Premium price on the price lists – Driving effect from the 2008 Budget THE RELAUNCH AIFA's announcement in the Official Gazette this week: frozen projects restart after last year's price cuts
A premium price of 100 million on drug price lists that could generate new investments in production and R&D of up to 1-1.2 billion euros by companies. It is with this bet that, two years after their only legislative birth, the program agreements between the Government and the pharmaceutical industries are about to take off.
After the decree at the end of October, in fact, the Board of Aifa (Medicine Agency) approved the tender last Thursday which dictates the rules for pharmaceutical companies to be able to access the incentives in the pipeline. The announcement, which will in all likelihood be published as early as next week in the "Official Gazette", will also be reported on the Aifa website (www.agenziafarmaco.it), where the list of companies that will ask for the incentives will then appear, therefore of those that will win it and the amount assigned.
Fruit of the strategy of the EU Council of Lisbon in 2000 and of that of Barcelona in 2002 (which recommends investments in R&D equal to 3% of the GDP by 2010, an all too ambitious goal for Italy today stuck at 1%), the program with the pharmaceutical industries were born by law with the 2006 Budget. Then, silence. Also because in the meantime, against the price cuts decided by the new government, companies had effectively blocked investment programs in our country quantified at around 1.5 billion.
At 70-80%, now, those programs should restart: a driving force, therefore, which is worth 1-1.2 billion. With all the precautions of the case. Sergio Dompé, president of Farmindustria, however, is not pessimistic: «It would be wrong to think that program contracts alone can relaunch pharmaceuticals. However, they are an important additional element that demonstrates the change in strategy and attitude towards the sector, together with the research incentives and IRES incentives, decided with the new Finance law».
In short, the combined provisions of the 2008 maneuver and program agreements could create a critical mass. Hence the government's decision to accelerate and that of AIFA to launch the tender for companies to access the 100 million premium price. Also because the times decided by the Agency to complete the operation are already at hand: presentation (electronic) by the end of March 2008 of the applications with the compilation of all the forms necessary for the evaluation, then by the end of June conclusion of the examination and compilation of the ranking by a special commission of already identified experts.
The investments to be evaluated move along four directions: development of clinical trials (phase I and II) which have the coordinating committee in Italy; opening or upgrading of production sites in Italy; opening or strengthening of research and development units; new permanent employment for both production and R&D.
The investments must concern drugs under development, authorized in Italy or intended for export. The incentives must not exceed 10% of the costs of the planned investments, and can be combined with other loans, if permitted by law. The duration of the program agreements will be 3 years, extendable by 12 months.
THE PROJECT
100 million
The resources (in euros) allocated to the premium price
3 years
The duration of the agreements
10%
Maximum ratio
on investments
31 March
The limit to submit
