April 3, 2019

Italian administrative court judgments on biosimilars

In the past two months, the Italian administrative courts issued two judgments on biosimilars that substantially confirmed the previous case law on the relevant subjects.

Specifically, in judgment no. 871 of February 5, 2019, the Italian administrative court of last instance (Consiglio di Stato), in upholding the first instance decision of the administrative court of the Lombardy Region, stated that:

  • in order to meet the requirements for the application of Italian Law no. 232/2016 which establishes that, when there are more than three biological/biosimilar products based on the same active substance, procurements must be made through the execution of framework agreements, the active substances of the relevant products must be exactly identical and cannot be merely “analogous” or have the same therapeutic indication; and
  • if there are no more than three biological/biosimilar products based on the identical active substance, the public tender may lawfully lead to the selection of (and the execution of the relevant agreement with) only one operator, provided that the doctor is always free to prescribe different products and the tendering authority is required to purchase such products from other operators.

More recently, the administrative Court of First Instance of the Tuscany Region issued a judgment (no. 400 of March 21, 2019) in relation to a decision adopted by the Tuscany Region on the governance of the process for the procurement of medicinal products.

According to the challenged decision, (i) regional healthcare facilities can only use, at the regional healthcare service’s expense, medicinal products selected through public tender procedures, except in cases previously authorized by the regional authorities in charge of the procurement process; and (ii) the assessment for granting such authorizations is largely based on economic criteria and pursues cost-containment measures. The administrative court annulled the challenged decision only for the procurement of biological and biosimilar products for the following main reasons:

  • biosimilars cannot automatically replace the corresponding originators (this is clearly stated in Italian Law no. 95/2012, Article 15). This means that such replacement cannot be made by pharmacists or by regional authorities in charge of the procurement of medicines. Only doctors may assess and decide when originators can be replaced by the corresponding biosimilars in the treatment of patients;
  • any guidelines provided by regional authorities concerning the use of medicines in the pursuit of cost-containment measures shall face the insuperable limit of the doctor’s prescription freedom; and

the decision on the possibility to use a certain medicinal product to treat patients cannot be made on the basis of economic or cost-containment criteria, but only in consideration of the therapeutic appropriateness and the need to assure the patient’s right to continue the original treatment, as granted by the law.

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