The 2017 Commission Report on the Paediatric Regulation

Commission report on orphan medicinal products

The 2006 Paediatric Regulation aims to address a gap in knowledge on how medicine should best be used by children. At the time of adoption of the Regulation, many products administered to children were still prescribed by doctors based on experience (off-label) rather than on the results of targeted paediatric clinical research. The Regulation intends to reduce the level of off-label use and increase the number of medicines specifically developed and tested for children.

In 2013, the Commission published a first report on the Paediatric Regulation and while it revealed some promising signs of progress, it found that, due to the length of medicinal products' development, it would take at least 10 years to gain a full understanding of the situation.

Under Article 50(3) of the Regulation, the Commission’s second report is due in 2017. It should assess the Regulation's impact on public health and businesses and is to be presented to the European Parliament and the Council, as the two legislative bodies that adopted the Paediatric Regulation in 2006. It is aimed at informing EU decision-makers about the experience with the Regulation.

Targeted stakeholder consultation on the experience acquired with the Paediatric Regulation

Targeted stakeholders

All stakeholders involved in the development, manufacture and/or commercialisation of paediatric medicines, as well as paediatric patient/parent groups, healthcare professionals and academia.

Period of consultation

From 15 November 2016 to 20 February 2017.

Objective of the consultation

The purpose of this consultation paper is to support the Commission in drafting its second report and to gather stakeholder views and feedback.

How to submit your contribution

Stakeholders are invited to comment on this consultation by 20 February 2017 at the latest. Responses should preferably be sent to sante-pharmaceuticals-B5@ec.europa.eu.

They can also be sent by post to Directorate-General for Health and Food Safety, Unit SANTE B/5, BE-1049 Brussels. The subject line of the letter or email should contain the reference "PCPM/16 — Paediatric Report".

When submitting your response, please include your name and e-mail address and specify if you are responding as an individual or as a representative of an organisation. If you represent an organisation, please indicate its name and category (company/business; public authority (local, regional, national, international); NGO; patient organisation; other).

If you represent a company, please state whether it falls within the EU definition of a small and medium-sized enterprise (i.e. less than €50 million annual turnover and fewer than 250 employees).

If your organisation is registered in the Transparency Register, please indicate your Register ID number at the beginning of your contribution.

You may choose to use the following template for preparing your response: Word version.

The consultation document

The consultation document can be downloaded here.

Reference documents

Before answering to the public consultation, we invite you to take a look at the following background documents:

The Paediatric Regulation Search for available translations of the preceding link (EC) No 1901/2006;
The 2013 Progress Report Search for available translations of the preceding link of the European Commission;
10-year Report to the European Commission - General report on the experience acquired as a result of the application of the Paediatric Regulation as prepared by the European Medicines Agency and its Paediatric Committee and its annex.

Contact details

Responsible service: Directorate-General for Health and Food Safety - Unit B5 - Medicines: policy, authorisation and monitoring.

E-mail: Sante-Pharmaceuticals-B5@ec.europa.eu.

Any queries about the public consultation should be sent to this mailbox.

Contributions to and results of the consultation

Received contributions will be published on this webpage, unless respondents choose an anonymised publication of their responses or do not authorise any publication of their responses.

In the interests of transparency, all stakeholders other than citizens and public authorities are invited to provide the public with relevant information about themselves by registering in Transparency Register and subscribing to its Code of Conduct. If the stakeholder is not registered, the submission is published separately from the registered organisations.

The results of the public consultation will be evaluated and an overview will be made available on this page.

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Specific privacy statement

Contributions will be published on the Internet. It is important to read the specific privacy statement attached to this consultation for information on how your personal data and contribution will be dealt with.