2 Facts and figures 2007 Facts and figures 2007 3

i n d e x

003 Pharmacies in Norway: Deregulation of establishment and ownership, strict professional regulation of operations

004 About the pharmacy trade Numbers of pharmacies and development Wholesalers and pharmacy chains Employees, training and competence Health personnel in pharmacies

007 The core activities of pharmacies – Good Pharmacy Practice Standards for Pharmacy Practice Prescriptions and requisitions p h a r m a c i e s in n o r w a y : Self care Rational prescribing and medicine use deregulation o f establishment Health promotion and ill-health prevention a n d o w n e r s h i p , s t r i c t p r o f e s - 009 Pharmacy finance Pharmacy turnover s i o n a l r e g u l a t i o n o f o p e r a t i o n s Pharmacy turnover by community pharmacies and hospital pharmacies Pharmacy margin according to prescription type Since 2001, Norway has had a liberalised system of 011 Sales of Medicines ownership and establishment for pharmacies. The Total sales by main categories in pharmacies Pharmacy Act which was put into force on March 1st Sales by ATC (Anatomical Therapeutic Chemical) group 2001 is based on the following criteria for ownership The 25 most sold substances according to value and establishment: Sales of non-prescription medicines in pharmacies Non-prescription medicines outside pharmacies – pharmacy turnover • Free establishment of pharmacies - no establishment criteria • Free ownership of pharmacies – anyone can own pharmacies, except pharmaceutical manufacturers and doctors 016 Medicine prices • No limit of the number of pharmacies that can be owned by one pharmacy owner – horizontally integrated pharmacy chains Price regulation for on-patent medicines are allowed Pricing system for generic medicines • Vertical integration between wholesalers and pharmacies / Experience with the “trinnpris” system pharmacy chains are allowed

At the same time, the Pharmacy Act is stricter on the professional 018 Price comparisons with other countries regulations, with detailed regulations and quality criteria.

The primary goals of the Pharmacy Act are: 020 Reimbursement of medicines • Correct use of medicines, both medically and financially Co-payment • Accessibility for all patients to safe and effective medicines, independent of the patients’ financial situation • Medicines should have as low prices as possible 022 About the Norwegian Pharmacy Association 4 Facts and figures 2007 Facts and figures 2007 5

Pharmacy chain Wholesaler Owner

Alliance apotek Holtung AS Alliance Boots Limited (English) Vitusapotek NMD Grossisthandel AS Celesio AG (German) Apotek 1 Apokjeden Distribusjon AS Tamro Oy (Finnish)/ Phoenix (German)

Table 1: Structure of ownership

Apokjeden/ Vitusapotek, Public Hospital Independent Other Total Alliance apotekene, Apotek 1, wholly owned pharmacies pharmasies, independent wholly owned wholly owned (no chain pharmacies connections) with a chain connection

135 211 158 33 22 63 622

Table 2: Number of pharmacies according to ownership by June 2008 a b o u t t h e p h a r m a c y t r a d e

numbers of pharmacies As a result of the changes in the Pharmacy Act, the general public wholesalers and In Norway wholesalers are demanded to deliver a complete assort- has considerably better accessibility to pharmacies, as the number ment of medicines all over the country. This might be one reason why and development of pharmacies has increased from 399 in February 2001 to 622 as pharmacy chains the number of medical wholesalers in Norway is only three. of June 2008. Three large international pharmacy chains, each vertically integrated No pharmacy in scarcely populated areas has closed down since with a pharmaceutical wholesaler, own approximately 80 per cent of the pharmacy reform. One reason for this is that the pharmacy the pharmacies in Norway. The three pharmacy chains and the chains have signed an agreement with the Ministry of Health and pharmaceutical wholesalers both have international owners. See table 1. Care Services to guarantee pharmacy coverage in a large number of scarcely populated areas. Table 2 shows the distribution of the number of pharmacies that are 100 % owned by the pharmacy chains, hospital pharmacies which are In 2001, Norway was second last in the OECD ranking of number publicly owned and other pharmacies which are independent or, in of inhabitants per pharmacy. Even if the number of inhabitants per some cases, minority owned by the chains. pharmacy has fallen sharply after the deregulation, Norway still has a relatively low pharmacy coverage compared to many European By June 1st 2008 there are 33 publicly owned hospital pharmacies countries. See figure 1. in Norway. The hospital pharmacies are part of the specialist health care service. These are organised as independent health authori- ties, owned by the regional health authorities. Two of these hospital

&)%%% +*% pharmacies are owned by charitable trusts, which have agreements &(*%% with the health authority.

