May 2013

Turkey: Market Access Tracker - 2013

Report Authors
Neil Grubert, M.A.
Nikhil Mehta, M.Eng.
Lulu Pickering, Ph.D.
Andreia Ribeiro, Ph.D.

Introduction:

Last Updated 31 May 2013
The Turkish pharmaceutical market is the 6th largest in Europe and the 16th largest in the world and experienced rapid growth until 2011. 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, 2011-2014.

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 (2000-2010), healthcare spending by government and private entities (2010); healthcare spending per capita (2000-2010).

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.

Outlook and implications for the pharmaceutical industry: 11 key factors to appreciate when doing business in India.

Exhibits: 25 data-rich tables and figures.

Fill out the form below to contact sales.

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 Müdürlügü (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
Decision Resources Group brands include: