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Pharmaceutical Pricing, Reimbursement, and Market Access in Turkey
Decision Resources, Inc, March 2011, Pages: 23
The Turkish pharmaceutical market is the 6th largest in Europe and the 16th largest in the world and has experienced rapid growth since 2003. 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 recent restrictions on market access for new imported drugs present serious challenges for multinational pharmaceutical companies (MNCs) interested in this emerging market.
Questions answered in this report:
- In 2003, the Turkish government launched the Health Transformation Program (HTP), a ten-year reform strategy intended to reduce inequalities in access to healthcare services by creating a universal health insurance fund. To what extent has the HTP extended access to health insurance for the Turkish population? What additional reforms has the government introduced?
- In December 2009, the Turkish government shocked the international pharmaceutical industry by restricting the launch of new imported drugs. What requirement has been introduced as a condition of marketing authorization? What are the implications for MNCs?
- Like most other emerging markets, Turkey historically offered much weaker intellectual property rights (IPR) than did mature pharmaceutical markets. What measures has the government implemented to improve intellectual property protection? How does the international pharmaceutical industry view the IPR environment in Turkey?
- Turkey has the lowest prescription drug prices of any major European pharmaceutical market. How does the method of setting drug prices in Turkey lead to such low prices? What impact have statutory discounts had on the pharmaceutical industry?
- Depending on the type of drug, the reimbursement decision-making process can have between one and four stages. What are the procedures for securing reimbursement in Turkey? What data are required in manufacturers’ submissions? How does the government apply internal reference pricing to drugs on the positive list?
Scope of the report:
- Socioeconomic and demographic background: projections of total population, senior population, and life expectancy at birth to 2030; key economic indicators; investment in healthcare.
- Organization and funding of the healthcare system: healthcare provision prior to 2003; key objectives and reforms of the Health Transformation Program; coverage of the General Health Insurance Scheme.
- Pharmaceutical regulation: procedure for obtaining marketing authorization for a new drug in Turkey; measures to harmonize Turkish regulatory affairs with practice in the European Union (EU).
- Intellectual property protection: timeline for introduction of patent and data exclusivity protection; industry reservations regarding Turkish intellectual property protection.
- Pharmaceutical pricing: pharmacy and wholesaler margins; use of external reference pricing in setting maximum ex-manufacturer prices; recent increases in statutory discounts imposed on the pharmaceutical industry.
- Admission to reimbursement: bodies involved in reimbursement decision making; reimbursement procedures for various types of drugs; data requirements for manufacturer dossiers; imposition of internal reference prices on covered drugs.
- Cost containment: national pharmaceutical budget and potential penalties for overspending; price cuts; prescribing restriction; patient out-of-pocket payments; use of generics.
- Outlook and implications for the pharmaceutical industry: comparative growth rates of Turkey and other leading emerging markets; recent slowdown in the Turkish market; challenges for multinationals in sustaining recent rapid growth in market share in Turkey; implications for the pharmaceutical industry of Turkish accession to the EU.
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