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Esther McVey (Tatton) (Con)
I beg to move,
That this House notes that the Medicines and Healthcare products Regulatory Agency (MHRA) continues to need substantial reform, as recognised by the Independent Medicines and Medical Devices Safety Review (IMMDS), with patient safety concerns persisting and exacerbating since the review’s publication in 2020; believes that the MHRA’s 2017 expert working group report on Primodos was deeply flawed, with IMMDS later concluding the drug had caused avoidable harm; further notes that the yellow card system for reporting suspected adverse drug reactions is failing, with no process for following up on serious or fatal reactions and conflicts of interest, with 75% of the MHRA’s funding being derived from industry fees, a concern raised in the Fourth Report of Session 2004-05 of the Health Committee, The Influence of the Pharmaceutical Industry, HC 42-I, published on 5 April 2005; also notes the MHRA’s delayed response to reports of myocarditis, pericarditis and vaccine-induced thrombotic thrombocytopaenia following covid-19 vaccination, despite action from regulators in other countries; and calls on the Government to fully implement the recommendations in the IMMDS review and to acknowledge the harm done to patients and the financial burden on the healthcare system as a result of the MHRA’s widespread regulatory failures.
I thank the Backbench Business Committee for granting this debate and the many colleagues from across the House who supported my application for it, especially the hon. Member for Blackley and Middleton South (Graham Stringer), and also the hon. Members for Bolton South and Walkden (Yasmin Qureshi) and for Great Yarmouth (Rupert Lowe).
The Medicines and Healthcare products Regulatory Agency is the body responsible for ensuring the safety and efficacy of medicines used in the UK. Its job is to oversee medical products, medicines, medical devices and blood components for transfusion. The responsibility it has is extremely important, as it comes with the potential not only to change people’s lives for the better, but to cause serious harm—even death—if poor decisions are made or safety signals are missed.
The MHRA is required to scrutinise applications from the pharmaceutical companies for new products and devices and to remain ever vigilant over existing drugs should safety problems arise post-authorisation. It has to weigh up the arguments for and against these products and devices. After all, the companies trying to get these products on to the market—and to keep them there—are driven, as all industries are, by commercial success. It is up to the MHRA to balance that with the health and safety of the UK and the public.
Alarm bells rang for many of us when, in March 2022, Dame June Raine, the chief executive of the MHRA, boasted of the agency’s transition from watchdog to enabler. Twenty years ago, the Health Committee report, “The Influence of the Pharmaceutical Industry”, found that the MHRA was unusual in being one of the few European agencies
“funded entirely by fees derived from services to industry”.
Not much has changed since, with the MHRA continuing to get 75% of its funding from the pharmaceutical industry. In this context, the agency’s transition from watchdog to enabler does little to quell suspicions of conflicts and the implications that has for patient safety.
One of the most worrying issues is the MHRA’s mismanagement of the yellow card system. Established in 1964, the system is a way for patients, relatives and healthcare professionals to report suspected adverse reactions to drugs or medical devices. The reporting scheme should be a valuable source of information about possible harms, and act as an early warning system, but there is gross under-reporting to it. As the IMMDS’s 2020 review put it, the system is
“too complex and too diffuse to allow early signal detection.”
Under-reporting is a big problem because it makes it difficult to spot safety signals and assign causation. That then translates into unnecessary harm or death, with devastating side effects from treatment going unnoticed for years, months or even decades. That was recognised by the IMMDS review led by Baroness Cumberlege in the case of Primodos, sodium valproate and surgical mess—I meant to say mesh, though perhaps the word should have been “mess.”
According to research from Bangor University in 2019, potentially avoidable adverse drug reactions cost the NHS £2.2 billion a year in hospital admissions. In 2018, the MHRA estimated that only 10% of serious reactions and between 2% and 4% of non-serious reactions are reported. More recently, it has claimed that reporting rates for covid vaccines are better due to higher public awareness, but it has not been able to point to published evidence to back up that claim. The yellow card is currently a voluntary scheme that doctors and members of the public can report to, but I echo calls from the Sling the Mesh campaign and others for the UK to follow the example of Denmark and Sweden by making it mandatory for all healthcare professionals to report suspected adverse reactions.
Let me turn to the MHRA’s failure to act promptly on evidence of adverse reactions. We have seen that historically. For example, sodium valproate was known to cause harm to unborn babies in the 1980s, yet the MHRA did not establish a valproate pregnancy prevention plan until 2018. The known harms to unborn babies were allowed to persist for over 30 years. More recently, in 2021, the MHRA reacted slowly to strong signals that there was a serious problem with the AstraZeneca vaccine causing an autoimmune condition called vaccine-induced thrombotic thrombocytopenia. Denmark and other European countries suspended the vaccine for all age groups on 11 March 2021. The MHRA, by contrast, only started to restrict the vaccine in some age groups nearly two months later, on 7 May—yet there was a signal in the yellow card reports as early as 8 February. How many people were needlessly exposed to a risk?
Sir Christopher Chope (Christchurch) (Con)
My right hon. Friend hits on an important point. What action did the MHRA take to apologise for or explain its failure to give adequate and timely warnings to potential patients?
Esther McVey
I do not believe that the MHRA has taken such action. We are probably still waiting for it. Hopefully, that will come out. People are also either not getting compensation quickly enough or not receiving compensation that is commensurate with the illness and damage caused to them.
It is worth noting what happened when The Daily Telegraph reported on the potential causal link between the AstraZeneca vaccine and blood clots in March 2021. The journalist who wrote the story received a threatening call from the MHRA warning that The Telegraph would be banned from future briefings and press notices if it did not soften the news—an extremely defensive approach for an agency whose No. 1 strategic objective is to maintain public trust through transparency and proactive communication. Does that sound like an agency that is doing its best to maintain public trust, let alone patient safety?
It is clear that the system does not work. We have good evidence that suspected adverse reactions are under-reported, but what about the ones that are reported? We know from freedom of information requests that the MHRA does not have a process for investigating and following up individual yellow card reports. We know that the retrieval of follow-up information from the yellow card database still requires manual extraction and that only 54% of deaths reported as possibly linked to exposure to one of the covid-19 vaccines were followed up by the MHRA. That is extremely worrying or, as Matt Hancock infamously described it in a 2021 WhatsApp message, “shonky”. The chief medical officer, Chris Whitty, replied to that message by saying that the system “needs to get better”.
Another long-standing problem with the MHRA is its lack of transparency. Take FOIs to the agency as an example. Between 2008 and 2017, only 41% of requests were successful. In 2021, 76% were answered outside the 20-working-day statutory response time. A culture of delay and secrecy has emerged, and MHRA’s behaviour around the Commission on Human Medicines meetings for the covid-19 vaccine benefit risk expert working group show that beyond any doubt. Minutes of the meetings were published just last month, four years after they took place—why the delay? They are stuffed full of redactions that leave us with many more questions than answers, particularly as to why the new vaccines were continually described as safe and effective.
In the meeting on 18 November 2020, the expert working group asks if Pfizer was “required to respond to the 36 questions asked by MHRA”. In response, the MHRA confirmed that “there is no formal obligation to reply”. Why is there no formal obligation to reply? Surely it is essential, when making such an important decision as to whether to allow a new vaccine to be rolled out to the nation, to have those replies. The minutes do not specify the 36 questions. Indeed, they do not appear to have been mentioned again.
I asked a written question last week to see whether, in the spirit of openness and transparency, the MHRA would publish those questions and any answers received from Pfizer. The response was that the MHRA does not intend to publish those questions or any subsequent responses. Why not? Is this not a matter of public interest? Those issues were not resolved before the MHRA gave the green light to start the vaccination of the nation.
Particularly worrying is the issue of lymphopenia, where blood does not have enough white blood cells, which was reported in phase 1 of the trials and then went away—not because they fixed the problem, but because testing for the condition was not conducted in phases 2 or 3.
In summary, the failure to act on the weaknesses of the MHRA will lead only to more harm and further damage to the public’s trust in the pharmaceuticals agency and those tasked with regulating it. My hope is that the debate will help bring those wide-ranging issues further to light and focus the Minister’s mind on finding solutions. I will end on the words of Dr Tom Jefferson of the University of Oxford:
“You cannot support both secrecy and vaccination. Requesting data is not a sign of being against drugs or vaccines; it shows that you favour transparency. Those who try to keep data confidential and criticise those who ask for evidence are anti an evidence-based approach. How can you have informed consent if you do not know precisely what is happening?”
Sir Christopher Chope
On that point, does my right hon. Friend accept that one of the consequences of the lack of transparency has been a public distrust of vaccines, which is spreading rapidly? As a consequence, for example, there is less take-up of MMR vaccines than there should be and used to be, and that is because of a lack of trust in the system.
Esther McVey
My hon. Friend makes a good point. If people lose trust in vaccines, the pharmaceutical industry and the regulatory agency, that is precisely what happens. We know that these vaccines are essential to many people, so we do not want that happen. We want to ensure that new vaccines and medicines coming into use are thoroughly tested and that, along the way, we keep an overall watch on whether they are working correctly.
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.
Perran Moon (Camborne and Redruth) (Lab)
I thank the right hon. Member for Tatton (Esther McVey) for securing a debate on what is an incredibly important campaign in support of the reforms to the MHRA. I would like to make clear my interest as an officer of the all-party parliamentary group on Primodos.
I will focus on the human case for reform. I would like to share part of a speech delivered at a recent APPG meeting by Jason Farrell, a journalist who has been instrumental in communicating the campaign for some time and who powerfully put into words the experience of Marie Lyon and other victims. He said:
“In October 1970, in Billinge maternity ward in Wigan, a woman gives birth to a girl. The baby is quickly rushed out of sight and later brought back swaddled. When Marie Lyon unwraps her daughter, she discovers half her baby’s arm is missing.
Meanwhile, in Portsmouth, Shirley Gubbins gives birth. Her daughter is so damaged, medics put her in a cupboard, assuming she will be dead within minutes. Shirley’s husband demands to see his child and discovers the baby’s back is twisted, her face disfigured, and one eye is missing. When she’s eventually allowed to see her baby, Shirley reacts in exactly the same way as Marie does: ‘She’s beautiful. She’s mine.’”
As a relatively new MP, I first met Marie Lyon, campaigner-in-chief and chairwoman of the Association for Children Damaged by Hormone Pregnancy Tests, just a few months ago at the request of a constituent. Marie has met many MPs in her years campaigning for recognition and justice for mothers and children affected by hormone pregnancy tests. I had not met many campaigners like her before, and I had certainly never met a leader with such reserves of stamina and such a profound sense of injustice.
I speak here on the shoulders of victims, families, activists, MPs, scientists and academics who have called for substantial reform of the MHRA and for the Government to acknowledge the harm done to patients and to implement the recommendations of the IMMDS. The harrowing stories of victims of this scandal after decades of fudges, obfuscation and inaction that have hindered their pursuit of justice must be heard again and again in the Chamber. The evidence is clear. The time for talk has long passed. It is time for us now to act.
