In this week’s episode of Broken Custodians we examine the UK's system of pharmaceutical self-regulation and consider how and why it has proved woefully unable to hold the industry to account for pandemic-era regulatory violations.
We talk with Dr Alan Black, a retired pharmaceutical industry physician, about his career in the industry and how he became involved in scrutinising regulatory and ethical transgressions during the pandemic. We start with the structure of the UK regulatory regime for pharmaceuticals, and in particular the relationship between the MHRA, the ABPI, and the industry’s self-regulatory authority, the PMCPA: it’s incredible that this industry, which can do great good but also has the potential to do immense damage to human health and life, has been permitted — for decades — to regulate itself.
We go on to examine the novel approval pathway for the Covid vaccine products, and in particular the use of supposedly temporary Conditional Marketing Authorisations for products which lack the long term safety and efficacy data required for a full authorisation. Dr Black explains how this regulatory context, combined with the later extension of the Covid vaccination program to healthy children, raised significant ethical concerns around risk–benefit balance, informed consent, and the use of children in a public health strategy primarily aimed at protecting older age groups.
Our conversation also touches on the erosion of the public’s trust in public health, reflecting on the messaging during the pandemic that the products approved for use were unequivocally “safe and effective”, despite their conditional regulatory approval by definition having meant that safety and efficacy data was incomplete.
We then turn to enforcement and accountability for regulatory violations, focusing on a series of PMCPA rulings involving Moderna and other Covid vaccine manufacturers, including findings of those companies having made misleading claims about safety and efficacy, offering unlawful inducements, and other serious breaches of the industry’s rules. We discuss the absence of meaningful penalties, and the rare decision to audit Moderna after a series of adverse findings. The conversation closes with broader reflections on transparency, the secrecy surrounding regulatory audits.
An edited transcript appears below. Here is the full episode which you can also find on YouTube, Spotify and Apple Podcasts…
For next week’s episode we’ll be joined by Tom Richmond to discuss AI in our classrooms.
Broken Custodians is an UsForThem podcast and Substack https://www.youtube.com/@Broken.Custodians
Transcript
Molly:
Welcome to Broken Custodians. Today we’re going to be talking to Dr Alan Black, who is a retired pharmaceutical physician.
Alan, it’s fair to say you are someone we’ve got to know pretty well over the last five or six years. We’ve both been quite heavily involved in looking at some of the excesses of the pandemic period, and in particular we’ve looked together at some of the behaviour of the pharmaceutical companies during that time.
We were very keen to have you on so that a wider range of people can hear a little bit about what you’ve been up to and the really important work that you’ve done.
Dr Alan Black:
Thank you Molly and Ben for inviting me to talk here today. It’s a great pleasure to be here.
Molly:
Maybe you could tell us a little bit more about your background and how you got into this.
Dr Alan Black:
My name’s Alan Black. After I qualified as a medical doctor, I worked in laboratory medicine for a while, and I then trained and worked in general practice for a period.
I then went to work in the pharmaceutical industry, where I subsequently worked for the next three decades.
Molly:
Maybe let’s start very quickly at the end.
So, the most recent thing that we’ve done together — and I know there’s been quite a lot of public interest in this — was a case about six months or a year ago now. It was brought jointly by a number of organisations and individuals, including UsForThem and yourself.
There was a case brought before the UK regulator, the PMCPA — and I’m sure we’ll talk more about that body in a moment — involving Moderna.
As a result of that joint case, Moderna was found by the UK regulator to have brought discredit upon the pharmaceutical industry and has been made to undergo an audit, which is a pretty rare occurrence in the UK.
Should we maybe talk a little bit more about that case?
Dr Alan Black:
As you quite rightly say, I think it was early in 2024, a group of doctors, clinicians and scientists had become aware that children had been offered inappropriate amounts of money to participate in a Moderna clinical trial.
They became aware of this, and I believe UsForThem did too, and there was concern about it.
Because they were aware of my background in pharma, they asked whether I could advise them on what they could do.
I advised them to make a complaint to the Prescription Medicines Code of Practice Authority, which is the industry self-regulatory body in the United Kingdom that deals with malpractice by the pharmaceutical industry.
Molly:
Should we just explain to people — because I think there are a lot of acronyms involved in pharmaceutical industry regulation — that there are two basic regulators, aren’t there?
Do you want to maybe say a couple of words about each of those?
