December 16, 2019

Regional Administrative Court of Tuscany: recent judgment on biosimilars

On November 26, 2019, the Regional Administrative Court of Tuscany (Tribunale Amministrativo Regionale – T.A.R.”, “Court”) ruled on the request for the invalidation of the Regional Council of Tuscany Resolution No. 457/2019 (“Resolution”) concerning the procedures for the supply and use of biosimilars in Tuscany.

The Resolution mainly provides for the use of biosimilars in healthcare facilities, both for new patients and for patients already in treatment with the correspondent originators.

Specifically, the Resolution was challenged for the following main reasons: (i) the unlawful introduction of automatic substitutability between biological and biosimilar medicines, and (ii) the breach of the principle under which the physician shall be free to prescribe the drug he/she considers appropriate.

The Court dismissed the appeal stating that the Resolution does not allow the pharmacist to automatically substitute the biological drug with one of its biosimilars (that is clearly prohibited by Article 15, paragraph 11-quater, of Decree Law No. 95/2012, converted into Law No. 135/2012) but rather the interchangeability between the two drugs. Interchangeability means the possibility for the prescribing physician to replace, once therapy has already begun, the originator drug (with an expired patent) with its own biosimilar, with the capacity to obtain the same clinical effect.

According to the Court, since the Resolution requires the physician to provide a summary and comprehensive justification to illustrate the reasons why he/she decides to continue using the originator instead of the biosimilar that was awarded in the public procurement procedure, this is not in breach of the prescriptive freedom of the physician. Indeed, the physician is still the person responsible for the final decision on the drug to be administered to the patient. Moreover, this motivation duty meets the need to ensure a fair balance between the protection of the prerogatives of the physician, the rights of the patient and the reasons behind the optimization and sustainability of public health expenditure.

In conclusion, the T.A.R. recognized the lawfulness of the Resolution, which is also consistent with the guidelines set out by the Italian Medicines Agency (AIFA) in its second position paper on biosimilars published on April 11, 2018.

This judgment is in line with the case law available so far on this topic and confirms the fundamental distinction between automatic substitutability and interchangeability of biosimilars/originators. Therefore, regional resolutions which provide for interchangeability between originators and biosimilars, granting in any case the physician’s right to prescribe the proper medicine to patients (regardless whether it is an originator or biosimilar) shall be considered to be compliant with Italian law.

< 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 news, insights 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.

March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
Search by...
Follow us on
Follow us on