The Director General Luca Pani spoke at the hearing in the Hygiene and Health Commission of the Senate, in relation to the "Sustainability of the national health service with particular reference to the guarantee of the principles of universality, solidarity and equity" and provided information on the subject of regional variability of pharmaceutical consumption under conventional regimes, also in relation to aspects linked to regional therapeutic handbooks, therapeutic diagnostic pathways and procurement tenders.
On the specific point of the discrepancy in access to medicines on a regional basis, he underlined how the regions repeat the assessment relating to the relationship between risk and benefit, already carried out at European and national level by AIFA, with a consequent dilation of the times to insert a product in their specific therapeutic handbook.
Above all, he clarified that the institutional tasks of AIFA include not only the assessment of the relationship between risk and benefit, but also that relating to the relationship between benefit and price, with respect to which the Agency has developed innovative methodologies that constitute a point of reference at European level.
With regard to the remuneration of the drug distribution chain, which according to current legislation must find its source of regulation in an Agreement between AIFA and the most representative trade associations, Pani illustrated the contents of a draft Agreement dated 16 October 2012, according to which the remuneration of pharmacists should be divided into three items, while that of wholesalers should consist of two constituent elements.
For both categories there is a fixed remuneration quota and a proportional remuneration quota; for pharmacists alone, he then explained, an additional quota of a rewarding nature is envisaged relating to generic drugs, or those with patent expired with a retail price corresponding to the reference price set by AIFA.
During the previous hearing, among the various topics addressed, he provided elements of knowledge relating to the size of the regulatory agencies and the reference operating context and underlined how in Italy pharmaceutical production represents 1.6% of GDP, based on data from the European Medicines Agency (EMA) referring to 2012.
He then placed the emphasis on the distribution of European experts operating in the reference sector, highlighting how, compared to a number of 3533 experts for the year 2012, 191 were those expressed by Italy.
During the last hearing, on the subject of funding methods for the Agencies and from a comparative point of view, he explained how in Italy there is a tripartite source of resources: the majority comes from tariffs, the minority comes from the State and, lastly, also from other types of financing. This tripartition is present only in Italy, France and the United Kingdom.
With regard to the trend of the Agency's income statement, Pani then highlighted how operational management has gone from negative results, in the two-year period 2007-2008, to ever increasing positive values.
The General Manager had also pointed out the constant growth, starting from 2005, in the number of reports through the network, with re
