The UK has no structures or agency of its own for approving and licensing medicines. It relies almost exclusively on the European Medicines Agency. The MHRA is an ancillary organisation. In precisely 15 months UK access to the EMA ends; abruptly if the "no deal" voices prevail.
Where are the UK's preparations for replacing this vital framework? The answer is: Non-existent. Not even embryonic. Just a statement by Hunt this summer that the UK "will look to continue to work closely” with the EMA, but we're ready "to establish our own system if necessary".
The EU started planning to relocate the EMA (currently in London) the week after Art50 was notified to much tabloid chagrin, the idea that EU agencies should be located in the EU having come as a shock. That's just RELOCATING. We, who actually need to REPLACE it, have done nowt.
Having worked for a similarly sized gov't agency for most my professional life, I estimate that in order to "establish our own system" and have everything in place to take over March 2019, we needed to have started two years ago. And even that would be tight. I'm deadly serious.
The setting up will require complex, technical, primary legislation, which will be hotly contested between strong counter-pulling lobbies and interests (big pharma, NHS, patient groups, ethics cmtees) and require extensive consultation, expert advice and debate.
Only at THAT point, can you start looking for a CEO, a board, expert staff, support, training, a building etc. In all honesty, 15 months isn't even enough time if you were ONLY looking at the recruitment of such technical staff. Especially in such a niche area.
Then there's cost. Even by Eurosceptic estimates the UK pays a fifth of an agency like the EMA. It would need to set up the UK equivalent for a fifth of the cost *just to break even*. This is fantasy of course. Testing, assessing and licensing a new drug is inelastic, cost-wise.
This exposes the myth of "saving lots of money by leaving the EU". Much of the money we paid was to centralise essential tasks, like the medicines regime, with huge efficiency and time savings. Not dealing with multiple authorities also reduces costs for pharma cos, ergo prices.
This simple example also puts to bed any "they need us more than we need them" nonsense. Yes, we are an important contributor to the EU. Yes we are also an important market. They *want* us, for sure. But we *need* them. Structurally. Desperately. Not forever, but certainly now.
The day the UK leaves, everything in the EU27 will function PRECISELY as it does now. Money will be tighter. Some of their sectors will face challenges. But none of their rules or processes change. They face no transition. We do -in a myriad ways- and are totally unprepared.
Because medicines is only one of a 100 such regimes that need replacing which will fall on the same unfathomably stretched civil service to do; the same exhausted people trying to also do the other 99 things, as well as renegotiate 700 treaties, on TOP of their ordinary duties.
So, what happens if there's "no deal", in this, as in a thousand other areas for which the UK has simply made NO preparations? This isn't fluff. It's life and death. Sick people will end up waiting for years for available treatments, stuck in a bottleneck of unapproved meds.
Does your faith and patriotism have the magical power to make technical legislation and multidisciplinary agencies just spring into being? Is it unpatriotic to raise the #Brexit alarm or quite the reverse? Am I a remoaner for thinking about this? Or are you a fool for not?
