State of children's medicines in the EU
Yesterday, the Commission presented a report to the European Parliament and the Council, on progress made in children's medicines since the Paediatric Regulation came into force 10 years ago.
Yesterday, the Commission presents a report to the European Parliament and the Council, on progress made in children's medicines since the Paediatric Regulation came into force 10 years ago. It concludes that positive advances in the development of medicines for children could not have been achieved without specific EU legislation – e.g. the authorisation of 260 new medicines. The Paediatric Regulation also gives a good return on investment. However, the report acknowledges that more effort is needed to combine the effects of the Paediatric with those of the Orphan medicines Regulation to address shortcomings in treating rare diseases in children.
Commenting on the report, Vytenis Andriukaitis, Commissioner for Health and Food Safety, said: "Whereas I am pleased with the overall progress made in improving children's access to safe, tailored medicines, I am committed to extending these positive gains to children with rare diseases. When we consider the advances in adult oncology, it upsets me deeply that we have not made the same progress in treating the cancers that affect children. In the next 10 years we must focus on making similar breakthroughs for children, by combining the incentives under the Orphans and the Paediatric Regulations, and by ensuring that the European Reference Networks - in particular 'ERN PaedCan' on paediatric cancer, reach full capacity".
- The number of agreed paediatric investigation plans (PIPs) – the first step in developing medicines for children, surpassed 1 000 in 2017. Of these, 131 were completed by the end of 2016.
- There is a clear upward trend in the number of completed PIPs, with over 60 % finalised in the last three years.
- The conditions with the highest number of completed PIPs are immunology/rheumatology (14 %), infectious diseases (14 %), cardiovascular diseases and vaccines (each 10 %).
- Due to the Regulation there has been a significant surge in new treatments for children with rheumatologic diseases, and area where there were very limited therapeutic options before 2007.
- Oncology (childhood cancer) is at the lower end of the agreed paediatric investigation plans, representing only 7% of completed PIPs.
- The report shows that the Regulation works best in areas where the needs of adult and paediatric patients overlap.
- There is also more research into paediatric medicines. The proportion of clinical trials that include children increased by 50 % between 2007 and 2016 from 8.25 % to 12.4 %, leading to more evidence-based information when medicines are used in children.
As an integral part of its assessment of the impact of the Paediatric Regulation, the Commission held a targeted stakeholder consultation which ran from November 2016 to February 2017. Following its adoption, Commissioner Andriukaitis will present the report's findings to people working in regulatory affairs, patients' groups and other stakeholders at a conference in Brussels on 21 November 2017.
This report is an essential intermediate step in the debate on a joint vision about the future parameters for paediatric and orphan medicines. Before proposing any amendments, the Commission will evaluate – in consultation with stakeholders and experts, how the combined effects of the Orphan and Paediatric Regulation can support medicine development in subpopulations of particular need, e.g. children with cancer. Results of this reflection will be presented by 2019 to allow the next Commission to take informed decision about possible policy options.
Follow us on Twitter: @EU_Health
 A Paediatric Investigation Plan (PIP) is a research and development programme that aims to ensure that a new product is tested for its potential use in children and that such tests become an integral part of the overall product development.
Latest News from
President von der Leyen marks the EU's commitment to the Partnership for Global Infrastructure and Investment (PGII) during the event hosted at the G20 in New Delhi12/09/2023 15:25:00
President von der Leyen recently (09 September 2023) spoke at the G20 event on PGII hosted by Prime Minister Modi and President Biden.
Summer 2023 Economic Forecast: Easing growth momentum amid declining inflation and robust labour market12/09/2023 13:25:00
The European Commission yesterday presented the Summer 2023 Economic Forecast
Climate change: Deal on a more ambitious Emissions Trading System (ETS)20/12/2022 10:33:00
On Saturday night, MEPs and EU governments agreed to reform the Emissions Trading System to further reduce industrial emissions and invest more in climate friendly technologies.
EU and Ukraine sign €100 million for the rehabilitation of war-damaged schools *20/12/2022 09:25:00
Exactly three months after President von der Leyen's announcement in her 2022 State of the Union Address, the European Commission and the Government of Ukraine have signed a €100 million support package for the reconstruction and rehabilitation of schooling facilities damaged in Russia's full-scale war of aggression against Ukraine.
NextGenerationEU: European Commission endorses positive preliminary assessment of Portugal's second request for €1.8 billion disbursement under the Recovery and Resilience Facility19/12/2022 16:33:00
The European Commission recently (16 December 2022) endorsed a positive preliminary assessment of Portugal's payment request for €1.8 billion of grants and loans under the Recovery and Resilience Facility (RRF), the key instrument at the heart of NextGenerationEU.
'Fit for 55': Council and Parliament reach provisional deal on EU emissions trading system and the Social Climate Fund19/12/2022 15:25:00
The Council and the European Parliament reached a provisional political agreement on important legislative proposals of the ‘Fit for 55’ package that will further reduce emissions and address their social impacts.
Ukraine: EU agrees ninth package of sanctions against Russia19/12/2022 14:33:00
The Commission welcomes the Council's adoption of a ninth package of hard-hitting sanctions against Russia for its aggression against Ukraine.
Council and European Parliament agree on new safety requirements for machinery products19/12/2022 13:25:00
The Council and the European Parliament negotiators have reached a provisional agreement on the regulation for machinery products. The proposed legislation transforms the 2006 machinery directive into a regulation.