Contents. Spain 90 Switzerland 91 Venezuela 92. Abstract 3. Accuracy 5. PharmaTrend Validation

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2 Contents Abstract 3 Accuracy 5 Retail Validation 7 Algeria 11 Argentina 12 Australia 13 Austria 14 Bangladesh 15 Belgium 16 Bolivia 17 Brazil 18 Bulgaria 19 Canada Central America 21 Chile 22 Colombia 23 Croatia 24 Czech Republic 25 Dominican Republic 26 Ecuador 27 Egypt 28 Estonia 29 Germany 3 Greece 31 Hong Kong 32 Hungary 33 India 34 Indonesia 35 Ireland 36 Italy 37 Japan 38 Jordan 39 Korea 4 Kuwait 41 Latvia 42 Lebanon 43 Lithuania 44 Malaysia 45 Mexico 46 Morocco 47 New Zealand 48 Pakistan 49 Paraguay 5 Peru 51 Philippines 52 Poland 53 Portugal 54 Saudi Arabia 55 Serbia 56 Singapore 57 Slovak Republic 58 Slovenia 59 Spain 6 Sri Lanka 61 Switzerland 62 Thailand 63 Tunisia 64 Turkey 65 Un. Arab Emirates 66 United Kingdom 67 Uruguay 68 USA 69 Venezuela 7 Vietnam 71 OTC Validation 72 Argentina 74 Austria 75 Belgium 76 Brazil 77 Bulgaria 78 Canada 79 Czech Republic 8 Finland 81 Germany 82 Greece 83 Hungary 84 Italy 85 Korea 86 Mexico 87 Poland 88 Portugal 89 Spain 9 Switzerland 91 Venezuela 92 PharmaTrend Validation 93 Austria 95 Belgium 96 Czech Republic 97 Finland 98 Germany 99 Hungary 1 Italy 11 Poland 12 Portugal 13 Spain 14 Switzerland 15 Hospital Validation 16 Austria 18 Belgium 19 Bulgaria 11 Canada 111 China 112 Germany 113 Italy 114 Korea 115 Philippines 116 Spain 117 Switzerland 118 United Kingdom 119 Specialty Markets Validation Forecasting Validation Accuracy (cont d) 124 Timeliness 129 Contact acts 13

3 Abstract Dear Client: With this edition of ACTS the IMS Health Annual Report on Quality Assessment we are continuing a 27-year tradition of documenting the quality of our products for our customers. Quality, which can be expressed quite simply as sound information at the right time, can be measured in terms of Accuracy and Timeliness of Delivery. These aspects of quality are paramount to users of IMS Health data and analytics, and through our publication of ACTS, we demonstrate our commitment to both. In performing our analysis, we hold our last year s performance against strict thresholds and then report on both achievements and challenges. Accuracy metrics are derived from validation processes that reflect how close our data estimates were to the industry s actual numbers. To make the comparison, we collect data down to the pack level on over 7, individual product forms from more than 2,3 pharmaceutical company affiliates in over 6 countries. Getting returns back from all 2,3 customers takes time normally a full year. For this reason, we can only update you now on validity metrics for 12; the validation process for 13 has just begun. With the 12 data, we ve generally seen a minor decline against prior year typically of one percentage point in the overall precision index, which is calculated as an aggregate of the precision in the retail, hospital, and pharmacy-based services. The overall precision level is evidence of continued stability for 12. It is perfectly in line with that of previous years when we saw only slight fluctuations on a high precision level of 93 to 94. This degree of stability is also visible in all underlying offering types: retail and pharmacy at 94 and hospital reports at 9. OTC offerings in the Consumer Health area even had their second-best year in a five-year history, at 93. Clearly, some markets saw economic pressure in 12, mostly in the Euro zone and shortly after the turning point of the European financial crisis. Validation results indicate that Accuracy in the US has declined by nearly two percentage points, mainly due to the fact that a series of blockbuster products faced patent expiration, which caused pre-expiry pipeline effects. Meanwhile, the precision level dropped in the two leading emerging markets, China and India, also driven by rapid changes in the logistics and infrastructure of pharmaceutical distribution. In contrast, 11 countries more than half from Latin America have shown improvement over the preceding year. On the delivery side, we are proud to report that a challenging trend has come to a stop: in the first three quarters of 13, delivery on average was made 24.9 days after the end of the reporting period exactly as it had been in the prior year. Meanwhile, on-target performance even improved to 82. This is not yet at the level set in 11 and earlier, but could be interpreted as a turning point. As in previous years, ACTS will give you an honest appraisal of the quality of IMS Health's core offerings, reporting on a mix of favorable and less favorable trends and conditions. Please be assured 3 acts 13

4 that the entire IMS Health Statistical Services team, the IMS Health Global Operations community and our local offices will strive for further improvement where necessary and retain the excellent results already achieved. The ACTS program is unparalleled across our industry and is very demanding in terms of time and effort. We would like to thank all our clients for helping to make this report possible through your outstanding collaboration. Your comments and questions are very welcome; we invite you to keep the discussion alive and help us make ACTS a superior and relevant reference. Yours sincerely, Stefan Ziegele Vice President IMS Statistical Services 4 acts 13

