Abstract of Dissertation

Keyword : Turkey; Health System; HTP; Universal Health Coverage; Drug Approval; Pricing; Reimbursement, Supply Chain; Generics; Biosimilars; Industry Trends

Objective : 1. To study the existing structure and functioning of the healthcare system 2. To study the system of healthcare financing 3. To understand the drug approval process and pharmaceutical pricing and reimbursement 4. To understand the distribution channels and pharmaceutical industry trends

Background : The project seeks to provide an in-depth understanding of the healthcare and pharmaceutical industry in Turkey, the scale of these markets and the scope for existing or new pharmaceutical companies to enter or expand into these markets to drive commercial value. In order to maximize the impact of any recommendations made to the client, it is essential to develop foundational expertise on the nation’s health system by studying its structure, regulatory stakeholders, financial flows in the health system, drug approval process, pricing and reimbursement regime, data exclusivity laws, drug supply chain and the analyst predictions for trends in the healthcare and pharmaceutical industry. This study explores the above facets of the Turkish healthcare system in detail, drawing upon secondary sources of information such as analyst reports, official reports from the World Bank, UN, WHO and OECD, journal articles and news reports from credible sources.

Methodology : Research Questions 1. What is the structure of the Turkish healthcare delivery and financing system? 2. What is the process of obtaining marketing authorization for a new drug in Turkey? 3. What is the process of drug pricing and reimbursement in Turkey? 4. How is drug procurement carried out in Turkey? 5. What are the key factors that will affect the Turkish health and pharmaceutical industry?

Findings : Turkey has implemented universal health coverage through the merger of four social security funds to form the Social Security Institution (SGK). The MoH is the largest regulator, provider and policymaker. Healthcare expenditure is increasing every year in Turkey, with the SGK being the largest payer. The SGK negotiates service contracts with the MoH, University Hospitals and private institutions on an annual basis. The Turkish Medicines and Medical Devices Agency (TITCK) regulates the pharmaceutical sector. It is responsible for drug approvals, sets drug prices through external price referencing and oversees the drug supply chain in the country. The SGK reimburses drugs after applying statutory discounts. Successive price cuts after 2011 and the frozen EUR-TRL exchange rate since 2009 led to a slump in the Turkish pharmaceutical industry, however, the government is responsive and has recently passed reforms to remedy the situation. Generics and biosimilars are receiving support from the MoH due to their role in reducing the cost of healthcare. The overall outlook for the healthcare and pharmaceutical sector is positive. Foreign investments in R&D and manufacturing are being encouraged through governmental policies that favor locally produced medicines. Public Private Partnership (PPP) has been hugely successful in Turkey and the number of PPPs in healthcare is on the rise.

Recommendations : The study has thrown light on the key stakeholders and regulatory processes followed in Turkey. Key insights have been developed on the drug approval process, pharmaceutical pricing and reimbursement regimes and data exclusivity laws. Information on the drug supply chain was gathered and overall industry trends have been analyzed. A foundational understanding of the Turkish healthcare and pharmaceutical industry has been developed. The study can be leveraged by the organization to provide recommendations to its clients who seek to enter or move to capture the Turkish market.