[1andrew1]

It would be great if the next government could improve on things like this.

...since Brexit there has been almost zero investment in the UK generics industry compared with £4bn in Europe, with manufacturing output down by one-third in the decade to 2021.

All these things have complex causes, but Samuels [boss of the British Generic Manufacturers Association who supply 4/5 of NHS drugs] points to two major Brexit factors.

First, he says budget cuts and restructuring at the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), have led to a doubling of wait times to get generic medicines approved.

So in 2019 it took 12 to 15 months for the agency to license generic medicines. But as a result of Brexit the MHRA lost the EU regulatory approvals work that provided 20 per cent of its budget. Now (December 2023) it takes 24 to 30 months to get a generic drug licensed.

“The MHRA currently has a backlog of approximately 500 generic medicines to license. The agency licenses 35 to 50 generics per month as its maximum capacity, so a 500-medicine backlog is over a year’s logjam,” Samuels says.

This can be fixed with more money. The resourcing of the UK’s post-Brexit regulators is out-of-whack with the country’s ambitions to be a “science superpower”. A Labour government could start to address that.

Second, under the terms of the UK-EU trade deal, the European Medicines Agency (EMA) does not recognise “batch-testing” (checking medicines conform to standards) that is done in the UK. This has to be done in Europe — so, just as Michel Barnier warned, the UK would not be allowed to become a “certification hub” off the coast of Europe.

...But Samuels argues for a bigger-picture view. In a world of pandemics, narrowing global trade blocs and the US no longer guaranteeing European security, a UK that was deeply committed to the European neighbourhood ought, he says, to be able to reframe narrow issues, such as medicines and cars, more broadly.

“If you were to think of medicines as a regional security issue, you’d want the whole of Europe, including the UK, to be resilient. The world has changed. We have two wars now in Ukraine and the Middle East and colleagues minded to take a regional perspective ought to be open to the issue of batch-testing.”

There are a series of big leaps there, but given the state of the world at the moment, it is worth both sides lifting their gaze to the horizon.

Source: Britain after Brexit newsletter. FT.com