Slovakia Pharmaceuticals and Healthcare Report Q1 2013
Business Monitor International, January 2013, Pages: 98
BMI View:
Slovak Prime Minister Robert Fico plans to unify the country's private and public health insurance funds into a single state-owned insurer, but there is likely to be a lengthy negotiation and a legal battle before this is realised. We do not expect either of the two private insurers - Dôvera or Dutchowned Union - will surrender their businesses without a fight, with Union in particular well-placed to oppose the move, potentially invoking EU law on protectionism. The outcome of this step towards a single insurer is broadly neutral for BMI's healthcare expenditure projections and is unlikely to have any meaningful impact until 2014 at the earliest, after which it would be negative for private healthcare providers.
Headline Expenditure Projections:
- Pharmaceuticals: EUR1.72bn (US$2.39bn) in 2011 to EUR1.65bn (US$2.10bn) in 2012; -3.8
%in local currency terms and -12.1% in US dollar terms. Local currency forecast broadly unchanged from Q412.
- Healthcare: EUR5.92bn (US$8.23bn) in 2011 to EUR6.03bn (US$7.65bn) in 2012; +1.7% in local currency terms and -7.0% in US dollar terms. Local currency forecast slightly lower from Q412, on account of new historical trends.
- Medical devices: EUR396mn (US$550mn) in 2011 to EUR396mn (US$503) in 2012; +0.2% in local currency terms and -8.4% in US dollar terms. Local currency forecast considerably lower from Q412, on account of new historical data.
Risk/Reward Rating:
In our latest Pharmaceutical Risk/Reward Rating (RRR) matrix assessing the 20 key markets in Emerging Europe, Slovakia remains in seventh position, with an unchanged composite score. We expect its risk profile to remain above average, supported by a pro-business operating environment, although risks are on the downside, considering authorities' move to unify healthcare insurance and improve labour conditions. In the meantime, rewards will continue to be depressed by factors including fiscal austerities and low population growth.
Key Trends And Developments
- As of the start of October 2012, the State Institute for Drug Control (SUKL) charges new fees list for marketing authorisations, variations, renewals and other procedures. Marketing authorisation holders will be able to generate variable symbols for their payments from the electronic application system. Charges now stand at EUR9,600 (US$12,525) for self-standing marketing authorisations of new products. For generic medicines or medicines with a wellestablished use, the government increased the fees to EUR8,000 (US$10,437).
- In August 2012, an analysis by the Institute for Economic and Social Reforms (INEKO) and Transparency International Slovakia (TIS) was reported to have found that the number of companies taking part in public tenders organised by hospitals in Slovakia were fewer than that in other industry sectors between January 2009 and March 2012. While hospital tenders attracted an average of just 1.7 bidders per tender during the period, three companies bid for public tenders in other sectors. Among reasons identified by the analysis for the small amount of bidders was announcing tenders for specific products that could only be delivered by one company. Other factors included late payments by hospitals, strong regulatory practices,
corruption, political issues and a segregated provider market.
BMI Economic View:
Economic activity slowed in Q312 according to flash estimates, with Slovakia's real GDP expanding by 2.2% year-on-year (y-o-y), from 2.6% y-o-y in the previous quarter. In quarteron-
quarter (q-o-q) terms, the economy expanded by 0.6% q-o-q. While a more detailed breakdown of economic growth has not been made available yet, we expect that growth was driven by external demand,
while household and government demand remained negligible contributors to economic activity. We hold to our end-2012 forecast for real GDP growth to reach 2.5%, falling to 2.0% of GDP in 2013. Over our 10-year forecast period, Slovak real GDP growth is forecast to average 2.9%.
