Legemiddelindustriforeningen Tall og fakta 2002. Content. Content page 5-6 Abbreviations page 7 Summary and comments page 10-11

Legemiddelindustriforeningen Tall og fakta 2002 Content Content page 5-6 Abbreviations page 7 Summary and comments page 10-11 Chapter 1: The medicine market in Norway page 12-13 1.01 The number of active substances on the Norwegian market page 14 1.02 New medicines and active substances page 15 1.03 Number of product names in Norway page 16 1.04 The number of marketing authorisations in Norway page 17 1.05 Top 25 pharmaceutical companies on the Norwegian market page 18 1.06 Top 25 medicines on the Norwegian market in terms of sales value page 20-21 1.07 The 25 most used medicines in terms of defined daily doses (DDD) page 22-23 1.08 Top 20 medicines in Norway in terms of packaging units page 24-25 1.09 Medicine sales by main therapeutic groups page 26-27 1.10 The ten largest therapeutic groups as measured by sales page 28 1.11 Private pharmacies sales composition page 29 1.12 Medicine sales in Norway page 30 1.13 Pharmacy chain affiliation page 31 1.14 Pharmacy chain market share page 32 Chapter 2: Financing medicines page 34-35 2.01 Public spending on reimbursable prescription medicines page 36 2.02 Public spending on health care and medicines page 37 2.03 Public spending on medicines as a percentage of public health exp. page 38 2.04 Payment for pharmaceutical consumption page 39 2.05 Public health care expenditure, NOK per capita page 40 2.06 Cost structure at Norway s largest hospital page 41 2.07 Expenditure on medicines in the private and public sector page 42 2.08 Net public spending on medicines page 43 2.09 Changes in medicine prices and the general rate of inflation page 44 2.10 Growth determined by volume, price and transition to new medicines page 45 2.11 Evaluation of the reference pricing system page 46 2.12 Innovative medicines share of total medicine sales page 47 2.13 Sales of innovative medicines by medicine group page 48 2.14 Cost structure in health care institutions page 49 2.15 Consumer medicine expences compared to other expences page 50 Chapter 3: Non-prescription medicines page 52-53 3.01 Top 20 non-prescription medicines in terms of sales value page 54-55 3.02 Non-prescription medicines, share of total market value (PPP) page 56 3.03 Non-prescription medicines, market share in selected countries page 57 3.04 Non-prescritpion medicines sales by selected therapy groups page 58 5

Tall og fakta 2002 Legemiddelindustriforeningen Chapter 4: The pharmaceutical industry in Norway page 60-61 4.01 Number of employees in the pharmaceutical industry in Norway page 62 4.02 Number of empl. in the pharma industry and the distribution chain page 63 4.03 Employees in pharma companies with production plants in Norway page 64 4.04 The number of reported clinical trials page 65 4.05 The pharma industry`s investments in research and development page 66 4.06 Investments in research and development, percentage of sales page 67 4.07 Research and development costs for new medicines page 68 4.08 Sales of parallel imported medicines in Norway page 69 4.09 Norway s imports and exports of medicines page 70 Chapter 5: International comparisons page 72-73 5.01 Leading pharmaceutical companies on the global market page 74 5.02 Mergers and acquisitions page 75 5.03 Leading pharmaceuticals on the global market page 76 5.04 Medicine prices and the general price level in some European countries page 77 5.05 Pharmaceutical consumption per capita in the Nordic countries page 78 5.06 Pharmaceutical expenditure per capita in the OECD page 79 5.07 Spending on health care and pharmaceuticals in the OECD page 80 5.08 Spending on medicines as share of spending on health care in OECD page 81 5.09 Publ. spending on medicines as % of publ. health care exp. in OECD page 82 5.10 Number of inhabitants per pharmacy in Europe page 83 5.11 The pharmaceutical industry s investment in R&D in Europe page 84 5.12 The pharmaceutical industry s investments in Europe and the U.S. page 85 5.13 VAT on medicines and other goods and services in Europe page 86-87 Chapter 6: Population and health page 88-89 6.01 National Insurance expenditure page 90 6.02 Sick leave by diagnosis page 91 6.03 Disability pensions by diagnosis page 92 6.04 Inhabitants per physician in Norway page 93 6.05 Average number of hospitalisation days page 94 6.06 Age distribution in the population page 95 6.07 The incremental change in life expectancy at birth page 96 6.08 Causes of death page 97 The Norwegian Association of Pharmaceutical Manufacturers (LMI) page 99 LMI s member companies page 100-101 6

Legemiddelindustriforeningen Tall og fakta 2002 Abbreviations AESGP ATC DDD EFPIA LIS NOK OECD OTC PPP PRP USD Association of the European Self-Medication Industry Anatomical Therapeutic Chemical, medical classification of medicines Defined daily dose, average value indicating the standard intake of a given medicine in 24 hours. European Federation of Pharmaceutical Industries and Associations Norwegian Drug Procurement Co-operation, co-ordinates hospital medicine procurement Norwegian kroner Organisation for Economic Co-operation and Development Over-the-counter, non-prescription medicines Pharmacy purchase price, price paid by pharmacy to wholesaler Pharmacy retail price, price paid by consumer to pharmacy American dollars 7

