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Bull World Health Organ 2014;92:630–640D | doi: http://dx.doi.org/10.2471/BLT.13.129114

Research

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Effect of the economic recession on pharmaceutical policy and medicine sales in eight European countries Christine Leopold,a Aukje K Mantel-Teeuwisse,b Sabine Vogler,a Silvia Valkova,c Kees de Joncheere,d Hubert GM Leufkens,b Anita K Wagner,e Dennis Ross-Degnane & Richard Laingd

Introduction European public authorities struggle to maintain a high level of access to health care while restraining increases in expenditure associated with an ageing population and higher demand.1–4 The recent global economic recession has put additional pres- sure on public budgets.5,6

In 2008, Europe was affected by the financial crisis. As the recession in Europe continued, the effect was felt especially in southern European countries and Ireland in 2010 and 2011. Soon the problem of financial debt for individual European countries developed into a crisis in the Eurozone, which then became a high priority for the European Central Bank and the European Parliament. All countries were urged to imple- ment cost-saving measures that affected public financing for health care.7

Recession, which is defined as two successive quarters of negative growth in gross domestic product (GDP), can have a detrimental effect on the health of the population because economic downturns are strongly associated with a decline in health-care utilization and a deterioration in health outcomes.8 For example, suicides and homicides increased among working-age men and women when unemployment rose rapidly during past recessions in Europe.9 In the current recession, the number of uninsured non-elderly Americans increased by 5.6 million between 2007 and 200910 and over a quarter of Americans reported reduced routine use of medi-

cal care.11 Over the same period, insurance policy deductibles and copayments for visits to physicians and for prescription medicines increased, leading to a greater cost burden for patients.12–14 Similar effects were seen in Greece. Studying the health effects of the economic crisis in the country it was found that patients had less access to care and preventive services and, consequently, faced higher risks of infection with sexu- ally transmitted diseases.15 The World Health Organization examined the influence of the recession on expenditure on, and the sales and prices of, medicines between 2007 and 2009 in 84 countries. It found that the economic recession had mixed effects and that the largest declines in medicine sales occurred in high-income countries and in Europe, particularly in the Baltic states.16

It has been shown that countries that were seriously af- fected by the crisis, such as the Baltic countries, Greece, Por- tugal and Spain, abruptly implemented several pharmaceutical policy measures between 2010 and 2011. This included price cuts, changes in reimbursement rates and the imposition of value-added tax on medicines.17 In other European countries, such as Italy, in which cost-containment measures were already in place when the crisis began, the implementation of planned policy changes was accelerated.18

Because different countries were affected differently by the recession and attempted to overcome budgetary constraints in different ways, we decided to analyse systematically how European pharmaceutical policies were affected by the reces-

Objective To identify pharmaceutical policy changes during the economic recession in eight European countries and to determine whether policy measures resulted in lower sales of, and less expenditure on, pharmaceuticals. Methods Information on pharmaceutical policy changes between 2008 and 2011 in eight European countries was obtained from publications and pharmaceutical policy databases. Data on the volume and value of the quarterly sales of products between 2006 and 2011 in the 10 highest-selling therapeutic classes in each country were obtained from a pharmaceutical market research database. We compared these indicators in economically stable countries; Austria, Estonia and Finland, to those in economically less stable countries, Greece, Ireland, Portugal, Slovakia and Spain. Findings Economically stable countries implemented two to seven policy changes each, whereas less stable countries implemented 10 to 22 each. Of the 88 policy changes identified, 33 occurred in 2010 and 40 in 2011. They involved changing out-of-pocket payments for patients in 16 cases, price mark-up schemes in 13 and price cuts in 11. Sales volumes increased moderately in all countries except Greece and Portugal, which experienced slight declines after 2009. Sales values decreased in both groups of countries, but fell more in less stable countries. Conclusion Less economically stable countries implemented more pharmaceutical policy changes during the recession than economically stable countries. Unexpectedly, pharmaceutical sales volumes increased in almost all countries, whereas sales values declined, especially in less stable countries.

a World Health Organization (WHO) Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Gesundheit Österreich GmbH, Stubenring 6, 1010, Vienna, Austria.

b WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Utrecht Institute for Pharmaceutical Sciences, Utrecht, Netherlands. c IMS Institute for Healthcare Informatics, Philadelphia, United States of America (USA). d Department of Essential Medicines and Pharmaceutical Policies, World Health Organization, Geneva, Switzerland. e Department of Population Medicine, Harvard Medical School, Boston, USA. Correspondence to Christine Leopold (email: christleopold@gmx.net). (Submitted: 19 August 2013 – Revised version received: 11 February 2014 – Accepted: 20 March 2014 – Published online: 16 June 2014 )

Research

Bull World Health Organ 2014;92:630–640D| doi: http://dx.doi.org/10.2471/BLT.13.129114 631

Research Economic recession and pharmaceutical policies

sion by comparing changes in pharma- ceutical pricing and reimbursement policies between economically stable and economically less stable countries. In addition, we investigated changes in the sale of pharmaceuticals in major therapeutic classes before and after the recession in these two types of countries. We expected that some of the cost-con- tainment policies, such as those affecting out-of-pocket payments, would shift the financial burden of medicines onto patients and hypothesized that pharma- ceutical sales would decline during this period, especially in less economically stable countries.

Methods Data sources

For this longitudinal study, we used data from two sources to derive information on pharmaceutical policies: (i) the Phar- maceutical Pricing and Reimbursement Information Network (Austrian Health Institute, Vienna, Austria), which col- lects information from experts in na- tional pharmaceutical pricing and from authorities responsible for reimburse- ment – the latter provide regular phar- maceutical policy updates; and (ii) the PharmaQuery database (IMS Health, Philadelphia, United States of America), which contains data on pharmaceuti- cal policies. In addition, we included information on policy changes reported in the published literature. We grouped policy changes into 6-month implemen- tation periods from January 2008 until December 2011 and we categorized policy as relating to one of three main areas: (i) pricing; (ii) reimbursement; and (iii) generic drugs. Table 1 defines the policy measures in these three areas.

Quarterly pharmaceutical sales data for the period January 2006 to December 2011 were obtained from the IMS MIDAS (Multinational Inte- grated Data Analysis System) Quantum pharmaceutical market research service (IMS Health, Philadelphia, USA). Data were expressed in standard units for the volume of sales and in constant United States dollars (US$) for the value of sales. A standard unit, as defined by IMS Health, is the smallest dose of a product – it may be one tablet or capsule for oral preparations, one teaspoon (i.e. 5 mL) for a syrup or one ampoule or vial for an injectable product. The value of sales was derived from the price deemed most accurate for the relevant country and

was expressed in constant US$, which were calculated by converting the local currency into United States dollars at a constant exchange rate. In most coun- tries, the price used was the ex-factory price; in Estonia, Finland, Greece and Ireland, ex-factory prices were derived from wholesale prices. Average stan- dard conversion factors, which were determined with the co-operation of the pharmaceutical industry for each country, were applied to estimate prices at various points along the distribution chain. The price calculations did not take into account any discounts between manufacturers, wholesalers and payers and were not adjusted for inflation.

Our study considered only prescrip- tion medicines, whether on or off patent, that were available in the retail market for the 10 highest-selling therapeutic classes. We identified the 10 highest- selling classes by ranking therapeutic classes according to their sales volume in each country. Together the combined sales volume of products in these 10 classes accounted for at least 50% of the total sales volume of all medicines in each of the eight countries from 2008 to 2011 (Table 2). Data were aggregated by therapeutic class for each country. We had no data on individual drugs.

