Parliamentary debates

MP Esther McVey said: “Listening to Members, the verdict on the MHRA is guilty as charged, confirming that it is in need of substantial reform.”

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.

Hansard

Health Minister Andrew Gwynne: “The previous Government were too slow on that (looking into the Cumberlege Report for financial redress). It is a priority for this Government. We are working at pace, and we remain focused on making meaningful progress. This is a complex area of work, involving several Departments, but we are committed to providing an update at the earliest opportunity. I have heard the desire for urgency today, and I hope we can make the progress that Members want to see.”

Hansard

To ask His Majesty’s Government what progress they have made in ensuring that those who have suffered complications following vaginal mesh implants receive financial compensation.

Read the Hansard report

Sling The Mesh gave evidence to health minister Maria Caulfield and senior health officials during an evidence session to hear progress made on the Government’s recommendations in the Independent Medicines and Medical Devices Safety report on surgical mesh, sodium valproate and Primodos.

Read the full evidence

A year after the First Do No Harm report was published, the Government publishes its response.

Hansard

Emma Hardy MP: This House notes the publication of the Independent Medicines and Medical Devices Safety Review, First Do No Harm; further notes the Government’s failure to respond to the recommendations of that review in full; notes the significant discrepancy between the incidence of complication following mesh surgery in the Hospital Episode Statistics and the British Society of Urogynaecology databases, as highlighted in the Royal College of Obstetricians and Gynaecologists’ Project Report, entitled Hospital Episode Statistics as a Source of Information on Safety and Quality in Gynaecology to Support Revalidation; notes that the Government’s plan to publish a retrospective audit to investigate the links between patient-level data to explore outcomes has not been fulfilled; notes that the moratorium on mesh implant procedures should not be lifted until that audit has been undertaken and the true scale of suffering established; notes Ministers’ failure to acknowledge recommendations relating to victims of Primodos; and calls on the Government to fully implement the recommendations for victims of mesh, sodium valproate and Primodos without further delay.

Hansard

The report makes for harrowing reading. Every page makes clear the pain and suffering that has been felt by so many patients and their families. They suffered “avoidable harm”. House of Lords calls for a Task Force to be set up immediately to implement the recommendations.

Hansard

“I have watched and read some of their testimonies. They left me shocked, but also incredibly angry and most of all determined to make the changes that are needed to protect women in the future.”

Hansard

Lord O’Shaugnessy: “From my time as a health minister, when I had responsibility for medicine and medical device regulation, and for promoting innovation in the NHS, that experience introduced me to the amazing benefits that come from life-changing and life-saving new therapies, but also exposed me to the dreadful harm that can occur – however rarely – as a consequence of the innovations on which we all rely.

Safety of Medicines and Medical Devices debate

Briefing papers

Toasters and plugs get tougher checks than medical implants. MP Owen Smith calls for national registries and tougher regulations, while Jackie Dyle Price calls on women suffering mesh complications to sue their surgeons for clinical negligence.

Hansard

“Having reviewed Baroness Cumberlege’s recommendation and having considered the NHS’s progress in implementing the relevant NICE guidelines across the system, the chief medical officer and senior clinicians have concluded that we should institute a pause in the use of vaginally inserted mesh to treat prolapse and the use of tape or slings to treat stress urinary incontinence. They have concluded that this should be done through implementation of a high vigilance programme of restricted practice.”

Read the full statement

The debate:

• calls for a retrospective audit into surgical mesh for pelvic organ prolapse and stress urinary incontinence
• notes that NICE guidance recommends against the use of surgical mesh for pelvic organ prolapse and that no NICE recommendations have been made for stress urinary incontinence
• notes that Sheffield University recently announced the development of a new mesh material
• calls on the Government to suspend prolapse and incontinence mesh operations while the audit is being carried out, to bring forward the NICE guidelines for mesh in stress related urinary incontinence from 2019 to 2018, and to commit to a full public inquiry into mesh if the audit suggests that this is the best course of action

Hansard

Shadow public health minister Sharon Hodgson says her mum is one of those suffering – yet her mum only realised when she saw Sharon on the Parliamentry TV talking about it. Read more

Health secretary Jeremy Hunt said: “To do better in the future, we need to ensure that patient voices are bought to the table as systematically and consistently as other voices in the system.”

Baroness Julia Cumberlege will assess:

• The robustness and speed the of processes, followed by the relevant authorities and clinical bodies to ensure that appropriate processes were followed when safety concerns were raised.
• Whether the regulators and NHS bodies did enough to engage with those affected to ensure their concerns were escalated and acted on.
• Whether there has been sufficient co-ordination between relevant bodies and the groups raising concerns.
• Whether an independent system is needed to decide what further action may ​be required in these cases or in the future.
• Whether there has been widespread harm requiring a public inquiry.

Hansard

Emma Hardy MP: Many hon. members present have been contacted by constituents affected by mesh surgery, which is a medical procedure used to treat incontinence and prolapse in women. The surgery, which usually takes less than half an hour, involves inserting a plastic mesh into the vagina to support the bladder, womb or bowel. It can also be used to treat rectal prolapses in both men and women. This debate is crucial, as it gives me and other colleagues the opportunity to be the voice for all those men and women who have been affected. Each individual story fits into the wider national and international narrative. This debate is our opportunity to call on the Government to do something about it and help to end the suffering of thousands of men and women in this country.

Hansard