In spring 2022, Dame June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), described the agency as having transformed itself “from watchdog to enabler”. In the same speech, she boasted that she “tore up the rule book and we allowed companies to immediately start juxtaposing, not sequential phases of clinical trials, but overlapping, beginning the next one before the previous had been finished”. Those changes would, no doubt, be welcome to a pharmaceutical industry now contributing 86% of the MHRA’s funding.
In 2005, the House of Commons Health Committee expressed concerns that pharmaceutical funding would lead the agency to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies”. The Committee also criticised the MHRA saying that it “failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate” and that “greater transparency is also fundamental to the medicines regulatory system. There has to be better public access to materials considered by the MHRA prior to licensing”.
The public have a right of access to recorded information held by public authorities under the Freedom of Information Act 2000 (FOIA), one of the pillars upon which open government operates. The main principle behind the Act is that people have a right to know about the activities of public authorities unless there is a good reason – a presumption or assumption in favour of disclosure. In addition to requiring publication of certain information, the Act facilitates public use of Freedom of Information Requests (FOIR).
The MHRA’s website states: “The agency’s guiding principle is full transparency unless non-disclosure is justified on the basis of established freedom of information exemptions.”
In common with other public authorities, the MHRA published a series of quarterly ‘disclosure logs‘ of FOIRs “answered in full or in part”, starting in 2005. The disclosure logs were limited to a simple summary of requests and did not include the response. For example, there is a FOIR ref 20/521 with the intriguing title “Request for data – Covid” and the MHRA categorised its response as “Disclosed in Full”. There is no way of finding out what information was provided without submitting a further FOIR.
The publication of disclosure logs ceased at the end of 2020 and the following note was published on the MHRA’s website: “Redacted responses to all FOI requests received by the MHRA from January 1st 2021 are now published on this page. The last disclosure log we will publish is October 1st-December 31st 2020.”
The set of individual FOIRs, published from January 1st 2021, is incomplete with missing responses for the weeks commencing January 11th and 18th 2021, and for the week commencing August 9th 2021. From the end of June 2021, there was a publication hiatus until mid-August 2021. Subsequent publication was haphazard, with delays of up to several months, suggesting internal review issues. The posting of individual FOIRs stopped completely at the end of April 2022 and the MHRA no longer publishes individual FOIRs or disclosure logs.
This suppression of information by the MHRA comes at a time when public confidence in regulation is already fragile. By contrast, the Ministry of Defence, a public authority with good reason to be cautious about transparency, publishes timely, weekly sets of suitably redacted FOI responses. It appears the MoD has a considerably greater commitment to transparency than the MHRA.
The only option remaining for individuals is to make their own FOIR, ideally through a publicly accessible platform such as WhatDoTheyKnow.com (WDTK). It is perhaps unsurprising that there was an increase from 59 FOI requests to the MHRA through WDTK in 2020, to 118 in 2021, and 122 in 2022. Notably, the MHRA refused 24% of the WDTK FOIR submitted in 2022 while no requests had been refused in 2020 and 2021.
Analysis of the 44 FOIA requests submitted to MHRA through WDTK year to date 2023 shows that 16 are currently being processed and two have been reported as “data not held”. Of the remaining 26, ten are significantly late, two have been referred back for Internal Review, and one has been referred up to the Information Commissioner; taken together, this represents a major failure to respond to the satisfaction of the requester.
In an attempt to place the missing disclosure logs (since January 1st 2021) and the unpublished FOIR (since May 1st 2022) in the public domain, I submitted two requests to the MHRA through WDTK on January 5th and 18th 2023, respectively.
Two months having passed, I have yet to receive the disclosure logs. On March 5th, my request for the unpublished individual FOIRs was refused under section 22 of the Act with the following message:
No decision has been taken to stop the publishing of FOI responses. We remain committed to publishing responses, but we accept that there has been a long delay and a backlog of responses to publish has now developed. We intend to resume publishing towards the end of March with the aim to have caught up the backlog over the next two to three months, and then establishing a more regular publication cycle.
Whilst we recognise there is a clear public interest in providing copies of our FOI replies, doing so ahead of our proposed publication timeframe would involve taking resource from our front line customer team to focus on this activity, leading to a delay in responses to customers making contact with the team. Given that we have a plan to begin publishing shortly we do not believe the public interest is best served by bringing this activity forward.
It seems we have to wait until April 2023 to be given access to FOIA responses from a year ago!
