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Poland Pharmaceuticals and Healthcare Report Q3 2012

Business Monitor International, June 2012, Pages: 104

The Poland 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 Poland's pharmaceuticals and healthcare industry.

BMI View: Despite numerous challenges, we continue to believe Poland is the most attractive pharmaceutical market in Central and Eastern Europe (CEE). While the long-awaited Drug Reimbursement Act introduced in Q112 faced fierce opposition from the public and members of the healthcare profession, and also resulted in volatility of pharmaceutical spending, we maintain our view of positive growth for 2012, projecting 1.6% year-on-year (y-o-y) expansion. Headline Expenditure Projections

- Pharmaceuticals: PLN33.37bn (US$11.26bn) in 2011 to PLN33.91bn (US$10.72bn) in 2012; +1.6% in local currency terms and -4.8% in US dollar terms. Local currency forecast unchanged since Q212.

- Healthcare: PLN111.08bn (US$37.51bn) in 2011 to PLN117.00bn (US$36.99bn) in 2012; +5.2% in local currency terms and -1.4% in US dollar terms. Local currency forecast slightly higher since Q212 because of new historical data.

- Medical devices: PLN6.60bn (US$2.23bn) in 2011 to PLN6.85bn (US$2.16bn) in 2012; +3.8% in local currency terms and -2.7% in US dollar terms. Local currency forecast broadly unchanged since Q212.

Risk/Reward Rating: While Poland retains its top spot in our Q312 Pharmaceutical Risk/Reward Ratings (RRRs) assessment of the CEE region, its composite score fell by 2.3% quarter-on-quarter. Poland’s pharmaceutical market growth is facing significant challenges in the coming months, largely because of the Drug Reimbursement Act, though we continue to view the country as a regional outperformer over the longer term, supported by large and growing population and healthcare provision improvements. Globally, Poland is 14th out of the 95 markets surveyed in our quarterly assessments, below the Netherlands and above China.

Key Trends And Developments
- In March 2012, Bayer released plans to build a financial and accounting centre for CEE in the Tri-City region of Poland (the three close coastal cities of Gdansk, Gdynia and Sopot). Hiring for the centre, which Bayer aims to complete within 2012, is expected to generate more than 200 jobs. The opening of the regional headquarters is part of Bayer’s strategy that also includes establishing joint-service centres in China and the Philippines and an international accounting office in Leverkusen, Germany.

- The need to contain costs has led to calls by the Polish Federation of Hospitals in March 2012 urging of public and private hospitals to make joint purchase orders for medical equipment, drugs, energy, gas and insurance. The policy is designed to eventually establish a group purchasing organisation to reduce procurement costs by 10-50%. Declarations of accession have been received from 70 hospitals. It is hoped the joint procurement of medical devices and other supplies will enable smaller hospitals to compete with larger hospitals’ purchasing power.

- Hospitals in Poland are facing huge shortages of cancer drugs due to the issues related to procurement. The buying issues developed after Austrian production facilities belonging to Sandoz, the generic pharmaceuticals division of Novartis, had problems at the beginning of April 2012. Sandoz, which is upgrading facilities on a regular basis, purchased the oncology portfolio of Ebewe Pharma for EUR1.1bn (US$1.46bn) in 2009. The upgrading process is causing some difficulties at production facilities, which are feeding into the procurement system.

- A new decree on reimbursed drug prescriptions allows doctors to use the Latin names of drugs or any other applicable names, including trade or chemical names in Polish and English, the Ministry of Health said in April. The statement came after the Porozumienie Zielonogorskie union and the Doctors’ Trade Union of Poland said the ordinance forces doctors to specify the trade name. The ordinance still requires doctors to indicate the level of reimbursement, which applies to specific products rather than a class of products.

BMI Economic View: We forecast Polish real GDP growth to slow from 4.3% in 2011 to 2.5% this year, which is substantially below consensus expectations. Fiscal consolidation and slower investment growth will make Poland more vulnerable to a contraction in the eurozone.

