The Cumberlege review was published by Baroness Julia Cumberlege in July 2020. Baroness Cumberlege’s review was highly anticipated, and it gave an honest report on England’s healthcare systems. This included the topic of patient medical complaints and how flawed the current healthcare system is in relation to complaining of harm caused by some drugs and medical devices.
The three main areas that the review focuses on are Primodos, Sodium Valproate and Surgical Mesh insertion. An issue that the review depicts is the way in which patients’ data is held in registries. Cumberlege refers to these databases and registries in her review and has defined them in the hope that they can be expanded into other medical areas in which medical devices are used as well as other general medical areas.
The topic of medical devices throughout the review has now guided the healthcare system to look into introducing new medical devices when treating not only female incontinence but other medical conditions.
These are the nine main recommendations made by Baroness Cumberlege in her review:
- That the Government immediately issues a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
- That a Patient Safety Commissioner is appointed. This person would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, and demands action.
- Separate schemes should be set up for Hormone Pregnancy Tests, valproate and pelvic mesh to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.
- A Redress Agency for those harmed by medicines and medical devices in future should be established.
- The establishment of two types of specialist centres, located regionally – for mesh, and separately for those affected by medications taken during pregnancy.
- The regulator of medicines and medical devices, the MHRA, needs to put patients at the heart of its activity, and to overhaul adverse event reporting and medical device regulation.
- That a central database should be created by collecting key details including the patient, the implanted device, and the surgeon.
- That the register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ clinical interests and specialisms.
- Finally, that the Government immediately sets up a task force to implement the Review’s recommendations.
The question here is what has changed since the publishing of the Cumberlege report, and have these recommendations been implemented in England?
As recommended, an apology was made shortly after the review was published in July 2020. The apology was given by the Department of Health and Social Care to the women and families affected by Primodos, Sodium Valproate and pelvic mesh, whose voices were not heard initially. An assurance has been given that the government will do more to listen and respond to those affected by Primodos, Sodium Valproate and Pelvic Mesh.
A change that is due to be implemented is for surgeons to work at new mesh centres throughout England. This has become necessary due to the absence of any training programmes currently, and the desire for surgeons to use credentialing to establish higher competence for pelvic mesh surgery. NHS England are planning to have the mesh centres go live in spring this year. The mesh centre roll out is due to take place as a direct result of the recommendations in the Cumberlege review.
An issue that was discussed in the review was the possibility of conflict of interests for doctors recommending the pelvic mesh. Many affected patients believed that because of the common failures of these devices that doctors were receiving financial benefits by heavily promoting them. Furthermore, they thought that their health was not being taken seriously enough and the review talks about the lack of adequate research, the correct consent of patients and lack of proper regulation. It has been discovered that members of the medical committees are commercially conflicted. Due to this, it has created more weight for an argument to have the GMC record doctors conflicts of interest. Part of the recommendations from the review is for doctors to have their financial interests declared and made public. Since the review, this is being considered by the Government and talks continue about its implementation.
Another change due to take place because of the Cumberlege review is for the government to appoint a new patient safety commissioner whose role will be to oversee the healthcare in England promoting safety for patients and patient views on the medicines and medical devices discussed in the review. This is prompted by treatments that have caused harm that should have been avoidable. The Government has made amendments to the Medicines and Medical Devices Bill to establish an independent patient safety commissioner. The commissioner will act as an independent advocate for patients.
Unfortunately, the government has rejected a recommendation made in the review to have an independent redress agency for patients who have suffered harm due to the medicines covered in the report or the medical devices.
The Government also rejected the creation of a taskforce in England to carry out the recommendations contained in the Cumberlege review. Although it is disappointing that both these recommendations have been rejected by the government, the need for patient engagement is said to have been recognised. Consequently, the Government is setting plans in motion to develop a patient reference group. This, it is said, is a way of making patients voices heard in a more systematic way.