Dr Alan Black:
There are laws and regulations which govern the way medicines are developed, licensed, sold and marketed in the UK. The body responsible for ensuring that people operate within that legal framework is the MHRA.
Molly:
Which is the organisation most people will have heard of.
Dr Alan Black:
Yes — it’s the UK drugs and healthcare regulatory body.
Now, when it comes to misbehaviour by the pharmaceutical industry, the MHRA has pretty much effectively delegated all of that responsibility to the ABPI — the Association of the British Pharmaceutical Industry.
That is the trade body for the British pharmaceutical industry.
So, the MHRA delegated almost the entire responsibility to the ABPI.
The ABPI then set up a body called the Prescription Medicines Code of Practice Authority — the PMCPA — whose responsibility it is to ensure that pharmaceutical companies operate within that legal framework.
In order to do that, they developed a code of practice called the ABPI Code of Practice.
All pharmaceutical companies operating in Britain that are members of the ABPI — which is the vast majority of them — are obliged to adhere to that code.
That being the case, the MHRA has pretty much effectively stepped back completely from regulation of the pharmaceutical industry.
And we’re not just talking about advertising here. That covers all sorts of things like communications with politicians, communications with budget holders, communications with the general public, medical advertising, communications with medical professionals and also journalists.
All of that is encompassed within the ABPI Code of Practice.
So, it’s quite an important document within the pharmaceutical industry.
Ben:
Just to help listeners acclimatise to what you’re saying here, the summary is that the UK’s pharma regulator has delegated responsibility for overseeing the pharma industry’s compliance with laws and regulations designed to protect the public, to the industry itself — and specifically to the body that’s meant to champion the pharmaceutical industry as a commercial enterprise.
When we first got our heads around that, it was quite a head-scratcher for us.
It’s not unique for industries to have a degree of self-regulation, but this is a very significant piece of self-regulation.
And we’ll come on to talk about some of the consequences of that in a while, I think.
But broadly speaking, they mark their own homework.
Dr Alan Black:
You could say that, yes.
I mean, they would defend that, and they’d probably say they mark each other’s homework.
But your point is well made.
Yes, it is effectively the trade body policing the trade.
Now, the PMCPA would say that they are independent of the ABPI.
I would challenge that a little bit, and maybe I can say more about that later if you like.
But I would challenge that independence, and for me therein lies part of the problem we currently have with pharmaceutical regulation.
Molly:
I wanted to get that on record quite early because I think it’s important that people understand what we’ve been doing more recently.
But maybe now let’s rewind back to 2019 — or really 2020 — when I think you first became concerned about some of the things that were happening right at the beginning of the pandemic.
Dr Alan Black:
The pandemic started at the beginning of 2020.
By the end of 2020, we were starting to see the late stages of development and early discussions around regulatory approval of the first Covid vaccines.
In December 2020, the first of these was approved in the UK. The first one was the Pfizer-BioNTech Covid vaccine, which was approved under Regulation 174, which is emergency regulation.
It was approved for temporary use in an emergency situation.
By January, that approval was changed to something called a Conditional Marketing Authorisation.
And this is where my antennae started to twitch a little bit.
The Conditional Marketing Authorisation was a new thing within the UK environment.
It was something that had been established within the European Union, but not within the UK.
After Brexit, there was a lot of work going on to bring those powers back into the UK.
So in January 2021, the initial emergency approval was changed to a Conditional Marketing Authorisation.
Now, the MHRA themselves say about Conditional Marketing Authorisations that they are issued when the safety and efficacy database available is not sufficiently comprehensive or complete to issue a full licence, but is expected to be so “soon”.
So, these vaccines were issued with a licence in circumstances where, by definition, the safety and efficacy databases were incomplete.
Those are the MHRA’s own words.
But the other thing to note is that they said the database was expected to be complete “soon”.
So, I contacted the MHRA and asked: in what way was the Pfizer vaccine’s efficacy and safety database incomplete, and what did they mean by “soon”?
When did they expect the data to be available?
The MHRA refused to answer either question.
Molly:
And when you say they refused to answer — did they just not reply?
Dr Alan Black:
No, they replied.
But they wouldn’t tell me what “soon” meant.
And it turns out that “soon” actually meant two years.
The Pfizer vaccine that initially received a Conditional Marketing Authorisation wasn’t granted full marketing authorisation until two years later.
Ben:
And is that unusual in the pharma world?
