Comparative analysis of serialization and verification systems between Turkey and Bulgaria – scientific, regulatory, and practical aspects

Background : In 1985, at a WHO Conference on the rational use of medicines in Nairobi, Kenya, the problem of “counterfeit medicines” was raised for the first time at the international level. In 2006, amid the ongoing mass influx of counterfeit medicines into markets in Asia, Africa, and developing countries (for example, alarming data from Nigeria show that up to 75% of the market is occupied by counterfeit medicines), the WHO announced the IMPACT initiative (International Medical Products Anti-Counterfeiting Taskforce) as the main tool and approach for WHO’s work against the problem of counterfeit medicines. Until 2006, the EU considered counterfeit medicines to be a problem in developing countries. It was only in 2007 that the EC initiated legislative changes, finalized in Directive 2011/62/EC and Regulation (EU) 2016/161. The cornerstone of this concept is the implementation of a tracking system for prescription medicines. Meanwhile, many countries are ahead of the EU and are implementing their own tracking, serialization, and verification systems; one of these countries is Turkey. Aim : To conduct a comparative analysis of serialization and verification systems between the Republic of Turkey and the EU (Bulgaria, respectively), taking into account the positive and negative aspects of the implemented regulatory regimes. Materials and methods : Analysis of the content of regulatory documents in Turkey and the EU and a systematic review of scientific publications. Results and discussion : The Turkish system is controlled by the state through the medicine agency, whereas in the EU, the system is created and managed on a non-governmental basis. Turkey’s ITS (İlaç Takip Sistemi) was launched in 2009 and is the world’s first fully functional end-to-end system, covering all stakeholders—manufacturers, wholesale distributors, pharmacies, and hospitals. The EU system started in 2019, based on the principle of end-to-end traceability plus an anti-tampering device; it applies mainly to prescription medicines. There are similarities, but also differences, between the two systems. The Turkish system is entirely centralized, state-controlled, and covers all medicines. The European system has elements of decentralization and operates on a non-governmental basis. However, both systems have an irreplaceable role in controlling the availability and accessibility of medicines on the market. Clearly, the Turkish system has more advantages, whereas the European system needs further improvement.