November 3, 2017

Published the new ministerial decree on compassionate use of medicinal products

On 7 September 2017, the Italian Ministry of Health issued a new decree on compassionate use of medicinal products (“Decree”) that, starting from 2 December 2017, will replace the previous ministerial decree of 8 May 2003. Following the entrance into force of the Code of Medicines in 2006, such decree was intended to be replaced by a new decree, but it has remained effective until now.

The Decree clarifies certain issues that were not covered under the old regulation (although they often have a consolidated application), but other questions remain unsolved. In particular, the Decree broadens the scope of compassionate use (i.e., free supply of medicinal products not available on the market by pharmaceutical companies under certain conditions, “CU”), with regard to both the medicinal products that can be supplied under a CU program and the patients who can benefit from the CU.

From the first perspective, CU programs can also apply with regard to:

(i) authorized medicinal products to be used “off-label”; and

(ii) authorized medicinal products not yet available in Italy.

These provisions raise several issues. In particular, the first needs to be coordinated with the existing legislative framework applicable to the off-label use of medicinal products, while the second clearly refers to the procedure introduced in Italy in 2012 to allow the marketing of centrally authorized products with a freely established price, as soon as they got the marketing authorization and while their price and reimbursement negotiation is still ongoing, under a “not negotiated reimbursed class” (C-nn).

From the patients’ perspective, CU programs are now open to:

(i) patients already treated with clinical benefit in a closed clinical trial to assure the therapeutic continuity; and

(ii) patients who cannot be included in a clinical trial (this could also have a broad application, since, literally, it seems not to be subject to the condition of the absence of valid therapeutic alternatives).

Since the supply of medicinal products under CU programs is to be free of charge, while the other early access mechanisms generally entail payments by the National Health System or local hospitals, the broadening of the scope of CU programs could trigger an increase of requests for their activation in the next future.

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