Dr Alan Black:
Well, it’s difficult to know because this was the first Conditional Marketing Authorisation issued in the UK.
But two years doesn’t sound like “soon” to me.
And that’s important because during that intervening period — while there still wasn’t sufficiently comprehensive safety and efficacy data even for adults — they approved the vaccine for use in healthy children.
So, you have a medicine that isn’t suitable for a full licence because there is insufficient safety and efficacy data available for adults, yet it was still approved and encouraged for use in healthy children.
For me, that raised all sorts of alarm bells and red flags.
Molly:
So this would’ve been fast-forwarding a little into the spring and summer of 2021.
This is when we, UsForThem, became involved in looking at the ethics of the vaccine rollout to children.
At the time I was asked to write a piece for The Telegraph about it and, as you identified, this was a product for which there didn’t appear to be any medium-term, let alone long-term, safety data.
I think it was around that time that we were put in touch, and I remember it very well actually — we had a long conversation about the ethics of this vaccine being rolled out to children. And that really began our journey together.
At the time, I certainly felt very isolated arguing for caution. And of course there was an enormous smear campaign that followed.
But we now know that the Government had an ethics committee which was also raising serious concerns — particularly around vaccinating children — on the basis that there was insufficient safety data. And we also know that that ethics committee soon after was sidelined and eventually disbanded.
So, can you tell us more about your journey from that point onward?
Dr Alan Black:
So much happened. Immediately after that time, when these vaccines started to be rolled out, they were all approved with Conditional Marketing Authorisations. So, they all had incomplete, non-comprehensive safety and efficacy data.
Molly:
Do you feel that was ever made clear to the public?
Dr Alan Black:
No. No, it wasn’t. If you remember, every time you tried to raise this point, you were bombarded with the phrase: “No corners were cut.”
That was the standard response.
Ben:
And of course that these products were definitively “safe and effective”, which is curious when you explain the definition of a Conditional Marketing Authorisation.
Molly:
So if we say corners were cut, what corners had to be cut in order for a conditional authorisation to be issued?
Dr Alan Black:
Well, by the MHRA’s own admission, the amount of efficacy data and safety data available was insufficient for them to issue a full marketing authorisation. That’s why it was “conditional”.
So they couldn’t make a fully informed judgement about the risk-benefit balance.
And as I say, initially we were talking about adults. Yet they still made the judgement that it was suitable for healthy children while those safety and efficacy databases remained incomplete.
I remember particularly in October 2021 the “All In, All Together” campaign, where national and local newspaper editors essentially agreed to act as mouthpieces for government propaganda.
There was a particularly egregious article published in the Mirror encouraging — I would say coercing — healthy children and parents to get vaccinated against Covid in order to “get back to normal” and protect vulnerable adults.
The headline was: “It’s incredibly safe.”
Three things struck me about that. First, the MHRA does not allow medicines to be advertised as “safe”. Second, the medicine was still under Conditional Marketing Authorisation, so nobody could honestly say it was definitively safe. And third — perhaps most unforgivable — the article was paid for by the Government without any declaration on the article itself. It turned out the funding came via the Cabinet Office.
Ben:
And you know that through Freedom of Information Act requests.
Dr Alan Black:
I made FOI requests because the article was labelled “advertorial”, meaning someone had paid for it. But there was no declaration of who.
When I started asking questions, the article was pulled. If you search for it now, you won’t find it. But I still have a copy.
Ben:
Maybe it’s worth pausing for a moment to talk about the ethics here.
To play devil’s advocate: the nation was in crisis. Many in Government saw vaccination as the route out of lockdown and restrictions. They had emergency mechanisms available to speed medicines through in those circumstances. So, what exactly is unethical about that?
Dr Alan Black:
Even by that stage of the pandemic, we had a very clear understanding that Covid risk was stratified: healthy children were at extremely low risk from serious outcomes.
So, when you’re assessing risk versus benefit — whether for a clinical trial, licensing decision or treatment decision — you have to ask: if the disease risk is already tiny for children, what benefit are you actually expecting from the medicine?
Especially when the adverse event profile is still not fully understood even in adults.
Ben:
But the argument at the time was that there was a benefit to society — to the community. Was that not a fair argument?
Dr Alan Black:
We didn’t know there was a benefit to the community. And one of the core ethical principles in medicine is that you do not use children as a shield for adults.