Country groups

We considered eight European countries in which the majority of the population was covered by a social security system or national health service: Austria, Esto- nia, Finland, Greece, Ireland, Portugal, Slovakia and Spain. We selected these countries because they represented a va- riety of geographical regions and levels of economic wealth and stability and had been affected by the recession to differ- ent degrees. We classified them as either economically less stable or economi- cally stable using categories defined by the Organisation for Economic Co- operation and Development (OECD) for the level of fiscal consolidation in 2012. Fiscal consolidation was judged according to whether the country had adopted either concrete policies aimed at stabilizing general government gross debt or a long-term target for the debt- to-GDP ratio of 60%. There were four categories of country: (i) those that had adopted a programme proposed by the International Monetary Fund, the Euro- pean Union and the European Commis- sion (e.g. Greece, Ireland and Portugal); (ii) those that were under clear market

pressure (e.g. Belgium, Hungary, Italy, Slovakia and Spain); (iii) those that had a substantial deficit or debt but which were under less market pressure (e.g. Austria, Denmark, Finland, France and Germany); and (iv) those that had no or only a marginal need for consolida- tion (e.g. Norway, Sweden and Switzer- land).21 In this study, we regarded eco- nomically less stable countries as those belonging to the first two categories (i.e. Greece, Ireland, Portugal, Slovakia and Spain) and economically stable coun- tries as those belonging to the third and fourth categories (i.e. Austria, Estonia and Finland).

Data analysis

First, we described and analysed the number of policy measures implement- ed per year, per country group and per policy category. Next, we determined the volume and value of the sales of drugs in each therapeutic class between 2006 and 2011 in each country and, then, we cal- culated the combined volume and value of the sales of drugs for all 10 therapeutic classes for each country. Since our find- ings for individual therapeutic classes and for all therapeutic classes combined were similar, we present only the results for all therapeutic classes combined.

For this analysis, we divided the volume and value of sales by the size of the country’s population to control for population growth; annual population figures were obtained from the OECD.22

We derived the annual and average growth rates over the study period using both the volume and value of pharma- ceutical sales per capita:

AGR y y

= − 

  



   ×

−

S S 1

1 100

(1)

AAGR AGR

= ∑ n

(2)

where AGR is the annual growth rate, Sy is the per capital sales in a year, Sy–1 is the per capital sales in the previous year, AAGR is the average annual growth rate and n is the number of years.

To compare changes in the volume and value of sales, we calculated the dif-

Bull World Health Organ 2014;92:630–640D| doi: http://dx.doi.org/10.2471/BLT.13.129114632

Research Economic recession and pharmaceutical policies

Table 1. National policy measures influencing pharmaceutical sales19

Policy measure Definition

Pricing Price cut A cost-containment measure whereby the set price of a medicine is reduced by the authorities. External price referencing External price referencing is the practice whereby the price of a medicine in one or several other

countries is used to derive a benchmark or reference price for the purpose of setting or negotiating the medicine’s price in a given country. Policy changes in external price referencing include the introduction or abolition of this pricing policy and altering the methodology (e.g. changing the basket of reference countries or the way of calculating the benchmark price).

Distribution remuneration (i.e. mark-ups, margins and fees for service)

Distribution remuneration is the payment of a health-care provider, whether an individual or an organization, for the services provided. In the distribution of pharmaceuticals, wholesalers and pharmacies are remunerated using mark-ups or regressive margin schemes or, for pharmacies alone, by paying a “fee for service”. With mark-ups, a defined linear or percentage amount is added to the cost of a good to ensure a profit at the wholesale or retail level or both. With regressive margin schemes, the margin is expressed as a percentage of the selling price. Policy changes in distribution remuneration include adjusting the mark-ups or margins used for wholesalers or pharmacies or changing the type of distribution remuneration for a defined actor. Changes may also be made to the types of medicines (e.g. reimbursable medicines or prescription-only medicines) to which distribution remuneration applies.

VAT on medicine VAT is a sales tax on products that is collected in stages. It is a wide-ranging tax that is usually designed to cover most or all goods and services, including medicines. Policy changes in VAT include the introduction or abolition of VAT on medicines and altering the VAT rate on medicines.

Extraordinary price review Price reviews involve reviewing the process by which the set price of a medicine was established. Reviews may or may not be performed in combination with reimbursement reviews. Reviews can be performed systematically (e.g. once a year) for all reimbursed medicines or for a group of medicines (e.g. for a specific indication) or at any time.

Reimbursement Reference price system With a reference price system, which is also referred to as internal or therapeutic reference pricing, the

third party payer determines a reference price for the reimbursement of medicines with a particular active ingredient or in a given therapeutic class. If the price of the medicine exceeds the reference price, the health-care consumer must pay the difference between the fixed reimbursed amount (i.e. the reference price) and the actual pharmacy retail price in addition to any copayments (e.g. prescription costs and percentage copayment rates). Policy changes in the reference price system include the introduction or abolition of a reference price system and changing the methodology by which clusters of medicines are established for determining a reference price (e.g. by grouping identical or similar medicines).

Out-of-pocket payments Out-of-pocket payments are payments made by health-care consumers that are not reimbursed by a third-party payer. They include cost-sharing, fixed or percentage copayments and informal payments to health-care providers.

Delisting Delisting is the exclusion of a medicine from a reimbursement list (e.g. a positive list), which often results in exclusion from reimbursement.

Generic drugs INN prescribing With INN prescribing, prescribers (e.g. physicians) are required to prescribe medicines using the INN for

the pharmaceutical (i.e. the name of the active ingredient) instead of a brand name. Policy changes in INN prescribing include its introduction or abolition, changing the way INN prescribing is organized (e.g. by imposing or eliminating financial incentives) and changing from indicative to obligatory INN prescribing.

Generic substitution Generic substitution is the practice of substituting a medicine, whether marketed under a trade name or generic name (i.e. a branded or unbranded drug), by a less expensive medicine (e.g. a branded or unbranded generic drug), which often contains the same active ingredients. Generic substitution may be encouraged (i.e. indicative generic substitution) or required (i.e. mandatory generic substitution). Policy changes in generic substitution include its introduction or abolition, changing the way generic substitution is organized (i.e. imposing or eliminating financial incentives) and moving from indicative to obligatory generic substitution.

Public campaigns Policies, regulations, measures and initiatives promoting the use of generic drugs or licensed, off- patent medicines are typically undertaken by government authorities. Policy on generic drugs may be targeted at prescribers, pharmacists, patients or consumers, or other stakeholders.

INN: international nonproprietary name; VAT: value-added tax.

Bull World Health Organ 2014;92:630–640D| doi: http://dx.doi.org/10.2471/BLT.13.129114 633

Research Economic recession and pharmaceutical policies

ference between the annual growth rate in the value of pharmaceutical sales and the annual growth rate in the volume of sales for each country.

