TOIn order to give content to the concept of "therapeutic equivalence between different active ingredients", reference cannot be made to the content of the "homogeneous therapeutic categories (Cto)", as these are used by the legislator for the sole purpose of classifying and reimbursing drugs . It is not "necessary, for the purposes of the decision, to verify whether the two concepts are actually different, but the decision on equivalence must be motivated and a verifiable decision-making process must be followed".
Le News del Sole 24Ore – 17/06/2016 – Fonte: Federfarma
To the
With this motivation, the Tar of Lazio with the sentences nos. 6417-6419/2016 filed on June 1st, canceled the note of the AIFA Director General no. 44992/P of 28 April 2014, concerning the request for evaluation regarding the therapeutic equivalence between medicines containing different active ingredients pursuant to article 15, paragraph 11-ter, of the decree law of 6 July 2012 n. 95, converted, with amendments, by law 135/2012, in the context of the new tender procedure for the supply of medicines for the local health authorities of the Veneto Region and consequent minutes of the meeting of the Technical-Scientific Commission for the evaluation of medicines of the 'Aifa of 7, 8 and 9 April 2014.
Tar of Lazio nos. 6417-6419/2016
The facts. La Regione Veneto proponeva alla Commissione tecnico-scientifica il quesito di equivalenza tereapeutica, ai sensi dell’articolo 15, comma 11-ter, del decreto legge 6 luglio 2012, n. 95, in relazione alla dichiarazione di sussistenza di equivalenza terapeutica sia tra i princìpi attivi “Omeoprazolo”, “Esomeprazolo” e “Pantoprazolo”, appartenenti alla categoria “ATC A02BC (inibitori della pompa protonica)” per le indicazioni del trattamento dell’esofagite da reflusso e delle ulcere duodenali e gastriche, sia tra i princìpi attivi “Leuprorelina” e “Triptorelina”, appartenenti alla categoria “ATC L02AE – Analoghi all’ormone liberante le gonadotropine”, per l’indicazione del trattamento del carcinoma alla prostata e dei suoi secondarismi, in cui sia indicata la soppressione della produzione di testosterone. L’equivalenza terapeutica di detti prodotti è stata affermata dall’Aifa, secondo le aziende, senza dare alcuna pubblicità e con effetti su tutte le Regioni italiane.
The facts.
Consequently, the declaration has a relevant commercial significance for the excluded companies. Furthermore, for the appellants, when the assessments of therapeutic equivalence expressed by AIFA should have been preceded by the definition of the notion of therapeutic equivalence, a definition which was not given by either the legislator or AIFA, since the circumstance of the use of the same active ingredient nor, much less, would it be possible to affirm it in the present case in which the active ingredient is different and has been declared to be 80 per cent overlapping.
The interest in acting of the manufacturing companies. Paragraph 11-ter of article 15 of decree law 95/2012, inserted by article 13-bis of decree law 18 October 2012, n. 179, the judges stated, prescribes that "in adopting any decisions based on the therapeutic equivalence between medicines containing different active ingredients, the Regions shall comply with the justified and documented assessments expressed by the Italian Medicines Agency", with the consequence that the opinion made by the Technical-Scientific Commission, binding the Regions, which cannot deviate from it, can be immediately challenged.
The company, precisely as the holder of the MA for medicines, has an interest in censuring the declared equivalence which it deems to be affected by irremediable errors, equivalence which, despite having been affirmed in relation to a specific question aimed at calling a specific tender, expresses a principle that can then be used in different venues and by other subjects. This is sufficient for the admissibility of the appeal.
In any case, the sentence states, competing companies must not participate in the procedure nor be made aware of the commission's decision as the law does not provide for it.
La sentenza, respinge la tesi delle aziende secondo la quale la mancata individuazione – normativa o regolamentare – della “equivalenza terapeutica tra medicinali contenenti differenti principi attivi” costituisce un vuoto che deve essere colmato dall’Aifa.
Corollario obbligato di tale premessa è che non possono considerarsi illegittime – nella parte in cui definiscono il concetto di «equivalenza terapeutica tra medicinali contenenti differenti principi attivi» – le Linee guida del 6 marzo 2014 e, per illegittimità derivata, il parere reso, in risposta alla richiesta della Regione Veneto dell’11 febbraio 2014, n. 61668, dalla Commissione tecnico-scientifica per la valutazione dei farmaci (Cts) dell’Aifa del 7, 8 e 9 aprile 2014 e fatto proprio dal Direttore generale dell’Agenzia nella nota n. 44992/P del 28 aprile 2014».
This conclusion, the judges stated, «does not change the fact that a universally applicable definition of therapeutic equivalence between medicinal products with different active ingredients is useful and can lead to a more rational application of the discipline and, above all, more suitable for the purpose pursued by the legislator, which is ensure greater uniformity on the territory of the State, eliminating the differences, sometimes sensitive, which are recorded between Region and Region on the equivalence between drugs and therefore, consequently, on the levels of health care".
Related news: Lazio Regional Administrative Court Judgment No. 06417/2016
Lazio Regional Administrative Court Judgment No. 06419/2016