Analysis of the Italian generic medicines retail market: recommendations to enhance long-term sustainability

Abstract

Italy is among the European countries with the lowest uptake of generic medicines. This paper provides a perspective on the Italian generic medicines retail market. Fast market entrance of generic medicines in Italy is hindered by several factors: the existence of Complementary Protection Certificates in the past, the large market for copies and multiple cases of patent linkage. Prices of generic medicines in Italy are low compared to other European countries. To contain pharmaceutical expenditure, pharmaceutical companies are currently forced to pay back in case of overspending, which disproportionally penalizes small and fast growing companies, to which most generic companies belong to. Current demand-side policies do not successfully stimulate the use of generic medicines. The current market environment surrounding the Italian generic medicines retail market (i.e., low prices, low volumes) threatens its long-term sustainability. Recommendations to enhance the long-term sustainability of the Italian generic medicines retail market round off this perspective paper.

Keywords:

• demand-side policiy
• generic medicine
• Italy
• market access
• pharmaceutical
• pricing
• reimbursement

Acknowledgements

The authors would like to thank E Picavet, M Lanzilotto, S Vogler and V Lorenzi for critically reviewing the manuscript and providing feedback.

Financial & competing interests disclosure

S Simoens holds the EGA Chair ‘European policy towards generic medicines.’ The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• The use of generic medicines in Italy is low compared to other European countries.

• This paper aims to provide a perspective on the Italian generic medicines retail market and how the current policy environment may affect the long-term sustainability.

• The current regulatory framework in Italy does not support the development of a generic medicines market.

• Patent linkage (i.e., the practice of linking the patent status of the originator medicine to decisions on marketing authorization, pricing or reimbursement of generic medicines) has been a long-standing barrier for uptake of generic medicines in Italy and still remains a problem.

• The current payback system for pharmaceutical companies in the case of overspending of the pharmaceutical retail budget disproportionally targets generic medicine companies.

• The concentration on the prices of generic medicines in combination with the limited diffusion of generic medicines in Italy may threaten the long-term sustainability.

• There is a lack of effective demand-side policies in Italy targeted at physicians, pharmacists and patients.

• The Italian government must take action to ensure the long-term sustainability of the Italian generic medicines retail market. Recommendations to enhance the long-term sustainability of the Italian generic medicines retail market are suggested at the end of this perspective paper.

Notes