The Italian Medicines Agency presented the first OsMed Report on the parallel import and export of medicines for human use.

The publication examines in an organic way a topic that has experienced significant growth in the three-year period 2016-2018, a period in which spending on products imported via parallel import was 450 million euros. 41.4% concerned approved expenditure and 58.5% private expenditure, for a total of 51 million packs.

“The overview of the policies undertaken at the international level is of interest for a broader reflection on the positioning of Italy compared to other countries” said the Director of the Agency Nicola Magrini. “Italy - he stressed - represents a market that is still young compared, for example, to Germany and the United Kingdom, but the international set-up is evolving due to both ongoing regulatory and geopolitical changes. Data collected on consumption and expenditure can therefore represent an exceptional opportunity for the efficient management of healthcare spending. It is important to know more and more and, thanks to this Report, data on how all medicines are imported and used will be brought to light”.

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 NHS.

“This phenomenon – as pointed out by Nicola Magrini - mainly concerns class C medicines, generally considered non-essential in terms of expenditure; however, we believe that they should be monitored with some attention. Even when the medicines are charged to the citizen, they should still be carefully monitored because the out of pocket represents a collective responsibility”.

In the three-year period 2016-2018, 90 million packages of medicines were exported with a possible value of over 2.2 billion euros (considering the price usually charged to the NHS in Italy for these medicines).

“That of parallel imports is an important, expanding sector on which we have begun to work to make the most of the data available to the Agency. The parallel trade market is relatively small, also because the flow of exports has never been studied. That is why we have decided to use all the tools available to see what we export and to which countries. We expect that making the data available will improve the quality of the analyses for the next few years”, said Francesco Trotta, Director of the HTA & Pharmaceutical Economy Division of the Italian Medicines Agency.

AIFA, in accordance with the most recent legislation, has adopted the simplified procedure for negotiating the price and reimbursement of medicines authorised with a parallel import procedure. This means that the company that intends to make use of the simplified procedure will have to make 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 (whether it is a so-called originator medicine or an equivalent/biosimilar).

“The dynamics of the market should be known and can be regulated: the simplified procedure determination goes precisely in this direction. The introduction of a regulatory mechanism like this will also help us to better understand how the pharmaceutical market moves internationally. These new tools of knowledge and intervention will also help us to orient supply and demand in a perspective of public interest” concluded Luca Arnaudo, Italian Medicines Agency.

The presentation was moderated by Giuseppe Traversa (AIFA) and the discussion was attended by Mauro De Rosa (University of Eastern Piedmont), Ernest Kasper (Affordable Medicines Europe) and, for AIFA, Francesco Trotta, Antonio Galluccio, Silvia Miriam Cammarata, Domenico Di Giorgio, Emanuela Pieroni and Luca Arnaudo.

The video of the conference is available at the following link: https://youtu.be/btWEwchYg-0

The Report is available on the institutional website of AIFA.

Published on: 30 March 2021