Medicines and Healthcare Products Regulatory Agency

Sharon Hodgson Excerpts

Thursday 16th January 2025 Commons Chamber

[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.