My Lords, although I am a member of the GMC board, I am not speaking on behalf of the GMC on this group of amendments.
I speak on behalf of my noble friend Lady Thornton’s Amendment 8, which seeks to beef up the duty of the Secretary of State to make regulations under Clause 1(1) in relation to the safety and availability of human medicines and the attractiveness of the relevant part of the UK as a place to conduct clinical trials or supply human medicines. Amendment 73 does essentially the same for medical devices. As she said, the concept of attractiveness is rather vague and open to misunderstanding, which makes a statutory definition so important. I have also put my name to Amendments 74 and 75 tabled by the noble Baroness, Lady Cumberlege, and will speak in support of her Amendment 12.
Apart from teasing out from the Government what attractiveness means, this is essentially an opportunity to draw out from the Minister their response to the noble Baroness’s report, First Do No Harm. The report is a stark and moving account of how thousands of patients were let down in a serious and life-changing way. I have met many of the campaigners involved and their stories were heart-rending, as she has said. I am particularly grateful to the organisation known as Sling the Mesh, whose representatives I had the pleasure of meeting. Noting that the noble Lord, Lord O’Shaughnessy, is speaking later, I say that I remember, after I asked an Oral Question about mesh, that he met campaigners and talked to them for some considerable time. That was very helpful in getting across to the Government and Ministers just what damage had been done by a procedure that for many women proved to be positive and life-affirming. The awful thing is that the women who had terrible outcomes were ignored, because it was inconvenient and the operation was so successful for quite a large percentage. The system completely pooh-poohed them. Even now, under the counter, there is a lot of resistance to the noble Baroness’s recommendations.
The noble Baroness found that the healthcare system—in which she included the NHS, private providers, regulators and professional bodies, pharmaceutical and device manufacturers—was disjointed, siloed, unresponsive and defensive. That is why her core recommendation is the appointment of an independent patient safety commissioner, a person of standing who sits outside the healthcare system, accountable to Parliament through the Health and Social Care Select Committee. Obviously we are debating this later, but it would be helpful to get some sense of the Government’s response. No doubt the Minister might point to the work of Aidan Fowler, the NHS national director of patient safety, and the strategy produced under the auspices of NHS England and NHS Improvement last year. That is fine so far as it goes; it makes the point that patient safety is about maximising the things that go right and minimising the things that go wrong for people experiencing healthcare.
I commend Aidan Fowler for his efforts and commitment. Does the strategy go far enough? Does it represent a systems approach to safety where that becomes the No. 1 objective of the NHS? Does it mean that all equipment and buildings in future will
be designed with safety as the first consideration? Will boards of NHS trusts treat safety as their No. 1 responsibility? Will that lead to a wholly different approach by the CQC, because I do not think that safety is a priority so far as it is concerned in its inspections? The big question is: will NHS England and NHS Improvement change their approach and make it clear that safety is an important priority for them? Unless they do, I do not think that any change will take place. The strategy—an NHS England strategy, of course—feels like a collection of good practices, but not something that will change the system, which clearly needs to happen.
To get some sense of this, I looked back to the report by Don Berwick, whom I regard as the guru on patient safety internationally, entitled A Promise to Learn and produced in 2013 in the wake of the Mid Staffs inquiry. Berwick was clear that the quality of patient care, especially patient safety, should be placed above all other aims. He said:
“Patient safety problems exist throughout the NHS as with every other health care system in the world. NHS staff are not to blame—in the vast majority of cases it is the systems, procedures, conditions, environment and constraints they face that lead to patient safety problems. Incorrect priorities do damage: other goals are important, but the central focus must always be on”
patient safety.
What Berwick said in 2013 holds good today. The NHS has made progress since then—I readily accept that—but on no count has safety been embedded as the No. 1 concern. That is what makes the report by the noble Baroness, Lady Cumberlege, so important and why she wants an external champion of patient safety, because it clearly ain’t going to come from inside. It is too diffuse. No one is responsible for patient safety. If Aidan Fowler were directly accountable to the Secretary of State and resided in the Department of Health and Social Care, I would begin to believe that that was a serious attempt, but because the Government have decided that all the national clinical directors should be placed under an NHS management system, direction and accountability at the top of the office have been lost. Therefore, the report by the noble Baroness, Lady Cumberlege, makes sense and will have to be listened to positively.
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