2013 APRIL 18 No. First update of the analysis of the impact of the Health Budget on the Medical Devices Sector

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1 No. 18 APRIL 2013 First update of the analysis of the impact of the Health Budget on the Medical Devices Sector Updated text following approval of the Stability Law 2013

2 Ernesto Veronesi Centre Director: Paolo Gazzaniga

3 First update of the analysis of the impact of the Healthcare Budget on the Medical Devices Sector Updated text following approval of the Stability Law 2013 Felice Cincotti Paolo Gazzaniga Valeria Glorioso Veronica Tamborini Centro Europa Ricerche CER Centro Studi Assobiomedica CSA Centro Studi Assobiomedica CSA Centro Studi Assobiomedica CSA

4 CONTENTS INTRODUCTION 1 IMPACT OF THE HEALTHCARE BUDGET Foreseeable public spending on medical devices 8 2. Effect on medical devices of the 5% cut in the purchasing of goods and services 9 3. Effect of the spending ceiling on medical devices 9 4. Effect of the direct measures on medical devices: summary Effect on medical devices of the reduction in spending on the services of accredited private operators Observations 15 SUMMARY AND CONCLUSIONS 17 APPENDIX 18 BIBLIOGRAPHY 20

5 INTRODUCTION The serious economic crisis affecting Italy and other industrialised western countries, on the one hand, and the latent problems that Italy has failed to address for decades (except in ideological and/or superficial terms, with measures of doubtful effectiveness), on the other, have recently come to a worrisome head. The government has responded to the situation in the National Health Service (NHS) by introducing various measures between July 2011 and the present time. These are examined below with particular reference to the medical devices sector. Overall, the measures represent a serious blow for the Italian NHS placing at risk as never before the very foundations of the NHS. In our view, the envisaged cuts in State funding far exceed the maximum achievable from possible efficiency improvements official numbers talk of cuts totalling 14,320 million euro over the three year period , including 8,520 million euro (about half of one point of GDP) in From its foundation in 1978 until now, the Italian SSN has expanded rapidly in both qualitative and quantitative terms. This growth in institutional importance has been accompanied by numerous measures to reorganise the public spending allocated to the sector (just as an example, various actions were taken in the early 1980s following the crisis in welfare systems experienced in 1979). From the beginning, along with other industrialised western countries, Italy has had to address the issue of economic sustainability, while maintaining a balance between the guarantees offered to citizens, consistency, and the organisation and quality of the services provided. The greatest challenge tackled and still being tackled by our country is to make public health spending sustainable, without prejudicing either the quality of the NHS services or equitable access to care. A full analysis of these problems is not possible here but, as often found in the literature, we can use a summary indicator, such as public healthcare spending as a percentage of GDP, to compare the Italian SSN with the systems found in other countries. Analysis of the relationship between public healthcare spending and total direct and indirect taxation in Italy and other OECD countries helps us to understand why, in the case of Italy, a drastic reduction in public healthcare spending is hard to justify. Figure 1 positions fourteen OECD countries (Italy, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Portugal, United Kingdom, Spain, United States of America and Sweden) 1 using two dimensions: their public healthcare spending as a percentage of GDP (vertical axis), and their total fiscal revenues from direct and indirect taxation, also as a 1 The countries analysed were selected from the thirty four members of the OECD based on the comparability of the information available. 1

6 percentage of GDP (horizontal axis) 2. In ideal circumstances, the position of each country along the vertical axis should be directly proportional to its position along the horizontal axis. In other words, in the ideal case, it would be legitimate to expect a country's public healthcare spending to be greater to the same extent that its fiscal revenues (and consequently available financial resources) are greater than those of another country 3. Figure 1 Relation between public healthcare spending (% of GDP) and fiscal revenues (% of GDP) in fourteen OECD countries, Denmark Public healthcare spending (% of GDP) France Germany United States Austria Belgium United Kingdom Italy Spain Portugal Finland Ireland Sweden 6 Greece Total direct and indirect taxation (% of GDP) Source: CSA processing of data taken from the OECD Health Data 2012 and AMECO 2010 databases. Note: both series of data relate to The 2010 data comes from the most recent OECD database (OECD Health Data 2012) and from the time series available from the AMECO database. In reality, as shown in figure 1, the situation is not always ideal. In particular, figure 1 highlights four quadrants (a, b, c, d) showing the existence of four types of country based on these two dimensions. a. The countries occupying the top right quadrant (Austria, Belgium, Denmark and the United Kingdom) have higher than average (vertical 2 Total fiscal revenues have been defined as those deriving from direct and indirect taxation since, in general, this is one of the main sources of finance for public healthcare spending in many countries (the only source, in the case of Italy). 3 Tables 1 and 2 present the data taken from the OECD Health Data 2012 and AMECO 2010 databases in order to produce figure 1. 2

