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Article History

Accepted: 7 October 2024

First Online: 21 November 2024

Declarations

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: Open access funding provided by Copenhagen University. The research leading to these results was conducted as part of the activities of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network, which is a public academic partnership coordinated by the Utrecht University, The Netherlands. The project has received support from the European Medicines Agency under the Framework service contract nr EMA/2020/46/TDA/L4.02. This document expresses the opinion of the authors of the paper, and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

: FD; AB; CK; HG; ABA; AA; AMS; IRV; PB; AP; IR; RG; FA; TLA declare no competing interests. MM is employed by Copenhagen Centre for Regulatory Sciences (CORS). CORS is a cross-faculty university anchored institution involving various public (Danish Medicines Agency, Copenhagen University) and private (Novo Nordisk, Lundbeck, Ferring Pharmaceuticals, LEO Pharma) stakeholders as well as patient organisations (Rare Diseases Denmark). The Centre is purely devoted to the scientific aspects of the regulatory field and with a patient-oriented focus and the research is not company-specific product or directly company related. In the past 7 years, CORS has received funding from Novo Nordisk, Lundbeck, Ferring Pharmaceuticals and LEO Pharma for projects not related to this study. MK has research contracts with Krka, Vizera, Clinres and Pharmalinea with the aim of statistical analysis and a grant from AstraZeneca as support to developments of sustainability and resilience of the Slovenian healthcare system after the COVID-19 pandemic. AK has research contracts with Krka with the aim of statistical analysis.

: The study has been approved for ethics by relevant review boards in the EU, namely the Ethics Committee of the Faculty of Medicine of the University of Porto, Portugal (rapport no. 92/CEFMUP/2023); the Research Ethics Committee, Greece (no. 11328/51,21/10/2022.); Institutional Review Board, Faculty of Pharmacy, University of Ljubljana, Slovenia (UL FFA EMA IMPACT 20.10.2022). Ethics approval was not required for this study in Denmark (as per The Danish National Center For Ethics, see ), the Netherlands (as per the Central Committee on Research Involving Human Subjects, see ), and Latvia (as per the Latvian Association of Sociology, see ).

: All interviewees received due information about the research project and submitted written informed consent forms about participation and citation prior to interviews. Processing of personal data complied with the EU General Data Protection Regulation.

: All interviewees received due information about the research project and submitted written informed consent forms about publication and citation prior to interviews. Processing of personal data complied with the EU General Data Protection Regulation.

: Data on organisations and clinical practice guidelines are available upon reasonable request. Please contact Helga Gardarsdottir (H.Gardarsdottir@uu.nl). Interview transcripts are not available.

: Not applicable.

: The conceptualisation of the work was carried out by MM, HG, and ABA. The methodology was developed by MM, IRV, AMS, PB, HG, RG, EP, IR, AB, CK, FD, TLA, FA, and MK. Formal analysis and investigation were conducted by MM, AA, AK, IRV, AMS, PB, HG, RG, EP, IR, AB, CK, FD, and MK. The original draft preparation was done solely by MM. Writing review and editing were performed by MM, AA, AK, IRV, AMS, PB, HG, RG, EP, IR, AB, CK, FD, TLA, FA, and MK. Funding acquisition was managed by MM, HG, and TLA while supervision of the project was overseen by MM and HG. Project administration was handled by HG with visualisations created by RG. All authors have read and approved the final manuscript.