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Facey, Elena Nicod, Entela Xoxi, Sheela Upadhyaya and Anna Zaremba were funded for this research from the European Commission\u2019s Horizon 2020 research and innovation programme for the IMPACT-HTA project (grant number 779312). The results presented here reflect the authors\u2019 views and not the views of the European Commission. The European Commission is not liable for any use of the information communicated. The other authors did not receive funding for this research.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Karen M. Facey, Jaime Espin and Entela Xoxi have received fees from various pharmaceutical companies for speaking and advisory roles, none of which relates to the topics in this paper. Elena Nicod is employed part-time by Dolon Ltd, no conflicts arise with this work. Emma Kent, Ang\u00e8l Link, Elena Nicod<sup>,<\/sup> Aisling O\u2019Leary, Inneke van de Vijver, Anna Zaremba, Tatyana Benisheva, Andrius Vagoras and Sheela Upadhyaya have no conflicts of interest that are directly relevant to the content of this article.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}},{"value":"No ethical approval was required for this study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"Completed templates included consent.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"All authors have provided consent for publication.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"All data are provided in Tables,and, no programming has been undertaken.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of Data and Material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}},{"value":"EX, EN, SU and KF developed the case study template. EN issued invitations to complete the template. KF\/SU contacted marketing authorisation holders to determine which countries might have OBMEAs. All authors completed a template and answered queries from KF. KF amalgamated responses and all authors (except TB and AV) contributed to several discussion meetings about results, clarification of processes and key messages. KF led the writing of the paper and all authors critically reviewed drafts and approved the manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 Contributions"}}]}}