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Health Policy 109 (2013) 7–13

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Public procurement of health technologies in Greece in an era of economic crisis Catherine Kastanioti a , Nick Kontodimopoulos a,∗ , Dionysis Stasinopoulos a , Nikolaos Kapetaneas a , Nikolaos Polyzos b a b

Health Procurement Committee (EPY), Ministry of Health and Social Solidarity, Zacharof 3, Athens 11521, Greece Secretary General (SG), Ministry of Health and Social Solidarity, Athens, Greece

a r t i c l e

i n f o

Article history: Received 26 September 2011 Received in revised form 18 March 2012 Accepted 19 March 2012 Keywords: Medical devices Pharmaceuticals Procurement EPY Economic crisis Greece

a b s t r a c t Public procurement is generally an important sector of the economy and, in most countries, is controlled by the introduction of regulatory and policy mechanisms. In the Greek healthcare sector, recent legislation redefined centralized procurement through the reestablishment of a state Health Procurement Committee (EPY), with an aim to formulate a plan to reduce procurement costs of medical devices and pharmaceuticals, improve payment time, make uniform medical requests, transfer redundant materials from one hospital to another and improve management of expired products. The efforts described in this paper began in early 2010, under the co-ordination of the Ministry of Health (MoH) and with the collaboration of senior staff from the International Monetary Fund (IMF), the European Commission (EC) and the European Central Bank (ECB). The procurement practices and policies set forth by EPY and the first measurable outcomes, in terms of cost savings, resulting from these policies are presented. The importance of these measures is discussed in light of the worst economic crisis faced by Greece since the restoration of democracy in 1974, as a result of both the world financial crisis and uncontrolled government spending. © 2012 Elsevier Ireland Ltd. All rights reserved.

1. Introduction Public procurement is the process whereby public authorities – including all levels of government and public agencies – buy goods and services or commission work and is generally an important sector of the economy. In Europe, public procurement currently accounts for 16.3% of the GDP [1]. National law in most countries regulates public procurement more or less closely in an attempt to prevent fraud, waste, corruption or local protectionism. It usually requires the contracting authority to call public tenders, if the value of the procurement exceeds a certain threshold. Government procurement is also the subject of the Agreement on Government Procurement, a plurilateral

∗ Corresponding author. Tel.: +30 2132010584; fax: +30 2132010418. E-mail address: [email protected] (N. Kontodimopoulos). 0168-8510/$ – see front matter © 2012 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.healthpol.2012.03.015

international treaty under the auspices of the World Trade Organization (WTO) focusing on the subject of government and local government agencies procurement [2]. National procurement policies in Europe are an important component for supporting the efficient and timely uptake of and access to new “health technology”, which according to the INAHTA definition includes pharmaceuticals, devices, procedures and organizational systems used in health care [3]. In principle, procurement can promote the diffusion of innovative technology via the efficient and transparent purchase of products with high quality and value [4]. Most countries have introduced various direct and indirect regulatory and policy mechanisms to influence or control procurement practices, from lists of devices for purchase and use to changes in financing systems. Although healthcare systems strive to improve cost-effectiveness, a paradox in procurement trends is observed. On the one hand, health systems are centralizing procurement and

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controlling prices in order to reduce unit costs [5], whereas on the other, those actions seem to hinder the introduction of new technology which can help to improve healthcare system efficiency [6]. By the end of 2009, due to both the world financial crisis and uncontrolled government spending, the Greek economy faced its most severe crisis since the reinstitution of democracy in 1974. In light of this situation, the Government has been striving to address existing inefficiencies and reduce the size and costs of its public sector. This obviously implies tax increases and cuts in many areas, including health care, especially as Greece has been paying a higher than necessary price for its health services. According to recent data collected through ESY.net – an operational web-based facility developed and implemented by the Ministry of Health (MoH) – 2010 health expenditures were reduced by 5%, compared to 2009 (i.e. directly before and after the crisis). The respective reduction for pharmaceuticals, medical supplies and consumables was significantly higher (20%) [7]. Reimbursement prices for medical devices in particular are being forced down in an effort to reduce expenditure. At the same time, efforts are required to evaluate and monitor the volume of devices used, through the use of modern information technology and guidelines. It has been suggested that these trends might, in the short term, shrink but also rationalize the device market [8]. In an attempt to rationalize public procurement in NHS hospitals, the Government enacted Law 3580/2007 emphasizing the centralization of procurement procedures via the reorganization of a Health Procurement Committee (hereinafter referred to as “EPY”). An in-depth description of the Greek health system is beyond the scope of this paper. Detailed information regarding the organization, financing and delivery of health services in Greece and on reform and policy initiatives in progress or under development is available elsewhere [9]. Hence, the purpose of this paper can be seen as twofold: (i) to provide a brief overview of the current economic crisis in Greece and how this has been affecting the healthcare sector and public procurement of medical devices and pharmaceuticals in particular and (ii) to present current procurement practices and policies set forth by the State Committee, particularly regarding reference price setting and centralized tenders, as well as the first measurable outcomes (in terms of cost savings) resulting from these policies. From a European perspective, few studies have been conducted on this topic and this study can be seen as a contribution to filling this gap. 2. The current economic crisis in Greece The Greek GDP expanded at an average annual rate of 4% from 2004 to 2007 and 2% during 2008 (at 2000 prices), constituting it one of the highest rates in the Eurozone. It was alleged that successive Greek governments had consistently and deliberately misreported the country’s official economic statistics to keep within the monetary union guidelines. This had enabled Greek governments to spend beyond their means, while hiding the actual deficit from the EU overseers. In May 2010, the Greek government deficit was again revised and estimated at 13.6% which was one

