As promised this week the Lion’s share of my blog is dedicated to the Medicines Health and Products Regulatory Agency (MHRA) Board meeting that I attended last week. As I reported on the UK Column News, there was a record attendance of online viewers, over 70 members of the public and patient safety groups. Thank you to our viewers who joined me, bravo. I am still a little mystified however why the MHRA Board feel the need to have a second, private meeting that same afternoon. What do they discuss there that they don’t discuss in front of all of us?
New-style MHRA Board Meeting, January 2024
The Medicines and Healthcare product Regulatory Agency (MHRA) board meetings have changed beyond all recognition from when they first started to be published as videos online. During lockup, members met on Zoom virtually; however, finally, in September 2021, the Board met once again for the first time in public. Back then, it was a very relaxed affair: no-one appeared to be taking much notice until UK Column started reporting on them two years ago. In 2024, it’s now a very slick, polished and staged pantomime. With reminders of camera angles pasted on the walls behind the board members, I half expected a make-up artist to powder some sweaty faces. As always, the meeting starts with introductions, declaration of conflicts of interest (there were none on this Board), and apologies for absence, of which there were more than usual, including Dr Alison Cave, Chief Safety Officer.
Dame June Raine’s report to the MHRA Board—verbatim transcript
Emphasis in bold type has been added by Debi.
Thanks very much indeed, Graham [Professor Graham Cook, Interim Co-Chair], and I know colleagues will have read the report, but as ever, just to stress how busy it has been for the agency. A lot in this report, but also, I might just highlight: new year, new beginnings, there's been some new things on the horizon since particularly the beginning of this month—and, of course, the key themes are always enabling access to healthcare products safely, to support science and innovation, and most importantly to deliver for patients.
So, in terms of enabling access, I really would like to flag that momentous date of 1 January, when our International Recognition Procedure (IRP) became law, and we look at this really very positively. We will be talking about it shortly in terms of harnessing the expertise of regulatory partners worldwide, to enable that smooth and streamlined access to innovation. But, of course, we’ve got to consider and debate at the Board here what our, if you like, USP [unique selling point] is, going forward. So, I know that will be a good discussion, but just wanted to highlight the importance of 1 January [2024].
We’re also looking at new assessment approaches for our established medicines. That’s been something that we've been discussing for a little while, but with the need to improve efficiency and eliminate backlogs, our teams in Established Medicines have really been putting their thoughts together on how to make this as effective as possible, and I know that later we’ll be talking about that too.
9 January was a special date, because we published our long-awaited roadmap for Medtech, and that has been really warmly welcomed—because, at long last—huge, massive piece of work, equivalent to a Bill—I think it's such a big piece of work that we’re able to begin to show the way forward, and that will matter for software, AI, diagnostics, some of the important technologies. So I just wanted to highlight what’s new.
I think it’s important to talk about, as a result of the McLean Report last week, what we’re doing to improve access to transformative products, particularly with the devices pathway, IDAP: looking at some really front runners, the eight out of about 80 applicants that will be pushing forward by 2025, and that’s got patient expert input as well. And, I think, a good example of the One Agency Approach. I always look for is a medicine for arthritis, called Golinumab, seen it in here: it’s coming off patent but our scientists are looking at international standards, so the whole agency is helping to deliver for this important population.
And I can’t leave the Science in Innovation part without mentioning polio. The news is that the Emergency Use listing by the WHO, thanks to the intervention of the regulator in Indonesia, is now pre-qualified, and that'’ a really important step. The scientists who’ve done this work really are leading the field, and this makes it much more accessible.
Finally, just delivering for patients and the public: colleagues will have heard last week about the European [Medicines] Agency’s action on valproate, particularly the risk of fathers handing down neurodevelopmental disorders. That’s a question that we're looking at, but—importantly—our new measures come into place. And their measures that have had the input of our valproate patients and stakeholders network to make sure that no-one who can be treated with something else is actually started on valproate.
So, and last of all, I think it’s again back to science. The Group B Strep Support Group came in and were treated to quite a lot of insights into what we as an agency are doing to eliminate this really nasty infection in newborns. None of it would be possible without our staff.
I’ve talked a fair bit, I know, but the credit all goes to the staff, who’ve been so committed throughout what’s been quite a challenging time. So I’ll stop there; it’s just some highlights to really bring to life. I know it’s quite a long read.
Question from the public on polio vaccine
Description as read out at the board meeting: One of the items in the Chief Executive’s report about the polio vaccine. The questioner has said that the report mentions the risk of vaccine-derived polio virus, and asks: how does that compare to wild polio numbers?
Chair: Okay, so that’s quite a specific question. Marc, do you want to come in on that?
Dr Marc Bailey [Director of the National Institute Biological Standards Laboratory, based at South Mimms (NIBSC)]: Thank you very much, Chair. So, polio is a subject of a very significant eradication programme internationally, and at this point there are known cases of wild-type polio in only two countries and significant work is being done to eradicate it.