5 Accuracy The IMS Validation Studies, with their global reach and standardized measures, provide pharmaceutical companies with an impartial and forthright reference with which to judge the quality of IMS data. By thus reporting on the precision of IMS decision-support tools, validation studies facilitate pharmaceutical companies international decision making. The Validation Process IMS conducts its Validation Studies in close co-operation with our service subscribers. Once we complete our year-end pharmacy audit, we supply our subscribers with software that presents our estimated yearly sales volume for each product pack. Subscribers then enter their actual sales volume based on what they supplied to retail pharmacies. We then calculate an R-Value representing the ratio of estimated sales as projected by IMS to actual sales as reported by our industry partners. For each product examined, we calculate an individual R-Value. We also calculate an average R-Value across all validated product forms. R-Values indicate the scale of overestimation or underestimation in IMS results. An R-Value of 1. is the ideal and would mean that our projection matched reality exactly. Due to the nature of statistical sampling, R-Values typically deviate from 1., and it is only practical to strive for individual R-Values that are clustered tightly around this theoretical ideal. We express audit precision (or the degree of clustering) as the percentage of all individual R-Values that fall within a predefined range of deviation around the average R-Value. The standard precision range is ±22.5 percentage points, sometimes paired with a tighter range of ±17.5 percentage points around the average over/underestimation. The greater the data precision, the more tightly R- Values will be clustered in the centre of this range. A precision value of 9 percent, paired with a zero percent bias, can be interpreted as follows: On average, IMS audit data reflect a high degree of homogeneity since 9 percent of the validated product forms lie between 22.5 percent and percent of the reported industry numbers. If we were to apply the tighter ±17.5 percent precision range to the same data as an additional measure, an 85 percent value would indicate that: 85 percent of the validated product forms were between 17.5 percent and percent of the average R- Value and 5 percent deviated by more than ±17.5 percent but less than ±22.5 percent. The remaining 1 percent were outside the ±22.5 percentage range. 5 acts 13

6 Conceptually, comparing IMS audit estimates with manufacturer sales data requires that the numbers be fully compatible. This compatibility hinges on the ability of companies participating in the validation study to segregate their internal sales data, isolating those sales channeled to the pharmacy retailing sector. The degree to which they can do this correlates closely with the technical infrastructure of the country and the complexity of the distribution system. When sales to other market sectors (e.g., tenders, exports) are not segregated and instead are included in a company s sales, the assumption is that IMS data have underestimated reality, and consequently they are viewed as incorrect. Parallel trade practices add another element of incompatibility to the data. Typically, manufacturers are unaware of the sales volume that sub-distributors and pharmacies export to other countries (parallel exports) or import from other countries (parallel imports). In parallel export situations, the industry numbers are usually inflated by sales that never entered the domestic pharmacy market. Conversely, in parallel import situations in which the imported items are not isolated, for example through official parallel traders, IMS numbers are usually inflated. Due to growing issues with data incompatibility, validation studies are gradually losing some of their potency as an objective measure of accuracy. Thus we are in the process of evaluating measures of data relevance for those regions highly affected by parallel business (e.g., European rim). Nevertheless, we believe that once we exclude products typically traded in parallel from the validation process, the exercise still provides a good overall picture of the accuracy and trends achieved in the individual markets. Validation Study results are considered to be representative of the survey universe if more than percent of the market is reflected in what our data partners send us. If the total market coverage reported by our data partners falls between 1 and percent, validation results may still give a good indication of change from one year to the next, but otherwise must be used with care. Studies with participation rates less than 1 percent are included in the ACTS report but marked as not representative. The 12 Validation Results The validation process usually starts 2-3 months after the close of the year being validated. Typically, it can take up to ten months after we receive final feedback and can complete the analysis of any given country. This year, the last completed materials for 12 were returned to us in February 14. The 12 participation level decreased slightly to a total of 39 companies on average participating in a country s validation process, compared to 4 companies in 11. In total, 2,321 company affiliates world-wide participated in the 12 validation surveys and supplied 7,927 product forms for analysis. Global Validation Results Until a couple of years ago, we only validated IMS retail audits while hospital, OTC and PharmaTrend offerings were quality-assessed more on a sporadic basis. Along with an upgrading of the ACTS validation process, we also incorporated these other standard deliverables in ACTS and have provided you lately with individual validation results. One request from our readers community was to 6 acts 13

7 summarize all individual validation results to one single metric the Global Index. This is an aggregate of all validations performed with uninterrupted 5-years data and serves as a high level indicator on IMS data accuracy. For 12, this global index utilizes the outcome from 88 validation studies and demonstrates a high degree of stability across the 5-years time period. Lately, a slight reduction by 1.2 percentage points has been visible but keeps the index at a robust value of still in line with previous years results. Global Index Retail Validation Results For the 12 validation studies, 61 countries provided analyzable results. No validation study was necessary in Denmark, Finland, the Netherlands, Norway and Sweden because we collect full census data in these countries. There, precision results are assumed to be 1 percent. This makes a total of 66 sets of validation results, of which 56 had uninterrupted five-year results. The overall degree of precision in IMS pharmaceutical reports is best described by an aggregated precision index for these 56 countries: Retail Index acts 13

