Among the latest signs of the imminent catastrophes being posed by Brexit, US pharma giant Merck has just announced that it is planning for a potential supply blackout when the UK leaves the EU and may stockpile as much as six months’ worth of goods to help prepare in advance for such an affair.
The alarming announcement comes mere weeks after the release of a new parliamentary report which says that patients’ access to key drugs will be at risk unless the government secures a post-Brexit deal for the pharma industry that will facilitate the closest possible regulatory alignment with the EU. It’s not just pharmaceuticals that are at risk, however; Brexit looks poised to have a disastrous effect on British public health in general.
Pharma under threat
US pharma tycoon Merck (known as MSD outside of North America) is the latest company to make contingency plans against the prospect of a calamitous outcome to Brexit negotiations. Having asked their customers if they would be capable of storing up to two months’ worth of supplies in advance of the UK’s exit from the EU, Merck plan to stockpile half a year’s worth of their own inventory.
Meanwhile, fellow UK-based pharma behemoths AstraZeneca and GlaxoSmithKline have both indicated they will be diverting significant funds towards expanding their operations in the EU. The former plans to invest £21.2 million (€24 million) into a Swedish facility, while the latter will spend as much as £70 million (€79.2 million) on its own alternative arrangements. That’s money which could have been spent on cancer research, says GSK.
For their part, the Business, Energy and Industrial Strategy (BEIC) Committee have highlighted the dangers inherent in any deviation from the framework set out by the European Medicines Agency (EMA). The EMA has already confirmed it will relocate to Amsterdam and there are concerns that the UK’s Medicines and Healthcare Regulatory Agency (MHRA) may no longer work in tandem with the European body.
Should that happen, it would necessitate duplicate regulations, resulting in lengthy border delays and higher expenses that may be transferred onto consumers’ shoulders. Worse still, new drugs might not even become available to British citizens at all; with the BIES Committee estimating each new treatment to cost around £45,000 under a separate framework, pharmaceutical companies could be deterred from entering the UK market altogether.
Rare disease sufferers set to suffer
With 37 million packs of medicine arriving to the UK from the EU every month – almost three-quarters of all pharmaceutical imports into the country – any disruption to that arrangement could be hugely detrimental to British public health. And no sector of society is more at risk than those suffering from rare diseases, who already have to endure continual postponements and delays in receiving access to their medication.
Spinal muscular atrophy (SMA) sufferers, for example, are currently campaigning to be granted access to apparent wonder-drug Spinraza both north and south of the border. Currently, Spinraza is only available to a small subset of the 1,300 Britons suffering from the disease, a rare neuromuscular disorder that leads to muscle wasting and often death. The situation has provoked strong criticism from patients and their families, especially since the drug has already been approved for reimbursement in numerous other developed countries, including the US, Spain, and France.
Unfortunately, this dismal state of affairs only seems set to deteriorate. Earlier this year, the National Institute for Health and Care Excellence (NICE) implemented a series of measures regulating new drugs into the British market. Chief among these measures was the introduction of a so-called “budget impact test”, which would slow down the approval of any drug projected to cost over £20 million in any one of its first three years in use. A simultaneous revamp of its Highly Specialised Technologies (HST) programme is also likely to slow down access to drugs for orphan (very rare) diseases.
This new legislation is bad enough on its own, without the potential ramifications of the MHRA separating from the EMA. For one father who quit his job to search for a cure for alkaptonuria (AKU), the condition which afflicts both his sons, and who is one year away from finishing a six-year study commissioned by the EMA, such a split would be catastrophic.
The cracks in a creaking NHS
In addition to the pharmaceutical industry and the patients who depend upon it, the medical profession is also likely to suffer from Brexit. The UK’s National Health Service (NHS) is already under considerable strain; a General Medical Council (GMC) report found that while A&E attendance rates have jumped up by 27% since 2012, registration of new doctors has only increased by 2% in that time.
The NHS currently relies on EU medics for up to 43% of its workforce in some parts of the country – and even with that imported labour, still has a shortfall of around 100,000 vacancies at present. A recent survey of 2,100 doctors educated in the European Economic Area showed that 61% were considering leaving the UK in the future, with over 90% of that percentage citing Brexit as a contributing factor. According to the BMA, one-fifth of EEA doctors have already made solid plans to relocate since the announcement of the Brexit referendum verdict in 2016.
Meanwhile, uncertainty over whether EU professionals will even be allowed to work in the UK after its secession from the bloc means that both students, doctors and medical experts fear being left in the lurch.
No-deal simply not an option
All of these symptoms combine to underline the gravity and potentially devastating consequences of a botched Brexit deal. UK Prime Minister Theresa May has signalled her intention to keep Britain within the EMA, though the EU is adamant it will retain autonomy on all decision-making. This has prompted some MPs to raise the concern that the UK would end up in a far more precarious position than before leaving the EU: bound to EMA rules, but powerless to influence them.
On this point, and on almost all others regarding how any ongoing collaboration would function, May has remained silent. With a £41.8 billion (€47.4 billion) pharmaceutical industry at stake, a fragile public healthcare system in the balance and millions of lives at risk, it’s imperative that May and her government work with the EU authorities to facilitate a seamless transition to the new state of play, whatever that may be. Viewed from this perspective, a successful Brexit quite literally becomes a matter of life and death.
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