Abstract
Pharmaceutical policy in Italy has been reshaped as a result of the 1993–4 crisis in which it was revealed that pharmaceutical companies, policy makers and top Department of Health officers had constructed an illegal system to set prices. Following this crisis, the rise of technical competency and leadership in the Italian Department of Health and, since 2000, in the Drug Regulatory Agency (Agenzia Italiana del Farmaco; AIFA) has achieved major improvements in many aspects of Italian pharmaceutical policy. These improvements have included increased transparency of decision making, the use of evidence-based medicine principles for reimbursement and pricing, and the use of generic drugs to lower prices.
As a result of these changes, pharmaceutical expenditure has been controlled and equity has improved, mainly because co-payments have been reduced, thus reducing private expenditure on reimbursable drugs. However, a short-term approach to cost containment has prevailed, and Italian pharmaceutical policy has neglected industrial parameters. Hence, the trend in pharmaceutical expenditure has been erratic, and Italy has not favoured localization of research and development and production in its territory.
The dominant issue of Italian health policy in recent years has been devolution of powers to regions, the intermediate tier of the Italian State. Overall, devolution has increased regional accountability on healthcare spending. However, regions react to enhanced freedom in different ways, reflecting their institutional capacity and competencies. This process has also affected pharmaceutical policy, more than in other decentralized healthcare systems (such as Germany and Spain). Such a situation is causing increasing regional variations and geographical equity concerns. In addition, the regional level appears rather inadequate to promote an industrial perspective unless it is supported by national initiatives.
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Notes
The assumed average maintenance dose per day for a drug used for its main indication in adults.
The last national agreement between the GPs Union and the SSN fixed incentives share at 30% over total remuneration. Weighted per capita payment accounts for 70% of total payment.
For further details on the effects of Italian Supplementary Patient Certificate, see Ghislandi et al.[31]
References
Mossialos E, Oliver A. An overview of pharmaceutical policy in four countries: France, Germany, the Netherlands and the United Kingdom. Int J Health Plann Manage 2005; 20 (4): 291–306
Jommi C. Pharmaceutical policy and organisation of the regulatory authorities in the main EU countries. Milan: Egea, 2001
Fattore G, Jommi C. The new pharmaceutical policy in Italy. Health Policy 1998; 46 (1): 21–41
AIFA (Agenzia Italiana del Farmaco). L’uso dei farmaci in I’alia: rapporto nazionale, Anno 2006. Rome: Ministero della Salute, 2007
Osservatorio Farmaci, CERGAS, Bocconi University. Report 19. Report annuale per il 2006. Milan: Bocconi University, 2006
Fattore G. Cost-containment and reforms in the Italian National Health Service. In: Mossialos E, Le Grand J, editors. Health care and cost containment in the European Union. Aldershot: Ashgate, 1999: 513–546
Jommi C, Cantù E, Anessi Pessina E. New funding arrangements in the Italian National Health Service. Int J Health Plann Manage 2001; 6 (4): 347–368
Anessi Pessina E, Jommi C, Cantù E. Phasing out market mechanisms in the Italian NHS. Public Money Manage 2004; 24 (5): 309–316
France G, Taroni F. The evolution of health-policy making in Italy. J Health Polit Policy Law 2005; 30 (1–2): 169–187
Anessi Pessina E, Cantu E. Whither managerialism in the Italian National Health Service? Int J Health Plann Manage 2006; 21 (4): 327–355
Cavallo MC, Gerzeli S, Vendramini E. Organizzazione e gestione delle cure primarie: un’indagine nazionale.’Milan: McGraw Hill, 2001
Mapelli V, Lucioni C. Spending on pharmaceuticals in Italy: macro constraints with local autonomy. Value Health 2003; 6 Suppl. 1: S31–S45