BMI Political View: The government will continue fiscal consolidation despite growing opposition and strains within the government. However, despite some setbacks, Civic Platform (PO) remains the most popular party in the country and the opposition is too divided to attract the majority needed to force a change in administration. PO and its main rival, the Polish People’s Party (PSL), have a history of compromise from the government they formed between 2007 and 2011.

Executive Summary 5

SWOT Analysis 7

Poland Pharmaceuticals Industry SWOT 7

Poland Political SWOT 8

Poland Economic SWOT 8

Poland Business Environment SWOT 9

Pharmaceutical Risk/Reward Ratings 10
Table: Central And Eastern Europe Pharmaceuticals Risk/Reward Ratings, Q312 10

Rewards 12

Risks 13

Poland – Market Summary 15

Regulatory Regime 16

Advertising Regulations 17

Other Regulatory Developments 18

Intellectual Property Regime 18

Intellectual Property Shortcomings 19

Pricing And Reimbursement Regime 20

Pricing Policies 21

Drug Price Inflation 22

Reimbursement Policies 23

Reimbursement Regime Changes 24

Industry Trends And Developments 28

Epidemiology 28

Healthcare System 29

Hospital Privatisation 30

Health Insurance 32

Research & Development 33

Clinical Trials 34

Developments In The Clinical Trials Sector 35

Medical Devices 36

Industry Forecast Scenario 38

Overall Market Forecast 38
Table: Pharmaceutical Sales, 2008-2016 40

Key Growth Factors – Industry 41
Table: Total Healthcare Expenditure, 2008-2016 44
Table: Government Healthcare Expenditure, 2008-2016 44
Table: Private Healthcare Expenditure, 2008-2016 45

Key Growth Factors – Macroeconomic 46
Table: GDP By Expenditure, Real Growth, 2008-2016 52

Prescription Drug Market Forecast 53
Table: Prescription Drug Sales, 2008-2016 54

Patented Drug Market Forecast 55
Table: Patented Drug Sales, 2008-2016 56

Generic Drug Market Forecast 57
Table: Generic Drug Sales, 2008-2016 58

OTC Medicine Market Forecast 59
Table: OTC Medicine Sales, 2008-2016 60
Table: OTC Medicne Sales By Subsector, 2007-2010 61

Pharmaceutical Trade Forecast 62
Table: Pharmaceutical Trade, 2008-2016 64

Medical Device Market Forecast 65
Table: Medical Devices Sales, 2008-2016 66

Key Risks To our Forecast Scenario 67

Competitive Landscape 68

Pharmaceutical Industry 68

Domestic Industry 68

Domestic Company Developments 69

Foreign Industry 72

Foreign Company Developments 73

Pharmaceutical Wholesale Sector 74

Pharmaceutical Retail Sector 76
Table: Number Of Pharmacies In Poland, 2004-2009 78

Company Profiles 79

Local Companies 79

Polpharma 79

Bioton 81

Multinational Companies 84

GlaxoSmithKline 84

Eli Lilly 86

Gedeon Richter 88

Krka 90

Lek (Sandoz/Novartis) 92

Demographic Outlook 94
Table: Population By Age Group, 1990-2020 (‘000) 95
Table: Population By Age Group, 1990-2020 (% of total) 96
Table: Key Population Ratios, 1990-2020 97
Table: Rural And Urban Population, 1990-2020 97

Glossary 98

BMI Methodology 100

How We Generate Our Pharmaceutical Industry Forecasts 100

Pharmaceutical Risk/Reward Ratings Methodology 101

Ratings Overview 101
Table: Pharmaceutical Risk/Reward Indicators 102

Weighting 103
Table: Weighting Of Components 103

Sources 103

Polpharma , Bioton , , GlaxoSmithKline , Eli Lilly , Gedeon Richter , Krka , Lek (Sandoz/Novartis) ,

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