Rasmus Borup1,2, Janine Morgall Traulsen1, Susanne Kaae3. 1. Section for Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark. 2. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Universiteitsweg 99, 3584CG, Utrecht, The Netherlands. 3. Section for Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, 2100, Copenhagen, Denmark. susanne.kaae@sund.ku.dk.
Abstract
BACKGROUND: Regulatory capture describes the phenomenon in which regulators (e.g. medical agencies) protect the interest of the companies they regulate rather than the interest of the public. Not much is known about the mechanisms of this potential threat within the area of pharmaceutical regulation. OBJECTIVES: Through a comparison of two EU member states, the Netherlands and Denmark, this study aimed to investigate how regulatory capture could exist in pharmaceutical regulation. The EU Falsified Medicines Directive was used as the case, as it provided an opportunity for national medicine agencies to interact with various stakeholders. METHODS: The processes of negotiation and implementation of the directive were mapped by interviewing 23 stakeholder representatives and triangulated with relevant documents. A meaning condensation method was applied to show how stakeholders were involved with authorities, and the theory of regulatory capture was used to interpret how the two countries were susceptible to capture. RESULTS: The Danish Medical Agency was central in all relevant processes, whereas in the Netherlands, the Ministry of Health initiated the processes during the negotiation phase and, subsequently, three medical agencies shared responsibilities in the implementation phase. During the negotiation phase, the Dutch process was more focused on consensus among stakeholders while the Danish process focused on preparing the subsequent implementation. Neither member state prioritised transparency during implementation, but rather focused on timely implementation. CONCLUSIONS: The processes of EU negotiations and implementation of the Falsified Medicines Directive were handled quite differently in Denmark and the Netherlands. It is possible that regulatory capture could be prevalent in both member states as policy makers were only in limited dialogue with patients. EU countries must decide whether this technocratic approach is acceptable, or whether they should make a more concerted effort to include the public.
BACKGROUND: Regulatory capture describes the phenomenon in which regulators (e.g. medical agencies) protect the interest of the companies they regulate rather than the interest of the public. Not much is known about the mechanisms of this potential threat within the area of pharmaceutical regulation. OBJECTIVES: Through a comparison of two EU member states, the Netherlands and Denmark, this study aimed to investigate how regulatory capture could exist in pharmaceutical regulation. The EU Falsified Medicines Directive was used as the case, as it provided an opportunity for national medicine agencies to interact with various stakeholders. METHODS: The processes of negotiation and implementation of the directive were mapped by interviewing 23 stakeholder representatives and triangulated with relevant documents. A meaning condensation method was applied to show how stakeholders were involved with authorities, and the theory of regulatory capture was used to interpret how the two countries were susceptible to capture. RESULTS: The Danish Medical Agency was central in all relevant processes, whereas in the Netherlands, the Ministry of Health initiated the processes during the negotiation phase and, subsequently, three medical agencies shared responsibilities in the implementation phase. During the negotiation phase, the Dutch process was more focused on consensus among stakeholders while the Danish process focused on preparing the subsequent implementation. Neither member state prioritised transparency during implementation, but rather focused on timely implementation. CONCLUSIONS: The processes of EU negotiations and implementation of the Falsified Medicines Directive were handled quite differently in Denmark and the Netherlands. It is possible that regulatory capture could be prevalent in both member states as policy makers were only in limited dialogue with patients. EU countries must decide whether this technocratic approach is acceptable, or whether they should make a more concerted effort to include the public.