Correspondence: Rossen Kazakov Executive Director, Association of Bulgarian Pharmaceutical Manufacturers 3 Traiko Stanoev Street 1797 Sofia, Bulgaria. Tel: +359 2 9700319; Fax: +359 2 9712086; E-mail: rkazakov@abphm.bg Web: www.abphm.bg

¹has been the Executive Director of the Association of Bulgarian Pharmaceutical Manufacturers (ABPhM) since 2004. In his current position, he is responsible for the operational and strategic development of the association, and relationship management with health institutions and organisations in Bulgaria and the EU. He has been successfully involved in the first and second phasing-in process of pharmaceutical legislation harmonisation in respect to Bulgaria's accession to the EU in effect from 1st January, 2007. He holds MSc in Economics and MA in English and is a chief editor of 'Pharmaceutical Bulletin', the official ABPhM quarterly magazine for health economics, pharmaceutical policy and legislative issues, and has participated as a speaker in major international conferences including Regulatory Challenges in the CEE Pharmaceutical Markets, the Global Generics Strategy Summit, Sales and Marketing in Generics, Global Pricing and Reimbursement Congress among others.

Received 5 December 2006; Revised 5 December 2006; Published online 20 February 2007.

Abstract

This paper aims to provide an informative and analytical view on healthcare policies on pricing and reimbursement in new accession countries, their reflection by the new national drugs legislations, and pricing and reimbursement policies, constraints and opportunities for the EU generic medicines producers. It is driven by the belief that having a greater understanding will help the pricing and reimbursement strategy planning process, and will enhance companies' performance while achieving greater awareness of the influence of the health policy factors in the region. A major stress is put on the process of change and the need for reformation of the healthcare policies on pricing and reimbursement, coming out of the EU enlargement process and legislation harmonisation. A snapshot is given of current pricing and reimbursement models together with a look at the Central and Eastern Europe drugs markets recent figures. Cost containment measures like economic evaluation of drugs, cross-countries price comparisons and parallel trade, and the slide from a branded to unbranded generics market are highlighted as the major factors that generic companies should take into account in the near future.