Results Changes in policy

Table 3, Table 4 and Table 5 (avail- able at: http://www.who.int/bulletin/ volumes/92/9/13-129114) summarize the 88 policy changes we identified in pricing, reimbursement and generic drugs, respectively. Economically stable countries implemented 7 or fewer policy changes each between 2008 and 2011; the lowest number was 2 in Finland (Table 6). Less economically stable countries implemented between 10 and 22 changes each; the highest number was 22 in Portugal. The greatest number of policy adjustments occurred in 2010 (33) and 2011 (40) and the most fre- quently used policy measures involved changes in out-of-pocket payments by patients (16), changes in regula- tions controlling the mark-up of prices (13) and price reductions (11). Some countries implemented several pricing measures. For example, Spain enacted four price cuts between 2008 and 2011. Most changes concerned reimbursable medicines and built on existing poli- cies; only a few changes involved newly

implemented policies, such as the in- troduction of internal reference pricing in Finland.17

Changes in sales

The small increase in the volume of pharmaceutical sales in all countries between 2006 and 2011 is shown in Fig. 1, Fig. 2, Fig. 3, Fig. 4 and Table 7: the average annual per capita growth in sales volume ranged from 0.8% in

Greece and 1.0% in Portugal to 3.7% in Ireland, 4.0% in Slovakia and 4.6% in Estonia. However, annual growth rates were much more variable: from 2006 to 2007 the growth rate was over 3.7% for all countries, with Estonia having the highest rate at 12.2%. Between 2007 and 2009, growth remained fairly stable in Austria and Finland but there was a sharp decline in Estonia: the annual growth rate was −0.5% from 2007 to

Table 2. Ten highest-sellinga therapeutic drug classes in eight European countries,b 2008–2011

Third-level code of the ATC classification20 Therapeutic class

A10C, A10H, A10J, A10K, A10L, A10M, A10N, A10S and A10X

Antidiabetes products

A02B Antiulcer products B01C Platelet aggregation inhibitors C10A, C10C and C11A Lipid regulators C09A and C09B ACE inhibitors, either as single agents or in

combination with other antihypertensives M01A and M02A Antirheumatics N02A Non-narcotic analgesics N06A Antidepressants R01A6, R01B and R06A Antiallergy drugs: systemic and nasal

preparations and topical products R03A, R03B, R03C, R03D, R03E, R03F, R03G, R03H, R03I, R03J and R03X

Respiratory agents

ACE: angiotensin-converting enzyme; ATC: Anatomical Therapeutic Chemical. a Together the products in these classes accounted for at least 50% of sales by volume in each country

under investigation. b Austria, Estonia, Finland, Greece, Ireland, Portugal, Slovakia and Spain.

Table 6. Policy measures influencing pharmaceutical sales in eight European countries, 2008–2011

Policy measure No. of measures implemented between 2008 and 2011a Total

Economically stable countriesb Economically less stable countriesb

Austria Estonia Finland Greece Ireland Portugal Slovakia Spain

Pricing Price cuts 0 0 0 2 2 3 0 4 11 External price referencing 0 0 0 3 0 2 2 1 8 Distribution remuneration 0 1 0 3 3 3 0 3 13 VAT on medicines 1 1 0 1 1 1 0 1 6 Extraordinary price review 0 0 0 2 2 1 1 1 7 Reimbursement Internal reference pricing 0 1 1 1 0 2 2 1 8 Out-of-pocket payments 4 1 0 0 1 5 3 2 16 Delisting 0 0 1 2 0 1 0 1 5 Generics INN prescribing 0 1 0 0 0 1 1 1 4 Generic substitution 0 0 0 0 0 0 0 0 0 Public campaigns and other generic policies

1 2 0 0 1 3 1 2 10

Total 6 7 2 14 10 22 10 17 88

INN: international nonproprietary name; VAT: value-added tax. a The number of measures implemented in each year was: 4 in 2008; 11 in 2009; 33 in 2010; and 40 in 2011. b The three economically stable countries implemented 15 measures during 2008–2011 compared with 73 in the five economically less stable countries.

Bull World Health Organ 2014;92:630–640D| doi: http://dx.doi.org/10.2471/BLT.13.129114634

Research Economic recession and pharmaceutical policies

2008 and −9.0% from 2008 to 2009. The growth rate declined in all economically less stable countries but more gradually. After the steep year-on-year decline in Estonia in 2009, the volume of sales grew 17.1% from 2009 to 2010. In contrast, the volume continued to decline in economically less stable countries: for example, from 2009 to 2010, there was a decline of −4.1% in Greece and −0.5% in Portugal. From 2010 to 2011, two of the less economically stable countries experienced a high growth in sales vol- ume (5.5% in Spain and 7.8% in Ireland), while the growth rate was between 1.0% and 3.1% in most other less economi- cally stable countries. The exception was Portugal, which experienced a decline of −3.7%.

The average annu a l p er c apit a growth in the value of sales between 2006 and 2011 varied between −2.1% in Portugal and 6.0% in Estonia. Af- ter 2009, all countries except Austria experienced a decrease in the value of sales in at least one year. The larg- est annual declines were observed in Greece (−13.5% from 2009 to 2010) and Portugal (−11.1% from 2010 to 2011). Moreover, the value of sales declined from 2010 to 2011 in all economically less stable countries.

Fig. 5 depicts the difference be- tween the annual growth rate in the value of pharmaceutical sales and the annual growth rate in the volume of sales in each country between 2006 and 2011. In general, between 2006 and 2008, the annual value of pharmaceutical sales increased more than the annual volume of sales in both economically stable and less stable countries, which indicates that the average price per unit increased. From 2009 onwards, during the period when most policy changes were imple- mented, the growth in the annual value of sales was less than the growth in the annual volume, which indicates a de- crease in average price per unit.

Discussion Although countries adjust their phar- maceutical policy frameworks continu- ously, a surge of policy changes seems to have taken place during the economic recession, particularly in 2010 and 2011. Unexpectedly, both economically stable and economically less stable countries

Fig. 1. Volume of pharmaceutical sales, quarterly, in three economically stable European countries, 2006–2011

Vo lu

m e

of sa

le s

(s ta

nd ar

d un

its p

er ca

pi ta

90 80 70 60 50 40 30 20 10

Year Austria EstoniaFinland

2006 2007 2008 2009 2010 2011

a The volume of pharmaceutical sales is for the 10 highest-selling therapeutic classes in each country.

Fig. 2. Volume of pharmaceutical sales, quarterly, in five economically less stable European countries, 2006–2011

Vo lu

m e

of sa

le s

(s ta

nd ar

d un

its p

er ca

pi ta

120

100

Year Greece SlovakiaPortugalIrelandSpain

2006 2007 2008 2009 2010 2011

a The volume of pharmaceutical sales is for the 10 highest-selling therapeutic classes in each country.

Fig. 3. Value of pharmaceutical sales, quarterly, in three economically stable European countries, 2006–2011

Va lu

e of

sa le

s (c

on st

an t U

S$ p

er ca

pi ta

Year Austria EstoniaFinland

2006 2007 2008 2009 2010 2011

US$: United States dollars. a The value of pharmaceutical sales is for the 10 highest-selling therapeutic classes in each country.

Bull World Health Organ 2014;92:630–640D| doi: http://dx.doi.org/10.2471/BLT.13.129114 635

Research Economic recession and pharmaceutical policies

experienced a slight increase in the consumption of pharmaceuticals in the 10 highest-selling therapeutic classes, as measured in standard units per capita. As expected, the annual growth in the per capita value of medicine sales decreased in economically less stable countries in 2010 and 2011.

