Market Access Tracker Program

July 2014

Turkey: Market Access Tracker - 2014

Introduction:

Last Updated 2 July 2014
The Turkish pharmaceutical market is the largest in the Middle East and Africa region, the 7th largest in Europe and the 16th largest in the world. This market experienced rapid growth until 2011, although growth has slowed over the past few years. A substantial increase in national investment in healthcare and the creation of a universal health insurance system have boosted demand for healthcare services, including prescription drugs. However, a tough pricing and reimbursement environment and restrictions on market access for new imported drugs present serious challenges for multinational pharmaceutical companies (MNCs) interested in this emerging market. New cost-containment measures unveiled in November 2011 and health technology assessment measures made effective in February 2013 have added to the industry’s woes.

Scope:

Market profile: Market access drivers; key opportunities and challenges; analysis of more than 40 market parameters.

Economic outlook: Global, regional, and country growth rates, 2004-2019.

Socioeconomic trends of 7 Middle East and Africa countries: Gross domestic product (GDP), nominal per capita gross national income (GNI).

Demographics of 7 Middle East and Africa countries projected to 2030: Population size; population growth rate; life expectancy at birth; median age; percentage of population aged 65 or more; percentage of population that is urban.

Healthcare investments of 7 Middle East and Africa countries: Healthcare spending as percentage of GDP (2001-2012), healthcare spending by government and private entities (2012); healthcare spending per capita (2002-2012).

Pharmaceutical markets (3 regions and 15 countries): Ranking by size; market sizes; market growth; Turkish pharmaceutical market; growth rates by volume and by sales; imported drug market share by volume and sales.

Healthcare system: Evolution of the Turkish healthcare system; impact of the Health Transformation Program; actions taken to achieve universal health insurance; reorganization of the Ministry of Health and its affiliates.

Regulation of pharmaceuticals: Key laws, regulations, and decision makers; requirements for marketing authorization; regulations for clinical trials and pharmacovigilance; harmonization activities; GMP requirements and delays; health technology assessment process; marketing authorization of imported, generic, biosimilar, and orphan drugs; promotion and advertising regulations; counterfeit drugs.

Intellectual property: Key decision makers; patent legislation; limitations of Turkish data protection provisions.

Pharmaceutical pricing: Wholesaler and pharmacy margins; use of external reference pricing as the starting point of price setting; reductions applied to external reference prices for various categories of drugs; statutory discounts levied by the social security system; recent changes to the pricing system; currency exchange issues.

Pharmaceutical reimbursement: Data requirements and procedures for admission to reimbursement; Turkish positive list; reimbursement applications; and use of internal reference pricing.

Cost containment: National pharmaceutical budget and potential penalties for overspending; price cuts; pharmacy discounts; prescribing restrictions; out-of-pocket payments; use of generics; rational drug use.

Hospital pharmacy: Public hospitals; positive list of inpatient drugs; tendering and contracts.

Pharmaceutical market: Import and export trends.

Commercial Outlook: 12 key factors to appreciate when doing business in India.

Exhibits: 25 data-rich tables and figures.


Search Reports

Mentioned in this report:

