Yes, that's the same MHRA regulator that stopped the #Covid19 ventilator programme descending into farce and helped fast-track coronavirus vaccines approvals -- for which it was lauded as "phenomenal" in UK govt's life sciences plan./2
And the same MHRA that Iain Duncan Smith in this TIGRR report on post-#Brexit deregulation said should have an expanded remit and be at heart of the 'build back better' plans, to maximise the strength of UK life sciences/3
And yet the MHRA is going to cut up to a quarter of its 1,200 staff as it 'restructures' -- the government says to become a "world-leading" regulator, but senior staff -- per letter seen @FinancialTimes -- have "deep concern" about what his happening/4
@FinancialTimes Experts in regulation of medicines/devices tell me that some restructuring IS needed -- to end the historical divide of meds/devices regime, to streamline clinical trials process etc (and work on this is being done) BUT hard to square this with massive cost-cutting/5
@FinancialTimes This is particularly so at a time -- per @kipping_michael of InnovateUK -- when new EU MDR regulations are forcing businesses to choose which products to register. Products are leaving the market, which won't be good for NHS patients. We need capacity. /6
@FinancialTimes@kipping_michael As Kipping tells me: βThe medical devices and in vitro diagnostics industry is facing a critical period. Cutting back on the UK regulator in the face of this challenge is deeply concerning.β /7
@FinancialTimes@kipping_michael But from the inside it just looks like the MHRA is in danger of being hollowed, becoming a rubber-stamper, not a world-leader. Per insider: βThe fear is companies will go to Europe or the US [for reg approvals] and then come back to us for a cheap, rubber-stamping exercise.β/8
@FinancialTimes@kipping_michael The government and the MHRA don't see it this way -- promising in a statement to βcontinue to be a world-class regulator that delivers the right outcomes for patients" but those claims ring hollow to experts and insiders I've spoken to /9
@FinancialTimes@kipping_michael This comes at a criticial juncture of medical devices and medical regulations after Brexit, where the UK has to make very strategic choices about how it retains its world-leading position in the field of medical regulation as it goes through a period of intense change/10
@FinancialTimes@kipping_michael There is a prize to be grasped here -- worth reading this piece by @SamuelMarcLowe and Prof Derek Hill on how the UK do this -- it is an area of genuine debate/discussion /11
@FinancialTimes@kipping_michael@SamuelMarcLowe But in the (marvelously understated) view of Prof Hill: "While there may be some benefits from restructuring the MHRA...it does seem like a strange time to be cutting its overall budget."
Others who cant be named said it was "crackers" and "bonkers" /12
@FinancialTimes@kipping_michael@SamuelMarcLowe Of course there is a bitter irony here...the MHRA is facing a Β£15m shortfall because it is losing Β£ms of year in fees that it no longer collects as a result of #Brexit and the UK's departure from the European Medicines Agency (that went to Amsterdam) /13
@FinancialTimes@kipping_michael@SamuelMarcLowe As a result of losing the EU funding stream that came with fees from registering products for use in the EU, the MHRA is being sucked back into the budget of the Dept of Health which is adding financial pressure. /14
@FinancialTimes@kipping_michael@SamuelMarcLowe The Govt can argue that you can do "more with less" -- streamlining, IT investment etc -- but to a lot of people in the industry it is very hard to square the rhetoric of "build back better", "world-beating" "innovation" with savage cuts to one of our genuine world beaters! ENDS
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Spent today at two colleges in Brighton talking to A-Level/BTec students... @RoedeanSchool @varndean ...it was uplifting! Yes grades have been inflated, but that is a) unavoidable without public exams b) better than the blind algorithm /1 #ALevelResults
@RoedeanSchool@varndean Why unavoidable? Because with no-one sitting exams, no-one has a 'bad day' or a 'good day'...so grades can only be awarded on the maximum potential of each student. Otherwise teachers are guessing/playing God. Each students has a 'basket of evidence' backing up their grade /2
@RoedeanSchool@varndean The result? About 45 per cent got A*/A which is crazy -- but surely better than the algorithm that discriminated (among other things) on class sizes. So (poorer) schools with bigger classes got marked down/3
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Ex EU commission Sir Jonathan Faull floats again the idea of βmutual enforcementβ as a solution to the NI protocol #brexit stand off:
βA dual autonomy approach would help with the Northern Ireland protocolβ via @FT /1 on.ft.com/3wMpKDq
@FT This idea broadly relies on either side enforcing the others laws...two separate, sovereign jurisdiction operating side by side to protect each other. It has long been favoured by Brexiters of ERG...but is hated by the EU. /2
@FT Here is old ERG-backed paper on the idea from Feb 21...it has been totally rejected by EU, but Brexiters continue to work on the plan, with legal advice from lawyers such as @jamesrwebber /3
@FT So what are we talking about? Medical devices - stents, implants, urine testers etc etc. Can the UK have it's own post-#Brexit regulatory regime? (Sure) Can that regime pay a dividend that makes UK hub for innovation, development, growth (Trickier). /2
The background is the EU introduced new Medical Devices Regulation in May after load of scandals (breast implants failing etc) ...but UK isn't following MDR, but is starting consultation on new UK regs designed to grasp "opportunity" of #Brexit /3
Q: how does the West keep China as rival, not allow it to become an enemy?
Annual #Ditchley Lecture by @TurnbullMalcolm ponders this -- break out the deck chair, put up the parasol and give this a read. Fascinating and thoughtful. /1
@TurnbullMalcolm What do you do when Western democracy is being assailed by destructive forces of populism (recalls storming of US Capitol) and China is getting ever-more assertive of its rival, autocratic system -- but for trade, for global problem solving (climate eg) we need China /2
How should our universities interact with China to deepen relations without opening door to technology theft, students getting in trouble back home? /3
It's OUT!! My weekly #Brexit Briefing for @ft
This week: the transition from "CE" safety marks (u see them on everything) to "UKCA" marks - the UK's post-Brexit copycat version - which is creating pointless headaches for business...stay with me /1
@FT So what's this about? Well, as an expression of UK sovereignty after #Brexit the UK decided that it wanted its own equivalent of a CE mark -- even tho it remained part of European Standards Organisation which co-ordinates standards -- so UKCA was born /2
@FT Since standards are the same, and most businesses (in non risky sectors) can "self-certify", you might think this is just what @SamuelMarcLowe calls "performative divergence" -- just for #brexit show and a bit of harmless form-filling. Alas not. /3
@FT@AlexanderPHRose So first the case. It stems from a decision last December by @trussliz to unilaterally allow 260,000 tonnes of "raw cane sugar" to enter the UK tariff-free, for one year. So far, so simple /2
@FT@AlexanderPHRose@trussliz But British Sugar Plc @BritishSugar has gone to court to argue that this 'autonomous' quota is a de facto subsidy to their US-owned rival Tate & Lyle Sugars @TateLyleSugars because T&L is the ONLY company in UK that refines *cane* sugar -- BS uses homegrown sugar beet/3