Medicines and Healthcare Products Regulatory Agency

Nusrat Ghani Excerpts

Thursday 16th January 2025 Commons Chamber

[Graham Stringer (Blackley and Middleton South) (Lab)]

It is a pleasure to follow the right hon. Member for Tatton (Esther McVey). I agree with every word she said. It is late in the day for a Thursday, so I will try not to repeat many of the pieces of evidence and arguments that she proposed, but they are all valuable contributions to this debate.

I will start by talking about the attitude of Members of Parliament and politicians to regulation in general. A long time ago, I had responsibility in the Cabinet Office for dealing with better regulations. I travelled around the country to look at businesses that complained about regulations and see how those regulations could be made better—that was 18 months of my life that I will never get back. I came to a number of conclusions after that. Politicians have a knee-jerk reaction when it comes to regulation. If a child dies, if there is a fire, or if there is another disaster of some sort, there is a cry from both sides of the House for more regulation— not necessarily better regulation and enforcement, but more regulation—when, in many cases, regulations are already there but inspections and enforcement have not taken place.

The other knee-jerk response, which my Government are giving at the moment, is to say, “Regulations are burdensome so we will try to get rid of some of them.” I do not think that either of those responses deals with the issue. We set up regulators—this afternoon we are talking about the MHRA—but, by and large, once they are set up, MPs and Ministers abdicate responsibility and do not consider them until there is a crisis.

When I had that responsibility, I went to see the European Medicines Agency—this was some time before we left the EU. One of the surprising things I found—or maybe it was not so surprising—was that I was the only Minister who had been anywhere near the place. It was the major European agency that this country got after the Maastricht treaty. It had wide-ranging and important powers, to deal both with the market and with regulation, but nobody bothered with it. If there had been a crisis, however, Ministers and shadow Ministers would have been queuing up to go there.

If there is a lesson, particularly in relation to the MHRA, it is that we should look at regulators—be they water, medicine or other regulators—all the time. We cannot as a Government and MPs abdicate our responsibility, because we then come to a crisis, and the electorate say, “Well, what are you doing?” and the answer is, “Not a lot; we have passed that on.” Those water regulators or medical regulators might be, as the right hon. Lady showed, pretty useless. We should be looking at them all the time.

I was a member of the Science and Technology Committee in 2012. Partly because of that experience, and partly because there was a lot of press discussion and debate about metal hips that were squeaking and not working very well when they had been implanted and about breast implants that were falling apart, potentially damaging and poisoning the recipients, we had an inquiry that reported in October of that year. I will read out some of the comments from the witnesses we heard from about the MHRA, because they are being repeated now. They are very similar to what the right hon. Member for Tatton said about the MHRA’s responses—secretive and slow. For instance, there was evidence that there were problems with metal hips for four years before the MHRA took any action whatsoever. Nearly 14 years later, it still has the same problems.

I asked Dr Heneghan from the Centre for Evidence-Based Medicine at the University of Oxford who had authorised those metal hips. His answer was extraordinary: “Nobody knows. I don’t know—nobody knows.” It was a different regulatory regime then, because we were part of the European Union. Anybody who had the competence—or at least the authority—in any country in the EU could give authorisation, but nobody knew which body had done it, and whether that body was composed of competent people and what evidence they had used to do so.

However, when the MHRA found out, it did nothing for four years. That is disgraceful, and there were all sorts of comments that I can give the House. One was from Dr Stephen O’Connor at the Institute of Physics and Engineering, who said that the MHRA was overly bureaucratic relative to other competent bodies, inefficient, and difficult to deal with. As the right hon. Member for Tatton showed, the MHRA does not answer FOI requests, and it does not tell us what is going on.

The Lancet said about the breast implants, which I will talk about next, that the MHRA was in paralysis and in need of reform. Again, that was a long time ago. It was a different issue with the breast implants, because the MHRA was dealing with a fraudulent product—the products that had been authorised were not the products that were being sold to surgeons to be implanted in women. However, the Committee asked for there to be random and regular testing of the bodies that were responsible for manufacturing those implants. I do not expect the Minister to know at this time, but will she check whether the authorities have done any of those randomised tests on those bodies?

That is the history. The right hon. Member for Tatton has basically analysed what is going on now, but I will just talk about what we learned during the covid period. We learned that many of the NHS’s constituent parts—although not the clinicians—were secretive. Earlier today in the Chamber, we talked about the Government’s response to the first part of the covid inquiry. At the present time, that inquiry is not getting to part of what went wrong during covid, which was the fact that the NHS did not tell us what was going on, and there was also a restriction on political debate. If we are to get the best policies in any crisis, and in the regular turn of events outside crises, we need transparency so that we know how things can be improved and what we can criticise.