Meanwhile, I have examined earlier requests escalated, as complaints, to the Information Commissioner (ICO). These show an average delay of just under a year between the initial request to the MHRA and the ICO’s decision. In 2017 there were just two complaints to the ICO about MHRA responses, and only one in each of the years 2018 to 2020. However, in 2021 30 complaints were taken to the ICO with 26 of the refusals being upheld, 12 citing section 14 of the Act (‘vexatious’ requests), the MHRA’s exemption of choice.
The ICO advises public authorities that for a request to be ‘vexatious’ it should be “likely to cause a disproportionate or unjustified level of disruption, irritation or distress”. Requests the MHRA apparently finds particularly vexatious are those seeking what the 2005 House of Commons Health Committee described as “materials considered by the MHRA prior to licensing”, as well as materials evidencing routine and additional pharmacovigilance activities.
In common with ICAN, HART and others, I have been seeking access to materials supporting the MHRA’s decision to license the AstraZeneca COVID-19 novel vaccine, Vaxzevria. Though quietly withdrawn from use in much of Europe, including the U.K., Vaxzevria remains licensed and has been administered to children. It has been disproportionately associated with adverse reactions and those damaged by it are being largely ignored by the authorities. Important information is being withheld from the public which has a right to see all the data provided by AstraZeneca to the MHRA.
In December 2020, Vaxzevria was granted temporary authorisation under Regulation 174 of the Human Medicine Regulations 2012. On June 24th 2021, it was authorised with a Conditional Marketing Authorisation (CMA), a label used to describe “medicinal products that address an unmet medical need, such as a lack of alternative therapy for a serious and life-threatening disease”. The MHRA Public Assessment Report on Vaxzevria goes on to state that: “CMAs may be granted where comprehensive clinical data are not yet complete.” The supporting Risk Management Plan for Vaxzevria identifies “missing information” and specifies a set of pharmacovigilance activities with milestone deliverables and due dates.
In late August 2022, I submitted a FOIA request for a number of these deliverables which, according to the Public Assessment Report, the MHRA should have received. The MHRA replied to say that the information I requested was “not held”, either because the surveillance activities had been “removed” or because delivery dates had slipped by up to a year, conveniently to December 2022. My requests for internal review have been “delayed” with the final message from the MHRA, dated January 20th 2023, stating “We apologise you have not yet received a response and we hope to respond to you as soon as we can.” At the time of writing, two subsequent FOIRs, submitted on February 4th 2023 and requesting specific deliverables identified in the current “Conditions of Authorisation for Vaxzevria” have yet to be satisfied.
The MHRA is in breach of the Act due to numerous delayed responses (from the second quarter of 2021) and withdrawal from its website of the ‘Publication Scheme’ in December 2014. It has also breached the Government’s principles of transparency and open government by removing its Publication Scheme in December 2014, ceasing publication of the Disclosure logs (from January 2021), ceasing publication of FOI responses (from May 2022), and arguably making excessive use of exemptions, particularly section 14 or ‘vexatious requests’ (from fourth quarter 2021 onwards).
The public have a right of access to the recorded information held by public authorities through an Act which is sometimes described as ‘purpose and applicant blind’. Instead, the MHRA has pulled up an information drawbridge, giving the impression that it is acting as ‘enabler’ for its paymaster, the pharmaceutical industry while being vexed, distressed or irritated by the public asking for important information.
It is time Parliament revisited observations it made in 2005 and asked whether it remains the case that the MHRA has “failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate” and whether it continues to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies”. On behalf of those injured by the COVID-19 novel vaccines, enabled by the MHRA, Parliament should urgently be finding out what the agency has to hide.
Prior to his recent retirement, Charles served as a military pilot followed by senior roles in the City and in school leadership.
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The R now stands for rubberstamping not regulatory.
As for the Oxford/AZ goo, I always come back to this creepy occasion and picture.
Hope they are now all suitably embarrassed and contrite. Though I doubt it.
MHRA – Do you have to be a conspiracy theorist to understand the power of predictive anagrams?
Do you have to vax up and give yourself the latest protection against everything just to ensure that you live as long as possible.I would advise against such a philosophy. Reality has a way of biting such people in the arse big time.
Just another cock-up.
Too well organised and co-ordinated, on a global basis, to be called a cock-up.
Indeed. My pet theories are either (1) they panicked when they discovered the leak and/or the US biosecurity people decided to run a real life exercise or (2) the leak was deliberate, in order to run a real life exercise. (1) is more plausible, IMO, because they still have some deniability.
Every cover-up in which two or more people conspire together, to conceal information which the public have a right to know, is a conspiracy. But it doesn’t necessarily mean that there is some mastermind behind it all planning it from the start.
The problem with the cock-up versus conspiracy debate is that there is no clear agreed definition of what is meant by ‘conspiracy’.
Yes indeed, and the cock-up advocates like to raise the “Bond villain” straw man.
