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Verfasst von:Volodina, Anna [VerfasserIn]   i
 Jahn, Albrecht [VerfasserIn]   i
 Jahn, Rosa [VerfasserIn]   i
Titel:Suitability of paediatric legislation beyond the USA and Europe
Titelzusatz:a qualitative study on access to paediatric medicines
Verf.angabe:Anna Volodina, Albrecht Jahn, Rosa Jahn
E-Jahr:2024
Jahr:7 February 2024
Umfang:10 S.
Fussnoten:Gesehen am 18.07.2024
Titel Quelle:Enthalten in: BMJ public health
Ort Quelle:[London] : BMJ Publishing Group Ltd, 2017
Jahr Quelle:2024
Band/Heft Quelle:2(2024), 1 vom: Feb., Artikel-ID e000264, Seite 1-10
ISSN Quelle:2753-4294
Abstract:Background Paediatric legislation has contributed to better access to appropriate treatments in the European Union and the USA by requiring paediatric research in return for financial incentives. This study explored whether similar policies could improve access to medicines in other countries.Methods We conducted 46 interviews with representatives from healthcare practice, patient organisations and health authorities from six countries (Australia, Brazil, Canada, Kenya, Russia and South Africa) as well as multinational pharmaceutical companies exploring their views regarding access barriers to paediatric medicines. Emphasis was placed on regulation-related barriers and the effect of the COVID-19 pandemic. Where participants were familiar with paediatric legislation, views regarding its relevance for domestic context were explored in depth.Results Insufficient paediatric research and development, regulatory hurdles and reimbursement constraints were reported to be relevant access barriers in all studied settings. In the absence of marketing registration or reimbursement, access to paediatric medicines was associated with increased legal, financial and informational barriers. Brazil, Kenya, Russia and South Africa additionally described overarching deficiencies in medicines provision systems, particularly in procurement and supply. The COVID-19 pandemic was said to have reduced regulatory hurdles while further heightening global access inequalities.Views regarding paediatric legislation were mixed. Concerns regarding the implementation of such policies focused on regulatory resource constraints, enforceability and potential reduction of industry activity.Conclusions The study findings suggest that paediatric legislation may be most impactful in mature health systems and should be accompanied by measures addressing access barriers beyond marketing registration. This could include strengthening domestic manufacturing capacities and technology transfer for medicines with high public health relevance. Ideally, legislative changes would build on global harmonisation of paediatric legislation, which could be achieved through existing WHO structures.
DOI:doi:10.1136/bmjph-2023-000264
URL:kostenfrei: Volltext: https://doi.org/10.1136/bmjph-2023-000264
 kostenfrei: Volltext: https://bmjpublichealth.bmj.com/content/2/1/e000264
 DOI: https://doi.org/10.1136/bmjph-2023-000264
Datenträger:Online-Ressource
Sprache:eng
K10plus-PPN:1895756413
Verknüpfungen:→ Zeitschrift
 
 
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