From the Assogenerici public assembly, scheduled today in Rome, the president Enrique Häusermann launches the appeal for the union between sustainability and solidarity. Nine requests on Governance
Assogenerici – 18 September 2018 (Extract)
By 2023, patents will expire on drugs that will cost 3.1 billion euros a year; in the three-year period 2018 - 2020, with the arrival of equivalent drugs of various patent expiring molecules, savings will be achieved 
accumulated in excess of 800 million euros. While on the biological front, between 2018 and 2022 seven molecules (adalimumab, trastuzumab, bevacizumab, insulin lispro, ranibizumab, teriparatide, pegfilgrastim) will lose their patent protection, which today boast an annual market of around 1 billion euros.
“The decrease in pharmaceutical expenditure documented by AIFA data was obtained thanks to the fact that most of the drugs used every day at the expense of the NHS are medicines with expired patents. But to obtain an efficient market for these products, adequate political choices are needed, capable of encouraging supply and demand: it is necessary to act both on the mechanisms of competition - guaranteeing rapid access to the market - and on communication addressed to doctors and patients", underlined Häusermann, listing the nine requests of the sector for the Governance Table.
1. cross-compensation caps-funds, maintaining any surplus in the pharmaceutical expenditure chapter;
2. review of the payback with criteria of fairness and certainty (shelves by company market share;
innovative breakthrough and orphans to current rules);
3. reinvest in pharmaceuticals all the savings deriving from equivalents and biosimilars;
4. provide for the obligation to reopen the hospital tender at the advent of the first equivalent;
5. draw up tender specifications that guarantee predictability and sustainability of supplies
(anti-deficiency);
6. review the PHT, standardizing the list of drugs distributed directly and on behalf and excluding off-patent drugs normally used in territorial assistance;
7. eliminate the patent linkage;
8. simplify the authorization and negotiation procedures of generic medicines;
9. support the adoption of the SPC Waiwer, both for export and for storage, eliminating the restrictions currently envisaged in the EU Commission proposal.
“Our companies want to continue to fulfill their role as generator of resources that they have up to now. For this to happen, the Round Table for the reform of pharmaceutical governance set up by Health must also listen to the voice of the production system, without prejudice. Our hope – he concluded – is to be able to start an open discussion at that table on a multi-year stability pact based on the identification and sharing of sustainable public purchasing policies”.
Assogenerics is the official body representing the generics and biosimilars industry in Italy. Founded in 1993, today it represents 51 multinational companies and Italian companies located throughout the country, which produce both for the domestic market and for foreign markets, as well as companies engaged in the production of drugs on behalf of third parties for the entire pharmaceutical industry , for a total of 36 production sites and 11 thousand employees: the 40% production workers; the 91% indefinitely; the 47% women.
The associated companies - for 48% with Italian capital (32% EU; 20% non-EU) - are located in the regions of Northern Italy for 86%, generate a total turnover of 3.2 billion euros with an export incidence equal to 40% and make average annual investments of 100 million euro.
Italian generic drug market: January-June 2018 data
Editor's note: the 82% of the generics market consists of 5 companies (Teva, Mylan, Sandoz, Doc generics, EG).
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