First posted: 18 May 2012
The Italian generic medicine market is small in comparison to the medicine market as a whole. Policy measures to stimulate the generic medicine market in the early 2000s appear to have had limited impact on the generic medicine market share. Market share of generic medicines has grown slowly, but continuously, from 0.9% in 1994 to 11.7% in 2010 in terms of value and from 1.4% in 1994 to 5.8% in 2010 in terms of volume (prescriptions) [1-2].
Sources: 1994–2004 , 2005–2010 .
Italy employs a range of pricing and reimbursement tools, including reference pricing, to control costs. As a result, drug prices in Italy are among the lowest in Europe .
The Italian market has not been very receptive to generics in the past, which explains the low volume of generics .
Most generic medicines in Italy are marketed by a branded-generic name .
International non-proprietary name (INN) prescribing for physicians is indicative and physicians do not have prescription volume targets or budgets for generics .
Generics substitution is allowed but not obligatory for pharmacists .
Growth of the Italian generics market is constrained by low economic growth, cost containment measures for reimbursable products and reference pricing .
However, the combination of high profile drugs losing patent protection and the need to reduce costs should provide a boost to the generics market. In addition to the blockbusters that have lost patent protection in Italy in the last couple of years, a large number of medicines will lose their national supplementary certificates during 2010 .
Highlights of the generics market in Italy
- Market share of generic medicines by prescription is 11.7%, accounting for 5.8% in value .
- The Italian Medicines Agency (AIFA) recommends, for clinical reasons, that no substitution of biologics takes place .
- Information campaigns were run in 2001 and 2005 to raise patient awareness of generics, however, effectiveness was not reported .
1. Simoens S, De Coster S. Sustaining Generic Medicines Markets in Europe. April 2006. [monograph on the Internet]. Brussels, Belgium, European Generic medicines Association (EGA) [cited 2012 May 11]. Available from: www.egagenerics.com/doc/simoens-report_2006-04.pdf
2. Assogenerici. Il Farmaco Generico: Numeri e Dimensioni Agoiornamento Giugno 2010 [The Generic Drug: Numbers and Dimensions June 2010] [page on the Internet]. Italy, Assogenerica [cited 2012 May 11]. Italian. Available from: www.assogenerici.org/articolihome/cs/AGGIORNAMENTO_DATI_ANNO_1°_SEMESTRE_2010.pdf
3. Aarkstore. Italy Pharmaceutical Market Overview Generic penetration set to rise. 1 December 2010.
4. Pisani J, Bonduelle Y. Opportunities and barriers in the biosimilar market: Evolution or revolution for generics companies? 2006.
5. Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Rational use of medicines in Europe. February 2010.
6. Espicom. Italy - Will the Italian generics market catch up with its European neighbours? 17 May 2010.
7. Horton LR, The European Experience With Follow-on Biologics Legislation. 21 November 2008.