The Italian pharmaceutical industry has witnessed several major developments in the last few months, including another set of price cuts, the falsified dossier scandal and plans to further liberalise the over-the-counter (OTC) sector, according to the recently published Italy Pharmaceuticals & Healthcare Report Q406.

As such, we are maintaining its projections for Italy’s drugs market, which is currently valued at approximately US$30bn and expected to reach US$36.6bn by 2010.

By Western European standards, Italy is perceived to be a corrupt country, placing 22nd out of 28 countries in the region, according to Transparency International’s 2006 Corruption Perceptions Index.

The index covers all industries, and it appears that the country’s healthcare sector had significant weighting in the scoreboard. In July 2006, Italy’s largest pharmaceutical company, Recordati, lost more than 10% of its market valuation and had trading in its shares temporarily suspended after it emerged that three of its senior executives had been arrested on bribery charges. Italy is trying to rein in healthcare spending, which is exacerbated by rising pharmaceutical costs. Spending on drugs in the Italian health service rose by 9.2% in the first eight months of 2006 compared to the same period in the previous year, according to the Italian Medicines Agency (Agenzia Italiana del Farmaco, or AIFA). The increase was mainly due to the introduction of a number of innovative, and therefore expensive, products to the Prontuario reimbursement list.

During Q406, Italian investigators were trying to determine whether generic pharmaceutical products had been authorised for marketing on the basis of falsified dossiers. AIFA asked that generics companies submit full details of bioequivalence studies for every formulation of every generic product, both those on the market and those awaiting approval, by mid-September. Subsequently, AIFA intended to revoke the marketing authorisations of 11 generic products after uncovering irregularities in their dossiers.

The Italian senate was debating legislation passed by the lower house in Q306 to further liberalise the OTC sector as part of discussions aimed at agreeing upon the country’s budget for 2007. It is understood that the proposed changes will result in lower prices, thereby benefiting consumers directly. Retailers are also set to gain through increased sales volumes as Italians up their intake of non-prescription medicines. Accordingly, we expect the value of the OTC sector to reach US$5.2bn by 2010.