Brexit negotiators have been urged to ‘put patients first’ following warnings children could miss out on lifesaving clinical trials when the UK leaves the EU.
Unless the right deal is reached, the UK may be unable to participate fully in collaborative trials and research activities – including those supporting children and adults with rare and complex diseases.
And it risks losing access to crucial EU infrastructure which implements the legislation authorising and managing clinical trials, posing ‘serious implications’ for patient access to medical research.
The warnings comes in a new briefing produced by the Brexit Health Alliance, which sets out how decision-makers on both sides can mitigate the risks to patient access to medical research.
It references a clinical trial, launched in 2013, which aims to find the best chemotherapy treatment for children and young adults with recurring neuroblastoma, a rare form of cancer which affects around 100 children every year in the UK. More than half of those with aggressive forms of the disease will see it return.
The rarity of recurrent neuroblastoma and the low number of patients means that the trial could not have happened in a single European country.
“This [type of] international collaboration is crucial for us to make progress for patients, specially for children and adults with rare cancers,” the briefing says.
A number of other examples exploring the value of UK-EU cooperation on rare diseases are included in the paper.
The alliance, a coalition of organisations from the NHS, medical research, industry, patients and public health organisations, is calling on negotiators to secure:
- A positive future cooperation model for research and innovation between the UK and the EU, which includes UK involvement in EU-funding programmes. It should also support health research, innovation networks and clinical trials.
- A straightforward and welcoming UK migration system to attract researchers, innovators, and their families.
- Continued UK participation in European Reference Networks for rare and complex diseases, to benefit patients in the whole of Europe.
- Maximum cooperation and harmonisation of frameworks governing regulation of medical research, medicines and medical devices. In particular, a pragmatic solution should be found so the UK can continue to engage with key regulatory bodies and shared infrastructures, including the new EU Clinical Trials Regulation.
“We need to make sure UK and EU patients do not lose out as the UK leaves the EU,” Niall Dickson, co-chair of the Brexit Health Alliance, said on Wednesday, International Rare Diseases Day.
“If patients are to continue to benefit from early access to new and better treatments, health technologies and cutting-edge medicines, we have to be able to take part in multinational research programmes and clinical trials. We have achieved so much through cooperation with European partners and this must continue.
“This can be done if the will is there – what patients need is an agreement which enables maximum cooperation in research and innovation between the EU and the UK, and maximum alignment with the rules regulating medicines and medical devices across Europe.”
‘Time is running out’
But he warned that “time is running out and with little more than 12 months before Britain leaves the EU, we need to settle this uncertainty as soon as possible.
“Let’s put patients first - both the UK Government and European Commission must make reaching an agreement on future research cooperation a priority.”
The publication is the latest in a series of briefings produced by the alliance to support Brexit decision makers on both sides.
Last month, the alliance warned the UK’s departure from the European bloc could wreak havoc with the supply of medicines.
Find out more
Access the Brexit Health Alliance’s new briefing, The impact of Brexit: Patient access to medical research
You can also find out more about the alliance and its members