&(%%% +%% All the hospital pharmacies and several of the pharmacies which are CjbWZgd[e]VgbVX^Zh &'*%% CjbWZgd[^c]VW^iVciheZge]VgbVXn not wholly owned by a pharmacy chain are members of Ditt Apotek. **% &'%%% Ditt Apotek is an agreement based chain (purchasing and range co- operation) which NMD Grossisthandel AS offers to pharmacists who &&*%% *%% own and run their own pharmacies. &&%%% By June 1st 2008 22 pharmacies are not connected to any chain ex- &%*%% )*% cept through a supply agreement with a wholesaler. Such agreements &%%%% do not hinder supplies from competing wholesalers, as the Pharmacy )%% CjbWZgd[e]VgbVX^Zh .*%% Act allows all pharmacies to use any wholesaler they want.

CjbWZgd[^c]VW^iVciheZge]VgbVXn .%%% (*% -*%%

-%%% (%% &..+ &.., &..- &... '%%% '%%& '%%' '%%( '%%) '%%* '%%+ '%%, '%%-

Figure 1: Number of pharmacies and inhabitants per pharmacy in Norway: Source: The Norwegian Pharmacy Association and Statistics Norway 6 Facts and figures 2007 Facts and figures 2007 7

Number of man-labour years

Cathegory January 1st 2002 January 1st 2008

M.Sc.Pharm (managers and pharmacists) 781 1058 B.Sc.Pharm (prescriptionists) 758 974 Pharmacy technicians 3295 3125 Others (nurses etc) 175 169 Total 5009 5326

Table 3: Number of employees in all pharmacies

t h e c o r e activities o f p h a r m a c i e s – g o o d p h a r m a c y p r a c t i c e

employees, training and The pharmacies are resource centres for knowledge about medicines standards for Using WHO’s guidelines for Good Pharmacy Practice and their correct use. Rational use of medicines can prevent, allevi- competence ate and cure illness and thereby contribute to good health. Providing pharmacy practice (GPP) in Community and Hospital Settings, trade guidance regarding the rational use of medicines, both to customers standards for pharmacies (Standards for Pharmacy and to health personnel, is an important contribution to the health Practice) in Norway have been developed, defining service. The pharmacies’ customers are the entire population. Many of the customers are elderly, and many need special consideration, four areas as the pharmacies’ core activities: competence and help. • Prescriptions and requisitions • Self care health personnel The professional staff in pharmacies consists of a pharmacy manager, • Rational prescribing and medicine use pharmacists, prescriptionists, pharmacy technicians and sometimes • Health promotion and ill-health prevention in pharmacies nurses. Pharmacy managers, pharmacists and prescriptionists are entitled to dispense medicines according to prescriptions and requisi- The standards describe the role of the pharmacies in relation to cus- tions. Pharmacy managers and pharmacists are educated as M.Sc. tomers/patients, in the health care service and society and express Pharm, prescriptionists as B.Sc.Pharm. the trade’s requirements on itself by making quality demands on the pharmacies’ activities within the four core areas. The pharmacy managers, the pharmacists, prescriptionists, pharmacy technicians and nurses in pharmacies are authorised health person- The trade standards are based on the central principle of the nel. Through the law concerning health personnel, they are subject customers’/patients’ needs and rights. Pharmacists, prescriptionists to the legal framework common for all groups of health personnel. and pharmacy technicians, as authorised health personnel, offer The law concerning health personnel lays down a number of duties health aid related to medicines according to the legal requirements as reflected in the law concerning patients’ rights. This legislation for responsible professional conduct. This is linked to the patients’ in combination with the authorisation system gives the public quality rights in the legislation. assurance for the professional performance in pharmacies and contributes to strengthen the patient safety. The legislation focuses prescriptions and The work of preventing, identifying and solving drug-related on requirements for proper professional conduct, maintenance of problems for individual customers/patients is central. This requires competence, rules regarding secrecy and documentation of health requisitions extensive contact with prescribers and involves considerable aid which is required of health personnel. guidance and advice directed at customers/patients. The aim is to make the customer/patient understand the goal of the treatment The percentage of pharmacist and prescriptionist man-labour years and to empower her to carry it out correctly. These aspects are of has increased from 31 % in 2002 to 38 % in 2007. The number of importance for the effect of the treatment. Evaluation and follow-up man-labour years by pharmacy technicians is reduced from 66 % in of prescription medicines and their use at customer/patient level 2002 to 59 % in 2007. contributes to compliance and rational medicine use. 8 Facts and figures 2007 Facts and figures 2007 9

