Q1 2013

www.businessmonitor.com

ROMANIA

PHARMACEUTICALS & HEALTHCARE REPORT

INCLUDES BMI'S FORECASTS

ISSN 1748-2127
Published by Business Monitor International Ltd.

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Business Monitor International

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Romania Pharmaceuticals And Healthcare Industry SWOT .................................................................................................................................. 7
Romania Political SWOT ....................................................................................................................................................................................... 8
Romania Economic SWOT..................................................................................................................................................................................... 8
Romania Business Environment SWOT ................................................................................................................................................................. 8

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Table: Emerging Europe Pharmaceutical Risk/Reward Ratings, Q113 ................................................................................................................. 9
Rewards ............................................................................................................................................................................................................... 10
Risks .................................................................................................................................................................................................................... 10

Table: NMA Authorisation Activity, 2007-2008 ................................................................................................................................................... 13
Pharmaceutical Advertising................................................................................................................................................................................. 14
Intellectual Property Regime ............................................................................................................................................................................... 14
Corruption ........................................................................................................................................................................................................... 17
Pricing Regime .................................................................................................................................................................................................... 17
Reimbursement Regime........................................................................................................................................................................................ 18
Co-Payments for Medical Services ...................................................................................................................................................................... 19
Public Sector Procurement .................................................................................................................................................................................. 20
Claw-Back Tax .................................................................................................................................................................................................... 21
Latest Claw-Back Tax Developments ................................................................................................................................................................... 22

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Epidemiology ....................................................................................................................................................................................................... 24
Communicable Diseases ...................................................................................................................................................................................... 25
Healthcare System ............................................................................................................................................................................................... 25
Private Healthcare Provision .............................................................................................................................................................................. 26
Private Healthcare Provision Developments ....................................................................................................................................................... 27
Healthcare Reform............................................................................................................................................................................................... 28
Pharmaceutical Payment Delays ......................................................................................................................................................................... 31
Research and Development (R&D) ...................................................................................................................................................................... 31
Clinical Trials ...................................................................................................................................................................................................... 32
Medical Devices................................................................................................................................................................................................... 32

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Pharmaceutical Market Forecast ........................................................................................................................................................................ 34
Table: Romania Pharmaceutical Sales, Historical Data and Forecasts .............................................................................................................. 35
Healthcare Market Forecast ................................................................................................................................................................................ 37
Table: Romania Healthcare Expenditure Trends, Historical Data and Forecasts ............................................................................................... 38
Table: Romania Government Healthcare Expenditure Trends, Historical Data and Forecasts .......................................................................... 39
Table: Romania Private Healthcare Expenditure Trends, Historical Data and Forecasts .................................................................................. 39
Key Growth Factors Macroeconomic ............................................................................................................................................................... 40
Prescription Drug Market Forecast ..................................................................................................................................................................... 41
Table: Romania Prescription Drug Market Indicators, Historical Data and Forecasts ...................................................................................... 42
Patented Drug Market Forecast .......................................................................................................................................................................... 43
Table: Romania Patented Drug Market Indicators, Historical Data and Forecasts ............................................................................................ 44
Generic Drug Market Forecast............................................................................................................................................................................ 45

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Table: Romania Generics Drug Market Indicators, Historical Data and Forecasts............................................................................................ 46
OTC Medicine Market Forecast .......................................................................................................................................................................... 47
Table: OTC Medicine Sales By Subsector, 2007-2010......................................................................................................................................... 48
Table: Romania Over-The-Counter (OTC) Medicine Market Indicators, Historical Data and Forecasts ........................................................... 49
Pharmaceutical Trade Forecast .......................................................................................................................................................................... 50
Table: Romania Pharmaceutical Trade Data And Forecasts (US$mn) ............................................................................................................... 52
Table: Romania Pharmaceutical Trade Data And Forecasts (RONmn) .............................................................................................................. 52
Medical Device Market Forecast .............................................................................................................................................................................. 53
Table: Romania Medical Device Market Indicators, Historical Data and Forecasts .......................................................................................... 54
Other Healthcare Data ........................................................................................................................................................................................ 55
Key Risks To BMIs Forecast Scenario ................................................................................................................................................................ 56