If the child is unlikely to benefit and the only purpose is to protect others, then from everything I was ever taught in medicine and pharma, that is deeply unethical.
Molly:
There are international ethical conventions which specifically recognise that principle, aren’t there?
Dr Alan Black:
Yes. The fundamental principle is that if a person cannot provide informed consent themselves — and children generally cannot — then if somebody else is consenting on their behalf, there must be a reasonable expectation that the child themselves may benefit.
Healthy children had an extremely low likelihood of severe Covid outcomes. So, the chances of significant benefit from participation were very small. Therefore, in my understanding of medical ethics, involving healthy children in those studies was unethical.
Ben:
And that thread runs through many of the regulatory concerns and complaints we later became involved in.
Dr Alan Black:
It also goes back to something else we heard repeatedly at the time.
When people said the vaccines were still experimental, we were told: “No, they’re licensed.” But they had only received Conditional Marketing Authorisation precisely because the comprehensive safety and efficacy data were incomplete.
If the data are incomplete, then the products are still experimental.
Molly:
And I think that point mattered enormously because there was such resistance to using the word “experimental”. Had it been acknowledged openly that these products were experimental, it would have engaged ethical frameworks such as the Nuremberg Code.
And I think it’s quite striking how quickly society abandoned principles that had previously been regarded as foundational.
Dr Alan Black:
If they weren’t experimental, they should have received a full marketing authorisation. If they didn’t receive full authorisation, then they were still experimental.
Ben:
And so in a sense, the whole rollout was a big medical trial.
Molly:
So this is 2021. Tell us more about what happened next and the various cases you became involved in.
Dr Alan Black:
Once people found out that I was prepared to give an opinion about these things, lots of people started contacting me with concerns about communications they’d seen in newspapers, online, on television or on the radio.
They wanted advice about what they could do and how they should go about raising concerns.
So, I advised a lot of people to complain to the PMCPA and helped them understand how to go about doing that. There were a lot of cases.
If you look at the period from 2020, when these vaccines first appeared, through to last year when the final complaints were being addressed by the PMCPA, you’re talking about almost six years’ worth of complaints and investigations.
I actually checked the numbers yesterday because I thought you might ask me about this. Over that period, there were 19 cases involving complaints about the behaviour of pharmaceutical companies while promoting their Covid vaccines.
All of the Covid vaccine manufacturers were involved in those complaints.
Molly:
And what kind of behaviours are we talking about here?
Dr Alan Black:
Some very serious things. Across those 19 cases there were 56 breaches of the ABPI Code of Practice. In fact, probably more than 56, because in some cases there were multiple breaches of the same clause.
Perhaps even more astonishingly, there were 10 ‘Clause 2’ breaches.
Now, I don’t want to get too technical, but Clause 2 is reserved for behaviour considered so serious that it brings discredit upon the pharmaceutical industry itself and reduces confidence in it.
The PMCPA itself says that Clause 2 is reserved for extremely serious cases. Yet there were 10 such findings during that period.
Molly:
And these were cases involving only the Covid vaccine manufacturers and their Covid products. So, this isn’t the pharmaceutical industry as a whole — this is just that very small subset.
Ben:
Essentially three products.
Dr Alan Black:
Exactly. Nineteen cases. Fifty-six breaches. Ten ‘Clause 2’ findings.
Molly:
And when you actually look at the findings themselves, this wasn’t trivial stuff.
I also had a look through them anticipating we’d be discussing this today.
We’re talking about findings including:
misleading the public about the safety and efficacy of products,
making unsubstantiated claims about safety,
misleadingly describing risks as “minimal”,
promoting prescription-only medicines to the general public,
promoting unlicensed medicines,
and what I think was my favourite phrase from the regulator: “provision of a pecuniary advantage”.
Ben, maybe you can translate that into plain English.
Ben:
It means ‘bribery’.
Dr Alan Black:
I’m glad you said that. The “pecuniary advantage” finding referred to a case where Moderna paid doctors to attend what was supposedly an advisory board meeting which, in reality, turned out to be promotional.
Ben:
Somewhere rather nice as well, wasn’t it?
Dr Alan Black:
Yes, I think it might have been Madrid, although I’m not absolutely certain.
And beyond that there were the more egregious cases involving inducements for children to participate in clinical trials.
That wasn’t just about inappropriate amounts of money — there were also things like teddy bears being offered. So, there was some very unpleasant behaviour involved.