7 dotted line) fiscal revenues, corresponding to public healthcare spending that is also higher than average (horizontal dotted line). These countries, therefore, are consistent overall with the ideal scenario outlined above. b. The countries occupying the lower left quadrant (Ireland, Greece, Portugal and Spain) are similarly consistent, despite being on the "low" side: their fiscal revenues are lower than average and their public healthcare spending is also lower than average. c. The countries occupying the upper left quadrant (France, Germany and the United States) depart from the ideal scenario: their lower than average fiscal revenues are accompanied by higher than average public healthcare spending. d. Lastly, the countries occupying the lower right quadrant (Italy, Finland and Sweden) also depart from the ideal scenario, this time for opposite reasons: their higher than average fiscal revenues are accompanied by lower than average public healthcare spending. Given these considerations, it emerges clearly that while Italy's fiscal revenues are among the highest, the percentage of public resources allocated to healthcare is among the lowest. Of course, this is a partial comparison between countries some of which are very different to others, especially when it comes to devising healthcare schemes (public and private insurance) and social protection schemes. Nevertheless, even with reference to the UK, whose model was borrowed for the Italian SSN, the "virtuous anomaly" presented by Italy is evident. Paradoxically, this situation could be restored to the theoretical normality in two ways: by decreasing our tax revenues or by increasing our public healthcare spending. For these reasons, cutting public healthcare spending in Italy is hard to justify. In reality, unfortunately, we know that the government has moved in exactly the opposite direction, by apparently betting that we can do equally as well with ever fewer resources. The question to be addressed, therefore, is if this scenario is realistic and, if it is, up to what point and under what conditions. Considering current regulations, we must accept that, in nominal terms, ordinary SSN funding will be lower in 2013 and, to a lesser extent, in 2014 than that envisaged for This marks a significant discontinuity with respect to the past 4 : in fact, the logic of containment (in a context of increasing resources) is replaced with a logic of cuts. In other words, the action taken to date to contain the growth of foreseeable spending, in order to contain the increase in State funding, is now replaced by measures intended to reduce spending in order, in turn, to lower the funding requirement. Furthermore, additional measures might also be taken in the same direction. 4 Looking back a few years, the Health Pact shifted from a cycle based on the ex post adjustment of annual State funding to the current cycle, in which the Regions are fully responsible for any health service deficit. 3

8 Table 1 Fiscal revenues in fourteen OECD countries (% of GDP), 2010 Indirect Taxation Direct On capital Total Taxation Total fiscal revenues EU Belgium Denmark Germany Ireland Greece Spain France Italy Austria Portugal Finland Sweden United Kingdom United States Source: CSC processing of data from AMECO 2010 database. Table 2 Public healthcare spending in fourteen OECD countries (% of GDP), 2010 Austria 8.4 Belgium 8.0 Denmark 9.5 Finland 6.6 France 8.9 Germany 8.9 Greece 6.0 Ireland 6.4 Italy 7.4 Portugal 7.0 United Kingdom 8.0 Spain 7.1 United States 8.5 Sweden 7.7 Source: CSA extraction from OECD Health Data