Tall og fakta 2002 Legemiddelindustriforeningen Unchanged rate of growth in the sales of medicines The sales of medicines from pharmaceutical wholesalers to pharmacies and hospitals increased in 2001 by 10,8 percent, thus amounting to 8,3 billion kroner PPP (pharmacy purchase price). This growth is somewhat higher than in 2000 when there was an increase of 9,7 percent, but lower than in 1999, when the increase was 13,5 percent. The sales from the pharmacies to the consumer (PRP - pharmacy retail price) were estimated at 12,7 billion kroner in 2001 vs. 11,4 billion kroner the previous year. Last year saw public reimbursement of medicine costs of app. 7 billion kroner. This corresponds to a 7,5 percent increase, which is lower than the aggregate growth in the sales of medicines in Norway. Increased growth in consumption The consumption of medicines as measured by the number of Defined Daily Doses (DDD) has grown by 7,3 percent in 2001. This is higher than in 2000 when the growth was 5,2 percent, but similar to the figure for 1999 which was 7,1 percent. This confirms the trend that has been observed during the past years, showing that the consumption in Norway approaches that of the other western European countries. Norway has however a low level of consumption of medicines per inhabitant. Together with Denmark, Norway has the lowest consumption of medicines in Scandinavia, as well as compared to other OECD-countries. High proportion of new medicines An important reason why the consumption and sales of medicines are increasing is the transition to new and often more expensive medicines, which are potentially more efficacious and/or exhibit less adverse drug reactions. In Norway innovative medicines represent more than 40 10 Summary and comments percent of the total sales of medicines, as measured by the pharmacy purchase price (PPP). As the population as a whole is growing older, there is an increasing need for medicines. A third reason for the increase is the advent of new medicines, which have made treatment possible for patients who previously had insufficient possibilities for medical treatment. The increase may also be related to an increased consensus across national borders on the treatment of various dis orders. Medicines having the highest sales Medicines for the treatment of cardiovascular disorders, asthma and mental (psychiatric) disorders top the list of medicines with the highest sales in Norway in 2001. The list thus reflects the large disease groups in the population. Cholesterol-lowering agents constitute the largest single group, representing 8,6 percent of the total sales of medicines in Norway, with medicines for the treatment of asthma being the second largest group at 7,1 percent. Three of the 25 top selling medicines are available in non-prescription size packs. Measured by the number of sold packs, the picture appears different. The list is here headed by nonprescription medicines, with pain-relievers and agents against congested sinuses as the largest groups. Decrease in the prices of prescription medicines The prices of prescription medicines from the wholesaler to the pharmacy have decreased also in 2001. On average the price reduction was 2,4 percent. On average the prices have been reduced by 0,7 percent per year during the past seven years. By comparison, the consumer price index, being the official figure of Statistics Norway regarding price development, has shown an average annual increase of 2,4 percent during

Legemiddelindustriforeningen Tall og fakta 2002 the same period. In 2001 the prices of all medicines were reduced by 2 percent on average, while the consumer price index increased by 3 percent. Prescription medicines constitute 91,6 percent of the total sales of medicines, and 56,6 percent as measured by the number of packs. Non-prescription medicines Non-prescription medicines represented 8,6 percent of the total sales of medicines in Norway, and 43,4 percent as measured by the number of packs sold. The sales of non-prescription medicines increased by 6,3 percent in 2001, which represents a lower rate of growth as compared to prescription medicines. Low costs and a low level of consumption Compared to most of the countries in Europe and to the OECD-countries, the cost of medicines in Norway is generally lower. The most recent figures from the National Insurance Administration and Statistics Norway show that the expenditure on medicines constituted just over 8 percent of the public expenditure on healthcare in Norway. The latest estimates of the OECD show that the costs of medicines constitute 10,6 percent of the total costs on healthcare in Norway. The reason for this discrepancy is, among other things, that the OECD emphasizes various factors differently than in Norway when making the estimates of healthcare costs. Also, Norway has the second lowest consumption of medicines among the OECD-countries. Measured in relative figures, the Norwegian consumption of medicines per inhabitant is for example 69 percent of that in Sweden. High rate of value added tax on medicines Norway is one of three countries in Europe which claims full rate of value added tax on medicines. Throughout the remaining European countries medicines that are being reimbursed by the government in general have a lower rate of value added tax than food and other goods. On the average the regular value added tax rate is 19,3 percent, while the value added tax on medicines on the average is 7,3 percent. Pharmacy chains The new Pharmacy Act, entering into force as of March 1st 2001, allows for ownership of pharmacies by others than certified pharmacists. Following the liberalisation of the Norwegian market, several foreign pharmacy chains have established offices in Norway. The three largest groups, Apokjeden, GEHE/NMD and Alliance Unichem, control by various forms of association more than 88 percent of the pharmacy sales points in the country. The Apokjeden is the largest with over 40 percent. By sales, these three groups have almost 82 percent of the total market. Again, the Apokjeden is largest having a 39,8 percent share. No figures for the veterinarian medicines market This year s issue of Facts and Figures does not contain figures showing the sales of medicines for veterinarian use. The reason for this is the unavailability of material for a sufficient elaboration of sales statistics for the past year. Due to changing routines for the reporting of sales, statistics of the sales of veterinarian medicines should be available in next year s issue of Facts and Figures. Available on the internet All figures, numbers and tables in this booklet are also available on the LMI s web site, www.lmi.no. The tables are being updated and entered onto the web site under the link Facts and Figures. 11

Legemiddelmarkedet i Norge Omsetningen av legemidler var på 8,3 milliarder kroner (AIP) i 2001. Økningen i omsetningen på 10,8 prosent fra 2000 til 2001 skyldes i hovedsak overgang til nye legemidler med bedre effekt og færre bivirkninger. Det er blant annet nyere lege midler innenfor behandling av rev matiske lidelser, astma og hjerte-karsykdommer som står for denne økningen. Med en befolkning som blir stadig eldre, øker også behovet for legemidler. Økningen kan også ha sammenheng med en større enighet på tvers av landegrensene om behandling av ulike lidelser. Prisene på resept belagte lege midler viser en nedgang på 2,4 prosent. I 2001 steg konsumpris indeksen med 3 prosent. Det kom totalt 42 nye virkestoff på markedet i 2001. Totalt finnes det nå 1050 virkestoff fordelt på 1915 legemiddelnavn i Norge. Legemiddelbransjen er en internasjonal bransje som blant annet kjennetegnes av fusjoner også på tvers av landegrensene. Fusjonene til tross, legemiddel markedet er preget av sterk konkurranse der ingen har høyere markedsandel enn 10,5 pro sent. Statistikken over de mest solgte legemidlene i Norge domineres av legemidler rettet mot de store sykdomsgruppene. Reseptbelagte legemidler omsettes for klart mer enn reseptfrie. Måler man i antall solgte pakninger, er salget noenlunde likt fordelt. The medicine market in Norway The sales of medicines amounted to 8,3 billion kroner (PPP) in 2001. The increase in sales of 10,8 percent from 2000 to 2001 was primarily due to a changeover to new medicines, more effective and having fewer adverse drug reactions. Among these are new medicinal products for the treatment of rheumatic disorders, asthma and cardiovascular diseases. With an increasingly older population, the need for medicines will also increase. The increase may also be related to an increased consensus across national borders regarding the treatment of various disorders. The prices of prescription medicines show a decrease of 2,4 percent. In 2001 the consumer price index increased by 3,0 percent. Altogether 42 active substances were introduced on the market during 2001. In total 1050 active substances distributed between 1915 medicine names are now marketed in Norway. The pharmaceutical industry is an international industry characterized among other thing by mergers across national borders. In spite of these mergers the pharmaceutical market is a very competitive one, in which none of the participants have a market share higher than 10,5 percent. Statistics showing the most sold medicines in Norway is dominated by medicines targeted on the most common groups of disorders. Prescription medicines have by far higher sales than non-prescription medicines. Measured by the number of packs sold, the sales are fairly evenly distributed between these two areas.