The right hon. Lady made the excellent point that keeping things secret encourages people who do not trust vaccines and have odd theories about how societies is controlled not to take the protection from vaccines. We know that no medicine is 100% safe, and there is no point in pretending they are safe, but vaccines have saved many lives over decades—more than decades; over a century—and it is good for society and for individuals that people understand that, and they will be less trusting if we do not tell them what is going on.

As recently as a few minutes ago, I got an email telling me that the UK Health Security Agency is still refusing to release the cost of the bird flu vaccines it has purchased. What possible reason can there be for not saying how much public money has been spent on a good cause? Having vaccines ready for any flu epidemic is a good thing because it saves people’s lives, as we have been discussing. Why should it be kept secret? Could the Minister to respond to that?

Is there any Member in the House who thinks that turning the MHRA, in the right hon. Lady’s phrase, from a watchdog to an enabler is a good idea, or even knows what it means and what is being enabled? I certainly do not know what is being enabled, but one of the things we should remember is that the MHRA and the whole of the health industry are swimming in a sea of pharmaceutical sharks. Pharmaceutical companies produce some extraordinarily wonderful products that keep us safe, but they also produce huge profits, and sometimes they get their products on to the markets by telling lies, or certainly by sins of omission. Everybody knows about the thalidomide case, and how long it took to prove it and to get compensation for the victims.

Almost at random, I have picked two other cases. With Paroxetine—I think that is how to pronounce it—GSK held back information because it did not release the tests that did not show a positive benefit. It also kept back tests that showed that Paroxetine increased the chances of children committing suicide, and it took a lot of investigation to get that—

[Madam Deputy Speaker (Ms Nusrat Ghani)]

Order. Mr Stringer, I assume you are coming to a conclusion soon.

[Graham Stringer]

I am. I have one sentence. I am sorry; I did not realise I had speaking for so long.

Lastly, Reboxetine is another example of where the information given out to doctors was inadequate because it did not show the negative tests. I use those two examples basically to show that the MHRA should not be enabling these things. It should be much more vigilant, and it should be asking for powers to demand the right to know all the information that drugs companies have before it says those drugs are as safe as they can be.

[Several hon. Members rose—]

[Madam Deputy Speaker]

Order. To enable us to get everyone in, I hope all Members will be mindful of those who are to speak after them.

[Sir Christopher Chope (Christchurch) (Con)]

I shall try to be brief, Madam Deputy Speaker. I follow the hon. Member for Blackley and Middleton South (Graham Stringer) by referring to a quote from Hayek’s book, “The Road to Serfdom”. I do not claim credit for identifying it myself; it was quoted in the other place by Lord Hannan of Kingsclere on 15 January in the context of the Football Governance Bill. He was talking about the growth of the administrative state, about which the hon. Gentleman was speaking at the beginning of his speech. Hayek said:

“The delegation of particular tasks to separate bodies, while a regular feature, is yet only the first step in the process by which a democracy…relinquishes its powers”.

That is in chapter 5 of “The Road to Serfdom” from 1944, so not much has changed. The MHRA is an example of what happens if we in this House transfer responsibility to unelected and unaccountable organisations.

It so happens that on the Order Paper for tomorrow is my Covid-19 Vaccine Damage Bill, which is sponsored by a former Attorney General. That Bill calls for an independent review of covid-19 vaccine damage. It calls on the Secretary of State to

“appoint a current or former High Court judge to lead an independent review of disablement caused by Covid-19 vaccinations administered in the United Kingdom and the adequacy of the compensation offered to persons so disabled.”

We know that more than 600 people have already been told by the agency responsible at the Department of Health and Social Care that they have suffered disabilities as a result of covid-19 vaccines. A large number of them, where the disability is in excess of 60%, have been awarded wholly derisory payments of £120,000 each.

My Bill goes on:

“The review must consider…the rates and extent of disablement caused by each type of Covid-19 vaccination offered in the United Kingdom”.

Relevant to this debate, the review must also consider

“the effectiveness of Medicines and Healthcare products Regulatory Agency monitoring of such side effects, and National Health Service and Government responses to such monitoring”,

as well as

“the adequacy of compensation offered to persons so disabled”.

There has always been an agreement, basically, that if something goes wrong for people who undertake vaccination voluntarily or are in receipt of other medical products—if they are doing the right thing by the country at large—and they have an adverse reaction, they will be able to look to the Government or the taxpayer to pay them some recompense under the scheme to which I have referred, if causation is established. The trust built by that scheme has been undermined by the long denial of the previous Government—and, to an extent, the current one—that any adverse reactions had been caused by the covid-19 vaccines, other than the most minor disablement. It has also been undermined by the fact that so many people have applied for a review of their cases. Some people—I think more than a thousand—have been waiting more than 18 months for a decision. That shows that this is a low priority for the Government.

