Romania Pharmaceuticals and Healthcare Report Q1 2013
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Romania Pharmaceuticals and Healthcare Report Q1 2013 Date: Pages: Price: ID:
January 16, 2013 93 US$ 1,175.00 R4CC4DD193BEN
Includes 3 FREE quarterly updates
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 BMI's assessment of Romania's Pharmaceutical and Healthcare Risk/Reward ratings. HEADLINE EXPENDITURE PROJECTIONS: Pharmaceuticals: RON12.76bn (US$4.18bn) in 2011 to RON13.52bn (US$3.78bn) in 2012; +6.0% in local currency terms and -9.7% in US dollar terms. Local currency forecast slightly down from Q412 on account of macroeconomic factors; US dollar forecast further impacted by exchange rate factors. Healthcare: RON30.17bn (US$9.90bn) in 2011 to RON32.07bn (US$9.86bn) in 2012; +6.3 %in local currency terms and -9.5% in US dollar terms. Local currency forecast slightly down from Q412 on account of macroeconomic factors; US dollar forecast further impacted by exchange rate factors. Medical devices: RON1.61bn (US$527mn) in 2011 to RON1.69bn (US$471mn) in 2012; +5.0% in local currency terms and -10.6% in US dollar terms. Local currency forecast slightly down from Q412 on account of macroeconomic factors; US dollar forecast further impacted by exchange rate factors. Risk/Reward Rating: Our Risk/Reward rating score for Romania's pharmaceutical market remains unchanged in Q113, at 55.3 out of the maximum 100 points. Despite operational improvements in recent years, Romania remains a challenging market, largely on account of low per capita incomes and spending on medicines, while the US dollar forecast for its pharmaceutical market continues to be negatively impacted by leu weakness. Regionally, Romania is again ranked sixth out of the 20 key markets surveyed in the Emerging Europe region. KEY TRENDS AND DEVELOPMENTS An estimated EUR85mn (US$110mn) is expected to be collected by the Romanian health ministry through the claw-back tax in 2012, supplementing the EUR33mn (US$43mn) recently allocated to the ministry by the government. The tax revenue, which will be transferred to the single health insurance fund, will be spent on hospitals, with priority given to regional network and emergency hospitals. Newly-launched drugs and medical supplies supervision programmes in Romania will reportedly also be allocated EUR880,000 (US$1.14mn). In October 2012, it was revealed that medicines and sanitary materials for emergency care units will be procured centrally in Romania from 2013, according to statements made by the interim health minister Raed Arafat. The government is to issue tenders for all medicines and sanitary materials
Romania Pharmaceuticals and Healthcare Report Q1 2013
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that are used in the 63 state-funded emergency care centres in the country. The tenders will help to control cost in emergency care, thereby reducing healthcare expenditure. The public health departments and health units have also been asked by Arafat to spend all available funds so that none remains at the end of the year. A new proposal related to patient co-payment rules in Romania stipulates that patients with a compulsory health insurance policy might pay less in patient co-payments, reported PMR in September 2012. The proposal suggests RON2-RON4 (US$0.57-1.15) patient co-payment tariffs for a consultation, subject to the professional qualifications of the doctor. The proposal also recommends RON10-30 (US$2.87-8.63) patient tariffs for one day in hospital and RON20-40 (US$5.75-11.51) for an extended hospital stay. Around 88.5% of Romanians prefer innovative drugs for the treatment of serious illnesses, Business Review reported in October 2012, citing a survey conducted by the IMAS Marketing & Sondaje Institute. Almost 80% of respondents feel that it is imperative to buy innovative drugs; however, only 19.5% were able to distinguish between generic drugs and original drugs. Of the total 1,036 Romanians surveyed, 45% stated that they wanted access to innovative drugs and 17% preferred generic drugs. BMI Economic View: Romanian consumer price inflation ticked up significantly in September, rising to 5.3% year-on-year (y-o-y) from just 3.5% the previous month. While this puts the inflation rate well above the central bank's target range (2.5% +/- 1 percentage point), we do not anticipate monetary policymakers to hike rates anytime soon, as price pressures appear to be mainly supply-side driven. Nevertheless, while we agree with Central Bank Governor Mugur Isarescu that the price spike is transitory, we are revising up our end-2012 inflation forecast, from 3.3% to 4.3%, to reflect the impact of higher food prices. BMI Political View: According to recent polls released by GSS 2000, Romania's governing Social-Liberal Union (USL) coalition would win 51.2% of the vote in an election held now, with the opposition centre-right coalition gaining just 23.4%. This supports our long-held view that Prime Minister Victor Ponta is set to remain in power following the December 2012 election, which we expect to prompt ongoing tensions between the Romanian government and European Union (EU)/International Monetary Fund (IMF), as his anti-austerity rhetoric raises questions over his administration's commitment to fiscal consolidation.
