Affiliations: Section of Clinical Pharmacology, Department of Medicine, University Hospital Rebro, Medical School Zagreb, Croatia
Note: [] Address for correspondence: Interna klinika Rebro, Kilpaticeva 12, 10000 Zagreb, Croatia.
Abstract: Awareness of the importance of transparency and accountability in drug legislation is not universal and is of relatively recent origin. It is not surprising that data on the accessibility of information in the drug regulatory systems of the “Central and Eastern European countries” (CEEC) are virtually non-existent. Where drugs are concerned, these countries tend to have a number of characteristics in common, namely 1) the lack of a national drug policy, i.e., a policy which as one of its elements should set out basic principles for the registration of new drugs and the re-assessment of those approved during the earlier period; 2) a serious lack of competent persons in this field, not only in the registration offices but also within the medical and pharmaceutical profession, i.e., experts who might be called upon by the registration office to provide technical advice on decision making; 3) lack of funds, since fees collected from manufacturers in connection with regulatory activities are regarded as taxes and do not accrue to the regulatory body or the Ministry of Health; and 4) non-availability of objective drug information. For such reasons, decisions based upon the systematic and expert assessment of evidence tend to be lacking, and the transparency of the drug regulatory process leaves much to be desired. No short term solution to this situation exists; long term solutions may be found with the assistance of the World Health Organization and various Non-Governmental Organisations; these could in particular improve the level of competence of governmental staff working with drugs, for example through providing seminars, working groups, educational grants and objective information. In such developments the International Society of Drug Bulletins should play an active role.
