Turkey: Healthcare System and Drug Regulatory Overview

Introduction

Turkey continues to align its drug regulatory system with that of the EU. However, the country still has some way to go: data exclusivity was only introduced in 2005, with the country remaining on the US Trade Representative watch list. Also of concern to pharmaceutical companies is the drug discounting scheme as well as the reference pricing system, with further price cuts expected in 2011.

Features and benefits

* Assess the key factors facing pharma in terms of healthcare expenditure, regulatory issues, pricing and reimbursement.
* Review the insurance and healthcare system in Turkey including recent health reforms.
* Gain insight into regulatory and intellectual property issues in Turkey.
* Review important pricing and reimbursement issues in Turkey.

Highlights

Turkey’s healthcare system remains highly fragmented, with health policy unevenly distributed and the rural population poorly served. However the reforms have helped reduce infant and maternal mortality and have significantly improved access to and use of healthcare services, particularly in primary care.
Turkey has long overspent on healthcare, spending a total of TRY55.4bn ($36.8bn) in 2010, which contributed to an overall budget deficit of TRY39.6bn ($26.3bn). Consequently, the government has implemented cost-cutting measures in order to cut the deficit, although this will ultimately impact pharmaceutical companies going forward.
Drug discounts in Turkey are having a negative impact on the pharmaceutical industry. Additional drug discounts of 9.5% to SSI was introduced in December 2010, increasing the generic discount from 11% to 20.5% and the discount on brands from 23% to 32.5%, reducing the commercial attractiveness of launching a brand in Turkey.

Your key questions answered

* What have been the main drivers of healthcare expenditure in Turkey?
* How have healthcare reforms in Turkey shaped the efficiency of the public healthcare system?
* What are the key regulatory and intellectual property concerns that may delay the country’s accession to the European Union?
* What impact are drug discounts having on the pharmaceutical industry in Turkey?
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Executive Summary
Turkey – Introduction
Turkey – Strategic scoping and focus
Turkey – Key findings
Healthcare expenditure
Insurance and healthcare system
Regulatory issues
Pricing and reimbursement
Related reports
TURKEY – HEALTHCARE EXPENDITURE
Turkey – Overspending on healthcare will impact pharma
TURKEY – INSURANCE AND HEALTHCARE SYSTEM OVERVIEW
Turkey – The Ministry of Health is the main regulatory body
Turkey – The Health Transformation Program
Turkey – Social security provides universal health coverage
Universal family practice aims to improve access to healthcare
Turkey – Private health insurance accounts for a very small percentage of healthcare coverage
Private health providers have been hit by governmental changes
TURKEY – DRUG APPROVAL AND REGULATORY PROCESSES
Turkey – Pharma regards Turkey’s regulatory environment as complex
Turkey is aligning its regulatory processes with the EU
Turkey – Intellectual property and data exclusivity
Data exclusivity provides limited protection for brands in Turkey
IP and data exclusivity is inadequately enforced
Turkey offers supplementary protection
Turkey – Drug counterfeiting
Turkey is a major source of counterfeit drugs
TURKEY – PRICING AND REIMBURSEMENT
Turkey – Key bodies influencing pricing and reimbursement
Turkey – Pricing issues
Turkey references prices from countries with some of the lowest drug prices in Europe
The latest governmental measures to address budget shortfalls has left pharma feeling vulnerable
Turkey – Reimbursement issues
Reimbursable pharmaceuticals are included on the Budget Implementation Guide
Turkey is attempting to improve its reimbursement system but delays remain
Hospital acquisitions are made through competitive tenders
Physicians can prescribe by brand name
Pharmacoeconomics procedures are not widely used in Turkey
BIBLIOGRAPHY
Turkey – Publications and online articles
APPENDIX
Exchange rates used in this report
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