Molly:
So there have been all these breaches of the UK regulatory framework. Some serious. Some, by the regulator’s own admission, among the most serious possible. What’s actually happened to these companies?
Because I think it is important people understand the consequences — or lack of consequences. Bearing in mind, as we discussed earlier, that this system is fundamentally self-regulatory. So then what happened?
Ben:
The answer is: not very much.
Dr Alan Black:
No. The PMCPA has no power to impose meaningful fines. What it imposes are what it calls “administrative charges”, which are supposedly intended simply to contribute towards the costs of processing complaints.
Between 2015 and 2023, if a company breached one clause of the code, the administrative charge was £3,500. If they appealed unsuccessfully, it rose to around £12,500. In 2024, those charges increased. So now, if a company breaches a clause, the administrative charge is £5,000. And if they appeal unsuccessfully, it becomes around £13,000.
Molly:
We’re laughing, but really, we shouldn’t be, because it’s absurd.
We’re talking about one of the most powerful industries in the world — an industry capable of doing enormous good, but also potentially enormous harm. And there appears to be no meaningful deterrent against misconduct.
Dr Alan Black:
The PMCPA and the industry itself place a great deal of emphasis on reputational damage associated with being found in breach.
Molly:
I think we came as close as anyone has to creating real accountability with the Moderna case — in huge part thanks to you, Alan — because that case ultimately resulted in Moderna being audited.
Should we talk a little about what that actually means in practice? And perhaps more importantly, what the public still doesn’t get to know?
Dr Alan Black:
Yes. As a result of the case, you were instrumental in bringing, there were actually three cases which together resulted in the audit of Moderna.
The first was the case involving inappropriate payments being offered to children participating in the study. That case went through early in 2024. Later that year, when the case report was published, you read through it — and credit to you for doing so — and you identified a discrepancy.
Back in the summer of 2023, when you first became aware of these payments, you had written directly to Moderna informing them about it. But in the eventual PMCPA case report, Moderna claimed they hadn’t become aware of the payments until January 2024, when the formal complaint was made. So, there was a clear discrepancy.
You pointed that out to the PMCPA, and the PMCPA subsequently found that Moderna had misled them and provided inaccurate information. In the original case, Moderna had already been found guilty of failing to maintain high standards and bringing discredit upon the pharmaceutical industry. In the subsequent case, they were again found to have failed to maintain high standards, to have misled the PMCPA and again to have brought discredit upon the industry.
At around the same time there was a third linked case. Someone from Moderna had co-authored a newspaper article about lessons from the Covid period together with a former Government minister heavily involved in the Covid response.
The article described the author simply as a former member of the Vaccine Taskforce. What it did not disclose was that he was currently a director of Moderna. So, the PMCPA found that Moderna had concealed its involvement and had effectively used the article to promote its vaccine.
As a result of those three linked cases, the PMCPA Appeal Board essentially threw its hands up and said: enough is enough. They ordered an audit of Moderna’s culture, governance and compliance systems. So, in July 2024, a compliance team went into Moderna’s offices to examine what had been going on.
Molly:
I remember being quite surprised when we first discussed this because, rather naively perhaps, I assumed the audit would be publicly available. But it isn’t. Neither the public — nor even we, as the complainants — get to see it.
Dr Alan Black:
That’s correct. And because the PMCPA is not a public body in the same way as the MHRA, it isn’t subject to Freedom of Information legislation either. The only information available is a very short summary attached as an addendum to one of the PMCPA case reports. That’s all we have.
Ben:
And essentially what that says is that they partially completed the audit, weren’t satisfied, and intend to return again later.
Dr Alan Black:
Yes. What it effectively says is that numerous issues were identified at Moderna.
Recommendations were made. Moderna requested 18 months to address the gaps identified.
Molly:
But we don’t know what those gaps are.
Dr Alan Black:
No. We don’t know what the issues are. We don’t know what the recommendations were. And we don’t know exactly what concerns were identified.
Molly:
Which many people will find shocking. Particularly because Moderna has simultaneously been presented as the UK Government’s flagship mRNA partner.
So, while this audit is happening, the Government is entering into huge strategic agreements with the same company.
Ben:
And audited because, through the evidence we submitted, it was effectively established that very senior officers at Moderna UK had provided false or misleading information to the regulator.
