NI Protocol calls over 2000 medicines to risk removal from Northern Ireland

Pharmaceutical

Great Britain currently supplies the majority of Northern Ireland's medicines. However, as of when the NI Protocol moratorium ends in January, the British Generic Manufacturers Association says providing some products will be increasingly problematic and, in some cases, unfeasible.

The NI Protocol intends to protect the EU single market and evade a 'hard border'. This means that while Great Britain remains exempt from the EU pharmaceutical regulatory system, Northern Ireland will still be bound by their laws. According to the EU, this is a 'creative solution' to guarantee the continuous distribution of medicine; however, the UK parliament calls for the removal of medicine from the protocol altogether. It is required to give a six months' notice before a drugs company can elicit the removal of a product. As reported by Cathy Harrison, the removal of each product would be evaluated by officials, and some substitutes may already be present on the market. A Stormont committee was told by Northern Ireland's chief pharmaceutical officer that so far, only a "relatively small" number had been officially reported for withdrawal.

“After months of asking for a stable agreement between the Government and EU, our companies have been forced to put on notice over two-thousand medicines for withdrawal from Northern Ireland“

Mr Samuels insists products with small profit margins, like generic medicines, will face the most risk. "Our industry delivers high volumes of medicines at low prices and with small commercial margins. It thrives on simplicity and efficiency but is now caught in a complicated situation with Northern Ireland - which under the Protocol is treated as part of the EU - requiring different medicines regulation rules to the rest of Great Britain. The result of this duplication would be to require extra warehousing, laboratory testing and technical specialists. This duplication could make supplying Northern Ireland in many cases unviable in the longer term."

A spokesman for the Department of Health said that they are working to "assess the impact of each discontinuation on a case by case basis" to "inform any mitigating actions needed to maintain supplies. These include (but are not limited to) communicating with the primary and secondary healthcare settings detailing any potential shortages or issues with the supply chain and the best alternative products".

The Chief Executive of the British Generic Manufacturers Association, Mark Samuels, said: "After months of asking for a stable agreement between the Government and EU, our companies have been forced to put on notice over two-thousand medicines for withdrawal from Northern Ireland. These steps have been taken with the utmost reluctance, but our members are being forced into an impossible position. We need all parties to set aside the politics of Brexit and put patients first."

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