8 Overall, the Retail Index over the 5-year period documents solid outcome in maintaining existing levels of data quality well above the 9 margin. However, in 12, the index showed decline of one percentage point over 11 and with 94. reached the lowest precision level of the last five years. Regional Retail Results The 66 countries are distributed over the greater IMS regions as follows: Regional Distribution of North America Latin America North Europe & Africa Central Europe East Europe South Europe & Mid East AsiaPacific Japan 8 3 Regional Retail Index 11/12 World North America Latin America North Europe & Africa Central Europe East Europe Improvement Deterioration South Europe & Mid East AsiaPacific Japan acts 13

9 Three regions managed to improve or maintain their 11 result also in 12. Japan continued to hold the lead with 99.7, followed by South Europe & Mid East at 97.4 and East Europe at Six regions declined compared to 11, most significantly AsiaPacific by 3.6 percentage points to All regions in detail and their main contributors to changes are listed below: IMS REGION PRECISION 12 IN CHANGE VS. 11 IN PERCENTAGE POINTS MAIN DRIVERS North America USA Latin America Venezuela, Chile North Europe & Africa United Kingdom Central Europe Germany East Europe Poland, Hungary South Europe & Mid East Greece, Spain AsiaPacific India, Korea Japan 99.7 ±. No change More details on the markets with an improved or declining precision are given in the following table: Results by Country IMPROVEMENT IN DETERIORATION IN COUNTRY COUNTRY Argentina Algeria Bolivia Bulgaria Chile Colombia Croatia Dominican Rep Ecuador India Greece Ireland Jordan Indonesia Lithuania Korea Peru Latvia Slovenia Lebanon Venezuela New Zealand Paraguay Serbia Sri Lanka Vietnam Eleven countries showed significant improvement (>2 percentage points) over 11. Remarkable growth of more than 14 percentage points can be reported for Bolivia. 15 countries showed more accentuated decline (>2 percentage points) over 11; five of them declined by ten and more percentage points. All these countries are in the focus of our quality-improving initiatives acts 13

10 Country-specific Results The validation studies mentioned on the following country pages refer to the IMS retail reports, with the following exceptions: COUNTRY Croatia, Czech Republic, Hungary, India, Poland, Serbia, Slovak Republic, Slovenia, United States Hong Kong, Indonesia, Vietnam Malaysia, Singapore MARKET COVERED Hospital market included Total market Total private market Further parts of this accuracy section, which follow the retail validation pages, highlight other validation initiatives of high interest to our data subscribers: OTC Validation Studies PharmaTrend Validation Studies Hospital Validation Studies Specialty Markets Validation Results Validating IMS Forecasting Services In addition, we are providing updates on the latest measures we ve taken to sustain today s quality levels: Universe Updates Data Capture Sample Fulfillment 1 acts 13

11 Algeria Retail Validation Study 12 Number of companies 13 The 12 LMNPA validation study was attended by 13 companies, two more than in Validated market share The participants supplied 235 product forms for evaluation, of which 1 (4) Number of R-Values 235 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 1 market share of the participating manufacturers was 27 in terms of units The overall bias turned from 1.3 underestimation in 11 to 1.2 overestimation in 12. Low and high sales volume products were overestimated by 3.9 and 1.5, respectively, whereas the medium sales volume group showed a small underestimation of ±17.5 ±22.5 The overall precision index declined from 84.2 in 11 to 78.4 in 12. The medium sales volume group surpassed this score at Low and high sales volume products had precision values of 76. and 76.1, respectively. Looking only at forms validated in both years, 11 and 12, the precision index declined from 85.3 in 11 to 83.1 in 12. Enhance projection methodology 11 acts 13

12 Argentina Retail Validation Study 12 Number of companies 64 The 12 PMA validation study was attended by 64 companies, the same number as in Validated market share The participants supplied 2,929 product forms for evaluation, of which 6 (2) Number of R-Values 2,929 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 6 market share of the participating manufacturers was 59 in terms of units The overall underestimation increased from 3.7 in 11 to 4.5 in 12. Low sales volume products were underestimated by 2.9, medium by 3.1, and the high sales volume group showed a 5.6 underestimation ±17.5 ±22.5 The overall precision index improved from 91.3 in 11 to 93.6 in 12. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 91. and 92.5, respectively. Looking only at forms validated in both years, 11 and 12, the precision index improved from 91.7 in 11 to 95.2 in 12. No action required from the statistical point of view 12 acts 13

