Türkiye's pharma inquiry targets reimbursement discount rules and pharmacy data flows

Türkiye's Competition Authority has taken the preliminary findings of its pharmaceutical sector inquiry to industry and public bodies, after a report that calls for changes to the way the public institutions discount on reimbursed medicines is applied and for limits on the pharmacy data that manufacturers can obtain. The authority hosted a workshop in Ankara on 21 September, opened by its President, Birol Küle, to discuss the findings, according to its announcement of 24 September.

The preliminary report, published on 10 August, examines competition concerns across the pharmaceutical value chain, from research and development and manufacturing to licensing, reimbursement, distribution and delivery to patients, the authority said in an earlier notice. It reviews the effect of patent rights and of licensing and reimbursement processes on market entry, assesses exclusivity practices and the sole authorised distributor model, and looks at competitive procedures in public procurement of medicines.

Procurement, exclusivity and patents

The workshop had three sessions: one presenting the report's findings, one on the future of competition and regulation with representatives of public institutions, and one gathering the views of the private sector and other stakeholders on the balance between competition, investment, innovation and access to medicines, according to the authority. Topics included the relationship between patents and competition, market entry conditions, exclusivity in pharmaceutical distribution, competition in public procurement of medicines, the reimbursement system and the public institutions discount.

The authority's notice said the inquiry had demonstrated the importance of competitive procedures in public procurement of medicines for the effective use of public resources, and discussed possible improvements within the existing legal, administrative and financial framework. Among the workshop's focus areas, the notice listed approaches to a more competitive distribution structure in procurement by public and private hospitals, and responses to the anti-competitive use of regulatory mechanisms.

The discount and the data

One of the report's most specific sets of recommendations concerns the public institutions discount, known in Turkish as KKİ, set under the reimbursement rules of the Social Security Institution (SGK). The preliminary report, published in Turkish, finds that uncertainty over the stage at which the discount is applied, its scope and who pays it is not fully consistent with SGK's powers to set reimbursement procedures under Law No. 5510, and says the gap in the rules must be closed.

The report recommends that the discount apply only to prescriptions reimbursed by SGK and approved through its MEDULA system, and that the financial responsibility rest with the manufacturer or importer that committed to the discount, without being passed down the chain to wholesalers or pharmacies. It proposes that verification be fully automated through an integrated data-sharing link between SGK's MEDULA and the Turkish Medicines and Medical Devices Agency's (TİTCK) drug tracking system, İTS, which it says would remove the need for pharmacies to submit documents and reduce errors, according to the report.

The competition concern is about data. If the discount can be applied after the sale, the report says, only transaction data should be shared, and through public authorities such as SGK or TİTCK or independent third parties, so that pharmacies' competitively sensitive data are not passed directly to suppliers. It also calls on TİTCK to introduce rules preventing the transfer of İTS passwords, GLN numbers and individual sales data to manufacturers, on both data protection and competition grounds, so that such data are used only for the oversight mechanisms of SGK and TİTCK.

The report also describes cases where suppliers apply the discount only partly or not at all to certain medicines. Pharmacies must still invoice SGK at the discounted price, which leaves them either absorbing the difference or charging it to patients without a legal basis, the report says.

What comes next

The authority says the workshop was meant to test the report's findings and policy recommendations against stakeholders' views and contribute to the policy development process, according to the notice. The preliminary report is not a decision and imposes no obligations; its recommendations are addressed to the regulators that run reimbursement, licensing and procurement. The announcements do not give a date for a final report.