Türkiye’de İlaç Fiyatlandırma ve Geri Ödeme Politikalarının AB Ülkeleri ile Karşılaştırılması

Year 2018, Issue: 108, 99 - 121, 01.03.2018

Seda Sönmez Gülnur İlgün

Abstract

Sağlık hizmetlerinin insan hayatında vazgeçilemez olması ülkelerin sağlık ve sağlık hizmetleriyle ilgili konulara eğilimlerini artırmıştır. Toplumun sağlık ihtiyaçlarını karşılayacak sağlık hizmeti sunmanın yolu ise iyi planlanmış bir sağlık sistemi ve kaynak dağıtım politikasına bağlıdır. Ayrıca sağlık ihtiyaçlarının istenen düzeyde karşılanması, sürekli olarak artış eğilimi gösteren sağlık harcamaları ile baş edebilme gücüne bağlıdır. Ülkelerin hem sağlık ihtiyacını karşılamak hem de artan sağlık harcamaları ile baş edebilmek için harcamaları artıran faktörleri doğru bir şekilde belirleyip ilgili alanlara sürekli düzenlemeler yapması gerekmektedir. Bu noktada toplam sağlık harcamaları içinde ilaç harcamalarının payının yüksek olması ve gün geçtikçe daha da yükselmesi tüm ülkeleri ilaç harcamalarının etkin bir şekilde kontrol altına alınmasını sağlayacak fiyatlandırma ve geri ödeme süreçlerine ilişkin sürekli olarak düzenlemeler yapmaya zorlamaktadır. Buradan hareketle bu çalışmada Türkiye’deki ilaç fiyatlandırma ve geri ödeme politikalarının Avrupa Birliği AB ülkeleri ile karşılaştırılması amaçlanmıştır. Bu amaca yönelik olarak PHIS indikatörlerinden fiyatlandırma ve geri ödeme başlığında yer alan indikatörler kullanılarak karşılaştırmalar gerçekleştirilmiştir. Değerlendirme sonucunda fiyatlandırma politikalarından AB ülkelerinde en çok uluslararası referans fiyatlandırma yönteminin kullanıldığı ve ülkelerin çoğunun üretici fiyatını kontrol ettiği ve normalde uygulanmakta olan KDV oranından farklı oranlarda KDV aldıkları görülmüştür. Geri ödeme politikaları kapsamında ise ülkelerin çoğunlukla pozitif liste kullandığı ve geri ödeme kriterlerinde sağlık teknolojilerinin değerlendirilmesini dikkate aldıkları görülmüştür.

Keywords

İlaç, Fiyatlandırma, Geri Ödeme, Türkiye, Avrupa Birliği Ülkeleri.

COMPARISON OF DRUG PRICING AND REIMBURSEMENT POLICIES IN TURKEY WITH EU COUNTRIES

Abstract

The fact that health services are essential in human life has increased countries’ focus on matters related to health and health services. The way of delivering health care to meet the health needs of a community depends on a well-planned health care system and resource allocation policy. In addition, meeting the health needs at the desired level depends on the ability to cope with the health expenditures, which tend to increase continuously. In order to meet the health needs and cope with increasing health expenditure, the countries need to accurately identify the factors that increase spending, and make continuous adjustments on these factors. At this point, the high share of drug spending within the total health expenditure and the gradual increase of this share compel all countries to make regular adjustments to their pricing and reimbursement processes to ensure that drug spending is effectively controlled. From this point of view, the purpose of this study is to compare the drug pricing and reimbursement policies in Turkey with those in the European Union EU countries. For this purpose, we made comparisons with PHIS indicators by using the ones included in the pricing and reimbursement headings. As a result of the evaluation, we found that, as a pricing policy, the EU countries mostly use the international reference pricing method, and most countries check the producer price and get different VAT rates than the normal VAT rate. In the context of reimbursement policies, we observed that countries often use a positive list and take into account the assessment of health technology in reimbursement criteria.

Keywords

Drug, Pricing, Reimbursement, Turkey, European Union Countries.

