Clinical trials for rare diseases will become almost impossible in the UK if the government fails to agree regulatory alignment with the European Union and secure access to European research collaborations, medical charities have warned.
Access to pan-European trials would be “very much impeded” if the UK and EU’s regulation on medicine diverge, according to Jayne Spink, chief executive of the charity Genetic Alliance UK.
“It’s completely impractical to imagine a scenario where a clinical trial for developing a rare disease medicine could be supported entirely by one state,” Spink told the House of Commons Health Committee on 12 December. This is because there are very few eligible patients, a particularity of this field that makes research more difficult.