The Windsor Framework might have solved some problems in Northern Ireland but it hasn’t sorted the Falsified Medicines Directive, says Terry Maguire…

When, in 2016, England decided it wanted to cut itself adrift from the EU, Scotland and Northern Ireland - which both voted strongly to remain - were forced to leave too. Ironically, our largest political party at the time, the DUP, was unique among UK political parties in officially endorsing Brexit. The DUP wasn’t always angry about Brexit.

The 1.9 million people who live in the only region of the UK that shares a land border with the EU became a major challenge when determining what Brexit would really look like. Three prime ministers struggled to square that circle and all failed. Medicines supply, always going to be a challenge, required intense negotiations to ensure essential medicines continued to arrive and, credit to the Department of Health, they did.

Now Rishi Sunak has, it seems, has solved the problem with medicines and most other goods. From now on medicines will not be subject to special measures when shipped from a wholesaler in Birmingham for patient use in Belfast …. I think.

While pharmacy colleagues in Great Britain back in 2016 celebrated the only compensation I can identify for leaving the EU- the scrapping of the Falsified Medicines Directive (FMD) – we were told in all likelihood it would remain law in N. Ireland. So we kept our heads down and did the minimum required: we registered with SecurMed, installed the right scanners and turned on the relevant computer programmes.

As the relevant European Directive came into force in February 2019 we were all still of the naïve belief that this onerous process would just pass us by. No such luck! So it was against this backdrop that I attended an evening training event in late February designed to bring me up to speed and get me doing what I should have been doing three years ago – decommissioning licensed medicines at the point of dispensing.

Back in 2017-18 - a faint memory now given the tribulations of Covid - I was all over this issue and had a large file which I have hidden away somewhere safe and now cannot find. Back then I had some practical concerns about FMD and was waiting until others had these ironed out before I committed. It seems I was not alone in this approach.

Figures provided at the training evening suggest that N. Ireland is not only bottom of the class when it comes to medicines decommissioned – we are in the special needs category. On average, French, Irish and German pharmacies are now decommissioning more than 50 per cent of dispensed items. We are just above 1 per cent.

‘Could do better’ was not the tone adopted by our medicines inspector, who asserted that we must do better and supported his comments with a PowerPoint slide entitled ‘Penalties’. It listed an escalator of enforcement actions, starting with an enforcement notice, moving on to a fine, and then, if you still refused to comply, a two-year prison sentence.

Where this custodial sentence would be served, a British, Irish or EU prison was not specified. Who would do the time and get the criminal record also was unspecified, but I am confident that a pharmacy superintendent will not easily escape blame.

The N. Ireland Protocol was an initial and interesting attempt to address the challenge of having a border that assured EU standards in its territory but did not have this border in the island of Ireland. It was a problem of ensuring that one country – the UK – could leave the EU while also ensuring that part of it – N. Ireland – could stay in a union.

Medicines seepage into the Republic of Ireland was clearly a challenge. Initial concessions on medicines from the EU were helpful but became a bit of a mess and, rather than improving patient safety, ran the risk of causing harm. N. Ireland-bound medicines from Great Britain got an additional series of product licenses to address EU border integrity concerns.

On leaving EU, the MHRA was no longer recognised as a competent body, so medicines licenced by MHRA and used in N. Ireland got an “N” product licence, a PLN. These packs, to be EU compliant, needed a 2D bar code so that they could be firstly commissioned by manufacturers and then decommissioned via the FMD scheme when dispensed in N. Ireland.

This really caused ordering mayhem as the computer systems did not recognise these ‘NI’ packs.

Then there was the N. Ireland MHRA Authorising Route (NIMAR). This essentially said that the EU won’t recognise MHRA but where a medicine shortage occurs our CPO can put the medicine onto the NIMAR list and that GB medicine is then totally legal in N. Ireland. It need not have a 2D bar code and we don’t need to worry about FMD.

So Rishi Sunak with his ingenious Windsor Framework seems to have succeeded in removing a lot of this technical complexity but I still have to comply with FMD. I therefore ask that our prime minister, the son of a pharmacist, or even the DUP, be sympathetic to my plight and if needed, keep me out of prison.

Terry Maguire is a leading pharmacist in Northern Ireland.