The current legislation guarantees full protection of the confidentiality of the analyzes and related investigations that led to the registration of a drug, but only if it is a new drug and not a generic one. This is the line indicated by the sentence of the Lazio Regional Administrative Court (n.10914/2007) which accepted the appeal of Schering-Plough, owner of the medicinal products Gentalyn cream and ointment and Gentalyn Beta containing gentamicin sulphate, for which, in 2004 and 2005 , AIFA has issued 38 marketing authorizations for medicines considered equivalent. The appellant company had been denied access by the Medicines Agency to the documents relating to the proceedings which had led to the authorization of the generics. Hence the opposition before the Administrative Court, which ruled in favor of the company, arguing that it is "precisely the lack of the element of novelty of the product, which justifies the request for access". The TAR explained that "if the abbreviated marketing authorization procedure concerns a medicinal product that is not new, but "essentially similar" to the original one, (i.e. assimilable in the qualitative and quantitative composition of the active ingredient, identity of the pharmaceutical form and bioequivalence) and the issuance of the AIC for equivalent is conditional on the production of studies that ascertain the identity of the pharmaceutical form and bioequivalence" then it is clear that the protection pursuant to art. 98, II° co of legislative decree n. 30 of 2005 which, in practice, guarantees the confidentiality of industrial secrets. "Consequently, access to bioequivalence studies or targeted alternative tests cannot be denied, with which the counterparties have demonstrated the identity of the qualitative and quantitative composition of the active substances in the pharmaceutical form of their "equivalent" medicines, compared to the specialties of the appellant, who had patented the original drug". However, the manufacturer of the equivalent drug also enjoys protection, because "the objective interest of the counterparties must also be protected so that information relating to the production methods and the so-called manufacturing "know-how" are not disclosed, for which they must be excluded from the access the summary descriptions of the method of preparation of the preparations of the counterparties". The TAR judged the reasons for the refusal opposed by AIFA to be "irrelevant", according to which the judgment on bioequivalence "is entrusted solely to the competence of the AIFA Technical-Scientific Commission". However, the administrative judge is of a different opinion: "In general, once the equation "technical discretion - unquestionable merit" has disappeared, the technical discretion of the work of the public administration, in relation to particular matters, must take place according to criteria, rules and parameters technical or scientific, directly or indirectly referred to by the legislation governing the power, for which the appreciation of these elements always pertains to the legitimacy of the choice and as such cannot be removed from judicial review (cf. Cons.giust.amm. Sicily, juridical section, January 29, 2007, n. 12). That said, the judicial review on the technical assessments of the public administration can after the law n. 205/2000 take place on the basis not of the mere formal and extrinsic control of the logical process followed by the administrative authority, but through the possible direct verification of the reliability of the technical operations in terms of their correctness as regards the technical criterion and the applicable procedure
