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