February 7, 2019

New law to settle the long-lasting dispute on the pharmaceutical payback for 2013-2017

On February 11, 2019, Italian Law no. 12/2019 was published in the Official Gazette of Italy, converting into law, with amendments, Italian Law Decree no. 135 of December 14, 2018 (also called the Simplifications Decree) aimed at simplifying certain administrative responsibilities for both private and public entities.

Italian Law no. 12/2019 added Article 9-bis to the previous text of Italian Law Decree no. 135/2018 concerning the health sector. Sections 3, 4, 5 and 6 of the article address the issue of the pharmaceutical payback for the years 2013-2017.

These provisions aim to end the long-lasting dispute between the Italian Medicines Agency (AIFA) and the marketing authorization holders (MA Holders) regarding the payment amount due to refund public pharmaceutical expenditure (payback) from 2013 to 2017, which was initiated following the publication of Italian Law Decree no. 78 of June 19, 2015.

Specifically, Italian Law no. 12/2019 states that if, by February 15, 2019, the full amount needed to reimburse the excess expenditure incurred by the public health system in purchasing pharmaceutical products will not be recovered, the MA holders will be required to pay at least € 2.378 million by April 30, 2019 to the so-called Payback Fund 2013-2017 set up by the Ministry of Economy and Finance.

By May 31, 2019, the Italian Medicines Agency will verify that the MA Holders have paid the amount indicated above. In order to perform this verification, AIFA will have to consider the amounts already paid by the MA Holders in relation to the payback for 2013-2017 and the payments made related to agreements established between AIFA and the MA Holders in order to settle the disputes concerning the payback for 2013, 2014 and 2015 (pursuant to Article 1, section 390, of Italian Law no. 205 of 2017) which remain in force. For the purposes of this verification, AIFA may also use data provided by the Ministry of Economic and Financial Affairs and the regions involved, and the result of this verification will be published on AIFA’s website.

AIFA’s confirmation that the full sum indicated of € 2.378 million has been paid will be considered as satisfactorily fulfilling the obligations of each MA Holder for payback for the years 2013-2017 and will subsequently trigger, in accordance with the law, the termination of any legal disputes pending before the administrative courts concerning determining the payback amount for those years.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the Life Sciences-Healthcare industry.
Read more
Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and Venture Capital transactions.

October 6, 2023
CBD products: the Administrative Court suspended until October 24 the recent Decree of the Italian Ministry of Health listing cannabidiol for oral use among narcotic drugs, due to the lack o...
October 4, 2023
The Guidelines for regulating contractual relations between universities and research institutes and private sponsors were adopted by the relevant Italian Ministries following the amendment ...
September 21, 2023
CBS products: from September 20th, compositions for oral administration of cannabidiol obtained from Cannabis sativa extracts shall be considered as narcotic drugs in Italy, as they have bee...
July 27, 2023
Payback on medical devices: Italian government announces extension of payment deadline to October 30, 2023
July 21, 2023
On July 21, 2023, the Italian Ministry of Health published new guidelines on health advertising of self-medication drugs (OTC) and non-prescription drugs (SOP), including advertising on new ...
Search by...
Follow us on
Follow us on