The mechanism of payback was introduced the first time in Italy with the Financial Law 2007 and allows the provision of economic resources to the Italian Regions to support the pharmaceutical expenditure. It also consents the containment and control of consumes of the pharmaceutical expenditure in Italy.
The mechanism of payback was used in several occasions during the years. Below there are reported some of the most relevant for pharmaceutical industries:
Payback 5% Law 27 December 2006, n 296, art 1, comma 796, letter g (Financial Law 2007)
The AIFA Determination n. 26 of 27 September 2006 foresees a 5% reduction on the public price including VAT of medicinal products reimbursed by the NHS. The mechanism of this payback in this case is used to allow to pharmaceutical companies to ask AIFA for the suspension of the 5% reduction on their medicinal products, in return to the payment to the Italian Regions of the amount equivalent to this reduction. This mechanism allows companies to make choices on the prices of their medicinal products based on the marketing strategies decided and planned by the companies itself.
Recently, AIFA has proposed to include in the next Balancing Law, the exclusion of this payback both for a administrative simplification and for a lack of economic advantages for the NHS.
Retail Payback (or Payback 1,83%)
The payback 1.83% was introduced according to art. 11, comma 6 of the Legislative Decree 78/2010, amended with modifications in the Law of 30 July 2010, n. 122 and further amended according to art. 2, comma 12-septis of the Legislative Decree of 29 December 2010 n. 225, converted into Law of 26 February 2011 n. 10.
This payback foresees the payment to the Italian Regions of the amounts correspondent to 1,83% of the public price of their medicinal products provided by the NHS, sold through the retail channel.
The amounts should be paid by pharmaceutical companies to the Italian Regions in two half-yearly instalments (the first amounts relating to the period 1 January – 30 June and the second amounts relating to the period 1 July to 31 December).
Payback Law 222/2007 and Law 135/2012 (Balancing of the Pharmaceutical Expense):
This last payback foresees the balancing of the overcome of the pharmaceutical expense from the MA Holders of medicinal products reimbursed by the NHS. Initially this mechanism was introduced for the balancing of the only territorial pharmaceutical expense (art. 5 of the Legislative Decree 159/2007, following converted into Law 222/2007) and later it was extended to the hospital pharmaceutical expense (art. 15, comma 8, of the Legislative Decree 95/2012 converted into Law 135/2012).
The hospital pharmaceutical expense was then modified with the Law of 11 December 2006 n. 232 (Balancing Law 2017) by including also the medicinal products in class A sold through direct distribution. This led to the redefinition of the hospital pharmaceutical expense in “direct purchase pharmaceutical expense”.
The mechanism foresees that, in case of the overcome of the cap of the national pharmaceutical expense, pharmaceutical companies should balance this overcome through the payment to the Italian Regions of amounts determined by AIFA for each company.
Initially this mechanism foresaw the overcome of the expense by the pharmaceutical companies proportionally to the overcome of the cap of the company budgets assigned by AIFA. However, with the new Balancing Law of 2019, the contribution of each company is not anymore calculated based on company budget assigned by AIFA, but has switch to a market-share calculation. This has determined a simplification of the entire process.
Written by: Flavia Selvaggio