Questionable Approach of Turkish IP Courts in Assessing Bolar Exemption
Article 85(3) (c) of the Industrial Property Law excludes marketing authorisation applications from the scope of patent rights. However, the IP courts’ interpretation of this has been disproportionately weighted against patent holders. Generic pharmaceutical companies can obtain a marketing authorisation by carrying out a number of procedures before the Ministry of Health. As a result, entities that apply for a marketing authorisation seven to eight months before the… »
Key Developments and Predictions for Life Sciences in Turkey
With Turkey having a population of 80 million that is covered by an extensive social healthcare system, the size and volume of the Turkish life sciences industry is significant. Despite many opportunities that accompany this potential for growth, it should also be noted that both the Turkish pharmaceutical and medical device industries remain heavily regulated in all aspects, ranging from market access, to pricing and reimbursement being covered by industry-specific… »
Pricing of Pharmaceuticals and the Fixed Exchange Rate
Healthcare and pharmaceuticals make up a highly regulated industry sector in Turkey, and the pricing of medicines is no exception. The prices of medicines that are to be marketed in Turkey are set in accordance with the Decision on Pricing of Human Medicinal Products (“Decision”) and the Communiqué on the Pricing of Human Medicinal Products (“Communiqué”) of 29 September 2017, issued by the Ministry of Health (“MoH”) who is vested with the competencies to regulate the… »
Market Access-Reimbursement Agreements
Until recently, there was no direct contractual relationship between the SSI and the pharmaceutical companies (“pharma companies”) regarding the pharmaceuticals purchased by the State. The pharma companies applied for the reimbursement of their products to the SSI and, once listed, companies sold their products to warehouses, which then distributed the products to the hospitals and pharmacies. In line with this sale and distribution chain, the SSI reimbursed the hospitals, or… »
Localisation of Previously Imported Products
In Turkey, the innovator pharmaceutical market is dominated by originator companies of foreign origin, with local companies active in the generics market. The government’s unease with the emphasis on imported products in the Turkish market beckoned the state development plan to procure local production in the pharmaceutical market, a political act affecting the activities of many pharmaceutical companies of foreign origin. The aforementioned state development plan triggered… »
Named Patient Programs
Named Patient Programs (“NPP”) is one of the exceptional importation regimes of pharmaceutical products without marketing authorisation (“MA”) in Turkey, or with marketing authorization, but which are unavailable in the Turkish market for various reasons. Only the Turkish Pharmacists’ Association (“TEB”) and the İbn-i Sina Health Social Security Center, established under the SSI, were authorized to import NPP products until December 2018. An amendment in the law was… »