The European Commission has launched a public consultation aiming at collecting views of stakeholders with regard to the use of medicinal products for children in Europe. Five years after it entered into force, the Commission aims to evaluate the strength and weaknesses of the legislative framework for paediatric medicinal products.
The Regulation 1901/2006 of the European Parliament and the Council of the 12 December 2006 on medicinal products for paediatric use aims to “facilitate the development and accessibility of medicinal products for use in the paediatric population, to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric populations”.
Rationale underpinning the adoption of the Regulation 1901/2006
The Regulation was seen by the legislator as a response to the absence of sufficient numbers of suitable, authorised medicinal products to treat conditions in children in the European Union. The lack of suitable, authorised medicinal products to treat conditions in children can be explained by the fact that pharmaceutical companies frequently did not carry out the necessary research and development to adapt medicinal products to the needs of the paediatric population. This left healthcare professionals with no alternative but to use off-label products and unauthorised products with the associated risks of inefficacy or adverse reactions.
The impact of the Regulation on medicinal products for paediatric use.
To address this problem the Regulation established a system of requirements, rewards and incentives together with horizontal measures to ensure that medicines were researched, developed and authorised to meet the therapeutic needs of children.
In 2013 the Commission will present to the European Parliament and the Council a general report on experience acquired further to the implementation of the Regulation. This report will include a detailed inventory of all medicinal products authorised for paediatric use since its entry into force.
Launch of a public consultation paving the way to drafting the Interim 5-year report.
In this regard, the Commission launched a public consultation aiming at seeking views and feedback from stakeholders on the first five years of application and paving the way to the draft general report.
The deadline to provide the Commission with an answer is 28 November 2012.
The consultation is available under the following website: http://ec.europa.eu/health/files/paediatrics/2012-09_publicconsultation_en.pdf