p h a r m a c y f i n a n c e

self care The customer/patient should be able to contribute to the preven- Norwegian authorities set maximum prices and maxi- tion and treatment of minor ailments and diseases. This includes mum pharmacy mark-up for all prescription medi- maintaining good health – with or without medicines and/or related products. cines. Several independent research studies have shown that prices on prescription medicines in The pharmacies give advice and guidance related to symptoms and Norway are among the very lowest in Europe. other health-related needs presented, and give guidance in the selection and use of non-prescription medicines. As a first contact point with the health care service, pharmacies can contribute to the Prescription and OTC medicines make up 80 % of all pharmacy efficient use of other parts of the health care service, by referring sales. While non-medicines make up 20 % of pharmacy sales, they customers/patients to physicians and other health personnel. represent a larger part of the pharmacy profit.¨

rational prescribing Direct contacts with medicine users together with contacts with The Government-owned National Insurance Scheme insures all prescribers and other health personnel give pharmacies insight into Norwegian citizens for medical expenses, and finances 61 % of and medicine use the population’s use of medicines. Pharmacies contribute to rational total sales of medicines in Norway. prescribing and use by, among other things, communicating their experiences to the authorities and other parts of the health care service.

health promotion and In co-operation with the authorities, the health care service, relevant organisations, user and patient groups, pharmacies are ill-health prevention working to enable the population to take better care of its health, and to prevent and avoid disease. Pharmacies take part in national and local health-promoting campaigns, such as campaigns against the use of tobacco. Pharmacies promote healthy lifestyles by distributing information, and give advice and guidance in the public health area. 10 Facts and figures 2007 Facts and figures 2007 11

2007 % change 2006-2007

Total pharmacy turnover, excl. VAT 16,554 3.4 Average turnover per pharmacy, excl. VAT 28 - 1.7

Table 4: Total and average turnover for pharmacies in 2007 (NOK million)

2007 % change % share NOK million 2006-2007 of total

Total turnover for community pharmacies, excl. VAT 13.650 3.6 82.8

Total turnover for hospital pharmacies, excl. VAT 2.842 2.5 17.2

Average turnover per community pharmacy, excl. VAT 24 -1.7

Average turnover per hospital pharmacy, excl. VAT 89 -0.7

Table 5: Total and average turnover in NOK millions by community pharmacies and hospital pharmacies (incl. VAT).

s a l e s o f m e d i c i n e s

Norwegian pharmacy gross mark-up for prescription only medicines Pharmacy margin according to total sales by main The low growth in medicine sales in Norway applies is based on a general calculation, based on the pharmacy purchas- categories in pharmacies in particular to the community pharmacies. While prescription type ing price: - the first NOK 200: 8 % growth for the community pharmacies has been - the rest (above NOK 200): 5 % almost 0 % during the past three years, the hospital - per packet: NOK 21.50 pharmacies have experienced a growth in sales of 10 From this mark-up, the pharmacy has to pay a Medicines Sales Tax % between 2004 and 2005, 5.3% between 2005 and to the state, on 1.3 % of the pharmacy purchasing price. 2006 and 4.7 % between 2006 and 2007 (see figure 2 and table 7).

This is partly due to the fact that few new medicines are introduced Prescription type 2007 for use outside the hospitals, whereas more new and often more Reimbursement prescriptions 15.9 % expensive medicines are to a greater extent brought into use by the specialised health services. Part of the reason is also a large de- Regular prescriptions 29,8 % crease in prices of generic medicines. The total turnover measured Total 18.3 % in defined daily doses (DDDs) rose by 3.7 % from 2006 to 2007. The trend whereby the hospital pharmacies have experienced a Table 6: Pharmacy gross margin 2007 - reimbursement and ordinary prescriptions Source: The Norwegian Pharmacy Association considerably stronger growth in medicine sales than the community pharmacies has lasted for several years.

Supply category 2007 2007 % share of total % change NOK million incl. VAT NOK million excl. VAT 2006-2007

Prescription medicines 14,580.2 11,666.9 88.1 1.3 Non-prescription medicines* 1,962.7 1,570.8 11.9 5.5 Total 16,542.9 13,237.7 100.0 1.8

Table 7 Sales according to supply category (NOK million) *) Includes all products classified as Non-prescription medicine (incl. products without ATC-number). 12 Facts and figures 2007 Facts and figures 2007 13

&+ &)#, IdiVa 8dbbjc^ine]VgbVXn &) =dhe^iVae]VgbVXn

&' &%#% .#* &%

- -#*

X]Vc\Z *#( + )#, ) '#% ' &#' &#, %#) %#( &#% % '%%(Ä'%%) '%%)Ä'%%* '%%*Ä'%%+ '%%+Ä'%%,

Figure 2: Turnover Trend (excl. VAT) for prescription medicines during 2003-2007

ATC 5th Substance Brand names, 2007 % change 2007 % change level (examples) NOK million 2006–2007 DDD million 2006–2007