13 Australia Retail+Hospital Validation Study 12 Number of companies 18 The first validation study, combining the Australian retail and hospital audits, was attended by 18 companies that supplied 779 Validated market share 6 product forms for evaluation. Of these, 17 Number of R-Values 779 (2) showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 17 market share of the participants was only 6 in terms of units and, therefore, not representative for the entire audit Low Med. High Total The bias analysis revealed an overall underestimation of 2.5 in 12. Low sales volume products were underestimated by 3.9 and medium by 2.2. Only few products were available in the high sales volume class, so these were grouped into the medium class for analysis. The results are presented in orange as they are not representative due to low validation coverage The precision analysis showed an overall result of 96.1 in 12. The high sales volume group surpassed this score at Low sales volume products had a precision outcome of Low Medium High Total Motivate more clients to participate in the validation study 13 acts 13

14 Austria Retail Validation Study 12 Number of companies 16 The 12 DPMOE validation study was attended by 16 companies, the same number Validated market share 25 as in 11. The participants supplied 654 product forms for evaluation, of which 5 Number of R-Values 654 (<1) showed extreme deviation and had to be excluded from the bias analysis. The Number of extreme values 5 validated market share of the participating manufacturers was 25 in terms of units The overall underestimation increased slightly, from 1.3 in 11 to 1.9 in 12. Low sales volume products were underestimated by 2.4, medium by 2.3, and the high sales volume group showed a 1.7 underestimation ±17.5 ±22.5 The overall precision index improved slightly from 97.8 in 11 to 97.9 in 12. The medium and high sales volume groups surpassed this score at 98.1 and 99.1, respectively. Low sales volume products had a precision value of Looking only at forms validated in both years, 11 and 12, the precision index declined slightly from 98.8 in 11 to 98.3 in 12. No action required from the statistical point of view 14 acts 13

15 Bangladesh Retail Validation Study 12 Number of companies 12 The 12 BCP validation study was attended by 12 companies, the same number as in Validated market share The participants supplied 1,617 product forms for evaluation, of which 69 (4) Number of R-Values 1,617 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 69 market share of the participating manufacturers was 39 in terms of units The overall underestimation increased from 18.7 in 11 to 22.4 in 12. Low sales volume products were underestimated by 25.1, medium by 22.9, and the high sales volume group showed a 21.4 underestimation ±17.5 ±22.5 The overall precision index declined from 77.2 in 11 to 75.2 in 12. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 51.1 and 65.4, respectively. Looking only at forms validated in both years, 11 and 12, the precision index declined from 78.2 in 11 to 75. in 12. New pharmacy census in progress Review regional granularity 15 acts 13

16 Belgium Retail Validation Study 12 Number of companies 8 The 12 LMPB validation study was attended by 8 companies, 7 less than in 1 Validated market share 8 when the last validation survey was conducted. The participants supplied 5 product Number of R-Values 5 forms for evaluation, 5 (2) had ex- treme deviation and were excluded from the Number of extreme values 5 bias analysis. The validated market share was only 8 in unit terms and, therefore, not representative for the entire audit The overall underestimation improved from 3. in 1 to 2.4 in 12. Low sales volume products were underestimated by 1.6 and medium by 2.5. As there were only few forms available in the high sales volume class, these were grouped into the medium class for analysis. Results presented in orange are not representative due to low validation coverage ±17.5 ±22.5 The overall precision index improved from 93.9 in 1 to 96. in 12. The medium sales volume group surpassed this score at Low sales volume products had a precision result of Looking only at forms validated in both years, 1 and 12, the precision index improved from 9.9 in 1 to 97.4 in 12. Motivate more companies to participate in the validation study 16 acts 13

17 Bolivia Retail Validation Study 12 Number of companies 45 The 12 PMBO validation study was attended by 45 companies, 17 less than in Validated market share The participants supplied 1,335 product forms for evaluation, of which 1 Number of R-Values 1,335 (15) showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 1 market share of the participating manufacturers was 55 in terms of units The overall underestimation improved further, from 11.7 in 11 to 9.8 in 12. Low sales volume products were underestimated by 5.6, medium by 8.7, and the high sales volume class showed a 1.9 underestimation ±17.5 ±22.5 The overall precision index improved strongly by 14.4 percentage points, from 4.8 in 11 to 55.2 in 12. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 43. and 5.6, respectively. Looking only at forms validated in both years, 11 and 12, the precision index improved from 45.3 in 11 to 56.1 in 12. Improve panel fulfillment 17 acts 13

18 Brazil Retail Validation Study 12 Number of companies 28 The 12 PMB validation study was attended by 28 multinational companies, the same Validated market share 18 number as in 11. The participants supplied 1,25 product forms for evaluation, of Number of R-Values 1,25 which 9 (<1) showed extreme deviation and had to be excluded from the bias analysis. Number of extreme values 9 The validated market share of the participating manufacturers was 18 in terms of units The overall underestimation increased by four percentage points, from 3.8 in 11 to 7.8 in 12. Low sales volume products were underestimated by 9.9, medium by 8.3, and the high sales volume group showed a 6.9 underestimation ±17.5 ±22.5 The overall precision index declined slightly, from 93.9 in 11 to 93.7 in 12. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 89.8 and 92., respectively. Looking only at forms validated in both years, 11 and 12, the precision index improved from 95.8 in 11 to 98.4 in 12. Conduct distribution channel survey in acts 13

