Member Info for RegulatorUK

"Absolutely solid authoritative set of tweets today. Lovely stuff. Even my head was wobbling today"

I'm rather looking forward to the next week or so...

When are you off to Porton Down?

"We also have the small matter of National and regional elections on May 6 to contend with.
Politically, the impending elections mean that the DHSC are limited in terms of what can be announced."

There are no national elections on May 6 - there are local and regional elections taking place in England, with Parliamentary elections in Scotland and Wales.

The pre-election period rules do not stop DHSC from making announcements - particularly during a pandemic. I think it is being used somewhat as an excuse by DHSC until they can see what way the **** show in Downing Street and the Tory party pans out...

"A conspiracy theorist might wonder whether the GLP hasn’t been discouraged from bringing a case against HMGov because currently no monies have been paid. The case might get thrown out of money hasn’t been paid"

That's nonsense. The case has already been brought before the court, with leave to proceed and a cost capping order having been granted. Whether HMG has breached the terms of the contract is irrelevant as to whether or not they complied with the law in granting the contract in the first place.

I've always said I don't believe that the Abingdon case is the strongest - but I think it was deliberately chosen as it gives the court a wide scope to clarify the extent to which Article 32 can be used to bypass proper procurement processes.

"Anyone that runs a business know suppliers are slow to pay up..its the norm.."

I think you mean "anyone who runs a supply business knows buyers are slow to pay up... it's the norm"

The statutory interest on that debt is stacking up nicely at 8.1% per annum...

The statutory interest on that government debt is going to stack up nicely...

"I can't see it being announced before May 6th due to purdah"

Pre-election period ('purdah' is not longer considered an appropriate term to use) rules for local elections do not stop central government making announcements.

"not sure but im planning on breaking into porton down on wednesday so will let you know then"

I shall ask my brother-in-law (who works there for PHE) to tell the guards not to shoot...

Morning all!

Lovely long and successful* weekend away (in North Yorkshire), with a deliberate decision not to look at this board. Seems I didn't miss much judging by the number of green boxes.

*I managed to get a pair a walking boots that fit properly, thanks to the lovely folks at Alt-Berg.

Interesting...

Oops! I meant:

"The Rat is in a frenzy today. Full of Red Bull and spewing out nonsense.
Beware The Rat!"

Which Rat?

"Comp, do we need PHE approval to sell the Visitect test?
Don’t think we do, it’s driven by the CE certificate."

Which Rat? Seems to be a few of them infesting the board...

"Comp, do we need PHE approval to sell the Visitect test?
Don’t think we do, it’s driven by the CE certificate."

CE/UKCA certification only applies (with the exception of a very small number of medical devices, e.g. pregnancy tests or blood sugar test devices) to professional use. If the medical device is intended for non-professional use then further authorisation from MHRA is required.

We do not need MHRA approval to sell the Visitect test for professional use. We would only need MHRA approval, and to go through the PHE review process/get an EUA, if we were intending to sell them for non-professional use.

You mean the link I posted earlier today?

It could be 'interesting'... ODX might end up making the Innova test.

See the list here: https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/outcome-of-the-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devices

"The MHRA List of medical devices given exceptional use authorisations was Updated on 20 April 2021
It looks like the Innova LFT kit, which the UK government has relied upon this past six months or so has been cancelled and the contract expires 22nd June 21."

I'm afraid not. The updated Innova test has been through the PHE Porton Down assessment process and passed. That means they will no longer need to rely of an EUA but will get authorisation from MHRA. The scope of that authorisation has yet to be announced.

""A key focus for Avacta is the supply side, confirming that it has access to 5-30m tests per month (subject to access of equipment funded by the UK government), when fully scaled up, and is in discussions with OEM partners and other LFT manufacturers in overseas markets to increase this further."

Government funded equipment."

As I understand it, access to government funded equipment is limited to those involved in the sovereign test scheme - which Avacta isn't at present. Whether they will put their test forward, once it is CE marked, for assessment as part of the PHE PD process has yet to be seen. They may struggle, given the relatively small testing sample to date.

"No look at @BigJock36 on Twitter, he likes to dish it out - showed his true colours on the day NCYT dropped 40% going after a few people. As you like to suggest to others, DYOR."

You made a specific claim about a specific tweet... and now refuse to link to the tweet. That says everything about your credibility.

"Could the lack of news on the selection of the next sovereign test be related to the fact we are in a period of Purdah due to the upcoming elections?"

The pre-election period rules ('purdah' is not considered an acceptable term these days) applies primarily to local governments structures when its local government elections. Whilst there was supposed to be a halt on official announcements during the period of national mourning following the death of Prince Philip, there is absolutely no reason the government couldn't make an announcement now on sovereign tests.