Tall og fakta 2002 Legemiddelindustriforeningen 1.01 Antall virkestoffer på det norske markedet The number of active substances on the Norwegian market 1060 1050 Virkestoff/Active substances 1040 1020 1000 980 960 980 1004 1019 940 1997 1998 2000 2001 År/Year Kilde: Statens legemiddelverk Source: The Norwegian Medicines Agency Tall ikke tilgjengelig for 1999 Figures not available for 1999 På det norske markedet finnes det i dag 1050 virkestoffer, en økning på 70 på fire år. Et virkestoff er definert som den kjemiske eller biologiske forbindelsen som gir den medisinske effekten i et ferdig fremstilt legemiddel. Økning i antall virkestoffer er et uttrykk for at man får flere muligheter i behandlingen av norske pasienter. Flere virkestoffer på markedet betyr også at man får flere nyvinninger - innovasjoner - på legemiddelmarkedet. 14 There are 1050 active substances on the Norwegian market today, an increase of 70 during the past 4 years. An active substance is defined as the chemical or biological ingredient responsible for the efficacy of a medicinal product. An increase in the number of active substances expresses an increased number of treatment options for Norwegian patients. An increased number of available active substances also indicates the entry of more innovative treatment options on the medicines market.

Legemiddelindustriforeningen Tall og fakta 2002 1.02 Nye preparater og virkestoffer New medicines and active substances År/ Year Nye preparater/ Utgåtte preparater/ Nye virkestoffer/ New medicines Withdrawn medicines New active substances 1998 215 124 36 2000 295 64 36 Kilde: Statens legemiddelverk Source: The Norwegian Medicines Agency Denne tabellen viser hvor mange nye preparater som er introdusert i Norge i de angitte årene. Med et preparat menes et bruksferdig legemiddel hvor virkestoffet (se tabell 1.01) og hjelpestoffer er satt sammen til for eksempel en tablett eller en injeksjonsvæske. Følgelig kan ett virkestoff finnes i flere preparater. I 2001 ble 42 nye virkestoffer og 400 preparater godkjent. For de nye preparatene som er godkjent i 2001 vil noen av dem inneholde helt nye virkestoffer som ble godkjent samme år, men andre kan være nye preparater av allerede eksisterende virkestoff, for eksempel generika eller nye styrker/formuleringer av orginalpreparater. This table shows the number of new medicinal products that have been introduced in Norway during the years given. A medicinal product is defined as a ready-to-use medicine in which the active substance (see table 1.01) and excipients have been composed into for example a tablet or a solution for injection. Consequently, one active substance may be found in more than one medicinal product. In 2001 42 new active substances and 400 medicinal products were granted a marketing authorisation. Some of the medicinal products approved in 2001 will contain new active substances which were approved this year, while others may be medicinal products containing previously approved active substances, for instance generics or new strengths/ pharmaceutical forms of original medicinal products. 15

Tall og fakta 2002 Legemiddelindustriforeningen 1.03 Antall legemiddelnavn i Norge Number of product names in Norway 2 500 Legemiddelnavn/Product names 2 000 1 500 1 000 500 1415 1637 1915 0 1998 2000 2001 År/Year Kilde: Statens legemiddelverk Source: The Norwegian Medicines Agency Mens tabell 1.01 viser at vi per 2001 har 1050 virkestoffer, viser denne tabellen antallet legemiddelnavn på det norske markedet. Et legemiddelnavn representerer som oftest et virkestoff fra en produsent. Flere legemiddelformer og -styrker (preparater) av et virkestoff produ sert av et firma vil dermed ha samme legemiddelnavn. 16 While table 1.01 shows a total number of 1050 active substances, this table shows the number of product names on the Norwegian market. A name of a medicine generally represents one active substance from one manufacturer. Several pharmaceutical forms and -strengths of an active substance manufactured by one company thus will have the same name.

Legemiddelindustriforeningen Tall og fakta 2002 1.04 Antall markedsføringstillatelser i Norge The number of marketing authorisations in Norway Markedsføringstillatelser/ Marketing authorisations 3 500 3 000 2 500 2 000 1 500 1 000 2038 1986 2108 2180 2209 2223 2244 2303 2355 2418 2492 2630 2706 2843 3008 3232 500 0 1970 1980 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 Kilde: Statens legemiddelverk Source: The Norwegian Medicines Agency År/Year Statens legemiddelverk utsteder markedsføringstillatelse for hver enkelt legemiddelform (for eksempel tabletter, injeksjonsvæske og kapsler) og hver eneste styrke. Ingen legemidler kan omsettes på ordinært vis før det foreligger en slik til latelse. Enkelte legemidler kan ha markeds føringstillatelse uten at de markedsføres i Norge. Fra 2000 er Norge omfattet av EUs system for godkjenning av legemidler. Legemidler som er godkjent i EUs sentrale prosedyre er inkludert i tallene for 2000 og 2001, men disse tallene omfatter bare antall legemiddelnavn - ikke antall faktiske markedsføringstillatelser. Tabellen inkluderer ikke naturlegemidler, radiofarmaka og parallellimporterte legemidler. The Norwegian Medicines Agency grants a marketing authorisation for each pharmaceutical form (for example tablets, solutions for injection or capsules) and each strength. No medicinal product may be marketed ordinarily until such a marketing authorisation has been granted. Some medicinal products may be covered by a marketing authorisation without being marketed in Norway. From 2000 on Norway is part of the European Union s system for approval of medicines. The figures for 2000 and 2001 include medicines that have been approved through the European Union s centralized procedure. However, these figures will only comprise the number of names of medicines, not the actual number of marketing authorisations. The table does not include herbal medicinal products, radiopharmaceuticals and parallel imported medicines. 17

