Market entry of innovative medicines in the Republic of Macedonia

To maintain and improve the quality of health care, the market entry of innovations should be stimulated. In the Republic of Macedonia, the existence of multinational innovative companies is difficult due to limited financial means and small market size. Our study aims to analyze the legislation in country and other circumstances that influence the innovative medicines’ market entry. In recent years, the regulation has been modified to facilitate the market entrance for innovative medicines. However, the discontinued legal procedures in the last year and the complicated procedures delay its completion and the inclusion of innovative medicines on the positive list. The inclusion of expensive innovative medicines should be based on scientific evidence on drug efficiency (first- and second-line therapies), pharmacotherapeutic and pharmacoeconomic indicators and health insurance fund’ financial possibilities. The presence of innovative medicines on the Macedonian market and their inclusion on the positive list shall be done according to the experience in the EU and countries in the region with comparative economic systems