IHS Global Insight Perspective | |
Significance | The AIFA has completed a restructuring process, and its new structure will come into effect from 1 October 2009; it has also announced that to date in 2009, it has reduced delays in registration procedures and other activities. |
Implications | The increased efficiency of AIFA is likely to be good news for the pharmaceutical sector on one level, as it will mean a reduction in the time it takes to launch a drug on the Italian market. |
Outlook | The creation of an enhanced department with responsibility for pricing and reimbursement and international price comparison within AIFA is most likely to be connected with the current drive to reduce pharmaceutical expenditure, in view of the current unfavourable economic conditions in Italy. |
The AIFA has announced the completion of its restructuring programme and the launch of the newly structured agency on 1 October. Under the restructuring programme, a number of new activity areas have been created, intended to provide a more functional division of competences, in order that the agency will be better able to ensure the safety and health of Italian citizens.
Main Points of New AIFA Structure |
|
Source: AIFA |
AIFA Hails Improvements in Efficiency
At the same time as announcing its new structure, AIFA has released information concerning its own activities, stating that in the current year it has processed all of the applications it received for drugs under both the national and mutual recognition procedures. It also cleared 26% of the backlog of mutual recognition procedure applications, according to its own press release.
Additionally, AIFA stated that it has cleared the backlog of applications for Certificates of Free Sale, which are required for Italian pharmaceutical producers to export medicines. The time it takes for these certificates to be issued has been reduced significantly, from 7 months to 15 days, according to Italian health news website Salute Europa.
AIFA also states in its press release that it has improved security systems and enhanced its pharmacovigilance capabilities, with particular reference to vaccines and medicines related to the A/H1N1 influenza (swine flu) pandemic.
Greater Say for Italian Regions
A new role of Area Co-Ordinator has been created by AIFA; the area co-ordinators will form an executive committee, which AIFA believes will result in a decentralisation of power in the regulation of the pharmaceutical industry in Italy. This is something that has been a problem in the past, according to the agency.
Outlook and Implications
With 50% of Italy's pharmaceuticals being exported, it is important for the backlog in the administrative procedures relating to exports to be cleared, particularly at a time of economic difficulty. Taken on face value, AIFA's increased efficiency is very good news for the pharmaceutical industry as a whole, as it could mean shorter delays in getting drugs on to the market. The changes in the structure of the agency appear to be sensible, and the merging of related activities could further enhance the agency's efficiency.
The creation of a new layer of regional responsibility in the form of area co-ordinators is a further development of AIFA's push to give more responsibility to the Italian regions in pharmaceutical policy, which is part of the regionalisation of the Italian healthcare system as a whole. Regional officers already sit on AIFA's Committee for Pricing and Reimbursement, and the appointment of area co-ordinators may help to increase the efficiency of the agency's activities across Italy.
However, the creation of an enhanced department to deal with pricing and reimbursement, drug consumption monitoring, and the comparison of prices in Italy with those in other countries appears to be designed to help ensure cost containment in pharmaceutical expenditure, with Italy's economy in recession and the Ministry of Health strongly focused on the promotion of generics as a means of keeping drug reimbursement expenditure down.