19 Bulgaria Retail Validation Study 12 Number of companies 59 The 12 BGPI validation study was attended by 59 companies, ten more than in Validated market share The participants supplied 851 product forms for evaluation, of which 16 (2) Number of R-Values 851 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 16 market share of the participating manufacturers was 58 in terms of units The overall bias turned from 1. underestimation in 11 to a small overestimation of.5 in 12. Low sales volume products were underestimated by 1.5, medium by.8, and the high sales volume group showed a 1.5 overestimation ±17.5 ±22.5 The overall precision index declined from 96.7 in 11 to 94.5 in 12. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 87.8 and 92.9, respectively. Looking only at forms validated in both years, 11 and 12, the precision index declined from 97.7 in 11 to 94.4 in 12. No immediate action required from the statistical point of view 19 acts 13

20 Canada Retail Validation Study 12 Number of companies 88 Data from 88 companies, one more than in 11, was available for the 12 CDH Drugstores validation study. In total, 3,259 prod- Validated market share 95 uct forms were processed, of which 7 (<1) Number of R-Values 3,259 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 7 market share equaled 95 in terms of units, representing the highest participation rate across all countries The overall overestimation increased slightly, from.6 in 11 to 1.2 in 12. Low and high sales volume products were both overestimated by 1. and medium sales volume products showed a 1.6 overestimation ±17.5 ±22.5 The overall precision index showed stability at 98.9 in 12. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 97.3 and 98.7, respectively. Looking only at forms validated in both years, 11 and 12, the precision index declined slightly from 99.1 in 11 to 98.9 in 12. No action required from the statistical point of view acts 13

21 Central America Retail Validation Study 12 Number of companies 31 The 12 PMCA validation study was attended by 31 companies, two more than in Validated market share The participants supplied 1,833 product forms for evaluation, of which 68 (4) Number of R-Values 1,833 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 68 market share of the participating manufacturers was 33 in terms of units The overall underestimation increased slightly, from 1.5 in 11 to 2.9 in 12. Low sales volume products were underestimated by 3.7, medium by 2.6, and the high sales volume classes showed a 3. underestimation ±17.5 ±22.5 The overall precision index improved slightly, from 87.4 in 11 to 87.9 in 12. The high sales volume group surpassed this score at Low and medium sales volume products had precision results of 77.1 and 87.6, respectively. Looking only at forms validated in both years, 11 and 12, the precision index improved from 89.1 in 11 to 91.8 in 12. Review projection level 21 acts 13

22 Chile Retail Validation Study 12 Number of companies 15 The 12 PMCH validation study was attended by 15 companies, two more than in Validated market share 11. The participants supplied 842 product forms for evaluation, of which only one Number of R-Values 842 (<1) showed extreme deviation and had to be excluded from the bias analysis. The Number of extreme values 1 validated market share of the participating manufacturers was in terms of units The 12 overall bias analysis revealed the same result of.1 overestimation as in 11. Low sales volume products were overestimated by 1.7, whereas medium and high sales volume products were underestimated by.4 and.3, respectively ±17.5 ±22.5 The overall precision index improved by 5.4 percentage points, from 93.6 in 11 to 99. in 12. The high sales volume group surpassed this score at a perfect 1. Low and medium sales volume products had precision values of 96.7 and 98.5, respectively. Looking only at forms validated in both years, 11 and 12, the precision index improved from 96.5 in 11 to 99.4 in 12. Conduct distribution channel survey in acts 13

23 Colombia Retail Validation Study 12 Number of companies 18 The 12 PMC validation study was attended by 18 companies, ten more than in 11. Validated market share 23 The participants supplied 1,78 product forms for evaluation, of which 82 (8) Number of R-Values 1,78 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 82 market share of the participating manufacturers was 23 in terms of units The overall underestimation improved from 9.8 in 11 to 7.8 in 12. Low sales volume products were underestimated by 2.7, medium by 4.8, and the high sales volume group showed a 1.4 underestimation ±17.5 ±22.5 The overall precision index declined from 84.3 in 11 to 82. in 12. The medium and high sales volume groups surpassed this score at 83.4 and 85.7, respectively. Low sales volume products had a precision value of Looking only at forms validated in both years, 11 and 12, the precision index improved slightly from 87.8 in 11 to 88. in 12. Conduct distribution channel survey Update universe and sample 23 acts 13

24 Croatia Retail+Hospital Validation Study 12 Number of companies 1 The 12 validation study, combining the Croatian retail and hospital audits, was attended by 1 companies, two more than in Validated market share The participants supplied 541 product Number of R-Values 541 forms for evaluation, of which 2 (<1) showed extreme deviation and had to be excluded Number of extreme values 2 from the bias analysis. The validated market share of the participants equaled 41 in terms of units The overall overestimation increased from.6 in 11 to 2.4 in 12. Low sales volume products were overestimated by.7, medium by 1.6, and the high sales volume group revealed a 3.4 overestimation ±17.5 ±22.5 The overall precision index improved from 95. in 11 to 99.7 in 12. The medium and high sales volume classes surpassed this score both at a perfect 1. Low sales volume products had a precision value of Looking only at forms validated in both years, 11 and 12, the precision index improved from 99.6 in 11 to 1 in 12. No action required from the statistical point of view 24 acts 13

