NI Protocol: Medicine supply still 'problematic and inefficient'

An organisation which represents medicines wholesalers says supplying Northern Ireland remains “challenging, problematic and inefficient”.

Martin Sawer, of the Healthcare Distribution Association, gave evidence to a House of Lords Committee examining the impact of the NI Protocol.

Mr Sawer said problems remain despite the EU changing its laws to ease the flow of medicines from GB to NI.

He added that supplies remain “OK” but he has major concerns about the future.

Mr Sawer said the regulatory “tectonic plates” of NI and GB are moving apart and measures to keep them together are “sticking plasters.”

He was echoed by Paul Williams from pharmaceutical manufacturer, Teva UK.

Mr Williams said there were still six outstanding issues to be addressed including requirements around the licensing and packaging of medicines.

Meanwhile, Michelle Riddalls from the Proprietary Association of Great Britain (PAGB), which represents manufactures of over-the-counter, non-prescription medicines, said most of the issues for her sector had been addressed.

However, she also raised an issue around the licensing of medicines.

The post-Brexit deal known as the Northern Ireland Protocol means NI is still inside the EU’s pharmaceutical regulatory system.

It gets most of its medicines from Great Britain, which is not.

This emerged as one of the protocol’s major difficulties, with pharmaceutical firms warning it would lead to withdrawal of products.

The EU accepted it was a problem and in April 2022 changed its laws so that medicines entering Northern Ireland from Great Britain will not need additional labelling or testing, things which would have been required by the protocol in its original form.

However, some drugs companies say the licensing procedure for medicines in Northern Ireland still has problems.

Licensing is a complex area; in the EU there is a role for the European Medicines Agency (EMA) and national regulators.

The protocol means the EMA’s role is effectively to approve innovative drugs for use in Northern Ireland while the MHRA approves things like generic medicines.

However, generics manufacturers effectively need two licences to supply the whole of the UK, one covering GB and one covering NI, which adds additional cost and complexity.