Social Care Funding (EAC Report)
Baroness Fookes Excerpts(3 years, 10 months ago)
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Baroness Fookes (Con) [V]
My Lords, I applaud the hard-hitting and very practical report of my noble friend Lord Forsyth and his committee, and I hope that it will provide a real springboard for the Government to take action at last—like many other speakers, I think “at last” is very much the phrase to use. I also applaud the masterly overview provided by my noble friend Lord Young, and I hope that that will also be taken seriously into consideration.
I do not pretend to have the kind of expertise that other Members in this afternoon’s debate have shown, but I remember, as a very young, inexperienced MP, wondering why there was a divide between healthcare and social care—it seemed to be wholly artificial. Now, with my greater experience, I realise that it was a tremendous error which has led to the social side being left behind and, as many others have said, badly treated in terms of the workers, their pay and so forth. I hope that, in future, there will be a much better effort to bring together these two sides of the profession, as I see it.
I have some, rather unusual experience of being in a residential care home after a very serious illness some four years ago. I did not feel able to go to my own home alone, so I was fortunately able to book into a very good residential care home, but what I saw amazed me. There were good workers, and I was greatly impressed by the care they showed to the various residents, including me, and the great skills that were required. It was a real eye-opener for me, and it makes me very anxious that they should all receive proper training and have a proper career structure and better payments. I very much hope that this will be one result of the debate we are having this afternoon, based as it is on the excellent report by my noble friend Lord Forsyth.
In a very short time, I will pay tribute to the unpaid carers—in other words, family and friends of people who need care, who do it for nothing. However, it does not come as nothing for them: in many cases, they will have had to give up, quite possibly, well-paid jobs because they cannot combine really good careers, and all that they involve, with caring on a day-to-day basis. It is not necessarily that they were unskilled or low-paid workers themselves, and, therefore, the sacrifice from them is very much greater. I do not think that this has ever been recognised.
I would be interested to know what the cost would be if we paid even the minimum wage to all those unpaid carers; we might then get a much better idea of the valuable service that they provide. We should take far more care of them, giving them some respite care in particular—because I feel that many of them get to the end of their tether. If they could just have a nice little break, it would permit them to go on, whereas, in other circumstances, they break completely. I hope that this will be the end of the pussyfooting of various Governments and that we actually get on and do something for the social care sector.
Ockenden Review
Baroness Fookes Excerpts(3 years, 11 months ago)
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con) [V]
My Lords, I start by echoing the very thoughtful words of the noble Baroness, Lady Thornton, and the noble Lord, Lord Scriven, in their reflections on this harrowing report. It does make desperately awful reading. Any noble Lord who took the time to read the report would surely be enormously moved, not just by the story of the cultural and practical problems at the Shrewsbury and Telford Hospital NHS Trust, but also by the personal testimony of Rhiannon Davies—who fought an 11-year campaign after the death of her daughter, Kate—and of Kayleigh Griffiths. They both campaigned stubbornly and with great determination after the deaths of their daughters. They have done a phenomenal thing in bringing this situation to light, and we owe them our compassion and our thanks for their hard work and determination.
We also owe great thanks to Donna Ockenden, who has done a memorable job in terms of this report. It is a massive enterprise that is the result of a huge human investment of time and emotional commitment by Donna and her staff. The report itself is not only huge in scale but great in the humanity with which it deals with this difficult subject. We give great thanks for that.
I reassure both the noble Lord, Lord Scriven, and the noble Baroness, Lady Thornton, that we absolutely take this report seriously. It does outline major issues in the culture of many maternity wards. That is a cultural challenge that is both recognised by the Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists, and something that they are working on very well indeed. But I accept that more can be done. In its application, the Government commit not only to implementing the recommendations at trust level but to ensuring that the message made very clearly in the Ockenden report is heard throughout the NHS system.
We are committed to a major investment in the education around midwifery, which includes the rewriting of curriculums, and the Better Births programme, which has already delivered enormous value. There will be a maternity programme review that will update the Better Births programme. There has also been a £9.4 million investment in maternity safety pilots, some of which will be focused on training and some of which will be on safety measures—exactly the kinds of measures that are alluded to in the report.
But the most challenging and, I think, moving element of the report is the stories of the parents themselves and how they were not listened to. This echoes the findings of the report by the noble Baroness, Lady Cumberlege, which, I think, has moved everyone in the House. Time and again we hear the same story, of how those who have witnessed wrong practices and poor culture in the NHS have had to fight the establishment so hard in order to have their voices heard. If any noble Lords heard Rhiannon Davies speak about her own experiences campaigning on this, who would not be moved by that?
We take on board very seriously the recommendations of the noble Baroness, Lady Cumberlege, for a patient safety commissioner. We acknowledge her amendment to the Medicines and Medical Devices Bill, and we look forward to the Report stage of that Bill in the new year.
I would also like to remind noble Lords that all maternity major incidents—certainly neonatal deaths, stillbirths and brain injuries—are now routinely referred to the Healthcare Safety Investigation Branch, which does an independent investigation. This is an important development since many of the incidents reported by the Shrewsbury and Telford Hospital NHS Trust report. HSIB is doing extremely important work, and I believe that this will be a very large improvement.
Both the noble Lord, Lord Scriven, and the noble Baroness, Lady Thornton, raised leadership. I reassure them both that we have put in place much stronger surveillance, both by the regulators—the CQC and others—and by NHS England to keep track of these sorts of incidents, so that we can much more quickly identify weak spots in the area.
On the question of staffing levels brought up by both noble Lords, I reassure them that the recruitment of midwives—3,000 were committed to in 2018—is going apace. We have committed to a major investment in marketing in order to ensure that we hit our targets on that.
The noble Lord, Lord Scriven, asked whether we were committed to change, or whether this report will sit on the shelf and gather dust. I reassure the noble Lord, and all noble Lords, that we are still very much committed to the maternity ambition to halve stillbirths, deaths and injuries between 2010 and 2025. We are already nearly half way there on that ambition, and we will work relentlessly to ensure that it is achieved.
