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Pharmaceutical policies in European countries in response to the global financial crisis

Objective: The objective of this paper is to analyze which pharmaceutical policies European countries applied during the global financial crisis. Methods: We undertook a survey with officials from public authorities for pharmaceutical pricing and reimbursement of 33 European countries represented in the PPRI (Pharmaceutical Pricing and Reimbursement Information) network based on a questionnaire. The survey was launched in September 2010 and repeated in February 2011 to obtain updated information. Results: During the survey period from January 2010 to February 2011, 89 measures were identified in 23 of the 33 countries surveyed which were implemented to contain public medicines expenditure. Price reductions, changes in the co-payments, in the VAT rates on medicines and in the distribution margins were among the most common measures. More than a dozen countries reported measures under discussion or planned, for the remaining year 2011 and beyond. The largest number of measures were implemented in Iceland, the Baltic states (Estonia, Latvia, Lithuania), Greece, Spain and Portugal, which were hit by the crisis at different times. Conclusions: Cost-containment has been an issue for high-income countries in Europe – no matter if hit by the crisis or not. In recent months, changes in pharmaceutical policies were reported from 23 European countries. Measures which can be implemented rather swiftly (e.g. price cuts, changes in co-payments and VAT rates on medicines) were among the most frequent measures. While the “crisis countries” (e.g. Baltic states, Greece, Spain) reacted with a bundle of measures, reforms in other countries (e.g. Poland, Germany) were not directly linked to the crisis, but also aimed at containing public spending. Since further reforms are under way, we recommend that the monitoring exercise is continued.


Introduction
Pharmaceutical pricing and reimbursement systems in European countries differ from the ones in many countries the world over. This is due to the overall organisation and funding of health care in which the pharmaceutical systems are embedded. All countries have as part of their obligation to the fulfillment of the right to health, the obligation to grant access to essential medicines, i.e., medicines that fulfill the priority needs of their population [1][2][3] . This is ensured in many countries outside of Europe by the provision of a range of selected medicines (i.e. essential medicines) in public sector facilities that are procured by the state. While eligible patients can access essential health expenditure and two thirds of pharmaceutical expenditure is on average covered by the public payers 9 . While marketing authorization has been harmonized in the EU 10 , pharmaceutical pricing and reimbursement remains the competence of the Member States. A key provision which all EU Member States have to comply with is the Transparency Directive 11 , which aims at guaranteeing pricing and reimbursement decisions to be taken in a transparent way within specific time-frames. It is however up to individual countries as to how they organize their pharmaceutical pricing and reimbursement system. While there are a few policies commonly used in several European countries (e.g. external price referencing), the specific design of the policy measures differs in the details 8,[12][13][14] . As a result, there are 27 different pharmaceutical pricing and reimbursement systems in the EU 9,15 .
Even though the countries in Europe, in particular in the EU, are mostly high-income countries, cost-containment of pharmaceutical expenditure and equitable access to medicines have been long-standing issues because of public sector spending limits. Since the 1990s, countries have been undertaking reforms with the aim of containing cost, in particular those costs borne by public payers [16][17] . On average, public pharmaceutical expenditure in the out-patient sector has increased in EU countries by 76 percent between 2000 and 2009 (median: 53 percent; lowest value: 21 percent; highest value: 243 percent), with a growth of 79% in the EU-15 (i.e. EU Member States before 2004 -in general, high income countries in Western, Northern and Southern Europe) and 71% in the EU-12 (i.e. "new" EU Member States which acceded on or after May 2004 to the EU; mainly Central and Eastern European countries) i .
The financial global crisis hit European countries from 2008 on. The first country affected in Europe was Iceland with the collapse of all three major banks in September 2008. Shortly afterwards the crisis hit the three Baltic states Estonia, Latvia and Lithuania. From early 2010 onwards the Eurozone countries (i.e. countries with the Euro as currency) of Greece, Spain, and Ireland were hit by a debt crisis. In 2011, the Greek crisis escalated, concerning mostly the refinancing of Greek public debts; and Greece, together with Portugal and recently Italy, appeared on the political agenda of the EU meeting in spring/summer 2011. These countries were urged to implement measures for budget savings.
The aim of this study was to explore that how the global financial crisis impacted the regulatory framework in the pharmaceutical sector in European countries. Another objective was to determine the type of pharmaceutical policies implemented over this time and in particular, those relating to pricing and reimbursement. However, an assessment of the impact of this policy implementation is beyond the scope of this paper.