25 Czech Republic Retail+Hospital Validation Study 12 Number of companies 29 The 12 validation study, combining the Czech retail and hospital audits, was attended by 29 companies, four more than in Validated market share The participants supplied 1,147 product Number of R-Values 1,147 forms for evaluation, of which four showed extreme deviation and had to be excluded Number of extreme values 4 from the bias analysis. The validated market share of the participants was 48 in terms of units The overall underestimation increased slightly, from.7 in 11 to.9 in 12. Low sales volume products were underestimated by 1.4, medium by.7, and high sales volume products were underestimated by ±17.5 ±22.5 The overall precision index declined marginally by.1 percentage point, from 99. in 11 to 98.9 in 12. The high sales volume group surpassed this score at a perfect 1. Low and medium sales volume products had precision values of 94.1 and 99.5, respectively. Looking only at forms validated in both years, 11 and 12, the precision index declined slightly from 99.4 in 11 to 99.1 in 12. No action required from the statistical point of view 25 acts 13

26 Dominican Republic Retail Validation Study 12 Number of companies 19 The 12 PMDR validation study was attended by 19 companies, twelve less than in Validated market share The participants supplied 1,251 product forms for evaluation, of which 122 Number of R-Values 1,251 (1) showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 122 market share of the participating manufacturers was 27 in terms of units The overall underestimation improved by 2.3 percentage points, from 8.4 in 11 to 6.1 in 12. Low sales volume products were underestimated by 6.9, medium by 3.4, and the high sales volume group showed a 7.4 underestimation ±17.5 ±22.5 The overall precision index declined by 6.4 percentage points, from 78.5 in 11 to 72.1 in 12. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 58.9 and 71.4, respectively. Looking only at forms validated in both years, 11 and 12, the precision index declined from 84.1 in 11 to 76. in 12. Pharmacy universe updated 26 acts 13

27 Ecuador Retail Validation Study 12 Number of companies 89 The 12 PME validation study was attended by 89 companies, one more than in 11. Validated market share 72 The participants supplied 2,449 product forms for evaluation, of which 8 (<1) Number of R-Values 2,449 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 8 market share of the participating manufacturers was 72 in terms of units The overall underestimation improved marginally from 4.8 in 11 to 4.7 in 12. Low sales volume products were underestimated by 2.7, medium by 3.7, and the high sales volume group showed a 5.8 underestimation ±17.5 ±22.5 The overall precision index improved from 94.4 in 11 to 97.2 in 12. The medium sales volume group surpassed this score at Low and high sales volume groups both had precision values of Looking only at forms validated in both years, 11 and 12, the precision index improved from 95.1 in 11 to 97.9 in 12. Include more distributors to improve panel coverage 27 acts 13

28 Egypt Retail Validation Study 12 Number of companies 46 The 12 PIE validation study was attended by 46 companies, 16 more than in 11. Validated market share 24 The participants supplied 64 product forms for evaluation, none of which showed any Number of R-Values 64 extreme deviation. The validated market share of the participating manufacturers equaled 24 in terms of units. Number of extreme values The overall underestimation improved by 2.1 percentage points, from 4. in 11 to 1.9 in 12. Low sales volume products were underestimated by 1.8, medium by 2.2, and the high sales volume class showed a 1.7 underestimation The overall precision index showed again a perfect result of 1 in 12. This excellent result is also distributed over all sales volume groups. Looking only at forms validated in both years, 11 and 12, the precision index remained at ±17.5 ±22.5 No action required from the statistical point of view 28 acts 13

29 Estonia Retail Validation Study 12 Number of companies 17 The 12 ESTPI validation study was attended by 17 companies, eleven more than Validated market share 15 in 11. The participants supplied 2 product forms for evaluation, of which 3 (1) Number of R-Values 2 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 3 market share of the participating manufacturers equaled 15 in terms of units The overall bias improved from a 2. underestimation in 11 to a small.9 overestimation in 12. Low sales volume products were underestimated by 1.4, medium by 1.3, and the high sales volume group showed a 2.3 overestimation ±17.5 ±22.5 The overall precision index improved slightly, from 88.1 in 11 to 88.4 in 12. The medium and high sales volume groups surpassed this score at 92. and 89.1, respectively. Low sales volume products had a precision value of Looking only at forms validated in both years, 11 and 12, the precision index improved from 92.5 in 11 to 94.4 in 12. Review projection level for OTC data 29 acts 13