The Deputy Speaker (Baroness Fookes) (Con)
We now come to the 20 minutes allocated for Back-Bench questions.
Lord Bethell (Con) [V]
My Lords, I pay tribute to the insight of the noble Lord, Lord Patel, who brings with him not only expertise as an obstetrician, but deep involvement in the patient safety agenda. I completely agree that collaboration and close working relationships between midwives and obstetricians absolutely benefit the collective care of mothers and babies. When that does not happen, and when agendas other than patient safety come into play—around natural births or what type of person should be present at a birth—it is absolutely to the detriment of the safety of both mother and child. I am absolutely determined that the Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists step up to their leadership role in resolving this cultural stand-off. As the noble Lord rightly put it, in almost every maternity centre in the country a fantastic service is provided by clinicians and nurses—but, when that chemistry goes wrong, patients suffer, and we cannot let that happen.
The Deputy Speaker (Baroness Fookes) (Con)
I do not see the noble Baroness, Lady Altmann, in her place, so I call the noble Baroness, Lady Blackstone.
Baroness Blackstone (Ind Lab)
My Lords, I declare an interest, as set out in the register, as the chair of the trustees of the Royal College of Obstetricians and Gynaecologists. As the Minister has admitted, this report makes shocking reading, so what steps will the Government take to monitor the improvements they are pledging for maternity services right across the country to avoid the tragedies that are revealed by this review? Will the Government commit to publishing the findings of any future evaluation and, in particular, data on the avoidable deaths and long-term disabilities that result from failures in the care of women during childbirth?
Lord Bethell (Con) [V]
I join others in paying tribute to the personal testimony of the noble Baroness. The story that she tells is extremely moving. One cannot think about the challenges and difficulties that she must have had since that awful night, which she so movingly describes. The report makes it clear that those with a BAME background have disproportionately high rates of difficulty at birth and in maternity services, something which undoubtedly we need to look at more carefully. However, the Ockenden report is not a historic grievances report, and that will not be the focus of our response.
The Deputy Speaker (Baroness Fookes) (Con)
Lord Mann? No? We will move on to the noble Baroness, Lady Stuart of Edgbaston.
Baroness Stuart of Edgbaston (Non-Afl)
My Lords, this is the second time in six months that this House has been exposed to quite harrowing tales of patients’ experiences in the NHS. I am glad that the Minister mentioned the report by the noble Baroness, Lady Cumberlege, and her call for a patient safety commissioner. Both the Ockenden and the Cumberlege report identified a problem with the culture in the NHS. We cannot go on having review after review. While it is important to listen to the patients’ experiences as part of putting things right, we must learn comprehensive lessons. Will the Minister therefore say just a little more as to how he intends to take the idea of the patient safety commissioner forward, and in particular how that patient safety commissioner will be independent of and not part of the NHS?
Lord Bethell (Con) [V]
My Lords, it would be premature of me to describe in too much detail how any patient commissioner may work, since we are half way through the Bill’s progress. But I would like to reflect on the very good arguments made by my noble friend Lady Cumberlege and her supporters during the Bill’s passage at Second Reading, in Committee and in the amendment-moving process. She has made very convincing arguments for how a patient safety commissioner can be an ultimate destination for those who have not found due process and a sympathetic ear elsewhere in the consideration of their grievances. It is entirely right that any commissioner, whether a victims’ commissioner or any other kind, should feel a strong sense of independence; that is a total benefit that we endorse in the provision of any commissioner. But commissioners are not enough; what we need is a change in culture. That is why Aidan Fowler, the DCMO looking at this, works so hard and why we have a patient safety agenda that works to address this at every level of hospital trusts.
The Deputy Speaker (Baroness Fookes) (Con)
All speakers have now been called, so we move to the next business without a break.
Medicines and Medical Devices Bill
Baroness Fookes ExcerptsTuesday 17th November 2020
(4 years ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-VII(Rev) Revised seventh marshalled list for Grand Committee - (17 Nov 2020)
Lord Bethell (Con)
My Lords, Amendment 105, tabled by the noble Baroness, Lady Thornton, would mandate consultation with the devolved Administrations before making regulations under Clause 16. This question has been raised by a very large number of those who have contributed. Amendment 132, also tabled by the noble Baroness, would insert after Clause 41 a separate obligation to consult on regulations made under the Bill that relate to matters within devolved competence.
Both amendments are unnecessary. It goes without saying that we will consult the relevant Northern Ireland departments where it may be possible to make regulations jointly under Parts 1 and 2 of the Bill for the benefit of the whole of the UK. I reassure the noble Baronesses, Lady Jolly and Lady Masham, and all others who mentioned consultation with the devolved assemblies that we are in very regular contact. There are fortnightly four-nations calls. These include NHS Digital where necessary. We intend to maintain this level of engagement. It has proved constructive and has contributed enormously to our plans for broad consultation on the mechanics of the Bill.
While medical device regulation relates to reserved matters, the provision of healthcare services, including the healthcare data collected, is devolved. As the regulations about the establishment and operation of the information systems encompass both areas of responsibility, it is right and proper that the Secretary of State is required to consult the devolved Administrations before making regulations under Clause 16(1).
The noble Baroness’s amendment appears on the list before my own, but Amendment 126 in my name, which I will come to shortly, is appropriate for this situation. It makes it very clear that the devolved Administrations will be consulted on regulations to be made under Clause 16. This reflects that provisions in those regulations may relate to devolved as well as reserved matters.
Amendment 127 in the name of the noble Lord, Lord Patel, is unnecessary. My Amendment 126, which I will come on to shortly, would apply a statutory duty to carry out a public consultation precisely because we know how important it is for patients and other stakeholders to be involved. The intent of Amendment 127 is already achieved by Clause 41 and is further clarified by the government amendment.