Dr Alan Black:
Yes, and the PMCPA explicitly acknowledged that they had been misled.
Molly:
You wrote a very powerful article recently asking whether it’s really appropriate for Moderna to remain the Government’s flagship partner while all this is happening. By the time the second audit takes place, they’ll effectively be halfway through their 10-year partnership agreement with the UK Government.
Dr Alan Black:
One additional thing we do know is that the PMCPA Appeal Board refused Moderna’s request for the full 18 months. Instead, they ordered a repeat audit within 12 to 15 months and said they expected to see “significant improvements” by then.
Exactly what that means, we don’t know. But importantly, they also stated that additional sanctions remained possible.
Molly:
What would those sanctions actually be?
Dr Alan Black:
The ultimate sanction would be expulsion from the ABPI. That happens extremely rarely. One recent example was Novo Nordisk. It’s regarded as an extreme step.
Ben:
But even then, that’s basically the equivalent of the other kids in the playground saying, “You can’t play with us anymore.”
The more serious question is whether the Government should continue regarding Moderna as a flagship strategic partner.
Dr Alan Black:
Exactly. By the time the second audit is completed and published, they’ll already be halfway through a 10-year strategic partnership.
Molly:
And the money will already have been spent.
Dr Alan Black:
Yes. And we still don’t know the full details of that agreement.
Molly:
Just thinking a bit about looking forward and where this leaves us, naturally, I think a point we haven’t touched on here, specifically as regards the Moderna mRNA contract, is that the other thing that has happened since the government entered into this contract is that America has just cancelled its US$700 million contract for mRNA products.
The US Health Department was absolutely explicit in saying it was because, on a risk-benefit basis, the case for mRNA vaccines in relation to respiratory viruses had not been made. We’re not talking here about advanced treatments for cancer or things like that. We’re talking about the bucket of drugs that we’ve discussed with Covid – the mRNA jabs for Covid, flu and other similar viruses.
The conclusion was that the risk-benefit case was not in favour of, or had not been shown to be in favour of, these vaccines. Our government just seems completely oblivious to that. I don’t know if you think that’s a fair comment?
Dr Alan Black:
Well, I can’t really comment in too much detail on what goes on in America. I just read the same articles as you do.
There certainly seems to be a rolling back of the kind of rubber-stamping that has been going on, particularly for low-risk groups, and a move towards saying that, for low-risk groups, they want to see actual clinical trial data to prove efficacy.
There does seem to be a definite rolling back in terms of the willingness to accept anything other than hard clinical trial data for efficacy, at least for the newer vaccines.
In the UK, it’s difficult to know to what extent the government’s hands are tied in that respect, because we don’t know the nature of the agreement they have with Moderna. It’s not been published anywhere, and any attempts to get information about it are knocked back. I have had requests for information about the agreement rejected on the grounds of excessive costs.
Molly:
So, this is through Freedom of Information requests?
Dr Alan Black:
Freedom of Information requests, yes. The contract is managed for the government by the Department of Health and Social Care and the UK Health Security Agency. I’ve asked them for information about the details of the agreement with Moderna, but they won’t provide it.
As I said, my requests have been knocked back on the grounds of excessive costs, while other people’s requests have been rejected on the grounds of commercial sensitivity.
Molly:
So we know taxpayers are funding this. But we don’t actually know how much.
Dr Alan Black:
Correct. We don’t know the scale of taxpayer commitment. We don’t know whether regulatory concessions were offered. We don’t know whether any favourable treatment exists. And because the agreement remains largely secret, we simply cannot assess it properly.
Molly:
Just pause on that. When you talk about regulatory concessions, are we essentially talking about products being given some form of favourable treatment?
Dr Alan Black:
At the Moderna facility in Oxford, at Harwell, we simply don’t know whether anything that’s been produced, manufactured or developed there is receiving any kind of favourable regulatory treatment. It may not be, but we don’t know.
Molly:
Am I right in thinking there was a similar concern in Australia, where there was effectively a relaxation of regulatory standards for a Moderna product?
Dr Alan Black:
There was certainly a suspicion of that. My understanding is that it related more to access and funding than to the approval process itself, but there was concern that Moderna had received favourable treatment. A body in Australia, perhaps equivalent to the National Audit Office here, looked into the matter and concluded there wasn’t a case to answer.