of the highest in the world relative to GDP and public debt was forecast, according to some estimates, to exceed 120% of GDP during 2010, again one of the highest rates in the world [9]. This situation brought on international disbelief in Greece’s ability to repay its sovereign debt. To avert such a default, the European Central Bank (ECB) the European Commission (EC) and the International Monetary Fund (IMF) agreed to a rescue package which involved giving Greece an immediate D 45 billion in bailout loans, with more funds to follow. To secure continuity of this funding, Greece has been required to adopt harsh austerity measures to control its deficit, with their implementation constantly monitored and evaluated by the ECB, the EC, and the IMF (referred to hereinafter as the “Troika”). 3. Health Procurement Committee (EPY) In Greece, procurement of medical devices and pharmaceuticals by public hospitals was done mainly through reference price setting and hospital-based tenders. Products were usually invoiced on a patient basis, at the time of use, resulting in elevated administration costs. The reestablishment of EPY, although first described in Law 3580/2007, officially occurred one year later. The currently serving President, Vice-President and seven members were appointed by the MoH in March 2010, with a two-year term and full time responsibilities. The primary objective of the committee is to inspect and ensure an acceptable level of quality of products and services and to control and reduce excessive costs generated from the public hospitals. By unifying the annual tenders carried out by the hospitals, EPY’s mission is to reduce procurement costs, improve payment time (currently exceeding three years on average), make uniform medical requests, transfer redundant materials from one hospital to another, and improve management of expired products. EPY assumes responsibility for incorporating the provisions of Directive EC/2004/18 on the coordination of procedures for the award of public contracts. These include (but are not limited to): a. Framework agreements, i.e. agreements between one or more contracting authorities and one or more suppliers in order to establish the terms of contracts, especially when it is related to prices and quantities for a specific period of time. b. Dynamic purchasing system, i.e. electronic purchasing techniques to help increase competition and streamline public purchasing. All suppliers are invited to submit their offers and technical specifications electronically using a specific coding system. c. Common procurement vocabulary (CPV), i.e. the reference nomenclature applicable to public contracts as adopted by EC Regulation 2195/2002, while ensuring equivalence with the other existing nomenclatures. Under the new centralized procurement system, a request is initiated at the lowest level of hospital management (e.g. a medical department) and from there transferred to the respective Regional Health System (hereinafter referred to as “YPE”) which will convey the demands of all hospitals under its jurisdiction to EPY. The Committee,

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Fig. 1. Structure of the Health Services Procurement Program.

before organizing a call for tender, will explore the possibility of standardizing similar requests which could involve going back to each hospital for appropriate alterations. As defined in the relative legislation, a potential supplier can take legal actions when distortion is suspected and, if the State is indeed at fault, the procedure will be cancelled and start all over again. To exacerbate an already demanding situation, the law specifies that EPY shall not have more than 40 employees (currently 26) to manage this very complex system. The reforms introduced by the Greek Government in 2010 have already yielded noticeable outcomes, particularly those regarding drug spending. The respective reform initiatives phased in during the first semester of 2011 have addressed reductions in hospital operating expenses and drug spending, administrative restructuring, and performance evaluation of hospital CEOs. EPY’s contribution, in accordance to the provisions of Law 3580/2007 and Presidential Declaration 118/07, involved the implementation of a series of policy initiatives related to medical device and pharmaceutical procurement in Greece, which are discussed further below. 3.1. Health Services Procurement Program The Health Services Procurement Program (hereinafter referred to as “PPYY”) is a uniform program in which healthcare providers make their procurement requests. The procedure involves defining products, services and drugs per CPV code, and approving all supplies for the following year, acceptable unit prices, maximum quantities, time and method of delivery and payment method. EPY also controls the tender process (declaration and contract standards, monitoring contract implementation, developing, organizing and promoting e-commerce rules). Finally, for the implementation of the PPYY, the committee plans the annual budget of expenditures, approves the