So, very few numbers of wild type. The polio virus that was used to vaccinate the vast number of the population has an unfortunate rate of reverting to wild type, and then you can see outbreaks occurring. Those can occur anywhere globally, and there is an international surveillance system, and the MHRA is very proud to participate in partnership with the UKHSA and other public health bodies in the UK to actually undergo surveillance for the people in Britain of such a situation. I don’t have exact numbers to hand, but if there was such a breakout, then the object is to vaccinate anybody who might be at risk, and that is where the NOPV2 vaccine comes in. It’s for Strain 2, one of three strains of polio, and it has an extremely low rate of reverting to wild type, and I do mean exceptionally low. And as such, it’s safe as a vaccination protection system, to prevent further vaccine derived outbreaks. So I hope that answers our question, and we can certainly reach for more figures if necessary.
Chair: No, I think that’s very thorough, and it’s slightly tangential to the work of the Board.
Debi’s note: Dr Bailey, however, omitted to tell us of a global ‘specialised polio laboratory’ at South Mimms.
Question from the public on health and safety at South Mimms Laboratory
Description as read out at the board meeting: Relates to the discussion on health and safety that the Board has just had, and it’s quite a specific question again. Does the South Mimms Laboratory have a Level 4 SAPO-trained officer? And are there arrangements in place for a SAPO 4-trained deputy? And I thought it might be useful if perhaps we could just explain what that acronym means, to start that off.
Dr Marc Bailey, Director of NIBSC: Certainly. So SAPO 4 stands for Specialised Animal Pathogens. It’s a type of containment for animal diseases that have been proven, or known, to cross over and infect humans. So an example is avian influenza, but there are other examples. It’s an extremely high level of containment requiring specialised containment facilities, trained staff, and a dedicated support system, which in this case includes a biological safety officer who is trained in understanding the nature of the animal pathogen involved, the risks and any specific handling. We have both a trained biological safety officer and a trained deputy in place of South Mimms—but just a note on the training. The training is an ongoing process, so they will both be receiving continuous updates and training to maintain proficiency.
Please note that an expert in health and safety was viewing the Board meeting, and there will be more on this in the very near future. Did Dr Marc Bailey confirm there the presence at South Mimms of a trained SAPO Level 4 Officer? I don’t recall him confirming that as such; could he be trying to hide something? It appears all is not as it should be at NIBSC. Pursuant to a recent Health and Safety Executive inspection of the site, there are, as I understand it, improvements to be made. Dr Bailey did add, however, that he hadn’t had sight of the report and would be updating the Board as soon as he could.
A few more key takeaways. There was no mention of the serious adverse reactions from the Covid–19 injection or the vaccine injured. Clinical trial applications from industry are being given the gold-star, fast-track treatment. No applications are backlogged and the MHRA hopes to be able to accelerate the process even more—to 60 days. You can thank Lord O’Shaugnessy for the acceleration. Please note, clinical trials are ‘experiments’.
Financially, it appears the MHRA is holding onto a £4.4 million surplus. Apparently, revenue from the pharmaceutical industry is up—and, while staff vacancies are down, so is the wage bill. But how does that work? For a respectable £75,000 per annum plus benefits, the MHRA is looking to employ a Head of Respiratory, Critical Care and Imaging. A handful of job vacancies can be found here, for anyone interested, and the Agency is also keen to splash the cash on vaccine experts.
The dates for the next board meetings can be found here. Please book a date in your diary to join us. The more that watch, the sweatier their palms get. What is the Medicines and Healthcare products Regulatory Agency? Perhaps it should be renamed the Bill Gates Pharmaceutical Enabling Agency (BiGPEA). So there you have it. Just a taster of what went on at the board meeting.
New Year and New Challenge for UK Companies House in 2024
Many thanks to Alison, one of our sharp-eyed members, for spotting this report from Louise Smythe, Chief Executive and (for England and Wales) Registrar of Companies House. Is this the start of digital identification through the back door?
Who has heard of the Economic Crime and Corporate Transparency Act? According to Companies House, 2023 was a turning point in the House’s history, as the Act gained royal assent in October 2023.
As Companies House comes to the end of the fourth year in its 2020–2025 strategy, dramatic changes are being announced: new priorities, new strategies, and—most importantly—more power. Here are some of the changes that will be introduced in March 2024, in Companies House’s own wording:
- Greater powers to query information. This means we’ll be able to scrutinise and reject information that seems incorrect or inconsistent with information already on the register. In some cases, we’ll be able to remove information.
- Stronger checks on company names.
- New rules for registered office addresses, which will mean all companies must have an appropriate address at all times. Companies will not be able to use a PO Box as their registered office address.
- A requirement for all companies to supply a registered email address.
- A requirement for all companies to confirm they’re forming the company for a lawful purpose when they incorporate. Every year, the company will need to confirm that its future activities will be lawful on their confirmation statement.
- Annotations on the register to let users know about potential issues with the information that’s been supplied to us.
- Taking steps to clean up the register, using data matching to identify and remove inaccurate information.
