Résumé

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.

Resumen

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.

ملخص

الغرض

تحديد التغيرات في سياسة المستحضرات الصيدلانية أثناء الكساد الاقتصادي في ثمانية بلدان أوروبية، وتحديد ما إذا كانت تدابير السياسة قد أدت إلى انخفاض مبيعات المستحضرات الصيدلانية وانخفاض الإنفاق عليها.

الطريقة

تم الحصول على معلومات عن التغيرات في سياسة المستحضرات الصيدلانية بين عامي 2008 و2011 في ثمانية بلدان أوروبية من المنشورات وقواعد بيانات سياسة المستحضرات الصيدلانية. وتم الحصول على بيانات بشأن حجم وقيمة المبيعات ربع السنوية للمنتجات بين عامي 2006 و2011 في الفئات العلاجية العشر الأعلى مبيعاً في كل بلد من قاعدة بيانات لأبحاث سوق المستحضرات الصيدلانية. وقمنا بمقارنة هذه المؤشرات في البلدان المستقرة اقتصادياً وهي النمسا وإستونيا وفنلندا بالمؤشرات في البلدان الأقل استقراراً وهي اليونان وأيرلندا والبرتغال وسلوفاكيا وإسبانيا.

النتائج

نفذت البلدان المستقرة اقتصادياً من اثنين إلى سبعة تغيرات في سياسات كل منها، بينما نفذت البلدان الأقل استقراراً من 10 إلى 22 تغيراً في سياسات كل منها. وحدث 33 تغيراً في السياسات في عام 2010 و40 تغيراً في السياسات في عام 2011 من أصل 88 تغيراً في السياسات التي تم تحديدها. وشمل ذلك تغيير المدفوعات التي يتحملها المرضى من جيوبهم الخاصة في 16 حالة ونظم هامش ربح الأسعار في 13 حالة وخفض الأسعار في 11 حالة. وازدادت أحجام المبيعات على نحو متوسط في جميع البلدان باستثناء اليونان والبرتغال اللذين شهدا انخفاضات طفيفة بعد عام 2009. وانخفضت أحجام المبيعات في مجموعتي البلدان، غير أنها انخفضت على نحو أكبر في البلدان الأقل استقراراً.

الاستنتاج

نفذت البلدان الأقل استقراراً من الناحية الاقتصادية المزيد من التغيرات على سياسة المستحضرات الصيدلانية أثناء الكساد عن البلدان المستقرة اقتصادياً. وازدادت أحجام مبيعات المستحضرات الصيدلانية، على نحو غير متوقع، في جميع البلدان تقريباً، بينما انخفضت أحجام المبيعات، لا سيما في البلدان الأقل استقراراً.

摘要

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。

Резюме

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.

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.¹1 Habl C, Antony K, Entleitner M, Fröschl B, Leopold C, Stürzlinger H, et al. Surveying, assessing and analyzing the pharmaceutical sector in the 25 EU Member States. Luxembourg: European Communities; 2006. Available from: http://ec.europa.eu/competition/mergers/studies_reports/oebig.pdf [cited 2014 May 7].
http://ec.europa.eu/competition/mergers/... ^–44 Seiter A. Access to medicines and the innovation dilemma – Can pharmaceutical multinationals be good corporate citizens? Bus Ethics Innov Ethics Sci Technol Assess. 2007;31:89–100. doi: http://dx.doi.org/10.1007/978-3-540-72310-3_6
https://doi.org/10.1007/978-3-540-72310-... The recent global economic recession has put additional pressure on public budgets.⁵5 Shelburne R, Trentini C. Public health in Europe: the 2007–2009 financial crisis and UNECE activities. Discussion paper series No. 2009.2. Geneva: United Nations Economic Commission for Europe; 2009. Available from: http://www.unece.org/fileadmin/DAM/oes/disc_papers/ECE_DP_2009-2.pdf [cited 2013 Feb 10].
http://www.unece.org/fileadmin/DAM/oes/d... ^,66 The economic situation in 2008-2009 in the Economic Commission for Europe region: Europe, North America and the Commonwealth of Independent States. Geneva: United Nations Economic and Social Council; 2009. Available from: http://daccess-dds-ny.un.org/doc/UNDOC/GEN/N09/331/44/PDF/N0933144.pdf?OpenElement [cited 2014 May 07].
http://daccess-dds-ny.un.org/doc/UNDOC/G...

