Bulgaria Pharmaceuticals and Healthcare Report Q4 2009

Bulgaria's pharmaceutical market has transformed from the low-value, low-growth market of just a few years ago to one of the fastest-growing in Central and Eastern Europe (CEE). EU accession has helped boost sales of higher value products, while regulatory developments have added greater transparency to operating in the country. Through to 2013, BMI forecasts a compound annual growth rate (CAGR) of 9.1% for the Bulgarian pharmaceutical sales. Using BMI's new 10-year forecasting model, a slightly lower 6.9% CAGR is projected.

Despite strong growth indicators, Bulgaria ranks a lowly 14th among the 20 markets surveyed in CEE.

Low absolute market value and per-capita spending are a drag on the market score, as are projected devaluations against the US dollar which will limit returns for foreign drugmakers. Other prominent negatives in terms of operating in the country include low levels of reimbursement for many treatments, high levels of bureaucracy and poor legal framework. Nevertheless regulatory conditions are improving at a considerable pace.

In 2009 a new positive drug list was introduced, containing more than 1,350 products. However, full coverage remains restricted to a limited number of chronic diseases. Limited coverage is still a major problem in terms of pharmaceutical spending, with a number of high-price medicines removed from the most recent positive list released in June 2009. For example, one of the drugs was an epilepsy treatment that costs BGN260 (US$185.63) per month, a level unaffordable for many patients.

In August 2009 Simeon Djankov, Bulgaria's new finance minister, stated that the government plans to reduce spending by billions in 2009 to achieve a balanced budget. According to Djankov, cuts to healthcare spending could form part of the initiative. Already-high levels of out-of-pocket spending on medicines means any further cut-backs in reimbursement could have a major detrimental effect on higher price products.

During 2009, the number of medicines available without a prescription will increase by over 30%, according to the Bulgarian Drug Agency (BDA). Bulgaria can be considered overly conservative in the range of medicines authorised for sale without a prescription, although this should improve as the BDA updates product statuses in accordance with EU guidelines.

HIV/AIDS has been highlighted as a serious and growing problem in Bulgaria. Nearly 70 people were registered during H109 compared with 62 during the same period last year. Every week an average of three new HIV/AIDS-positive persons are registered. BMI's Burden of Disease Database (BoDD) estimates that the number of disability-adjusted life years (DALYs) lost to HIV/AIDS in Bulgaria was 1,905 in 2008.