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British batch testing policy to help pharmaceuticals avoid duplication

Multinational pharmaceutical companies will welcome confirmation of UK government policy on batch testing of medicines in Britain, which seeks to limit duplicate testing requirements and the associated costs involved, an expert has said.

Catherine Drew of Pinsent Masons was commenting after the government made permanent arrangements that have applied since Brexit, which enable pharmaceutical companies to import medicines to the UK from countries within the EU and wider European Economic Area (EEA) without having to engage in British batch testing or obtain certification from a UK ‘qualified person’.

The UK government maintains a list of approved countries for import, which covers certain countries that the UK does not have a mutual recognition agreement with on batch testing. EU and EEA countries are, so far, the only countries on the list.

The government said the policy protects patient safety and aligns with the aims of its life sciences vision, which include avoiding adding unnecessary regulation.

Confirmation of the policy came after the government consulted earlier this year on the future strategy for batch testing of medicinal products in Great Britain. In its response paper, the Department of Health and Social Care said 72% of respondents favoured the chosen policy.

Drew said the consultation outcome is beneficial to multinational companies because batch testing is both time and cost intensive and therefore avoiding duplicative testing operations will hopefully prevent unnecessary delays in bringing medicines to the UK market. She said, though, that the solution isn't bilateral as the EU has not adopted the same approach.

“As indicated by the number of respondents to the consultation who supported this option, the approach being adopted is welcomed by industry as a pragmatic solution, avoiding duplication and additional cost,” Drew said.

The government said it intends to make the policy permanent using powers it has to legislate under the Medicines and Medical Devices Act 2021. It said that since the policy is already in operation, there will not be a two-year implementation period to allow industry to prepare.

The government also confirmed that it plans to issue guidance to the pharmaceutical sector on the long-term operation of its approved list, including on how the membership would be reviewed in due course.

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