Amendments 128 and 129, tabled by the noble Baroness, Lady Thornton, and the noble Lord, Lord Sharkey, would commit the appropriate authority to consult all those listed before making regulations under the Bill. We all wish to ensure that a range of views are adequately captured. However, we do not wish to inadvertently rule out contributions from those accidentally not listed. Those listed in the amendments would not necessarily be directly affected by each regulation. For example, regulations relating to human medicines prescribing would not affect veterinary medicines. I reassure the noble Lord and the noble Baroness that the consultations will have depth and reach, and that medical research charities will be fully involved. Requiring consultation with all those listed would be unduly burdensome and seemingly add little value to the making of regulations.
On Amendment 130 in the name of the noble Baroness, Lady Thornton, I completely understand that there are perhaps some concerns with the extent of consultation, or, indeed, its duration, or that the Government might seek to consult on proposed regulations without sufficient notice to those wishing to comment. This is simply not the case, but limiting us in this way may hinder the delivery of important regulations coming into force. If the Bill were to be significantly delayed, it would mean that we could not make an efficient start on consulting stakeholders on key policy areas, such as on a future regulatory system for medical devices.
Whether consultation is conducted prior to the Bill achieving Royal Assent or afterwards, we will make it clear to stakeholders when the consultation processes will start and end. Consultations will be targeted, form part of a process of engagement and last for a proportionate amount of time. For my part, I cannot wait for the process to begin. It is very exciting.
I know that noble Lords want to know our plans for consultation, as do I, and when precisely that will begin. I reassure my noble friend Lady McIntosh that we will publish responses to consultation. We will follow the Cabinet Office guidance, which is extremely stringent. I am incredibly enthusiastic to reach that next step and to begin to make changes to the regulatory regime to deliver a comprehensive, stand-alone and first-class medical devices system, as well as to consult and have the benefit of informed views, like those of the noble Lords, Lord Kakkar and Lord Patel, among others, when we discussed provisional rapid licensing.
I want to make changes to the clinical trials regulations and to consult on how we can make improvements and update definitions. Also, of course, I want to bring in the medical devices information system regulations so that we can establish a world-leading medical devices safety regime. I indicated the intention to consult in the first quarter of 2021 on the innovative medicines fund. We intend to start public consultation on the medical devices information system in May 2021. We also hope to take forward the medical devices regulations consultation over the summer of 2021. There is obviously sequencing to do on all the other measures that we will want to bring in. I will update the House on our consultation plans in due course. The dates are dependent on getting the Bill done, of course.
As to Amendment 126 in my name, I heard the noble Lord, Lord Blencathra, ask at Second Reading how Parliament could be consulted on regulatory changes. Others reflected on the importance of consulting patients on the regulatory changes that impacted or mattered to them. I know that there has been concern about whether the relationship to the pharmaceutical and medical device industries is such that they might be unduly weighted in consultation, but I assure noble Lords that that is not the case.
To provide reassurance, Amendment 126 changes the obligation in Clause 41 to public consultation. The effect of the amendment would not be to prevent the appropriate authority from inviting responses from certain stakeholders or groups as the authority might consider appropriate. Engagement and close working will continue, but Amendment 126 will ensure greater transparency and enable even more people to become involved in the consultation.
The duty to consult the devolved nations on Clause 16 has been the subject of ongoing conversations and correspondence between Ministers in the devolved nations and me. I spoke earlier about the nature of these regulations relating to both reserved and devolved matters. Specific considerations will need to be taken into account in relation to how the devolved healthcare systems function and we want to ensure that any information system that we create is as effective as it can be. The information system will provide an important tool for improving the safety of medical devices for patients throughout the four nations of the United Kingdom. It has always been our intention to consult fully the devolved Administrations on the development of the regulations. I am making this change to provide greater reassurance and confidence, both to the devolved nations and to Peers who have raised the significance of ensuring interoperability between any such information system and devolved healthcare systems.
The final change made to Clause 41 by Amendment 126 will mean that participants engaging with the consultation can understand how the considerations have been taken into account so far. This additional transparency will, I hope, provide noble Lords with assurances that we have taken the criticisms on board and have provided a method for Parliament, the public and stakeholders to know how our thinking progresses throughout the development of regulations made under the Bill.
The combination of these changes strengthens the consultation requirement in the Bill. I hope that, taken together with amendments that I have made elsewhere in the Bill, it goes some way to meeting your Lordships’ concerns and that the noble Baroness will feel able to withdraw her amendment. I commend my Amendment 126.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I have received a request to speak after the Minister from the noble Lord, Lord Hunt of Kings Heath. I am not clear whether the noble Lord, Lord Patel, also wishes to do so. Perhaps that could be clarified.
Lord Hunt of Kings Heath (Lab) [V]
I thank the Minister for his extensive response. Essentially, he has relied on the well-known departmental argument that, by listing certain categories of organisation, you exclude others. However, legislation that has been passed in the last few years has often contained extensive lists of organisations to be consulted. Amendment 128, which I support, would give Ministers the power to consult any other persons that the authority considered appropriate. I wonder whether the Minister will just answer this. He would surely accept that this Bill is highly unusual in giving a huge amount of powers to Ministers essentially to change primary legislation through regulation and extensively to alter the regulatory framework for medicines and medical devices. Given that, we should be careful about similarly open-ended regulations on consultation. The amendment would provide reassurance to the key sectors that they will be consulted, but it would also give discretionary power to Ministers to add to that on the occasions when greater flexibility was needed.
Lord Bethell (Con)
My Lords, I acknowledge the noble Lord’s point that the Bill puts huge emphasis on the effective and impactful nature of our consultation arrangements. That is very much our approach. He is entirely right that these consultations are key. That is why we have sought, as I have this afternoon, to give reassurances about our approach to consultation.
On the noble Lord’s point about the listing of groups, we have in mind two considerations. The first is that, by listing one group and not another, you assign a degree of legislative weight on one group and not the other. That is an unfortunate result of a listing process such as he describes. Secondly, as I have said, not all the groups that you could list in one part of the Bill would be relevant for all parts of the Bill. For that reason, we are reluctant to provide lists of groups that technically have to be consulted on every aspect of the Bill.
