Kwasi Kwarteng responds to Brexit dig from SNP MP
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According to the British Generic Manufacturers Association (BGMA), a UK-wide licensing agreement must be agreed between the two sides in order to stop critical shortages of medicines moving between Great Britain and Northern Ireland. Post-Brexit, Northern Ireland remains as part of the EU’s regulatory system due to the protocol. Due to this, chief executive of the association, Mark Samuels told Express.co.uk up to 2,400 medicines have been put on notice for withdrawal from Northern Ireland due to the new regulatory requirements.
Mr Samuels warned the industry had been on “red alert” and the regulatory uncertainty has put the supply of medicines in a potentially “terrible situation”.
He said: “Not all medicines will be suddenly stopped but rather that it leaves us on a knife-edge.
“You know, anytime there’s a change, challenge or problem with the supply chain, then that knife-edge situation becomes a real crisis with a substantial shortage.
“That I think is the realistic issue if we don’t get a proper solution.”
According to Mr Samuels, 910 medicine have now been withdrawn due to difficulties post-Brexit.
Due to the risk to medical supplies, the UK Government has called for the regulatory process around medicines to be removed from the protocol.
In order for the medicines to comply with the protocol, duplicate warehousing, test facilities, and technical specialists would have to be set up in Northern Ireland.
In response to the UK proposal, the EU put forward a plan in its non-paper, whereby batch testing could remain in the UK but would require measures such as EU inspections on UK facilities and a specified label on the packaging.
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While welcoming any attempt to resolve issues, the BGMA has warned the EU’s plan would make trade even harder and more complex.
Mr Samuels, however, concluded the industry is in a dangerous position and must have an agreement as soon as possible.
He said: “We’ve been sounding the alarm since January, since before January.
“We’ve been certainly long since before January, and highlighting to the government and the Commission that we were on red alert.
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“And we’re very worried about this. And that we needed a solution by July.”
He concluded: “We desperately want to supply medicines to patients.
“And this regulatory uncertainty from January as has forced us into the terrible situation we’re in.”
The group has called for a UK-wide licensing agreement in order to maintain the flow of medicines entering Northern Ireland.
A generic drug is a substance which contains the same ingredients as a branded drug but is sold once the originator’s patent has expired.
As they are not brand names, drugs such as aspirin or paracetamol save the NHS vast amounts of money.
According to NHS Digital figures, more than one billion items are prescribed every year.
Due to the trade of generic medicine, it is estimated the NHS saves approximately £13billion a year.
In order to protect the medicine trade for the time being, the UK announced the extension of grace periods relating to drugs for an indefinite time period.
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