Our study shows that economi- cally stable countries implemented fewer policy measures between 2008 and 2011 than economically less stable countries. The most f re quent ly i mplemente d policy changes targeted out-of-pocket payments for patients. Previous studies have shown that increases in copay- ments, such as prescription fees, tend to lead to lower medicine utilization, especially in times of economic reces- sion and increased unemployment.23–30 Policy measures such as the medicine price cuts (also applied in the form of discounts) that were implemented in Greece, Portugal and Spain could have had a negative effect on the availability of medicines if they caused pharmaceutical companies to withdraw their products from national reimbursement lists.31 Contrary to our expectations, however, we did not observe a major decline in the consumption of pharmaceuticals during the recession in the therapeutic categories studied as most countries continued to experience a moderate positive annual growth in sales volume. However, in line with media reports of drug shortages in Greece and Portugal, our data showed that the sales volumes of important medicines for chronic diseases, such as angiotensin-converting enzyme inhibitors and antidepressants, dropped drastically in these two coun- tries in 2010.31 Hence, although the over- all growth in sales volume was positive, the rate of growth appears to have fallen to below the prerecession level, which ranged from 5% to 12%.

In contrast, the rate of growth in the value of pharmaceutical sales de- clined, especially in economically less stable countries. This decrease may have been due partly to inflation: the average inflation rate in 2010 and 2011 gener- ally ranged between 2.0% and 3.4%, although it was as low as −1.6% in 2010 in Greece and as high as 5.1% in 2011 in Estonia.32 Our analysis did not take inflation into account. The decrease may also have occurred because the

Fig. 4. Value of pharmaceutical sales, quarterly, in five economically less stable European countries, 2006–2011

Va lu

e of

sa le

s (c

on st

an t U

S$ p

er ca

pi ta

45 40

35 30 25

20 15

10 5

Year 2006 2007 2008 2009 2010 2011

Greece SlovakiaPortugalIreland Spain

US$: United States dollars. a The value of pharmaceutical sales is for the 10 highest-selling therapeutic classes in each country.

Table 7. Per capita growth in pharmaceutical sales for the 10 highest-selling therapeutic classes in eight European countries, by volume and value, 2006–2011

Country Per capita annual sales growth (%)

2006– 2007

2007– 2008

2008– 2009

2009– 2010

2010– 2011

Average for 2006–2011

Volume of salesa

Economically stable countries Austria 4.6 4.0 2.7 1.5 1.1 2.8 Estonia 12.2 −0.5 −9.0 17.1 3.1 4.6 Finland 3.7 3.8 2.3 3.4 1.0 2.8 Economically less stable countries Greece 5.6 0.3 0.7 −4.1 1.5 0.8 Ireland 4.1 1.4 4.3 0.8 7.8 3.7 Portugal 6.1 1.8 1.1 −0.5 −3.7 1.0 Slovakia 6.1 7.1 1.7 4.1 1.0 4.0 Spain 6.4 0.2 1.5 0.7 5.5 2.9 Value of salesb

Economically stable countries Austria 7.3 6.3 2.2 0.4 1.5 3.5 Estonia 20.5 5.2 0.3 7.0 −3.2 6.0 Finland 3.1 6.3 −2.2 −2.6 0.7 1.1 Economically less stable countries Greece 13.3 7.0 6.8 −13.5 −2.4 2.2 Ireland 7.6 7.2 3.6 −1.9 −3.4 2.6 Portugal 5.4 2.0 −2.2 −4.6 −11.1 −2.1 Slovakia 12.0 14.6 0.6 0.5 −0.9 5.4 Spain 6.1 3.1 2.7 −0.4 −3.7 1.6

a The volume of sales was measured in standard units per capita (IMS Health, unpublished data, 2012). b The value of sales was measured in constant United States dollars per capita (IMS Health, unpublished

data, 2012).

Bull World Health Organ 2014;92:630–640D| doi: http://dx.doi.org/10.2471/BLT.13.129114636

Research Economic recession and pharmaceutical policies

pharmaceutical policies implemented in economically less stable countries had the desired effect of lowering public spending while maintaining access to medicines at a relatively stable level. For example, utilization could have shifted to less expensive or generic medicines. Nevertheless, even if sales volumes were maintained at lower prices, since several policy measures probably increased out- of-pocket payments for patients, the financial burden on patients may have increased.

The case of Estonia needs to be discussed separately. After a decade of rapid growth before the recession, during which public sector expenditure grew 6.5 times,21 Estonia experienced a major decline in GDP in 2009. Public sector spending was cut by 6.6% – a reduction of 100 million euros compared with 2008 – and there was a 50 million euros reduc- tion in health insurance expenditure.33 A previous study identified a large decline in the consumption of pharmaceuticals of −18% between 2008 and 2009,16 which was mirrored in our data. In response, Estonia implemented strict cost-saving measures with respect to medicines, re- duced sick leave coverage and increased the workload of clinical staff without increasing their salaries.16,33 Our data show that, by 2010, the consumption of pharmaceuticals had returned to a

level similar to that before the recession, which paralleled Estonia’s relatively quick recovery from the recession overall.21

Early in the recession, countries not only implemented few policies changes overall but also implemented no policies that targeted consumption by specific patient groups or in specific therapeutic areas. Recent studies show that fewer policy changes were implemented in 2012 and 2013 than during the recession and that there was a trend towards poli- cies that targeted high-cost medicines.34 Several countries have explored alterna- tive policies for sharing the financial risk of selected, new, high-cost medicines, such as value-based pricing models or risk-sharing agreements.35–38 The effect of these new approaches still needs to be determined.

Our study had several limitations. We did not take into account the dif- ferenc es in phar mac eut ic a l p olic y frameworks that existed between all countries before the economic recession or between regions within some coun- tries (e.g. Italy or Spain). Moreover, it was not always clear whether a country implemented a policy as a short-term reaction to recession-related budgetary constraints or whether the policy was part of a planned long-term change to the system. For instance, in Finland, the implementation of internal refer-

ence pricing in 2009 had been planned long before the recession.39 Major policy changes, such as the introduction of reference price systems, may take several years to implement since many stake- holders are involved.40 However, most of the policy changes related to the reces- sion involved adjusting existing policies and could be implemented relatively quickly. Although these policies might, as desired, contain costs over the short- term, they could have substantial long- term effects on the use and affordability of medicines and could have negative consequences for health.41–44 We focused our analysis on the sale of products that accounted for the majority of pharma- ceutical sales by volume. It is possible that policy changes had a differential influence on the sale of less frequently used products, including those used by patients with rare diseases. However, at least one price cut in Greece exempted orphan drugs for rare diseases.

Another limitation is that, since data on the value of sales are expressed in constant US$ and disregard discounts and rebates, they do not reflect actual spending by third-party payers. In addi- tion, an individual country’s data might include different products within each therapeutic class. Moreover, medicines sales may also be influenced by other market variables, such as patent expira- tion. During the study period, patents expired on several highly used products, including diabetes medications, antiul- cerants, platelet aggregation inhibitors, lipid regulators, angiotensin-converting enzyme inhibitors and antidepressants. The price reductions accompanying patent expiries may have combined with policies promoting generic prescribing to reduce the value of sales while limit- ing the decline in sales volume. Finally, the rapid implementation and the dif- ferent timing of policies in different countries meant that we were unable to attribute the observed change in phar- maceutical sales to any single policy or set of policies or to make statistical comparisons of responses to policy be- tween countries.

