It is now 12 months since the Independent Inquiry into the issues raised by the convicted breast surgeon, Ian Paterson, published its report. The report made for difficult reading and describes the terrible harms that can occur when the malpractice of an individual, rogue surgeon goes unchecked.
In my statement to Parliament on 28 April 2020 I reluctantly announced a delay in our work to respond to the report. The Covid-19 pandemic has continued to exert unprecedented pressures on the health system, and this has necessitated a pragmatic response to the recommendations of the Paterson Inquiry.
The independent sector has stepped up and supplied much needed additional capacity for the NHS in its treatment of NHS patients during the response to the pandemic.
We have taken stock of all the recommendations and engaged with stakeholders across the system to gather views on the best way forwards. As part of this we have listened carefully to former patients of Ian Paterson through regular conversations with representatives of the three main patient groups and a bespoke event to ensure their voices are heard.
The immediate safety of patients has been our top priority and we have sought and received reassurance that the recalls of patients by University Hospitals Birmingham NHS Foundation Trust and Spire Healthcare have proceeded as quickly as possible.
When the recommendations have provided a clear way forward, we have worked with our system partners to put in place, or require, effective action. We will continue to consider all the recommendations and produce a full response to the inquiry’s 15 recommendations during 2021.
Today I am able to update the House on the Government’s initial response to the following five recommendations of the Independent Inquiry into the Issues raised by Paterson, and update on three other developments.
Recommendation 2 - Information to Patients: We recommend that it should be standard practice that consultants in both the NHS and the independent sector should write to patients, outlining their condition and treatment, in simple language, and copy this letter to the patient’s GP, rather than writing to the GP and sending a copy to the patient.
NHS England and NHS Improvement will examine how current guidance published by the Academy of Medical Royal Colleges (AoMRC) in 2018 on writing outpatient clinical letters addressed to patients (and copied to their GP) using simple, appropriate language can be incorporated into the requirements of the NHS standard contract.
Recommendation 4 – Consent: We recommend that there should be a short period introduced into the process of patients giving consent for surgical procedures, to allow them time to reflect on their diagnosis and treatment options. We recommend that the GMC monitors this as part of ‘Good Medical Practice’.
The General Medical Council (GMC) published its revised good practice guidance on consent on 30 September 2020. This came into effect on 9 November 2020 and sets out seven principles of decision making and consent, including giving patients the information they need to make a decision and the time and support they need to understand it. The GMC will work with organisations across the UK’s health services to support doctors to embed this into their everyday practice.
Recommendation 5 - Multidisciplinary Team (MDT): We recommend that CQC, as a matter of urgency, should assure itself that all hospital providers are complying effectively with up-to-date national guidance on MDT meetings, including in breast cancer care, and that patients are not at risk of harm due to non-compliance in this area.
Specific questions relating to MDT are already included in appropriate CQC service frameworks. As part of a longer-term strategy (based upon a short- and medium-term action plan that includes this recommendation) the CQC will work to ensure these become mandatory elements of its assessment and inspection approaches and communicate its expectations to service providers.
Recommendation 7 – Patient Recall and Ongoing Care: We recommend that the University Hospitals Birmingham NHS Foundation Trust board should check that all patients of Paterson have been recalled, and to communicate with any who have not been seen.
University Hospitals Birmingham NHS Foundation Trust (UHB) contacted 4,394 patients between May and August 2020. This has given rise to 355 enquiries. Following receipt of each enquiry, the patient /relative was contacted directly by a member of a dedicated team to ensure that the Trust was responding in a way that was respectful and responsive to individual patient preferences. For patients who underwent a breast procedure, care was reviewed by a Consultant Breast Surgeon who was independent from the Trust. For patients who had a general procedure e.g. hernia repair or a varicose veins/other vascular procedure, care was reviewed by a consultant from UHB.
Recommendation 8 – Patient Recall and Ongoing Care: We recommend that Spire should check that all patients of Paterson have been recalled, and to communicate with any who have not been seen, and that they should check that they have been given an ongoing treatment plan in the same way that has been provided for patients in the NHS.
By December 2020 Spire Healthcare had contacted all known living patients of Ian Paterson for whom they had addresses (approximately 5,500). Spire Healthcare is currently ensuring that those patients’ care has been fully reviewed, that the outcome of the reviews has been fully communicated to them and that, if required, they are getting the support and care that they needed. Additionally, several hundred people have contacted Spire as a result of the letters sent out last year. A proportion of these are having their care reviewed by an independent consultant surgeon and some have been referred for counselling, follow up support or, where clinically appropriate, treatment. Spire Healthcare will continue their review of patients’ care during 2021.
In addition, we are taking three legislative actions to drive up patient safety and ensure care provided by the independent sector is closely scrutinised.
- First, prior to the publication of the recommendations of the Independent Medicines and Medical Devices Safety Review the Government acted in June last year to amend the then Medicines and Medical Devices Bill to create the power to establish a UK-wide medical device information system. This system will mean that in future, subject to regulations, we can routinely collect medical device, procedure and outcome data from both NHS and private provider organisations across the UK, ensuring that no patient in the UK falls through the gaps. The Government is also considering how best to supply patients with the details of any device that has been implanted, to ensure they can continue to access that information in the future.
- Secondly, following the Independent Medicines and Medical Devices Safety Review the Government is establishing a Patient Safety Commissioner (PSC) for England with responsibility for medicines and medical devices. The main duties and powers of the PSC are detailed in the Medicines and Medical Devices Act which achieved Royal Assent on 11 February 2021 and establishes the Commissioner role. The PSC for England will be able to exercise their powers in both the independent sector and the NHS.
- Thirdly the White Paper, published in February 2021 setting out legislative proposals for the Health and Care Bill, announced our intention to extend the remit of the Health Service Safety Investigation Branch to private providers.
The report of the Paterson Inquiry shone a light on a set of harrowing events over many years and recommended a way forward to improve safety and quality in both the NHS and the independent sector. I believe it is right that we have taken urgent action where we can, and we will respond in full to the inquiry during 2021.
This statement has also been made in the House of Lords