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The Pharmaceutical Market: Portugal Published on June 2011

Report Summary Espicom's highly regarded world pharmaceutical market reports have been redesigned to provide enhanced strategic intelligence in a user-friendly format. Each report provides in-depth information, setting the pharmaceutical market in context. The reports provide:

Five-year projections for economic, demographic, health expenditure, health workforce and pharmaceutical market indicators. Specialised intelligence on OTCs, generics, biologics and biosimilars. Exclusive economic and demographic data from the Economist Intelligence Unit (EIU) for each market in the series. A separate statistical health file, comprising health expenditure, health infrastructure, health services and health personnel. The reports are updated quarterly, providing you with the latest information for a full year. In addition, the service will keep you up to date with market and industry news on a regular basis. THE PHARMACEUTICAL MARKET: PORTUGAL - REVIEW The macroenvironment remains tough for the Portuguese pharmaceutical market. Politically, a general election was held in June 2011, following the resignation of the prime minister in March 2011. Economically, Portugal is the second smallest economy in Western Europe. After real GDP growth in 2010, the Economist Intelligence Unit (EIU) projects economic contraction in the 2011-2012 period, followed by an average growth of below 1.5% in the 2013-2016 period. In April 2011, Portugal asked the European Commission for financial help. This move was not a surprise, although the prime minister had previously insisted that Portugal did not need external help to finance its debt. Legally, IPR regulations are harmonised with EU procedures. Demographically, Portugal has one of the smallest populations in Western Europe, but the EIU projects that the number of people aged 65 years and over will increase to represent nearly one-fifth of the total population in 2016. Pharmaceutical sales growth in Portugal will be low in the forecast period. In US dollar terms, pharmaceutical sales are expected to fall in 2011, due to a weaker exchange rate of the euro against the US dollar, and to grow very slowly in the forecast period, affected by the projected weaker exchange rate. In euro terms, pharmaceutical sales are projected to increase modestly, due to the government's cost-containment measures, which are expected to be implemented in the 2011-2016 period. In 2016, the pharmaceutical market will rank as one of the smallest in Western Europe. In per capita terms, Portugal will have the lowest expenditure. The country will consume more retail medicaments, fuelling generic penetration. Generic growth, however, is expected to slow down in the medium-term. Market opportunities to explore in the forecast period include biotechnology and pharmacogenetics. The Portuguese pharmaceutical market is heavily regulated in an effort to contain costs. In September 2010, the government approved a Decree-Law which effectively reduced drug prices, encouraged the use of electronic prescriptions and introduced two main changes in the reimbursement system. This was the second drug price cut in 2010, making it a cumulative price cut of nearly 15% in less than one year. In terms of reimbursement, the new reference price will be the average of the cheapest five medicines in each homogenous group. Additionally, the special reimbursement status and the general A reimbursement status will be reduced. In March 2010, the government passed another Decree-Law which approved the general drug reimbursement system, changed the rules for the evaluation of drugs purchased by SNS hospitals, and modified the price system for prescription and reimbursed non-prescription medicines. ENHANCED STRATEGIC INTELLIGENCE

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>> Get this Report Now by email! Espicom's highly regarded world pharmaceutical market reports have been redesigned to provide enhanced strategic intelligence in a user-friendly format. Each report provides in-depth information, setting the pharmaceutical market in context. The reports provide: Five-year projections for economic, demographic, health expenditure, health workforce and pharmaceutical market indicators. Specialised intelligence on OTCs, generics, biologics and biosimilars. Exclusive economic and demographic data from the Economist Intelligence Unit (EIU) for each market in the series. A separate statistical health file, comprising health expenditure, health infrastructure, health services and health personnel. The reports are updated quarterly, providing you with the latest information for a full year. In addition, the service will keep you up to date with market and industry news on a regular basis. HEALTHCARE STATISTICS A comprehensive tabula review, comprising demographics, epidemiology, health expenditure, hospital and primary care infrastructure & services and healthcare personnel, is additionally included.

Table of Content Table of Contents

EXECUTIVE SUMMARY 1 Snapshot: Strategic Espicom Analysis 2 Snapshot: Key Data Projections 3 MACROENVIRONMENT 4 POLITICAL 4 ECONOMIC5 LEGAL6 EU Patent Protection & Intellectual Property Rights 6 Proposal for Unitary Patent 6 Patent Settlements 6 EU Supplementary Protection Certificates6 EU Data Exclusivity7 DEMOGRAPHIC 7 Projections 7 Demographic Indicators8 Birth Rate 8 Death Rate 8 Infant Mortality 8 Life Expectancy at Birth 8 EPIDEMIOLOGY 9 DISEASE BURDEN 9 DISEASE PREVALENCE10 Communicable Diseases 10 HIV/AIDS 10 Non-communicable Diseases 10 Cancer 10