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 implement cost-saving measures that affected public financing for health care.⁷7 Schrader K, Laaser CF. Die Krise in Südeuropa oder die Angst vor dem Dominoeffekt. Griechenland, Portugal und Spanien im Krisentest. Kiel: Institut für Weltwirtschaft; 2012. German. Available from: http://www.ifw-kiel.de/pub/kd/2012/kd500-501.pdf [cited 2014 May 7].
http://www.ifw-kiel.de/pub/kd/2012/kd500...

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.⁸8 Averting a human crisis during the global downturn: policy options from the World Bank’s Human Development Network. Washington: World Bank; 2009. Available from: http://siteresources.worldbank.org/NEWS/Resources/AvertingTheHumanCrisis.pdf [cited 2014 May 7].
http://siteresources.worldbank.org/NEWS/... For example, suicides and homicides increased among working-age men and women when unemployment rose rapidly during past recessions in Europe.⁹9 Stuckler D, Basu S, Suhrcke M, Coutts A, McKee M. The public health effect of economic crises and alternative policy responses in Europe: an empirical analysis. Lancet. 2009;374(9686):315–23. doi: http://dx.doi.org/10.1016/S0140-6736(09)61124-7 PMID: 19589588
https://doi.org/10.1016/S0140-6736(09)61... In the current recession, the number of uninsured non-elderly Americans increased by 5.6 million between 2007 and 2009¹⁰10 Holahan J. The 2007–09 recession and health insurance coverage. Health Aff (Millwood). 2011;30(1):145–52. doi: http://dx.doi.org/10.1377/hlthaff.2010.1003 PMID: 21134911
https://doi.org/10.1377/hlthaff.2010.100... and over a quarter of Americans reported reduced routine use of medical care.¹¹11 Lusardi A, Schneider D, Tufano P. The economic crisis and medical care usage. National Bureau of Economic Research Working Paper. Hanover: Dartmouth College; 2010. Available from: http://www.dartmouth.edu/~alusardi/Papers/healthcare_031610.pdf [cited 2014 May 7].
http://www.dartmouth.edu/~alusardi/Paper... 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.¹²12 Fronstin P. The impact of the recession on employment-based health coverage. EBRI Issue Brief. 2010;342(342):1–22. PMID: 20578430^–1414 McKee M, Stuckler D, Martin-Moreno JM. Protecting health in hard times. BMJ. 2010;341:c5308. doi: http://dx.doi.org/10.1136/bmj.c5308 PMID: 20880907
https://doi.org/10.1136/bmj.c5308... 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 sexually transmitted diseases.¹⁵15 Kentikelenis A, Karanikolos M, Papanicolas I, Basu S, McKee M, Stuckler D. Health effects of financial crisis: omens of a Greek tragedy. Lancet. 2011;378(9801):1457–8. doi: http://dx.doi.org/10.1016/S0140-6736(11)61556-0 PMID: 21988763
https://doi.org/10.1016/S0140-6736(11)61... 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.¹⁶16 Buysse IM, Laing RO, Mantel-Teeuwisse AK. Impact of the economic recession on the pharmaceutical sector [Internet]. Geneva: World Health Organization; 2010. Available from: http://apps.who.int/medicinedocs/en/m/abstract/Js17419e/ [cited 2013 Feb 10].
http://apps.who.int/medicinedocs/en/m/ab...

It has been shown that countries that were seriously affected by the crisis, such as the Baltic countries, Greece, Portugal 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.¹⁷17 Vogler S, Zimmermann N, Leopold C, de Joncheere K. Pharmaceutical policies in European countries in response to the global financial crisis. South Med Rev. 2011;4(2):69–79. doi: http://dx.doi.org/10.5655/smr.v4i2.1004 PMID: 23093885
https://doi.org/10.5655/smr.v4i2.1004... 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.¹⁸18 de Belvis AG, Ferrè F, Specchia ML, Valerio L, Fattore G, Ricciardi W. The financial crisis in Italy: implications for the healthcare sector. Health Policy. 2012;106(1):10–6. doi: http://dx.doi.org/10.1016/j.healthpol.2012.04.003 PMID: 22551787
https://doi.org/10.1016/j.healthpol.2012...