9 Table 3 Official estimates of the savings expected from the Healthcare Budget (millions of euro) Foreseeable SSN funding 108, , ,236 Reduction in SSN funding, Law 111/2011 2,570 5,520. Goods and services 1,500 1,850 Reference prices 750 1,100 Ceiling on medical devices (5.2% from 2013) Pharmaceutics 1,000 1,000. Patients' contributions 2,000. Personnel 600. Forensic checks ( ) Reduction in SSN funding, Law 135/ ,800 2,000. Goods and services % reduction in spending on supplies Lower ceiling on medical devices (4.9% in 2013 and % from 2014) Reduction in beds Pharmaceutics Accredited care Reduction in SSN funding, Stability Law ,000. Goods and services 600 1,000 10% reduction in spending on supplies (from 2013) Lower ceiling on medical devices (4.8% in 2013 and % from 2014) Total reduction in SSN funding 900 4,970 8,520 Planned funding 107, , ,716 Total savings expected on medical devices, based on n.a. 1,250 1,750 official estimates Source: CSA and CER processing based on the technical reports attached to the following draft laws S. 2814/2011, S. 3396/2012 and C ( ) This reduction is not in substance a real cut: in fact, in the past these resources were included as part of the national health service funding, but were set aside and not distributed to the Regions. With the current reorganisation of the system of transfers, commencing from 2013 the resources needed for forensic checks will be paid directly to the administrations concerned, thus simplifying the allocation process. Table 3 presents the sequence of measures taken over the past year and a half 5 and the savings expected from each, based on official assessments, highlighting those measures that directly affect spending on medical devices. While there are no doubts that the efforts made do actually seek to employ better the resources absorbed by the SSN, is it also true at the moment that employ "better" means, more precisely, employ "less". By contrast, the intention should be to employ "differently : saving in some areas, in order to spend and invest more in others. Above all, the current enormous territorial disparity, in terms of access to services and technology, must also be addressed 6. Indeed, as is well 5 Laws 111/2011, 94/2012, 135/2012 (the last two derive from the spending review ) and the Stability Law 2013 (Law 228/2012). 6 For further analysis, see Petrarca G., Bussone M.C. and Fattore G. (2011), and Petrarca G. and Bussone M. (2011). 5

10 recognised, the Italian SSN taken as a whole merits a leading position in many areas among international healthcare systems. Nevertheless, it is also true that certain regional healthcare systems (RSS) are far from being considered as good examples of efficiency, effectiveness and equity. Manoeuvres such as spending reviews mostly address the amount of spending rather than its quality, especially when faced with an impelling need to restore economic financial equilibrium, as in the case of the public sector debt accumulated by Italy. This said, the country also has another absolute requirement, closely related to the first, being the need to count on real and stable economic growth. In this regard, it must be stressed that many countries with fewer scientific and technological skills than those available in Italy are targeting research, especially that into health technologies, as a driver for growth. Here, by contrast, not enough is being done to build on the public and private skills and potential available within the healthcare sector (see Production, research and innovation in the medical devices sector: open questions Assobiomedica, May 2012). 6

11 IMPACT OF THE HEALTHCARE BUDGET We seek to respond here to the following questions: i. What is the saving expected on spending on medical devices? ii. iii. Is this objective reasonable and achievable without modifying the quality and quantity of public services? What can the medical devices sector learn from the measures that have been taken? The new Health Pact, due last April, should have identified how to make the necessary savings. In the absence of this agreement between the State and the Regions, our analysis can only refer to the approximate amounts contained in the official documents available, which cover the expense headings to be attacked and the savings expected from each. A more detailed assessment of the appropriateness of such measures must be deferred until (if ever) further details are made available. Starting from the overview of expected savings, we analysed the principal measures taken over the past year in relation to the medical devices sector, namely: 5% reduction in the spending on outstanding contracts for goods and services, but only in the second half of 2012 (given that this measure also cuts spending by 10% from 1 January 2013); determination of reference prices from 2013; ceiling on spending on medical devices based on the national funding of the SSN from While the first two measures encompass all goods and services, the third relates specifically to medical devices, placing an annual ceiling on such expenditures, beyond which the Regions become responsible. In this regard, it appeared appropriate to consider the reference prices to be fixed for medical devices 7 as the principal tool for cutting expenditure on them in order to comply with the 7 Art.17 of Decree 98 dated 06/07/2011, regarding the rationalisation of healthcare spending, calls on the public contracts observatory to publish reference prices from 01/07/2012 for the medical devices, hospital pharmaceuticals, healthcare and non healthcare services identified by Age.Na.S. (National Agency for Regional Healthcare) from among those with the greatest impact on overall healthcare spending. In July 2012, the public contracts supervisory authority (Avcp) managed to establish reference prices for 163 categories of medical device. These reference prices were later suspended by the Lazio Administrative Court, which handed down three parallel rulings on 23/11/2012. Lastly, Decree 82 dated 11/01/2013 has established further quality, standards and safety criteria for the identification of medical devices prior to the fixing of reference prices, a tool which is considered essential. 7

