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 the pharmacies, for the prices of the listed products.
For a long period of time, the industry needed a special type of reimbursement where the conditions could be set, together with the SSI, and the normal price and reimbursement rules did not apply for specific special products.
With the enactment of Law of the Social Security and General Health Insurance Law numbered 6552 in September, 2014, alternative reimbursement models also became a hot topic in the Turkish healthcare industry. The complementary provisions introduced with the Regulation on the Alternative Reimbursement of Pharmaceuticals, published in February, 2016, allows companies and the SSI the benefit of discussing the terms and conditions of an alternative reimbursement model for special products. The system has the ultimate purpose of providing swifter access for patients with respect to innovative pharmaceuticals concerning their reimbursement.
In parallel to the SSI’s amendments, the TITCK has also introduced guidelines for the prioritization of MA applications of special products that have advantages in terms of public health and public finance. A commission established under the TITCK, and composed of members working both under the MoH and the SSI, evaluates companies’ prioritization applications.
Although the regulatory developments in the last few of years are significant, the industry is still expecting the preparation and publication of a guidelines specific to orphan drugs. On the other hand, with the acceptance of the TITCK as an official member to the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the period for a locally manufactured product to access the global market is expected to be shortened.