The pharmaceutical industry has long required a unique model for price setting where its conditions could be negotiated with the SSI, exempt from regular price and reimbursement rules given to innovative products.
With the enactment of the Social Security and General Health Insurance Law numbered 6552 in September 2014, alternative reimbursement models became an essential topic in the Turkish healthcare industry. The complementary provisions introduced with the Regulation on the Alternative Reimbursement of Pharmaceuticals, published in February 2016, allow companies and the SSI to benefit from discussing the terms and conditions of an alternative reimbursement model for particular products. It was expected that alternative reimbursement models, in which the SSI would enter a direct contractual relationship with pharmaceutical companies, would ultimately allow patients to access innovative pharmaceuticals faster. Currently, however, these models appear to determine pharmaceutical prices.
In addition, the conclusion of an action filed against specific provisions of the Regulation on the Alternative Reimbursement of Pharmaceuticals, led to the annulment of some articles on grounds of procedural deficiency, as the SSI had issued the regulation without receiving the opinion of the Ministry. Since the entire text was not the subject of the action, only some of the provisions were brought before the court, and the remainder of the Regulation is still in force, including the article of the law that permits alternative reimbursement models.
Following the annulment decision, it was expected that the SSI would update the Regulation on the Alternative Reimbursement of Pharmaceuticals by re-publishing the annulled articles. Instead, the SSI published the new Regulation on the Reimbursement of Pharmaceuticals, including articles that will update the principle of confidentiality of the discount rates applied in these alternative models. The principle of confidentiality implemented with the Alternative Reimbursement Regulation, has been re-introduced with the amendment made in the Pharmaceutical Reimbursement Regulation. However, it is unclear whether the Alternative Reimbursement Commission will be convened or if pharmaceutical companies will make new reimbursement agreements with the SSI for confidential and special discounted prices. It is thought that the upcoming elections will play a role in how the this issue will develop, which is highly critical for the country’s economy and companies.