Romanian Society of Pharmaceutical Sciences
 

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COMPARATIVE ANALYSIS OF THE TIME TO MARKET ACCESS IN BULGARIA, POLAND AND ROMANIA FOR MEDICINES WITH MARKETING AUTHORISATION UNDER THE EMA’S EARLY ACCESS-SPECIFIC PROCEDURES

MARIA DIMITROVA 1, ADINA TURCU-ȘTIOLICĂ 2*, IVO TSEKOV 1, PAWEL KAWALEC 3, RAFAL NOWAK 3, GUENKA PETROVA 1

1 Medical University of Sofia, Faculty of Pharmacy, Department of Organization and Economy of Pharmacy, 2-Dunav Street, 1000, Sofia, Bulgaria
2 University of Medicine and Pharmacy of Craiova, Faculty of Pharmacy, 2-4 Petru Rareș Street, 200349, Craiova, Romania
3 Institute of Public Health, Jagiellonian University Medical College, Faculty of Health Sciences, Department of Nutrition and Drug Research, Krakow, Poland

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The harmonised European regulatory framework for the marketing authorisation (MA) of medicinal products has been evolving rapidly. The European Medicines Agency (EMA) has played a pivotal role in reducing the timeframe for the authorization of medicinal products, thereby facilitating timely access to medicines and minimizing redundant efforts between MAHs and regulatory authorities across Member States of the European Union (EU). To shorten patients' access to innovative therapies, EMA has established specific adaptations to the centralized MA procedure, including conditional MA, accelerated assessments and MA under exceptional circumstances. However, despite these early access mechanisms, the availability of innovative medicines remains inconsistent and is, in some cases, subject to delays across different EU markets. Notably, the time required for market access to the same medicinal product varies significantly among Member States, with longer delays frequently observed in Central and Eastern European regions compared to other parts of the EU. Bulgaria was found to have the highest availability index among the three assessed countries (0.33), even though the National Health Insurance Fund in Bulgaria began reimbursing medicines only in the year following the negotiation of financial agreements with the MA holder. Decisions regarding the financial and logistical accessibility to medicines continue to be made at the national level, leading to considerable disparities in access to identical medicinal products. These differences are predominantly influenced by variations in national medicines pricing and reimbursement requirements, or by the lack of adequate funding for early-access medicines, which are yet to achieve full alignment across Member States.