We suggest that future research focuses on the effect of policy changes in only a few countries by exploring the relationship between changes in medi- cine utilization and health outcomes. Moreover, since some of our findings were not in line with our expectations, we recommend that studies of the effect

Fig. 5. Difference between the annual growth in the value and volume of pharmaceutical sales,a,b in eight European countries,c 2006–2011

Di ff

er en

ce b

et w

ee n

gr ow

th in

v al

ue a

vo lu

m e

of sa

le s (

pe rc

en ta

ge p

oi nt

s) a

–5

–10

–15

Year range 2006–2007 2007–2008 2008–2009 2009–2010 2010–2011

Austria Spain PortugalSlovakia Ireland

EstoniaEconomically stable Economically less stable Greece

Finland

a The graph illustrates the percentage point difference between the annual percentage growth in the value of pharmaceutical sales for the 10 highest-selling therapeutic classes and the annual percentage growth in the volume of sales. The volume of sales was measured in standard units per capita and the value of sales was measured in constant United States dollars (US$) per capita.

b A negative value implies that the volume of sales increased more in a year than the value of sales, which indicates a decrease in the average price per unit.

c Austria, Estonia, Finland, Greece, Ireland, Portugal, Slovakia and Spain.

Bull World Health Organ 2014;92:630–640D| doi: http://dx.doi.org/10.2471/BLT.13.129114 637

Research Economic recession and pharmaceutical policies

of new pharmaceutical policies should monitor access to medicines and look for potential barriers to access.

In conclusion, the ways in which countries responded to the recession differed greatly, with less economically stable countries implementing a larger number of policies that affected the pharmaceutical sector than economi- cally stable countries. Our evidence shows that, despite numerous policy changes and contrary to our expecta- tions, overall consumption of phar- maceuticals in the 10 highest-selling therapeutic classes continued to increase in most countries; there was no clear difference between economically stable and less stable countries. The observa- tion that the value of sales declined while the volume was maintained may indicate that pharmaceutical purchasing

became more efficient. However, since many policies were designed to shift the financial burden to patients, future research should investigate the effect of changes in pharmaceutical policy, expenditure and utilization on equitable access to medicines, on the affordability of essential medicines for households, on the appropriate use of medicines and on health outcomes. ■

Acknowledgements Data were obtained under licence from the MIDAS Quantum pharmaceutical market research service of IMS Health Incorporated, USA. During the research, C Leopold was a PhD candidate at Utrecht University and a visiting scholar at the Department of Population Medi- cine that resides within the Harvard Pilgrim Health Care Institute and is

an appointing department of Harvard Medical School.

Competing interests: H Leufkens and A Mantel-Teeuwisse received funding from public–private partnerships (e.g. IMI and TI Pharma under the condition that no company-specific product or company-related study was conducted). In addition, unrestricted research fund- ing was provided by the Netherlands Organisation for Health Research and Development, the Dutch Health Care Insurance Board, the EU 7th Frame- work Programme, the Dutch Medicines Evaluation Board and the Dutch Minis- try of Health. S Valkova was employed by IMS, which is funded through sales of information services to both industry and government.

ملخص تأثري الكساد االقتصادي عىل سياسة املستحرضات الصيدالنية ومبيعات األدوية يف ثامنية بلدان أوروبية

الغرض حتديد التغريات يف سياسة املستحرضات الصيدالنية أثناء كانت إذا ما وحتديد أوروبية، بلدان ثامنية يف االقتصادي الكساد املستحرضات مبيعات انخفاض إىل أدت قد السياسة تدابري

الصيدالنية وانخفاض اإلنفاق عليها. سياسة يف التغريات عن معلومات عىل احلصول تم الطريقة ثامنية يف و2011 2008 عامي بني الصيدالنية املستحرضات بلدان أوروبية من املنشورات وقواعد بيانات سياسة املستحرضات الصيدالنية. وتم احلصول عىل بيانات بشأن حجم وقيمة املبيعات الفئات يف و2011 2006 عامي بني للمنتجات السنوية ربع العالجية العرش األعىل مبيعًا يف كل بلد من قاعدة بيانات ألبحاث يف املؤرشات هذه بمقارنة وقمنا الصيدالنية. املستحرضات سوق البلدان املستقرة اقتصاديًا وهي النمسا وإستونيا وفنلندا باملؤرشات والربتغال وأيرلندا اليونان وهي استقرارًا األقل البلدان يف

وسلوفاكيا وإسبانيا. النتائج نفذت البلدان املستقرة اقتصاديًا من اثنني إىل سبعة تغريات 10 من استقرارًا األقل البلدان نفذت بينام منها، كل سياسات يف

إىل 22 تغريًا يف سياسات كل منها. وحدث 33 تغريًا يف السياسات أصل من 2011 عام يف السياسات يف تغريًا و40 2010 عام يف تغيري ذلك وشمل حتديدها. تم التي السياسات يف تغريًا 88 املدفوعات التي يتحملها املرىض من جيوهبم اخلاصة يف 16 حالة 11 يف األسعار وخفض حالة 13 يف األسعار ربح هامش ونظم حالة. وازدادت أحجام املبيعات عىل نحو متوسط يف مجيع البلدان باستثناء اليونان والربتغال اللذين شهدا انخفاضات طفيفة بعد عام 2009. وانخفضت أحجام املبيعات يف جمموعتي البلدان، غري أهنا

انخفضت عىل نحو أكرب يف البلدان األقل استقرارًا. االقتصادية الناحية من استقرارًا األقل البلدان نفذت االستنتاج أثناء الصيدالنية املستحرضات سياسة عىل التغريات من املزيد مبيعات أحجام وازدادت اقتصاديًا. املستقرة البلدان عن الكساد البلدان مجيع يف متوقع، غري نحو عىل الصيدالنية، املستحرضات األقل البلدان يف سيام ال املبيعات، أحجام انخفضت بينام تقريبًا،

استقرارًا.

摘要经济衰退对八个欧洲国家医药政策和药品销售的影响目的识别八个欧洲国家在经济衰退中的医药政策变化，并判别政策措施是否导致药品销售量和支出的减少。方法从出版物和药品政策数据库获取八个欧洲国家 2008 年和 2011 年之间医药政策变化信息。从医药市场研究数据库中获得每个国家 2006 年到 2011 年之间 10 个销量最高治疗类产品季度销售数量和价值的数据。我们将奥地利、爱沙尼亚和芬兰等经济稳定的国家与希腊、爱尔兰、葡萄牙、斯洛伐克和西班牙等经济不稳定国家的这些指标进行比较。结果在经济稳定的国家中，每个国家实施二至七项政策变化，而在经济不稳定的国家中，每个国家实施 10

至 22 项政策变化。在识别的 88 项政策变化中，33 项发生在 2010 年，40 项发生在 2011 年。其中 16 个案例涉及改变患者自付政策，13 个案例牵涉到改变标价制度，11 个案例与改变降价方案相关。除了希腊和葡萄牙在 2009 年出现轻微的下降外，所有国家的销售量都适度增长。两组国家的销售价值都有所降低，但经济不稳定国家下降更多。结论较之经济稳定的国家，经济不太稳定国家在经济衰退时期实施更多医药政策变化。出人意料的是，几乎所有国家药品销量都有增加，而销售价值则下降，在经济不稳定国家尤其如此。

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Résumé

Effet de la récession économique sur la politique pharmaceutique et les ventes de médicaments dans huit pays européens Objectif Identifier les changements de politique pharmaceutique au cours de la récession économique dans huit pays européens et déterminer si les mesures politiques ont entraîné une baisse des ventes et des dépenses en matière de produits pharmaceutiques. Méthodes Les informations relatives aux changements de la politique pharmaceutique entre 2008 et 2011 dans huit pays européens ont été obtenues à partir des publications et des bases de données sur la politique pharmaceutique. Les données sur le volume et la valeur des ventes trimestrielles des produits entre 2006 et 2011 pour les 10 classes thérapeutiques les plus vendues dans chaque pays ont été obtenues à partir d’une base de données d’études de marché sur les médicaments. Nous avons comparé ces indicateurs dans des pays économiquement stables: Autriche, Estonie et Finlande, par rapport aux indicateurs mesurés dans des pays moins stables: Grèce, Irlande, Portugal, Slovaquie et Espagne. Résultats Les pays économiquement stables ont chacun mis en œuvre