References

• Antonissen, Yoeriska, DeSwaef, Andre (2009), PHIS Hospital Pharma Report Belgium 2009, Pharmaceutical Health Information System; Commissioned by the European Commission, Executive Agency for Health and Consumers and the Austrian Federal Ministry of Health, Belgium.
• Araştırmacı İlaç Firmaları Derneği (AİFD) (2012), Türkiye İlaç Sektörü Vizyon 2023 Raporu, PWC, Türkiye.
• Bilim, Sanayi ve Teknoloji Bakanlığı (2015), Türkiye İlaç Sektörü Strateji Belgesi ve Eylem Planı 2015-2018, Bilim, Sanayi ve Teknoloji Bakanlığı, Ankara.
• Çelik, Yusuf, Seiter, Andreas (2008), “Turkey: Pharmaceutical Sector Analysis”, http://apps.who.int/medicinedocs/documents/s16766e/s16766e.pdf (Erişim Tarihi: 16.02.2017).
• Deloitte (2016), The Essential Guide for Individuals in Luxembourg Tax, Social Security, Labor Environment, Immigration, Luxembourg.
• DeSwaef, Andre, Antonissen, Yoeriska (2008), PPRI Pharma Profile Belgium 2008, Pharmaceutical Pricing and Reimbursement Information; Commissioned by the European Commission, Directorate-General Health and Consumer Protection and Austrian Federal Ministry of Health, Family and Youth, Belgium.
• Drummond, Michael, Jönsson, Bengt, Rutten, Frans, Stargardt, Tom (2011), “Reimbursement of Pharmaceuticals: Reference Pricing Versus Health Technology Assessment”, The European Journal of Health Economics, 12(3): 263-271.
• Dylst, Pieter, Simoens, Steven (2010), “Generic Medicine Pricing Policies in Europe: Current Status and Impact”, Pharmaceuticals, 3(3): 471-481.
• EFPIA (2016), The Pharmaceutical Industry in Figures Key Data 2016, Brussels, Belgium.
• Elliott, Deirdre, Byrne, Gerald (2007), PPRI Pharma Profile Ireland 2007, Pharmaceutical Pricing and Reimbursement Information; Commissioned by the European Commission, Directorate-General Health and Consumer Protection and Austrian Federal Ministry of Health, Family and Youth, Ireland.
• European Union (2017), “Pricing and Reimbursement of Medicinal Products”, https://ec.europa.eu/growth/sectors/healthcare/competitiveness/ products-pricing-reimbursement_en (Erişim Tarihi: 01.02.2017).
• Ferrario, Alessandra, Kanavos, Panos (2013), Managed Entry Agreements for Pharmaceuticals: The European Experience, LSE, Belgium.
• Franken, Margreet, Stolk, Elly, Scharringhausen, Tessa, de Boer, Anthonius, Koopmanschap, Marc (2015), A Comparative Study of The Role of Disease Severity in Drug Reimbursement Decision Making in Four European Countries. Health Policy, 119(2): 195-202.
• Gürsoy, Kadir (2016), “An Analysis of Public Pharmaceutical Policy, Pricing and Spending in Turkey”, Sosyal Güvenlik Dergisi, 6(1): 225-243.
• Hernandez, Hector, Soriano, Fernando H., Tuebke, Alexander, Vezzani, Antonio, Amoroso, Sara, Coad, Alexander, Gkotsis, Petros, Grassano, Nicola (2016), The 2016 EU Industrial R&D Investment Scoreboard, Institute for Prospective and Technological Studies, Joint Research Centre, European Union.
• Hogan Lovells International LLP (2014), Pricing & Reimbursement Schemes in Major European Countries, EU Pricing & Reimbursement, Munich.
• Hu, Jia, Mossialos, Elias (2016), “Pharmaceutical Pricing and Reimbursement in China: When The Whole is Less Than The Sum of Its Parts”, Health Policy, 120(5):519-534.
• IMS Health (2015), “Global Medicines Use in 2020: Outlook and Implications”, http://www.imshealth.com/en/thought-leadership/quintilesims-institute/ reports/global-medicines-use-in-2020 (Erişim Tarihi: 27.01.2017)
• İEİS (2016), Türkiye İlaç Sektörü 2015, İlaç Endüstrisi İşverenler Sendikası, İstanbul.
• İEİS (2017), “Temel Konular”, http://www.ieis.org.tr/ieis/tr/issues/9 (Erişim Tarihi: 08.02.2017)
• Kanavos, Panos, Nicod, Elena, Espin, Jaime, van den Aardweg, Stacey (2010), Short-and Long-Term Effects of Value-Based Pricing vs. External Price Referencing, EMiNet.
• Kanavos, Panos, Vandoros, Sotiris, Irwin, Rachel, Nicod, Elena, Casson, Margaret (2011), Differences in Costs of and Access to Pharmaceutical Products in The EU, European Parliament.
• Kenneally, Martin, Walshe, Valerie (2012), “Pharmaceutical Cost-Containment Policies and Sustainability: Recent Irish Experience”, Value in Health, 15(2): 389-393.
