Responses to the public Consultation on the Paediatric Regulation

The results of a public consultation on the experience acquired with the Paediatric Regulation (Regulation (EC) No 1901/2006) in preparation of a Commission report on this legislative instrument have been published. The consultation took place from 19 September to 28 November 2012 and reflects a first impression of the experience made with the new regulation. A more comprehensive report is planned to be published in 2017, which is supposed to include an analysis of the economic impact of the rewards and incentives, an analysis of the Regulation's estimated consequences for public health and proposals for necessary amendments.

Overall, the Commission received 43 responses from different stakeholders. Most of them came from pharmaceutical companies and paediatric networks. Other replies were received from national competent authorities, ministries and agencies, but also clinicians, pharmacists, consultants and other entities, including patient and parent organisations.

Feedback gained during the consultation phase comprised for example cultural changes, remarks on the PUMA concept, possible delays in adult applications, burdens and rewards.

A large majority of respondents agreed that the Paediatric Regulation has paved the way for paediatric development, making it an integral part of overall product development. However some respondents criticised that a lot of administrative burden has been created and that some small companies, especially those established outside the EU, are not yet fully aware of the paediatric requirements in the European Union. Respondents generally agree that the fact that only one paediatric use marketing authorisation (PUMA) has been granted to date is a clear disappointment

Others criticised the Commission's intention not to consider any amendments of the Paediatric Regulation at this point in time.

Other concerns were reflecting the societal paradigm that children should be protected from clinical research, so companies might hesitate testing their products in children.


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