Tall og fakta 2002 Legemiddelindustriforeningen 1.05 De 25 største legemiddelfirmaene på det norske markedet The top 25 pharmaceutical companies on the Norwegian market Plassering 2001 Firma / Omsetning 2001 (2000) / Company AIP, millioner kr Total Sales 2001 Rank 2001 (2000) PPP, NOK million Andel av totalmarkedet / Share of T e 2 (2) GlaxoSmithKline 770,3 9,3 % 4 (4) MSD (Norge) A/S 672,2 8,1 % 6 (6) Nycomed Pharma AS 316,9 3,8 % 8 (15) Wyeth Lederle 235,6 2,8 % 10 (7) Paranova AS 218,4 2,6 % 12 (10) ovo Nordisk Scandinavia AS 214,7 2,6 % 14 (16) B 210,8 % 16 (13) Alpharma AS 187,6 18 (20) chering-plough A/S 163,6 2,0 % 20 (22) rganon A/S 119,3 1,4 % 22 (19) Farmagon AS 107,2 1,3 % 24 (25) UCB Pharma AS 83,4 1 % Sum omsetning 25 største firmaer / Aggregate sales top 25 companies 7 219 781 369 86,9 % Sum total omsetning 2001/ Aggregate sales all companies 8 311 782 396 100,0 % Tall fra 2001 Figures from 2001 Kilde: LMI/Farmastat Source: LMI/Farmastat 18

Tall og fakta 2002 Legemiddelindustriforeningen 1.06 De 25 legemidlene på det norske markedet med høyest omsetning The top 25 medicines on the Norwegian market in terms of sales value Plassering Legemiddel/ Omsetning 2001 Andel av Hovedindikasjon/ 2001 (2000) / Medicine AIP, millioner kr/ totalmarkedet/ Main indication Rank 2001 (2000) PPP, P, NOK million Tot 2 (2) L 247,3 3,0 % Hø ol/high cholesterol 4 (5) Cipramil 163,4 2,0 % Dep Depression 6 (4) Norvasc 158,2 1,9 % Hø High blood pressure r 8 (8) Zyprexa 109,5 1,3 % /Schizophrenia 10 (23) Pravachol 86,4 1,0 % Hø ol/high cholesterol 12 (116) Celebra 85,7 1,0 % Leddgikt/slitasjegikt/ Rheumatoid arthritis/osteoarthritisis 14 (9) Seroxat 80,1 1,0 % Dep Depression 16 (13) Pulmicort 74,5 0,9 % Astma/Asthma 18 (190) Nexium 72,3 0,9 % 20 (16) arduran CR 65,6 0,8 % ø e 22 (24) ozaar Comp 62,9 0,8 % Hø e 24 (22) Sandimmun Neoral 60,2 0,7 % T Transplantation Sum omsetning 25 største legemidler/ 2 736,5 32,9 % Sum omsetning alle legemidler/ Aggregate sales all medicines 8 311,8 100,0 % Tall fra 2001 Kilde: LMI/Farmastat Figures from 2001 Source: LMI/Farmastat 20

Legemiddelindustriforeningen Tall og fakta 2002 Tilsammen omsatte disse 25 legemidlene for 2,7 milliarder kroner (AIP), noe som tilsvarer litt mindre enn en tredjedel av totalomsetningen i 2001. Oversikten domineres av legemidler mot hjerte-karsykdommer, astma og psykiske lidelser, og gjenspeiler de store folkesykdommene i landet. Oversikten over legemidlene med høyest omsetning i Norge inkluderer også parallellimport. Altogether, these 25 medicines reached sales of 2,7 billion kroner (PPP), corresponding to somewhat less than a third of the total sales of medicines for the year 2001. The list shows predominance of medicines for the treatment of cardiovascular diseases, asthma and mental disorders, reflecting the largest disease groups in the country s popu lation. The list of medicines with the highest sales in Norway also comprises parallel-imports. 21

Tall og fakta 2002 Legemiddelindustriforeningen 1.07 De 25 mest brukte legemidlene i definerte døgndoser (DDD) The 25 most used medicines in terms of defined daily doses (DDD) Plassering Legemiddel / DDD per 1000 Vekst 00-01/ Hovedindikasjon/ 2001 (2000)/ Medicine innbyggere Growth 00-01 Main indication Rank per døgn / 2001 (2000) inhabitantsts per day 2 (2) Flux 52,3 18,7 % Karies/Caries 4 (6) Lipitor 30,2 31,7 % ø High cholesterol 6 (4) Nycoplus C-Vitamin 25,7-7,9 % Vi 8 (8) 19,4-9,9 % ø e 10 (12) Zyrtec 17,7 6,2 % llergi/allerg gy 12 (9) Trionetta 16,6-4,6 % Pr Contraception 14 (14) Selo-Zok 16,3 15,9 % Hø High blood pressure r 16 (16) trivin 13,8 7,4 % T Nasal congestion 18 (19) Trinor diol 11,2-4,3 % Pr 20 (23) rednisolon 10,6 1,1 % Hormonterapi/Hormone therapy 22 (28) Nycoplus Folsyre 10,3 17,3 % Vitamin deficiency 24 (29) arevan 9,3 5,5 % lodpropp/thrombosis Sum/Su m 487,0 Totalt salg/total sales 1213,0 7,3 % Andel av totalmarkedet/ Share of total market 40,2 % Tall fra 2001 Kilde: LMI/Farmastat Figures from 2001 Source: LMI/Farmastat 22

Legemiddelindustriforeningen Tall og fakta 2002 Det reseptbelagte legemiddelet Albyl-E er det mest brukte legemiddelet i Norge, målt i døgndoser. Det brukes for å redusere risikoen for infarkt, slag og andre alvorlige følger av blodpropp. Legemiddelet brukes også som smertestillende middel, særlig hos pasienter med revmatiske lidelser. Oversikten har generelt et stort innslag av legemidler mot hjerte-karsykdommer, og gjenspeiler således hva som er en av de store folkelidelsene i Norge. Medikamentet med høyest omsetning, Zocor, er også det tredje mest brukte målt i døgndoser. Selv om reseptbelagte legemidler dominerer oversikten, er også en rekke legemidler som fåes i reseptfrie pakninger representert. Legemiddelet med høyest reseptfri omsetning, Paracet, er det 13. mest brukte legemiddelet i Norge. I gruppen for legemidler mot psykiske lidelser, finner man bare ett, Cipramil, på denne oversikten. The prescription form of the medicinal product Albyl-E is the most frequently used medicine in Norway, as measured by the number of Defined Daily Doses. It is being used to reduce the risk of myocardial infarction, stroke and other serious sequels of thrombosis. The medicine is also being used as a pain-relieving agent, especially in patients with rheumatic disorders. There are on the whole many medicines for the treatment of cardiovascular disorders on the list, thus reflecting what is one of the major disease groups in the Norwegian population. The medicine having the highest sales, Zocor, is also the third most frequently used one, measured by Defined Daily Doses. Even though prescription medicines are predominant on the list, many of the medicines available in non-prescription packs are represented. The medicine with the highest non-prescription sales, Paracet, is the 13. most frequently used medicine in Norway. Only one of the medicines in the group for the treatment of mental dis orders, Cipramil, is found on this list. 23

