Disclosing Generics Applications

The Italian Medicines Agency (AIFA) has issued new guidelines on its future policy on the disclosure of generics (Gxs) applications.

AIFA stated that "further to consultations with Italian and European institutions, as well as the industry and the Italian courts" (presumably the Italian administrative courts where cases were recently brought by leading pharmaceutical companies), AIFA has decided to change the procedure whereby AIFA will process patent holders' requests for information on Marketing Authorisation (MA) applications filed by generics manufacturers.

From October onwards, AIFA will publish a list of all the active substances for which MA applications have been filed in accordance with Article 10(1) and 10(3) of Directive 2001/83/EC. According to AIFA, publishing that list will meet the requirements of the Italian Freedom of Information Act (Law 241/1990), according to which affected third parties are entitled to be informed of any administrative procedure being commenced.

AIFA has decided that it will not authorise the disclosure of Gxs files to patent holders before the completion of the regulatory procedure, unless exceptional circumstances require otherwise. In particular, for medicinals that are not reimbursed by the National Health Service, such disclosures will be authorised only once the opinion of the Scientific Commission has been submitted. In terms of medicinals that are reimbursed, disclosures will be authorised once price negotiations have been completed. In essence, this will mean that disclosure of Gxs files will be authorised at the very end of the regulatory process, i.e. just before Gxs MAs are published in the Official Gazette.

AIFA has gone on to confirm that it will be adhering to recent case law by the Supreme Administrative Court whereby it judged that the existence of patent rights is irrelevant in terms of including approved Gxs in the reimbursement list.

The List of Active Substances

AIFA did not clarify whether the list of active substances for which article 10 (1) or 10 (3) MA applications are filed will include just the active substances or the names of the actual generics manufacturers filing the MA applications as well. The first list for new MA applications filed for September 2010 was published online on 7 October: http://www.agenziafarmaco.it/it/content/lista-sostanze-attive . The list indicates the relevant active substances, the type of procedure (national, mutual recognition or centralised/decentralised) and the number of MA applications filed for each active substance. The identity of the Gxs manufacturers is not revealed.

What will this mean?

In the past, AIFA's reaction to requests made by right holders (under the Freedom of Information Act) for the disclosure of Gxs applications was to send the relevant generics manufacturer a letter asking if it objected to such request. A copy of such letter was also sent to the patent holder and the right holder was thus officially informed of the identity of the Gxs manufacturer filing the MA application.

Under the new procedure – assuming that AIFA will not include the names of the Gxs manufacturers in the next lists – it may become increasingly harder for right holders to be officially informed of who is filing Gxs applications. As a result, the new AIFA procedure may well be seen to be breaching the Freedom of Information Act.

On a more positive note, since 7 October 2010, patent holders are able to monitor MA submissions by active substances in Italy using an online tool.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.