A photograph of blue medicine pills in a jar. The Cumberlege Review looked at issues arising from two medicines and a medical device.

The Government Response to the Cumberlege Review

Nadine Dorries, the Minister for Patient Safety has recently issued an update on the Government’s response to the Cumberlege Review.

What is the Cumberlege Review?

Baroness Julia Cumberlege was asked to chair the Independent Medicines and Medical Devices Safety (IMMDS) Review. The review, announced in February 2018, examined the healthcare system’s response to concerns raised by patients and their families about:

  • Primodos – a hormone pregnancy test;
  • Sodium valproate – an anti-epileptic drug; and
  • Surgical mesh – used to repair pelvic organ prolapse and managing stress urinary incontinence.

The review published its report on 8 July 2020. We wrote about the nine recommendations that were made last July.

The Government’s response to the Cumberlege report

On 11 January 2020 Nadine Dorries issued an update on how the government has responded, so far.

Apologise to those affected

In July the government apologised to all women impacted by the medicines and device that featured in the review.

Appoint a Patient Safety Commissioner

The review’s main recommendation was to establish an independent Patient Safety Commissioner. Before Christmas, draft legislation was amended to enable this. Once appointed, the commissioner will promote patient safety and the views of patients in relation to medicines and medical devices. To help them fulfil their duties, they will have the power to make reports and recommendations, as well as request and share information with the NHS and the private sector.

Create an independent redress agency

The government do not currently plan on creating an independent redress agency, to compensate those injured by harmful medicines and medical devices. They point to the fact that similar schemes have been implemented in the past, without the need for an independent agency.

Creating specific schemes to compensate victims of the subjects of the review

The government has said that this proposal is still under consideration.

Set up specialist centres for victims of mesh and medications during pregnancy

By Spring 2021 specialist services for people who are suffering as a result of mesh should be available.

However, the government are still considering the proposal to set up services for those affected by medicines in pregnancy.

The Medicines and Healthcare products Regulatory Agency (MHRA) needs substantial revision

The MHRA recognise that the recommendations are important and affirm that patient safety is their top priority.

They have already begun a programme of work to:

  • Improve how they work with patients
  • Reform systems for reporting adverse incidents
  • Strengthen the evidence base for their regulatory decisions.

In recognition of them understanding the importance of strengthening their evidence base for medicine use during pregnancy, they have already published a report on ways that healthcare data can be better collected and analysed. They have also established a Safer Medicines in Pregnancy and Breastfeeding Consortium, who have published a strategy to improve information of medicines for women during pregnancy and breastfeeding.

Specifically, in relation to Sodium valproate, a Valproate Safety Implementation Group has been created. They will work to reduce the harm caused by valproate.

The creation of a patient-identifiable register of devices implanted

In June, last year, the government proposed legislation that would enable the creation of a ‘UK-wide medical device information system’. The process for this becoming law is ongoing.

Improving the transparency of payments made to clinicians

The government is still considering this issue. They recognise that all clinical decision-making staff should have to declare interests (not just doctors) and the need for this information to be accessible by patients. They will consider how to do this with the General Medical Council (GMC) and other stakeholders and patient representatives.

Set up a task force to implement the review’s recommendations

The government has no plans to follow this recommendation. Instead, they will rely on a cross-system working group.

They have also created a Patient Reference Group to make sure patients get a say in the process.

Early Days

It’s still too early to say whether the government’s response has been sufficient or effective. But the update is likely to provoke a mixed response.

Any progress is great, but it’s worth bearing in mind that some of the people affected by the issues in this review, have already waited decades for answers. For them, progress must feel slow.

And for the government there’s never been a more important time to instil the public faith in them and the MHRA, so positive progress must be a priority.

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