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 was released in 2017. It assessed the Regulation's impact on public health and businesses and was 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
Period of consultation
From 15 November 2016 to 20 February 2017.
Contributions to and results of the consultation
A summary of the responses is available here.
Below are the public responses to the above-mentioned public consultation:
- AGAL (Italy)
- A.G.M.E.N. F.V.G. (Italy)
- aPODD Foundation (UK)
- Bone Cancer Research Trust (UK)
- The Swedish Childhood Cancer Foundation (Sweden)
- Christopher’s Smile (UK)
- Cancer Research UK (UK)
- German Society of Pediatrics and Adolescent Medicine (Germany)
- ESCAP - European Society for Child and Adolescent Psychiatry
- EURORDIS - Rare Diseases Europe
- Fondatioun Kriibskrank Kanner (Luxembourg)
- IKAM - German Initiative “Better Medicines for Children” (Germany)
- Imagine for Margo - Children without cancer (France)
- ITCC - The European Consortium for Innovative Therapies for Children with Cancer
- Grace Kelly Ladybird Trust
- ASSOCIATION LISA FOREVER (France)
- Nuffield Council on Bioethics (UK)
- PRESCRIRE (France)
- SIOPE - The European Society for Paediatric Oncology
- Solving Kids’ Cancer (UK)
- Deťom s rakovinou n.o. (Slovakia)
- Zoé4life (Switzerland)
- BPI - German Pharmaceutical Industry Association (Germany)
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- EUCOPE - European Confederation of Pharmaceutical Entrepreneurs
- Gilead Sciences International Ltd (UK)
- IPFA - International Plasma Fractionation Association
- Medicines for Europe
- Mundipharma Research
- F. Hoffmann-La Roche Ltd
- Therakind Ltd (UK)
- vfa (Germany)
- AEIOP - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA (Italy)
- Associations de parents (France)
- EHC - European Haemophilia Consortium
- Le Manifeste des enfants malades (France)
- Le Défi de Fortunée (France)
- Peter Pan (Italy)
- European Chiropractors Union
- CM-EAP / RITIP / HULP-UCICEC / Hospital Clinico Universitario de Santiago - Clinical Trials Unit / RECLIP (Spain)
- Department of Clinical Pharmacology, Bispebjerg Hospital, University of Copenhagen (Denmark)
- EAHP - European Association of Hospital Pharmacists
- ESDP - European Society for Developmental Perinatal and Paediatric Pharmacology VZW
- German Medical Association (Germany)
- Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom / Royal College of Paediatric and Child Health (UK)
- EnprEMA - European Network of Paediatric Research at the European Medicines Agency
- ESPGHAN - European Society for Paediatric Gastroenterology, Hepatology and Nutrition
- The Institute of Cancer Research, London (UK)
- NIHR Clinical Research Network’s Children’s Specialty Group (UK)
- SAFE-PEDRUG research consortium
- Austrian Medicines & Medical Devices Agency (Austria)
- BfArM (Germany)
- Finnish Medicines Agency (Finland)
- Ministry of Health (France)
- HPAR - Health Products Regulatory Authority (Ireland)
- Dutch government
- Paul-Ehrlich-Institut (Germany)
- UK government
- EUCROF - European CRO Federation (The Netherlands)
- CMWP / EFGCP - Children’s Medicines Working Party / European Forum for Good Clinical Practice
- FIAGOP - Federazione Italiana Associazioni Genitori Oncoematologia Pediatrica (Italy)
- GKV - National Association of Statutory Health Insurance Funds (Germany)
- Klaus Rose (Switzerland)
All stakeholders involved in the development, manufacture and/or commercialisation of paediatric medicines, as well as paediatric patient/parent groups, healthcare professionals and academia.
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.
The consultation document
The consultation document can be downloaded here.
Before answering to the public consultation, we invite you to take a look at the following background documents:
- The Paediatric Regulation (EC) No 1901/2006;
- The 2013 Progress Report 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.
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.