October 1, 2017

The Consiglio di Stato rules Italian regions cannot introduce restrictions to the prescription of innovative drugs

The Italian administrative court of last instance (“Consiglio di Stato”), in its recent ruling no. 4546 of 29 September, 2017, stated that Italian regions cannot issue recommendations to limit the prescription of innovative drugs compared to those established by the Italian Agency for Medicines (the “AIFA”).

1. The background

The Regional Technical Committee of the Veneto Region (the “Committee” and the “Region”), is in charge of delivering opinions and recommendations on single drugs or therapeutic categories, drawing up pharmacological guidelines and diagnostic-therapeutic pathways, monitoring the appropriateness, and the safety and expenditure of medicines. The Committee approved some evidence-based recommendations regarding the prescription of innovative oncology medicines and, in particular, Avastin and Perjeta, marketed by Roche S.p.A. (“Roche”). The Committee’s recommendations classified Avastin as:

  • ‘moderately recommended’ in the treatment of patients with certain conditions,
  • ‘moderately recommended’ for patients with a specific condition, and
  • ‘not recommended’ in two other cases.

Roche challenged these recommendations before the administrative court of first instance of the Region (“TAR Veneto”), which rejected Roche’s claim (ruling no. 1150 of 6 November 2015). Then, Roche appealed the TAR’s ruling before the Consiglio di Stato.

2. The principles highlighted by the Consiglio di Stato

The Consiglio di Stato confirmed the principle, already stated in several previous judgements, that the AIFA is the entity entitled by the Italian law with all the functions relating to the release of marketing authorization of medicinal products, their classification, their therapeutic indications, the determination of prices, the reimbursement regime, and the monitoring of their consumption. These competences have been repeatedly and uniquely qualified as exclusive.

Therefore, if a drug is classified by AIFA as hospital drug (H class), this means that it can only be used in a hospital environment, as constituting the hospital level of assistance guaranteed by the National Health Service. Hospital treatment includes the administration of drugs and, in this case, of innovative oncology medicines, such as Avastin and Perjeta. Consequently, regions are precluded from establishing more restrictive conditions and criteria for the delivery of a medicinal product classified by the AIFA as a hospital drug, since such a limitation would inevitably jeopardize the essential levels of assistance that shall be provided by the National Health Service to all citizens, in equal conditions, throughout the national territory.

3. The Consiglio di Stato’s decision

The principles above, applied to the present case, led the Consiglio di Stato to uphold Roche’s appeal and annul the Veneto Region recommendations for the following main reasons:

(i) The recommendations introduced additional limits and stringent controls over the use of certain pharmacological therapies with respect to the conditions and requirements already identified at the national level by the AIFA, departing sensitively from the AIFA’s national determinations and discriminating against patients who are resident in Veneto (since the Region would not grant, from this respect, the same level of assistance as that granted by the other Italian regions),

(ii) the Region, in pursuing the purpose of limiting health spending, has established, with these recommendations, well-defined prescriptive objectives that affect the merits of the choices of prescribing physicians who thus undergo strong, inevitable conditioning. It is also evident from the circumstance that the recommendations provide for monitoring of their implementation, every six months, by verifying compliance with specific expected usage indicators and the allocation of the economic resources, and

(iii) the recommendations, in directing doctors and healthcare facilities to the use of alternative therapies instead of the drugs qualified as moderately recommended or even in some cases not recommended, has established, implicitly but clearly, an equivalence between different active principles, which would in turn require a prior evaluation by the AIFA, the only entity qualified by the law to make such an assessment.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
Read more
Our highly-ranked team of professionals will provide newsinsights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

April 27, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on the borderline between medical devices and medicinal products in order to support the uniform application of Regulation...
April 5, 2022
Electronic prescriptions: the current modalities of transmission from doctors to patients and from patients to pharmacies are extended until 31st December 2022
March 24, 2022
EU Medical Device Coordination Group (MDCG) approves “Guidance” on appropriate surveillance of devices covered by certificates according to the MD Directives, under the transitional prov...
March 21, 2022
Published Decree of Health Ministry identifying the ethics committees of national significance for clinical trials of medicinal products and medical devices
February 23, 2022
Published Decree of Health Ministry providing measures to enhance no-profit clinical trials and to regulate transfers of data and results of no-profit studies for registration purposes
Search by...
Follow us on
Follow us on