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Letter from London
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Ruddock A. Letter from London. Natl Med J India 2019;32:120
In 2016, then Prime Minister David Cameron threw the United Kingdom under the bus (upon which Boris Johnson′s team pasted the notorious lie that leaving the European Union [EU] would redirect £350 million a week from Brussels to the National Health Service [NHS]) in an effort to preserve a fractured Conservative party. Theresa May, clinging on as current prime minister, is adhering to the same playbook, pandering to ever more extreme interests while vowing to deliver on ′the will of the British people′ by taking us out of the EU. I voted to remain, unwavering in my conviction that this tiny isle is a better place to be thanks to its entanglement with the people and opportunities of the European continent and the world beyond. I am not, therefore, one of the British people whose will May claims to be serving. Rather, I am part of that distasteful band she has dismissed as ′citizens of nowhere′ for our commitment to internationalism and global experience, whose votes to remain in the EU are contorted into a disdain for the UK by those in favour of leaving.
Much of the time, Brexit still feels ominous but ineffable. Like a dark cloud on the horizon bringing its inclement contents ever closer, but whose tangible effects I cannot yet discern. For sanity′s sake, I periodically turn away, tuning out the hum of news, seeking distraction in more hopeful things. But the reality always comes crashing home before long. A Brexiteer will say something so ignorant, so self-serving and vile, that it is impossible to ignore its sulphurous after effects. Or the prime minister is overheard on the radio repeating the falsehood that she is putting country before party. Occasionally, it will be a friend who just can′t help herself saying, ′I still can′t believe it.′ And down we all spiral into confrontation with the populist age in which we, along with much of the world, are living through.
Sometimes, however, the forthcoming change is right there in front of us, in undisguised, unavoidable technicolour. Responsible for the scientific evaluation of human and veterinary medicines developed for use in the EU, the European Medicines Agency (EMA) has been based in London since it was established in 1995 to harmonize regulation across all 28 member states. Under current arrangements, companies can submit a single application to the EMA to obtain a marketing authorization that is valid in EU, EEA (European Economic Area) and European Free Trade Association (EFTA) countries. Being a member of the EMA also gives the UK ′tier 1′ market status, meaning that pharmaceutical and medical device companies prioritize the UK as a market for launching their products.1 However, the EMA cannot function in a non-member state. So, following a ballot in November 2017, Amsterdam was anointed the agency′s new home. And in March 2019, the news showed people folding up the flags of the member states, as 900 staff left the building and an EU agency ceased to function in the UK.
The UK has its own national regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA), which currently deals with national authorisations intended for marketing only in the UK. The intention is for the MHRA to become a sovereign regulator outside the EMA, but with regulatory equivalence and close working relationships through the European Medicines Regulatory Network (EMRN). However, if the government fails to agree with Brussels a deal with clear terms of departure from the EU, the UK′s participation in the EMRN will cease and contingency legislation will be required for the MHRA to take on the necessary functions for regulating medicines on the UK market. If the UK leaves the EMA arrangements and develops its own drug approval system, it may lose its tier 1 status and find itself at the back of the queue for new medicines.
Around three-quarters of the medicines and more than half the devices that the NHS uses, come into the UK via the EU. Logically, then, European and UK supply chains of medicines and medical technologies are deliberately very closely integrated; new tariff agreements or inspections could cause significant disruption to the supply of medicines to patients, particularly those that are time and temperature sensitive. , Even products made in the UK could be affected if they rely on ingredients imported from the EU. The government has put in place contingency plans for no deal which include stockpiling medicines and devices to build up at least 6 weeks of extract stocks above usual levels. Nevertheless, there are concerns; the government′s own plans show that in the event of no deal there is likely to be significant disruption to cross- channel import routes for up to 6 months.
And what of the people who research, develop, prescribe and deliver these medicines? Around 139 000 of the NHS′ 1.2 million staff are foreign nationals--that equates to one in eight. Almost half of these are from the EU. The number of people from the EU joining the Nursing and Midwifery Council (NMC) has fallen by 90% since the Brexit vote compared with the same period pre- referendum. A survey by the British Medical Association (BMA) found nearly half of doctors from the EU were considering leaving the UK. One in six academics at British universities working in medicine, dentistry and health are from EU countries. Their work depends on cross-border mobility and opportunities to collaborate in networks, such as the European reference networks for rare diseases, of which the UK coordinates six. In the event of a no deal Brexit, this cooperation would end.
The clouds are gathering, their implications mounting like the tension before a storm. It is real, it is happening, it has consequences for human lives that we will be confronting for many decades to come. We are not ready. But on we go, relentlessly forward into the obscurant mists of nostalgia for a time that never was.
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