1 L04AB01 Etanercept Enbrel 446,3 4,0 1,2 9,8 2 R03AK06 Salmeterole and other remedies for Seretide 324,5 -4,8 19,3 -4,7 obstructive lung diseases 3 C10AA05 Atorvastatin Lipitor 306,3 -18,6 82,8 -3,8 sales by atc (anatomical The ATC group L Antineoplastic and immunomodulating agents has had the largest increase in sales for human medicines. This is a 4 L04AB02 Infliximab Remicade 290,7 18,3 1,3 17,4 ­therapeutic chemical) group result of among other elements a continued strong increase in the 5 A02BC05 Esomeprazole Nexium 246,7 -27,7 22,8 -15,2 sales of the TNF inhibitors Enbrel, (etanercept), Remicade (inflixi- 6 N02BE01 Paracetamol Pinex, Panodil, 240,1 4,7 34,8 3,8 mab) and Humira (adalimumab). Paracet 7 L04AB04 Adalimumab Humira 206,4 26,4 0,5 25,8 The ATC group C Cardiovascular system had in 2007 as in 2006 a reduced sale by value despite a stronger growth measured in DDD. 8 N05AH03 Olanzapin Zyprexa 205,3 2,0 4,7 2,9 This is a result of the “trinnpris” system’s strong contribution to 9 R03AK07 Formoterole and other remedies for Symbicort 203,8 6,5 11,5 4,2 reducing prices for several medicines with large sales within this obstructive lung diseases group of medicines. 10 C10AA01 Simvastatine Zocor 181,3 -32,5 183,5 28,7 11 C09DA01 Losartan and diuretics Cozaar Comp 171,8 3,7 21,1 3,2 12 C07AB02 Metoprolole Selo-Zok 171,6 -10,0 41,2 3,6

ATC 1st 2007 % change 2007 % change 13 N06AB10 Escitalopram Cipralex 163,9 17,9 25,2 19,4 level Main groups NOK million 2006–2007 DDD million 2006–2007 14 N07BA01 Nicotine Nicotinelle, 162,1 3,0 5,9 3,5 Nicorette A Alimentary tract and metabolism 1 869 0,4 443,9 2,9 15 L02BB03 Bikalutamide Casodex 150,0 10,2 3,3 8,9 B Blood and blood forming organs 816 4,6 208,9 3,5 16 M01AE01 Ibuprofen Ibux 149,4 10,2 21,7 7,7 C Cardiovascular system 2 202 -6,3 759,9 7,1 17 N02AA59 Codein, combinations excl. psykoleptics Paralgin Forte, 148,3 -0,5 21,1 -1,0 D Dermatologicals 453 5,2 2,9 6,5 Pinex Forte G Genito urinary system and sex hormones 897 6,1 159,8 -2,6 18 L03AB07 Interferon beta-1a Avonex, Rebif 138,8 7,3 1,1 6,1 H Systemic hormonal preparations, excl. sex hormones and 395 2,0 69,5 2,5 19 H01AC01 Somatropin Genotropin, 134,5 -3,1 0,6 0,5 insulins Humatrope J Antiinfectives for systemic use 818 1,6 33,9 3,5 20 C09CA06 Kandesartan Atacand 123,0 17,7 24,9 16,9 L Antineoplastic and immunomodulating agents 2 575 10,4 22,4 9,3 21 N06AX16 Venlafaksin Efexor 119,5 -7,6 11,0 5,4 M Musculo-skeletal system 586 -11,3 96,6 0,3 22 A10AC01 Insulin(human) Insulatard 114,9 -4,3 12,6 -4,0 N Nervous system 3 358 1,9 352,2 3,4 23 N03AX09 Lamotrigin Lamictal 114,2 -5,0 4,3 17,6 P Antiparasitic products, insecticides and repellents 62 12,1 1,4 3,1 24 C09CA01 Losartan Cozaar 109,2 5,0 15,7 3,6 R Respiratory system 1 716 0,5 278,3 2,1 25 N06BA04 Metylfenidat Concerta, 108,1 25,2 7,7 20,4 S Sensory organs 381 0,2 28,6 -0,4 Ritalin V Various 156 -2,2 0,2 6,1 Sum 25 4730,7 -1,3 579,8 9,3 Total 16 282 1,5 2 458,4 3,7 Combined total 16 282 1,5 2 458,40 3,7

Table 8: Sales of medicines in relation to ATC classification Table 9: The 25 most sold active substances ranked according to value in 2007 (NOK million) 14 Facts and figures 2007 Facts and figures 2007 15

ATC 5th 2007 % change 2007 % change % change level Active substance Brand names (examples) NOK million 2006–2007 DDD million 2006–2007 2006-07