Tall og fakta 2002 Legemiddelindustriforeningen 1.08 De 20 mest solgte legemidlene i Norge i antall pakninger The top 20 medicines in Norway in terms of packaging units Plassering Legemiddel del / Antall pakninger Andel av totalt Hovedindikasjon/ 2001 (2000)/ Medicine solgt X 1000/ antall pakninger Main indication Rank Number of units solgt/ 2001 (2000) sold X 1000 Sales in unit 2 (2) bux 2 737 3,9 % Smerter/Pain 4 (5) Albyl-E 1 005 1,4 % Blodpropp/Thrombosis 6 (6) Rhinox 855 1,2 % Tett nese/ /Nasal congestion 8 (9) movane 695 1,0 % Sø ø Insomnia 10 (10) Zyrtec 669 0,9 % Allergi/Allerg gy 12 (12),8 % Fungal infections 14 (21) Selo-Zok 542 0,8 % Hø High blood pressure r 16 (16) Somadril 516 0,7 % Ryggsmerter/Low back pain 18 (15) 509 0,7 % T Nasal congestion 20 (17) Fenazon-Koffein 496 0,7 % Smerter/Pain Sum salg 20 største legemidler/ Aggregate sales top 20 medicines 22 692 32,0 % Sum salg alle legemidler/ Aggregate sales all medicines 70 912 100,0 % Tall fra 2001 Kilde: LMI/Farmastat Figures from 2001 Source: LMI/Farmastat 24

Legemiddelindustriforeningen Tall og fakta 2002 Oversikten over de mest solgte legemidlene målt i antall pakninger domineres av legemidler som hovedsakelig selges i reseptfrie pakninger, særlig midler mot lette smerter, feber og tett nese. Paracet fra den norske legemiddelprodusenten Weifa er det mest solgte legemiddelet i Norge i antall pakninger, fulgt av Ibux og Otrivin. Det totale salget var i 2001 på 70,9 millioner pakninger. De 20 største legemidlene solgte til sammen 22,7 millioner pakninger, og representerte mindre enn en tredjedel av totalsalget. Ser man derimot på omsetningen i antall definerte døgndoser (DDD), er legemiddelet Albyl-E det mest brukte, med 52,6 DDD per 1000 innbyggere per døgn i 2001 (se tabell 1.07). The list showing the most sold medicines, as measured by the number of packs, is dominated by medicines that are mainly sold in non-prescription packs, particularly agents against light pains, fever and congested sinuses. Paracet from the Norwegian manufacturer Weifa is the most sold medicine in Norway by number of packs, followed by Ibux and Otrivin. The total sales in 2001 were 70,9 million packs. The 20 largest medicines had aggregate sales of 22,7 million packs, representing less than one third of the total sales. Considering the sales measured by the number of Defined Daily Doses (DDD), however, the medicine Albyl-E is the most frequently used, with 52,6 DDD per 1000 inhabitants per day in 2001 (see table 1.07). 25

Tall og fakta 2002 Legemiddelindustriforeningen 1.09 Omsetning av legemidler fordelt på terapeutiske hovedgrupper (ATC Medicine sales by main therapeutic groups (ATC) ATC-gruppe/ATC-group Salg AIP 2001 mill. kr/ Sales PPP 2001 NOK million Vekst 2000-2001 prosent/ Growth 2000-2001 percent Andel av totalmarkedet 2001 prosent/ Share of Total Sales 2001 percent Salg AIP 2000 mill. kr/ Sales PPP 2000 NOK million C Hjerte og kretsløp/ Cardiovascular system 1 801 7,6 % 21,7 % 1 674 N Sentralnervesystemet/ Central nervous system 1 570 10,4 % 18,9 % 1 422 R Respirasjonsorganene/ Respiratory system 945 7,3 % 11,4 % 881 A Fordøyelsesorganer og stoffskifte/ Alimentary and metabolism 941 3,0 % 11,3 % 913 L Antineoplastiske og immunmodulerende midler/ Antineoplastic and immunomodulating agents 676 25,1 % 8,1 % 540 G Urogenitalsystemet og kjønnshormoner/ Urogenitals and sex hormones 438 9,4 % 5,3 % 400 M Muskler og skjelett/ Musculo-skeletal system 433 40,6 % 5,2 % 308 J Systemiske anti-infektiva/ Systemic antiinfectives 424 10,6 % 5,1 % 383 B Blod og bloddannende organer/ Blood and bloodforming organs 398 18,2 % 4,8 % 337 D Dermatologiske midler/ Dermatologicals 205 6,6 % 2,5 % 192 H Hormoner til systemisk bruk, ekskl. kjønnshormoner/ Systemic hormones excl. sex hormones 198 6,9 % 2,4 % 185 S Sanseorganer (øye- og øremidler)/ Sensory organs 172 8,1 % 2,1 % 160 V Varia (kontrastmidler, allergenekstr. etc.)/ Various 93 10,7 % 1,1 % 84 P Antiparasitære midler/ Antiparasitic products 18 16,0 % 0,2 % 16 Total 8 312 10,9 % 100,0 % 7 495 Tall fra 2001 Kilde: LMI/Farmastat Figures from 2001 Source: LMI/Farmastat 26