Schwabb et al seem to be plainly visible. Indian Knickyknacky seems quite happy to lick his leather shoes and pant.
Presumably a conspiracy can be cocked-up?
If you have to ask that question – you already know the answer. The data is damning and evidence of serious wrongdoing.
If in doubt ( and you’ve got nothing specific to say about an article ) the latest dose of Doug Brodie should have you covered. It’s his ‘swan song’ finale!
”I’ve done what few other commentators have done by linking the abuses that the globalists have inflicted on us through their Covid scam to the abuses they are inflicting on us without any morally valid mandate through their equally unjustified other scams:
“climate change”, Agenda 2030 and The Great Reset, the Ukraine war, national sovereignty sellout to the Bill Gates and CCP controlled WHO, online censorship and “safety” (and suppression), 15-minute cities, air pollution, health-hazardous 5G, the dysfunctional NHS, out-of-control immigration, gender and identity politics wokery, identity verification, central bank digital currencies, cost of lockdown inflation, deliberately created food shortages, crippling energy costs, … what a catalogue of oppressions!”
https://metatron.substack.com/p/covid-climate-change-agenda-2030
Thank you Mogwai very interesting Substack tons of information and interesting videos brilliant stuff.
My daughter works in information governance for a local authority so I have a slight insiders view as to what has been going on with FOI at the moment.
Her team worked throughout lockdown, which was incredibly difficult at first whilst they waited for technical issues to be overcome – she was logging on to work at 7 am to download the files she needed as there was no way she would have had access to the server later in the morning as there was so much demand with everyone working from home.
As lockdown progressed, so did the volume of work. They were receiving easily twice as many requests by the summer of 2020 as before lockdown, perhaps because people had more time to make requests. And the proportion of people making incoherent and ludicrous requests as well. People were less tolerant too – repeated vicious nasty emails being sent the minute a request was a day overdue, instant demands for internal reviews followed by more requests etc. They lost 2 members of the team in 2021 to elsewhere as the pressure had got so bad. People who waited patiently got pushed back in the queue because others turned nasty. And their employer kept refusing to get more staff in because they are pretty much broke, until the Information Commissioner’s fines started to roll in.
So I can understand the delay if the MHRA is anything like a local authority. The information officers are probably constantly chasing those with the info to come up with the goods, and being fobbed off themselves. I rather think that the IC is in much the same situation as well – they have taken months to come back with decisions for requests that have been escalated to them. It’s all a big mess and requiring far more skilled manpower than was ever envisaged when it was set up.
Just keep asking. They have to reply eventually.
Why aren’t they releasing key vaccine safety data? I’m sure it’s just a “cock-up”, not a conspiracy
It is as if we have become accustomed to women wearing tampons in public and then any message issued is somehow affirmed by this menstrual status. It really isn’t I have had one older relative and a friend in his forties die after taking these injections. I am afraid Mrs Raine that you won’t be immune for much longer.
VG article., but one quick factual query regarding MHRA funding.
I read somewhere fairly recently (no longer sure where) that MHRA received 86% of its funding from big pharma up until some point in 2022.
Can anyone confirm or refute this, preferably with a link?
Ah yes, I heard that from Dr Malhotra.
Freedom of Information request on whether the MHRA receives funding from the Bill and Melinda Gates Foundation (FOI 21-624) – GOV.UK (www.gov.uk)
“The majority of our income comes from the pharmaceutical industry through fees.”
I am one of those who had a simple request rejected as being vexatious, because several people had made the same request, which in fact should have made it easier to deal with. The ICO backed up MHRA. I decided not to appeal further as being counter productive as an amateur in this area.
How many requests have you made to the MHRA? Is this your first, or have you made about half a dozen or so in the past few months, all on a similar theme?
If it’s your first request, then there is no way that they can call it vexatious, even if several other people have made the same request, unless they can prove that you are acting in concert with them.
If it’s one of a series, then you’ll struggle to get anywhere.
Have they answered any of your previous requests (even with a fob off)?
Too many organisations are funded by the very companies they’re supposed to be regulating. It’s one thing for newspapers to self-regulate when all they do is print stories. It’s another when organisations such as the WHO – which is a front for the Gates Foundation and various other shady groups – are deciding on our liberty and what drugs are put in our bodies.
I understand Reagan’s concerns about the WHO in the 80s and why he slashed funding, but the fact that Big Pharma and the likes of Gates are now funding it makes me feel it needs to be returned to funding by nations only, the present staff cleared out and its workers be thoroughly screened for Big Pharma and Chinese connections.
Bearing in mind the last 3 years, would we be better or worse off if the WHO didn’t exist?