Danny Kruger (East Wiltshire) (Con)
I will be as quick as I can be, Madam Deputy Speaker. I want to talk about over-prescription and the vaccines. I acknowledge my role as the co-chair and past chair of the beyond pills all-party parliamentary group, which the hon. Member for Stroud (Dr Opher) chairs in this Parliament. I thank the secretariat for the great work it does to support the group.
We have a crisis of over-prescription in our country, with the rates of prescription drugs being given to people going up vertiginously. Prescriptions have doubled over the last 12 years. Nearly 9 million people—one in five adults—are on antidepressants, which is way too high a figure. Many people should never have been put on these drugs—they should have been offered non-chemical alternatives—and they should be supported to withdraw. I very much hope that the MHRA and the Government more widely will heed the calls we are making on the APPG for better training of GPs, better labelling of these drugs and withdrawal services for people who want to come off them.
In addition to social prescribing, which I am sure the hon. Member for Stroud will talk about from his experience, I want to mention the important potential role of digital therapeutics, which are not properly commissioned by the NHS but could be a big part of the answer.
I want to talk briefly about the role of the MHRA in over-prescription, particularly with respect to anti-depressants. We know from evidence, from anecdote and from coroners’ reports that SSRIs—selective serotonin reuptake inhibitors—can cause people to take their own lives. There are dozens of documented cases. The most prominent of those recently has been the tragic case of Thomas Kingston, whom I knew and whose family I have been speaking to since his death. Tom shot himself last February after being put on SSRIs. In fact, he was put on that SSRI after another SSRI caused him to feel absolutely awful, so he was put on two in very quick succession.
The coroner for Gloucestershire, who conducted the inquest, recommended much clearer communication of the risks of these pills, and she is not the first coroner to make that recommendation. I pay tribute to The Times for its campaigning to highlight the fact that so many coroners’ reports have not been heeded by the authorities. I wish they had been, as it might well have saved many lives.
Esther McVey
The number of people who have taken their lives after coming off SSRIs shows that it is not a one-off or rare. There are many people, including one of my constituents, aged only 25, who took her life. I congratulate my hon. Friend on raising this issue. What more can we do to raise awareness of the effects of withdrawal from these antidepressants?
Danny Kruger
The tragedies that we read and hear about are bringing to light the chronic problem of over-prescription in our society. I am afraid that the MHRA is to blame. A review is under way, but it does not sufficiently recognise the direct harms that these pills can induce in people. I hope that through better labelling and regulation, and a better culture of alternative prescriptions, we can reduce the tragedies that we are so familiar with.
Let me quickly comment, following on from my hon. Friend the Member for Christchurch (Sir Christopher Chope), on the experience of the MHRA during the covid epidemic. The vaccines were developed at a frantic rate. We can be very impressed by the speed of the taskforce and pay tribute to the work of the private sector, particularly our world-leading research base. The Government managed to act at great speed, largely because they bypassed Whitehall. But significant questions remain, which my hon. Friend raised, about whether the vaccines are genuinely safe and effective.
It is right that people ask questions about the data on excess deaths and wonder if there is a connection with the vaccine—that is not inappropriate. Ultimately, there is only one way to answer that question: to have the data. However, we do not have access to that data. The Government hold it and, extraordinarily, they have made it available to the pharmaceutical companies that produce the vaccines, but not to researchers—individual-level death data that shows who was dosed with what vaccines and which of them died.
In a debate in the House last April, and previously in correspondence with Ministers, I clearly and simply asked for that data to be made available to researchers, anonymised as appropriate. The UK Health Security Agency has admitted that the data exists, but has refused to release it, almost unbelievably, because of the risk to the mental health of the relatives of the dead. That begs the question, does the data show a link between the vaccines and those deaths? The information tribunal is due to rule on that matter shortly, and I fervently hope that common sense will prevail and the data can be made available to disprove the link, so that our minds and those of our constituents can be put at rest. There is also a case with the information tribunal about the data held by the MHRA on the vaccines’ safety for pregnant women. Again, the agency has been withholding that data for two years.
Let me finish by observing, in the light of the comments made by hon. Members across the House, that we have a genuine problem with the regulation of the medical industry and of medical products. I very much welcome the appointment of R. F. Kennedy to the role of Health Secretary in the United States. He will shake things up over there. Perhaps the Minister can be our own RFK over here, and bring some genuine transparency to the health system.
Mrs Sharon Hodgson (Washington and Gateshead South) (Lab)
I thank the right hon. Member for Tatton (Esther McVey) for securing this important debate, and I am very happy to be called to speak on such an important issue.
As chair of the First Do No Harm all-party parliamentary group, I am very interested in the need for MHRA reform in the context of the mesh, Primodos and valproate scandals. However, for time’s sake, I will focus my remarks on MHRA reform and the mesh scandal in particular, not least because the right hon. Lady opened the debate so well, and my hon. Friend the Member for Bolton South and Walkden (Yasmin Qureshi) will speak about the Primodos scandal and I do not want to steal any of her thunder.
I want to start by paying tribute to all the campaigners we have worked with over so many years on the “First Do No Harm” report scandal, especially Kath Sanson from Sling the Mesh, Marie Lyon, who has been mentioned, from the Primodos campaign, and Janet Williams and Emma Murphy from the valproate campaign. I also must pay tribute to Baroness Cumberlege, who recently retired from the other place, who was the author of the independent medicines and medical devices safety review and the former co-chair of the First Do No Harm all-party parliamentary group. She has been a great support to me over the years. Thanks to her invaluable hard work highlighting key recommendations to prevent future health scandals, including vital MHRA reform, we know what we need to do. Now we must get on with the job.