12 ceiling. Accordingly, this work does not estimate the specific impact of introducing reference prices we assumed that the savings due to the imposition of reference prices (750 million euro in 2013 and 1.1 billion euro in 2014), estimated in the technical reports accompanying the draft budget laws, relate solely to goods and services other than medical devices on the basis that this effect is included among the overall savings expected from compliance with the ceiling. 1. Foreseeable public spending on medical devices The official estimate for foreseeable spending on medical devices is 7 billion euro 8. The information available does not clarify how this estimate was made ( e.g. whether or not it includes the rental and leasing of healthcare equipment). This is a significant point, being an element of uncertainty about the portion of spending to which the quantified savings actually relate. Comparison can be made with latest available information, relating to 2010, obtained from the accounts of public healthcare organisations (Table 4). Table 4 Spending on goods and services (millions of euro), 2010 % of total G&S % of total health spending Purchase of goods 14, Medical 14, Pharmaceutical products 7, Medical devices 6, Non medical Purchase of non medical services 7, Maintenance 1, Medical Leases and rentals Medical leases and rentals Total purchases of goods and services 24, Total health spending ( ) 112, Source: CSA and CER processing using EC data from the Ministry of Health and RGSEP. ( ) This amount is stated net of depreciation and interregional transfers. NB: items not mentioned (and not included in the total of health spending) include the depreciation of tangible fixed assets, which is included in the accounts of public healthcare organisations without distinguishing between the portion relating to medical assets and that relating to other fixed assets. This said, the 7 billion euro indicated by the government has nevertheless been used as a basis for the calculations, on the assumption that it comprises all spending on medical devices. 8 See, in this regard, the technical note issued by the government on 24 July 2012 (see Chamber of Deputies, Studies Department Accounts Section, no. 672, Part II, 2012) and the technical report attached to the draft Stability Law 2013 (C. 5534), page 90. 8

13 2. Effect on medical devices of the 5% cut in the purchasing of goods and services In general, the technical report refers to an attackable amount of about 22 billion euro which, under the rules, should exclude pharmaceutical products for hospitals 9. Compared with this, a hypothetical saving of 5% would amount to 1.1 billion, while official sources indicate a savings objective of "just" 505 million in 2012, most likely because the measure only applies to the second half of the year. The steady reduction in expected savings reflects the gradual expiry of outstanding contracts, plus the fact that from 2013 the measure does not apply to contracts for the supply of devices 10. Further information would be needed to confirm the above numbers, as noted by the Accounts Department of the Senate which, among other matters, believes that this measure might also result in considerable disputes and supply problems for healthcare operators as a consequence of decisions taken to cancel the supply contracts concerned 11. Notably, the measure states that healthcare operators need not comply with the provisions laid down, on condition that the Regions achieve a balanced budget. Given the above, we estimated the impact of the measure on public spending on medical devices, considering its application over a period of six months 12 : the expected saving would be 175 million euro, corresponding to 34.7% of the total saving expected in 2012 from this measure (and 19.4% of the total savings expected in 2012 from the entire budget manoeuvre). 3. Effect of the spending ceiling on medical devices With regard to medical devices, we estimated the overall impact of the ceiling, initially set by Law 111/2011 at 5.2% of the SSN requirement for 2013 and subsequently lowered by Law 135/2012 (to 4.9% in 2013 and 4.8% from 2014) and then by Law 228/2012, the Stability Law 2013 (to 4.8% in 2013 and 4.4% from 2014). As with the procedure used to calculate the spending ceiling on non hospital pharmaceuticals, the SSN funding taken for comparative purposes is considered net of the resources available for the unreported and reserved activities of healthcare operators 13. Commencing from the foreseeable spending, 7 billion euro (the official figure), and the following the changes in the rules governing the ceiling and the reduction in available funding, we estimated the impact of each of the measures examined and their overall effect. 9 See the technical report attached to draft law S See the technical note issued by the government on 24 July See Senate Accounts Department, Reading Note no. 135, 2012, page Due to the application of a specific ceiling on such spending from On this matter, see the technical report attached to draft law S. 3396, page

