management and processing of plasma at the national level.

The new law represents a significant step toward revising and adapting the National Health System to the needs of an evolving context.