As we have heard, colleagues here today are in agreement that the MHRA is in need of urgent and substantial reform. One area in particular is the need for mandatory reporting of adverse events to the yellow card by healthcare professionals. Contrary to responses I received when I asked questions on the topic in the House, which argue that the current system works, it does not. It is broken. Let me be clear: the current voluntary system, which doctors enjoy, enabling them to choose whether to log side effects and complications to the MHRA yellow card, is simply unacceptable. This voluntary system has led to many adverse events going unreported. The system must be made mandatory, but that fix alone will not work if the data is there but is not used. The information must be tracked and assessed in real time by the MHRA, to spot trends of harm so that treatments can be stopped immediately if needed, to prevent the repetition of mistakes and, in turn, to prevent their escalation into further health scandals, as we have seen with mesh, valproate and Primodos.
Comparison of datasets conducted by Sling the Mesh found that a whopping two thirds of mesh complications —some as serious as slicing into bladders, bowels or through vaginal walls—were not logged by healthcare professionals to the MHRA yellow card. If these excruciating examples are not interpreted by healthcare professionals as worthy of reporting, what reason do we have to trust that healthcare treatments are safe? We need to see the MHRA at the heart of patient safety, properly and efficiently regulating and recording and not just nodding treatments through like a tick-box exercise.
Mesh, for example, was allowed from the 1990s onwards on the basis that it was equivalent to hernia mesh. Without any post-market surveillance by the MHRA, it was allowed to be aggressively sold, free rein, in the UK. This ultimately led to thousands of women, including my very own mam, being irreversibly harmed. Had reporting been mandatory, the sheer scale of women impacted could have at least been reduced through spotting a clear pattern of harm and putting a stop to it. It is clear that we need to change the current system, and fast.
Most of the scandals we are talking about today affect women, so women’s voices must be taken seriously. We should not have to wait until media coverage publicly shames health scandals or documentaries force account-ability and answers upon us. The MHRA needs to be functioning and not just responding to treatments causing harm, but regulating and preventing them in the first place. Surely this is the absolute least we should expect from a regulation agency that is supposed to ensure the safety and effectiveness of patients and the medicines and medical devices that they receive—hence: first do no harm.
Rupert Lowe (Great Yarmouth) (Reform)
I should start by alerting people to my declared interests relating to the pharmaceutical industry.
All of us familiar with the growth of the quango will be aware of how these unelected, unaccountable organisations have come to control and dominate British public life—not us, the democratically elected Members, but the quangos. Failure is rewarded and never punished. No organisation encapsulates that point as comprehensively as the MHRA. Its role is essentially to ensure that medicines and medical devices are safe and effective—where have we heard those words before? How can it possibly be trusted to regulate properly when it is funded largely by the companies it is tasked with regulating? It is simply human nature for a conflict like this to impact on the decision-making process.
The biggest challenge in the MHRA’s history was the covid response, and it failed. It enabled the biggest assault on civil liberties and economic prosperity in my lifetime, which was lockdown—the greatest scandal of them all. It was, quite simply, the most disgraceful period of recent history. The MHRA’s insistence on vaccines for all enabled lockdown restrictions to continue for as long as they did. It must take part responsibility for the consequences: vast NHS backlogs, mental health issues rife, soaring alcohol-related deaths, obesity booming, children’s development wrecked, long-term illnesses mounting, increased substance abuse, domestic violence on the rise, unnoticed child neglect, fathers missing the birth of their children and elderly loved ones left to rot and die alone. We were not even allowed to mourn the dead properly. The wicked list is endless.
None of it was based on any science, and certainly not the vaccination of almost the entire population—including, disgracefully, young children. This was a hideous dereliction of duty by the MHRA. It was not just children it forced the covid vaccination on, but tens of millions of people who had absolutely no need for it whatsoever. There was clear risk from taking the vaccine—not just the initial two doses, but the booster following them. The evidence for the vaccine was simply not there, particularly considering that by that stage, almost the entire population had actually caught the virus, which gave far more effective natural protection than any man-made intervention. The MHRA knew that, but it failed to act. Why? Was it under political pressure not to undermine the wretched covid response? Had it been honest about the real need—or lack thereof—for population-wide vaccinations, the whole case for lockdown would have collapsed.
As of 4 November, there had been 489,991 adverse reaction reports from covid-19 vaccines in the UK. Those are just the reported issues. What is the true number? When individual after individual reports feeling far worse after taking the vaccine than they ever did after the virus, should we not question whether that vaccination was necessary? The MHRA failed. This was simply not a vaccine that was needed by the entire population.
We were fed the lie that taking the jab would protect vulnerable loved ones, which was disgraceful dishonesty. The vaccine did not prevent transmission—we know that now, and we knew that then. It should always have been a fully free and informed choice. If an elderly man in his 90s believes that the virus poses more of a threat than the vaccine, then let him take it. For almost everyone under 70, that is a risk analysis that falls firmly in the camp of not having the vaccine. Don’t even get me started on the abhorrent vaccine passport policy—one of the most evil policies devised by Government in living memory.
The MHRA should have provided full and transparent data so that educated adults could make their own decisions for themselves and for their families. It must act as an independent barrier against both political expedience and corporate profit, protecting public health above all else.