That’s actually a good example because the issue was raised publicly, investigated and a conclusion was reached. In the UK, by contrast, the secrecy surrounding the agreement with Moderna is almost total. We simply don’t know what’s been offered, if anything, in terms of regulatory concessions. It would be helpful to know.
Molly:
It’s an interesting point, and probably one we’ll come back to. The idea that such large sums of taxpayer money can be spent without meaningful public scrutiny is troubling. We’ve seen that in a number of contexts during the pandemic, including around the indemnities provided to vaccine manufacturers.
I think many people were surprised by the extent of the secrecy involved. I’d be interested to hear where you think this leaves the industry, particularly in terms of the regulatory framework and what reforms we should be aiming for.
Dr Alan Black:
I have to be pessimistic. Whatever reforms we might aspire to, I think they’re unlikely in the current climate.
Successive governments have been committed to attracting investment in UK research, science and pharmaceuticals, and the pharmaceutical industry is a major contributor to that agenda.
Any government is likely to be cautious about taking steps that could be perceived as discouraging investment.
Ben:
One of the few figures that was published about the Moderna partnership was the claim that it would contribute around £10 billion over ten years to UK life sciences.
So, it’s clearly very important to the government. It creates that sense of an industry becoming too important, or too big to fail, doesn’t it?
Dr Alan Black:
There are aspects of the current regulatory system, particularly the PMCPA, that I think need reform. If Covid has demonstrated anything to me, it’s that the current self-regulatory model isn’t fit for purpose.
I don’t want to criticise the PMCPA itself. There are many capable and committed people there trying to do the right thing. But they’re being let down by a lack of resources and, frankly, by the structure they’re operating within.
Ben:
And by a lack of powers. They don’t really have the tools they need, do they?
Dr Alan Black:
No. I’d like to see the PMCPA become more independent from the ABPI, both in terms of appointments and funding.
I’m not suggesting it shouldn’t be funded by the pharmaceutical industry — I’d rather that than taxpayers footing the bill — but there should be greater independence in how those arrangements are managed.
The PMCPA also needs the resources to do its job properly. Cases shouldn’t be taking more than a year to resolve. And penalties should be just that: penalties. Not administrative charges. They should be meaningful, punitive and capable of acting as a deterrent.
I know it’s not a perfect comparison, but there may be lessons to learn from the regulation of the financial sector.
Ben:
That’s exactly right. In other industries, penalties are often linked to the benefit gained from the misconduct. If a company has profited from unethical marketing, the consequences should bear some relationship to that gain. Otherwise, there’s little deterrent effect.
Dr Alan Black:
I’d also like to see the PMCPA given genuine investigative powers so that it doesn’t have to rely on members of the public identifying problems and bringing complaints. I worry about the things that aren’t being picked up.
Molly:
And the fact that so much of this work has fallen to members of the public — campaign groups, independent researchers and individuals like yourself with the expertise and time to pursue these issues — is remarkable.
Most people simply don’t have the capacity to do that. It’s extraordinary that an industry of this size is, to such a significant extent, being held to account by ordinary members of the public.
Dr Alan Black:
Exactly. And that brings me to my final point. I’d like to see the MHRA take a more active role in overseeing the PMCPA.
Molly:
If that happened, could it help address what is clearly a trust problem?
Whatever people’s views on the Covid vaccines, it’s obvious that this period has had wider consequences for public confidence, including confidence in other vaccination programmes.
Trust will only be rebuilt if people can see that poor behaviour is being identified and dealt with properly.
Dr Alan Black:
I’m not optimistic that much will change, but ultimately, we should be able to rely on politicians to provide effective oversight in an area this important. The last major parliamentary investigation into the influence of the pharmaceutical industry was the Select Committee inquiry in 2005.
Ben:
And it was pretty scathing.
Dr Alan Black:
It made a number of recommendations. Some were implemented, but most were not.
In preparation for today, I went back and reread the report. One passage stood out to me just as strongly as it did when I first read it. In its concluding remarks, the committee said:
“Our overarching conclusion is that the UK pharmaceutical industry is in many ways outstanding. It conducts excellent research, produces products which make a vital contribution to the health of the nation and is of great economic importance. However, for want of critical scrutiny by, and lack of deference and accountability to, the public and public bodies, the industry lacks the discipline and quality control that it needs, but cannot itself provide.”
I think that’s every bit as true today as it was in 2005.
Ben:
I agree. And that’s probably as good a place as any to leave it.
Alan, thank you very much.
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