14 Table 5 Health Service Budget, : reconstruction of the impact on spending (millions of euro) Foreseeable SSN funding 111, ,236 Foreseeable Unreported and reserved LHA activities data SSN funding relevant for ceiling 111, ,480 Foreseeable spending on medical devices according to official data 7,000 7,000 Effect of Reduction in SSN funding, Law 111/2011 ( ) 2,500 5,450 SSN funding relevant for ceiling, Law 111/ , ,030 Law 111/2011 Expected impact on spending on medical devices Spending on medical devices with ceiling of 5.2% 1,356 5,644 1,278 5,722 Reduction in SSN funding, Law 135/2012 1,800 2,000 Effect of SSN funding relevant for ceiling, Law 135/ , ,030 Law 135/2012 Spending allowed (ceiling of 4.9% in 2013 and 4.8% in 2014) 5,230 5,185 Expected impact on spending on medical devices Reduction in SSN funding, Law 228/ ,000 Effect of SSN funding relevant for ceiling, Law 228/ , ,030 Law 228/2012 Spending allowed (ceiling of 4.8% in 2013 and 4.4% in 2014) 5,095 4,709 Expected impact on spending on medical devices Total effect Total expected impact on spending on medical devices 1,905 2,291 Source: CSA and CER processing based on the technical reports attached to the following draft laws S. 2814/2011, S. 3396/2012 and C ( ) The above data does not include the cut of 70 million euro from the annual cost of forensic checks, the resources for which are included among the unreported and reserved activities, since they are not relevant to the determination of the ceiling. This exercise, summarised in table 5, highlights an inconsistency between the official data for the expected savings and the foreseeable spending on medical devices. Starting from foreseeable spending of 7 billion euro, the estimated savings (totalling 1,905 million euro in 2013 and 2,291 million in 2014) are different to and much higher than those indicated via official channels (1,250 million euro in 2013 and 1,750 million in 2014). This difference is largely attributable to an underestimate (in our view) by the government of the effect of introducing the ceiling (Law 111/2011), while the differences relating to the subsequent lowering of the ceiling are much smaller. It can be shown (see the Appendix, where the overall impact of the ceiling is broken down to separate the effect of the ceiling from that of the reduction in spending) that the official estimate of the savings attributable to the spending ceiling is based on foreseeable spending of 6.4 billion euro, which is less than the amount specified subsequently by the government. This inconsistency is not insignificant: with foreseeable spending of 7 billion euro, the reduction in public spending on medical devices due to introduction of the 10

15 ceiling would be about 27% in 2013 and 33% in , which is much more than that implied by the official estimates (18% and 25% respectively). The impact estimated in the above way relates to the entire sector. In this regard, by its nature, the measure governing reference prices (credibly the principal measure expected to deliver the desired savings) has a potential impact on various market segments and their firms that may differ considerably on a case by case basis. Lastly, the Regions are made responsible for any breaches of the spending ceiling: they will either have to contain their healthcare spending or draw on resources available within their regional budgets. Those Regions that keep their healthcare spending in balance are not required to make up any differences. Figure 2 Relationship between SSN funding of the Regions and public spending on medical devices (millions of euro), SSN funding (millions of euro), Cam Sic Lom Cal Laz Bas Ven EmR Lig Bol Pie Pug Sar Mol Mar Abr FVG Umb Tre Tos VdA Public spending (SSN) on medical devices (% of funding), 2010 Source: CSA processing using EC data from the Ministry of Health and CIPE Resolution 25/2011. Figure 2 shows the positioning of Italy's Regions and Autonomous Provinces with respect to public spending on medical devices and SSN funding. The data relates to 2010, being the most recent year for which the Ministry of Health has made available the income statements (PL) of SSN entities. The funding information, stated in millions of euro, reflects the allocation between Regions of the financial resources made available by the SSN, i.e. without distinguishing between the 14 In this regard see Chamber of Deputies, Studies Department Accounts Section, no. 672, Part II,

