UK calls time-out on post-Brexit rules opposed by industry


It has been more than four years since the UK left the EU, but the government is still being forced to delay the introduction of border control rules that could have consequences for the life sciences sector. 

Importers of lab reagents and materials used in the manufacture of medicines have been given a six-month extension to make changes to their supply chains to accommodate bureaucracy introduced as a result of Brexit, including border paperwork and checks.

Customs and regulatory checks have been imposed on goods leaving the UK for the EU since the start of 2021, after a one-year post-Brexit transition period, leading to port delays and prompting some British exporters to stop supplying the EU market. The UK delayed checks in the other direction to minimise the impact of leaving the single market and customs union.

Checks on some product categories, such as food and animal products, have now begun, but the Department for Environment, Food & Rural Affairs (Defra) has implemented another extension for products used in life sciences, including animal by-products, according to the BioIndustry Association (BIA).

These products will be treated as low-risk until 31st July 2024 under the new post-Brexit import regime, known as the Border Target Operating Model (BTOM), which came into force on 31st January.

BIA objected strenuously to the BTOM, which came into force on the same day that the new rules were published, giving the industry no time to prepare for the changes, which classify imported products into low, medium, or high risk, with each category requiring different paperwork and notification requirements.

The 31st January deadline introduced health certification checks for medium-risk animal products, plants, plant products, and high-risk food and feed of non-animal origin from the EU.

The trade organisation had argued that navigating the new complexity could have caused severe delays in the UK’s life sciences supply chain, putting a brake on the R&D and manufacturing of medicines and undermining the UK’s much-vaunted ambition to be a superpower in the sector.

“We are pleased the government has listened to our sector’s legitimate and reasonable concerns about the speed at which these new rules were being brought in,” said BIA chief executive Steve Bates.

“It is clear that eight years after the UK voted to leave the EU, the government is still struggling to deal with the myriad complex problems that that momentous decision created,” he added. “If the UK is to continue to stay world-leading in advanced industries like life sciences, we need clear and sensible rules and regulations, and a cooperative approach to be taken by government with both industry and our trading partners.”

However, the BIA is still not happy about the new border rules, which it says are overly strict and not implementable for life sciences products.

“We hope Defra’s new stance is an opportunity for further collaborative work with industry to refine them in the coming months,” said Bates. The BIA will use the derogation period to work with members who import laboratory reagents and medicines manufacturing materials to try to get a more proportionate treatment under the BTOM.