I take the noble Lord’s point that broad, effective and deep consultation is critical to the effective implementation of the Bill and to the drafting of thoughtful and effective regulations. All those involved in the Bill, including the department and me, very much agree with that point. That is why I tabled the amendment.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I have not received any further requests to speak, so I call the noble Baroness, Lady Wheeler.
Baroness Wheeler (Lab)
I thank the Minister for his extensive and helpful response, particularly on the comments made by my noble friend Lord Hunt about the groups that are consulted. This has been an excellent debate and I have little to add, as noble Lords put forward the issues so ably, in particular on the importance of listening to patients and patient representatives so that the consultation is meaningful and well thought through, given the enormous powers that are in the Bill and will be set out in the regulations. It is timely for my noble friend to remind us of the context of the DPRRC and Constitution Committee reports. I asked the Minister to consider whether Clause 41 should specifically include reference to consultation with the devolved authorities. If he could come back to me on that, that would be helpful. I also asked some questions about his correspondence, which I hope he will agree to follow up.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
We now come to the group beginning with Amendment 108. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Clause 35: Disclosure of information
Amendment 108
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I understand that the noble Baroness, Lady McIntosh of Pickering, has withdrawn, so the next speaker will be the noble Lord, Lord O’Shaughnessy.
Lord O'Shaughnessy (Con)
My Lords, I will speak to Amendment 108. In doing so, I remind noble Lords of my interests as listed on the register and my membership of the First Do No Harm All-Party Group, set up by my noble friend Lady Cumberlege. It seems that the debate and discussion on this issue revolve around the use of “may” or “must”, as is often the case in legislation —we are all familiar with this. I fully understand why the Bill uses the word “may” in relation to concerns as set out currently in the clause because, as described, they involve ambiguity. That is implicit in the way the clause is framed. It therefore requires judgment about the balance of risks, which is difficult to prejudge.
It seems that Amendment 108 is a build, as they say, on this and an elegant solution to the existence of a higher-risk category of the kind that the noble Lord, Lord Patel, my noble and learned friend Lord Mackay and my noble friend Lady Cumberlege have talked about. It would leave “may” in place for when ambiguity exists, but would introduce “must” when, in their words,
“there is a clear threat to public safety”,
which is the highest category of risk. It seems unconscionable to think that, when there is knowledge of such risks, they should not be communicated; indeed, there should be, if there is not already, an obligation to do so. Consequently, I feel that this amendment improves on the Bill. It seems perfectly logical and rational to me, and I hope my noble friend the Minister will be sympathetic.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I next call the noble Baroness, Lady Jolly, and I dare say that there will be a little pause before she speaks.
Baroness Jolly (LD) [V]
I support Amendment 108, led by the noble Lord, Lord Patel, which would place a duty on the Secretary of State to disclose information they hold
“relating to a medical device where there is a clear threat to public safety.”
Amendment 114, also in the name of the noble Lord, Lord Patel, would retain Regulation 3B of the Medical Devices Regulations 2002, which was inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 and, among other things, requires the 2002 regulations to comply with the Data Protection Act 2018.
I support these amendments but wonder what might be the process to contact patients in the event of a fitted medical device fault, which might lead to a threat to public safety if it was more than just one. Would it be the same sort of process as that for recalling certain faulty domestic appliances, which, by law, also need to be recorded? Noble Lords may chuckle, but there is a system there. Where the patient has a medical device implanted, who is responsible for taking patient contact information?
More importantly, how does the patient ensure that their contact data is up to date? Will it link, using the unique patient reference number: their 10-digit NHS number? It would need the patient to ensure that their personal data is kept up to date via the website or app. Many do use the NHS app, but, given the patient demographic, I would not be that confident in relying on that mechanism. I am not sure that the general public are ready for that requirement or, in many cases, have the capacity or devices to fulfil it. Could the Minister clarify this for me?
Baroness Thornton (Lab)
I am very grateful to the noble Lord, Lord Patel, and the noble and learned Lord, Lord Mackay of Clashfern, for bringing these amendments to the Committee. They are quite different, although linked. On Amendment 108, which would place a duty on the Secretary of State to
“disclose information … about concerns relating to a medical device where there is a clear threat to public safety”,
the noble Lord, Lord O’Shaughnessy, absolutely got it when he said that this is not a “may” but really is a “must”. The thing about this that would interest me most, because it is an important duty, is how it could happen: what would trigger such a disclosure, where would it come from and how would it be handled?
The only thing I would ask about this issue is whether a Secretary of State is the right person to do that. I have in mind someone who is now a respected noble Lord of this House, who fed his daughter a burger to show us that beef was safe during the BSE outbreak, which led to the creation of the Food Standards Agency as an independent organisation that would say, “This food is actually unsafe”, to the Government. It quite rightly has the powers to bring about a closure or recall. This is exactly the right place to be on patient safety. The only question I would pose is: is that the right person to do it?
Amendment 114, on Regulation 3B, worries me enormously. I would need to have an explanation from the Minister as to why he would remove confidentiality and seemingly protect commercial interests. It is very worrying, and the Committee needs to know the justification for that because it looks to me like it probably needs to remain in place.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I understand that there was an error, and the noble Baroness, Lady Bennett, was not called, so I call her now.
Baroness Bennett of Manor Castle (GP) [V]
Thank you, Madam Deputy Chairman; I resisted the urge to leap in. My contribution, anyway, will be brief. I want to build on my remarks in the previous group and, in particular, to address Amendment 108 in the name of the noble Lord, Lord Patel. I referred then to the article in the British Medical Journal about the medical-political complex. We have seen over the decades, again and again, in respect of medicines, pesticides and herbicides, situations where there has been growing concern about a particular chemical. Critics have come under tremendous pressure, including critics often from Governments—critics in official positions—from very large, powerful commercial interests to remain silent.
The noble and learned Lord, Lord Mackay of Clashfern, asked how anyone could not speak out in a situation where they saw that there was a danger or a serious cause for concern. We have seen again and again, however, situations where people, including Ministers in Governments, have come under tremendous pressure. Does the Minister not think that an amendment such as that proposed by the noble Lord, Lord Patel, would protect the Government, the individual and the public if she or one of her successors were in a situation where there was grave cause for concern but also very powerful multinational company forces at play?