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>> Get this Report Now by email! Cardiovascular Diseases 10 HEALTHCARE - ACCOMPANYING HEALTH STATISTICS 11 EU DIRECTIVE11 Cross-Border Healthcare Directive 11 ORGANISATION 11 Ministry of Health 11 National Health Service 12 EXPENDITURE 13 Projections 13 Health Insurance 14 INFRASTRUCTURE 15 Hospital Infrastructure15 Outpatient Infrastructure 16 SERVICES 17 Inpatient Services17 Outpatient Services17 WORKFORCE 18 Projections 18 REGULATORY AFFAIRS 19 EU REGULATORY AUTHORITY 19 EU MARKETING REGISTRATION 19 Centralised Procedure 19 NATIONAL REGULATORY AUTHORITY19 NATIONAL MARKETING REGISTRATION 20 POST-MARKET SURVEILLANCE21 LABELLING & PACKAGING 22 PROMOTION 23 Advertising 23 Personal Selling23 PRICING & REIMBURSEMENT 25 PRICING 25 EU NM CAPR25 EU Transparency of Pricing Mechanisms 25 National Pricing25 Pricing Margins 27 Medicinal Presentations by Price Range27 REIMBURSEMENT 28 Reimbursement Applications 29 Reimbursed Medicines29 DISTRIBUTION CHANNELS 31 WHOLESALING31 Wholesalers31 Wholesale Associations 31 GROQUIFAR 31 RETAILING32 Pharmacy Regulation 32 Pharmacies 33 ANF 34

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>> Get this Report Now by email! MARKET ANALYSIS 35 SIZE 35 Projections 35 Historical Figures 37 Current Structure 38 Pharmacy Sales 39 SNS Hospital Sales 43 PRODUCT DEVELOPMENT 46 EU IMI 46 National Requests for Clinical Trials46 National Research & Development 46 MANUFACTURING 47 TRADE 49 Exports 49 Imports 51 Balance of Trade 55 COMPETITION 56 TRADE ASSOCIATIONS 56 APIFARMA 56 Health Cluster Portugal 58 PharmaPortugal 60 TRADE FAIR 60 EXPOFARMA 60 COMPANY INTELLIGENCE61 Foreign Research-Based Producers 61 Faes Farma (Acquired Laborat贸rios Vit贸ria) 61 Fresenius Kabi (Acquired Labesfal) 61 Jaba Recordati (Acquired Jaba) 61 Local Research-Based Producers 61 Azevedos (Including Sofarimex) 61 Bial 62 Bluepharma 62 Hovione 62 Medinfar (Including Farmalabor)63 OTC PHARMACEUTICALS 64 MARKET SIZE 64 GENERIC PHARMACEUTICALS 66 REGULATION 66 EU Marketing Registration66 MARKET SIZE 66 COMPETITION 68 Trade Association68 APOGEN 68 Foreign Generic Producers68 Hikma Farmac锚utica Portugal 68 Local Generic Producers 69 Generis Farmac锚utica 69 Tecnimede (Including Farmoz and West Pharma) 69

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>> Get this Report Now by email! Competitive Strategies69 BIOLOGICS & BIOSIMILARS 70 REGULATORY AFFAIRS 70 EU Approval Process 70 EU Regulation of Biosimilars 70 EMA Guideline Documents71 Biosimilar mAb Guideline 71 COMPETITION 72 Trade Associations 72 APBio72 Biocant Park73 Company Intelligence 73 Alfama 73 Bioalvo 73 Biopremier 74 Biotecnol 74 Biotempo 74 Crioestaminal 74 Gene PreDiT 74 GenIbet 74 LEF 74 TechnoPhage 75 Thelial 75 CONCLUSIONS: OPPORTUNITIES & CHALLENGES 76 Strategic Espicom Analysis 76 MACROENVIRONMENT 76 EPIDEMIOLOGY 76 HEALTHCARE 76 REGULATORY AFFAIRS 77 PRICING & REIMBURSEMENT77 DISTRIBUTION CHANNELS 78 MARKET 78 COMPETITION 79 OTC PHARMACEUTICALS 79 GENERIC PHARMACEUTICALS 79 BIOLOGICS & BIOSIMILARS79 Radar Analysis 81 SWOT Analysis 81 DIRECTORY 82 COMPANY INTELLIGENCE 82 Research-Based Producers82 Foreign Research-Based Producers 82 Local Research-Based Producers82 Generic Producers 82 Foreign Generic Producers 82 Local Generic Producers82 Biologic Companies82 Local Biologic Companies 82

