Elfi De Weerdt1, Steven Simoens2, Luc Hombroeckx3, Minne Casteels4, Isabelle Huys5. 1. KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Herestraat 49, PO Box 521, 3000 Leuven, Belgium. Electronic address: elfi.deweerdt@pharm.kuleuven.be. 2. KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Herestraat 49, PO Box 521, 3000 Leuven, Belgium. Electronic address: steven.simoens@pharm.kuleuven.be. 3. KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Herestraat 49, PO Box 420, 3000 Leuven, Belgium. Electronic address: luc.hombroeckx@pharm.kuleuven.be. 4. KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Herestraat 49, PO Box 521, 3000 Leuven, Belgium. Electronic address: minne.casteels@kuleuven.be. 5. KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Herestraat 49, PO Box 521, 3000 Leuven, Belgium. Electronic address: Isabelle.huys@pharm.kuleuven.be.
Abstract
INTRODUCTION: Different causes of drug shortages can be linked to the pharmaceutical legal framework, such as: parallel trade, quality requirements, economic decisions to suspend or cease production, etc. However until now no in-depth study of the different regulations affecting drug shortages is available. The aim of this paper is to provide an analysis of relevant legal and regulatory measures in the European pharmaceutical framework which influence drug shortages. METHODS: Different European and national legislations governing human medicinal products were analyzed (e.g. Directive 2001/83/EC and Directive 2011/62/EU), supplemented with literature studies. RESULTS: For patented drugs, external price referencing may encompass the largest impact on drug shortages. For generic medicines, internal or external reference pricing, tendering as well as price capping may affect drug shortages. Manufacturing/quality requirements also contribute to drug shortages, since non-compliance leads to recalls. The influence of parallel trade on drug shortages is still rather disputable. CONCLUSION: Price and quality regulations are both important causes of drug shortages or drug unavailability. It can be concluded that there is room for improvement in the pharmaceutical legal framework within the lines drawn by the EU to mitigate drug shortages.
INTRODUCTION: Different causes of drug shortages can be linked to the pharmaceutical legal framework, such as: parallel trade, quality requirements, economic decisions to suspend or cease production, etc. However until now no in-depth study of the different regulations affecting drug shortages is available. The aim of this paper is to provide an analysis of relevant legal and regulatory measures in the European pharmaceutical framework which influence drug shortages. METHODS: Different European and national legislations governing human medicinal products were analyzed (e.g. Directive 2001/83/EC and Directive 2011/62/EU), supplemented with literature studies. RESULTS: For patented drugs, external price referencing may encompass the largest impact on drug shortages. For generic medicines, internal or external reference pricing, tendering as well as price capping may affect drug shortages. Manufacturing/quality requirements also contribute to drug shortages, since non-compliance leads to recalls. The influence of parallel trade on drug shortages is still rather disputable. CONCLUSION: Price and quality regulations are both important causes of drug shortages or drug unavailability. It can be concluded that there is room for improvement in the pharmaceutical legal framework within the lines drawn by the EU to mitigate drug shortages.
Authors: Tomasz Bochenek; Vafa Abilova; Ali Alkan; Bogdan Asanin; Iñigo de Miguel Beriain; Zeljka Besovic; Patricia Vella Bonanno; Anna Bucsics; Michal Davidescu; Elfi De Weerdt; Natasa Duborija-Kovacevic; Jurij Fürst; Mina Gaga; Elma Gailīte; Jolanta Gulbinovič; Emre U Gürpınar; Balázs Hankó; Vincent Hargaden; Tor A Hotvedt; Iris Hoxha; Isabelle Huys; Andras Inotai; Arianit Jakupi; Helena Jenzer; Roberta Joppi; Ott Laius; Marie-Camille Lenormand; Despina Makridaki; Admir Malaj; Kertu Margus; Vanda Marković-Peković; Nenad Miljković; João L de Miranda; Stanislav Primožič; Dragana Rajinac; David G Schwartz; Robin Šebesta; Steven Simoens; Juraj Slaby; Ljiljana Sović-Brkičić; Tomas Tesar; Leonidas Tzimis; Ewa Warmińska; Brian Godman Journal: Front Pharmacol Date: 2018-01-18 Impact factor: 5.810