technical specifications of products and services and assumes the financial management (consolidation of requests per insurance fund, procurement contracts, payments to suppliers and providers, finding resources for timely repayments of debts and previous-year inventory). The structure of the PPYY and the involvement of the various purchasing bodies in its implementation are presented in Fig. 1. Under the 2010 PPYY, 90% of all tenders (with a budget of D 2 billion) conducted by the hospitals and their respective YPE were completed and reached contract assignment by the end of November 2011. Implementation of the abovementioned procedures resulted in savings of approximately D 180 million, i.e. the difference between estimated budget and actual contract prices [10]. Most of the remaining tenders were at the technical and/or economic evaluation stage and were expected to reach contract assignment by the end of year. The 2011 PPYY approved by EPY amounted to a budget exceeding D 2.3 billion (stated in Law 1650/2011) and allowed hospitals and other health care organizations to enter their requests for products, services and drugs through their supervising YPE via a new web-based application. Higher cost savings are expected both percentage-wise and in absolute numbers. In 2010, seven centrally coordinated national tenders were issued by EPY for two-year framework agreements for products which, until recently, public hospitals purchased directly from suppliers at massively inflated prices. These included cardiovascular implants (intracoronary prostheses, pacemakers, defibrillators), hemodialysis filters and needles, peritoneal dialysis systems, intraocular lenses and orthopedic materials, with an estimated overall budget exceeding D 400 million. The first two framework agreements for “Filter Needles” and “Peritoneal dialysis Systems” were completed in July 2011 and September 2011, respectively. Contract assignment of the remaining framework

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Fig. 2. Annual savings from six completed “Framework Agreement” tenders. Data available at [11].

agreements was expected at the end of 2011. It is noteworthy that six completed national tenders have revealed that the actual prices for the products (i.e. after the competition), compared to the estimated budgets before the competition were reduced by 30–75%, resulting in annual savings exceeding D 80 million [11] (Fig. 2). A similar tender for prosthesis and other orthopedic supplies is currently in progress, via an e-auction tender.

their accounting and information systems. The remaining hospitals were gradually completing the necessary technical updates of their existing systems, in order to properly apply the abovementioned coding systems. It is worth noting that according to current data, the average price reduction achieved is estimated at 30%, whereas for several items at 60% or more. 3.3. Hospital Drugs Procurement Program

3.2. Price List Observatory In most countries, even more so in the Greek context, transparency is a significant concern regarding procurement. A Price List Observatory (PLO) – described in Law 3846/2010 – was created in May 2010, by which prices of common products and services are compared among hospitals, with the intention of expanding it in the future to include healthcare institutions abroad. Important objectives of the PLO are to achieve greater price transparency, to control costs and influence coverage decisions by setting the maximum price ceiling for tenders. Inclusion of a product in the List requires relevant data reaching EPY from the hospitals through a web-based application and subsequently being processed in collaboration with special interest groups such as scientific societies and suppliers associations, to ensure unbiased product descriptions. At the same time, invoices are processed to determine the reference price. In the eighteen months of operation of the PLO, EPY has collected and categorized, at the most affordable prices, approximately 18,000 supplies used by the hospitals, thus setting benchmark standards for Greece. Medical supplies and pharmaceuticals have been coded according to the Global Medical Device Nomenclature system (GMDN) and coding of National Organization of Medicines (“EOF Barcode”) respectively. By November 2011, GMDN coding and EOF Barcode were used by 90% and 95% of the NHS hospitals respectively to efficiently monitor their supplies through

Tendering is a common measure for the procurement of hospital pharmaceuticals and can be very effective in reducing pharmaceutical prices, at least in the short-term [12]. By May 2011, Greek NHS hospitals and EPY were required to conduct tenders for the procurement of hospital drugs with an approved budget of approximately D 800 million. Until then the Drug Pricing Committee of the MoH set pharmaceutical prices based on the average of three lowest prices in the 27 Member States. EPY performed the first tender for hospital drugs in July 2011 using the e-procurement method, and specifically for four active substances on behalf of three Hospitals with a total budget exceeding D 2 million. The e-auction process resulted in annual economic savings of 80%. On an even larger scale, the second e-tender for hospital drugs conducted in November 2011 involved twenty three active substances on behalf of all Greek Hospitals with a total budget exceeding D 80 million [13]. In this case the e-auction process resulted in substantially lower prices which, according to the information in Table 1, are estimated at 57%. 4. Discussion and conclusions Past procurement policies and procedures in Greece have undermined the efficient functioning of NHS hospitals and have even been criticized for distorting competition. At present, an enormous effort is being made to reform the Greek health care system under the supervision of

