London Partner Andrew Shindler authored an article for Pharmaphorum examining the effects of the Brexit trade deal on the pharma sector in the United Kingdom and the European Union. The EU-UK Trade and Cooperation Agreement (TCA) does not include comprehensive provisions for regulated industries, such as pharma, creating regulatory complications for businesses in these sectors, he writes.
“The sizeable gap in the TCA is the EU and UK’s failure to agree on mutual recognition of conformity assessments, approval bodies, product markings or labelling, other than the very limited provisions on good manufacturing practice (GMP),” Shindler explains. “Without it, medicinal products and medical devices must be shown to meet the requirements of both separate markets, if they are to be sold there. Pharmaceutical, biotech and medical device companies must therefore now comply with two distinct regulatory regimes, which may diverge increasingly over time, to market their products in both the UK and the EU.”
“For the pharma and device sector, the TCA is a mixed blessing,” he adds. “While its general rule allowing products across the border without tax, duty or quota is of huge importance, the glaring omission of mutual recognition considerably weakens that benefit.”
Sign up for our newsletter and get the latest to your inbox.