The question is: who regulates the regulator? Who protects against regulatory capture? How did the MHRA allow politicians, celebrities and even its own agency to describe these vaccines as safe and effective, when yellow card data clearly showed it is not universally safe and certainly not universally effective? How could MHRA CEO June Raine say she had transformed the MHRA from a watchdog to an “enabler” of the pharmaceutical industry—an oxymoron for a watchdog that is meant to safeguard public health? It is Parliament’s duty now to exercise its sovereign power to ensure that we learn from the myriad of mistakes.
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.
Dr Simon Opher (Stroud) (Lab)
Thank you, Madam Deputy Speaker. I have quite a lot to say here, but I shall squeeze it into four minutes.
First of all, having a regulator funded by a drug company is genuinely a case of marking one’s own homework, and we need to change that straightaway. I think we need a reform there.
From clinical experience, I would also say that the yellow card system does work, but that we never get any feedback from it. That is one of the problems. The other problem is that clinically one is often not sure whether or not something is an adverse effect. We need a very easy system that can just be fired off. The right hon. Member for Tatton (Esther McVey) mentioned low white blood cells, for example, and whether that was a reaction. Then, when a number of different doctors get it, we can accumulate that information.
If I may, I want to say a few things about vaccinations. Vaccinations save far, far more lives than they cause damage. Every medicine that has ever been invented has side effects and I do not deny vaccine side effects. However, the vaccine saved hundreds of thousands of lives. I ran the covid vaccination service in our area in Dursley. At the height of the pandemic, if we injected 180 people over 80, we saved a life—that is incredible. Compared to that, the side effect rate was incredibly small. It does exist and we need to look at it, but let us not get on the backs of vaccines. Vaccines have saved more lives than anything else.
I really want to talk about antidepressants, on which the hon. Member for East Wiltshire (Danny Kruger) has already said a few words. We have a problem with over-prescribing in this country. Some 8.7 million people are on antidepressants. My hon. Friend the Member for Blackley and Middleton South (Graham Stringer) spoke about Paroxetine causing increased risks of suicide. We need to wean ourselves off medications. National Institute for Health and Care Excellence guidelines say that for mild to moderate depression we should not start tablets, yet they are started. That is because people have become a bit over-medicalised, we have 10-minute appointments and no psychological therapies. We must also make use of social prescriptions, available to the NHS, where we can prescribe to patients something that is not medical. We need to de-medicalise what is going on. That can include lots of different things, such as exercise and being very creative. In fact, yesterday I went with the Lord Mayor of Westminster and Lu Jackson to St John’s Wood library for a Comedy-on-Prescription event. Making people laugh can avoid the need for medication. We need to look at those things much more seriously and get people off tablets.
The right hon. Member for Tatton (Esther McVey) said that one of her constituents took their own life when they were trying to get off antidepressant medication. The MHRA needs to put warnings on the packet, but it has failed to do so. We also need a support mechanism for people coming off tablets. Of the 8 million people on antidepressants, about 2 million are trying to get off them, so it is a major problem. GPs, actually, are not that well informed about this. There are some very strong Maudsley guidelines based around micro-tapering, so that people can come off slowly and safely. Some kind of support service might have helped her constituent and stopped them taking their own life.
In conclusion, we have a pandemic of over-prescription and we need to start looking at that. As chair of the beyond pills all-party parliamentary group, with the hon. Member for East Wiltshire we are trying to reduce prescriptions and make it safe for people to come off antidepressants.
Iqbal Mohamed (Dewsbury and Batley) (Ind)
Before being elected to this House I worked for nearly 20 years in the pharmaceutical regulation and compliance industry. I know from first-hand experience the critical role that the MHRA must play in protecting the public and its indispensable role in ensuring public trust in the medical sector. My comments, therefore, come from a place of wanting to ensure that that trust, so painstakingly built up, continues to be strengthened.
A recent survey by the Association of the British Pharmaceutical Industry found that 80% of respondents felt the MHRA’s lack of capacity was undermining industry trust and deterring domestic investment—problems compounded by Brexit, which has created obstacles to co-operation in the European Union. Faced with a large backlog of clinical trial applications, one would imagine the obvious solution is to make more resources available to recruit and train new staff, and to rebuild relationships with our European partners. However, the Prime Minister seems more determined to demonstrate his commitment to slashing red tape and the need to, as he says, “regulate smartly and regulate creatively”. I must admit I get very nervous when I hear that kind of language used in relation to the pharmaceutical industry, because it is normally code for measures that threaten safety standards even further.
The need for openness, transparency and regulation is probably greater than ever before. Recently, I have had constituents raise with me why the animal feed additive Bovaer, which is given to cows to reduce methane, is not tested or approved to MHRA pharmaceutical standards and why it is not even listed on milk cartons. Constituents have raised concerns with me about the use of carcinogenic chemicals in our food. We know that a host of chemicals that are banned from being used in food in the European Union are permitted in the United States. It is perfectly understandable for people to fear that, amid the bonfire of red tape that the Government are planning to set alight, some things that better protect us might go up in smoke.
Constituents have also raised questions with me about the latest impact of the covid-19 vaccines. Before anyone starts accusing me of being an anti-vaxxer, I took both covid vaccines and agree that they saved many lives, but it is also the case that legitimate concerns have been voiced about long-term side effects. We now know that in the largest vaccine study to date, two very rare side effects—a neurological disorder and inflammation of the spinal cord—have been detected. Other studies have confirmed side effects including inflammation of the heart muscle and the lining around the heart, particularly in young males, as well as blood clots in the brain’s venous sinuses.
Today we stand united in our commitment to safeguarding the health and wellbeing of our citizens. The motion highlights critical issues within the MHRA that demand our immediate attention and action. The Independent Medicines and Medical Devices Safety Review has shed light on persistent and exacerbated patient safety concerns since its publication in 2020, and it is our duty to ensure that the MHRA undergoes substantial revision to address those issues. The safety of our citizens must be paramount, and we cannot afford to overlook the shortcomings that have been identified.
