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Article History

Accepted: 17 March 2021

First Online: 8 April 2021

Declarations

:

: LCD was funded by a PhD fellowship grant to the University of Copenhagen from LEO Pharma A/S. LEO Pharma A/S was aware of, but had no decisive role in, the design or conduct of the study, collection, management, analysis, or interpretation of data, or the decision to submit the manuscript for publication. TM’s work is supported by the Collaborative Research Program for Biomedical Innovation Law, a scientifically independent research program supported by the Novo Nordisk Foundation (Grant NNF17SA0027784).

: LCD was funded by a PhD fellowship grant to the University of Copenhagen from LEO Pharma A/S. LEO Pharma A/S was aware of, but had no decisive role in, the design or conduct of the study, collection, management, analysis, or interpretation of data, or the decision to submit the manuscript for publication. At the time of the study, MLDB was an employee of the Copenhagen Centre for Regulatory Sciences (CORS). CORS is a cross-faculty university anchored institution involving various public (Danish Medicines Agency, Copenhagen University) and private stakeholders (Novo Nordisk, Lundbeck, Ferring Pharmaceuticals, LEO Pharma) as well as patient organizations (Rare Diseases Denmark). The center is devoted to the scientific aspects of the regulatory field with a patient-oriented focus; its research is not company or product-specific; and it has received funding from LEO Pharma A/S for this project, as well as from Novo Nordisk, Ferring Pharmaceuticals, and Lundbeck for other projects not related to this study. Currently, MLDB is employed by Utrecht University as a senior researcher conducting research under the umbrella of the Center for Pharmaceutical Policy and Regulation. This center receives no direct funding or donations from private parties, including those in the pharmaceutical industry. Research funding from public–private partnerships, e.g., IMI, The Escher Project (), is accepted under the condition that no company-specific product or company related study is conducted. The center has received unrestricted research funding from public sources, e.g., World Health Organization (WHO), Netherlands Organization for Health Research and Development (ZonMW), the Dutch National Health Care Institute (ZIN), EC Horizon 2020, the Dutch Medicines Evaluation Board (MEB), and the Dutch Ministry of Health. TM’s work is supported by the Collaborative Research Program for Biomedical Innovation Law, a scientifically independent research program supported by the Novo Nordisk Foundation (Grant NNF17SA0027784). TM is a scientifically independent IP Advisory Board Member of the Danish Life Science Company Chr. Hansen A/S. The company had no role in the design or conduct of the study, collection, management, analysis, or interpretation of data; or the decision to submit the manuscript for publication. SKS, MvdW, HH, and ABA declare that they have no conflict of interest.

: No ethics approval was required according to Danish law (<i>Act on Research Ethics Review of Health Research Projects</i>, 2011, ); however, ethical considerations were met. All participants are anonymous, and all material is stored confidentially. All data collection and processing were carried out in compliance with the <i>European General Data Protection Regulation</i> (GDPR). The Faculty of Health and Medical Sciences at the University of Copenhagen approved the processing of personal data in the study (journal no.: SUND-2018-09).

: All participants included in the study provided written informed consent.

: Not applicable.

: All authors contributed to the study conception and design. Material preparation and data collection were performed by LCD. Analyses were performed by LCD, SKS and ABA. The first draft of the manuscript was written by LCD, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.