Die Rolle des Bereichs Heilmittel des Bundesamtes für Wirtschaftliche Landesversorgung in der Schweiz
Ausland
Abstract
Securing the Drug Supply in Switzerland during Shortages / The Role of the Medicinal Products Unit of the Federal Office for National Economic Supply
As early as 2002, strategic stocks were used to compensate for a shortage of antibiotics. Over the last years this problem aggravated. A larger number of vital medicinal products have not been available on the Swiss market for up to several months. In 2009 and 2012 strategic stocks were released to compensate for these drug shortages. Reasons for such shortages of essential medicinal products are manifold. Dependence on very few providers and long-term production planning tightened the response times of manufacturers; financial savings resulted in diminished stockpiling along the whole supply chain. The overall reduced reaction capacity resulted in increasing numbers of (global) drug shortages. The Federal Office of National Economic Supply (FONES) has the legal power to intervene in the free market, whenever the (private) industry is no longer able to cope with a deteriorating supply situation. On this legal basis, essential medicinal products are subject to compulsory stockholdings. The importer/manufacturer is legally obliged to maintain a defined stock volume of the respective medicinal product. The permission to release these stocks is restricted to the Federal Department of Economic Affairs, Education and Research in case of a severe national shortage. In addition, FONES is authorized to demand from the industry any information necessary to monitor the specific product provision. So far, permanent market monitoring has been limited to scarce goods and the period of the supply disruption. A more extensive market observation of the goods at risk or affected by supply disruptions should facilitate a better understanding of shortage mechanisms in order to enable early intervention with appropriate measures.
Prof. Stefan Mühlebach studierte Pharmazie in Bern, wo er auch promovierte und habilitierte. Seit 2000 lehrt er nebenamtlich an der Uni Basel als Professor für Pharmakologie und Spitalpharmazie. Von 1980 bis 2005 leitete er die Spitalapotheke in Biel und dann in Aarau. Er war maßgeblich an der Einführung der Weiterbildung FPH „Spitalpharmazie“ in der Schweiz beteiligt. Von 2005 bis 2007 leitete er beim Schweizerischen Heilmittelinstitut Swissmedic die Pharmakopöe und die schweizerische |