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I have received a request to speak after the Minister, so I call the noble Baroness, Lady Thornton.
Baroness Thornton (Lab)
My Lords, I thank the Minister for her explanation in response to Amendment 114. My desire to explore the issue slightly more is partly a result of what the noble Baroness, Lady Cumberlege, and others have said. It is also partly a result of the very helpful discussions this morning about the time that it is going to take to get the protection on devices in place. If we have another mesh situation, will that be able to emerge in this period of time? If so, who will be responsible for saying that it is not a safe device?
The Deputy Chairman of Committees (Baroness Fookes) (Con)
We now come to the group consisting of Amendment 117. Once again, I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 117
The Deputy Chairman of Committees (Baroness Fookes) (Con)
Before I call the next speaker, I must tell the Committee that we normally have a break about now but it has been suggested that we delay it until there is the vote in the Chamber, expected very soon, and that we then take 15 minutes. In the meantime, I call the noble Lord, Lord Patel.
Lord Patel (CB) [V]
My Lords, first, it was a privilege to put my name to the amendment moved by my noble friend Lady Cumberlege. It is a pleasure to follow her powerful speech, which made the case for an independent patient safety commissioner so powerfully that I am tempted to say that no more needs to be said about the amendment except for the Minister to accept it. But of course I cannot do that. I will try to make a case for why now is the time to accept what the noble Baroness is asking for. The time for her amendment has come.
I strongly support the amendment. It was one of the key recommendations of the noble Baroness’s report First Do No Harm to establish an independent commissioner for patient safety and to do this through legislation. The need to address patient safety as an important aspect of healthcare was identified in England following the publication of the report An Organisation with a Memory. This was the watershed moment in the history of patient safety development. In 2001, a report was produced, Building a Safer NHS for Patients, which led to the establishment of the National Patient Safety Agency for England; a national reporting and learning system was to be developed as part of it. In 2006, Safety First, a report for patients, clinicians and healthcare managers, was published, with the objective of recasting the functions of the National Patient Safety Agency. It was after that that I took the chair of it.
The National Patient Safety Agency did develop several good and respected methodologies and publications, and introduced some fundamental patient safety protocols, but it lacked the power and authority of an organisation established in statute. Functioning as an arm’s-length body of the Department of Health, and at its behest, was not the way to establish patient safety. In my view, it weakened its ability to deliver patient safety across the NHS.
As chair, I remember having to try to persuade management at NHS Confederation meetings that alert notices related to patient safety needed to be implemented. This lack of statutory authority meant that hospital trusts were not required to follow any guidance or alert notices. On Friday 1 June 2012, the functions of the NPSA were transferred to the special commissioning board as the NPSA fell victim to the cull of quangos. So what has happened since? Regulatory organisations have come and gone. NHS structures have changed and continue to do so. The NHS is a bit of a political football; I remember that, when I suggested that the political parties stop using it as one, the noble Lord, Lord Hunt, laughed at my comment. Change is a constant feature.
Patient safety documents and policies from 2000 to the present day all sound alarmingly familiar: progress is slow and incremental, even at present. An NAO report criticised the pace of change as regards patient safety, saying that it was too slow and that those who manage trusts focused more on financial budgets than patient safety. One result was the Mid Staffs crisis: we all remember how devastating that report was, particularly in what it had to say about the major patient safety failings.
We now have another devastating report, First Do No Harm. It is the second, and I hope the last, call for us to establish patient safety through legislation and on behalf of patients. The Government’s response to the Francis report defines the current patient safety system. Patient safety became an important aspect of government policy, with several initiatives and three global ministerial meetings, et cetera, but the processes are the same. Have things changed? In my view, not much, especially in terms of a clear demonstration of reducing patient harm. The patient safety organisations that exist are still part of and accountable to NHS departments, not to patients.
The noble Baroness focused her amendment on the safety of medicines and medical devices. Of the top five areas of patient safety errors, harm related to medicines and medical devices rank second and fourth. She is right to focus on these two areas as the first task of the commissioner for patient safety. A 2018 review of errors related to medicine estimated that 237 million errors occur every year in England. The national reporting and learning system had 204,000 incident reports related to medicine, while 712 deaths are attributed yearly to medicine-related harm, costing annually something like £70 million.
Data in relation to the harm associated with medical devices is not as readily available, except when investigated as part of a report such as First Do No Harm. However, figures from the USA can be used as a proxy, as its larger population may give some indication of the scale and types of devices implicated. A recent report in the USA showed the following as examples: 60,000 cases related to the use of surgical mesh; a similar number in relation to defibrillators; and 104,000 cases related to hip prosthesis. There were many more. These data clearly show not just the level of safety issues in relation to medicines and medical devices but the need to address them.
It is time to give patient safety the legal status it needs, as the noble Baroness, Lady Cumberlege, said. It is time for a bolder and more ambitious vision to make patient care safer. I believe that her amendment does this and I strongly support it.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I understand that there may be a delay in the vote taking place in the House for technical reasons. I do not think that we can go on here indefinitely so I suggest that I call the noble Lords, Lord Hunt of Kings Heath, and we break then regardless.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, it is a great pleasure to follow the noble Lord, Lord Patel. No doubt we will have further debates about the role of politics in the National Health Service. I would just say to him that I think the failure of NHS England is, in many ways, an example of how we end up with a quango that seems unaccountable to Parliament but Ministers wash their hands of many of the decisions that they make. The problem is that you can end up with the worst of all worlds.
That perhaps reflects some of the issues relating to patient safety because, thanks to the Minister, we all enjoyed meeting the person responsible for patient safety in NHS England. The problem is that NHS England has many other responsibilities, including financial and target responsibilities. Patient safety does not really seem to be that body’s top concern.
