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".
The News of the Sole 24Ore – 17/06/2016 – Source: Federfarma
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in 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".
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
To effect, he canceled the race. According to the judges, the extreme conciseness of the evaluation elements contained in the opinion of the AIFA director general of 28 April 2014 is compounded by the structural lack of the preliminary investigation support of the CTS which expressed its final opinion not only by failing to account for the doubts of the reasons for overcoming the rapporteur's preliminary requests, but essentially not offering any tangible technical-scientific evaluation element.
The facts. The Veneto Region proposed to the Technical-Scientific Commission the question of therapeutic equivalence, pursuant to article 15, paragraph 11-ter, of the decree law of 6 July 2012, n. 95, in relation to the declaration of existence of therapeutic equivalence between the active ingredients "Omeoprazole", "Esomeprazole" and "Pantoprazole", belonging to the category "ATC A02BC (proton pump inhibitors)" for the indications of the treatment of reflux and duodenal and gastric ulcers, both between the active ingredients "Leuprorelin" and "Triptorelin", belonging to the category "ATC L02AE - Gonadotropin-releasing hormone analogues", for the indication of the treatment of prostate cancer and its secondaries, in which the suppression of testosterone production is indicated. The therapeutic equivalence of these products has been affirmed by AIFA, according to the companies, without giving any publicity and with effects on all Italian regions.
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 interest in acting of the manufacturing companies.
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.
The sentence rejects the thesis of the companies according to which the failure to identify - legislation or regulation - the "therapeutic equivalence between medicines containing different active ingredients" constitutes a void that must be filled by AIFA.
An obligatory corollary of this premise is that the Guidelines of 6 March 2014 cannot be considered illegitimate - in the part in which they define the concept of "therapeutic equivalence between medicines containing different active ingredients" - the Guidelines of 6 March 2014 and, for derived illegitimacy, the opinion given, in response to the request of the Veneto Region of 11 February 2014, n. 61668, by the Technical-Scientific Commission for the Evaluation of Medicines (Cts) of AIFA of 7, 8 and 9 April 2014 and endorsed by the Director General of the Agency in note no. 44992/P of 28 April 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
