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Focus on Regulation

Commission opens public consultation on the EU Paediatric Regulation

On 15 November 2016, the European Commission (“the Commission”) opened its second report on Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use, as last amended (“the Paediatric Regulation” or “the Regulation”) for public consultation. The consultation deadline for the draft report is 20 February 2017.


The Paediatric Regulation was adopted in 2007 with the intention of reducing the level of off-label use of medicinal products administered to children and increasing the number of medicinal products specifically developed and tested for children.

In 2013, in accordance with the provisions of Article 50(2) of the Regulation, the European Commission published a first report concerning the general impact of the Paediatric Regulation. Article 50(3) of the Regulation lays down an obligation for the European Commission to publish a second report by 26 January 2017.

The second report is intended to evaluate the impact of the Paediatric Regulation from the perspective of economics and public health. This report is also intended to assess whether amendments should be made to the Regulation. The European Commission has opened its draft for this second report for public consultation to gather stakeholder views and feedback on these two aspects.

The public consultation

The consultation document consists of several statements reflecting on possible lessons learnt from the application of the Paediatric Regulation. These statements are based on:

  • the 10-year report to the European Commission prepared by the European Medicines Agency (“EMA”) and its Paediatric Committee;
  • an external study on the Regulation’s economic impact ordered by the European Commission;
  • the experience of the European Commission’s departments;
  • and reflections on the Paediatric Regulation published in literature and discussed at stakeholder conferences.

The input of interested parties is sought on these statements and, more specifically, on the questions contained in the boxes that follow each statement.

Impacts of the Regulation

For the purpose of obtaining stakeholder views, the European Commission’s draft report on the Paediatric Regulation lists some of the impacts that the Regulation has had on public health and the pharmaceutical industry over the past ten years of its implementation. These include the overall increasing availability of paediatric medicinal products, the reasonable costs for pharmaceuticals companies of developing such medicinal products and the functioning reward systems introduced by the Regulation.

The document discusses the importance of paediatric investigation plans (“PIP”). These are the main tool of the Regulation to ensure that previously unmet therapeutic needs in children are researched and that appropriate medicinal products are developed.

In its consultation document, the European Commission states that between 2007 and 2015, 99 PIPs were completed and over 230 new medicinal products and indications for paediatric populations were authorised. The consultation document also states that, currently, almost 1,000 PIPs have been agreed on by the EMA’s Paediatric Committee.

In addition, the document provides that clinical trials in children that are initiated as part of an agreed PIP represent about 30% of the paediatric trials recorded in the EU Clinical Trials database (“EudraCT”).

The document further includes figures concerning the cost for pharmaceutical companies of compliance with PIPs. To assess these costs, the European Commission has conducted an evaluation of PIPs agreed over the last ten years. The evaluation shows that the total research and development costs per PIP amounts on average to € 18.9 million. The evaluation also shows that each PIP includes an average of three clinical studies. With the addition of administrative costs, the estimated average incurred costs, per PIP, is just below € 20 million in total.

The consultation document also discusses the reward system provided in the Regulation. Rewards may take the form of a 6-month supplementary protection certificate (“SPC”) prolongation or a two-year extension of market exclusivity for orphan-designated products. This reward system enables companies to recuperate the additional costs incurred as a result of the requirements of the Paediatric Regulation. An analysis of the PIPs completed so far shows that 55 % of the completed PIPs benefitted from a reward.

For further information visit: http://ec.europa.eu/health//sites/health/files/files/paediatrics/2016_pc_report_2017/paediatric_consultation_document.pdf