This seems to be the very point that the noble Baroness, Lady Cumberlege, makes. Her report’s conclusion is really rather shocking in many ways. She made a general conclusion from the three areas that she investigated. She said that the healthcare system
“is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially.”
That is a devastating critique, particularly in relation to patient safety.
I forgot to declare an interest as a member of the GMC board, but I must make it clear that I am not speaking on behalf of the GMC.
The noble Baroness’s recommendation of a patient safety commission is so powerful because she proposes that somebody sits outside the current system, accountable to Parliament and not to Ministers or the devolved NHS management system. She argues for the commissioner to have the necessary authority and standing to talk about, report on, influence and cajole where necessary without fear or favour on matters related to patient safety.
In pointing to the Children’s Commissioner, the noble Baroness, Lady Cumberlege, has really put her finger on it. This gives us an idea of the sort of person we need—someone who, like the Children’s Commissioner, challenges the positions of Governments, schools, unions and local authorities. As the noble Baroness said, I am certain that it was the Children’s Commissioner’s comments that led to the reopening of schools. I do not believe that somebody in a government department or a quango could have done that. She did it because, personally, she is a very admirable person, but structurally, because she is wholly independent.
The noble Baroness made some very telling points when she anticipated a potential criticism of her report. The core of it is that many organisations already have some responsibility for patient safety in their remit. That is true, and they all do good work, but she is right because none of them really has patient safety as a systematic approach to the NHS as their sole remit. Until we have some independent agency or person with patient safety as their sole remit, I am afraid that I do not think that we will make progress. We must accept that, if patient safety is one of many objectives of an organisation, compromises inevitably have to be made.
There is a tension between funding, throughput, targets and patient safety—not always, but sometimes. Here, I turn back to my experience as a foundation trust chair. The trust boards hold a huge amount of tension within them. Of course they are concerned with patient safety and quality, but they are also under the cosh from NHS England and the regulator, NHS Improvement, for their overall performance, whether financial or in throughput. I certainly accept the argument that many of the best organisations where everything runs well include patient safety, but to deny that there is a tension between these other objectives and patient safety is disingenuous.
That is why we look forward to the Minister making a strong statement. If he simply says that this is outside the Bill’s scope, as we have been told consistently, it will not cut the mustard, because we could easily start expanding and extending the Bill as we get other legislation and when the Government finally respond to the report of the noble Baroness, Lady Cumberlege. In my view, the Bill will not leave this House unamended unless the Government can make it clear that they are determined to implement the noble Baroness’s central recommendation.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
My Lords, I suggest that the Committee adjourn for 15 minutes.
Medicines and Medical Devices Bill
Baroness Fookes ExcerptsWednesday 28th October 2020
(4 years ago)
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The Deputy Chairman of Committees (Baroness Fookes) (Con)
My Lords, the Grand Committee is resuming its deliberations. We now come to the group beginning with Amendment 26. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. The noble Baroness, Lady Finlay, is no longer able to move Amendment 26, so the noble Lord, Lord Hunt, will do so on her behalf.
Amendment 26
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I have received a request to speak after the Minister. I call the noble Baroness, Lady Cumberlege.
Baroness Cumberlege (Con) [V]
My Lords, it has been a really interesting debate. One of the things that I have found so wonderful in this House is all the professors. I did not go to university and, when I listen to the professors and the way they care for their students—and in this case I am something of a student—I really value it. I thank the noble Lord, Lord Patel, for pointing out the dilemmas that we face. They are very difficult. I am sure that the Minister also feels that: it is how you balance what we are trying to achieve as a successful United Kingdom in innovation, marketing and all the rest of it, and the dilemma of safety as well.
I thank the noble Lord, Lord Kakkar, very much. I need to read very carefully in Hansard what he said and then come to some conclusions. I am not sure that we have quite cracked it, but I believe we are working towards it. The noble Lord, Lord O’Shaughnessy, had some really interesting ideas about how we can take this forward, and we need more work to be done on it.
I want to say one thing. In the review, we were so horrified by the stories that we heard that we said we had to do something to prevent further surgeries taking place in women who were suffering so deeply. We called it the pause; we went to NHS England and the department and very quickly they agreed to our pause, with six safety conditions that had to be introduced if it was to be lifted—and, of course, they still have not been introduced. That was in July 2018.
The interesting thing about the pause is that, because surgeons were prevented from using what they would see as the normal solutions to stress urinary incontinence, with pelvic mesh, they started to think of different ways in which to do things and help women, ensuring that the discomfort that they had through these conditions was ameliorated. We are getting innovation in a very interesting way. I am convinced that such innovation would not have taken place if we had not introduced the pause. But it should not have been us, the review team, who introduced it. It should have been the healthcare system, which had put forward some measures and thoughts about it years before, but nothing happened. Of course, that was one of the burdens that I carried throughout the review—that promises were made and nothing happened. We called the healthcare system glacial; it just did not move. There are some hugely bright people in this country and throughout the healthcare system and beyond, in universities and everything else. Surely, if we could only utilise the wonderful brains that we have in this country, we could do much better.
I thank my noble friend for the very full summing-up today. The categories of risk relevant to devices have been so badly used in the past in terms of how pressure has been put on to change the risk when people knew that harm was being committed. We have a meeting with the MHRA, and I am sure that a lot of these issues will be discussed.
I thank the noble Lord, Lord Hunt, for introducing the amendment. It is very difficult to pick up somebody else’s work, but he did it with his usual tremendous skill.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
We now come to the group beginning with Amendment 27. I again remind noble Lords that anyone wishing to speak after the Minister should email the Clerk during the debate.
Amendment 27
Lord Clement-Jones (LD)
My Lords, I am very glad that I put my name down to speak on this group of amendments. I had designed my contribution to be about the government amendments. Having heard the noble Lord, Lord Patel, I am reassured that I am not tilting at windmills. I hope that when the Minister winds up on this group she will be much more explicit about the purpose behind Amendments 48 and 109 and the limitations on their use. There are very thin explanatory statements accompanying the amendments. I heard the helpful paraphrase from the noble Lord, Lord Patel, but, regrettably, I did not receive the Minister’s letter although I have spoken on health data issues in the Trade Bill at some length. I share the noble Lord’s concerns.
