On 7 January 2022, the judgment of the Council of State (15 March 2021, No. 3095) was issued on the appeal filed by Bayer against the Ministry of Health, Ministry of Economy and Finance, Agenzia Italiana del Farmaco (AIFA) for the annulment of the Decree of the Ministry of Health of 2 August 2019 on "Criteria and procedures by which the Italian Medicines Agency determines, through negotiation, the prices of medicines reimbursed by the National Health Service" and the Guidelines for the compilation of the Dossier in support of the application for reimbursement and pricing of a medicine pursuant to the Ministerial Decree of 2 August 2019 - version 1.0 - 2020.

Bayer's complaints were based on two arguments:

• • The poor quality of regulation that merely reproduces the content of primary sources without introducing any innovation;
  • The Ministerial Decree would contain 'blank regulatory rules' that allow AIFA to act in an unconstrained manner, without being able to stipulate the criteria for administrative action.

The Council of State rejected Bayer's appeal, upholding the first instance ruling. Inasmuch as the contested measures have a general and abstract value, i.e., they regulate the drug price negotiation procedure as a whole and, therefore, are not capable of producing a 'concrete and current injury', which is a prerequisite for the judicial challenge of administrative measures.