Importers of laboratory reagents and materials used in the manufacture of medicines in the UK’s life sciences sector have been given a six-month extension to make the necessary changes to their supply chains for new post-Brexit border paperwork and border inspections.
Defra has agreed that intermediate animal by-products, laboratory reagents and derived products for pharmaceutical use, including the manufacture of pharmaceuticals and laboratory reagents, will be treated as low-risk until 31 July 2024 under the new post-Brexit import regime, known as the Border Target Operating Model.
This gives companies a six-month reprieve from the original start date for the new rules of 31 January. The rules themselves were also published on 31 January, leaving no time for companies to prepare for their implementation.
The agreement comes after the BioIndustry Association (BIA) raised the sector’s concerns that the life sciences industry did not have sufficient time to prepare and that some companies have thousands of different products to categorise into low, medium or high risk under the new regime.
Each categorisation requires a different approach to notification and paperwork for importation into the UK. This complexity could have caused severe delays in the UK’s life sciences supply chain, putting at risk the research, development and manufacture of valuable innovative medicines, and undermining the Government’s ambition for the UK to be a life sciences superpower.
Steve Bates OBE, CEO of the BIA, said, “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.
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.
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. Whilst the six-month extension is welcome, the new border rules are still not proportionate or implementable for life science products.
We hope Defra’s new stance is an opportunity for further collaborative work with industry to refine them in the coming months.”
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