Methodology
We collected information about pharmaceutical policies implemented by European countries via a survey conducted with the public authorities for pricing and reimbursement represented in the PPRI (Pharmaceutical Pricing and Reimbursement Information) network.
PPRI is a networking and information-sharing initiative on pharmaceutical policies from a public health perspective which emerged from a European Commission co-funded project under the same name 18  The reasons why we decided to survey the information via PPRI were three-fold: Firstly, we consider the PPRI representatives as the ideal agency to have access to this kind of information, since they are dealing with pricing and/or reimbursement decisions on a daily basis in the representative countries. Secondly, a common understanding of concepts and a shared language built on a joint terminology has developed among members 19 , and this provides a level of quality assurance. Thirdly, this study was initiated by PPRI network members who, in the light of changes due to the financial crisis, proposed in spring 2010 to regularly monitor the reforms in the national pharmaceutical systems.
To collect the information, we developed a questionnaire asking for specific measures in the field of pricing (price cuts, price reviews, margin changes, discounts/rebates, changes in value-added tax) and reimbursement (changes with regard to reimbursement lists, reimbursement rates, co-payments, reference price systems, reimbursement reviews) and changes in generic policies. The questionnaire explicitly asked to list further measures. The first round of this policy monitoring exercise was launched on 1st September 2010, and the questionnaire surveyed the period from January 2010 to September 2010 including a discussion on planned measures. The investigation was repeated on 2nd February 2011 in order to obtain updated data for the second half of 2010 and the beginning of 2011, with an outlook on the first half of the year 2011.
In both rounds, the questionnaires were sent to all 33 PPRI member countries. Although the same cohort of countries were included in both rounds of surveys, some countries participated in only one round: 20 countries, thereof 15 EU Member States, out of the total of 33 European countries which were at that time represented in PPRI responded to at least one of the surveys. Sixteen countries, of 11 EU Member States, participated in the first survey and 13 countries, thereof i Data from the PHIS (Pharmaceutical Health Information System) database, accessed on 11 August 2011; further information regarding the methodology (data sources, limitations, etc.) see the PHIS database, publicly accessible at http://phis.goeg.at and http://whocc.goeg.at from October 2011 on. ii It is PPRI's policy not to list the names of staff and officials of institutions represented. The institutions which are members of PPRI are listed on the PPRI website (http://ppri.goeg.at).

Policy interventions by type
Price reductions of pharmaceuticals were the most frequent cost-containment measure, which countries applied during the review period (a total of 15 price reductions in 11 countries).
The second most common measure was a change in copayments, which constituted usually but not always an increase in cost for the patients (a total of 13 measures in nine countries, thereof increases in the prescription fee and higher co-payment   represented regarding their countries responses to the financial crisis. In a few cases, we contacted country representatives for updates and/or validation. Table 1    Poland: increase (7 → 8%) Abbreviations: EPR = external price referencing (= international price comparison), EU = European Union, NHS = national health service, OTC = over-the-counter medicines, PPRS = Pharmaceutical Price Regulation Scheme (UK) * Please note that the term "margin" is used in this table as a broad term covering different kinds of distribution remuneration (e.g. margins, mark-ups, fees).

