Healthcare, Regulatory and Reimbursement Landscape Portugal

Portugal Debt Crisis Strangling Pharma Sector Growth

The Portuguese pharmaceutical market has struggled in recent years, and new government policies restraining the profits of the generics industry are likely to aggravate these existing problems, states the latest report by research and consulting firm GlobalData.

In May 2011 Portugal’s government agreed a reform program with the EU and International Monetary Fund (IMF) to restore market confidence and raise potential growth, receiving a financial rescue package of US$108 billion (€78 billion). However, this came with an obligation to enforce healthcare budget cuts as part of austerity measures, and these efforts threaten to damage the country’s pharma industry, says the new report*

The government introduced a pricing policy in 2012 guaranteeing that any new generic drug entering the market is priced at least 50% lower than its branded equivalent, aiming to increase the use of generics as a cost-containment tool and reduce public healthcare expenses. This is hampering the generic market, with an estimated value of US$670.6m for 2012 dropping significantly from  US$745.1m in 2011.

Despite this, the generics market still has huge potential for development, as the patent cliff provides opportunities for generic manufacturers. Blockbuster drugs such as Amgen’s Neupogen, AstraZeneca’s Nexium, Bristol-Myers Squibb’s  Abilify, and Pfizer’s Celebrex are all due to lose their patents in the next two years, opening the market to generic versions of these products.

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Portugal’s financial reforms also bring other challenges to the pharma market. In 2013, the government plans to raise domestic revenue through implementing higher corporate and personal taxes, which will act as a burden on pharmaceutical companies operating in Portugal, including major multinational companies Novartis, Merck, Pfizer, Roche, AstraZeneca, and Abbott; and major domestic pharmaceutical companies Bial, Bluepharma and Hovione.

The Portuguese government’s inability to clear many outstanding debts has also led to difficulties with outstanding payments to pharmaceutical companies standing at US$1.5 billion in 2012, leading major players such as Roche to start cutting drug supplies to public hospitals.

Portugal’s pharmaceutical market is projected to show modest growth in the near future, from a value of US$5.1 billion (€3.9 billion) in 2012 to approximately US$5.6 billion (€4.4 billion) by 2020, at a Compound Annual Growth Rate (CAGR) of 1.2%. The medical device market is projected to grow at a CAGR of 3.1% from US$1.5 billion in 2012 to US$2 billion in 2020.

Healthcare, Regulatory and Reimbursement Landscape - Portugal This report provides analysis of the healthcare, regulatory, and reimbursement landscape in Portugal. It identifies key trends in the healthcare market and provides insights into the demographic, regulatory, and reimbursement landscape, as well as the healthcare infrastructure. Most importantly, it provides valuable insights into the trends and segmentation of the pharmaceutical and medical device markets.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GlobalData’s team of industry experts.

Reasons to buy

This report will enhance your decision-making capability by allowing you to -

- Develop business strategies by understanding the trends shaping and driving the healthcare market in Portugal

- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments, and companies likely to impact Portugal’s healthcare market in the future

- Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors

- Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment, and strategic partnership

- Identify, understand, and capitalize on the opportunities and challenges in Portugal’s healthcare market

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Table of Content

1 Table of Contents 4
1.1 List of Tables 5
1.2 List of Figures 7

2 Introduction 9
2.1 Report Guidance 9

3 Overview of the Pharmaceutical and Medical Device Markets 10
3.1 Pharmaceutical Market 10
3.1.1 Market Overview 10
3.1.2 Pharmaceutical Imports and Exports 13
3.1.3 Supply Channels 14
3.1.4 Market Segments 16
3.1.5 Major Therapeutic Areas 21
3.1.6 Major Players 23
3.2 Medical Device Market 49
3.2.1 Market Overview 49
3.2.2 Overview of Top Five Segments 51
3.2.3 Diagnostics Market 62
3.2.4 Major Players 64
3.3 Market Drivers and Barriers 83
3.3.1 Drivers 83
3.3.2 Barriers 83

4 Market Access 85
4.1 Reimbursement and Payer Landscape 85
4.1.1 Healthcare System Overview 85
4.1.2 Drug Reimbursement Process 86
4.1.3 Overview of Insurance Providers 88
4.1.4 Patient Share in Healthcare Spending 89
4.1.5 Price Trends in Healthcare Services 90
4.1.6 Pricing Policies 91
4.2 Regulatory Landscape 92
4.2.1 Overview of Regulatory Agencies 92
4.2.2 Marketing Authorization Procedure for Pharmaceutical Products 92
4.2.3 New Medical Device Approval Process 101
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing 106
4.2.5 Licensing Process for Pharmaceutical Exports and Imports 106
4.2.6 Intellectual Property Rights 106
4.2.7 Clinical Trial Regulations 109
4.2.8 Pharmaceutical Advertising Regulations 110
4.2.9 Pharmacy Regulations 110
4.2.10 Labeling and Packaging Regulations 110

5 Country Analysis 112
5.1 Political Environment 112
5.1.1 Political Structure 112
5.1.2 Analysis of the Current Political Environment 112
5.1.3 Healthcare Policy Initiatives 113
5.2 Economic Landscape 113
5.3 Economic Indicators 114
5.3.1 Gross Domestic Product 114
5.3.2 Gross National Income 118
5.3.3 Inflation 119
5.3.4 Currency Exchange Rate 123
5.3.5 Foreign Direct Investment 124
5.3.6 Foreign Exchange Reserves 125
5.3.7 Trade Balance 126
5.3.8 Government Net Debt 128
5.3.9 Government Structural Balance 130
5.3.10 Major Industries 132
5.4 Demography 133
5.4.1 Population 133
5.4.2 Education and Literacy 147
5.4.3 Employment 148
5.4.4 Disease Burden 150
5.5 Healthcare Infrastructure 152
5.5.1 Healthcare Facilities 152
5.5.2 Healthcare Parameters 156
5.5.3 Environmental Health 158
5.5.4 Healthcare Personnel 160
5.6 Healthcare Expenditure 162
5.6.1 Overview 162
5.6.2 Major Components of Healthcare Spending 163
5.6.3 Share of Public and Private Sectors 164
5.6.4 Spending in Healthcare R&D 164
5.7 Trade Associations 165
5.7.1 Portuguese Pharmaceutical Industry Association 165
5.7.2 Portuguese Generic Medicines Association 165
5.7.3 National Pharmacy Association 165
5.7.4 Wholesalers Association of Chemical and Pharmaceutical Products 165
5.7.5 Portuguese Association of Bioindustries 165
5.8 Trade Fairs 166

6 Opportunities and Challenges 167
6.1 Opportunities 167
6.2 Challenges 167

7 Appendix 169
7.1 Abbreviations 169
7.2 Bibliography 170
7.3 Methodology 175
7.3.1 Coverage 175
7.3.2 Secondary Research 175
7.3.3 Forecasting 175
7.3.4 Expert Panel Validation 176
7.4 Contact Us 176
7.5 Disclaimer 176

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