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Table 1 Annual savings resulting from the implementation of e-auctions for 23 active substances. A/A

Unit price before e-auction (D )a

Unit price after e-auction (D )

Annual cost before e-auction (D )b

Annual cost after e-auction (D )c

Annual savings (%)

Annual savings (D )

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Total

22.14 14.71 0.7 3.99 51.48 84.03 20.69 10.19 58.39 187.67 6.73 13.19 137.61 276.44 17.57 27.57 4.75 6.82 2.69 55.91 1.26 2.34 5.18

1.35 1.20 0.03 2.67 35.40 53.35 6.57 4.19 6.43 11.46 4.22 7.99 7.11 13.03 15.10 22.54 0.68 0.54 1.19 19.02 0.46 1.27 2.87

12,530,426 1,838,958 407,054 8,773,412 2,762,940 7,268,318 14,999,286 345,396 1,197,148 3,144,958 866,646 13,420,846 539,584 4,151,124 596,016 4,869,782 459,052 1,533,210 406,980 2,753,373 872,415 963,057 1,934,038 86,634,019.00

420,000 170,506 26,000 6,066,174 1,899,918 4,614,242 5,387,663 147,739 129,989 195,026 570,000 9,300,000 30,000 220,000 541,577 4,269,346 68,886 128,130 199,900 1,000,033 340,000 450,000 1,100,000 37,275,128.11

−96.65 −90.73 −93.61 −30.86 −31.24 −36.52 −64.08 −57.23 −89.14 −93.80 −34.23 −30.70 −94.44 −94.70 −9.13 −12.33 −84.99 −91.64 −50.88 −63.68 −61.03 −53.27 −43.12 −56.97

−12,110,426 −1,668,452 −381,054 −2,707,238 −863,022 −2,654,077 −9,611,623 −197,657 −1,067,159 −2,949,932 −296,646 −4,120,846 −509,584 −3,931,124 −54,439 −600,436 −390,166 −1,405,080 −207,080 −1,753,340 −532,415 −513,057 −834,038 −49,358,890.89

Data available at [13]. a Refers to National Organization of Medicines (EOF) prices. b Refers to annual costs based on EOF prices. c Refers to the same quantity of substances.

the MoH and guidance of the Troika. The Government has been forced to introduce reforms and also to implement the provisions of existing legislation, e.g. Law 3918/2011 initiating joint purchase of medical services and goods to achieve substantial expenditure reductions through price-volume agreements [14]. The constant reforms to the public procurement processes imply that the system remains uncertain and complicated. Moreover, legislation passed in March 2011 will transform EPY into a Technical Specifications Committee in 2013. Tenders will be shifted to the Regional Health Systems (YPE) to be implemented on a regional basis. Policy initiatives set forth by EPY in its relatively brief period of operation have already produced positive outcomes. For instance the PLO – a policy mechanism set forth to guide public procurement and serve as a reference pricing for designated products – has demonstrated its added value to the Greek economy and is used as a reference by other public-sector agencies, e.g. military hospitals, public insurance organizations, etc. Sickness Funds and hospitals have recently started to reimburse only devices whose prices are in parity with those published by EPY’s Observatory. Indicative of its acceptance by the Greek society are the thousands of hits on EPY’s website. Other European countries have also introduced reference pricing as a regulatory measure to control procurement costs, with mixed results. For example, as applied to the procurement of medical aids, reference pricing in Germany has had moderate impacts on containing costs, compared to those that have been observed in the context of pharmaceuticals [15]. In Italy, legislation passed in 2007 specified that reference pricing be applied only to devices for which