2 à 7 changements de politique, tandis que les pays moins stables en ont mis en œuvre 10 à 22 chacun. Sur les 88 changements de politique identifiés, 33 ont eu lieu en 2010 et 40 en 2011. Ils impliquaient des changements dans les paiements restants à charge pour les patients dans 16 cas, des plans d’augmentation des prix dans 13 cas et des baisses de prix dans 11 cas. Les volumes des ventes ont augmenté modérément dans tous les pays à l’exception de la Grèce et du Portugal qui ont connu de légères baisses après 2009. Les valeurs des ventes ont diminué dans les deux groupes de pays, mais elles ont davantage chuté dans les pays moins stables. Conclusion Les pays moins stables économiquement ont mis en œuvre plus de changements de politique pharmaceutique au cours de la récession que les pays économiquement stables. De manière inattendue, les volumes des ventes de médicaments ont augmenté dans presque tous les pays, alors que les valeurs des ventes ont baissé, en particulier dans les pays moins stables.

Резюме

Влияние экономического спада на фармацевтическую политику и продажи медикаментов в восьми европейских странах Цель Идентифицировать изменения фармацевтической политики в период экономического спада в восьми европейских странах и определить, привели ли политические меры к снижению продаж фармацевтических препаратов и расходов на них. Методы Информация об изменениях в фармацевтической политике за период 2008-2011 гг. в восьми европейских странах была получена из публикаций и баз данных фармацевтической политики. Данные об объемах и суммах квартальных продаж продукции за 2006-2011 гг. для десяти самых продаваемых терапевтических классов в каждой стране были получены из базы данных исследований фармацевтического рынка. Были сопоставлены показатели экономически стабильных стран (Австрия, Эстония и Финляндия) с подобными показателями менее стабильных стран (Греция, Ирландия, Португалия, Словакия и Испания). Результаты В каждой из экономически стабильных стран было реализовано от 2 до 7 изменений в политике, в то время как в

каждой из менее стабильных странах – от 10 до 22 изменений. Из 88 выявленных изменений в фармацевтической политике 33 произошли в 2010 году и 40 – в 2011 году. Они включали: изменения неофициальных расходов для пациентов в 16 случаях, схемы повышения цен в 13 случаях и снижение цен в 11 случаях. Объемы продаж умеренно выросли во всех странах, за исключением Греции и Португалии, где имелось незначительное снижение после 2009 года. Продажная стоимость снизилась в обеих группах стран, причем в более значительной степени в менее стабильных странах. Вывод Экономически менее стабильные страны реализовали больше изменений фармацевтической политики в период экономического спада, чем экономически стабильные страны. Неожиданным результатом явилось то, что объемы продаж фармацевтической продукции увеличились практически во всех странах, тогда как продажная стоимость снизилась, особенно в менее стабильных странах.

Resumen

El efecto de la recesión económica sobre la política farmacéutica y la venta de medicinas en ocho países europeos Objetivo Identificar los cambios en las políticas farmacéuticas en ocho países europeos durante la recesión económica y determinar si las medidas de política dieron lugar a una reducción en las ventas y a un gasto menor en productos farmacéuticos. Métodos La información sobre los cambios en las políticas farmacéuticas entre 2008 y 2011 en ocho países europeos se obtuvo a partir de publicaciones y bases de datos sobre políticas farmacéuticas. Los datos sobre el volumen y valor de las ventas trimestrales de productos entre 2006 y 2011 en las 10 clases terapéuticas más vendidas en cada país se obtuvieron de una base de datos de investigación del mercado farmacéutico. Comparamos estos indicadores en los países económicamente estables (Austria, Estonia y Finlandia) con los de los países menos estables (Grecia, Irlanda, Portugal, Eslovaquia y España). Resultados Cada uno de los países económicamente estables implementó entre dos y siete cambios de políticas, mientras que los

países menos estables implementaron entre 10 y 22 cada uno. De los 88 cambios de políticas identificados, 33 tuvieron lugar en el año 2010 y 40, en el año 2011. Implicaron cambios en los pagos directos por atención sanitaria para pacientes en 16 casos, programas de aumento de precios en 13 casos y recortes de precios en 11. Los volúmenes de ventas aumentaron moderadamente en todos los países excepto en Grecia y Portugal, que experimentaron descensos ligeros a partir de 2009. El valor de las ventas disminuyó en ambos grupos de países, si bien fue mayor en los países menos estables. Conclusión Los países económicamente menos estables implementaron más cambios en las políticas farmacéuticas durante la recesión que los países económicamente estables. Sorprendentemente, los volúmenes de ventas de productos farmacéuticos aumentaron en casi todos los países, mientras que el valor de las ventas disminuyó, especialmente en los países menos estables.

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n co

un tr

ie s,

a 2 00

8– 20

Po lic

y m

ea su

re Im

pl em

en ta

ti on

d at

e of

ch an

ge in

p ol

ic y

1s t h

al f o

f 20

08 2n

d ha

lf o

f 20

08 1s

t h al

f o f

20 09

2n d

ha lf

o f

20 09

1s t h

al f o

f 20

10 2n

d ha

lf o

f 20

10 1s

t h al

f o f

20 11

2n d

ha lf

o f

20 11

Pr ic

e cu

t N

on e

Po rt

ug al

: 3 0%

ic e

cu t f

ge ne

ric s

Po rt

ug al

: 5–

12 %

ic e

cu t f

ge ne

ric s

N on

e G

re ec

e: e

m er

ge nc

y pr

ic e

cu ts

to a

m ax

im um

o f 2

7% fo

r a ll

re im

bu rs

ed m

ed ic

in es

(e xc

ep t

or ph

an d

ru gs

); off

-p at

en t

m ed

ic in

es c

ut to

9 0%

o f o

rig in

co st

. Ire

la nd

: 4 0%

p ric

e cu

t f or

o ff-

pa te

nt m

ed ic

in es

. Sp

ai n:

F irs

t p ric

e cu

t o f u

p to

% fo

r g en

er ic

s; s

ec on

d pr

ic e

cu t o

f 7 .5

% fo

r h ea

lth -c

ar e

pr od

uc ts

, i nc

lu di

ng o

rig in

m ed

ic in

es , i

m po

se d

in th

e fo

of a

d is

co un

t s ha

re d

by a

ll ac

to rs

th e

su pp

ly c

ha in

; i n

ad di

tio n,

4% p

ric e

cu t f

or o

rp ha

n dr

ug s

an d

a 20

% p

ric e

cu t f

in co

nt in

en ce

p ro

du ct

Po rt

ug al

: 7 .5

% p

ric e

cu t f

bi ol

og ic

al m

ed ic

in es

a nd

H IV

od uc

ts .

