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[theotherjourney7]

“.. MHRA issues statement to me on whether or not Brexit accelerated the Pfizer vaccine licencing process.

They confirm licencing has taken place under provisions as set out in EU law.

By extension Brexit hasn't (as some ministers have claimed) allowed us to licence early.

In the EU, drugs are licensed by the European Medicines Agency.

But since 2012 the UK MHRA has been allowed (using Regulation 174 of the Human Medicine Regulations 2012) to give temporary approval to an unlicensed product in the event of a pandemic or public health emergency.

That's been the case as part of the EU. Indeed, that Reg comes via European directive 2001/83/ECAs transposed into EU law. That's why the MHRA says: "These provisions are compliant with existing European law, and will remain in place after the end of the Brexit transition period"

Problem is, several prominent ministers have said something quite different.

Matt Hancock told Times Radio that “Because of Brexit we’ve been able to make a decision [to approve the Pfizer vaccine] based on the UK regulator, a world class regulator, and not go at the pace of the Europeans who are moving a little bit more slowly. We do all the same safety checks and the same processes, but we’ve been able to speed up how they’re done because of Brexit.”

As the MHRA are saying this isn't right. It would always have been possible for the UK to do this under Regulation 174.

It's possible that once we've left the EU we might be able to distribute the vaccine differently, separated from EU law. That's a point Matt Hancock was asked about in the House and which may well be right.

But that's a different point to whether the licensing was done more quickly because of Brexit, because it wasn't.

This should be obvious because we are still obeying EU law because the transition period isn't over yet.

Several other ministers were more explicit than Hancock. Nadine Dorries said: "A month ago, we changed the regs to exempt us from requiring EU approval. We would still be waiting if we hadn’t. Thanks to #Brexit we can now move ahead swiftly and safely."

The first part is true, we did change the regs to be exempted from EU approval. We would still be waiting if not. But the second part isn't true. It's not thanks to Brexit that we can do that.

Because- to repeat, we haven't really Brexited yet, because we're still subject to EU law.

If the referendum had never happened, we could have done this (indeed, one can imagine clamour from Eurosceptic Tory MPs who would have insisted on it).

It's possible that had we still been a full member, the government of the day might have chosen to stick with the EMA process and not move more quickly. But they might not. The point is Brexit hasn't allowed us to do something we couldn't have done.

Indeed, Hungary (a full EU state) is doing it to licence the Russian Sputnik vaccine, to the EU's chagrin, but they're doing it.

Then there were Jacob Rees Mogg's comments: "We could only approve this vaccine so quickly because we have left the EU..."

"Last month we changed the regulations so a vaccine did not need EU approval which is slower."

This time the truthful part of the statement is inverted. The second part is right, the first wrong. Yes the regs allowed licensing, no we didn't approve it so quickly because we have left the EU. Because, again for regulatory purposes we haven't, which ministers should probably know and understand.

The govt itself as acknowledged this. On 23rd November the DHSC welcomed the MHRA review into the Pfizer vaccine in a press release they acknowledge this grace period. They confirm that EU legislation (in UK law) permits emergency approval of a vaccine, via a Regulation 174.

It says after the transition period ends the MHRA will have new powers to act more quickly. But that's not what's happened now.

This is presumably why the Prime Minister, despite entreaties to suggest this was a "Brexit bonus" declined to endorse what his ministers had said in his briefing earlier this week, but he didn't directly contradict them either.

This has been fact checked by others but this isn't really a story about Brexit anyway at this point. Rather given the MHRA's quite clear statement (buttressing what their Director has said in public) it's about ministers being accurate in what they're saying about important matters of public policy. Pg 27 of the ministerial code is clear. It carries an annex of The Seven Principles of Public Life and says officeholders should be "truthful". Truthful implies correcting the record even if a mistake has been made, which these may have been..

But it hasn't happened yet.