30 Germany Retail Validation Study 12 Number of companies 35 The 12 DPM validation study was attended by 35 companies, two more than in Validated market share The participants supplied 3,139 product forms for evaluation, of which 46 (1) Number of R-Values 3,139 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 46 market share of the participating manufacturers was 24 in terms of units The overall underestimation increased slightly from 3.7 in 11 to 5.2 in 12. Low sales volume products were underestimated by 3.4, medium by 3.8, and the high sales volume group showed a 6.4 underestimation ±17.5 ±22.5 The overall precision index declined from 97.1 in 11 to 95.6 in 12. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 92. and 95.2, respectively. Looking only at forms validated in both years, 11 and 12, the precision index declined slightly from 97.5 in 11 to 96.7 in 12. Review direct sales projection frame 3 acts 13

31 Greece Retail Validation Study 12 Number of companies 85 The 12 GPI validation study was attended by 85 companies, 17 more than in 11. Validated market share 69 The participants supplied 1,74 product forms for evaluation, of which 27 (3) Number of R-Values 1,74 showed extreme deviation and had to be excluded from the bias analysis. The validated Number of extreme values 27 market share of the participating manufacturers was 69 in terms of units The overall bias analysis revealed a 2.6 underestimation in 12. Low sales volume products were underestimated by 3.1, medium by 2.7, and the high sales volume group revealed a 2.5 underestimation ±17.5 ±22.5 The overall precision index improved further, from 85.5 in 11 to 89.2 in 12. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 71.9 and 89., respectively. Looking only at forms validated in both years, 11 and 12, the precision index declined slightly from 9.1 in 11 to 89. in 12. New universe study conducted Enhance sampling method based on universe study outcome 31 acts 13

32 Hong Kong Retail Validation Study 12 Number of companies 26 Data from 26 companies, ten less than in 9 when the previous validation study Validated market share 31 was conducted, was available for the 12 HKPA validation study. In total, 964 product Number of R-Values 964 forms were processed, of which 132 (14) showed extreme deviation and had to be excluded Number of extreme values 132 from the bias analysis. The validated market share equaled 31 in terms of units The overall underestimation showed stability at 11.8 in 12. Low sales volume products were underestimated by 19.8, medium by 18., and the high sales volume group had a 2.6 underestimation ±17.5 ±22.5 The overall precision index declined from 75.2 in 9 to 73. in 12. The high sales volume group surpassed this score at 8.. Low and medium sales volume products had precision values of 6.3 and 67.7, respectively. Looking only at forms validated in both years, 9 and 12, the precision index declined marginally from 83.8 in 9 to 83.7 in 12. Review projection level and panel composition 32 acts 13

33 Hungary Retail+Hospital Validation Study 11 Number of companies 82 The 12 validation study, combining the Hungarian retail and hospital audits, was attended by 82 companies, eight less than in Validated market share The participants supplied 1,73 product Number of R-Values 1,73 forms for evaluation, of which 19 (1) showed extreme deviation and had to be excluded Number of extreme values 19 from the bias analysis. The validated market share of the participating companies equaled 76 in terms of units The overall underestimation improved from 4.1 in 11 to 1.7 in 12. Low sales volume products were underestimated by 1.5, medium by 1.9, and the high sales volume group showed a 1.7 underestimation ±17.5 ±22.5 The overall precision index declined slightly, from 98.6 in 11 to 96.9 in 12. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 94.6 and 96.4, respectively. Looking only at forms validated in both years, 11 and 12, the precision index declined slightly from 98.7 in 11 to 97.7 in 12. No action required from the statistical point of view 33 acts 13

34 India Retail+Hospital Validation Study 12 Number of companies 17 The 12 validation study, combining the Indian retail and hospital audits, was attended by 17 companies, six more than in Validated market share They supplied 1,8 product forms for Number of R-Values 1,8 evaluation, of which 143 (12) showed extreme deviation and had to be excluded Number of extreme values 143 from the bias analysis. The validated market share was 8 in units and, therefore, not representative for the entire audit The overall underestimation increased by six percentage points, from 4.7 in 11 to 1.7 in 12. Low sales volume products were underestimated by 6.8, medium by 8., and the high sales volume group showed a 13.1 underestimation. Results presented in orange are not representative due to low validation coverage The overall precision index declined by 4.7 percentage points, from 86.5 in 11 to 81.8 in 12. Looking only at forms validated in both years, 11 and 12, the precision index improved by 4.3 percentage points, from 86.6 in 11 to 9.9 in Motivate more companies to participate in the validation study 34 acts 13

35 Indonesia Total Market Validation Study 12 Number of companies 62 Data from 62 companies, sixteen less than in 11, was available for the 12 ITMA Validated market share 43 validation study. In total, 4,981 product forms were processed, of which 843 (17) Number of R-Values 4,981 showed extreme deviation and had to be excluded from the bias analysis. The validated market share equaled 43 in terms of units. Number of extreme values The overall bias increased slightly to a 1.2 underestimation. Low sales volume products were underestimated by 6.6, medium by 4., and the high sales volume group showed a slight.1 underestimation ±17.5 ±22.5 The overall precision index declined to 66.7 in 12. The low sales volume class surpassed this score at Medium and high sales volume products had precision results of 64.3 and 66.7, respectively. Looking only at forms validated in both years, 11 and 12, the precision index improved from 73.6 in 11 to 8.7 in 12. Enhance projection methodology Improve data collection and coding quality 35 acts 13