Legemiddelindustriforeningen Tall og fakta 2002 Denne oversikten tar for seg legemidler fordelt på terapeutiske grupper i henhold til ATC-systemet. Dette systemet brukes for å klassifisere legemidler, slik at en lett finner frem til midler med beslektede virkestoffer. Det brukes også i statistikk over legemiddelbruk og omsetning. Systemet er anbefalt av WHO som et globalt klassifikasjonssystem. I ATCsystemet gis alle legemidler et kodenummer (ATC-nummer) bestående av inntil 5 ledd eller nivåer. Første nivå er anatomisk hovedgruppe, annet og tredje nivå er tera peutiske undergrupper, fjerde nivå er kjemisk terapeutisk undergruppe og femte nivå er kjemisk substans. Denne tabellen baserer seg på første nivå, og inneholder alle grupper for legemidler til mennesker. Alle beløp er oppgitt i AIP. Legemidler mot hjerte- og karsykdommer representerer en drøy femtedel av den totale legemiddelomsetningen i Norge. Legemidler mot lidelser i sentralnervesystemet, det vil først og fremst si ulike psykiske lidelser, representerer også opp mot en femtedel av den totale omsetningen. Veksten innen de store terapigruppene er stort sett jevnt fordelt. Unntakene er terapigruppene L og M. Terapigruppe L omfatter blant annet lege midler som brukes i behandling av kreft, og immunsuppressive legemidler, som brukes ved organtransplantasjoner. Terapigruppe M omhandler lidelser i muskler og skjelett. I begge gruppene har det kommet viktige nye legemidler. This list presents medicines by therapeutic groups according to the ATC-system. This system is being used to classify medicines, for easy reference to medicines with related active substances. It is also being used in Statistics on consumption and sales of medicines. The system has been recommended by the WHO for use as a global classification system. Within the ATCsystem all medicines are assigned one code number (the ATC-number) consisting of up to 5 parts or levels. The first level is the main anatomical group, the second and third level are therapeutic subgroups, the fourth level is the chemical, pharmacological or therapeutic subgroup, and the fifth level is the chemical substance. This table is based on the first level, and contains all groups containing medicines for humans. All amounts are given in PPP. Medicines for the treatment cardiovascular diseases represent just over one fifth of the total sales of medicines in Norway. Medicines for the treatment of disorders of the central nervous system, i.e. various mental disorders, also represent close to one fifth of the total sales. The growth within the major therapeutic groups is in general evenly distributed. The therapeutic groups L and M are exceptions. The therapeutic group L comprises among other things medicines used for the treatment of cancer, as well as immunosuppressive medicines, which are used in organ transplants. The therapeutic group M comprises musculo-skeletal disorders. Within both these group important new medicines have been introduced. 27

Tall og fakta 2002 Legemiddelindustriforeningen 1.10 De ti største terapigruppene etter omsetning The ten largest therapeutic groups as measured by sales Kolesterolsenkende legemidler/ Serum lipid reducing agents 712 1. C10 2. R03 Legemidler til behandling av astma/ Antiasthmatics Legemidler til behandling av depresjon og demens/ Psychoanaleptics 530 590 ATC-gruppe nivå 2 ATC-group level 2 3. N06 4. C09 5. A02 6. N02 7. N05 8. M01 9. J01 10. G03 Legemidler til behandling av høyt blodtrykk (via renin-angiotensin-systemet)/ Agents acting on the renin-angiotensin system (blood pressure) Legemidler til behandling av magesår og halsbrann (syrenøytraliserende)/ Antacids, medicines for treatment of peptic ulcer and flatulence Smertestillende legemidler og migrenemidler/ Analgesics Beroligende midler, midler mot angst/ søvnvansker og psykose/psycholeptics Betennelsesdempende midler og midler mot leddgikt/ Antiinflammatory and antirheumatic products Legemidler til behandling av infeksjoner, systemisk bruk/ Antibacterials for systemic use Kjønnshormoner, prevensjonsmidler m.m./ Sex hormones, anti-contraceptives 284 265 309 294 426 425 465 0 100 200 300 400 500 600 700 800 Kilde: LMI/Farmastat Source: LMI/Farmastat Mill. kr/nok Million Tall fra 2001 Figures from 2001 Tabellen viser legemiddelsalget til de 10 største gruppene på ATC-nivå 2. Mens nivå 1 angir anatomisk hovedgruppe, angir nivå 2 terapeutiske hovedgrupper. Kolesterolsenkende legemidler er den største gruppen, og står for 8,6 prosent av samlet omsetning av legemidler i Norge. Deretter kommer legemidler til behandling av astma, som står for 7,1 prosent. De 10 største gruppene står for noe over halvparten av legemiddelomsetningen i Norge. 28 The table shows the sales of medicines within the 10 largest groups at the second ATC-level. While the first level shows the main anatomic group, the second level represents the main therapeutic groups. The largest group contains medicines used to reduce the level of cholesterol in the blood, and represents 8,6 percent of the total sales of medicines in Norway. It is followed by medicines for the treatment of asthma, representing 7,1 percent. The 10 largest groups represent more than half of the total sales of medicines in Norway.

Legemiddelindustriforeningen Tall og fakta 2002 1.11 Apotekenes totale omsetning, fordeling på varegrupper Private pharmacies' sales composition Reseptfrie legemidler Non-prescription drugs 12% Reseptpliktige legemidler Prescription drugs 72,3% Handelsvarer Non-pharmaceuticals 15,7% Tall fra 1998 Figures from 1998 Kilde: Norges Apotekerforening Source: Norwegian Society of Proprietor Pharmacists Nesten tre fjerdedeler av apotekenes totale omsetning i 1998 kom fra resept pliktige legemidler. Omsetningen av resept pliktige legemidler er strengt regulert. Myndighetene fastsetter blant annet hvilken avanse apotekene får lov til å ta. Når det gjelder reseptfrie legemidler, kan imidlertid apotekene fritt velge hvilken pris og avanse de ønsker å ta. 1998 tallene fra Norges Apotekerforening viste at reseptfrie legemidler utgjorde 12 prosent av apotekenes totale omsetning, og er således den minste varegruppen. Ikkefarmasøytiske produkter, eksempelvis naturmidler og bandagistprodukter, ut gjorde 15,7 prosent av totalomsetningen. Almost three quarters of the total sales from pharmacies in 2001 are accounted for by prescription medicines. The sale of prescription medicines is strictly regu lated. The authorities e.g. determine the highest allowed gross margin for the pharmacies. Regarding non-prescription medicines the pharmacies are free to set prices and gross margins. In 1998 figures from the Norwegian Society of Proprietor Pharmacists showed that the sales of non-prescription medicines comprised 12 percent of the total sales from the pharmacies, and thus is smallest group of products. Non-pharmaceutical products, for example herbal remedies and other non-medicinal pharmacy products, comprised 15,7 percent of the total sales. 29