• Kullmann, David (2010), PHIS Pharma Profile United Kingdom 2010, Pharmaceutical Health Information System (PHIS); Commissioned by the European Commission, Executive Agency for Health and Consumers and the Austrian Federal Ministry of Health, United Kingdom.
• Leopold, Christine, (2014), Pharmaceutical Policy Analysis–A European Perspective on Pricing and Reimbursement in Challenging Times, Doctoral dissertation, Utrecht University.
• Lichtenberg, Frank R, Tatar, Mehtap, Çalışkan, Zafer (2017), “The Impact of Pharmaceutical Innovation on Health Outcomes and Utilization in Turkey: A Re-Examination”, Health Policy and Technology, 6(2): 226-233.
• Lopes Sophie, Zimmermann Nina, Vogler Sabine (2009), PHIS Indicators Taxonomy 2009, Commissioned by the Executive Agency for Health and Consumers and the Austrian Federal Ministry of Health in the framework of the Pharmaceutical Health Information System Project, Paris / Vienna.
• Lopes, Sophie, Marty, Christian, Berdai, Driss (2011), PHIS Pharma Profile France 2011, Pharmaceutical Health Information System; Commissioned by the European Commission, Executive Agency for Health and Consumers and the Austrian Federal Ministry of Health, France.
• Mäntyranta, Tania, Martikainen, Jaana, Kivioja, Akseli, Paldán, Mareena (2007), PPRI Pharma Profile Finland 2007, Pharmaceutical Pricing and Reimbursement Information; Commissioned by the European Commission, Directorate-General Health and Consumer Protection and Austrian Federal Ministry of Health, Family and Youth, Finland.
• Martínez Vallejo, Mercedes, Ferré de la Peña, Piedad, Guilló Izquierdo, Maria J., Lens Cabrera, Carlos (2010), PHIS Pharma Profile Spain 2010
• Pharmaceutical Health Information System; Commissioned by the European Commission,Executive Agency for Health and Consumers and the Austrian Federal Ministry of Health, Spain.
• Martini, Nello, Folino Gallo, Pietro, Montilla, Simona (2007), PPRI Pharma Profile Italy 2007, Pharmaceutical Pricing and Reimbursement Information; Commissioned by the European Commission, Directorate-General Health and Consumer Protection and Austrian Federal Ministry of Health, Family and Youth, Italy.
• McGuire, Alistair, Drummond, Michael, Rutten, Frans (2004), “Reimbursement of Pharmaceuticals in the European Union”, Regulating Pharmaceuticals in Europe: Striving for Efficiency, Equity and Quality: Striving for Efficiency, Equity and Quality, Elias Mossialos, Monique Mrazek, Tom Walley (eds.), McGraw-Hill Education, Bungay.
• Närhi, Ulla (2009), PHIS Hospital Pharma Report Finland 2009, Pharmaceutical Health Information System; Commissioned by the European Commission, Executive Agency for Health and Consumers and the Austrian Federal Ministry of Health, Finland.
• OECD (2017), “Pharmaceutical spending (indicator)”, https://data.oecd.org/ healthres/ pharmaceutical-spending.htm (Erişim Tarihi: 01.02. 2017).
• Özer, Safiye, Thomsen, Elisabeth, Schüder, Paul (2013), PHIS Pharma Profile Denmark 2011, Pharmaceutical Health Information System; Commissioned by the European Commission, Executive Agency for Health and Consumers and the Austrian Federal Ministry of Health, Denmark.
• Panteli, Dimitra, Arickx, Francis, Cleemput, Irina, Dedet, Guillaume, Eckhardt, Helene, Fogarty, Emer, … Busse, Reinhard (2016), Pharmaceutical Regulation in 15 European Countries, Health Systems in Transition, WHO.
• Pita Barros, Pedro (2010), “Pharmaceutical Policies in European Countries”, Advances in Health Economics and Health Services Research, 22: 3-27.
• Schumock, Glen T, Li, Edward C, Suda, Katie J, Wiest, Michelle D, Stubbings, JoAnn, Matusiak, Linda M, Hunkler, Robert J, Vermeulen, Lee C (2016), National Trends in Prescription Drug Expenditures and Projections for 2016, American Journal of Health-System Pharmacy, 73(14): 1058-1075.
• SGK (2017) “İlaç Katılım Payı”, http://www.sgk.gov.tr/wps/portal/sgk/tr/ saglik/ilac_ve_ eczacilik (Erişim Tarihi: 15.02.2017).
• Shafiq, Yasir, Kösters, Jan Peter, Muhammad, Ameer (2015), Pharmaceutical Policies: Effects of Policies that Determine Which Drugs are Reimbursed, John Wiley & Sons, The Cochrane Library.
• Simoens, Steven (2012), “A Review of Generic Medicine Pricing in Europe”, GaBI Journal, 1(1); 8-12.