I have a series of questions to put to the Minister in relation to those amendments. Can the Minister confirm that they do not, as such, permit the sharing of NHS patient data, whether related to medicines or medical devices and whether anonymised or not? The new UK-Japan trade agreement permits either party, in its Article 8.73, to share source codes and algorithms for regulatory purposes. This is directly relevant to modern medical devices. Is this why the Government are seeking the provision inserted by Amendment 109? In agreeing the trade deal, did the Government realise that they did not have a clear power to do so? How widely do the Government interpret these two amendments? What is their essential purpose and subject matter? I am raising this and the noble Lord, Lord Patel, raised it. What are the constraints as the Government see them?
Of course, there is an important patient safety issue in terms of the operation of medical devices. I entirely take the point raised by the Lord, Lord Patel, that there is no specificity in the article about that but does that mean that UK medical device manufacturers will, as a matter of routine, need to reveal their source codes and algorithms? Is this to be a standard provision in trade agreements, permitted by these provisions? What safeguards will there be against IP infringement and know-how theft in these circumstances?
I am sorry to throw these questions at the Minister in this fashion, but it comes as a result of me not having any brief from the Minister in the first place. We have all commented on the fact that the government amendments, tabled as they have been, need a fair bit of explanation. I hope the Minister can answer some of these questions and I look forward to her reply, but it may be that she prefers to write after Committee.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I understand that the noble Lord, Lord Lansley, has withdrawn so I call the next speaker on the list, the noble Baroness, Lady Jolly.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
My Lords, that concludes the work of the Committee this afternoon. The Committee stands adjourned. I remind Members to sanitise their desks and chairs before leaving the Room.
Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 5) Regulations 2020
Baroness Fookes Excerpts(4 years, 1 month ago)
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The Deputy Speaker (Baroness Fookes) (Con)
The noble Lord, Lord McColl of Dulwich, has withdrawn, so I call the noble Lord, Lord Shipley.
Baroness Uddin (Non-Afl)
My Lords, it is a pleasure to congratulate the noble Baroness, Lady Fox. In our younger days we shared many platforms in the antiracist movement. Of course, that was before she departed completely from my political principles, but I look forward to working with her on common grounds.
The Government must lead by consensus, with clarity of messages and adequate financial support for the millions of our citizens who are experiencing such draconian measures, financial collapse, and strain on their mental and physical well-being. The spat with Mayor Burnham has certainly taken attention away from the serious impact of these regulations, including the lack of an effective test, trace and track system.
From the outset, the Government have been utterly inconsistent in their dealings with leaders of local authorities, many of which are facing massive reductions in basic services for the elderly and people with disabilities, and the decimation of voluntary organisations that have been the backbone—the bedrock, actually—of vulnerable communities. Some local authorities are facing bankruptcy, as the noble Lord is well aware. The collapse of the hospitality sector and associated businesses has had a profound impact on local authorities, as has been mentioned, and will continue to have such an impact unless the Government provide sufficient financial measures for them in their critical role in underpinning and delivering these protection measures.
The Deputy Speaker (Baroness Fookes) (Con)
I understand the noble Baroness, Lady Gardner of Parkes, has withdrawn, so the next speaker will be the noble Lord, Lord Bhatia.
Health Protection (Coronavirus, Local COVID-19 Alert Level) (Medium) (England) Regulations 2020
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Baroness Uddin (Non-Afl) [V]
My Lords, it is a real privilege to follow my noble friends Lord Robertson and Lord Rooker. Tiered approaches may seem fit for the purpose now, as we deal with differing rates in admissions across the country and across boroughs in London. However, it has to be said that the rapid rate of government announcements has caused manic confusion among the general public. I agree with the noble Lord, Lord Bilimoria, that clarity in message is critical. Even in areas described as medium risk, there is a deepening fear that we are about to hit a catastrophic health crisis without sufficient financial measures for significant numbers of our citizens—vulnerable citizens and communities. I have some general questions for the Minister and I look forward to his consideration and responses.
What specific measures are in place to protect front-line staff with protected characteristics? Will the Government assure this House that, unlike in the first few weeks and months, front-line staff of minority heritage will not be pushed into Covid management without safeguarding their well-being? I am citing many who lost their loved ones during the first outbreak. Given that we know people of minority heritage continue to be at risk of ending up in ICU admissions, will the Government ensure that those doing test and trace door to door have proficiency in the languages for the populations there? What additional resources will be given to areas in the middle tier to prevent them going to the more critical grade?
We also know that families with disabled children who have learning disabilities and autism, and their carers, have experienced adverse impacts in services and their mental well-being. What plans and resources are in place to meet the upcoming needs for services to ensure that we meet our obligations on human rights and equal rights? I have asked this question before and it has not been answered. What protocols exist to ensure that parents and carers of people with learning disabilities and autism can be with their loved ones, should they wish to be, when members of their families end up in hospital for treatment? I would really like to be written to if it is not possible to answer this. What protocols exist and are they being issued as guidelines to all front-line services?
Some of the exemptions are applicable to people with disabilities who are able to participate in games, outside and indoors. I understand the sentiment in ensuring that activities and provisions on playing sport are available to them. Are we not overlooking the need to safeguard the health and protection of the groups of people who have until now been shielding?
Are the criteria for shifting at-risk areas in the medium category to a higher grade being communicated to local authorities in advance so that they can prepare sufficiently, and will adequate extra resources be made available to cities and regions, whatever their political leadership?
Finally, boroughs such as Tower Hamlets and Newham have seen incredible levels of infection and admissions, which now include young people and children. What consideration is being given to ensure that we do not airbrush children out of the danger zone, as we seem to be doing?
The Deputy Speaker (Baroness Fookes) (Con)
As the noble Lord, Lord Berkeley, has withdrawn, I call the noble Baroness, Lady Jolly.