36 Ireland Retail Validation Study 12 Number of companies 12 The 12 IPI validation study was attended by 12 companies, eleven less than in 11. Validated market share 6 The participants supplied 188 product forms for evaluation, of which 6 (3) showed extreme Number of R-Values 188 deviation and had to be excluded from the bias analysis. The validated market Number of extreme values 6 share of the participating manufacturers was only 6 in terms of units and, therefore, not representative for the entire audit The overall bias turned from 1.2 underestimation in 11 to 1. overestimation in 12. Low sales volume products were overestimated by.1 and medium by 1.2. Only few forms were available in the high sales volume class, so these were grouped into the medium class for analysis. Results presented in orange are not representative due to low validated market coverage The overall precision index declined from 95.4 in 11 to 91.4 in 12. The medium sales volume group surpassed this score at Low sales volume products had a precision result of Looking only at forms validated in both years, 11 and 12, the precision index remained at a perfect 1. ±17.5 ±22.5 Motivate more companies to participate in the validation study 36 acts 13

37 Italy Retail Validation Study 12 Number of companies 29 The 12 IMF validation study was attended by 29 companies, one more than in 11. Validated market share 32 The participants supplied 1,81 product forms for evaluation, of which ten (<1) Number of R-Values 1,81 showed extreme deviation and had to be excluded from the bias calculation. The validated Number of extreme values 1 market share of the participating manufacturers was 32 in terms of units The overall underestimation increased slightly by.3 percentage points, from 2.2 in 11 to 2.5 in 12. Low sales volume products were underestimated by 2.4, medium by 3.7, and the high sales volume class revealed a 1.9 underestimation ±17.5 ±22.5 The overall precision index declined from 98.7 in 11 to 96.8 in 12. The high sales volume group surpassed this score at 98.. Low and medium sales volume products had precision results of 94.4 and 96.1, respectively. Looking only at forms validated in both years, 11 and 12, the precision index declined slightly from 99.1 in 11 to 98.3 in 12. No action required from the statistical point of view 37 acts 13

38 Japan Retail+Hospital Validation Study 12 Number of companies 53 The 12 JPM validation study was attended by 53 companies, two more than in 11. Validated market share 71 The participants supplied 3,56 product forms for evaluation, of which six (<1) Number of R-Values 3,56 showed extreme deviation and were excluded from the bias analysis. The validated Number of extreme values 6 market share of the participating manufacturers was 71 in terms of units The overall bias improved to +.1 in 12. Low sales volume products were overestimated by.5, medium by 1.2, and the high sales volume group showed a.1 overestimation ±17.5 ±22.5 The overall precision index showed again a very good result in 12, ending at The high sales volume group surpassed this score at a perfect 1. Low and medium sales volume products had precision indices of 99. and 99.6, respectively. Measurement at the tighter ±17.5 interval revealed a precision result of No action required from the statistical point of view 38 acts 13

39 Jordan Retail Validation Study 12 Number of companies 1 The 12 JPI validation study was attended by 1 companies, five less than in 11. The Validated market share 17 participants supplied 349 product forms for evaluation, of which 7 (2) showed extreme Number of R-Values 349 deviation and had to be excluded from the bias analysis. The validated market Number of extreme values 7 share of the participating manufacturers was 17 in terms of units The overall underestimation improved further, from 16.6 in 11 to 1.1 in 12. Low sales volume products were underestimated by 4, medium by 6.8, and the high sales volume group showed a 13.7 underestimation ±17.5 ±22.5 The overall precision index improved by 6.3 percentage points, from 69.1 in 11 to 75.4 in 12. The medium sales volume group surpassed this score at Low and high sales volume products had precision values of 83.2 and 72., respectively. Looking only at forms validated in both years, 11 and 12, the precision index declined slightly from 76.9 in 11 to 76.3 in 12. Motivate more companies to participate in the validation study 39 acts 13

40 Korea Retail Validation Study 12 Number of companies 16 The 12 KPA validation study was attended by 16 companies, three less than in 11. Validated market share 12 The participants supplied 696 product forms for evaluation, of which 31 (4) showed Number of R-Values 696 extreme deviation and had to be excluded from the bias analysis. The validated market Number of extreme values 31 share of the participating manufacturers was 12 in terms of units The overall underestimation increased from 11. in 11 to 15.9 in 12. Low sales volume products were underestimated by 18.9, medium by 14.3, and high sales volume products showed a 16.7 underestimation ±17.5 ±22.5 The overall precision index declined from 88. in 11 to 82.9 in 12. The high sales volume group surpassed this score at Low and medium sales volume products had precision values of 64.4 and 78.1, respectively. Looking only at forms validated in both years, 11 and 12, the precision index declined from 88.8 in 11 to 79.1 in 12. Review projection level and panel composition Improve data collection and coding quality 4 acts 13