For a long period of time, the pharmaceuticals industry needed a special model of reimbursement where the reimbursement conditions could be set, together through negotiation with the SSI, and the normal price and reimbursement rules did not apply for innovative 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 an important 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, as well as the SSI, the benefit of discussing the terms and conditions of an alternative reimbursement model for special products. It was expected that alternative reimbursement models, in which the SSI will enter into a direct contractual relationship with pharmaceutical companies, will ultimately allow patients to access innovative pharmaceuticals faster. Today, however, these models also appear to be used to control pharmaceutical prices.
In parallel with the SSI's amendments regarding alternative reimbursement, 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, composed of representatives of the MoH and the SSI, evaluates companies' prioritization applications.
Although these amendments made in the last few years are significant developments, there are still no specific licensing, pricing and reimbursement rules for 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.
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