Spain Pharmaceuticals and Healthcare Report Q4 2009

In BMI’s Business Environment Ratings for Q409, Spain remains placed fourth out of the nine Western European Markets surveyed. Spain’s large and generously subsidised drug market, low generic penetration, ageing population and stable economic and political system mean that it scores highly compared with its regional neighbours. Relative weaknesses are slow population growth, bureaucratic processes, as well as low pharmaceutical prices that encourage parallel trade. Nevertheless, we forecast that the Spanish pharmaceuticals market – which is ranked among the top five in Europe and the top 10 in the world by value – will increase by a compound annual growth rate (CAGR) of 4.32% between 2008 and 2013, rising from EUR15.3bn (US$21.8mn) to EUR18.9bn (US$23.9mn). While the generic market remains considerably less developed than those of its European Union (EU) peers, industry players, led by the Spanish Association of Generic Drugs (AESEG), have been calling for a unified approach to generics. According to the association, the increased use of generics could potentially save EUR6.8bn in drugs expenditure over the next decade.

Measures could include the elimination of co-payments on generics, prescription control and mandatory generic dispensing. Presently, each of the 17 autonomous regions in Spain operates their own policies regarding pharmaceutical reimbursement and dispensing. AESEG has additionally called for a change in Spain’s reference pricing system, believing that the downward pressure on the cost of medicines has slowed the development of the non-patented drugs market. This view is mirrored by the Spain’s National Pharmacists’ Association (FEFE), which recently called for a better generic medicine’s policy, criticising measures that constantly lowered the price of medicines for also eroding the role of generics. There has been a notable increase in clinical trial activities and funding in Spain in recent years, despite a complex and bureaucratic operating environment.

Most recently, in July 2009, the Spanish Ministry of Health created a new office to improve the situation by acting as a middleman between the Spanish regulatory agency and researchers and sponsors. Around the same time, the Spanish government, and a local drugmaker signed a deal with US-based Novavax to license its vaccine production technology and construct the country’s first vaccine manufacturing plant. The vaccines plant, which will have the capacity to produce 15mn doses of seasonal flu vaccine per year, should commence exports by 2012. As in other developed countries, cardiovascular and cerebrovascular diseases and cancer are some of the leading causes of mortality and morbidity in Spain, with diabetes also an issue. However, according to a study sponsored by Pfizer, which surveyed 9,955 patients from Spain and a number of other global markets, including Canada and France, the percentage of patients who have lowered their low-density lipoprotein LDL (bad) cholesterol almost doubled over the last decade. The survey, published in June 2009, concluded that lipid-lowering therapy has become considerably more successful than in the previous decade. Specifically, the number of patients successfully reaching target LDL cholesterol levels rose from 38% to 73% overall, with Spain recording a level of 47%.