Garattini S. Cultural shift in Italy’s drug policy. Lancet 1995; 346 (8966): 5–6
Walley T, Mrazek M, Mossialos E. Regulating pharmaceutical markets: improving efficiency and controlling costs in the UK. Int J Health Plann Manage 2005; 20 (4): 375–398
Paris V. Pharmaceutical regulation in France 19802–2003. Int J Health Plann Manage 2005; 20 (4): 307–328
Busse R, Schreyögg J, Henke KD. Regulation of pharmaceutical markets in Germany: improving efficiency and controlling expenditures? Int J Health Plann Manage 2005; 20 (4): 329–349
De Wolf P, Brouwer WBF, Rutten EFH. Regulating the Dutch pharmaceutical market: improving efficiency or controlling costs? Int J Health Plann Manage 2005; 20 (4): 351–374
Gerzeli S, Jommi C, Villa S. Politic he regionali e variabilità delle spesa farmaceutica convenzionata. Economia Pubblica 2003; 33 (5): 93–129
Jommi C, Fattore G. Regionalization and drugs cost-sharing in the Italian NHS. Eur Observer 2003; 3: 1–4
Damiani G, Federico B, Oradei M, et al. Impact of drug policy on the use of parenteral cephalosporin in Italy. Pharm World Sci 2002; 24 (5): 169–171
Formoso G, Liberati A, Magrini N. Practice guidelines: useful and participative method? Survey of Italian physicians by professional setting. Arch Intern Med 2001; 161 (21): 2037–2042
Fattore G, Torbica A. Inpatient reimbursement system in Italy: how do tariffs relate to costs? Health Care Manage Sci 2006; 9 (3): 251–258
Mapelli V. Cost-containment measures in the Italian healthcare system. Pharmacoeconomics 1995; 8 (2): 85–90
Brenna A, Grassi M, Lucioni C. L’effetto del ticket m’derateur sui farmaci: presupposti economici ed analisi statistica. Pavia: La Goliardica Pavese, 1984
Hanau C, Rizzi D. Econometria dei provvedimenti pubblici sull’assistenza farmaceutica: il caso dell’Emilia Romagna. Economia Pubblica 1986; 3: 177–183
Anessi Pessina E. The effect of user charges on the utilisation of prescription medicines in the Italian National Health Service [dissertation]. Ann Arbor (MI): UMI Dissertation Services, 1997
Atella V, Schafheutle E, Noyce P, et al. Affordability of medicines and patients’ cost-reducing behav’our: empirical evidence based on SUR estimates from Italy and the UK. Appl Health Econ Health Policy 2005; 4 (1): 23–35
Association of European Self-Medication Industry (AESGP). Economic and legal framework for non-prescription medicines. Brussels: AESGP, 2006
Associazione Nazionale delle Imprese Farmaceutiche di Automedicazione (ANIFA). Numeri e indici dell’auto medicazione. Milan: Anifa, 2006
Jommi C. Italy: past reforms and future prospects. Eurohealth 2001; 2: 11–13
Ghislandi S, Krulichova I, Garattini L. Pharmaceutical policy in Italy: towards a structural change? Health Policy 2005; 72 (1): 53–63
Garattini L, Ghislandi S. Off-patent drugs in Italy: a short-sighted view? Eur J Health Econ 2006; 7 (1): 79–83
Istat (Istituto Nazionale di Statistica) website [online]. Available from URL: http://www.istat.it [Accessed 2007 May 15]
Jommi C, Paruzzolo S. Public administration and R&D localisation by pharmaceutical and biotech companies: a theoretical framework and the Italian case study. Health Policy 2007; 81: 117–130
Acknowledgements
The Pharmaceutical Observatory, CERGAS, is financed by Astra Zeneca, Bayer, GlaxoSmithKline, Merck Sharp and Dohme, Pfizer and Roche. This work has been carried out independently from these companies. The supporting companies did not participate in the following: (i) study design; (ii) the collection, analysis and interpretation of data; (iii) the writing of the report; and (iv) the decision to submit the paper for publication. The authors thank Carlo Lucioni (Director of Pharmacoeconomics, Italian Research Articles) and Amelia Compagni (CERGAS) for their revision and comments.
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Fattore, G., Jommi, C. The Last Decade of Italian Pharmaceutical Policy. Pharmacoeconomics 26, 5–15 (2008). https://doi.org/10.2165/00019053-200826010-00002
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DOI: https://doi.org/10.2165/00019053-200826010-00002