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Last week, the Independent Medicines and Medical Devices Review, more commonly known as the Cumberlege review, was published. In February 2018, then Health and Social Care Secretary, Jeremy Hunt, commissioned the review to examine how the healthcare system in England responds and can respond better to reports of harmful side effects from medicines and medical devices.

In the report’s covering letter to the Secretary of State, Baroness Cumberlege states that the entire healthcare system is “disjointed, siloed, unresponsive and defensive” and has failed to listen to patient concerns.

The report, entitled ‘First Do No Harm’, does not make for light reading, with patients’ testimonies described as “harrowing” along with the assertion that affected patients “have been dismissed, overlooked, and ignored for far too long”. The researchers conclude that, based on their findings, the system is “not safe enough” for “those taking medications in pregnancy or being treated using new devices and techniques”.

Some of the key systemic failings identified include the insufficient pre-market testing and post-marketing surveillance and long-term monitoring of outcomes, the inability of the system to answer key questions despite collecting a huge amount of information, and the presence of manufacturers who are “motivated by sales, speed to market and return to shareholders”. The report notes the fact that the system has been unable thus far to identify failings, which suggests that it has either “lost sight of the interests of all those it was set up to serve or does not know how best to do this”.

Notable recommendations include:

  • The appointment of a Patient Safety Commissioner.
  • A new independent Redress Agency for those harmed.
  • Networks of specialist centres to provide treatment for those adversely affected by mesh and medications taken during pregnancy.
  • Changes to the MHRA, primarily in relation to adverse event reporting and medical device regulation.
  • A central patient-identifiable database with the key details of the implantation of all devices at the time of the operation.
  • Expansion of the GMC register to include a list of financial and non-pecuniary interests for all doctors. Additionally, there should be mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.
  • A task force set up by the Government immediately to implement these recommendations.

The report also requested an apology from the Government, which was given shortly after its publication by Health Minister Nadine Dorries, responsible for matters of patient safety, and the Secretary of State Matt Hancock. Dorries acknowledged the pain suffered by patients and their families, and said the Government is taking the time to absorb the recommendations before responding in full.

Commenting on the report’s findings, Dame Barbara Hakin, Chair of the Health Tech Alliance, said: “The Health Tech Alliance welcomes this timely report by Baroness Cumberlege. Health technologies have the potential to transform the healthcare system but can only do so if patients are kept at the heart of innovation. We support the review’s efforts to enhance the patient voice and ensuring that the healthcare system is able to respond quickly and decisively to issues of patient concern.”