1 N02BE01 Paracetamol Pamol, Paracet, Pinex 182,2 -0,3 17,1 -3,6 3,4 2 N07BA01 Nicotine Nicorette, Nicotinell 162,1 3,0 5,9 3,5 -0,4 3 M01AE01 Ibuprofen Ibumetin, Ibux 117,1 10,7 10,1 8,5 2,0 4 R01AA07 Xylometazoline Otrivin, Zymelin 90,7 0,4 22,7 -0,9 1,3 5 A01AA01 Natriumfluorid Flux, Fluorette, Xerodent* 58,5 3,0 117,0 -2,3 5,4 6 R06AE07 Cetirizine Zyrtec, Reactine, Acura 55,1 2,5 7,9 3,5 -1,0 7 R05CA10 Combinations Cough and cold remedies 45,6 15,4 3,9 6,6 8,3 8 A02BA53 Famotidine, combina- Pepcid 44,7 21,7 1,4 17,9 3,2 tions 9 G01AF02 Clotrimazol Canesten for vaginal use 40,7 -0,1 1,7 -5,1 5,3 10 N02BB51 Fenazon, combinations Antineuralgica, Fanalgin, 35,3 -0,6 4,1 -5,8 5,4 excl. psycholeptics Fenazon-koffein Sum 832,0 4,1 191,8 -1,1 5,3 Total 1 898,9 5,6 392,9 -0,4 5,3

Table 10: The 10 most sold active substances in pharmacies – non-prescription medicines (NOK million and million DDD)

sales of non-prescription Self care is one of the pharmacies’ core work areas. Pharma- total sales of medicines According to the Norwegian Institute of Public Health, sales outside medicines in pharmacies cies have an important task in advising and guiding in the use of pharmacies during 2007 accounted for 38% of sales of medicines non-prescription medicines. Non-prescription medicines are sold in on the general sales list on the general sales list (basic range), measured in DDDs. In 2006 pharmacies and in outlets under the supervision of a pharmacy. this share was 36%. Total sales of these medicines (pharmacy and A selection of non-prescription medicines is also sold outside outside) have risen by approximately 7 % from 2006 to 2007. pharmacies. The grocery retail sector also sells a small range of other medicines such In total, pharmacies sold non-prescription medicines for NOK 1.9 as antacids, travel sickness medicines and cough mixtures. These ac- billion. This constituted 9.2 percent of the total turnover for count for a negligible share of total medicine sales outside pharmacies. pharmacies, compared to 9.0 % in 2006. As a group, the growth in sales of non-prescription medicines was 5.6 percent compared to 2006.

non-prescription medicines A selection of non-prescription medicines is sold outside pharmacies.

outside pharmacies On 1 January 2003, sales of a selection of nicotine preparations for – pharmacy turnover smoking cessation became permissible outside pharmacies. On 1 November 2003, the range of medicines that could be sold outside pharmacies was widened with a number of other non-prescription Substance Sales by million DDD % change Share of Share of medicines. The list of medicines that can be sold outside pharma- 2007 2006-2007 grocery grocery sector 2006* sector 2007 cies, (The general sales list) covers in total 33 substances. However, turnover outside pharmacies has concentrated on simple pain- Calcium carbonate 1.7 0 - - relieving medicines (paracetamol, ibuprofen, phenazone combi- Ibuprofen 16.8 13 37 % 38 % nations), and nose decongestion sprays (xylometazoline). These Phenazone-caffeine 4.8 - 3.5 15 % 14 % represent a minimum list, which is a requirement for sales defined by the Norwegian Medicines Agency. The nicotine preparations can Paracetamol 30.8 4 39 % 44 % be sold without fulfilling the requirements of the minimum list. Nicotine 7.3 10 13 % 16 % Oxymetazoline ** 4.5 -4.5 - - By 1 January 2008, there were almost 6100 sales locations outside pharmacies for the medicines included in the regulation. (Source: Xylometazoline 46.7 9 39 % 50 % The Norwegian Medicines Agency.) Expectorantia 3.0 - - - Meclozine 1.7 - - - Total 117.4 7 37 %* 38 %

Table 11 Non-prescription medicines (in the basic range) sold in the grocery sector and pharmacies combined Source: Norwegian Institute of Public Health, The Norwegian Pharmacy Association * 1Q.-3Q ** May be sold outside pharmacies but are not included in the range sold through the grocery retail sector. 16 Facts and figures 2007 Facts and figures 2007 17

Sales last 12 months prior to generic > 100 NOK mill. > 100 NOK mill. competition*

Point of time for price reductions

reduction When there are generic alternatives 30 % 30 % 30 % available and stable generic competi- tion. reduction 6 months after generic alternatives 55 % 75 % 75 % are available

Sales last 12 months prior to generic > 15 NOK mill > 30 NOK > 100 competition* mill. and < NOK 100 NOK mill. mill. Point of time for price reductions reduction At the earliest 12 months after last 65 % 80 % 85 % ordinary reduction