In conclusion, let us not forget that our primary responsibility is to the people we serve. We must act with urgency and determination to rectify those issues with the MHRA. By implementing these recommendations, we can work towards a safer, more responsive healthcare system that prioritises patient safety and trust above corporate profits and interests
Neil Duncan-Jordan (Poole) (Lab)
I thank the right hon. Member for Tatton (Esther McVey) for securing this important debate. My interest in the issue stems from the fact that one of my constituents, Barbara Manning, was affected by Primodos, and, along with the tireless campaigner Marie Lyon—who has already been mentioned today—has been seeking justice ever since.
For the benefit of Members who do not know this, let me explain that between 1958 and 1978, Primodos was a hormone pregnancy test that was given to about 1.5 million women in the form of pills. It was taken off the market in 1978 amid concerns about the effect on the unborn children of those who were pregnant, but the link has never been formally recognised by regulators or the manufacturer. Some research at the time suggested that there might be an association between the drug and miscarriages, and babies born with shortened limbs, abnormalities in their internal organs, brain damage and heart defects. Many of those children died before reaching adulthood, and of those still alive, some are blind, deaf and brain-damaged.
In 2017, a report from an expert working group of the Commission on Human Medicines concluded that there was no causal association between Primodos and severe disabilities in babies, but there are real concerns about the conflict of interests involving some of those on the expert working group and their connections to the big pharmaceutical companies involved in the scandal.
On 8 July 2020, Baroness Cumberlege published her in-depth findings on how the health system responds to reports from patients about harmful side effects from medicines and medical devices. On the MHRA, she said:
“A regulator must work both for patients and with them. This hasn’t been the case in the past. We are recommending that the regulator of medicines and medical devices… is overhauled. It needs to change and radically improve the way that concerns about medicines and devices are detected and acted upon. The regulation of devices in particular needs urgent change. The MHRA needs to engage more with patients and track how medicines and devices improve—or fail to improve—patients’ health and quality of life. It needs to raise public awareness of its role and it needs to ensure that patients have a core role in its work.”
The review also concluded that the state and manufacturers have a moral responsibility to provide ex gratia payments to those families who have experienced avoidable harm due to their failure to remove Primodos from the market.
The duty of the regulator was to protect women. It chose to protect the manufacturer instead. Thousands of women and unborn children were exposed to a risk that was widely acknowledged at the time. That should not have happened. It now falls to us to put right that injustice, to persuade the manufacturer to pay compensation to those affected families and to reform the regulatory system, so that it protects patients in the future.
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.
Alison Bennett (Mid Sussex) (LD)
I thank the right hon. Member for Tatton (Esther McVey) for bringing forward this really important debate and for her excellent opening speech, which was very informative. In the interests of time, I will keep my remarks brief.
The Medicines and Healthcare products Regulatory Agency is tasked with vital work, and we all agree that it is there to protect and promote public health. As a number of Members have set out, it is concerning that despite the MHRA’s obvious importance, it clearly faces a number of challenges that need to be addressed. The Cumberlege review highlighted a conflict of interests, because the MHRA relies on fee income from pharmaceutical companies; as the hon. Member for Stroud (Dr Opher) said, this is a case of the agency marking its own homework. It is not a great way to set up its funding.
The hon. Member for Dewsbury and Batley (Iqbal Mohamed) made a really important point about Brexit, which is the elephant in the room. As with so many parts of our economy, Brexit caused major disruption to the pharmaceutical industry. Among other things, the loss of the prestigious European Medicines Agency from London to Amsterdam damaged trust in the UK’s pharmaceutical investment space.
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.
Dr Luke Evans (Hinckley and Bosworth) (Con)
I congratulate my right hon. Friend the Member for Tatton (Esther McVey) on securing this debate, and on giving Members from across the House the opportunity to raise issues such as Primodos, breast implants, mesh, SSRIs, vaccines and MMR. As a clinician, I have seen patients who have been affected by all these issues, and I know the heartfelt difficulties that they have faced—not only in what has happened to them, but in trying to resolve the problems. It is a testament to her that she has given the House the chance to debate these issues, and I am not sure that the public have ever paid so much attention to a regulator, even in the financial crisis. The MHRA has suddenly become something that people know.
I often used to explain to patients that a regulator should be like a good referee: we should not see them, but they should be there to hold people to account and know the rules. However, modern refereeing is about more than that. A referee has already met the players beforehand, and speaks to the public about how things work. They help to shape the way in which the rules should be interpreted, allowing us to improve the game.
The hon. Member for Great Yarmouth (Rupert Lowe) asked who regulates the regulators, and the answer is that this House is accountable. That accountability is key.
What are the functions of the MHRA? They are: to ensure that medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy; to secure safe supply chains for medicines, medical devices and blood components; to promote international standardisation and harmonisation to ensure the effectiveness and safety of biological medicines; to educate the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use; and to enable the development of innovation and research that benefit public health.
I welcome the MHRA’s new chair, Professor Anthony Harnden, who was appointed at the start of the year. I hope he is listening to this debate, as it will be important for him in setting his priorities. I pay tribute again to my right hon. Friend the Member for Tatton because, whether or not the MHRA knew this debate was happening, I noticed during my research that all the guidance was updated on the MHRA’s website only yesterday. That is testament to the power of this place, even if inadvertently.
