Spain’s drug regulator reports that 17% more new drug products were registered last year than in 2009, and that 72% of these were generics.
In its annual report for 2010, the national agency for drugs and medical devices, the AEMPS, reveals that it authorised 1,629 generic drugs during 2010, compared with just 315 innovator products. These results follow a trend of steadily-rising numbers of authorisations, led by generics, since 2006, when 930 generics were approved compared to just 285 innovator products. In 2007 the numbers of drug products registered totaled 1,176 generics and 559 innovators, while for 2008 the figures were 1,423 and 599 respectively, and in 2009 they were 1,214 and 360, respectively.
The largest number of authorisations last year by therapeutic category were for central nervous system treatments which, with 372 registrations, accounted for 27.25% of the total. Next were: cardiovascular products – 313, or just under 23%; oncology – 143, 10.48%; gastrointestinal and metabolic – 143, 10.48%; infectious diseases – 108, 7.91%; genitourinary – 64, 4.7%; blood – 60, 4.4%; respiratory – 56, 4.1%; muscular – 39, 2.86%; hormones – 16, 1.17%; sensory organs – 15, 1.1%; dermatologicals – 14, 1.03%: and others – 23, 1.69%.
These figures reflect moves by national and local governments in Spain to boost the use of generics, which account for just 14% of the domestic market by volume, a much lower share than elsewhere in Europe, where the average is 35%-45%, and accounts for the fact that pharmaceuticals represent a relatively high 20.5% of Spain’s total national health care spending.
Analysts at IHS Global Insight point out while the trend in authorisations reported by the AEMPS is positive for generic drugmakers, the scenario must be viewed with caution, given the continued existence in Spain of a number of factors that slow market penetration by generics, including the current internal reference price system, which the generics industry regards as a major setback.
• Earlier this year, Business Monitor International (BMI) estimated that the value of the Spanish pharmaceutical market had fallen from 16.59 billion euros ($23.22 billion) in 2009 to 15.61 billion euros ($20.75 billion) in 2010, a decline of 5.9% in local currency terms and 10.6% in US$ terms, and largely as a result of price cuts. To 2014, the firm expects the market to decline by an average of 1.73% a year in local currency terms, falling to a value of 15.20 billion euros by 2014.
