Brexit: Growing differences between drugs approved for GB and NI, says report - BBC

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Close-up of a pistillate  pharmacist searching for medicine   medicine   successful  retention  rack. Woman hands looking for medicine   successful  a retention  rack successful  the infirmary  pharmacy store.Image source, Getty/Luis Alvarez

Image caption,

The Nuffield Trust has been examining the wide impacts of Brexit connected the UK wellness system

By John Campbell

BBC News NI Economics & Business Editor

There are increasing post-Brexit differences betwixt which medicines are approved for usage successful Northern Ireland and the remainder of the UK, probe from a wellness deliberation vessel indicates.

The Nuffield Trust has been examining Brexit's impact connected the wellness system.

More than 100 products person been approved for usage successful Great Britain but not Northern Ireland, it suggests.

Conversely since 2021, 52 products person been granted selling authorisation for Northern Ireland but not successful GB.

It does not needfully mean that definite types of drugs are wholly unavailable successful Northern Ireland, alternatively it whitethorn beryllium that a peculiar formulation produced by a peculiar shaper has not been licensed.

The Nuffield Trust said a caller illustration of a merchandise licensed successful Great Britain but not Northern Ireland is simply a generic mentation of the Parkinson's illness cause Ropinirole, produced by Sciecure Pharma.

Meanwhile, the Slovenian institution Sandoz Farmacevtska Druzb has introduced aggregate painkillers to the Northern Ireland market, but not elsewhere successful the UK.

Stormont's Department of Health said its precedence is to support equity of entree to caller medicines for the radical of Northern Ireland with the remainder of the UK.

A spokesperson added that it continues to enactment with the Medicines and Healthcare products Regulatory Agency (MHRA) to this end.

"This includes utilisation of the Northern Ireland MHRA Authorised Route (NIMAR), which has been designed to guarantee that radical successful Northern Ireland tin proceed to entree medicines should objective request beryllium incapable to beryllium met done authorised products oregon immoderate different regulatory routes," the spokesperson added.

This means that immoderate medicines that bash not person a circumstantial Northern Ireland authorisation tin inactive beryllium made disposable successful Northern Ireland.

The post-Brexit woody known arsenic the Protocol means Northern Ireland is inactive wrong the EU's pharmaceutical regulatory system.

However, it gets astir of its medicines from Great Britain, which is not.

Image source, Getty Images

Image caption,

The post-Brexit woody known arsenic the Protocol means Northern Ireland is inactive wrong the EU's pharmaceutical regulatory system

The EU accepted it was a occupation and successful April 2022 changed its laws truthful that medicines entering Northern Ireland from Great Britain volition not request further labelling oregon testing, things which would person been required by the protocol successful its archetypal form.

Licensing is simply a analyzable area; successful the EU determination is simply a relation for the European Medicines Agency (EMA) and nationalist regulators.

The protocol means the EMA's relation is efficaciously to o.k. innovative drugs for usage successful Northern Ireland portion the MHRA approves things similar generic medicines.

However, generics manufacturers efficaciously request 2 licences to proviso the full of the UK, 1 covering GB and 1 covering NI, which adds further outgo and complexity.

Stormont has raised concerns

The Nuffield Trust said it is hard to supply a precise fig for medicines introduced successful Great Britain but not successful Northern Ireland owed to those continuing EMA support powers successful Northern Ireland.

However, it said that looking astatine each of the 597 products MHRA has approved for Great Britain since the commencement of 2021, lone 8 were besides approved for Northern Ireland nether the aforesaid sanction and institution and it seemed that lone a number had been approved by the EMA.

It added: "While a case-by-case survey would beryllium needed to supply a precise number, this suggests that the fig of products present disposable successful Scotland, England and Wales but not Northern Ireland is apt good into triple figures."

Stormont's Department of Health said it was presently considering the study and has raised its concerns relating to divergence with the UK government.

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