Tall og fakta 2002 Legemiddelindustriforeningen 1.12 Omsetningen av legemidler i Norge Medicine sales in Norway År/Year Legemiddelomsetning AUP mill. Legemiddelomsetning AUP per 2001-kroner/ innbygger i 2001-kroner Medicine sales PRP, P, NOK mill. Medicine sales PRP per capita 2001- currency 2001-currency 1985 4 810 1 053 1995 8 864 2 028 1997 9 983 2 260 1999 11 373 2 551 2001 12 700 2 814 Tall fra 2001 Figures from 2001 Kilde: LMI/Farmastat og Statistisk sentralbyrå Source: LMI/Farmastat and Statistics Norway Den totale legemiddelomsetningen i Norge ut fra apotek i 2001 er anslått til 12,7 milliarder kroner. Tallene for totalsalg i 2000 er justert noe ned i forhold til fjorårets utgave av Tall og Fakta. Legemiddelsalg per innbygger i Norge var i 2001 på 2 814 kroner. Av dette betalte myndighetene drøyt to tredjedeler. Alle kronebeløp i denne tabellen er oppgitt i 2001-verdi. 30 The total sales of medicines from the pharmacies in Norway in 2001 is estimated at 12,7 billion kroner. The figures for aggregate sales in 2000 have been adjusted somewhat down compared to last years edition of Facts and Figures. Sales of medicines per inhabitant in Norway in 2001 amounted to 2814 kroner. The government covered approximately two thirds of this amount. All figures in this table showing kroner are given in 2001-values.

Legemiddelindustriforeningen Tall og fakta 2002 1.13 Antall apotek etter kjedetilhørighet Pharmacy chain affiliation SYKEHUSAPOTEK HOSPITAL PHARMACIES 6,0 % ANDRE APOTEK OTHER PHARMACIES 5,8 % ALLIANCE UNICHEM ALLIANCE UNICHEM 14,0 % APOKJEDEN APOKJEDEN 40,2 % Tall fra 2001 Figures from 2001 GEHE/NMD GEHE/NMD 34,0 % Ny apoteklov, som trådte i kraft 1. mars 2001, gjør det mulig for andre enn farmasøyter å eie apotek. Konsesjon for eierskap og drift ble adskilt, og det ble mulig å velge andre organisasjonsformer for apotek enn personlig selskap. Etter liberaliseringen av det norske apotekmarkedet, har utenlandske apotekkjeder etablert seg i Norge. Apotekene har ulike tilknytningsformer til kjedene, fra innkjøpsavtaler via franchiseavtaler og delvis eierskap til å være heleid av kjedene. I Apo kjeden er den finske grossisten Tamro Distribution majoritetseier. De to andre store apotekkjedene er tyske GEHE/NMD og britiske Alliance Unichem. Kjedeoversikten for 2001 viser at Apokjeden, som første etablerte apotekkjede i Norge, holder stand som den største kjeden med en andel på 40,2 prosent av apotekene. Kilde: LMI/Farmastat Source: LMI/Farmastat A new Pharmacy Act, which came into force March 1st 2001, allows for ownership of pharmacies by other legal entities than certified pharmacists. The concepts of operation and licence for ownership were separated, and other company forms than personal firms were allowed for. Following the liberalisation of the Norwegian pharmacy market, foreign pharmacy chains have established offices in Norway. The pharmacies have various forms of association with the chains, from purchasing agreements through franchising agreements and part ownerships, to being wholly owned by the chains. The Finnish wholesaler Tamro Distribution is the majority owner within the Apokjeden chain. The two other large pharmacy chains are the German GEHE/NMD and the British Alliance Unichem. The graph for 2001 shows that Apokjeden, which established the first chain of pharmacies in Norway, is keeping up as the largest chain, with a share of 40,2 percent of the pharmacies. 31

Tall og fakta 2002 Legemiddelindustriforeningen 1.14 Apotekomsetning etter kjedetilhørighet Pharmacy chain market share ANDRE APOTEK OTHER PHARMACIES 3,6 % SYKEHUSAPOTEK HOSPITAL PHARMACIES 14,5 % APOKJEDEN APOKJEDEN 39,8 % ALLIANCE UNICHEM ALLIANCE UNICHEM 13,7 % Tall fra 2001 Figures from 2001 GEHE/NMD GEHE/NMD 28,4 % Kilde: LMI/Farmastat Source: LMI/Farmastat To av apotekkjedene i Norge har kontroll over sin egen distribusjon ved at de har grossistvirksomhet integrert i kjeden. Dette gjelder Apokjeden med Tamro som grossist samt GEHE/NMD. Oversikten over apotekomsetning etter kjedetilhørighet viser at sykehusapotekene har stor omsetning. (jfr. tabell 1.13). Overfor publikum er Apokjeden først og fremst profilert som Apotek 1, mens NMDs mest profi lerte apotek gjenkjennes som Vitus apotek. Begge disse kjedene har også knyttet til seg mindre kjedeprofilerte apotek. 32 Two of the pharmacy chains control their own distribution by having wholesale operations as an integral part of their activities. This applies to Apokjeden with Tamro being the wholesaler, as well as to GEHE/NMD. The graph showing pharmacy sales according to chain membership shows that the hospital pharmacies have high sales (ref. table 1.13). Towards the public the Apokjeden pharmacies are mainly profiled as Apotek 1, while NMD s most strongly profiled pharmacies are recognized as Vitus Apotek. Both of these chains have also ties to pharmacies that are less strongly profiled as belonging to the chain.

