Medicines and Healthcare Products Regulatory Agency

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?

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?

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.

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.

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.

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.

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

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.

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

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”.

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

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.

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 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?