Medicines and Healthcare Products Regulatory Agency
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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.