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.