Table 12: Pricing system for generics – price reductions by January 1st 2008 *Sales for 12 months, Public selling price incl VAT in NOK million medicine p r i c e s

price regulation for Norwegian authorities set a maximum pharmacy All pharmacies have to offer their customers at least one generic purchase price (AIP) for every prescription medicine brand within each group on the exchange list at this reduced price. on-patent medicines This price is also the maximum amount refunded by the National given a market authorisation in Norway. This is in Insurance Administration. Exceptions apply where the doctor has addition to the traditional regulation of the pharmacy found medical reasons for denying the pharmacy from generic sub- stitution. In such circumstances, the National Insurance Administra- maximum sales price (AUP) and the maximum phar- tion system will refund the full price of the medicine. macy mark-up. experience with the Both the calculations carried out by The Norwegian Pharmacy The setting of a maximum price is a two-stage procedure: Association and an assessment carried out by the Norwegian First, a maximum purchase price for pharmacies (AIP) is set for “trinnpris” system Medicines Agency show that the “trinnpris” system has to a large the medicine in question. Thereafter, a maximum mark-up from extent worked as intended and has yielded the expected savings. the pharmacy’s sale for each medicine is set. In total, this fixes the According to the Norwegian Medicines Agency the system has medicine’s maximum sales price from the pharmacy (AUP). been predictable, relatively simple to administrate and could be implemented quickly. Compliance with the system has also been The Norwegian Medicines Agency has worked out guidelines for satisfactory. setting the maximum AIP. The main rule is that the maximum AIP is set to be the average of the three lowest market prices for the Sales for substances included in the “trinnpris” system in 2007 medicine in the following countries: Sweden, Finland, Denmark, amounted to NOK 1,690 million. Germany, United Kingdom, the Netherlands, Austria, Belgium and Ireland. This type of price regulation is often called “International reference pricing”

pricing system for The Norwegian Medicines Agency sets a maximum sale price also generic medicines for generic medicines. The top-selling substances with generic competition are regulated by the so called “trinnpris” (tiered) pricing system. When the “trinnpris” system was introduced on 1 January 2005, it applied to 21 substances. By 1 January 2008, the number of substances had risen to 42.

This pricing system ensures that the prices for medicines automati- cally fall when the medicines get stable generic competition. In this pricing system, medicines for which the patent has expired and which are listed on the Norwegian Medicines Agency’s exchange list get reduced prices. The price reductions are tiered, see table 12. 18 Facts and figures 2007 Facts and figures 2007 19

Norway Sweden Denmark Finland UK Germany Netherlands Belgium Austria Ireland

A) All substances Price per dose 100,0 109,6 113,8 123,7 104,4 138,7 117,4 156,7 122,7 234,6 B) Patented substances (without actual generic competition in Norway) Price per dose 100,0 112,0 123,9 124,2 101,7 124,2 100,0 154,2 119,7 196,7 C) Non-patent substances (with actual competition in Norway)

Price per dose 100,0 105,3 95,6 122,8 109,0 166,8 147,3 161,3 128,2 300,5

D) Substances in the “trinnpris” system

Price per dose 100,0 108,0 109,1 127,4 136,4 174,4 215,9 210,1 194,4 518,1

Table 14: Bilateral indices (public selling price) for all substances, Norwegian weights p r i c e comparisons w i t h o t h e r c o u n t r i e s Norway is the cheapest or among the cheapest The report is based on data from IMS Health about the 300 most countries for medicines in Western Europe. This ap- used substances in Norway during the first six months of 2007. The data set included price, volume (packaging and dosages), plies both for medicines covered by patents and for patent status, original/generic, packaging size, presentation form, medicines with generic competition. At the same strength, etc. In addition to data from Norway, data from Sweden, Finland, Denmark, Germany, the UK, the Netherlands, Austria, time, distribution margins for Norwegian pharmacies Belgium and Ireland were also collected. It is prices from these and medical wholesalers are among the lowest. countries that are used to set maximum prices for prescription medicines in Norway. These are the main findings in the most comprehensive analysis of the price of medicines ever carried out in Norway. The report, which Volume-weighted average prices for each substance were cal- was published on May 28th 2008, was compiled by the Institute for culated for the wholesalers’ purchase price and the pharmacies’ Research in Economics and Business Administration (SNF) on behalf selling price, as well as total mark-up for wholesalers and pharma- of the Minister of Health, Mrs. Sylvia Brustad. The report compares cies (relative margin). Average prices and relative margins were the price of medicines and margins in Norway with the nine Euro- compared to those of the other countries in the investigation. pean countries selected by the Norwegian authorities as being the most comparable. The data were then analysed by calculating price indices and by regression analysis in order to test whether the differences in price The investigation used several methods, all of which place Norway were statistically significant. as the cheapest or one of the very cheapest countries, based on prices and consumption during the first six months of 2007. The report also establishes that the distribution margins in Norway – the The investigation shows that Norway has the lowest prices on total earnings of pharmacies and pharmaceutical wholesalers – are actual results medicines of all the ten comparison countries, when the Norwegian among the lowest in Europe. consumption of medicines is used as the basis (line A). The price difference compared to other countries is particularly great for the The price level in Norway in 2008 is even lower than the report medicines included in the “trinnpris” (tiered pricing) system (line D). states. The prices of a number of medicines with generic competi- These are the most consumed medicines with generic competition. tion were cut by a further NOK 113 million as from 1 January 2008. This price cut was not picked up by the investigation, which was based on figures from 2007. 20 Facts and figures 2007 Facts and figures 2007 21

