1. The Pharmaceutical Industry in Europe Key data INDUSTRY (EFPIA Total) (*)1990200020022003 Production63,127121,311158,647170,000 (e) Exports23,18089,443144,022170,000 (e) Imports16,11362,810108,063130,000 (e) Trade balance7,06726,63335,95940,000 (e) R&D expenditure7,94117,66120,16421,100 (e) Employment (units)500,762540,106588,091588,000 (e) R&D employment (units)76,28787,625100,503100,500 (e) Pharmaceutical market value at ex- factory prices 43,00586,696104,180111,500 (e) Values in € million unless otherwise stated (*) Excluding Turkey Source: EFPIA member associations (official figures) – (e): EFPIA estimate

2. European total pharmaceutical exports, imports & trade balance 1980-2003 (€ million) Note:Data 2003: EFPIA estimate Data based on SITC 54 Source:EFPIA Member Associations (official figures)

3. EU Trade balance – High technology sectors (€ million) – 2002 Source: Eurostat, SITC 54

4. Source: IMS World Review 2004 Breakdown of the world pharmaceutical market – 2003 sales

5. Breakdown of the world pharmaceutical market 1990 - 2003 Total pharmaceutical market value 1990: 135,900 million Euros 173,000 million Dollars Total pharmaceutical market value 2003: 412,290 million Euros 466,300 million Dollars Source: IMS World Review 2004

6. Total pharmacy market (at ex-factory prices) Average annual growth rate 1992-2002 Source: EFPIA member associations, PhRMA, JPMA

7. New Molecular Entities 1989-2003 Source: SCRIP Publications - EFPIA calculations (according to nationality of mother company)

8. Pharmaceutical R&D expenditure in Europe, USA and Japan, 1990-2003 € million, 2002 constant exchange rates Data 2003: estimate EFPIA & PhRMA Source: EFPIA member associations, PhRMA, JPMA

9. Pharmaceutical R&D expenditure in Europe, USA and Japan, 1990-2003 Million of national currency units* * National currency units: Europe: € million; USA: $ million; Japan: ¥ milliion x 100 Data 2003: estimate EFPIA & PhRMA Source: EFPIA member associations, PhRMA, JPMA

10. Source: EFPIA, 2000 Location of R&D spending by EU companies 1990-1999

11. Biopharmaceuticals Europe versus USA (2002) EuropeUSA Turnover (€ million)8,73331,994 R&D expenditure (€ million) 5,27417,201 Net loss (€ million)2,9219,913 Number of public companies (units) 102318 Number of employees (units) 33,304142,900 Source: Ernst & Young, ‘Beyond Borders, The Global Biotechnology Report 2003’ (data relate to publicly traded companies)

12. Share of Global Biotechnology Revenues Publicly traded companies (2002) Note: Global revenues of € million 43,730 (USA: 31,994; Europe: 8,733; Canada: 1,550; Asia/Pacific: 1,453) Source: Ernst & Young, ‘Beyond Borders, The Global Biotechnology Report 2003’

13. Share of Global Biotechnology R&D Expenses Publicly traded companies (2002) Note: Global R&D expenses of € million 23,269 (USA: 17,201; Europe: 5,274; Canada: 586; Asia/Pacific: 208) Source: Ernst & Young, ‘Beyond Borders, The Global Biotechnology Report 2003’

14. Source: CMR International Number of new molecular entities (NMEs) and biotechnology products first launched worldwide 1990-2003

15. R&D as a percentage of sales 1985-2003 Source: EFPIA Member Associations (official figures) – (e): EFPIA estimate

16. Number of Drugs in active R&D 1999-2003 Source: SCRIP, May 2003

17. EU / US ‘Global’ Environment USA Basic patent (20 years) Patent Term Restoration – max 5 years, 1984 Biotech Patent, 1983 Orphan Drug Act, 1984 Same levels of IPRs across all States Bayh-Dole Act + National Institutes for Health Economic environment (direct access to a large unified market; competitive market pricing) EUROPE Basic patent (20 years) SPC – max 5 years, 1992 Biotech Patent 2000-yet to be applied in 8 MS Orphan Drug Reg., 2000 Lower IPRs in some EU MS (+ EU enlargement) European Framework Research Programme Economic environment (no direct market access; price controls; free movement of goods)

18. R&D Expenditure as a percentage of GDP (2002) Note:Greece, Italy, Japan, The Netherlands, Switzerland: 2000 data; Belgium, Denmark, Germany, Ireland, Portugal, Spain, Sweden, Acceding countries: 2001 data Source:EUROSTAT & DG Research, ‘Statistics on Science and Technology in Europe: data 1991-2002’, February 2004; Swiss Federal Statistical Office (Switzerland)

19. 70 % USA 18 % Europe 4 % Japan 8 % ROW Innovation – Market penetration Geographical breakdown (by main markets) of sales of new medicines launched during the period 1998 - 2002 Source: IMS, 2003

20. Product life cycle in US and Europe Time Sales Europe US Delay in Market Access Utilisation and Price Level Generic competition Source: GSK European policies do not reward innovation but neutralise generic competition

21. Share of Parallel Imports in Pharmacy Market Sales (%) - 2002 % Note: Denmark, Germany, The Netherlands, Norway, Sweden, UK: Data 2002 Norway: share of total market sales (estimate) Source: EFPIA Member Associations

22. Total market sales (at ex-factory prices) in EU acceding countries (2002 – € Million) Note: Bulgaria, Estonia, Latvia, Lithuania: pharmacy sales only Source: IMS Health

23. EU Acceding & Candidate Countries GDP per capita (PPS) - € 2002 Source: Eurostat, Statistics in Focus 47/2003

24. Delays From Pricing And/Or Reimbursement Application To Reimbursement 0100200300400500600700800 Belgium Greece Portugal France Austria Finland Italy Norway Spain Netherlands Switzerland Sweden Denmark Ireland Germany UK (Days) Increasing overall delay P&R PricingReimbursement Publication 180 days90 days In Belgium - until January 2002, the transparency commission process had to be conducted before a company could apply for reimbursement of a given product. In France, only ambulatory care products have been included in this analysis. In Italy and Sweden the pricing and/or reimbursement procedure can start as soon as CPMP opinion is available (for centrally approved medicines). This analysis does not reflect the impact of recent reforms in Italy. In Spain anecdotal evidence suggests that delays have increased recently. In Switzerland a more comprehensive study concerning 191 files shows an average delay over 180 days. Finland has a two-tier reimbursement system, with a slower process for treatments of chronic diseases (reimbursed at 75%) and serious or life-threatening diseases, and a faster one for acute diseases. Delays shown in this study do not reflect this distinction, and actual pricing and reimbursement delays are typically longer for medicines in the 75%/100% reimbursement categories