16 essential levels of care referred to in CIPE (interministerial committee for economic planning) decision 25 dated 25 May Lastly, the line drawn at 4.8% indicates the spending ceiling envisaged for 2013 by Law 228/2012. Clearly, the majority of Regions were positioned well above 4.8% in 2010, except for Campania and Sicily; Lombardy and Calabria, on the other hand, were the only Regions relatively close to the 4.8% limit. This diverse picture is likely to be unchanged today and can be explained, at least in part, by the different publicprivate mix in the provision of healthcare services at regional level. Figure 3 Simulation of the percentage change in SSN spending on medical devices following imposition of the 4.8% ceiling, Piedmont Valle d'aosta Lombardy A.P. Bolzano percentage amounts A.P. Trento Veneto Friuli VG Liguria Emilia Romagna Tuscany Umbria Marche Lazio Abruzzo Molise Campania Puglia Basilicata Calabria Sicily Sardinia Source: CSA processing using EC data from the Ministry of Health and CIPE Resolution 25/2011. The exercise performed was to simulate the imposition of a 4.8% funding ceiling on the medical device spending of Regions and Autonomous Provinces, using the 2010 data. As can be seen from figure 3, the Regions with relatively high public spending on medical devices with respect to the available funding would also be those most affected by the ceiling imposed. Clearly, the establishment of a single spending ceiling for all Regions may result in distortions. 15 The black bars indicate the Regions currently subject to the rescheduling of their healthcare deficit; the grey bars identify the Regions not subject to a rescheduling plan. 12

17 4. Effect of the direct measures on medical devices: summary Summarising, on the assumption that foreseeable spending is 7 billion euro, we estimate that the medical devices sector would be required to contribute as follows to the overall saving required by the budget manoeuvre under review: 19.4% in 2012, 38.9% in 2013 and 27.1% in 2014 (table 6). These percentages are clearly much more than proportionate (3 4 times greater) to the historical incidence of medical devices on total healthcare spending. Table 6 Overall impact of the Healthcare Budget (% of total expected savings) on spending on medical devices (millions of euro), Total reduction in SSN funding ( ) 900 4,900 8, Our estimates Expected savings from the measures on medical devices 175 1,905 2, inc. due to reduction in supplies inc. due to ceiling on medical devices (with spending as per Note 24/7) Official estimates 1,905 2, Expected savings from the measures on medical devices 175 1,250 1, inc. due to reduction in supplies inc. due to ceiling on medical devices (spending recalculated) 1,250 1, Source: CSA and CER based on the technical reports attached to the following draft laws S. 2814/2011, S. 3396/2012 and C ( ) These numbers do not include the cut, from 2013, of 70 million euro from the annual cost of forensic checks. The contribution for is higher than that stated officially (as shown by the data presented in the lower part of table 6, where we have aggregated the effects of the ceiling, already analysed by measure in table 3). For 2012 on the other hand, in the absence of clarification from the government, the estimated saving borne by medical devices is estimated herein (see section 2). At this point, we can reply to the second question raised, i.e. whether or not such savings are reasonable and achievable without modifying the quality and quantity of public services. In our view, these numbers (concerning the savings on medical devices in absolute terms and as a percentage of total spending on goods and services) are excessive and cannot be deemed to represent reasonable objectives. On the one hand, as stated by the Senate's Accounts Department, the technical reports do not provide enough quantitative information to check the appropriateness of the measures in relation to the expenditure savings expected. On the other, if our reasoning is correct, we have found an inconsistency in the official numbers. 13

18 Further, confirming the perplexities surrounding the numbers used for the budget manoeuvre, the government has also made declarations about the alleged room available to reduce the spending on medical devices. Such reductions would be possible just by eliminating inefficiencies in the purchasing procedures followed by public healthcare organisations 16. The Supervisory Authority for public contracts for works, services and supplies (Avcp) has apparently identified significant differences between the prices paid by public organisations for equivalent supplies: on average, the purchase prices currently used are alleged to be about 33% higher than the benchmark parameter. Accordingly, a simple realignment of prices would recover about 2.3 billion euro (being 33% of 7 billion euro), which is virtually the same as the amount estimated by us. The real point, however, is that the considerations expressed by AVCP have been shown to be highly arbitrary, based on calculations containing serious methodological errors that, in some cases, were also made incorrectly 17. Based on this discussion, it is increasingly difficult to imagine that these measures are designed to rationalise or even merely revise spending, compatible with the maintenance of public services. On the contrary, it is widely held that a reduction in State funding on this scale is bound to have adverse consequences in terms of the lower guarantees offered to citizens, both quantitatively (reduced access to services) and qualitatively (reduced access to modern and innovative technologies), commencing from those Regions that already have shortcomings of this type. 5. Effect on medical devices of the reduction in spending on the services of accredited private operators This measure was not mentioned earlier, since it does not relate directly to medical devices. Nevertheless, it will have an impact (albeit indirect and hard to determine at this time) on the market for the related technologies. Accordingly, it is considered here in order to complete the reasoning. At the regional budgeting stage, this measure requires the redetermination of volumes and tariffs for specialist out patient and hospital services in order to reduce the related spending, with respect to 2011 levels, by 1% in 2013 and 2% from In order to estimate the impact of the measure on the purchasing of healthcare services from accredited private operators in the market for medical devices, it is necessary to know its current incidence on the total domestic sales of the firms in the sector. Since this number is not available, we have arbitrarily estimated it to be 50% of the entire private market concerned (in turn estimated to be 25% of the total market for medical devices). Based on this, the contraction in sales from supplies of this type to accredited private healthcare organisations is estimated to 16 See the technical report attached to draft law C. 5534, page Bizzotto G., Glorioso V. and Gazzaniga P. (2012). 14