  • Organizations:
  • - Adalet ve Kalkinma Partisi (AKP; Justice and Development Party)
  • - Akılcı İlaç Kullanımı Bölümü (Department of Rational Drug Use)
  • - Araştırmacı İlaç Firmaları Derneği (AIFD; Association of Research-Based Pharmaceutical Companies)
  • - Bağ-Kur (Social Araştırmacı İlaç Firmaları Derneği Security Organization for Artisans and the Self-Employed)
  • - Beşeri Tıbbi Ürünler Ruhsatlandırma Danışma Komisyonu (Advisory Committee for the Authorization of Medicinal Products for Human Use)
  • - Biyoyararlanım ve Biyoeşdeğerlik Tespit ve Değerlendirme Komisyonu (Bioavailability and Bioequivalence Assessment and Evaluation Committee)
  • - Çalışma ve Sosyal Güvenlik Bakanlığı (CSGB; Ministry of Labor and Social Security)
  • - Devlet Planlama Teşkilatı Müsteşarlığı (DPT; State Planning Organization)
  • - Dış İlişkiler ve Avrupa Birliği Genel Müdürlüğü (DAGM; Directorate General for Foreign Affairs and the European Union)
  • - Emekli-Sandigi (Government Employees’ Retirement Fund)
  • - European Medicines Agency
  • - FDA
  • - Fiyat Belirleme Komisyonu (Price-Setting Committee)
  • - Geri Ödeme Komisyonu (Reimbursement Committee)
  • - İlaç Endüstrisi İşverenler Sendikası (IEIS; Pharmaceutical Manufacturers Association of Turkey)
  • - İlaç ve Eczacılık Genel Müdürlüğü (IEGM; General Directorate of Pharmaceuticals and Pharmacies; GDPP)
  • - İlaç ve Tibbi Cihaz Kurumu (Pharmaceuticals and Medical Device Agency)
  • - İşçi Sigortaları Kurumu (ISK; Workers’ Insurance Agency, now called the Sosyal Sigortalar Kurumu [SSK, Social Insurance Agency])
  • - Kamu Ihale Kurumu (KIK; Public Procurement Authority)
  • - Klinik Araştırmalar Danışma Kurulu (Clinical Trials Advisory Board)
  • - Klinik Araştırmalar Derneğine (Clinical Research Association)
  • - Organization for Economic Cooperation and Development (OECD)
  • - Pharmaceutical Research and Manufacturers of America (PhRMA)
  • - Sağlığın Geliştirilmesi Genel Müdürlüğü (SGGM; Directorate General of Health Promotion)
  • - Sağlık Araştırmaları Genel Müdürlüğü (SAGEM; Directorate General of Health Research)
  • - Sağlık Bakanliğı (SB; Ministry of Health)
  • - Sağlık Politikaları Kurulu (Health Policy Board, part of the Ministry of Health)
  • - Sağlık Teknolojisi Değerlendirme Daire Başkanlığı (Department of Health Technology Assessment)
  • - Sağlık Yatırımları Genel Mu ̈dürlügü (SYGM; Directorate General of Health Investments)
  • - Sosyal Güvenlik Kurumu (SGK; Social Security Institution)
  • - Sosyal Sigortalar Kurumu (SSK; Social Insurance Agency, originally called the İşçi Sigortaları Kurumu [ISK; Workers’ Insurance Agency])
  • - State Planning Organization
  • - Strateji Geliştirme Başkanlığı (SGB; Department of Strategy Development in the Ministry of Health)
  • - Teknoloji-Farmakoloji Danışma Komisyonu (Advisory Committee for Technology and Pharmacology)
  • - Türk Eczacıları Birliği (TEB; Turkish Pharmacist Association)
  • - Türk Patent Enstitüsü (TPE; Turkish Patent Institute)
  • - Türkiye Bilimsel Ve Teknolojik Araştirma Kurumu (TÜBİTAK; Scientific and Technological Research Council of Turkey)
  • - Türkiye Farmakovijilans Merkezi (TÜFAM; Turkish Pharmacovigilance Center)
  • - Türkiye Halk Sağlığı Kurumu (THSK; Public Health Agency of Turkey)
  • - Türkiye Hudut ve Sahiller Sağlık Genel Müdürlügü (HSSGM; Turkey General Directorate of Border and Coastal Health)
  • - Türkiye İlaç Sanayi Derneği (TiSD; Pharmaceutical Industry Association of Turkey)
  • - Türkiye İlaç ve Tibbi Cihaz Kurumu (TITCK; Turkey Pharmaceuticals and Medical Devices Agency)
  • - Türkiye İstatistik Kurumu (TÜIK; Turkish Statistical Institute)
  • - Türkiye Kamu Hastaneleri Kurumu (TKHK; Public Hospitals Authority of Turkey)
  • - U.S. Trade Representative (USTR)
  • - United Nations Population Division
  • - World Bank
  • - World Trade Organization
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