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On the 8th of July The UK Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege published its long awaited report. Titled “First Do No Harm” it comes after a two-year review of patients in relation to Primodos, sodium valproate and pelvic mesh implants. Hernia mesh was not included in the review.
The review was announced in the English House of Commons on 21st February 2018 by Jeremy Hunt the then secretary of State for Health and Social Care. Its purpose was to examine how the healthcare system in England responds to reports about harmful side effects from medicines and medical devices and to consider how to respond to them more quickly and effectively in the future. The review team interviewed hundreds of people whose lives had been affected and also received written evidence. The team also took evidence from those in the healthcare system including regulators, professional bodies, manufacturers and policy makers.
The Review’s major recommendations
· That the UK Government immediately issue 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 to hold the system to account, monitor trends and demand action
· That separate schemes should be set up for Hormone Pregnancy Test, valproate and pelvic mesh to meet the cost of providing additional care and support for those who have experienced avoidable harm and are eligible to claim
· That a Redress Agency for those harmed by medicines and medical devices in future should be established. This will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systematic failings, rather than blaming individuals
· That there should be established two types of specialist centres, located regionally for mesh and separately for those affected by medication taken during pregnancy
· That 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 should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctor’s clinical interests and specialisms
· That the Government should immediately set up a task force to implement the Review’s recommendations
Speaking about the report John Beer PEOPIL President said today “this is a bold and far reaching report which must be hugely welcomed by those who have campaigned tirelessly for years. The report has identified critical failings in the system which has led to unnecessary patient harm and suffering for many years. Having commissioned this important work the UK Government must not ignore the recommendations influenced by those resistant to change. This must be essential reading for all countries around the world interested in protecting patients from harm.”
Mr Beer continued “the first step in making progress is recognising that we have a system which is deficient and does not protect patients. The next step is to act proactively to achieve change to ensure as far as possible that the scandals of recent years are not repeated “.
He added “any system whereby hospitals are permitted to conduct their own independent reviews of adverse events has to be questioned. The voice of the patient is often silent in such investigations where they should be at the centre of the investigation and have full access to all information obtained. This presents a violation of the obligations of Governments under the European Convention of Human Rights”.
Urging the Scottish Government to take similar action Lauren Sutherland QC and PEOPIL medical negligence head also commented “these recommendations must be embraced by the Scottish Government to protect Scottish patients. Baroness Cumberlege found the system to be “disjointed, siloed, unresponsive and defensive”. There was a failure to listen to patients and recognise that “the patients are its raison d’etre”.
Ms Sutherland added “sadly the review did not include Essure, Roaccutane, PIP breast implants, cervical cancer vaccination, in utero exposure to hormones and valproate use in children. Hopefully there can be consideration of other areas where patients have been harmed at some point in the future and similar schemes introduced”.
 This test was withdrawn from the market in the 1970’s and was thought to be associated with birth defects and miscarriages
 This is an effective anti-epileptic drug which causes physical malformations, autism and developmental delay in many children when it is taken by their mothers during pregnancy
 Used in the surgical repair if pelvic organ prolapse and to manage stress urinary incontinence
John Beer, President of PEOPIL