Regulation of the pharmaceutical market in the Western Balkan countries

Abstract

The goal of the pharmaceutical policy of the governments of the Western Balkan countries was to harmonize the pharmaceutical legislation with the European Union. Drug regulatory mechanisms were introduced, simplifying requirements for drug registration, professional licensing, and pharmaceutical business operations. Ethical standards were reviewed, price controls were established, and drugs were actively included in national health insurance systems. To contain costs, a "positive drug list" with appropriate co-payments was introduced, as well as pooled purchases and open tenders to ensure lower prices. Nevertheless, there are a number of challenges: non-enforcement of rules and standards, limited access to medicinal products for low-income population, ineffective distribution of resources, incomplete distribution of drugs in the pharmacy network, lack of control over prescribing by doctors.