Medicine supplies threatened by NI protocol

Pharmaceutical manufacturer Teva has raised concerns that, despite changes made earlier this year by the EU to protect the supply of medicines from Great Britain to Northern Ireland, unresolved issues still threaten the continued provision of some drugs.

In a consultation on the NI Protocol Bill, the firm has identified at least one ‘very significant’ issue surrounding the treatment of Centralised Procedure (CP) product licences.

Teva has advised that to ensure the continued supply of products approved via the CP route in NI, an EU authorization is required, meaning a company requires two different product licences – one to cover GB and another to cover NI.

The firm added that the need for two product licences “creates an administrative and cost burden that will make many medicines unviable to supply to NI.”

The protocol is a post-Brexit trading deal agreed upon by the UK and the EU in 2019.

Under the current legislation, NI is still inside the EU’s pharmaceutical regulatory system while GB is not. However, issues have arisen as NI gets most of its medicines from GB.

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

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

While the move has allowed firms to continue supplying medicines to NI without additional complexities, those requiring CP licences are still under threat.

Teva’s warning has been echoed by the consumer healthcare group PAGB. They have urged for an intervention to ensure medicines licenced via the CP route can be sold in both GB and NI as a single pack, without divergence in the licences behind them.

The UK government is now proposing a dual regime that allows goods made to either EU or UK standards to be sold in Northern Ireland.

However, health think tank, the Nuffield Trust says the dual regime would “create a very complex situation” in which “pharmacists and doctors would be prescribing, and dispensing drugs approved and tested under two different systems, with different mechanisms for detecting falsified medicines.”

Related: Centrally Authorised Products – Key considerations when converting to UK MAs post-Brexit and the impact of the Northern Ireland Protocol