According to article 98, 2nd indent, of legislative decree 30/2005, data concerning tests or other unknown data, whose collection requires a considerable effort and which submission is necessary in order to obtain the marketing authorization of chemical, pharmaceutical or agricultural products involving the use of new chemical entity (e.g. registration dossier data) shall be protected.
On the other hand, according to law n. 241/1990 and its relevant implementing rules (d.p.r. 184/2003, hereinafter, the Law), any interested person may have access to Administrative Documents1 (which include of course also documents held by the administration although have not been created by it – e.g. registration dossier data) unless some of the exceptions to disclosure provided by the legislation apply (e.g. confidentiality of the documents held by the Administration and belonging to third parties). Furthermore, also in cases where an exception to disclosure may in principle apply (confidentiality), the Administration may eventually decide to grant access to such documents if, for example, the refuse to grant access would undermine third party rights of defence and/or even third party economic rights.
The approach followed by Italian Medicines Agency (AIFA) so far, as to requests for access to documents, was to refuse access to information relating to registration dossiers (unless an express consent is given on that respect by the marketing authorisation holder). Such an approach was even more stringent in cases of pending marketing authorisation (MA) applications. However, such an approach might be subject to changes in the near future due to recent developments of the Italian relevant jurisprudence.
Recent decision of the Italian Supreme Administrative Court (Conseil d’Etat), indeed, in case “Schering Plought S.p.A. v. Epifarma S.p.A. and Others” of 13th of June 2008, n. 2975 (re: Gentalyn cream and Gentalyn Beta), upholding the decision of the administrative court of first instance on the same subject matter and ordering AIFA to grant access to data contained in the registration dossier of generic companies, makes somehow uncertain whether and to what extent AIFA will be able to maintain its previous position on this matter in the future.
The Court, in particular, with accepting the claimant argumentations, stated that “the decision of granting the marketing authorisation for a generic medicinal product based on the bioequivalence assessment with the reference product belonging to the same company requesting access, directly affects the rights of the latter company, due to its potential competitive effect against the reference product itself. This, therefore, determines the concrete, direct and actual interest of the originator company to have access to the relevant data contained on the registration dossier. In light of the above, the request for access should be considered legitimate, as intended, for the purpose of protecting its own interests on the pharmaceutical market, to verify the actual therapeutic equivalence between the generic product and the reference product”.
It is difficult to say whether and to what extent the above precedent will eventually affect the “attitude” of AIFA towards such requests for access to documents in the near future. However, it may already be envisaged an increased number of such requests coming from originator companies, associated with an increase percentage of chances of success of such applications, in particular, in all those cases where the requestor will be in a position to demonstrate: (i) its actual and qualified interest to gain access to such data (in particular, in terms of potential prejudice) and (iii) the actual nature and relevancy of such data, vis-à-vis with the bioequivalence of the products concerned.
Finally, it should be noted that, interesting enough, both Italian Courts (Court of First Instance and Supreme Administrative Court), (i) expressly limited the scope of such access only to that data necessary to identify the actual bioequivalence between the originator and the relevant generic medicinal products (with the exclusion, therefore, of all data relating to the description of “the preparation methods” of the latter) (ii) on dealt with (actual) “interest in the access” in cases of already completed marketing authorisation procedure. As to the latter, indeed, in the current absence of clear indications from the court, it somehow predictable a conservative approach will be adopted by AIFA in all case of ongoing (still pending) marketing authorisation procedures2, that is to say the Italian Agency will likely refuse access to registration dossier data on all such lastly referred cases.