Finansiering av legemidler Financing medicines Legemiddelbransjen er en av de mest - hvis ikke den mest - regulerte bransje i Norge. Her i landet er det myndighetene som fastsetter prisene på reseptpliktige legemidler. Prisene på reseptfrie legemidler har derimot blitt bestemt av markedet siden 1995. Maksimal innkjøpspris (AIP) fastsettes av Legemid del verket. Stortinget fastsetter apo tekenes maksimale avanse ved salg av reseptpliktige legemidler. Norske lege middelpriser inn til apotek lå våren 2000 på et europeisk gjennomsnitt. Fra 1. juli 2000 ble et nytt prissettingssystem iverksatt. Dette systemet har bragt norske lege middelpriser på et lavere nivå. Den største delen av legemiddelforbruket er finansiert ved at folketrygden dekker utgifter til lege midler forskrevet på blå resept. Det offentlige finansierte 68,6 prosent av de totale legemiddelutgiftene i 2000. Den private andelen av finansieringen omfatter pasientens utgifter til reseptfrie legemidler, reseptpliktige legemidler på hvit resept og egenandeler av lege midler på blå resept. Egenandelstaket, det vil si pasientens utgifter til legebesøk og medisiner på blå resept i løpet av et kalenderår, var 1450 kroner i 2001. Den private andelen av de totale legemiddel utgiftene utgjør 31,4 prosent. The pharmaceutical industry is one of the most - if not the most - strongly regulated industries in Norway. In this country the government exercises its authority to fix the prices of prescription medicines. On the other hand, market forces have regulated the prices of non-prescription medicines since 1995.The maximum purchase price (Pharmacy Purchase Price) is determined by the Norwegian Medicines Agency. The parliament fixes the maximum gross margin for retailing of prescription medicines. Norwegian medicine prices to pharmacies were in the spring of 2000 on the average level for Europe. As of July 1st 2000 a new system for setting prices came into force. This system has brought the prices of medicines in Norway down to a lower level. The greater part of the medicines consumption is financed through the National Insurance scheme, in which medicines prescribed through the blue prescription list system are automatically covered. 68,6 percent of the total costs of medicines in 2000 were publicly financed. The private part of the financing is comprised of the patient s expenses for non-prescription medicines, for non-reimbursable prescription medicines prescribed by white prescription, as well as co-payment when buying medicines prescribed by blue prescription. The rate of co-payment, i.e. the patient s expenses for physician s consultations and blue prescription medicines through one calendar year, amounted to 1450 kroner in 2001. The private share of the total medicines expenditures represents 31,4 percent.

Tall og fakta 2002 Legemiddelindustriforeningen 2.01 Offentlige utgifter til legemidler på blå resept Public spending on reimbursable prescription medicines 6 000 5 000 4509 4838 5301 5317 5679 Mill. kr/nok Million 4 000 3 000 2 000 1 000 0 1996 1997 1998 1999 2000 År/Year Kilde: Rikstrygdeverket Source: National Insurance Administration Tall i 2000-kroner/ Figures in 2000 currency I Norge refunderer folketrygden deler av utgiftene til legemidler for pasienter med kronisk sykdom. Målsettingen med refusjonsordningen ( blåreseptordningen ) er å sikre befolkningen lik tilgang til effektive og sikre legemidler uavhengig av inntekt og bosted. Den svake veksten i 1999 henger sammen med at egenandelene økte for eldre og uføre. Tallene er oppgitt i faste 2000-priser og eksklusiv frikortordningen. 36 In Norway the National Insurance Administration reimburses parts of the expenses on medicines for patients suffering from chronic diseases. The object of the reimbursement scheme ( the blue prescription scheme ) is to secure equal access to effective and safe medicines for the whole population, regardless of level of income and place of domicile. The slow growth during 1999 is related to the increase in co-payment for the elderly and for the disabled. The figures are given in fixed 2000 prices, not taking into account the scheme for exempting patients from payments for blue prescription medicines above the co-payment rate.

Legemiddelindustriforeningen Tall og fakta 2002 2.02 Offentlige utgifter til helsevesen og legemidler Public spending on health care and medicines År BNP Offentlige utg. Offentlige utgifter Offentlige utg. til Year mill kr til helsevesenet til legemidler legemidler pr innb. Public spending Public spending on health care on medicines Public spending GDP NOK millioner kr % av BNP millioner kr % av BNP on medicines million NOK million % of GDP NOK million % of GDP per capita 1988 877 265 58 089 6,6 3 529 0,4 837 1989 895 095 56 545 6,3 3 681 0,4 870 1990 909 972 57 561 6,3 4 021 0,4 946 1991 929 015 61 326 6,6 4 363 0,5 1 021 1992 934 198 62 594 6,7 4 709 0,5 1 095 1993 958 627 62 915 6,6 4 980 0,5 1 152 1994 998 303 64 444 6,5 5 263 0,5 1 210 1995 1 036 943 67 635 6,5 5 659 0,5 1 295 1996 1 126 254 72 867 6,5 6 035 0,5 1 374 1997 1 170 182 77 652 6,6 6 487 0,6 1 492 1998 1 167 972 84 234 7,2 7 084 0,6 1 604 1999 1 230 138 90 237 7,3 7 078 0,6 1 589 2000 1 423 864 93 598 6,6 7 819 0,5 1 736 Tall i 2000-kroner Figures in 2000 currency Kilder: SSB, RTV, LIS og LMI/Farmastat Sources: Statistics Norway, National Insurance Administration, LIS and LMI/Farmastat Selv om kronebeløpet det offentlige bruker til legemidler har økt betydelig det siste tiåret, har utgiftene til legemidler som andel av BNP stort sett vært konstant. I tabellen er det gjort noen estimeringer i beregningene. Blant annet kjenner man ikke de eksakte tallene for omsetning av legemidler fra apotek til forbruker (AUP-tall). Tallene før og etter 1999 er ikke direkte sammenlignbare fordi det har vært nødvendig å hente dem fra ulike kilder. Even though the monetary amount spent by the government on medicines has increased substantially during the past 10 years, the expenditure on medicines as a share of GDP has in general been kept at a constant level. In the table some estimates have been made in the calculated values presented. For example, the exact figures for sales of medicines to the consumer are not known (PRP-figures). The figures for the years prior to and after 1999 are not directly comparable since they have been collected from different sources. 37

Tall og fakta 2002 Legemiddelindustriforeningen 2.03 Offentlige legemiddelutgifter i prosent av offentlige helseutgifter Public spending on medicines as a percentage of public health expenditure Legemidler/Medicines 8,4 % Andre helseutgifter/other health care expenses 91,6 % Kilder: HD, RTV, LIS og LMI Sources: Ministry of Health, National Insurance Administration, LIS and LMI Tall fra 2000 Figures from 2000 Statens utgifter til legemidler utgjør en relativt liten andel av utgiftene til fore bygging og behandling av sykdom. Legemidler utgjør 8,4 prosent av de offentlige helseutgiftene i Norge. Dette er lavt internasjonalt sett (se tabell 5.09). 38 The government s expenditure on medicines represents a relatively small share of the total costs for prophylactic and curative health care. The cost of medicines represents 8,4 percent of the public spending on health care in Norway. This is a low figure by international standards (see table 5.09).