Turkey. Pharmaceutical Market Risks 2014

Key Issues of Concern:

• Intellectual property protections: Patents and data protection relating to pharmaceuticals have been officially recognized in Turkey since 1995 and 2005, respectively, but there remain significant areas needing regulatory and legislative improvement. Turkey does not provide an effective mechanism for resolving patent disputes before the marketing of follow-on products and concerns remain with the current draft revision to the patent law. Further, Turkey inappropriately ties the regulatory data protection period (RDP) to the patent term and the lack of RDP for combination products is still an unresolved issue. Finally, the combination of an RDP term that starts with first marketing authorization in the European Union and regulatory approvals delays results in a severe restriction on the actual period of RDP provided.
• Delayed regulatory approvals: The period required to complete the regulatory approval process for medicinal products significantly exceeds the 210 days stated in the regulations. 
• Local inspection requirements: Lack of resources and the absence of reasonable transitional procedures at the Ministry of Health (MOH) to conduct Good Manufacturing Practices (GMP) inspections at every pharmaceutical production facility are adding to the significant registration delays, thereby delaying patient access to innovative medicines and negating the benefits of the patent and data protection period.
• Government price controls: The Turkish Government established unrealistic pharmaceutical budgets for 2010-12 by insisting on the budget figures projected in 2009 and not updating the budget to reflect the healthcare system‘s actual needs and economic growth. The outdated budget figures disregarded parameters such as economic growth, inflation and exchange rate fluctuations, and resulted in forced price discounts at unsustainable levels that hinder access to innovative medicines. Moreover, despite the rapidly growing demand for innovative healthcare products and services, Turkey continues to impose unrealistic budget expenditures for pharmaceuticals in 2014, without releasing any of the existing burdens caused by draconian price discounts and exchange rate fluctuations.

Source: PHARMACEUTICAL RESEARCH ANDMANUFACTURERS OF AMERICA(PhRMA)SPECIAL 301 SUBMISSION 2014