An Investigation of the Attractiveness and Feasibility of Introducing Temocillin to the Swedish or Scandinavian Market

Sammanfattning: Antibiotic resistance is a global health concern. Its increasing development is seemingly due to the irresponsible use of antibiotics and their availability. To ensure the correct treatment of patients and avoid unnecessary strain on the individual and society as a whole, it is vital to ensure access to both new and old antibiotics where there is a distinct need. Temocillin is an antibiotic used in the treatment of febrile UTIs. It is currently unavailable in Sweden, although being well-established and proven effective in other European countries. Hence, this report aims to investigate the introduction of temocillin to the Swedish or Scandinavian market in regards to the economic, technical, medical, and regulatory possibilities and barriers. The research is based on literature, internet, and database reviews and empirical data collection through interviews with people of expertise within the fields of antibiotic resistance and concerned aspects. This study emphasizes the great potential of introducing temocillin to Sweden. The evident conclusion drawn is that a production of the antibiotic is not possible in Sweden in the near future. Despite this, an identified supply chain in Europe can enable a role for Sweden as a distribution country. Through a performed break-even analysis, the calculated break-even point and profit margins indicated a low risk of financial loss for a MAH acting as the supplier of temocillin, such as the company Eumedica S.A.. Only 1 % of the Swedish market would have to be covered to break even, and regardless of the estimated volumes of usage upon introduction being either 50 % or 25 % of the total medical need, a profit is likely. In addition, temocillin holds a great medical and social value. However, the obvious obstacle observed is its out-dated documentation. The dossier is of the wrong format, which complicates the regulatory procedure. Thus, this needs to be taken into consideration for an introduction to be possible.