ArticlePharmaceutical medicine2019
Regulatory Capture in Pharmaceutical Policy Making: The Case of National Medicine Agencies Related to the EU Falsified Medicines Directive.
Article in Pharmaceutical medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed, 4 citations in OpenAlex.
- Implementing pharmaceutical track-and-trace systems: a realist review.BMJ global health · 2021Article
Corrections and comments
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Authors and funding
3 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRegulatory 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.
objectivesThrough 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.
methodsThe 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.
resultsThe 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.
conclusionsThe 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.
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Registered trials
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