19 be: 12 million euro in 2013 and 24 million euro in Observations So we now come to the third question posed for this work: what can we learn from the measures taken? Ignoring the numbers contained in the budget manoeuvre which, we repeat, in our view are not credible or supported by analytical data and, more especially, are potentially extremely dangerous for the SSN (to the extent implemented without thinking) its content sends a clear signal: from here on, the healthcare system and the market for technologies in Italy must either evolve, abandoning the logic and behaviours that mark the past and still apply today, or both will suffer major reversals. A health service increasingly for the wealthy and a general impoverishment of its technology are now decidedly real risks. Against this background, greater efforts are needed to obtain: a. increased transparency about the spending and activities of the regional healthcare services; b. the reorganisation of the networks of healthcare services based on reasons of appropriateness, as well as on financial considerations; whether in terms of funding, tariffs or reference prices for bidding competitions, cutting is obviously easier than acting to reorganise Italy's healthcare services; nevertheless, reorganisations remain the principal way to achieve the most significant improvements in efficiency; for example, it is unacceptable for the remote delivery of various services (socalled telemedicine) to become a financial self inflicted wound for healthcare firms (given the absence of ad hoc reimbursement mechanisms); c. greater transparency about the cost of goods and services requested and offered, purchased and supplied; d. an approach to investment in innovation by firms that focuses more on the economic sustainability of the system, on the one hand, and an approach to the governance of innovation by decision makers that is more open towards firms, on the other. All this creates an absolute requirement for ethical behaviour by all parties, and for approaches to the sector and the market that are not crushed by short term considerations. On this second point, just considering the economic aspects, we must warn about the likely recessionary effects of an approach to the health service based on progressive cuts in public spending. The same efforts dedicated to the spending review must now be dedicated to equipping Italy with a strategic plan designed to attract private investment and European funding for R&D in the area of 15

20 healthcare technologies. In Italy, the investment in R&D unfortunately remains insufficient due, principally, to the disappearance of the so called "locomotive" effect provided by public spending in relation to private investment. In other words, Italian public investment in R&D does not provide a sufficient incentive for investment by firms, except to a modest extent. The reasons for this are well known. This said, Italy is still a country with great potential. Potential that now, more than ever, must be harnessed to attract investment in R&D and generate innovation. In particular, the health service and the medical devices sector offer major development opportunities for the country and, in this light, various new initiatives must be devised, including those that ensure the necessary sustainability of the system. This last objective must not be pursued to the detriment of quality (of the healthcare technologies and the services available), but rather by emphasising quality as a driver of development. Despite all the inter regional and infra regional diversities, our healthcare system can still count on skills and technologies that undoubtedly place it among the most advanced in the world. In particular, the fact that the Italian medical profession is excellent and at the forefront in the use of numerous innovative healthcare technologies, clearly represents an important strength of our system that must be used to the maximum extent to promote our ability: to manage projects, in order to benefit from the opportunities made available by the European funding of innovation; to offer services to firms in terms of R&D, the transfer of technology and clinical testing. All players must step up a level in terms of quality, with responsible discussion between stakeholders that focuses on the strategic aspects and not just on shortterm contingencies. 16

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