reimbursement o f m e d i c i n e s

All persons who are either residents or working as co-payment Within the National Insurance Scheme a co-payment is required ­employees in Norway or on permanent or movable from most patients. Persons receiving minimum old-age pension or minimum disability pension and children below 12 years of age ­installations on the Norwegian Continental Shelf do not pay a co-payment. The co-payment in 2008 is 36 % of sales are compulsorily insured under the National Insur- value, but no more than 510 NOK for each prescription. If the pa- tient’s total combined co-payment on medicines, visits to physicians ance Scheme, financed by national taxes. Also certain or psychotherapy combined exceeds 1740 NOK before the end of the cate­gories of Norwegian citizens working abroad are year, then the patient will receive a “free card” and do not have to c­ompulsorily insured. pay further co-payment during the year.

The National Insurance Scheme, administered by the National Insur- For generic medicines the reimbursement price normally is equiva- ance Administration, offers reimbursement for certain medicines lent to the price of the cheapest generic alternative, as defined by to patients suffering from chronic illnesses according to a list of the “trinnpris” system. If the patient insists on having the more ex- diagnoses with a set of criteria the patients have to meet. For each pensive alternative, then the patient will have to pay the difference diagnosis there is a corresponding list of reimbursable medicines. between the actual price, and the price of the cheaper alternative in The Norwegian Medicines Agency decides the inclusion of medicines addition to the normal co-payment. Exceptions apply when the phy- in the reimbursement programme, upon application from the phar- sician has found medical reasons for denying the pharmacy the right maceutical industry. A health economic evaluation of the product is to generic substitution. In such cases, the National Insurance Scheme mandatory when applying for reimbursement. reimburses the price of the product chosen by the physician, and the patient only has to pay the normal co-payment. The National Insurance Scheme financed approximately 61 percent of total drug sales in Norway in 2007. Total turnover of drugs in 2007 was 16.5 billion NOK. The National Insurance Scheme’s expenditure for drugs in 2007 was 10.0 billion NOK. 22 Facts and figures 2007 Facts and figures 2007 23

administration phamacy services As of 1 June 2008, The Norwegian Pharmacy Association including The Pharmacy Service Department operates several common the organisation AS Apotekernes Hus had 40 employees. services for the trade and associated businesses: The association’s employees are skilled in pharmacy, economy, statistics, IT and teaching. Nordisk nummercentral (Nordic Number Office) On behalf of the Nordic pharmaceutical industry, the Nordic Number For information about individuals (names, phone number etc) Office (NNC) allocates Nordic article numbers for pharmaceuticals to – try www.apotek.no be marketed in one or several of the Nordic countries.

other companies Vareregistersentralen – VRS (Norwegian Article Number Registry) A number of business activities are organised in AS Apotekernes VRS maintains and updates the pharmacies’ common article Hus. Special mention should be made of NAF-Data AS. registers. VRS co-operates with the Norwegian Medicines Agency NAF-Data AS sells, maintains and develops an IT system which is and the National Insurance Administration regarding information used by all pharmacies – called FarmaPro. A new version, FarmaPro exchange. The register forms the basis for Norwegian public drug 5 based on the latest Microsoft technology, is launched in 2008. consumption statistics. It is also used in individual IT systems for physicians.