Coronavirus Act 2020: Temporary Provisions
Baroness Fookes Excerpts(4 years, 1 month ago)
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Lord Moynihan (Con)
My Lords, at this seminal and important moment in our parliamentary consideration of Covid-19 legislation, we sadly find ourselves having to contribute not to a debate, as defined by intervention and response, but to a pastiche of parliamentary points of view. I intend to use my time to cover three key issues for the Government as we move towards a further six months which will no doubt witness a similar avalanche of Statements and regulations on the subject.
First, I echo many of the contributions today and ask the Government to ensure that parliamentary consideration takes place before, not after, the Executive have taken action. The Government will be surprised by how much they will benefit by listening to recommendations regarding the content of their proposals. Above all, they will need to present them clearly, on time and in a sympathetic and concise way. Making appropriate parliamentary time available would not be an impediment where there is political will. Consideration of outdated legislation, which we have done over successive Fridays, makes a mockery of parliamentary scrutiny. For background reading on the importance of this issue, I recommend taking careful note of the contributions made by my frustrated noble friends Lord Forsyth and Lord Dobbs, whose views I fully endorse.
Secondly, please can the Government, the university authorities and all involved with young people and education treat young people with respect and sympathy, not with threats, intimidation and the imposition of a far stricter regulatory framework than elsewhere in society? Reassurance, sympathy and clear guidance to university undergraduates is needed. I was at home in Scotland over the weekend talking to parents of students at Glasgow University. One mother said that her son, away from home for the first time, said he felt lonely and imprisoned. He had already isolated for 10 days when three students in his bubble tested positive, although they were asymptomatic and learned of their condition only through tests. He was now to be isolated for another 10 days. A return for Christmas with his family was in question, and he faced disciplinary action according to threatening emails received from university authorities. He was left in his room with less space to move around than the average prisoner. Everyone wants good government, but clarity of messaging and sympathy are essential. We have had months to prepare for the return of students to universities. I hope that a priority for the Government over the next six months will be a focus on young people with clarity of messaging about next year’s exams, improvements to online teaching over dodgy internet connections, respect for their rights and sensitivity to the fact that they can barely afford to pay fees and accommodation costs, and face the prospect of even larger loans than they have ever faced for a much reduced service.
Finally and critically, there are the sports bodies which currently face a crisis which could further damage the young and create a lost generation of activity. As has been noted in the latter part of this debate, the future of the sector is perilous. The arts industry received £1.57 billion in July. Professional sports bodies returned to televised competition at the request of the Government but no professional club in, for example, rugby has any gate income, and without that, which can be arranged in a Covid-safe way, large wage bills continue to be paid. Players have on occasion taken major pay cuts, and numerous redundancies have been made. They would have been able to cope if fans had been allowed back under strict safety controls in the stadia. The time is now, as evidenced around the world, for a return of fans in a limited, Covid-safe manner—unlike closing time at 10 pm in city centres. As my noble friend Lord Naseby eloquently put it, the young are at the forefront of the measures necessary to improve health, well-being and the improvement of the lives of local communities. We should now look to the sport, recreation and activity sector to tackle growing societal issues, including reducing health inequalities, obesity and crime, easing loneliness and enhancing social cohesion in the long winter months when we will be living with Covid. I urge the Government to take action.
The Deputy Speaker (Baroness Fookes) (Con)
My Lords, the next speaker was omitted from the list in error. I call the noble Lord, Lord Wigley.
Covid-19: Response
Baroness Fookes Excerpts(4 years, 4 months ago)
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Lord Bethell [V]
Anyone who has stood at the Dispatch Box to answer questions on PPE, as I have done, will feel extremely proud of the fact that we have managed to purchase a very large amount of it under very difficult circumstances. We have also responded well to the challenge of a global collapse in the PPE supply chain. Despite appearances, we have substantial stockpiles of both near-term seven-day and further-term 90-day PPE resources; by that, I am very pleased. Competition does not necessarily guarantee either quality or delivery. I pay tribute to colleagues in the NHS, in the Cabinet Office and at DH who have, under extremely difficult circumstances, thoroughly checked out the delivery and bona fides of the contracts we have signed while working closely with the NSA to avoid fraud. We continue to work closely with both domestic and overseas suppliers, which I would argue has delivered a valuable result for the country.
Baroness Fookes (Con) [V]
I will follow on from the question posed by the noble Baroness, Lady Watkins of Tavistock. Have the Government worked out an order of priority in which people might receive a vaccine? Would it be front-line workers, the elderly or even—perhaps—government Ministers?
Lord Bethell [V]
My Lords, the Cabinet Office is charged with the role of deciding the order of priority. There are precedents for this; it is a well-established list that is decided at a level outside the DH. I do not know if Cabinet Ministers are given priority, but I slightly suspect that junior Ministers are not.
Medicinal Cannabis
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Baroness Fookes (Con) [V]
Given the importance my noble friend attaches to tests, may I ask whether any have started, the dates on which they started and when we might expect results?
Lord Bethell
The noble Baroness is very specific in her questions, and I am afraid I am not able to answer them specifically because they are subject to restrictions and confidentiality. Where I agree with the thrust of her question is that we have been in a bit of a cul-de-sac in this area, but the department is working hard to unblock the problems that have existed. Despite Covid, we appear to be making some progress on this.
Covid-19: Masks
Baroness Fookes Excerpts(4 years, 5 months ago)
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Baroness Fookes (Con) [V]
My Lords, I very much welcome the chance to enter this debate. If there are powerful reasons now for wearing face masks, I think it is up to the Government to give very clear, practical guidance to members of the public as to what kind of face mask they should use. I feel that single cloth masks are probably worse than useless, but I would like guidance on that, as well as guidance on actually using them. On my limited excursions outdoors, I have seen people take them on and off, and touch their faces. I wonder whether this really makes it difficult for them to be as hygienic as they should be. Finally, I think we need guidance on their disposal. Are they to be the type that can be washed thoroughly, and if so, how? If they are to be disposed of, are they to be disposed of very safely indeed? I hope that the Minister will be able to give us some real guidance on these matters.