• Stargardt, Tom, Busse, Reinhard, Dauben, Hans-Peter (2008), PPRI Pharma Profile Germany 2008, Pharmaceutical Pricing and Reimbursement Information; Commissioned by the European Commission, Directorate-General Health and Consumer Protection and Austrian Federal Ministry of Health, Family and Youth, Germany
• Stargardt, Tom, Vandoros, Sotiris (2014), “Pharmaceutical Pricing and Reimbursement Regulation in Europe”, Encyclopedia of Health Economics, 3: 29-36.
• Storms, Harrie, Schreurs, Margreed (2010), PHIS Hospital Pharma Report the Netherlands 2009, Pharmaceutical Health Information System; Commissioned by the European Commission, Executive Agency for Health and Consumers and the Austrian Federal Ministry of Health, Netherlands. Sundhedsloven (2014), https://www.retsinformation.dk/Forms/r0710.aspx?id= 152710#Afs10 (Erişim Tarihi: 25.02.2017).
• Tatar, Mehtap (2010), PHIS Hospital Pharma Report Turkey 2010, Pharmaceutical Health Information System; Commissioned by the European Commission, Executive Agency for Health and Consumers and the Austrian Federal Ministry of Health, Turkey.
• Teixeira, Ines, Vieira, Isaura (2008), PPRI Pharma Profile Portugal 2008, Pharmaceutical Pricing and Reimbursement Information; Commissioned by the European Commission, Directorate-General Health and Consumer Protection and Austrian Federal Ministry of Health, Family and Youth, Portugal.
• Vardica, Areti, Kontozamanis, Vassilis (2007), PPRI Pharma Profile Greece 2007, Pharmaceutical Pricing and Reimbursement Information; Commissioned by the European Commission, Directorate-General Health and Consumer Protection and Austrian Federal Ministry of Health, Family and Youth, Greece.
• Varol, Nebibe, Saka, Ömer (2006), “Health Care and Pharmaceutical Policies in Turkey After 2003”, Europe, 14(4): 29-32.
• Vogler, Sabine, Habimana, Katharina (2014), “Pharmaceutical Pricing Policies in European Countries, Vienna: Gesundheit Österreich Forschungs-und Planungs GmbH.
• Vogler, Sabine, Habl, Claudia, Bogut, Martina, Von ina, Luka (2011), “Comparing Pharmaceutical Pricing and Reimbursement Policies in Croatia to the European Union Member States”, Croatian Medical Journal, 52(2): 183- 197.
• Vogler, Sabine, Kilpatrick, Kate (2015a), “Analysis of Medicine Prices in New Zealand and 16 European Countries”, Value in Health, 18(4): 484-492.
• Vogler, Sabine, Paris, Valérie, Ferrario, Alessandra, Wirtz, Veronika J., Joncheere, Kees de, Schneider, Peter, Pedersen, Hanne Bak, Dedet, Guillaume and Babar, Zaheer-Ud-Din (2017), “How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned From European Countries”, Applied Health Economics and Health Policy, 15: 307-32.
• Vogler, Sabine, Zimmermann, Nina, de Labry, Antonio O, Espin, Jaime (2015c), “Reimbursement Measures in European Countries–Findings of a Bibliometric Literature Review”, Journal of Pharmaceutical Policy and Practice, 8(1): 1-2.
• Vogler, Sabine, Zimmermann, Nina, Ferrario, Alessandra, Wirtz, Veronika V, Babar, Zaheer-Ud-Din (2015b), “Challenges and Opportunities for Pharmaceutical Pricing and Reimbursement Policies”, Journal of Pharmaceutical Policy and Practice, 8(1): 1-3.
• Vogler, Sabine, Zimmermann, Nina, Habimana, Katharina (2016), “Stakeholder Preferences About Policy Objectives and Measures of Pharmaceutical Pricing and Reimbursement”, Health Policy and Technology, 5(3): 213- 225.
• World Health Organization (2012), Policies and Priority Interventions for Healthy Ageing, Copenhagen World Health Organization, Regional Office for Europe.
• Yalçın Balçık, Pınar, Karsavuran, Seda (2012), “Dünyada ve Türkiye’de İlaç Fiyatlandırması”, Hacettepe Sağlık İdaresi Dergisi, 15(2): 38-67.
• Zimmermann, Nina, Vogler, Sabine (2012), PPRI/PHIS Pharma Profile Austria 2012, Pharmaceutical Pricing and Reimbursement Information (PPRI) / Pharmaceutical Health Information System (PHIS), Vienna.
• Zuidberg, Christel (2010), “The Pharmaceutical System of the Netherlands, A Comparative Analysis Between the Dutch Out-Patient Pharmaceutical System, in Particular the Pricing and Reimbursement Characteristics, and Those of the Other European Union Member States, with a Special Focus on Tendering-Like Systems, Vienna: Gesundheit Österreich GmbH”, http:// whocc.goeg.at/ (Erişim Tarihi: 10.02.2017).