Policy interventions by countries
The highest number of measures were implemented in the Baltic states, Greece, Spain, Portugal and Iceland.
Greece started to react to the crisis in spring 2010, with a bundle of emergency measures -some of which implemented temporarily. From May 2010 onwards, several price reductions were implemented, together with a reduction in the wholesale margin and twice an increase in the VAT on medicines followed by a decrease at the beginning of 2011. The frequency of price reviews for medicines having entered the market during the last four years increased from one, to three times a year. Generic prices were set at 90% of the original medicines' prices (before: equal level). A positive list and a negative list were planned to be re-introduced. The competence for pricing, previously split among three ministries, was shifted to the Ministry of Health in spring 2011 22 .
Spain introduced two emergency laws in March and May 2010. The price of expensive generics were cut by 30%, while original medicines and orphan medicines were discounted by 7.5% and 4% respectively on the pharmacy retail price, which were borne by industry, wholesale and pharmacies together, were implemented instead of price cuts. Spain also instituted procedural changes, e.g. in the reference price system and external price referencing, allowing lower prices and aligning the laws with existing practice 23 .
The reaction of Ireland, the third country hit by the crisis during 2010, was slightly different. Ireland did not take so many measures as Spain and Greece, and also considered the pharmaceutical industry as a considerable investor and employer within the Irish economy. Some policies had already been implemented earlier, such as the wholesale and pharmacy margin in 2009, and a refinement in external price referencing The average number of 2.7 policy interventions per country demonstrates that European countries were active in developing and implementing pharmaceutical policies over the time period of the survey. Our study supports a previous observation from the 1990s that EU Member States perform, on average, at least one policy measure per year 34 . However, it is important to realize that the average number of measures implemented per country might be misleading. This is because, at least for the years 2010/2011, policy changes were concentrated in a few countries -labeled "crisis countries", as well as a few other countries which had reforms that were not directly attributable to the financial crisis (e.g. Germany, Poland, a current discussion about organizational changes in France following the Mediator scandal 35 ). Whether affected by the crisis or not, containing pharmaceutical expenditure appears to be the key reason for countries aiming to reform their pharmaceutical sector. Our study adds to previous findings that cost-containment has been an issue for high-income countries, who aim to maintain equitable access to medicines within public sector spending constraints 9,16-17 .
This paper does not assess the impact of the measures since, though considered important and adding on the impact analysis of the global economic recession on countries world-wide done by the World Health Organization 36 , this would be premature and incomplete for the most recent crisis countries. Commonly set measures like increases in co-payments (including decrease in reimbursement rates) and in the VAT rates might be an indication for limited accessibility of medicines, even if exemptions from copayments for vulnerable groups were observed (e.g. Portugal) and in some countries VAT for reimbursable medicines is not In the 1990s policy interventions in high-income European countries were successful in containing growth rates in pharmaceutical expenditure and, in particular, in public pharmaceutical expenditure, but this was done at the expense of the patients with increases in private pharmaceutical expenditure 16,34 . In the new millennium some policy intervention proved successful in terms of cost-containment for public payers, and this was achieved without an increase of the out-of pocket payments 9 . This was mainly due to more rational use of medicines, including greater application of instruments of health economics including HTA 37-38 and a rational selection process for reimbursement in which reference price systems increasingly play a role 39 . Demand-side measures collated under the "4 Es" methodology (i.e. education, engineering, economics, and enforcement) [40][41][42] are recommended. In the Baltic states strict cost-containment measures targeting all stakeholders, including patients, were observed as first reaction to the crisis; follow-up measures were implemented in the field of the "4 Es" and had a focus on the enforcement aspect (e.g. making INN prescribing Pharmaceutical policies in European countries obligatory). We need to see if such developments will also take place in the more recent crisis countries. For this phase of the financial crisis we have data that the crisis response was successful in terms of savings in public expenditure which Spain, Greece and, to some extent, also Ireland could achieve [22][23][24] , but equity and accessibility aspects should also be explored. Another issue for future analyses could be an assessment if the outcomes achieved are worth the efforts made since these measures -no matter if in response to the crisis or generally aiming at costcontainment -are time-intensive for the officials, and if and how they might be implemented more efficiently. Nonetheless, the need to regularly refine and adjust pharmaceutical policies cannot be questioned: The impact of policies usually appears to be rather short-term, and its effect will probably fade out after two and three years unless no further and/or accompanying measures are set, since actors will adjust the situation according to their interests 34 .
Measures affecting the pharmaceutical industry raised concerns about medicines availability, which has been an issue, especially for small national markets in European countries. At the beginning of the crisis in Greece, some pharmaceutical companies announced their withdrawal from the Greek market 43 , as they claimed that they could not accept the price reductions, but to date this has not been the case (personal communication).
In the distribution chain, wholesale and pharmacies were equally affected by changes in their payment schemes, following on changes performed in the years before (e.g. in the Czech Republic, Ireland, Romania) 44 . In spite of the crisis in a few countries (e.g. Spain, Portugal) pharmacy margins, or at least a part of it, were increased, partly following an agreement that pharmacies were compensated in return for other crisis-related reforms. In some cases, the margin changes were not linked to the crisis.
We acknowledge that countries might have undertaken further policy measures which were not included in our summary of results. Nonetheless, we attempted to gather information about the major reforms since we asked the technical people responsible for pharmaceutical pricing and reimbursement in the countries. We also repeated the survey after seven months (thus also guaranteeing full coverage for the survey period for those countries only answering the second round), and ensured data validation by the information providers and checked literature and materials, in particular for some missing countries. Due to their repeating character, annual measures (e.g. price and/or reimbursement reviews) are likely not to have been listed by all countries undertaking them. We could only assess policy measures to the extent as they were publicly known. As a result, confidential arrangements including discounts or other savings offered in return for avoiding other measures, which might have taken place, are not included in the results.
The counting of the measures posed some problems, as some (planned) reforms included a bundle of, sometimes, interlinked measures. Measures like price cuts and de-listings which affected individual products were only considered when undertaken systematically for a group of medicines and in such cases counted once.
One limitation of the study is the short survey period. The survey started at the beginning of 2010, i.e. in the middle of the global financial crisis. In order to allow analyses over a longer time period and as the global financial crisis continues the authors plan to continue this policy monitoring exercise on a bi-annual basis. The survey methodology proved to be adequate for the purpose and will be, with some minor modification of the questionnaire, continued to be used. This regular exercise will also allow us to check which of the discussed and planned policy measures were actually implemented and in which form, and what the results have been, and share the findings with interested parties, among those competent authorities, thus offering the possibility to learn from the experiences of other countries.