Yes, I probably should have said ‘if it really has to be kept at all!!’ The issue is, though, that the UN and connected agencies were (naïve as it sounds) about countries cooperating after over 30 years of bloody global conflict and some sort of meeting point between nations has its uses.
These organisations have become too big, though, and – as Milton Friedman commented about big government – big business has ended up running them.
The UN could realistically be run out of one office building in Geneva and hire a conference centre once in a while for the leaders of countries to get together.
A major issue compromising the UN from the outset was that bad people were allowed to be part of it. Founding member Taiwan was booted out in favour of the most brutal, murderous country in the history of the human race: Red China. The Soviet Union was allowed in, which, as Ayn Rand pointed out at the time, reached a farcical point where American conduct in Korea was being overseen by the UN Security Council, which included the Soviet Union. However, the Soviet Union was supporting the communists in what is now North Korea.
As the UN has got ever bigger, it’s sucked up ever more money and become beholden to all manner of dodgy organisations. So much of its work is ‘public-private’ collaboration now, which effectively means corporations and other entities now have access to a major governmental meeting point and thus are able to manipulate international treaties and national governments. It’s not the organisation many of its founders would have wanted. And Red China is brilliant at bribing and manipulating Western politicians and businessmen, of course, which led to Tedros becoming the WHO boss and pushing Chinese ideology on the world during the scamdemic.
All these organisations are a bit like a computer that hasn’t been serviced for a long time. They need a shutdown-reboot with all the trash emptying out and all the systems restored to factory defaults.
The WHO should be shut down. Full stop.
One wonders what her Damehood was awarded for. Not administrative efficiency, for sure
she should be sacked and the whole board replaced.
Probably for proactively changing the mission of her organisation from regulator of potentially dangerous novel therapies to enabler of unproven bio toxins. Without actually consulting anyone. Or looking up the meaning of ‘Thalidomide Tragedy’
I want to know why she is still in post, why hasn’t she retired? She is I believe 70+ – surely? What is the retirement age for civil servants such as her?
It would be interesting to find out who in the MHRA or Pfizer for that matter have been jabbed with their mRNA products?
From what I have read jobs at the MHRA and big pharma interchangeable.
90% of MHRA employees will eventually work for Big Pharma.
And 90% of MHRA employees come from Pharma….no conflict of interest here…
This sociopathic parasite on the face of humanity should join Hancock, Whitty, Johnson et al on the scaffold. At the earliest opportunity.
Bob Moran has already made them an offer….
Wonderful
Yes well if they need someone to pull the handle..
Join the orderly queue….
“Why is the MHRA Refusing to Release Key Vaccine Safety Data?”
The answer will undoubtedly be in the T&Cs the Government signed off with Big-Pharma companies. Get hold of the contract and all will be revealed.
Agreed. The pharma companies are more powerful than the governments now.
Unplanned….
Hancock references the terrorist WHO leader and demands Kill Gates ‘owes him one’…on the endless stabbinations with implants…just a cockup
When it comes to Covid and the experimental gene therapies, Parliament’s got far too much to hide about its own appalling record to bother itself with finding out what the MHRA is hiding.
The MHRA is yet another state organisation that is unfit for purpose. That’s hardly a surprise given the CEO’s behaviour at a dinner of her University alumni when she smugly boasted that she had decided to change the focus of the organisation from regulator to enabler; no doubt at the behest of the companies that provide 86% of her budget. She is yet another politicking, incompetent bureaucrat burnishing her credentials for a gong. If she had even the smallest iota of conscience then she should have witheld approval until all the safety work on the so called ‘vaccines’ was completed.
Meanwhile, without the political pressure, her organisation take a different path. They have recently taken about 4 years to approve a product for sale in pharmacies that was previously avaialble on prescription only. This product a local, as opposed to systemic, oestrogen had been available for over 30 years in the UK with a perfect safety record. However, as one of their ‘expert’ advisors still believed the now discredited ‘HRT causes cancer’ trial they kept on asking for more and more irrelevant data. They didn’t want to accept that a year’s dosage of the product was equivalent to one oral tablet of systemic HRT, nor would they accept the previous safety data. But then this was only a product to help women with vaginal atrophy; not a silver bullet to save the world from 99% of all known germs.
The MHRA fulfils the old Mafia maxim “The fish rots from the head”
All governments and their regulatory bodies are in hock to the big pharmaceutical companies, all of which have a profit motive far above that of carrying out properly conducted research or providing honest information about their products. This allows people managing drug controls to receive far higher salaries than they otherwise would, and makes their objectivity limited and their conclusions biased.
Usually when the government hides stuff from us its because they were in the wrong and acted unlawfully.