The last Government did a lot in this space, particularly focusing on patient safety and access. They introduced new regulations on medical devices, with the classic example being diabetes monitoring, but they also set out to attract innovation. Their reforms have helped to make the UK an attractive market for medical technologies. I am pleased that both sides of the House agree that this is a great place for the UK to find growth.
These developments were based on a consultation-led approach, following the changes we have had since 2021, when there was a consultation on the future regulation of medical devices. This led to a proportionate and phased approach that minimises supply disruptions and supports system readiness.
Under the last Government, a road map for implementation was set out on 9 January 2024. Again, I am pleased to see that the current Government updated the road map in December. This has the regulatory aims of adapting new technologies, strengthening patient safety and providing clarity for manufacturers that are trying to bring products to market.
All these significant changes try to balance medical technology advances, market capture, patient access, affordability and clinical outcomes. However, as we have heard in this debate, this is all well and good, but “perception versus reality” comes to mind. We arguably have one of the best regulatory regimes in the world and, post Brexit, there is a real opportunity to lead the way. Counter to what the Lib Dem spokesperson, the hon. Member for Mid Sussex (Alison Bennett), said, it is because of Brexit that we were able to regulate around our vaccines.
As has been said today, there are still serious concerns about the system, surveillance and resources, given the medical tech boom. This is a wide debate, so I will focus my remarks on three areas: the current medical market, the emerging medical market, and communications with the public, perceptions and beliefs.
When it comes to the system for current medications, we need only consider what we heard earlier about SSRIs, and particularly their impact on sexual dysfunction —I happen to have that casework on my desk at the moment. Do the Government believe that the yellow card system works, or will they consider a review?
When it comes to emerging markets, we have to remember that the MHRA has a statutory role not only in regulating but in the advertising and promotion of medicines in the UK. We have seen thousands of online adverts for weight-loss injections, such as Ozempic. The Times found approximately 6,500 adverts that mention GLP-1 on Meta’s ad library between January 2022 and the end of June 2024. And Sky has reported that, according to Simple Online Pharmacy, which has access to wholesale figures, 500,000 people in the UK are currently using things like Wegovy.
I would be grateful if the Government could set out what support they are offering the MHRA to ensure that it can fulfil its roles and functions properly, given that it has to manage promotion, safety and supply in all these areas. Are there any plans to review whether the MHRA is able to meet these conditions in a changing medical world?
Finally, and most importantly, if I were to be critical of the MHRA, I would say that the key thing missing on the list of objectives, as set out by the new chair, is communication. Let me finish where I started: a regulator has never been more in the public eye. As a clinician, I know how difficult it is to wade through complex medical data that is both conflicting and opaque. As my right hon. Friend the Member for Tatton pointed out, freedom of information requests and transparency are key to our understanding of this area. Will the Government look to review how the MHRA interacts with the public, how it communicates with grassroots professionals, and what it can do to explain the hugely important work that it does?
To conclude, as my hon. Friend the Member for Christchurch (Sir Christopher Chope) and the hon. Member for Dewsbury and Batley (Iqbal Mohamed) pointed out, this is all about trust. I think it was Reagan who said, “Trust, but verify”. That seems particularly apt for this debate—for that is the role of a regulator, but it is also the role of the Government and the public. We must build a regulatory system that all can trust, and do so inherently, but that is also easily verifiable at any point. If we can achieve that, we can build a trusted ecosystem that is good for innovation, good for the economy, and, most importantly, good for the people.
The Minister for Secondary Care (Karin Smyth)
I congratulate the right hon. Member for Tatton (Esther McVey) on securing this debate and thank her and all those who have spoken for their contributions. We have heard some powerful stories of failure as well as some useful experiences. I have to thank my hon. Friend the Member for Stroud (Dr Opher), the hon. Member for Dewsbury and Batley (Iqbal Mohamed) and the shadow Minister for sharing their expertise. I have heard many of these stories before in my 10 years in this place. Sadly, I have also had a constituent who shared her experiences with me, for which I am grateful. Frankly, those experiences shocked me and my staff.
I congratulate my hon. Friends the Members for Camborne and Redruth (Perran Moon), for Washington and Gateshead South (Mrs Hodgson), for Poole (Neil Duncan-Jordan), for Bolton South and Walkden (Yasmin Qureshi) and many others who have brought their experiences to this place, shining a light on the issues. It is right for us to debate this matter. Six months into the job and I am still learning, Madam Deputy Speaker, so I am grateful for being able to take part in this debate.
I can assure my hon. Friend the Member for Blackley and Middleton South (Graham Stringer) that I cannot answer everything, and I am glad that he recognised that. The right hon. Member for Tatton has focused my mind, for which I am very grateful. If I do not do justice to the points that have been raised, I will write to Members about specific things. I am meeting representatives from the MHRA and will be very clear about our expectations. It is absolutely the role of Parliament to be the ultimate monitor of its work.
The MHRA plays a vital role in fulfilling the Government’s health mission: balancing its responsibilities to maintain product safety and championing innovation. I will, if I may, be clear about the role of an enabler. It is about enabling innovative products to reach patients without compromising patient safety and without unnecessary delay.
It is thanks to vaccines and medicines such as antibiotics and modern surgical procedures that we are living longer, healthier, and more active lives. No medical product is completely free of risk; the main objective of the safety monitoring process is to identify any new risks that may emerge. When that happens, the MHRA must take its responsibility seriously, rigorously and transparently when balancing population risks and benefits of each medical product, taking prompt and decisive action whenever that is needed.
