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Summary of the Consolidated Text on Rare Diseases

The 26 May 2021 The Chamber of Deputies, after more than two years of work in the Social Affairs Committee, has approved the bill promoting the support of research and production of orphan drugs and the treatment of rare diseases.
The 13 October 2021 was announced unanimous approval of the Consolidated Text on Rare Diseases in the Senate Committee on Hygiene and Health.
The 3 November 2021 was unanimously approved in committee in deliberation.
From the moment the law enters into force, with its publication in the Official Gazette, the 5 deadlines within which to produce the 5 acts necessary for the full implementation of the Consolidation Act will start to run:

  • Establishment of the National Committee for Rare Diseases (within 2 months - MinSal decree)
  • Establishment of the Solidarity Fund for persons suffering from rare diseases (within 3 months - Decree of the Ministry of Labour in agreement with the Ministry of Health and MEF)
  • Agreements to be made by the State-Regions Conference: approval of the Second National Plan for Rare Diseases and reorganisation of the Network and definition of ways to ensure adequate information for health professionals, patients and families (within 3 months)
  • Ministry of Health Regulation (within 6 months)

Towards the end of 2022, we can begin to see the real effects of this law.

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