Mark Samuels, Chief Executive of the British Generic Manufacturers Association (BGMA), said: “We welcome the Government’s attempt to find a solution to medicines supply for Northern Ireland – however the situation is dragging on to long. We need both sides to agree a resolution for Northern Ireland immediately. Over many months, we have been vocal about the need for companies to know the regulatory rules for which they need to plan. Without an agreement between the Government and the EU, uncertainty prevents manufacturers from planning. The manufacturing, quality control and supply chain for medicines are highly complex – they cannot be reengineered overnight. Four out of five drugs used by the NHS are generic medicines, and this large scale exacerbates the supply chain complexity.
“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. This situation threatens to prevent companies from supplying an identical product to Great Britain and Northern Ireland. 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.
“After months of asking for a stable agreement between the Government and EU, our companies have been forced to put on notice over 2,000 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.”