The Quality Management System as a Factor for the Competitiveness of the Bulgarian Pharmaceutical Manufacturers

Abstract

Introduction: The regulatory requirements for the quality of medicines and the strong competition in the pharmacy sector necessitate the establishment of effective quality management systems (QMS) that both meet regulatory requirements and contribute to enhancing the competitiveness of pharmaceutical manufacturers. The aim of the study is to investigate the attitudes of the Bulgarian pharmaceutical companies’ senior managers to the QMS as a factor of competitiveness. Materials and methods: An analysis of scientific literature on the competitiveness of pharmaceutical manufacturers in Bulgaria was carried out. Semi-structured interviews were conducted with executives and quality managers between May 2017 and August 2018. An online semi-structured interview with 17 closed-ended questions and 5 open questions was sent to 34 companies, with responses received from 21 respondents. Results: The competitive pressure in the pharmaceutical market in Bulgaria, according to the majority of the senior managers of pharmaceutical manufacturers (76%), is stronger in terms of the price of pharmaceuticals compared to quality, unlike the competitive pressure of the world market where the quality is of prime importance. All respondents have indicated that the QMS can significantly influence competitiveness. According to more than half of the respondents (52%), effective QMS contributes to increasing competitiveness, mainly by reducing the number of defective / rejected products, which is related to lowering total costs. Conclusion: Effective QMS has an impact on various business indicators and its contribution is most significant in ensuring quality of the products and activities; reducing costs and increasing profitability; expanding external markets and introducing innovation. Bulgarian manufacturers have a positive attitude towards the effective functioning of the QMS and use it as a means of adding value.