Every day, children are treated with drugs that have only been approved for adults. This means that there is often little knowledge about effective and safe dosage in children and there is a lack of suitable administration methods. According to current EU figures, more than half of the medicines used for children are not authorised for them. This goes against the right of children to an adequate and safe provision with medicines. More clinical trials in children would be needed to address this deficit. At the same time, research involving children has a particular ethical sensitivity both for the children concerned and for their parents and physicians, especially when it comes to research for the benefit of third parties.
At the end of January 2007, the EU regulation on medicinal products for paediatric use came into force, which requires a paediatric investigation plan for every new medicinal product to be authorised to set out a development programme for use in children. This should lead to a better provision of medicines for children. At the same time, however, there are still reservations about exposing children, who themselves cannot give legally valid consent to their inclusion in research, to the risks of pharmaceutical studies.
The Federal Ministry of Education and Research has proclaimed a Science Year 2011 on health research, with the aim to raise public awareness of the opportunities and prospects but also the associated ethical and socio-political issues of research for our health. As a contribution to the Year of Science, the German Ethics Council aimed to draw attention to the existing situation regarding drug research with children and invited the public to an evening event in the “Bioethics Forum” series. Discussions focused on the following aspects:
- Is the use of medicines outside the approved areas of application (off-label use) in children ethically justifiable?
- Is pharmaceutical research with children ethically justifiable or even necessary in view of the current supply situation?
- What are the risks of pharmaceutical research involving children?
- Is it acceptable to expose a sick child to the risks of a medical study for the future benefit of the affected patient group?
- Do we need more information about paediatric studies and do we need better care?
Following introductory presentations on the latest amendments to pharmaceutical legislation, their implementation in practice and ethically relevant considerations, the above questions were discussed on the podium and in dialogue with the audience. The German Ethics Council aims to raise public awareness of the topic “pharmaceutical research with children” and to contribute to the education of affected parents.