expenditure represents more than 50% of the global expenditure for medical devices, however it was actually never implemented in practice. The foreseen negotiating capacity for greater amounts of products is typically diminished by the extended time span required for the public tenders. Even in France for example, where the procedure is more adaptable and completely decentralized at the hospital level [16], procurement in public hospitals is more costly than similar transactions in private hospitals, even though they tend to be much smaller than public hospitals (and therefore offer fewer opportunities for benefits of scale). Speed of payment and the capacity to negotiate have made the difference. In other countries with decentralized health systems such as Italy and Spain, there is a clear tendency to centralize purchasing as a way to strengthen market power and reduce the administrative costs of hospitals [17]. Although this centralization has proved to leverage economies of scale and specialization, the long-term impacts of this kind of standardization process are still debated. Hence, more evidence is required on the optimal level of centralization or decentralization for medical device procurement. This is particularly true in the case of innovative medical technologies where the potential implications of centralized and highly controlled procurement policies, should be considered in conjunction to non-financial incentives of professional and organizational behavior to understand their diffusion and uptake in Greece and elsewhere [17]. Comparing procedures between countries can undoubtedly contribute to an international discussion on procurement; however such comparisons were not a direct objective of this study.

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It is worth noting that Greek hospitals usually select employees (doctors, nurses and administrative staff) to form purchasing committees for the tendering process. Despite being interdisciplinary groups, they are usually comprised of employees lacking knowledge of the procurement legislation and uniformed about current procurement practices. The same applies, in many cases, to the staff of the hospitals’ purchasing departments as well, resulting in an inability to provide guidance and assistance to the committees. At present EPY is trying to overcome this communication problem and the delays it imposes, by setting a common purchasing framework made up of comprehensible stages, and most importantly conveying this information to the regional health authorities and the hospitals. Short (yet formal) training courses in the methodology and applications of procurement (and perhaps evaluation and assessment) in health care might be immediate future goals. Furthermore, the lack of an integrated health care system has also resulted in the inability to establish an effective Health Technology Assessment (HTA) mechanism in Greece [18], although the Research Center for Biomaterials (EKEVYL) is expected to play a significant role in filling this gap in the near future. The link between procurement and HTA is that to achieve true efficiencies, procurement decisions should not be based solely on price, which is the standard for most countries, but on value. Therefore, it is a potential tool to support value-based purchasing/procurement by providing evidence on the costs and benefits of technologies. Although recent legislation ensures that pharmaceuticals will be assessed on the basis of effectiveness and cost-effectiveness, medical devices are, until now, used providing they have a CE Mark. In absence of a formal HTA structure, procurement and reimbursement is currently based mainly on their price. In extreme cases other assessment criteria may be arbitrarily considered, however this has generated a great deal of inefficiency, bureaucracy and corruption [8]. The inefficiencies and shortcomings of the Greek NHS, since its establishment in 1983, are well known and have been covered extensively in the literature [19–21]. Legislative initiatives undertaken in the 1990s to confront these inefficiencies were not successful due to political particularism, fiscal constraints and administrative weaknesses, thus resulting in either partial implementation or total abolition of the attempted reforms [22]. A second round of legislative measures were passed in 2000 to tackle the shortcomings and inefficiencies, however a change in the political scene once again hindered any effort to introduce modern scientific management into the health care system. Even before the onset of the current economic crisis, cost-containment and efficiency were again designated as top priorities on the recent health system reform agenda. Ensuring that current efforts are successful and that history doesn’t repeat itself is extremely important, especially in light of the obligation Greece has undertaken to contain health care costs under the memorandum signed with the “Troika”. Procurement, as a core dimension of financing, is at the heart of most efforts. For example, the MoH coordinated a project in 2011 to restructure the entire hospital

sector, mainly by merging smaller and less efficient hospitals with the aim of lowering the total costs of the services they provide. Among the numerous and multilevel objectives of this effort (described in Law 3984/2011) was the consolidation of hospital purchasing departments as well. This implies procurement requests and the overall tender process being unified for the “interconnected” hospitals (usually two to six hospitals under common management). Although it is still early to judge the success of this particular reform, the first positive results were expected by the end of 2011. The reestablishment of EPY, i.e. a state procurement committee to centrally coordinate annual tenders carried out by public hospitals with a view to reducing procurement costs, is a step in the right direction and in concordance with practices in other European countries. Experience gained over the past two years suggests that a high degree of collaboration between the “key players” is required to support effective and efficient procurement. This might involve a more formal role for physicians in the procurement process to support decision-making based on both health considerations and cost, as has been suggested elsewhere as well [23]. The first measureable cost savings resulting from policies adopted by EPY are indeed encouraging, despite being based on relatively short-term data. A future detailed quantitative study using data collected at least over a three-year period is expected to better advocate the contribution of EPY to the Greek health economic sector. At present, the Committee is focusing on implementing the policies described in this paper, and more importantly on conveying the new requirements to the individual hospitals from where the purchasing process is initiated.

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