Conclusions
This study demonstrates that numerous cost-containment measures were undertaken in mainly high and middle income European countries during the 2010-2011 financial crisis. While a bundle of policy measures were implemented in countries which were hit significantly by the crisis, all countries appear to be constantly working on optimizing their pharmaceutical systems. In several countries reforms were undertaken, which also aimed at containing public pharmaceutical expenditure, but they were not directly linked to the crisis. Price cuts, changes in co-payments, distribution margins and VAT rates on medicines, which could be implemented rather swiftly, were used as first tools. Many initiatives included the promotion of generic medicine use and the enforcement of policies for more rational use of medicines. Since further reforms are under way, changes in pharmaceutical policies will continue to be monitored. It is recommended to follow up with the applied methodology of this policy monitoring exercise which was piloted successfully in this study. Further research, in particular an impact assessment of the effects of the reforms on the availability and accessibility of medicines, is suggested and should also consider information collected in future policy monitoring exercises.

Authors contributions
All authors contributed to the paper's conception, design and production. SV drafted and revised the article with contributions from NZ, CL and KDJ and considering feed-back by PPRI network members. NZ developed the policy monitoring exercise tool in close cooperation with the other authors, performed the survey and compiled the preliminary results. All authors participated in a critical revision and have approved the final version for submission.

Pharmaceutical policies in European countries
pricing and reimbursement in the EU Member States and eleven further countries; see http://ppri.goeg.at) who participated in this policy monitoring exercise. Additionally, they have been providing a wealth of further information in written or oral form which was very helpful for this article. According to the information policy agreed within the PPRI network, the names of the PPRI participants are not published.