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Pharmaceutical Industry ...................................................................................................................................................................................... 57
Domestic Pharmaceutical Sector ......................................................................................................................................................................... 57
Foreign Pharmaceutical Sector ........................................................................................................................................................................... 58
Table: Members of ARPIM, 2011 ........................................................................................................................................................................ 58
Pharmaceutical Company Developments ............................................................................................................................................................ 59
Pharmaceutical Wholesaling ............................................................................................................................................................................... 60
Pharmaceutical Retail ......................................................................................................................................................................................... 62
Table: Pharmacies & Pharmaceutical Storehouses, 2000-2006 (000s) ............................................................................................................... 62

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Local Companies ...................................................................................................................................................................................................... 63
Zentiva Romania .................................................................................................................................................................................................. 63
Actavis Romania (Sindan).................................................................................................................................................................................... 65
Terapia Ranbaxy.................................................................................................................................................................................................. 67
Antibiotice Ia i ..................................................................................................................................................................................................... 69
LaborMed Pharma............................................................................................................................................................................................... 73
Multinational Companies .......................................................................................................................................................................................... 75
GlaxoSmithKline (Europharm) ............................................................................................................................................................................ 75
Roche ................................................................................................................................................................................................................... 77
Sanofi ................................................................................................................................................................................................................... 78
Novartis ............................................................................................................................................................................................................... 79
Pfizer ................................................................................................................................................................................................................... 80
Krka ..................................................................................................................................................................................................................... 81
Merck & Co ......................................................................................................................................................................................................... 82

Table: Romanias Population By Age Group, 1990-2020 (000) ......................................................................................................................... 84
Table: Romanias Population By Age Group, 1990-2020 (% of total)................................................................................................................. 85
Table: Romanias Key Population Ratios, 1990-2020 ......................................................................................................................................... 86

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How We Generate Our Pharmaceutical Industry Forecasts ................................................................................................................................ 89
Pharmaceutical Risk/Reward Ratings Methodology ............................................................................................................................................ 90
Ratings Overview ................................................................................................................................................................................................. 90
Table: Pharmaceutical Business Environment Indicators ................................................................................................................................... 91
Weighting ............................................................................................................................................................................................................. 92
Table: Weighting Of Components ........................................................................................................................................................................ 92
Sources ................................................................................................................................................................................................................ 92

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BMI View: While it is clear that drugmakers operating in Romania are far from happy with the latest
revisions to the pharmaceutical claw-back tax, and the tax remains unfairly punitive, all things
considered, the August 2012 amendments are a small improvement, though definitely not what producers
would have wanted ideally. With part of the objective of the claw-back tax to improve the timeliness of
payments for reimbursed medicines, which has been a major difficulty for drug producers and
distributors over the last four years, there are some upsides to this mechanism working effectively. The
tax remains most punitive for generic drugmakers with lower-value medicines and could lead to these
cheaper medicines exiting the market. The tax continues to weigh on BMIs assessment of Romanias
Pharmaceutical and Healthcare Risk/Reward ratings.
Headline Expenditure Projections:
Pharmaceuticals
- - Local currency forecast slightly
down from Q412 on account of macroeconomic factors; US dollar forecast further
impacted by exchange rate factors.
Healthcare:
- - Local currency forecast slightly down
from Q412 on account of macroeconomic factors; US dollar forecast further impacted by
exchange rate factors.
Medical devices:
- - Local currency forecast slightly
down from Q412 on account of macroeconomic factors; US dollar forecast further
impacted by exchange rate factors.
Risk/Reward Rating: - - - - - -
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Key Trends And Developments
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