Table of Contents 
5 EXECUTIVE SUMMARY
5 Catalyst
5 Key findings
7 HEALTHCARE EXPENDITURE
7 Spain has a lower healthcare spend per capita compared to other developed markets
10 Settlement of SNS debts to pharmaceutical companies is a positive point
11 INSURANCE AND HEALTHCARE SYSTEM
11 Key healthcare regulatory bodies
12 Health insurance is provided primarily through the SNS and supported by supplementary
private healthcare
17 Primary care versus hospital care in Spain: primary care is delivered in primary healthcare
centers
19 Healthcare reforms in Spain have focused on reducing costs
24 REGULATORY ISSUES
24 Drug approval and regulatory processes in Spain
28 Intellectual property issues in Spain
29 Data exclusivity issues in Spain – the 8+2+1 rule
30 Clinical trials regulation in Spain
31 Drug counterfeiting in Spain
31 Parallel trade
34 BIBLIOGRAPHY
34 Publications and online articles
42 APPENDIX
42 Contributors
42 Exchange rates used in this report

List of figures 
7 Figure 1: Spain – healthcare spending comparison to other key markets, 2010
12 Figure 2: Spain – health insurance system
13 Figure 3: Spain – healthcare system by source of funding
15 Figure 4: Spain – different levels of control of healthcare system functions
24 Figure 5: Spain – routes to obtaining marketing authorization
30 Figure 6: EU – the 8+2+1 market exclusivity rule

List of Tables
9 Table 1: Spain – healthcare expenditure indicators, 2006–09

17 Table 2: Spain – primary versus specialist care
18 Table 3: Spain – hospital bed and healthcare worker density, 2004–10
19 Table 4: Spain – major healthcare reforms, 1984–2012
22 Table 5: Spain – selected regional cost containment initiatives in 2010–12
42 Table 6: Currency exchange rates, 2011