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 recession by comparing changes in pharmaceutical 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-containment policies, such as those affecting out-of-pocket payments, would shift the financial burden of medicines onto patients and hypothesized that pharmaceutical 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 Pharmaceutical Pricing and Reimbursement Information Network (Austrian Health Institute, Vienna, Austria), which collects information from experts in national pharmaceutical pricing and from authorities responsible for reimbursement – the latter provide regular pharmaceutical policy updates; and (ii) the PharmaQuery database (IMS Health, Philadelphia, United States of America), which contains data on pharmaceutical policies. In addition, we included information on policy changes reported in the published literature. We grouped policy changes into 6-month implementation 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 Integrated 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 countries, the price used was the ex-factory price; in Estonia, Finland, Greece and Ireland, ex-factory prices were derived from wholesale prices. Average standard 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 prescription 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, Estonia, Finland, Greece, Ireland, Portugal, Slovakia and Spain. We selected these countries because they represented a variety of geographical regions and levels of economic wealth and stability and had been affected by the recession to different degrees. We classified them as either economically less stable or economically 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 European Union and the European Commission (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 consolidation (e.g. Norway, Sweden and Switzerland).²¹21 Restoring public finances, 2012 update [Internet]. Paris: Organisation for Economic Co-operation and Development; 2012. Available from: http://www.oecd.org/gov/budgeting/restoringpublicfinances-reportoutliningthefiscalconsolidationplansof30oecdcountries.htm [cited 2014 May 7].
http://www.oecd.org/gov/budgeting/restor... In this study, we regarded economically less stable countries as those belonging to the first two categories (i.e. Greece, Ireland, Portugal, Slovakia and Spain) and economically stable countries 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 implemented 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 calculated the combined volume and value of the sales of drugs for all 10 therapeutic classes for each country. Since our findings 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.²²22 OECD. StatExtracts. Health. Demographic references [Internet]. Paris: Organisation for Economic Co-operation and Development; 2013. Available from: http://stats.oecd.org/ [cited 2014 May 7].
http://stats.oecd.org/...

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

To compare changes in the volume and value of sales, we calculated the difference 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 (available 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 frequently used policy measures involved changes in out-of-pocket payments by patients (16), changes in regulations 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 policies; only a few changes involved newly implemented policies, such as the introduction of internal reference pricing in Finland.¹⁷17 Vogler S, Zimmermann N, Leopold C, de Joncheere K. Pharmaceutical policies in European countries in response to the global financial crisis. South Med Rev. 2011;4(2):69–79. doi: http://dx.doi.org/10.5655/smr.v4i2.1004 PMID: 23093885
https://doi.org/10.5655/smr.v4i2.1004...

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 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 volume (5.5% in Spain and 7.8% in Ireland), while the growth rate was between 1.0% and 3.1% in most other less economically stable countries. The exception was Portugal, which experienced a decline of −3.7%.

The average annual per capita growth in the value of sales between 2006 and 2011 varied between −2.1% in Portugal and 6.0% in Estonia. After 2009, all countries except Austria experienced a decrease in the value of sales in at least one year. The largest 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 between 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 implemented, the growth in the annual value of sales was less than the growth in the annual volume, which indicates a decrease in average price per unit.