Sp ai

n: p

ric e

in cr

ea se

o f

10 –2

0% fo

r a m

ox ic

ill in

- co

nt ai

ni ng

m ed

ic in

es to

ev en

t t he

ir w

ith dr

aw al

fro

m th

e m

ar ke

Ire la

nd : p

ric e

cu ts

G re

ec e:

3 5%

p ric

e cu

t f or

-p at

en t m

ed ic

in es

b ef

or e

pa te

nt e

xp iry

a nd

1 5%

p ric

e cu

t f or

g en

er ic

s. Sp

ai n:

g ra

du al

p ric

e de

cr ea

se s

Ex te

rn al

p ric

e re

fe re

nc in

g N

on e

N on

e N

on e

G re

ec e:

lc ul

at io

n m

et ho

d ch

an ge

Sl ov

ak ia

: re

fe re

nc e

co un

tr ie

s ch

an ge

Po rt

ug al

: c al

cu la

tio n

m et

ho d

ch an

ge d.

ai n:

c al

cu la

tio n

m et

ho d

ch an

ge d

N on

e G

re ec

e: c

al cu

la tio

n m

et ho

d ch

an ge

Sl ov

ak ia

: c al

cu la

tio n

m et

ho d

ch an

ge d

G re

ec e:

c al

cu la

tio n

m et

ho d

ch an

ge d.

rt ug

al : r

ef er

en ce

c ou

nt rie

s ch

an ge

(c on tin

ue s.

. . )

Economic recession and pharmaceutical policies Research

640B Bull World Health Organ 2014;92:630–640D| doi: http://dx.doi.org/10.2471/BLT.13.129114

lic y

m ea

su re

Im pl

em en

ta ti

on d

at e

of ch

an ge

in p

ol ic

1s t h

al f o

f 20

08 2n

d ha

lf o

f 20

08 1s

t h al

f o f

20 09

2n d

ha lf

o f

20 09

1s t h

al f o

f 20

10 2n

d ha

lf o

f 20

10 1s

t h al

f o f

20 11

2n d

ha lf

o f

20 11

D is

tr ib

ut io

n re

m un

er at

io n

N on

e N

on e

N on

e Ire

la nd

: w

ho le

sa le

m un

er at

io n

ch an

ge d

Po rt

ug al

: w ho

le sa

re m

un er

at io

n ch

an ge

d (i.

e. th

e lin

ea r m

ar gi

n fo

r no

nr ei

m bu

rs ab

le m

ed ic

in es

as in

cr ea

se d)

; p ha

rm ac

y re

m un

er at

io n

ch an

ge d

(i. e.

th e

lin ea

r m ar

gi n

fo r

no nr

ei m

bu rs

ab le

m ed

ic in

es w

in cr

ea se

d) .

Sp ai

n: p

ha rm

ac y

re m

un er

at io

n ch

an ge

d (i.

e. p

ar t o

f t he

ar m

ac y

re m

un er

at io

n fo

r ex

pe ns

iv e

m ed

ic in

es w

in cr

ea se

N on

e Es

to ni

a: w

ho le

sa le

m un

er at

io n

ch an

ge d.

re ec

e: w

ho le

sa le

m un

er at

io n

de cr

ea se

su pp

ly c

ha in

d is

co un

ab ol

is he

Ire la

nd : w

ho le

sa le

m un

er at

io n

fo r h

ig h-

co st

m ed

ic in

es c

ha ng

(t he

H ig

h- Te

ch S

ch em

e) ;

w ho

le sa

le re

m un

er at

io n

fo r

th e

ge ne

ra l s

ch em

e fo

r l ow

- in

co m

e pa

tie nt

s de

cr ea

se d.

ai n:

w ho

le sa

re m

un er

at io

n ch

an ge

ph ar

m ac

y re

m un

er at

io n

ch an

ge d

G re

ec e:

p ha

rm ac

y re

m un

er at

io n

ch an

ge d.

rt ug

al : w

ho le

sa le

a nd

ar m

ac y

re m

un er

at io

n ch

an ge

d in

F eb

ru ar

y 20

fro m

li ne

ar to

re gr

es si

re m

un er

at io

n, w

hi ch

w as

eff

ec tiv

el y

a de

cr ea

VA T

m ed

ic in

e N

on e

N on

e A

us tr

ia : V

de cr

ea se

d fro

m 2

0% to

% .

Es to

ni a:

V AT

cr ea

se d

fro m

5 %

N on

e Ire

la nd

: V AT

in cr

ea se

d to

2 1%

fo r

no n-

or al

p re

pa ra

tio ns

. Po

rt ug

al : V

AT in

cr ea

se d

fro m

5 %

6 %

N on

e G

re ec

e: V

AT d

ec re

as ed

fr om

% to

6 .5

% .

Sp ai

n: V

AT in

cr ea

se d

fro m

to 1

0% fo

r h ea

lth -c

ar e

pr od

uc ts

N on

Ex tr

ao rd

in ar

y pr

ic e

re vi

ew N

on e

Ire la

nd :

re vi

ew o

f re

im bu

rs ed

ed ic

in es

N on

e N

on e

Po rt

ug al

: r ev

ie w

o f s

el ec

te d

ac tiv

e su

bs ta

nc es

. Sp

ai n:

p ric

e re

vi ew

, t ak

in g

pr ic

e cu

ts in

to a

cc ou

G re

ec e:

re vi

ew o

f n ew

p ric

e lis

ts , t

ak in

g pr

ic e

cu ts

in to

co un

t. Ire

la nd

: r ev

ie w

o f b

ra nd

s an

d pa

ra lle

l i m

po rt

s.b

Sl ov

ak ia

: r ev

ie w

o f

re im

bu rs

ed m

ed ic

in es

N on

e G

re ec

e: re

vi ew

re su

lte d

in a

w p

ric e

lis t t

ha t i

nc lu

de d

an a

ve ra

ge 1

0. 2%

p ric

e re

du ct

io n

H IV

: h um

an im

m un

od efi

ci en

cy v

iru s;

VA T:

v al

ue -a

dd ed

ta x.

a A

us tr

ia , E

st on

ia , F

in la

nd , G

re ec

e, Ir

el an

d, P

or tu

ga l,

Sl ov

ak ia

a nd

S pa

in .

b A

p ar

al le

l i m

po rt

is th

e im

po rt

o f a

p at

en te

d or

tr ad

em ar

ke d

pr od

uc t f

ro m

a c

ou nt

ry w

he re

it is

a lre

ad y

m ar

ke te

d, o

fte n

at a

lo w

er c

os t.

(. . . co nt in ue d)

Bull World Health Organ 2014;92:630–640D| doi: http://dx.doi.org/10.2471/BLT.13.129114 640C

Research Economic recession and pharmaceutical policies

Ta bl

e 4.

