The Independent Medicines and Medical Devices Safety Review has been underway for two and a half years, chaired by Baroness Julia Cumberlege who has been at the centre of health care policy for decades. In her letter to the Secretary of State, Baroness Cumberlege said, “While we literally applaud our health and social care workers for their heroism and commitment, the health care system can sometimes forget that patients are its very raison d’etre”. Patients must be listened to and heard.
The report was published on the 8 July 2020 and its purpose was to make recommendations for improving the health care systems’ ability to respond where concerns have been raised about the safety of particular medical interventions.
Importantly, the review particularly takes into account patient experiences and features the stories of how lives have been adversely affected by the treatments of Primados, Sodium Valproate and Pelvic Mesh Implants.
The review was asked to consider how the patient’s voice could be strengthened so that there could be a “system that listens, hears and acts – with speed, compassion and proportionality”. It was found that there were common links between the three treatments in question.
- All were taken or used by woman.
- During the review, patients were asked about their experiences and gave evidence. These patients each told similar stories of their battles to be listened to when things went wrong.
- Help groups and mutual support groups have been formed by these patients
- Patients have been campaigning for years, resorting to the Media and appealing to politicians to take up the cause, as the health care system were not listening to them.
The Cumberlege enquiry considered a range of evidence during its investigation., including speaking personally to those who had suffered harm.
The main recommendations were as follows:
- The government should issue a full apology on behalf of the Health Care System to the families affected by Primodos, Sodium Valproate and Pelvic Mesh Implants.
- There should be the appointment of a Patient Safety Commissioner, who would be an independent public leader with a statutory responsibility, championing the value of listening to patients and promoting users’ perspectives, in seeking to promote patient’s safety.
- A new Independent Redress Agency should be created for those harmed by medicines and medical devices, modelled on those operating effectively in other countries.
- Separate schemes should be set up for each of the three interventions to meet the cost of those who have experienced avoidable harm and are eligible to claim.
- Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those affected by medications taken during pregnancy.
- The MHRA (Medicines and Healthcare products Regulatory Agencies) need substantial revision, particularly in relation to adverse event recording and medical device regulation. There is a need for better engagement with parents and their outcomes and a greater role in public protection.
- A central patient – identifiable database should be created by collecting key details of the implantation of all devices at the time of operation; this can be linked to special registers to research and audit outcomes.
- There should be greater transparency if payments are made to clinicians. The register of the GMC (General Medical Council) should be expanded to include a list of financial and non-pecuniary interests. In addition, there should be mandatory reporting by pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.
- The Government should immediately set up a task force to implement the Reviews’ recommendations; its first task should be to set out a timeline for their implementation.
If you would like further information from our Clinical Negligence team, please do not hesitate to get in touch.