<> "The repository administrator has not yet configured an RDF license."^^ . <> . . "Multi-country comparative analysis of paediatric regulatory\r\nframeworks and their impact on access to medicines in times of\r\npandemic and beyond."^^ . "In the field of public health, the importance of access to essential medicines has been a focus\r\nof attention. For children, improving access is even more urgent as the lack of medicines with\r\npaediatric labelling and age-appropriate formulations is a global health problem. The European\r\nUnion and the United States have adopted paediatric regulatory framework more than 15 years\r\nago, that requires and rewards paediatric pharmaceutical research (hereafter referred to as\r\npaediatric legislation). In this way, both regions have been able to stimulate the research and\r\nmarketing authorisation of medicines for children and thus to improve access to age-appropriate\r\ntreatments.\r\nPaediatric legislation becomes an indispensable commodity in times of health crisis. It ensures\r\nthat the medical needs of this vulnerable population are addressed without undue delay. For\r\nexample, vaccines against Coronavirus disease COVID-19 have been rapidly developed for\r\npaediatric use. From 2023, the European pharmaceutical legislation is under review with the\r\naim of further strengthening paediatric research. However, the vast majority of children live\r\noutside of Europe and the United States where the role of regulatory frameworks in access to\r\npaediatric medicines is not well understood.\r\nThis research aimed to examine regulatory frameworks in six countries with different health\r\nand economic status and to develop regulatory recommendations for better access globally.\r\nCountries selected for analysis were Australia, Brazil, Canada, Kenya, Russia, and South\r\nAfrica. The research employed a mixed-method design with qualitative and quantitative\r\nmethods and included three studies each pertaining to a research objective. The analytical\r\nframework from the National Collaborating Centre for Healthy Public Policy in Canada was\r\nused to synthesise and interpret the results obtained.\r\nResults: Authorisation availability of paediatric medicines and formulations in the studied\r\ncountries was lower compared to Europe and the United States. Generic medicines generally\r\ndid not contain age-appropriate formulations even when they were available from the\r\noriginator. Regulatory barriers to access were identified in all countries. These included a lack\r\nof harmonisation of paediatric research requirements, poor availability of medicines with\r\npaediatric use information and formulations. Brazil, Kenya, Russia, and South Africa\r\nadditionally described overarching health system barriers, such as poor financing and supply.\r\nChildren in these countries continue to suffer from the diseases well-saturated with novel\r\ntreatments, which indicates barriers to access at the health system level. The COVID-19 pandemic temporarily reduced regulatory barriers. In middle-income countries, however, the\r\nimpact on access to medicines has been limited due to weak health systems. Medicines\r\ndeveloped under paediatric legislation ranged from common childhood vaccines to highly\r\nspecialised treatments, some of which were later included in the World Health Organisation´s\r\nlists of Essential Medicines. However, the spectrum of addressed diseases was not fully in line\r\nwith the needs, as evidenced by the burden of disease. Among others, medicines for neonatal\r\nand poverty-related diseases were substantially underrepresented. Acceptance of paediatric\r\nlegislation was hampered by concerns about its equity and feasibility.\r\nConclusions: Regulatory frameworks in the studied countries remain unable to support access\r\nto paediatric medicines and formulations in a systematic manner. National marketing\r\nauthorisation is essential for equitable access but in case of paediatric medicines it cannot be\r\nachieved without binding regulatory measures. Overall, the research highlights the need for a\r\nglobally harmonised paediatric regulatory framework that would contain needs-based rewards\r\nand obligations for pharmaceutical companies. While regional legislative efforts are underway,\r\nthey should become global. The impact of regulatory measures may be limited if not combined\r\nwith a robust system to deliver medicines to patients and industry activity in a country.\r\nTherefore, efforts to strengthen the health system and support for the domestic manufacturing\r\nsector remain necessary elements of access to medicines. Finally, continued public health\r\nefforts to reach all Sustainable Development Goals are required to effectively reduce the disease\r\nburden in children, particularly in the low-and middle-income countries."^^ . "2025" . . . . . . . "Anna"^^ . "Volodina"^^ . "Anna Volodina"^^ . . . . . . "Multi-country comparative analysis of paediatric regulatory\r\nframeworks and their impact on access to medicines in times of\r\npandemic and beyond. (PDF)"^^ . . . "Volodina_Anna_28_01_1985_Dissertation.pdf"^^ . . . "Multi-country comparative analysis of paediatric regulatory\r\nframeworks and their impact on access to medicines in times of\r\npandemic and beyond. (Other)"^^ . . . . . . "indexcodes.txt"^^ . . . "Multi-country comparative analysis of paediatric regulatory\r\nframeworks and their impact on access to medicines in times of\r\npandemic and beyond. (Other)"^^ . . . . . . "lightbox.jpg"^^ . . . "Multi-country comparative analysis of paediatric regulatory\r\nframeworks and their impact on access to medicines in times of\r\npandemic and beyond. (Other)"^^ . . . . . . "preview.jpg"^^ . . . "Multi-country comparative analysis of paediatric regulatory\r\nframeworks and their impact on access to medicines in times of\r\npandemic and beyond. (Other)"^^ . . . . . . "medium.jpg"^^ . . . "Multi-country comparative analysis of paediatric regulatory\r\nframeworks and their impact on access to medicines in times of\r\npandemic and beyond. (Other)"^^ . . . . . . "small.jpg"^^ . . "HTML Summary of #36663 \n\nMulti-country comparative analysis of paediatric regulatory \nframeworks and their impact on access to medicines in times of \npandemic and beyond.\n\n" . "text/html" . . . "300 Sozialwissenschaften, Wirtschaft, Recht"@de . "300 Social sciences"@en . . . "610 Medizin"@de . "610 Medical sciences Medicine"@en . .