UK facing 90% raid on key medicine supplies over hated Brexit deal – Frost urged to act

Northern Ireland Protocol will not be renegotiated says Barnier

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According to analysis from Informa Pharma Intelligence, the additional costs of implementing new regulatory procedures could threaten manufacturer’s ability to export low-cost generic drugs to Northern Ireland from within the UK.

The Brexit grace period is set to end at the start of 2022 and pharmaceutical companies have raised concerns due to the lack of a clear political solution.

Ian Schofield, executive editor of Pharma Insights at Informa, said: “The Brexit vote, and the UK’s stance on leaving the single market, forced a separation between the UK’s MHRA and the EMA.

“Whilst the separation itself is a lengthy process that requires a re-evaluation of each detail of the UK’s drug approval processes, the impact of the Northern Ireland protocol remains an ongoing area of tension with potentially significant impacts on the availability of generic drugs to Northern Irish citizens.

“Worryingly, an easy solution to this is not forthcoming even with the deadline fast approaching.”

Any potential shortage of critical drugs would be an additional consequence for Northern Ireland.

Under the terms of the Protocol, agreed as part of the 2019 Brexit withdrawal agreement, chilled meats are banned from being shipped from Britain to Northern Ireland.

When the protocol came into force at the start of this year, a six-month grace period was put in place on the introduction of the ban on chilled meats.

By 2022, companies who wish to export from Britain to Northern Ireland will be required to have established specific batch control and release facilities which meet EU standards.

Mr Schofield told the i: “Adherence to these rules is likely to be expensive, particularly for generics companies with high-volume, low turnover products, as they will need to foot the cost of compliance.

“Some companies say they may have to withdraw up to 90 percent of their medicines from the Northern Ireland market as EMA standards add an extra quality control burden and cost.

“This could threaten the access of these companies to the Northern Ireland market, and more importantly the ability of Northern Irish citizens to purchase generic drugs.”

The Government said the extension of the Brexit grace period would cover the import of medicines into Northern Ireland.

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A spokesman for the Department of Health and Social Care said: “Under the standstill all grace periods which come under the Northern Ireland protocol have been indefinitely extended – including customs, SPS [Sanitary and phytosanitary products] and medicines.

“Though there are different original end dates for the grace periods, the extension applies to all of them.”

However, Mr Schofield lashed out at the Government’s interpretation of the grace period extension.

He said: “This is a different grace period relating to the imposition of customs checks on trade in agrifood products.

“They were supposed to take effect earlier this year but their introduction was deferred in March and then again in June.

“The grace period for pharmaceutical batch testing and release is a separate issue.”

According to the British Generic Manufacturers Association (BGMA), a UK-wide licensing agreement must be agreed between the two sides in order to stop critical shortages of medicines moving between Great Britain and Northern Ireland.

Post-Brexit, Northern Ireland remains as part of the EU’s regulatory system due to the protocol.

Mark Samuels, chief executive of the association, told Express.co.uk up to 2,400 medicines have been put on notice for withdrawal from Northern Ireland due to the new regulatory requirements.

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