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List of Tables Espicom Analysis of the Pharmaceutical Market, 2011 2 Key Data Projections, 2011-2016 3 Political Landscape, 2011 4 Regional Ranking of Projected Economies, 2016 5 Projected Economy, 2011-2016 5 Regional Ranking of Projected Demographics, 2016 7 Projected Demographics, 2011-2016 7 Demographic Indicators, 2000-2008 8 Deaths by Selected Causes, 2000-2008 9 Regional Health Administrations, 201012 Regional Ranking of Projected Health Expenditure, 2016 13 Projected Health Expenditure, 2011-201613 Health Expenditure, 2000-2008 (US$ Billion) 14 Health Expenditure, 2000-2008 (Billion Euros) 14 Hospitals by Sector, 1997-2007 15 Oupatient Facilities by Type, 1998-2008 16 Regional Ranking of Projected Physicians, 2016 18 Projected Physicians, 2011-2016 18 Marketing Authorisation Applications by Procedure, 2000-2009 20 MA Renewals, 2000-2009 21 ADR Notifications, 2000-2009 21 Annual Drug Price Reviews, 2000-2009 26 Medicinal Presentations by Price Range, 2008 27 Reimbursement Applications by Type, 2000-2009 29 Reimbursed Medicines, 2004-2008 29 Reimbursed Medicines by Prescription Classification, 2008 30 Reimbursed Medicines by Reimbursement Category, 2008 30 Reimbursed Medicinal Presentations by Reimbursement Category & Pharmacotherapeutic Group, 2008 30 Drug Wholesalers, 2002-2008 31 Pharmaceutical Members of GROQUIFAR, 2010 31 Pharmacies & Pharmacy Extensions in Portugal, 1990-2009 33 Pharmacies & Pharmacy Extensions in Portugal by Region, 2009 33 Regional Ranking of Projected Pharmaceutical Markets at Retail Prices, 2016 35 Projected Pharmaceutical Market at Retail Prices, 2011-2016 36 Historical Pharmaceutical Market at Retail Prices, 1995-2010 37 Pharmaceutical Sales by Type, 2003-September 2010 (Million Euros) 38 Pharmacy Sales by Value & Volume at Retail Prices, 2003-September 2010 39 Net SNS Pharmacy Sales at Retail Prices, 2002-September 2010 40 Gross SNS Pharmacy Sales at Retail Prices, 2004-2008 41 Gross SNS Pharmacy Sales at Retail Prices by Prescription Origin, 2008 41 Gross SNS Pharmacy Sales at Retail Prices by Therapeutic Area, 2008 42 Gross SNS Pharmacy Sales at Retail Prices by Leading MA Holders, 2008 43 SNS Hospital Sales, 2007-September 2010 44 SNS Hospital Sales by Leading Hospitals, 200944

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>> Get this Report Now by email! SNS Hospital Sales by Therapeutic Area, 2009 45 SNS Hospital Sales by Provision Area, 2009 45 Requests for Clinical Trials, 2005-200946 Production of Raw Materials & Pharmaceuticals, 1996-2009 (Million Euros) 47 INFARMED's Registered Producers, 200948 Pharmaceutical Exports by Category, 2004-2008 (US$000s) 49 Pharmaceutical Exports by Country/Region, 2008 (US$000s) 50 Pharmaceutical Imports by Category, 2004-2008 (US$000s) 51 Imports of Raw Materials by Country/Region, 2008 (US$000s) 53 Imports of Antisera & Vaccines by Country/Region, 2008 (US$000s) 53 Imports of Medicaments by Country/Region, 2008 (US$000s) 54 Pharmaceutical Balance of Trade, 2004-2008 (US$000s) 55 Members of APIFARMA, 2010 56 Members of Health Cluster Portugal, 2010 58 Members of PharmaPortugal, 2010 60 MNSRM Sales at Retail Prices, 2007-September 2010 (Million Euros) 64 MNSRM Sales, 2007-September 2010 (Million Units) 65 Generic Pharmacy Sales by Value & Volume, 2003-September 2010 66 Members of APOGEN, 201068 Members of APBio, 2010 72 Biocant Park's Companies, 2010 73 Espicom Analysis of the Pharmaceutical Market, 201180 SWOT Analysis of the Pharmaceutical Market, 2011 81

List of Charts Regional Comparison of Top 6-16 Projected Pharmaceutical Markets at Retail Prices, 2016 36 Historical Pharmaceutical Market at Retail Prices, 1995-2010 37 Pharmacy Sales by Value at Retail Prices, 2003-2009 39 Net SNS Pharmacy Sales at Retail Prices, 2002-2009 40 Pharmaceutical Exports, 2003-2008 (US$ Millions) 49 Pharmaceutical Imports, 2003-2008 (US$ Billions) 51 Pharmaceutical Imports by Country/Region, 2008 (%) 52 Pharmaceutical Balance of Trade, 2003-2008 (US$ Billions) 55 Generic Pharmacy Sales by Value, 2003-2009 67 Radar Graph of the Pharmaceutical Market, 2011 81

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