The new legislation about “Discipline of the therapeutic use of an investigational medicinal product” (Ministerial Decree September 7, 2017) which abrogates the Decree 8 May 2003 as amended, was published in the Italian Official Journal on November 2^nd 2017 and will enter into force 30 days after the publication.

The new Decree contains important updates including:

• The possibility to request a compassionate use for medicinal products already authorized but not yet available on the Italian market.
• In case of rare diseases or rare tumors, the possibility to base the compassionate use request on the results of Phase I clinical trials that have proven the activity and the safety of the medicinal product at a specific dose/therapeutic regimen even in therapeutic indications other than the concerned one.
• The introduction of a new submission procedure with the request to be submitted by the physician(s) to the Ethics Committee (EC) only; then the opinion issued by the EC will be electronically forwarded to AIFA within 3 days as of the opinion date.
• The requirement for the company to previously inform AIFA about the starting date of the compassionate use program and the estimated duration of the free of charge supply of the concerned medicinal product.
• The inclusion of the Pharmacovigilance requirements provided for in Ministerial Decree 30 April 2015.

Regulatory Pharma Net team and experts are available to support companies to comply with the new requirements.

AIFA has recently circulated on its website the communication about the price increase of Class C medicinal products subject to medical prescription.
As foreseen by Article 1, paragraph 3 of the Law Decree n. 87 dated May 27th, 2005 the prices of the medicinal products classified in C class subject to medical prescription, with reference to art. 8, par. 10, letter c), of the Law December 24th 1993 n. 537, can be increased only in January of every odd year.

Companies that wish to apply for a price increase are requested to comply with the following dispositions:

• The company must communicate the price variation within and no later than January 31st, 2019
• The communication has to be received at least 15 days before the effective date of the new price
• The company must indicate the effective date of the new price (not prior to January 1st, 2019), the MA number, the medicinal product description and its presentations, the public price in force, the new price including the variation, the indication of the percentage change and any other possible annotation

Regulatory Pharma Net team is available to support companies in the documentation preparation and submission.

Following the legislative decree n.18 of 17 March 2020, AIFA published an explanatory note on Compassionate Use regarding treatment of COVID-19.

The request to start compassionate use programs for the treatment of COVID-19 must be sent in advance to the Single National Ethics Committee identified by the law (INMI L. Spallanzani) and to AIFA.

The opinion of the Single National Ethics Committee is formulated with an emergency procedure and it is immediately applicable for all the centers and all the patients treated, whereas the nominal therapeutic uses remain subject to the current legislation and therefore remain under responsibility of the local ethics committees.

All the treatments that have received a positive opinion will be published on the institutional website of AIFA, in the appropriate section “Emergency COVID-19”.

Regulatory Pharma Net team is available to fully support companies for any query and for the preparation and submission of the documentation related to compassionate use programs.