BMI Political View:
The adoption of a number of revisions to Slovakia's labour market code designed to improve worker's rights poses both near- and long-term risks to the economy. From a short-term perspective, increasing labour market rigidity at time of slowing economic growth and rising payroll levies could prompt companies to begin laying off employees in anticipation of additional costs. From a long-term viewpoint, the reforms could reduce Slovakia's competitiveness, prompting foreign investors to seek new bases for manufacturing operations
Executive Summary 6
SWOT Analysis 8
Slovakia Pharmaceuticals Industry SWOT 8
Slovakia Political SWOT 9
Slovakia Economic SWOT 9
Slovakia Business Environment SWOT 9
Pharmaceutical Risk/Reward Ratings 11
Table: Central And Eastern Europe Pharmaceutical Risk/Rewards Ratings, Q113 11
Rewards 12
Risks 12
Slovakia - Market Summary 14
Regulatory Regime 15
Pharmaceutical Promotion and Advertising 16
Recent Regulatory Developments 17
Intellectual Property (IP) Regime 17
Pricing Regime 18
Table: Indexed Price Build-Up For Prescription And Non-Prescription Medicines In Slovakia 19
Reimbursement Regime 20
Pricing And Reimbursement Developments 21
Industry Trends And Developments 24
Epidemiology 24
Table: Main Causes Of Mortality And Morbidity In Slovakia 25
Communicable Diseases 25
Healthcare Sector 26
Recent Healthcare Sector Developments 27
Health Insurance 27
Private Health Insurance 29
Recent Health Insurance Developments 29
Research & Development 32
Biotechnology 32
Table: Members of BITCET, 2011 32
Table: Members SLOVBIOTECH, 2010 33
Clinical Trials 33
Medical Device Market 34
Table: EU Medical Devices Classifications 34
Industry Forecast Scenario 37
Pharmaceutical Market Forecast 37
Table: Pharmaceutical Sales, Historical Data and Forecasts 38
Healthcare Market Forecast 40
Table: Healthcare Expenditure Trends, Historical Data and Forecasts 41
Table: Government Healthcare Expenditure Trends, Historical Data and Forecasts 41
Table: Private Healthcare Expenditure Trends, Historical Data and Forecasts 42
Key Growth Factors - Macroeconomic 43
Table: Long-Term Macroeconomic Forecasts 44
Prescription Drug Market Forecast 45
Table: Leading OTC Medicines in Slovakia, by 2011 Volume- 46
Table: Prescription Drug Market Indicators, Historical Data and Forecasts 47
Patented Drug Market Forecast 48
Table: Patented Drug Market Indicators, Historical Data and Forecasts 49
Generic Drug Market Forecast 50
Table: Members of GENAS, 2011 52
Table: Generics Drug Market Indicators, Historical Data and Forecasts 52
OTC Medicine Market Forecast 53
Table: Leading Prescription Medicines in Slovakia, by 2011 Volume 54
Table: Over-The-Counter (OTC) Medicine Market Indicators, Historical Data and Forecasts 55
Table: OTC Medicine Sales Breakdown, 2004-2009 55
Pharmaceutical Trade Forecast 57
Table: Pharmaceutical Trade Data And Forecasts (US$mn) 58
Table: Slovakia Pharmaceutical Trade Data And Forecasts (EURmn) 58
Medical Device Market Forecast 59
Table: Slovakia Medical Device Market Indicators, Historical Data and Forecasts 60
Other Healthcare Data Forecasts 61
Key Risks To BMI's Forecast Scenario 63
Competitive Landscape 64
Pharmaceutical Industry 64
Table: Registered Pharmaceutical Manufacturers 64
Members of SAFS, 2011 65
Pharmaceutical Distribution 66
Table: ADL Members, 2011 (Manufacturers, unless otherwise indicated) 67
Pharmaceutical Retail 67
Company Profiles 71
Local Companies 71
Zentiva (Sanofi) 71
Biotika 74
HBM Pharma (formerly Hoechst-Biotika) 76
Imuna Pharma 78
Multinational Companies 80
GlaxoSmithKline 80
Sanofi 81
Pfizer 83
Novartis 85
Merck & Co 86
Roche 87
Demographic Outlook 88
Table: Population By Age Group, 1990-2020 ('000) 89
Table: Population By Age Group, 1990-2020 (% of total) 90
Table: Key Population Ratios, 1990-2020 91
Table: Rural/Urban Population Split, 1990-2020 91
Glossary 92
BMI Methodology 94
How We Generate Our Pharmaceutical Industry Forecasts 94
Pharmaceutical Risk/Reward Ratings Methodology 95
Ratings Overview 95
Table: Pharmaceutical Business Environment Indicators 96
Weighting 97
Table: Weighting Of Components 97
Sources 97
Company Profiles
Local Companies
Zentiva (Sanofi)
Biotika
HBM Pharma (formerly Hoechst-Biotika)
Imuna Pharma
Multinational Companies
GlaxoSmithKline
Sanofi
Pfizer
Novartis
Merck & Co
Roche
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