I've approached the Department for Health and Social Care and Number 10 for a comment or to provide an explanation for how their ministers' statements tally with what the MHRA has told me but so far they've declined to do so.”-Lewis Goodall

[tekmodetech]

Sphero lays off dozens as it shifts focus to education

Sphero was prepared to overcome the world final 12 months. The corporate quintupled its product launch schedule, flying excessive with the help of a Disney licensing deal that gave the world several Star Wars droids and speaking Spider-Man and Lightning McQueen robots.

However following a vacation season that did not stay as much as expectations, the corporate lately laid off 45 workers members globally, TechCrunch has realized, a transfer it says has impacted departments company-wide.

The vast majority of the layoffs have been centered within the firm’s Colorado headquarters, however workers cuts additionally affected its world places of work within the U.Ok. and Hong Kong. 

“We restructured our group on Friday to higher align with our product wants,” a spokesperson for the corporate advised TechCrunch. “As we glance to our product growth schedule for 2018 and past, we weren’t going to go that deep, so we needed to make some adjustments for the way the groups have been structured.”

The transfer is a step again for the corporate and a little bit of a shock for many who have been following its trajectory from afar. After taking part in Disney’s accelerator again in 2014, the startup obtained a small funding from the leisure goliath and commenced manufacturing on a BB-8 toy launched alongside 2015’s blockbuster Star Wars return, The Pressure Awakens.

In 2017 alone, the corporate launched new toys primarily based on R2D2, The Final Jedi‘s BB-9E, Spider-Man and Pixar’s Vehicles franchise, together with Sphero Mini, a smaller, sub-$50 model of the smartphone managed ball that began all of it. 

The startup had bolstered its headcount to fulfill the calls for of its a lot accelerated output.

It’s telling, after all, that the layoffs come so quickly after the vacations. Whereas not disastrous, the lastly tally pointed to the necessity for a rethink in technique going ahead. “[Sales weren’t] precisely what we had anticipated,” the spokesperson stated. “We nonetheless take into account ourselves a younger startup. It’s the appropriate time to pivot.”

The lower comes because it shifts towards a product roadmap extra according to the pre-2017 days — placing it at nearer to at least one to 2 merchandise per 12 months. “That is likely to be our candy spot,” the spokesperson added. “We’re nonetheless fairly younger, however the one a part of our enterprise that continues to shine is what we’re doing in schooling. This permits our firm to deal with that imaginative and prescient.”

This restructuring finds Sphero investing rather more of its current assets into the schooling facet of its enterprise. The corporate has been working within the class for a while, leveraging its creations in an providing designed to focus on faculties, however that facet has largely taken a backseat to Sphero’s extra business choices till now. 

Academic robotics — STEM/STEAM particularly — is an especially aggressive area, as nicely. CES final week was overloaded with corporations large and small pushing into the class with quite a lot of totally different platforms, and from the appears of issues, subsequent month’s Toy Fair in New York gained’t be a lot totally different. 

However Sphero has the marked benefit of constructing on prime of its personal standard robotics platform. In actual fact, it ran standard pilot packages in its native Colorado that garnered protection in locations like Wired and The New Yorker final 12 months and in 2016.

The firm’s SPRK+ Education presents educators and fogeys a platform for instructing coding and robotics. Sphero’s bundle lets youngsters program its linked toys by means of coding, providing an actual world robotics platform on a budget.

“[Education] is one thing we will really personal,” the corporate’s spokesperson says hopefully. “The place we do nicely are these experiences we will 100-percent personal, from inception to go-to-market.”

Sphero co-founder and CTO Ian Bernstein additionally lately left the corporate to spin out out a brand new startup, Misty Robotics. It isn’t designed to be a direct competitor, focusing as an alternative on dwelling assistant robotics, however former staffers did be part of Bernstein on the new firm. Misty will even have its personal programmable robotic, although its providing, the Misty I, is targeted totally on grownup builders.

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