News Alert: 4th Draft of Northern Ireland Protocol Focuses on “Uninterrupted Security of Supply of Medicines”

PRICENTRIC BRIEF

• The European Commission has proposed a number of amendments to the Northern Ireland protocol draft, focused on ensuring “uninterrupted security of supply of medicines” from Great Britain to Northern Ireland
• The proposal stipulates that companies in the UK would “keep all their regulatory functions where they are currently located” when supplying the Northern Irish market, ultimately enabling the UK to continue acting as a hub for the supply of generic medicines to Northern Ireland from January 2022 despite being outside the European Union (EU)
• The majority of Northern Ireland’s drugs come from Britain, which ignites the concern that overall access to medicines could be damaged by the protocol once the grace period ends; since the UK left the EU, the trade situation between the UK and Northern Ireland has been contentious, but the Protocol hopes to allay a number of issues that are still prevalent

THE DETAILS

DUBLIN, Ireland — The European Commission has proposed a number of amendments to the Northern Ireland protocol draft, focused on ensuring “uninterrupted security of supply of medicines” from Great Britain to Northern Ireland.

The proposal stipulates that companies in the UK would “keep all their regulatory functions where they are currently located” when supplying the Northern Irish market, ultimately enabling the UK to continue acting as a hub for the supply of generic medicines to Northern Ireland from January 2022 despite being outside the European Union (EU).

The protocol amendment notes that “it appears to be too costly for certain operators currently based in Great Britain to move regulatory compliance functions and related logistics and testing facilities (namely, the marketing authorization holder, quality control [batch] testing, the qualified persons responsible for batch testing and release and for pharmacovigilance) to Northern Ireland or the EU, as well as to comply with the importation requirements, such as the manufacturing import authorisation, as required by the Protocol. As a result, some companies may decide no longer to supply medicines to the Northern Irish market, which might create a public health risk.”

In September, the British Generic Manufacturers Association (BGMA) expressed concerns that the EU’s plans for the supply of medicines to Northern Ireland following the finalization of Brexit are “unworkable.”

The comment came at the same time as the British government indefinitely extended the grace period until Northern Ireland will fall under the EU’s regulations.

According to the group, the EU’s plan 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).”

The majority of Northern Ireland’s drugs come from Britain, which ignites the concern that overall access to medicines could be damaged by the protocol once the grace period ends.

The group has previously warned that more than 2,000 medicines could be withdrawn from Northern Ireland’s market, following the release of the “Northern Ireland Protocol – next steps” report.

Since the UK left the EU, the trade situation between the UK and Northern Ireland has been contentious, but the protocol hopes to allay a number of issues that are still prevalent.

Learn more about Pricentric ONE and our Global Pricing Solutions!