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Bulgaria Pharmaceuticals and Healthcare Report Q4 2012

Business Monitor International, September 2012, Pages: 86

The Bulgaria Pharmaceuticals and Healthcare Report provides industry professionals and strategists, corporate analysts, pharmaceutical associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on Bulgaria's pharmaceuticals and healthcare industry.

Executive Summary BMI View: The Commission on Protection of Competition (CPC)’s criticism of the National Health Insurance Fund (NHIF)’s pricing rules is unlikely to discourage the fund from pursuing price reductions for medicines. As BMI has been highlighting since February, Bulgarian drug prices will be under considerable pressure in 2012 and 2013 as the strongly politically supported new minister of health and head of and the NHIF implement and plan for more aggressive mechanisms for cutting drug prices.

Headline Expenditure Projections

- Pharmaceuticals: BGN2.10bn (US$1.49bn) in 2011 to BGN2.23bn (US$1.44bn) in 2012;
+6.1% in local currency terms and -3.3% in US dollar terms.

- Healthcare: BGN5.12bn (US$3.64bn) in 2011 to BGN5.22bn (US$3.38bn) in 2012; +1.9% in local currency terms and -7.1% in US dollar terms.

- Medical Devices: BGN281mn (US$200mn) in 2011 to BGN285mn (US$185mn) in 2012;
+1.7% in local currency terms and -7.4% in US dollar terms.

Risk/Reward Ratings:
Bulgaria is ninth out of the 20 markets surveyed in the region, with the country’s score standing at 52 out of 100. The score takes into account the challenges for drugmakers operating in Bulgaria such as the price pressure on drugs, in addition to positive factors such as the increasing per capita consumption of medicines.

Key Trends And Developments:

- In August 2012, the government’s proposal to introduce a ceiling on the cost of generic drugs reimbursed by the state of 65% of the price of the innovative drug attracted strong opposition from the Bulgarian Generic Pharmaceutical Manufacturers’ Association (BGPharmA). The association, which comprises 18 Bulgarian and international generic drug companies, fears this measure will allow Rx medicine manufacturers to drive their generic drug competitors out of the market. BGPharmA said Rx medicine manufacturers will significantly reduce the prices of original drugs just before the expiry of their patents. In such a scenario, generic drugs would be available at prices lower than their cost price.

- The salaries of medical staff in Bulgaria will increase after they signed a collective labour contract, said Minister of Health Desislava Atanasova in July 2012. Salaries will increase by about 20% on an average, with the biggest hike being for new nurses. Healthcare employees working night shifts will also benefit a lot from the salary hike, said Atanasova.

BMI Economic View:

A more pronounced weakness in external demand for Bulgarian exports and a larger concomitant slowdown in domestic demand, as export-intensive industrial activity slows, mean we have revised down our 2012 and 2013 real GDP growth forecasts to -0.1% and 1.6% respectively, from 0.6% and 1.9%. The domestic banking sector’s exposure to peripheral eurozone banks will restrict credit growth and continues to pose major downside risks to economic growth.

BMI Political View:
We expect Bulgaria to gradually improve its weak political risk profile over the next decade. The country scores poorly in BMI’s political risk ratings in comparison to other major emerging European economies. EU conditionality will be a major driver of the improvements.

Executive Summary 5

SWOT Analysis 7

Bulgaria Pharmaceuticals And Healthcare SWOT 7

Bulgaria Political SWOT 8

Bulgaria Economic SWOT 8

Bulgaria Business Environment SWOT 9

Pharmaceutical Risk/Reward Ratings 10
Table: Central And Eastern Europe Pharmaceutical Risk/Reward Ratings, Q412 10

Rewards 11

Risks 11

Bulgaria – Market Summary 13

Regulatory Regime 15

Pricing Regime 16

Drug Policy Amendments Passed In 2011 17

Drug Policy Amendments For 2012 18

Legislative Changes To Drug Policy In 2013 And Beyond 19

Drug Price Inflation 20

Reimbursement Regime 20

Reimbursement Regime Developments 22

Intellectual Property Environment 23

Trademark Disputes 24

Pharmaceutical Advertising 24

Industry Developments 26

Epidemiology 26
Table: Main Causes Of Death In Bulgaria (per 100,000 population) 26

Healthcare Sector 27

Healthcare Reform Through To 2020 28

Healthcare Financing 30
Table: NHIF Budget 31

Research & Development 32

Clinical Trials 32

Medical Devices 33
Table: Classification Of Medical Devices In The EU 33

Industry Forecast Scenario 34

Pharmaceutical Market Forecast 34
Table: Pharmaceutical Sales, 2008-2016 35

Key Growth Factors – Industry 37
Table: Healthcare Expenditure, 2008-2016 38
Table: Government Healthcare Expenditure, 2008-2016 39
Table: Private Healthcare Expenditure, 2008-2016 39

Macroeconomic Forecast Scenario 40
Table: Bulgaria Economic Activity, 2011-2016 44

Prescription Drug Market Forecast 46

Bulgaria Pharmaceuticals & Healthcare Report Q4 2012

© Business Monitor International Ltd

Page 4
Table: Prescription Drug Sales, 2008-2016 47

Patented Drug Market Forecast 48
Table: Patented Drug Sales, 2008-2016 49

Generic Drug Market Forecast 50
Table: Generic Drug Sales, 2008-2016 51

OTC Medicine Market Forecast 52
Table: OTC Medicine Sales, 2008-2016 53

Medical Device Market Forecast 54
Table: Medical Device Sales, 2008-2016 55

Pharmaceutical Trade Forecast 56
Table: Pharmaceutical Trade, 2008-2016 57

Key Risks To our Forecast Scenario 58

Competitive Landscape 59

Pharmaceutical Industry 59

Company Activities 59

Wholesale Sector 61

Retail Sector 61
Table: Pharmaceutical Wholesale And Retail Market, 2007-2010 62

Company Profiles 63

Local Companies 63

Sopharma 63

Biovet 66

Actavis Bulgaria 68

Multinational Companies 70

GlaxoSmithKline 70

Novartis 71

Sanofi 72

Pfizer 74

Merck & Co 75
Table: Population By Age Group, 1990-2020 (‘000) 77
Table: Population By Age Group, 1990-2020 (% of total) 78
Table: Key Population Ratios, 1990-2020 79
Table: Rural/Urban Population Split, 1990-2020 79

Glossary 80

BMI Methodology 82

How We Generate Our Pharmaceutical Industry Forecasts 82

Pharmaceutical Risk/Reward Ratings Methodology 83

Ratings Overview 83
Table: Pharmaceutical Risk/Reward Indicators 84

Weighting 85
Table: Weighting Of Components 85

Sources 85

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