News

HDA UK Media and Political Bulletin – 16 September 2021

Media Coverage

Brexit: EU medicine supply plans for Northern Ireland ‘unworkable’
BBC News, John Campbell, 15 September 2021

BBC News reports on a statement by the British Generic Manufactures Association (BGMA) regarding the Northern Ireland protocol and its subsequent impact on medicines supply to the region.

Specifically, the BGMA takes issue with the requirement that medicines entering Northern Ireland would be subject to separate regulatory standards than those supplied to Great Britain.

In its statement responding to the European Commission’s July non-paper, the BGMA said: “The proposed EU solution fails to recognise the added complexity its additional measures would bring… The alternatives – a UK-wide licence for medicines – would serve Northern Irish patients best.”

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Brexit: EU medicine supply plans for Northern Ireland ‘unworkable’
BBC News, John Campbell, 15 September 2021 

A pharmaceutical trade association has warned that EU proposals for guaranteeing the supply of medicines to Northern Ireland are “unworkable”.

The Northern Ireland Protocol means Northern Ireland remains in the EU’s pharmaceutical regulatory system.

The EU is preparing to change some of its laws to help maintain GB-to-Northern Ireland medicines exports.

But the British Generic Manufacturers Association believes the EU’s plan is misconceived.

There is currently no risk to supplies as movement of medicines from Great Britain to Northern Ireland is covered by a grace period.

Last week that grace period was indefinitely extended by the UK government.

The issue concerns the strict regulatory and quality control requirements for batch testing and labelling of medicines.

Under the terms of the protocol, medicines would need to be batch tested in Northern Ireland or the EU, which would need duplicate warehousing, laboratory testing and technical specialists.

This would increase costs and complexity so, in response, some Great Britain distributors have said they intend to stop selling some products in Northern Ireland.

Northern Ireland’s Department of Health has said it had been notified that 910 medicines were due to be withdrawn with a further 2,400 at risk.

In response, the EU has proposed that the batch testing of medicines due to be shipped to Northern Ireland could continue to happen in Great Britain, with certain safeguards.

Those safeguards include separate licences for Northern Ireland and placing Northern Ireland-specific labels on packs.

But the BGMA said the problem remained the separate regulatory treatment of Northern Ireland medicines.

“The EU’s proposal would make trade in medicines, and supplying Northern Ireland, even harder since it hammers home the need for a separate and specialised Northern Ireland product (distinct from a GB one),” it said.

“The proposed EU solution fails to recognise the added complexity its additional measures would bring.

“In an environment where margins are razor-thin, extra complexity isn’t feasible. The alternatives – a UK-wide licence for medicines – would serve Northern Irish patients best.”

Overall the EU has proposed “a set of measures that we believe are unworkable”, it said.

Last week, European Commission Vice President Maros Sefcovic said he would do “whatever it takes” to guarantee the supply of medicines.

The UK government has proposed that medicines should be entirely removed from the scope of the protocol.

HDA UK Media and Political Bulletin –  16 September 2021

From Factory to Pharmacy

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