On supporting safety, the MHRA recognises the need constantly to seek to improve its safety monitoring systems to deliver better results for people. Recent improvements include implementing the new Safety Connect IT system, following recommendations from the Cumberlege Review. This IT system will improve the efficiency of reporting and processing of yellow card reports, much of which we have heard about today, supporting the prompt identification and assessment of new safety concerns.
In addition, the MHRA makes use of real-world data via the clinical practice research datalink, which collects anonymised patient data from a network of GP practices, across the UK, encompassing data from 60 million patients, including 18 million currently registered patients.
The MHRA has recently launched a pilot, in partnership with Genomics England, to create a rich source of genetic information to investigate the role of genetic pre-disposition in the development of serious adverse drug reactions. The aim is to establish a yellow card biobank to reduce the number of harmful side effects caused by medicines—a step towards personalised prescribing.
The Cumberlege review also highlighted the need to improve the regulation of implantable medical devices. In November last year, the Government introduced new regulations to strengthen the requirements for manufacturers to proactively monitor and report on medical devices once they are on the market, which was noted by my hon. Friend the Member for Washington and Gateshead South.
We plan to lay further reforms before Parliament this year, including unique device identifiers and implant cards to improve the traceability of implanted devices, as well as increasing the classification of devices to ensure that they receive the highest scrutiny throughout their lifetime. Finally, the MHRA has made some progress in response to the wider set of recommendations set out in Baroness Cumberlege’s report. It listened carefully to the people who gave evidence and to the review’s findings, and is committed to bring about those changes. It is our job to ensure that that happens.
The yellow card scheme provides the backbone of our safety monitoring system. The scheme relies on voluntarily reporting from patients, parents, caregivers and healthcare professionals. The MHRA also collects reports of suspected safety concerns involving defective, falsified or fake healthcare products. Last year, it assessed more than 118,000 reports, and identified 134 safety signals, but I take onboard the comments made today. When safety signals lead to confirmed risks, the MHRA can introduce specific risk minimisation measures, such as introducing particular warnings about the risk of side effects in the product information, restricting the use of the medicine or medical device, or suspending or removing the medicine or device from the market. The MHRA will continue to proactively encourage the reporting of adverse effects through improvements such as those within the new Safety Connect system, and will ensure that there are better connections between clinical systems, working with the wider healthcare system.
The MHRA recognises that there have been delays in some of the regulatory services that it provides, including licence applications for innovative and generic medicines, variations to licences, and inspections of manufacturing and laboratory premises. Since September 2024, all new applications for marketing authorisations of established medicines are being assessed within expected timescales. That element is therefore improving, but we will keep a close eye on it.
I reiterate my thanks to the right hon. Member for Tatton. This has been an informative and, bizarrely, a wide-ranging but focused debate. Trust is really important. Patients have to be at the heart of our work, and that of the MHRA. Patient safety is the foremost priority. The MHRA is continuing to work on improving engagement and involving patients in decision making throughout the life cycle of the products that it regulates. It will continue to work to facilitate patient access to new medicines and medical devices, in collaboration with health system partners across the UK. The regulator maintains its focus on continuous improvement, and has implemented new ways of working to maximise productivity in ways that put patients and public health outcomes first. I take the point made by the shadow Minister, the hon. Member for Hinckley and Bosworth (Dr Evans), that communication around that is key.
The MHRA has turned around performance on clinical trials and is on track to deliver all regulatory services within statutory timelines by the end of March 2025. Later this year, as part of its programme of reform, we will introduce new point of care manufacturing legislation that will make the MHRA the first regulator in the world to introduce a tailored framework for innovative manufacturing methods, taking the manufacture and supply of medicines to patients. It is truly an exciting development, and I pay tribute to those involved.
The process for recruiting the new chief executive is well under way. We welcome Professor Anthony Harnden. His strategic focus is on helping the organisation to protect patient safety through robust surveillance systems, embracing risk-proportionate regulation and fostering an inclusive workplace where people flourish. Without putting him on the spot, we should think about organising a parliamentary event of some sort to bring people together to discuss matters with the MHRA and build that trust. I am pleased to support its work. It is internationally recognised as a regulator. We want to do better. The Government will ensure that the MHRA is better.
Esther McVey
I thank all Members who have stayed late to speak today, many of them recounting the deeply moving and harrowing experiences of their constituents. All contributions reinforced the failings of the MHRA. In fact, listening to Members, the verdict on the MHRA is guilty as charged, confirming that it is in need of substantial reform. I feel sure that the Minister will ensure that that reform starts here and now.
Question put and agreed to.
Resolved,
That this House notes that the Medicines and Healthcare Products Regulatory Agency (MHRA) continues to need substantial reform, as recognised by the Independent Medicines and Medical Devices Safety Review (IMMDS), with patient safety concerns persisting and exacerbating since the review’s publication in 2020; believes that the MHRA’s 2017 expert working group report on Primodos was deeply flawed, with IMMDS later concluding the drug had caused avoidable harm; further notes that the yellow card system for reporting suspected adverse drug reactions is failing, with no process for following up on serious or fatal reactions and conflicts of interest, with 75% of the MHRA’s funding being derived from industry fees, a concern raised in the Fourth Report of Session 2004-05 of the Health Committee, The Influence of the Pharmaceutical Industry, HC 42-I, published on 5 April 2005; also notes the MHRA’s delayed response to reports of myocarditis, pericarditis and vaccine-induced thrombotic thrombocytopaenia following covid-19 vaccination, despite action from regulators in other countries; and calls on the Government to fully implement the recommendations in the IMMDS review and to acknowledge the harm done to patients and the financial burden on the healthcare system as a result of the MHRA’s widespread regulatory failures.