NPA policy manager Helga Mangion said yesterday (December 20) that the body is “encouraged" by the European Commission's plans to enable medicines to be supplied from Britain to Northern Ireland in the long term.

The Commission could amend its own legislation to facilitate the implementation of the Northern Ireland protocol, it suggested in proposals published last week (December 17).

Among the proposed changes, generic medicines would continue to be authorised under national UK procedures, in compliance with EU rules on medicines – which would enable medicines to continue to be available in Northern Ireland at the same time as in the rest of the UK.

Ms Mangion added: “We have been talking to the government, the Medicines and Healthcare products Regulatory Agency and other stakeholders about these issues for months, highlighting the concerns of our members in Northern Ireland.”

However, the NPA “of course” awaits “the final outcome of the negotiations”, she cautioned.

 

What is the EU proposing?

 

Under the EU’s new proposals, all regulatory functions would remain where they are within the UK. Repeated batch testing would not be necessary if it had already been done in Britain or the EU, the European Commission added.

British companies could continue to use the same pack and leaflet for all parts of the UK, with no need for separate Northern Ireland-specific packaging.

Under the terms of the Northern Ireland protocol, which is part of the Brexit deal, Northern Ireland has remained in the EU’s single market for goods. Since January 2021, the protocol has mandated that Northern Ireland must follow EU medicine regulations.

The new proposals represent a swerve from the current terms of the protocol, which could see manufacturers based in Great Britain needing to relocate infrastructure – including testing facilities – or regulatory functions to Northern Ireland or the EU.

The current Northern Ireland protocol has a grace period in place until December 31, allowing Britain to continue to supply medicines to Northern Ireland “with a pragmatic approach to applying EU rules on importation and unique identifier requirements”.

 

Concerns over “medicine shortages and increased procurement costs”

 

Ms Mangion said: “Earlier this year, the NPA issued an appeal to negotiators to reach an understanding that will allow manufacturers and suppliers to continue to supply medicines as normal.”

The NPA has always been concerned that the “additional costs and complexity of getting medicines into Northern Ireland could result in some manufacturers and suppliers not bringing products to the market”, she added.

The organisation fears this could lead to medicine shortages "and an increase in procurement costs”, she said. “Manufacturers have been informing the government of their intention to withdraw hundreds of medicines from the market in Northern Ireland,” she warned.

 

Proposals are a “lasting solution”

 

European Commission vice-president for interinstitutional relations and foresight, Maroš Šefčovič, said the EU’s “genuine commitment” to ensure the supply of medicines into Northern Ireland was being turned into “a lasting solution” in a statement published on December 17 following the proposals announcement.

He added that the protocol “has the flexibility to work on the ground”.

In October, the European Commission proposed that pharmaceutical companies in Great Britain could “keep all their regulatory functions where they are currently located” when supplying the Northern Irish market.

Following that announcement, NPA chief executive Mark Lyonette told delegates at The Pharmacy Show in Birmingham that the UK “must” maintain the supply of medicines in Northern Ireland or “we’re going to see some pretty horrific consequences”.