April 9, 2021

Parallel import of medicines: New simplified AIFA procedure for negotiating price and reimbursement

Thanks to Giulia Conforto for collaborating on this article

On March 25, 2020, the Italian Agency of Medicines (Agenzia Italiana del Farmaco – “AIFA”) published a resolution on the simplified procedure for negotiating the price and reimbursement of parallel imported medicines (Directorial Determination No. 357/2021).

According to the AIFA, the new procedure pursues cost savings in Italy for this category of medicines in an innovative way with the introduction of possible automatic steps in the setting of prices and a drastic reduction in the timeframe for completing the reimbursement procedure.

The negotiation procedure

An importing company that intends to employ the simplified negotiation procedure must submit to the appropriate AIFA offices (HTA and Drug Economics Sector) a dossier for the relevant medicine with a price proposal that provides for a reduction of at least 7% compared to the price to the public of the corresponding product already marketed in Italy.

After administrative verification of the documentation submitted, AIFA communicates to the applicant the start date for the procedure and any additional negotiating conditions required to complete the procedure.

If all the negotiation conditions from the importing company are accepted, the procedure is then submitted to the AIFA board of directors for approval, followed by the adoption of the relative determination.

In specific cases, such as, for example, those in which a monitoring register or conditional access to the market (MEA) must be implemented, the HTA and Drug Economics Sector can submit the procedure in advance to the AIFA advisory committees (CTS and CPR).

For medicines on transparency lists, the suggested price reduction may not lead to a price for the public that is lower than the relevant reference price.

In the event of failure to propose a price that reflects a reduction of at least 7% compared to the public price of the corresponding product already marketed in Italy or in line with the reference price, the simplified procedure does not apply and ordinary negotiations take place.

The first OsMed Report on the Parallel Import and Export of Medicines, a value of 450 million euros

The new procedure was discussed during the presentation of the first OsMed Report on the Parallel Import and Export of Medicines for Human Use on March 30, 2021.

After the presentation, the AIFA published the OsMed Report on the Parallel Import and Export of Medicines for Human Use, which is the first report on the subject produced by the AIFA.

The publication thoroughly examines a topic that experienced significant growth in the three years 2016—2018, a period when spending on products imported via parallel import amounted to 450 million euros. Of these, 41.4% were public expenditures and 58.5% private expenditures, for a total of 51 million packages.

The national parallel import market is mainly made up of medicines purchased directly by citizens (58.5%) with a high presence of class-C medicines and only 41.5% of medicines reimbursed by the National Health Service (NHS).

The flow of exports, investigated in the last part of the report, is of particular interest for our country, since Italy has historically been a country with a high production capacity for the export of medicines, due to both economic and structural factors. In the three years 2016–2018, 90 million packages of medicines were exported, with a potential value of over 2.2 billion euros (based on the price typically charged to the NHS in Italy for these medicines).

In addition to seeking to make optimal use of the data and to optimize the integration of the information gathered from various available sources, this report is designed to serve as a useful tool for identifying and planning any further areas of intervention within the framework of existing health policies.

< Back to blog
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and 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.

March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
Search by...
Follow us on
Follow us on