Medicines and Healthcare Products Regulatory Agency

Debate between Christopher Chope and Esther McVey

Thursday 16th January 2025 Commons Chamber

[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.