pharmacy policy The Norwegian Pharmacy Associations educational services The framework terms are one of the core working areas for The The association’s educational services cover producer-independent Norwegian Pharmacy Association. The work is carried out through continuing and postgraduate education, primarily for pharmacy hearings, dialogue and contact meetings with ministries, govern- technicians. Additionally, special courses for other professionals are ment authorities and political authorities, in co-operation with other also arranged. participants in the pharmaceuticals area, by development of docu- a b o u t t h e n o r w e g i a n p h a r m a c y mentation, analysis and statistics, and contacts with mass media. Service production system The centralised service production system for pharmacy products association publications, etc has as its goal to secure good availability of medicines which are The Norwegian Pharmacy Association (Apotekfore- The Norwegian Pharmacy Association publishes, among others: not offered by the pharmaceutical industry. The system is adminis- ningen) is the trade organisation for pharmacies in • Apotekforeningens Tidsskrift (The Journal). See also tered by the company ServiceProduksjon AS (SPAS). The Norwegian www.apotektidsskrift.no Norway and their owners. According to the associa- Pharmacy Association has the product responsibility for these • Apotek og legemidler (Pharmacies and pharmaceuticals) – Trade pharmacy products. tion’s rules, The Norwegian Pharmacy Association shall statistics on the pharmacies’ operation and sales of medicines primarily work to secure the best possible and predict- • Apotekboka (The Pharmacy Book) – Overview of laws and regu- The Norwegian Pharmacy Association is a member of Nordisk lations for the pharmacy and pharmaceutical trade able framework terms for the pharmacies. In addition Apoteksforening – NA (The Nordic Pharmacy Association), a joint • Handbook for pharmacy outlets organisation for the pharmacy associations in Denmark, Finland, the association shall work to promote the pharmacies a • A weekly e-mail newsletter Norway and Sweden (Apoteket AB). The board consists of the clear and valuable position within the health care sys- elected leaders of each country’s association. tem, the pharmacy profession and towards consumers. trade statistics The Norwegian Pharmacy Association receives data from the intenational co-operation pharmacies and produces common trade statistics. The purpose is The Norwegian Pharmacy Association also fulfils some joint functions The Norwegian Pharmacy Association is also a member of Fédéra- to create knowledge and documentation as the basis for input to and service tasks on behalf of the trade. tion Internationale Pharmaceutique / International Pharmaceutical authorities and for public debate. Federation (FIP), which is a world-wide professional organisation for The system is based on all sales registered in the pharmacy com- All Norwegian pharmacies, 622 in total, are members of the associa- pharmacists, and Europharm Forum, which is a network of national members puter system FarmaPro. The statistics system includes, among other tion as of 1 June 2008. Included in this figure are 33 publicly owned pharmacist organisations in Europe, linked to WHO. things, detailed overviews of medicine sales with prices, reimburse- hospital pharmacies. ment and anonymised prescription information. The Norwegian Pharmacy Association is an observer to The Phar- maceutical Group of the European Union (PGEU), a political organ the board As of 1 June 2008, the board consists of representatives from independent pharmacies, hospital pharmacies and the pharmacy chains working within the EU system. The organisation follows develop- Apokjeden AS, Alliance UniChem Norge AS and NMD Grossisthandel AS. ments within the pharmacist profession and the pharmacy sector, The names of the representatives and their personal deputies are and produces policy documents in areas important to pharmacies. available at the Norwegian Pharmacy Associations home page www.apotek.no by choosing “Om Apotekforeningen” on top of front page. Design and print by GrafiaAS / 08-49681 / www.grafia.net. Kommunikasjon Photo by Jens Sølvberg 2008facts and figures f a c t s a n d f i g u r e s Facts and Figures 2008 The majority of statistics in this publication is based on The Norwegian Pharmacy Association’s trade statistics which includes all sales registered in the pharmacy computer system FarmaPro in nearly all Norwegian pharmacies. 2008 Additional information in English on the Norwegian medicinal market and prices on medicines in Norway is available from The Norwegian Pharmacy Association in print or on our website www.apotek.no

Request may be sent to [email protected] or to

Apotekforeningen, Postboks 5070 Majorstuen, NO-0301 Oslo, Norway

Pharmacies and Pharmaceuticals FACTS AND FIGURES – PHARMACIES AND PHARMACEUTICALS IN NORWAY is a brief presentation of Norwe- gian pharmacies and their trade organisation Apotekforeningen (The Norwegian Pharmacy Association). in Norway 2008

FACTS AND FIGURES – PHARMACIES AND PHARMACEUTICALS IN NORWAY contains basic facts on pharma- cies, sales of medicines, regulation of pharmacies, the Norwegian reimbursment system etc.

Apotekforeningen (The Norwegian Pharmacy Association) is the trade organisation for pharmacies in Norway and their owners. According to its rules, the organisation shall primarily work to secure the best possible and predictable framework terms for the pharmacies. Apotekforeningen fulfills some joint functions and service tasks on behalf of the trade. In addition the organisation shall work to secure the pharmacies a clear and valuable position within the health care system, the pharmacy profession and towards consumers.

Apotekforeningen Postboks 5070 Majorstuen, 0301 Oslo telefon: +47 21 62 02 00, fax +47 22 60 81 73 e-post: [email protected] www.apotek.no