The impact of Brexit on paediatric care must be followed closely over the next few years – Dr Mark Turner and Sarah Collen explain why.
The health secretary, Jeremy Hunt, recently indicated that it is unlikely that the UK will remain in the European Medicines Agency (EMA) system post-Brexit. This raises a number of question about how the development and approval of new medicines will be regulated in the UK.
Children have benefited from the single regulatory system at EU level. Before the system was developed, very few medicines used by children were tested in children, so doctors were often guessing about which dose to use or whether a medicine was safe. Given recent developments (more on this, below), particular attention should be paid on the impact Brexit could have on the development of new and better medicines for children.
No country is big enough to develop medicines for children in isolation – it’s important to recruit across borders into clinical trials so that studies are sufficiently large to assess the effects of medicines properly.
Historically, variation in standards and legislation have been a major barrier to conducting international trials and research on new medicines for children. However, over the past decade that variation has begun to decline, thanks mainly to a number of EU legislative and policy initiatives, and in particular, the EU Paediatric Regulation.
The 2006 Paediatric Regulation (currently under review) is of particular importance as it aims to ensure high-quality research into the development of medicines for children. Specifically, the regulation ensures that, over time, the majority of medicines used by children are tested and authorised for such use. It has the dual aim of obliging and incentivising industry to conduct paediatric clinical trials.
Although it has come under criticism, it was a welcome step and one which the UK played a strong role in supporting and implementing at EU level. It has certainly contributed to increased research in medicines for children in Europe – since 2006, the percentage of paediatric clinical trials has risen.
In 2006, 8 per cent of all trials registered on the European trials database were due to recruit at least one child. In 2015, 18 per cent of all registered trials planned to recruit at least one child. Over this period the number of children due to be included in registered trials increased from 3,648 to 211,302. This 60-fold (6,000 per cent) increase in the number of children who will contribute to medicines research includes a significant growth in research about children funded by the pharmaceutical industry. It will be necessary to ensure Brexit does not reduce the opportunities for British children to participate in, and benefit from, research about new medicines.
The EU has also played an important role as a source of funding for multinational paediatric studies, particularly European clinical trials on off-patent use of medicines in children. During the 2006-2013 period, 19 pan-European research projects aimed at generating data about off-patent medicines in support of achieving market authorisation received EU funding. All these trials had UK involvement because of access to EU funds. British children will share the benefits of these trials with children in other countries.
More recently, the UK played a pivotal role in setting up a much needed pan-European Paediatric Clinical Trials Infrastructure – a group of hospitals ready to conduct research on a range of medicines.
The Paediatric Clinical Trials Infrastructure is on the roadmap of the European Strategic Forum for Research Infrastructure which lists the most important priorities for support from governments in Europe. The UK government has a strong record of support research infrastructure through the NIHR and the UK is well-placed to be part of pan-European collaboration about children’s medicines.
In addition, the European pharmaceutical industry has committed to supporting a pan-European paediatric trials network through the EU’s Innovative Medicines Initiative (IMI) programme. European pharmaceutical companies will contribute €67m to this, with the European Commission matching the same amount of funding for non-industrial partners. The UK is providing scientific coordination of a strong bid for this funding.
If successful, this network would improve treatment for NHS patients by speeding up access to new medicines. Research that can ask 79 million European children to join studies will identify successful medicines more quickly than research that ask 11 million UK children to join studies.
Beyond Brexit, the priority will be to ensure that the UK continues to have access to these useful collaborations and infrastructure, and that the potential funding gap for international paediatric trials will be met. If UK children are to continue to benefit from sharing the results of research with European children, there must be ways to join European research projects, including funding for researchers in Britain to recruit British children.
Children are a vulnerable group and special attention should be paid to ensure that leaving the EU will not result in any unintended consequences, such as lesser access for British children to European clinical studies, possible delays in accessing new treatments, or reduced collaborative research between the NHS and the best paediatric centres across Europe.
It should not be forgotten that paediatric research results in improvements in child health and healthcare outcomes, and improving the health and wellbeing of children has significant implications for adult health. Paediatric research, therefore, is a key aspect of the sustainability of the NHS.
The impact of Brexit on paediatric care is one to be followed closely over the coming years.
Co-authored by Dr Mark Turner, senior lecturer and consultant in neonatology at the University of Liverpool and Liverpool Women’s Hospital, and Sarah Collen, senior policy manager at the NHS European Office.
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