Suchergebnisse

Background: During the last three decades tremendous progress has been made in the discovery and development of a lot of new molecules in many pharmaceutical areas. These families of real innovative treatment comprise "originator" molecules (first molecule released, which can be under patent or with expired patent), as well a "generic" version of those originator molecules, whose patent has expired. Usually the patent expires 15–20 years after the creation of the originator molecule. Main objective: This research focuses on the effects of the arrival of generic and or therapeutic competitors on the market, in terms of impact on the market share and prices. Methodology: Between 2005 and 2007 we follow three classes of medicinal products in the cardiovascular area: ACE inhibitors, sartans and statins. They have been studied on the Bulgarian market because there is no regulation in the country stimulating the generic market. The official database of the Bulgarian Health Insurance Fund was used to test our two hypotheses concerning the impact of the generics on market share and prices. To test our hypotheses, a t-test analysis, Kolmogorov Smirnov, one and two way ANOVA analyses were performed. Results: Our results confirm that the generic competition, in general, changes the market. These changes decrease the price of the medicines. The generic competition is not regulated in the country and this fact could negatively influence our study because it does not correspond to world trends. Furthermore, our results confirm that the creation of a sustainable generic pharmaceutical market requires active regulatory and marketing measures at all levels including incentives for manufactures, physicians and dispensers.

Aim To analyze the pharmacy network (structure and resources) in Bulgaria, Croatia, Serbia, and Slovenia and its relation to public expenditures for medicines. Methods We performed a cross-sectional study using the officially published data for the period 2003-2008 in four selected countries. Data sources were relevant national institutions. Results In 2008, Serbia had 27.5, Bulgaria 66.8, Croatia 59.5, and Slovenia 71.2 pharmacists per 100000 inhabitants. There was a significant difference in the number of pharmacists per 100000 inhabitants between all countries except between Bulgaria and Slovenia. The number of inhabitants per one pharmacy was significantly different between all observed countries. The expenditures for medicines per capita in 2008 were between (sic)30.34 in Bulgaria to (sic)137.03 in Slovenia, with a significant difference between all countries except between Bulgaria and Serbia. The number of pharmacists per 100000 inhabitants and expenditures for medicines per capita were positively correlated in all observed countries, except in Bulgaria. Conclusion There were significant difference in the structure and availability of the pharmacy service in all selected countries. Expenditures for medicines were positively correlated with the number of pharmacists in all countries, except in Bulgaria. Our findings could be valuable to national regulatory bodies for the creation of national drug policies.

Background: The manufacture of medicinal products for human use in the European Economic Area is governed by European Directives and Regulations stipulating the relevant principles and guidelines of Good Manufacturing Practice, describing the minimum standard to be fulfilled in the production processes. Aim: To present analysis of the deficiencies reported following Good Manufacturing Practice inspections in Bulgaria in two consecutive years (2016, 2017) and to compare them with results from similar inspections reported by other EU member states. Materials and methods: A retrospective study was carried out by reviewing the complete Good Manufacturing Practice inspection reports of all manufacturers conducted by the Bulgarian Drug Agency in 2016 and 2017, according to relevant requirements and applicable local legislation. The items reviewed were scope of inspection, type of companies, classification of deficiencies – 'critical', 'major' and 'other significant deficiencies', their nature and reference to EU Good Manufacturing Practice. Results: The analyzed data included 55 inspections, revealing 460 various deficiencies, of which 2 were critical and 102 – major. Twenty inspections were performed in 2016 vs. 35 inspections in 2017.The pattern of deficiencies was similar to the findings of other EU regulatory agencies, showing that equivalent requirements were applied. Our analysis showed that Bulgarian Drug Agency inspectors rarely raised deficiencies related to Computer Systems, Qualification/Validation, Personnel and Qualification of Suppliers unlike other EU regulators agents. Conclusions: Our analysis of Good Manufacturing Practice inspection findings in 2016 and 2017 showed that the Bulgarian Drug Agency demonstrated its ability to detect non-compliances and take necessary regulatory actions. Quality related issues constitute the main reasons for non-compliances with the requirements.Publishing the results from the inspections performed by the national competent authorities enhances the regulatory transparency that can be useful for industry to improve its Good Manufacturing Practice compliance.