Discussion

Although countries adjust their pharmaceutical policy frameworks continuously, 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 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 economically stable countries implemented fewer policy measures between 2008 and 2011 than economically less stable countries. The most frequently implemented policy changes targeted out-of-pocket payments for patients. Previous studies have shown that increases in copayments, such as prescription fees, tend to lead to lower medicine utilization, especially in times of economic recession and increased unemployment.²³23 Marmot MG, Bell R. How will the financial crisis affect health? BMJ. 2009;338:b1314. doi: http://dx.doi.org/10.1136/bmj.b1314 PMID: 19359306
https://doi.org/10.1136/bmj.b1314... ^–3030 Ornelas A. Recession-hit nations owe pharma firms billions [Internet]. Bern: Swissinfo.ch; 2012. Available from: http://www.swissinfo.ch/eng/business/Recession-hit_nations_owe_pharma_firms_billions.html?cid=32185254 [cited 2013 Jul 10].
http://www.swissinfo.ch/eng/business/Rec... 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.³¹31 PGEU statement on medicine shortages in European Community pharmacies [Internet]. Brussels: Pharmaceutical Group of European Union; 2013. Available from: http://www.pgeu.eu/en/library/2-position-papers/154-pgeu-statement-on-medicine-shortages-in-european-community-pharmacies.html [cited 2013 Jun 10].
http://www.pgeu.eu/en/library/2-position... 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 countries in 2010.³¹31 PGEU statement on medicine shortages in European Community pharmacies [Internet]. Brussels: Pharmaceutical Group of European Union; 2013. Available from: http://www.pgeu.eu/en/library/2-position-papers/154-pgeu-statement-on-medicine-shortages-in-european-community-pharmacies.html [cited 2013 Jun 10].
http://www.pgeu.eu/en/library/2-position... Hence, although the overall 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 declined, especially in economically less stable countries. This decrease may have been due partly to inflation: the average inflation rate in 2010 and 2011 generally 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.³²32 Harmonised Indices of Consumer Prices (HICPs) – inflation rate. Annual average rate of change (%) 2006–2013 [Internet]. Brussels: EUROSTAT; 2013. Available from: http://epp.eurostat.ec.europa.eu/tgm/table.do?tab=table&plugin=1&language=en&pcode=tec00118 [cited 2014 Jan 20].
http://epp.eurostat.ec.europa.eu/tgm/tab... Our analysis did not take inflation into account. The decrease may also have occurred because the 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,²¹21 Restoring public finances, 2012 update [Internet]. Paris: Organisation for Economic Co-operation and Development; 2012. Available from: http://www.oecd.org/gov/budgeting/restoringpublicfinances-reportoutliningthefiscalconsolidationplansof30oecdcountries.htm [cited 2014 May 7].
http://www.oecd.org/gov/budgeting/restor... 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 reduction in health insurance expenditure.³³33 Economic slowdown shaping healthcare system [Internet]. Gütersloh: Health Policy Monitor; 2009. Available from: http://hpm.org/en/Surveys/PRAXIS_-_Estonia/13/Economic_slowdown_shaping_healthcare_system.html [cited 2014 May 7].
http://hpm.org/en/Surveys/PRAXIS_-_Eston... A previous study identified a large decline in the consumption of pharmaceuticals of −18% between 2008 and 2009,¹⁶16 Buysse IM, Laing RO, Mantel-Teeuwisse AK. Impact of the economic recession on the pharmaceutical sector [Internet]. Geneva: World Health Organization; 2010. Available from: http://apps.who.int/medicinedocs/en/m/abstract/Js17419e/ [cited 2013 Feb 10].
http://apps.who.int/medicinedocs/en/m/ab... which was mirrored in our data. In response, Estonia implemented strict cost-saving measures with respect to medicines, reduced sick leave coverage and increased the workload of clinical staff without increasing their salaries.¹⁶16 Buysse IM, Laing RO, Mantel-Teeuwisse AK. Impact of the economic recession on the pharmaceutical sector [Internet]. Geneva: World Health Organization; 2010. Available from: http://apps.who.int/medicinedocs/en/m/abstract/Js17419e/ [cited 2013 Feb 10].
http://apps.who.int/medicinedocs/en/m/ab... ^,3333 Economic slowdown shaping healthcare system [Internet]. Gütersloh: Health Policy Monitor; 2009. Available from: http://hpm.org/en/Surveys/PRAXIS_-_Estonia/13/Economic_slowdown_shaping_healthcare_system.html [cited 2014 May 7].
http://hpm.org/en/Surveys/PRAXIS_-_Eston... 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.²¹21 Restoring public finances, 2012 update [Internet]. Paris: Organisation for Economic Co-operation and Development; 2012. Available from: http://www.oecd.org/gov/budgeting/restoringpublicfinances-reportoutliningthefiscalconsolidationplansof30oecdcountries.htm [cited 2014 May 7].
http://www.oecd.org/gov/budgeting/restor...