Table of Content Executive Summary SWOT Analysis Romania Pharmaceuticals And Healthcare Industry SWOT Romania Political SWOT Romania Economic SWOT Romania Business Environment SWOT Pharmaceutical Risk/Reward Ratings Table: Emerging Europe Pharmaceutical Risk/Reward Ratings, Q113 Rewards Risks Romania - Market Summary Regulatory Regime Table: NMA Authorisation Activity, 2007-2008 Pharmaceutical Advertising Intellectual Property Regime Corruption Pricing Regime Reimbursement Regime Co-Payments for Medical Services
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Public Sector Procurement Claw-Back Tax Latest Claw-Back Tax Developments Industry Developments Epidemiology Communicable Diseases Healthcare System Private Healthcare Provision Private Healthcare Provision Developments Healthcare Reform Pharmaceutical Payment Delays Research and Development (R&D) Clinical Trials Medical Devices Industry Forecast Scenario Pharmaceutical Market Forecast Table: Romania Pharmaceutical Sales, Historical Data and Forecasts Healthcare Market Forecast Table: Romania Healthcare Expenditure Trends, Historical Data and Forecasts Table: Romania Government Healthcare Expenditure Trends, Historical Data and Forecasts Table: Romania Private Healthcare Expenditure Trends, Historical Data and Forecasts Key Growth Factors - Macroeconomic Prescription Drug Market Forecast Table: Romania Prescription Drug Market Indicators, Historical Data and Forecasts Patented Drug Market Forecast Table: Romania Patented Drug Market Indicators, Historical Data and Forecasts Generic Drug Market Forecast Table: Romania Generics Drug Market Indicators, Historical Data and Forecasts OTC Medicine Market Forecast Table: OTC Medicine Sales By Subsector, 2007-2010 Table: Romania Over-The-Counter (OTC) Medicine Market Indicators, Historical Data and Forecasts Pharmaceutical Trade Forecast Table: Romania Pharmaceutical Trade Data And Forecasts (US$mn) Table: Romania Pharmaceutical Trade Data And Forecasts (RONmn) Medical Device Market Forecast Table: Romania Medical Device Market Indicators, Historical Data and Forecasts Other Healthcare Data Key Risks To BMI's Forecast Scenario Competitive Landscape Pharmaceutical Industry Domestic Pharmaceutical Sector Foreign Pharmaceutical Sector Table: Members of ARPIM, 2011 Pharmaceutical Company Developments Pharmaceutical Wholesaling Pharmaceutical Retail Table: Pharmacies & Pharmaceutical Storehouses, 2000-2006 (000s) Company Profiles Local Companies Zentiva Romania Actavis Romania (Sindan) Terapia Ranbaxy Antibiotice Ia?i LaborMed Pharma Multinational Companies
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GlaxoSmithKline (Europharm) Roche Sanofi Novartis Pfizer Krka Merck & Co Demographic Outlook Table: Romania's Population By Age Group, 1990-2020 ('000) Table: Romania's Population By Age Group, 1990-2020 (% of total) Table: Romania's Key Population Ratios, 1990-2020 Glossary BMI Methodology How We Generate Our Pharmaceutical Industry Forecasts Pharmaceutical Risk/Reward Ratings Methodology Ratings Overview Table: Pharmaceutical Business Environment Indicators Weighting Table: Weighting Of Components Sources
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