- Sharing data with other government departments and law enforcement agencies.
Stories in Brief
Disease X
The World Economic Forum met at Davos, and was buzzing with news of Disease X. Bill Gates appeared to be delighted at the prospect. My question is: how many of us buy into this another time around? Do those in Davos, the WHO and the United Nations really think we will ever trust what they say again? No-one appears too worried that a vaccine and a US Congressional Bill have been cooked up without anyone even knowing what Disease X is. More fear, more anxiety and no doubt more jabs.
Measles
Yet more fear. According to the UK Health and Security Agency (formerly Public Health England), we are in the grip of a measles epidemic, and a national incident has been declared. I don’t suppose it has anything to do with the fact that the UK has lost its precious measles eradication status and that the WHO is piling the pressure on for us to regain it. Enter the new campaign to get all our kids injected with the triple Measles, Mumps and Rubella (MMR) vaccine. I wonder why parents and youngsters are not accepting the invitation to grab a jab. Would that have anything to do with trust and low confidence, by any chance? For the record, there has only been one death from ‘late effect’ measles since 2020. NHS England has just launched a ‘catch-up campaign’, to entice those eligible to be jabbed. Do you know what is happening in your local school or college?
1 in 22 people in England have a disabled parking badge
Yes I must admit, I had to read that statistic twice before the information sank in.
One in every twenty-two people in England have a ‘blue badge’, otherwise known as a disability parking badge. In March 2023, 1.14 million badges were issued—a staggering rise of more than 100,000 as compared with March 2022.
Has anyone thought to ask why? Could some of it be attributed to vaccine injury? Will anyone bother to ask or look?
People with severe mental illness dying younger
Why do those with severe mental illness now face a life expectancy reduced by up to 20 years? According to the Research Centre of Mental Health, a report commissioned by NHS England suggests that many are dying because of preventable or treatable physical health problems. The barriers listed include distrust in healthcare and professionals, unsurprisingly. Could Covid–19 vaccination be responsible for this sudden reduction in life expectancy? Can you guess what may be coming next? Annual physical checks for everyone with severe mental health illness? I call it surveillance.
NHS Emeritus scheme announced—retired doctors set to make a return to the NHS
NHS Emeritus will allow retired doctors to return to the NHS. With ever-increasing waiting lists of people who need outpatient appointments, as opposed to surgical procedures, this is a more cost-effective way to employ doctors than hiring expensive agency staff, which cost the NHS more than £3 billion in 2020–2022. The programme is scheduled to last for a year.
Davos secrets: Caviar, champagne and magic mushrooms
The New York Post published an interesting article on the secrets of WEF attendees. The menu doesn’t just stop at gold-leaf desserts. The sky’s the limit, and nothing and no-one is off their exclusive VIP guest list. It’s all in the badge colour, don’t you know. As their private jets line the runways, one has to wonder how they are getting away with any of their phoney climate change agenda. One thing is for sure: no matter what they try to do, they will never regain trust, because they never had it in the first place.
And Finally
The elephant in the room in British health is the Assisted Dying Bill. It appears that, with the support of likely next Prime Minister Sir Keir Starmer and household name Dame Esther Rantzen, it’s full steam ahead for a ‘good death’—due to come to the UK in 2024.
What is the difference between assisted dying and end-of-life care?
Assisted dying is where the person concerned makes a conscious decision to end their life and ingests a substance to cause their death.
End-of-life care is where a medical professional administers drugs to induce death—alias euthanasia, with or without your consent.
Most of us will be familiar with end-of-life care for those who are terminally ill, but the invitation to snuff out your life will include anyone elderly who are ‘tired of life’ (there is a parallel movement in Dutch politics to enact this option under the description of ‘life completed’), as well as those at any age suffering with mental illness or autism. I watched the Excess Death debate hosted by Together: it makes for very difficult but necessary viewing. Participating were Professor Patrick Pullicino, Professor Kevin Yuill and many traumatised families who had lost loved ones to the horrors of NHS end-of-life care.
Baroness Tanni Grey-Thompson has warned that “changes to the law in the UK around assisted dying could leave disabled people with no choice but to end their lives”.
I will be following up on this very worrying development.
Every week, I seem to end this blog asking people whether they have an emergency plan. Could you cope if the lights went out and your phone went dead? Do you have enough in your pantry, should we experience food shortages? Do you have a full tank of fuel in case the fuel pumps go down? Several European national military chiefs are now asking their populations these very questions. Already, our supply and distribution network is suffering from severe delays, and we may soon see gaps on our shelves. For newbies to prepping, I can thoroughly recommend The Prepper’s Blueprint, a step-by-step guide to help you through any emergency. We all have to start somewhere. Perhaps now is the time to invest in a water distiller?
Until next week. Stay warm.
God bless,
Debi.
Also I say unto you, Whosoever shall confess me before men, him shall the Son of man also confess before the angels of God; but he that denieth me before men shall be denied before the angels of God. Luke 12:8,9
