“Brexit” officially entered the English language here in the UK in December 2016 with its inclusion into the Oxford English dictionary; and following Prime Minister Theresa May triggering Article 50 last week, this means Britain should officially leave the EU no later than April 2019.
It is tempting to make political comment on Brexit – but since we don’t yet know what it looks like, all we can do is lobby and plan for possible outcomes. For the next two years Britain’s politicians, will be working on a deal for leaving the EU, the countdown is now officially ticking.
I would like to see a form of mutual recognition between the Medcines and Healthcare products Regulatory Agency (MHRA) and the European Medcines Evaluation Agency (EMEA).
From a recent seminar I attended where the industry and the MHRA discussed this topic , I would say the chances of that happening are almost zero. It seemed like there would be nothing better than for the MHRA to get some of its independence back and forge its own path, but this is daft – they mutually recognise each other now, so why not just keep the same arrangements in place? Each will blame the other for deviation from this most sensible route, , so in the end, I suspect, the emotional drive for independence will overrule the rational drive for simplicity.
This is a shame. The International Conference of Harmonisation - Good Clinical Practice (ICH-GCP) has suffered badly at the hands of the law makers already, and this situation will get worse rather than better because of Brexit.
ICH-GCP started life as an effort for standardisation, to remove the myriad of international regulations that made setting standards for clinical trials very hard to achieve. As it was codified to law, that single standard (that took many years to create) was subtly changed as it entered each set of law books. This was a step backwards in standardisation, although making GCP into law was intended to make it easier to enforce of course. In my view this was never required; simply not approving products for sale is as strong a power as is needed to keep pharma companies following the standard.
Now I predict we will add a further set of UK elements to the law, gold plating and polishing up a new set of shiny regulations for us to proudly put on the watchdogs virtual mantelpiece and make it harder still for pharma companies to follow the rules.
My challenge to the MHRA and EMEA…
Prove me wrong.