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 policies that targeted high-cost medicines.³⁴34 Leopold C, Vogler S, Bucsics A. Aktuelle Heilmittelausgaben und arzneimittelpolitische Trends in Europa. Soziale Sicherheit. 2013;9:414–29. German. Several countries have explored alternative policies for sharing the financial risk of selected, new, high-cost medicines, such as value-based pricing models or risk-sharing agreements.³⁵35 Kanavos P, Nicod E, Espin J, van den Aardweg S. Short- and long-term effects of value-based pricing vs. external price referencing. Brussels: Directorate-General for Enterprise and Industry; 2010. Available from: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/valuebased_pharmapricing_012010_en.pdf [cited 2014 May 7].
http://ec.europa.eu/enterprise/sectors/h... ^–3838 Kanavos P. Ferrario A. Managed entry agreements for pharmaceuticals: the European experience. Brussels: Directorate-General for Enterprise and Industry; 2013. Available from: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/mea_report_en.pdf [cited 2014 May 7].
http://ec.europa.eu/enterprise/sectors/h... The effect of these new approaches still needs to be determined.

Our study had several limitations. We did not take into account the differences in pharmaceutical policy frameworks that existed between all countries before the economic recession or between regions within some countries (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 reference pricing in 2009 had been planned long before the recession.³⁹39 Pohjolainen L. Reference price and price competition – evidence from the Finnish pharmaceutical market [thesis]. Helsinki: Aalto University; 2012. Available from: https://aaltodoc.aalto.fi/handle/123456789/3456 [cited 2012 Aug 20].
https://aaltodoc.aalto.fi/handle/1234567... Major policy changes, such as the introduction of reference price systems, may take several years to implement since many stakeholders are involved.⁴⁰40 Habl C, Vogler S, Leopold C, Schmickl B, Fröschl B. Referenzpreissysteme in Europa. Analyse und Umsetzungsvoraussetzungen für Österreich. Vienna: ÖBIG Forschungs- und Planungsgesellschaft mbH; 2008. German. However, most of the policy changes related to the recession 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.⁴¹41 Wladysiuk M, Araszkiewicz A, Godman B, Szabert K, Barbui C, Haycox A. Influence of patient co-payments on atypical antipsychotic choice in Poland: implications once generic atypicals are available. Appl Health Econ Health Policy. 2011;9(2):101–10. doi: http://dx.doi.org/10.2165/11318840-000000000-00000 PMID: 21271749
https://doi.org/10.2165/11318840-0000000... ^–4444 Ong M, Catalano R, Hartig T. A time-series analysis of the effect of increased copayments on the prescription of antidepressants, anxiolytics, and sedatives in Sweden from 1990 to 1999. Clin Ther. 2003;25(4):1262–75. doi: http://dx.doi.org/10.1016/S0149-2918(03)80082-6 PMID: 12809972
https://doi.org/10.1016/S0149-2918(03)80... We focused our analysis on the sale of products that accounted for the majority of pharmaceutical 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 addition, 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 expiration. During the study period, patents expired on several highly used products, including diabetes medications, antiulcerants, 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 limiting the decline in sales volume. Finally, the rapid implementation and the different timing of policies in different countries meant that we were unable to attribute the observed change in pharmaceutical sales to any single policy or set of policies or to make statistical comparisons of responses to policy between 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 medicine utilization and health outcomes. Moreover, since some of our findings were not in line with our expectations, we recommend that studies of the effect 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 economically stable countries. Our evidence shows that, despite numerous policy changes and contrary to our expectations, overall consumption of pharmaceuticals 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 observation 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 Medicine that resides within the Harvard Pilgrim Health Care Institute and is an appointing department of Harvard Medical School.

References

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