I hope that when the Minister responds to the debate, she will be able to explain why the Government will block my Bill again tomorrow. If they were taking this issue seriously, as they should be, they would be open to and supportive of the establishment of an independent review of disablement.

[Madam Deputy Speaker (Ms Nusrat Ghani)]

Order. I am setting a five-minute time limit.

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[Several hon. Members rose—]

[Madam Deputy Speaker (Ms Nusrat Ghani)]

We are going to have to drop the time limit to four minutes. I call Dr Simon Opher.

--- Later in debate ---

[Yasmin Qureshi (Bolton South and Walkden) (Lab)]

My interest in this matter arises as I chair the APPG on Primodos, and it is a campaign that I and many other MPs have been working on for the past 12 years. On one occasion, after a big debate, the Minister ordered an expert working group to be set up. The MHRA was supposed to examine the evidence. We the campaigners and Members of Parliament thought that all the documents we had would be looked at by the MHRA, but clearly it did not look at them. The MHRA was supposed to engage with the victims and their families, but they were not spoken to or dealt with properly, and there was no thorough examination.

In fact, some of the members of the expert working group, which was set up by the Commission on Human Medicines, had connections with pharmaceutical companies. We wanted the MHRA to look at the documents, which showed very clearly that in the 1970s it was accepted by the then Committee on Safety of Medicines that this drug was causing deformities. However, the chief medical officer at the time colluded with the manufacturer, destroyed the evidence and refused to help.

We have documents that show that the manufacturer knew there was a cover-up, and yet the MHRA refused to look at them. Subsequently, Professor Carl Heneghan from Oxford University looked at the same material the EWG had looked at and came to a completely different conclusion: he said the evidence showed that there was a connection. The EWG was asked to look at whether there was a causal connection, and it changed its recommendation again. The former Prime Minister, Mrs May, was also not convinced by the expert working group. We persuaded her to set up a review chaired by Baroness Cumberlege, who said there was avoidable harm and that the victims should be compensated.

Throughout all those years, the Government of the day did not want to communicate with us, and they have not been dealing with this issue properly. They have always relied on the expert working group’s report, which has held the victims back and held us back from pursuing a possible legal claim. We say to the Government now that the EWG report needs to be relooked at, and Professor Carl Heneghan’s study of it should also be looked at. Scientific evidence has been produced using an experiment on zebrafish which shows that there is a link with this drug, and we have sent this to the Commission on Human Medicines for the Department to look at.

We must remember that this drug is 40 times the strength of the morning after pill. Women were given this pill and told it had no effect other than to see whether they were pregnant, and it then caused this damage. I ask the Minister today, with the new Government now in place, to please relook at this; the report by the EWG, which was set up by the MHRA, has been discredited, so please stop listening to it.

[Madam Deputy Speaker]

I call the Liberal Democrat spokesperson.

--- Later in debate ---

[Alison Bennett]

In the interests of time, I will not.

Brexit caused significant confusion for companies looking to sell products from Great Britain to Northern Ireland. It has also slowed down the time in which novel medicines and treatments can be approved for use, as pharmaceutical companies have understandably prioritised obtaining a single approval, allowing access to 27 markets via the EMA.

Meanwhile, strict affordability models imposed by the National Institute for Health and Care Excellence mean that companies face a further hurdle before their products can reach patients. Again, that diminishes the attractiveness of the UK market post Brexit. To help address this issue, the MHRA introduced the international recognition procedure a year ago to streamline the authorisation process by incorporating assessments from trusted regulatory partners worldwide, including the EMA. However, that relies on those partners having already approved the products, so UK patients will inevitably still have access to medicines later than people in other countries, including EU member states. When I met representatives of Roche Diagnostics, based in Burgess Hill in my constituency, they told me about the industry’s serious concerns that the additional GB-specific conformity checks required could be prohibitively expensive and lead to significant delays.

As things stand, the forecast is looking gloomy. My Liberal Democrat colleagues and I are committed to addressing these issues head-on, and to helping the MHRA become world leading. First, we are pushing to expand the MHRA’s capacity by halving the time for treatments to reach patients suffering from illnesses such as cancer. Secondly, we encourage the Government to fully implement the recommendations of the Cumberlege review, including on compensation, corrective surgery and psychological support for those who were failed and who suffered from faulty devices and drugs. Thirdly—this is vital—the Government should actively seek a comprehensive mutual recognition agreement with the EMA to promote faster access to new and novel medicines and medical devices. That would reduce red tape, cost and friction, providing hope for those who need access to these lifesaving and life-enhancing medicines and devices.

[Madam Deputy Speaker]

I call the shadow Minister.

--- Later in debate ---

[Madam Deputy Speaker (Ms Nusrat Ghani)]

I call the Minister.