On 25 November 2020, the European Commission published the inception impact assessment on the revision of the Orphan and Paediatric Regulation. EU legislation on medicines for children and rare diseases was introduced in the early 2000’s, to address the lack of medicines in this area. Now, the revision of the Regulations will be open for consultation until 06/01/2021. This initiative will explore the need for adequate measures to address several shortcomings in the functioning of the existing framework detected during a recent evaluation. Annagrazia Altavilla, Chair of TEDDY Network, underlined the importance of this initiative, that demonstrates the effort to meet the needs of paediatric population also when affected by rare diseases: “European policy makers have provided a number of incentives for the development of medicines for orphan diseases as early as 1999 through the Orphan Regulation and created obligations for medicines developers to investigate their products in children through the Paediatric Regulation adopted in 2006. Although these regulations have been successful in meeting their objectives, better integration of regulatory pathways would be helpful in stimulating more global drug development of paediatric orphan medicines, including innovative drug development approaches and the prioritization of unmet medical needs in paediatrics. For this reason, TEDDY Network will be engaged in contributing to this initiative.”
More information on how to participate in the public consultation is available at this link.