BIA Urges Adoption of Science-Based Approach to Gene Editing and GMO Regulations

In a March 18, 2021 press release, the BioIndustry Association (BIA) has released comments urging the UK government to take a science-based approach to the regulatory framework for gene editing and genetically modified organisms (GMOs).

The BIA’s comments have been submitted to the Department for Environment, Food and Rural Affairs (Defra), which is undergoing consultation on the regulation of genetic technologies. A judgement by the Court of Justice of the European Union (CJEU) on regulating gene edited products as GMOs has been a key focus for the consultation, from which BIA has advised the government to diverge.

Additionally, BIA has also requested that the government put in place an exemption scheme for medicines containing or consisting of GMOs that are undergoing clinical trials. By approaching the regulation of gene editing and GMOs in a more innovation-friendly way, BIA reports that the United Kingdom would remain a globally competitive location for clinical development and patients would gain rapid access to potentially curative medicines.

“Gene editing and GMOs have enormous potential to help us tackle health and environmental problems. Defra’s consultation on the regulation of genetic technologies is a clear opportunity to ensure the UK is at the forefront of these technologies and upholds its position as an attractive destination for foreign investment and top global talent to conduct their research,” said Steve Bates OBE, CEO of BIA, in the press release. “Given the CJEU’s judgment to regulate gene edited products as GMOs, it should be noted that the wider GMO regulations on the UK’s statute are burdensome and ineffective. Without addressing the underlying problems of these regulations, the UK will not be able to reap the benefits of gene editing and GMOs, whether in healthcare or tackling climate change. By adopting a science-based regulatory system which regulates the product instead of the process and has the confidence of the public, the UK would enable more start-ups to be created from our excellent science base, attract global investment, help deliver on the government’s levelling up agenda and ambition to make the UK a global life sciences cluster.”

Source: BIA