lic y

ch an

ge s o

n ph

ar m

ac eu

ti ca

ls re

im bu

rs em

en t i

n ei

gh t E

ur op

ea n

co un

tr ie

s, a 2

00 8–

20 11

Po lic

y m

ea su

re Im

pl em

en ta

ti on

d at

e of

ch an

ge in

p ol

ic y

1s t h

al f o

f 20

08 2n

d ha

lf o

f 20

08 1s

t h al

f o f

20 09

2n d

ha lf

o f

20 09

1s t h

al f o

f 20

10 2n

d ha

lf o

f 20

10 1s

t h al

f o f

20 11

2n d

ha lf

o f

20 11

Re fe

re nc

e pr

ic e

sy st

em N

on e

N on

e Fi

nl an

in tr

od uc

tio n

of in

te rn

re fe

re nc

e pr

ic in

N on

e Po

rt ug

al : p

ric e–

vo lu

m e

ag re

em en

t s pe

ci fie

d Es

to ni

a: c

al cu

la tio

n m

et ho

d ch

an ge

Sl ov

ak ia

: r ef

er en

ce p

ric e

sy st

em c

ha ng

ed to

ta ke

re ek

p ric

e cu

ts in

to a

cc ou

Po rt

ug al

: p ric

e ca

lc ul

at io

n m

et ho

d ch

an ge

d an

d ne

ge ne

ric g

ro up

s in

tr od

uc ed

. Sl

ov ak

ia : n

ew c

lu st

er s

m ed

ic in

es e

st ab

lis he

Sp ai

n: p

ric e

ca lc

ul at

io n

ch an

ge d

to u

se lo

w es

t d ai

tr ea

tm en

t c os

ts a

s a

ba si

G re

ec e:

p ric

in g

ch an

ge d

be a

t o r b

el ow

th e

re fe

re nc

e pr

ic e

O ut

-o f-

po ck

pa ym

en ts

A us

tr ia

: pr

es cr

ip tio

n fe

e in

cr ea

se d

N on

e A

us tr

ia :

pr es

cr ip

tio n

fe e

in cr

ea se

Po rt

ug al

: re

im bu

rs em

en t

ra te

in cr

ea se

d fro

m 9

to 1

00 %

fo r

ge ne

ric s

fo r

lo w

-in co

m e

pe ns

io ne

rs ;

re im

bu rs

em en

t ra

te in

cr ea

se d

fro m

3 7%

6 9%

fo r

in fe

rt ili

ty d

ru gs

N on

e A

us tr

ia : p

re sc

rip tio

n fe

e in

cr ea

se d.

rt ug

al : a

bo lit

io n

of o

ut -o

f- po

ck et

p ay

m en

ts fo

r o rg

an ,

tis su

e an

d st

em c

el l t

ra ns

pl an

t pr

oc ed

ur es

Ire la

nd : i

nt ro

du ct

io n

of €

0 .5

0 pa

ym en

t p er

p re

sc rip

tio n

m ed

ic in

Po rt

ug al

: r ei

m bu

rs em

en t

ra te

s ch

an ge

d fo

r a ll

m ed

ic in

es , i

nc lu

di ng

tip sy

ch ot

ic s.

Sp ai

n: u

nd er

pr iv

ile ge

d pa

tie nt

s in

M ad

rid g

iv en

fr ee

ce ss

to p

ro du

ct s

fo r s

ev en

re d

is ea

se s

A us

tr ia

: p re

sc rip

tio n

fe e

in cr

ea se

Es to

ni a:

e lim

in at

io n

co pa

ym en

t l im

it.

Sl ov

ak ia

: c os

t- sh

ar in

g ag

re em

en ts

im pl

em en

te d.

ai n:

c op

ay m

en t l

in ke

d to

tie nt

’s in

co m

Po rt

ug al

: f as

te r

re im

bu rs

em en

t r ev

ie w

s. Sl

ov ak

ia : l

im its

im po

se d

on c

er ta

in re

im bu

rs em

en t

ca te

go rie

s; re

im bu

rs em

en t

lis t t

o be

p ub

lis he

d m

or e

fre qu

en tly

D el

is tin

g N

on e

N on

e Fi

nl an

Se ro

qu el

lis te

N on

e N

on e

N on

e G

re ec

e: in

tr od

uc tio

n of

ne ga

tiv e

lis t o

f e xc

lu de

d pr

od uc

ts th

at in

cl ud

co nt

ra ce

pt iv

es a

nd li

fe st

yl e

m ed

ic in

es .

Po rt

ug al

: d el

is tin

g of

1 6

br an

de d

no np

re sc

rip tio

n m

ed ic

in es

, i nc

lu di

pa ra

ce ta

m ol

, o ra

l om

ep ra

zo le

, c on

tr ac

ep tiv

an d

an tih

is ta

m in

es .

Sp ai

n: d

el is

tin g

of s

el ec

te d

m ed

ic in

G re

ec e:

4 9

m ed

ic in

es w

er e

de lis

te d

af te

r a p

ric e

re vi

a A

us tr

ia , E

st on

ia , F

in la

nd , G

re ec

e, Ir

el an

d, P

or tu

ga l,

Sl ov

ak ia

a nd

S pa

in .

Bull World Health Organ 2014;92:630–640D| doi: http://dx.doi.org/10.2471/BLT.13.129114640D

Research Economic recession and pharmaceutical policies

Ta bl

e 5.

lic y

ch an

ge s o

n ge

ne ri

c d ru

gs in

e ig

ht E

ur op

ea n

co un

tr ie

s, a 2

00 8–

20 11

Po lic

y m

ea su

re Im

pl em

en ta

ti on

d at

e of

ch an

ge in

p ol

ic y

1s t h

al f o

f 20

08 2n

d ha

lf o

f 20

08 1s

t h al

f o f

20 09

2n d

ha lf

o f

20 09

1s t h

al f o

f 20

10 2n

d ha

lf o

f 20

10 1s

t h al

f o f

20 11

2n d

ha lf

o f

20 11

IN N

p re

sc rib

in g

N on

e N

on e

N on

e N

on e

N on

e Es

to ni

a: c

ha ng

e fro

op tio

na l t

o co

m pu

ls or

y ge

ne ric

p re

sc rib

in g

Sl ov

ak ia

: o pt

io na

l g en

er ic

es cr

ib in

g in

tr od

uc ed

Sp ai

n: o

pt io

na l g

en er

pr es

cr ib

in g

in tr

od uc

ed .

Po rt

ug al

: c om

pu ls

or y

ge ne

ric

pr es

cr ib

in g

sp ec

ifi ed

G en

er ic

bs tit

ut io

n N

on e

N on

e N

on e

N on

e N

on e

N on

e N

on e

N on

Pu bl

ca m

pa ig

ns a

ot he

r g en

er ic

lic ie

A us

tr ia

: ge

ne ric

s in

fo rm

at io

n ca

m pa

ig n

N on

e N

on e

N on

e Es

to ni

a: g

en er

ic c

am pa

ig n

Es to

ni a:

e -p

re sc

rib in

g in

tr od

uc ed

. Ire

la nd

: r eb

at es

fo r g

en er

ic s

ab ol

is he

Po rt

ug al

: c am

pa ig

n to

om ot

e ra

tio na

l m ed

ic in

us e;

d is

pe ns

in g

of u

ni t d

os es

th er

th an

s ea

le d

pa ck

ag es

; pr

ic es

to b

e di

sp la

ye d

pa ck

ag in

Sl ov

ak ia

: e st

ab lis

hm en

t of

h ea

lth te

ch no

lo gy

se ss

m en

t i ns

tit ut

Sp ai

n: n

at io

na l g

en er

ic s

ca m

pa ig

Sp ai

n: u

ni t d

os e

di sp

en si

in tr

od uc

ed fo

r f ou

r su

bs ta

nc es

Po rt

ug al

: e -p

re sc

rib in

g in

tr od

uc ed

a nd

o pe

ni ng

ur s

of p

ha rm

ac ie

s ch

an ge

Po rt

ug al

: e nt

ry o

f 2 5

ac tiv

e ge

ne ric

s ub

st an

ce s

in to

e m

ar ke

t t o

be e

xp ed

ite d

su bj

ec t t

o re

so lu

tio n

pa te

nt d

is pu

te s

IN N

: i nt

er na

tio na

l n on

pr op

rie ta

ry n

am e.

a A

us tr

ia , E

st on

ia , F

in la

nd , G

re ec

e, Ir

el an

d, P

or tu

ga l,

Sl ov

ak ia

a nd

S pa

in .

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