The Italian Medicines Agency, through a monitoring activity conducted by the HTA & Pharmaceutical Economics Department, publishes the second report on the effects of the simplified procedures for negotiating generic and parallel import medicines, which were introduced during 2020 and 2021.

The "Simplified price and reimbursement procedure for equivalent/biosimilar medicines" was introduced in October 2020. To date, the impact of this procedure is as follows:

• a 32% increase in the number of procedures submitted in 2022 compared to 2020 and a respective reduction in median approval times of 50%: 194 procedures were evaluated in 119 median days in 2020, while 257 procedures were evaluated in 2022 in 60 median days;
• the simplified procedure continues to be preferred by pharmaceutical companies, compared to the regular procedure: in 2022, 85% of generic procedures were conducted under this simplified negotiation and approved in 56 median days, compared to 92 median approval days in 2021;
• the reduction is observed not only on medians (equal to 50%), but also on other indices: from 2020 to 2022, the approval time of these procedures in terms of average and mode decreased by 31% and 26%, respectively, and the variability (width of the IQR) also decreased over time by 22%.

Da marzo 2021 è stata introdotta la “Procedura semplificata di negoziazione del prezzo e di rimborso dei farmaci di importazione parallela”. Ciò ha permesso la riapertura del mercato delle importazioni parallele di medicinali e ha consentito di valutare 111 procedure semplificate in 44 giorni mediani nel 2021 e 104 procedure semplificate in 38 giorni mediani nel 2022.

The "Simplified price negotiation and reimbursement procedure for parallel imported medicines" was introduced in March 2021. This allowed the reopening of the market for parallel imports of medicines and made it possible to evaluate 111 simplified procedures in 44 median days in 2021 and 104 simplified procedures in 38 median days in 2022.

The positive impacts on the National Health Service persist also in 2022:

• the reduction in approval times translates into an economic advantage for the National Health Service;
• the reduction in negotiation times has made it possible to increase the availability of medicines in each therapeutic area, thus favouring greater competition and greater availability of alternatives;
• the presence of parallel imported medicines is also an opportunity to reduce the cost-sharing fee charged to citizens.