Taking Back Control – The Post-Pandemic Landscape for Life Sciences Regulation

Robin Blaney and Sarah Cowlishaw’s commentary was included in a Legal Business article examining the new regulatory landscape in the UK and the EU following the COVID-19 pandemic.

Commenting on the separate regulatory regimes in the UK and the EU as a result of the UK’s exit from the EU, Robin said that “companies are finally waking up to the fact that there is already divergence now, and that divergence is only going to get bigger.”

Sarah describes the UK’s creation of the UK Conformity Assessed (UKCA) marking framework as a “full circle approach” as the UKCA aligns many of its proposals with the EU. She also notes that the UK Medicines and Healthcare products Regulatory Agency (MHRA) is engaged in talks about “not moving to a mandatory UKCA mark for medical devices, but rather continuing to recognize the [European] CE mark.” The EU is being equally collaborative, with Sarah pointing out that the EU “don’t want to stop companies coming to the UK at all – they want to make sure that we still have access to the market.”