Covid-19
Debate between Lord Bethell and Baroness Fookes(2 years, 9 months ago)
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, I am enormously grateful to the noble Baronesses, Lady Thornton and Lady Brinton, for their thoughtful questions. The noble Baroness, Lady Thornton, put it extremely well: we are at a delicate inflection point. It is a moment when the whole country needs to be cautious about rushing into change, but it is also a moment when the vaccine is having an enormous impact and change is therefore appropriate.
Infection rates are rising dramatically, but we cannot avoid the fact that hospitalisations and deaths are holding relatively steady. Today, there are 2,970 Covid patients in beds and 470 on ventilators. This is a massively smaller proportion than in the pre-vaccination spikes, when the connection between infection, hospitalisation and death was much firmer and more profound. At the same time, as the noble Baroness, Lady Thornton, rightly pointed out, waiting lists are huge and the gap for diagnostics for severe diseases, such as cancer, is extremely concerning. It is our responsibility to step up to that deficit and not be wholly distracted by Covid. This is therefore a moment when we have to balance competing demands on our healthcare; we are trying to hit the right balance.
On masks, I pay tribute to the Lord Speaker for his leadership in this area and on asymptomatic testing. I saw his Twitter post where he was being swabbed for his LFD test—a commendable sign of leadership. He and the noble Baroness, Lady Brinton, are entirely right: we should wear masks out of consideration for others, including others who may not have had the vaccine or may not be able to have the vaccine. However, it is also entirely right that central government cannot mandate every aspect of human behaviour for months and years to come. I take great pleasure in the sight of local leaders using their influence to inspire the public in this matter. I remind the noble Baroness, Lady Brinton, that DPHs are able to bring in mandatory measures where there are areas of outbreak. People need to know that the wearing of masks has an impact, and we are hopeful that they will go along with that. Although legal restrictions are being removed, the guidance will recommend that masks continue to be worn in certain situations, and businesses will be encouraged to support staff and customers who continue to wear masks.
In line with businesses, public services have always been free to set their own entry policies as long as they meet their existing obligations, including under the Equality Act. Public services must continue to protect workers and others from risks to their health and safety, including from Covid. That is only right and fair.
On the very important question of the immuno- suppressed and the immunocompromised, both noble Baronesses made extremely powerful points. I want to express in very clear terms my personal sympathy for all those who have concerns about the impact of the vaccine and for whom the rise in infections presents a very real threat to their health. However, I flag the Public Health England report on the clinically extremely vulnerable group as a whole. It makes it clear that there is little reduction in vaccine effectiveness for them compared to those who are not in high-risk groups, with between 76% and 93% effectiveness after a second dose. The PHE data also suggests reduced effectiveness for the immunocompromised and the immunosuppressed, particularly after one dose, but effectiveness after two doses is much higher. These general figures mask substantial variations, which we have discussed before—we would expect this between one set of compromised systems and another—but future studies will provide much more granularity on that. It is not right, however, to suggest that all those with compromised immunities are left unprotected by the vaccine.
The guidance for those who are clinically extremely vulnerable was updated and published on 12 July, as the noble Baroness, Lady Brinton, pointed out. This confirms that changes to social distancing rules in step 4 will also apply to the CEV, who are advised to continue considering additional precautions that they may wish to take on board. I hear very clearly the noble Baroness’s points about anomalies in the guidance; I will take those back to the department and try to tidy up the documentation as she advises.
I can inform the House that we are writing to NHS clinicians to update them on them on the latest position regarding vaccine effectiveness for these groups and provide information on potential treatment options currently under development, such as monoclonal antibody therapies and novel antivirals, as well as access to antibody testing. This guidance will support clinicians in their conversations with patients. This is such a variegated group that that kind of personalised advice is critical.
The interim JCVI advice is that all clinically extremely vulnerable people, including immunosuppressed individuals and their household contacts, should be prioritised for a booster vaccine in the autumn. We are continuing to invest in the OCTAVE study, which will provide further data on patients with suppressed immune response. Interim results for the immediate response to the vaccine will be available from the middle of July.
We are absolutely focused on ensuring that the population is given clear guidance. The NHS app is undoubtedly an area that needs to evolve. Its effectiveness as a technological tool in giving people counsel and advice when they have been in close proximity to someone with the infection is extremely valuable. We are looking at ways in which that value can be enhanced.
On the specific question of the noble Baroness, Lady Brinton, about Malta, it is for member states to determine what they accept at their borders regarding vaccines. Foreign travel advice recently published for Malta misleadingly reported that it would not accept the specific batches received from the Serum Institute of India in the UK. This has now been resolved with agreement from the Maltese Government, and Malta is now accepting proof of vaccination from any Covid vaccine administered in the UK.
Turning to those who, as the noble Baroness, Lady Brinton, rightly pointed out, stepped forward for the critical AstraZeneca vaccine clinical trials, being on a vaccine trial absolutely should not disadvantage them. The Government intend to take any action available to ensure that that is the case. We are working with clinical research sites to add participant information of vaccine clinical trials to the national immunisation management service—NIMS—to allow participants to access their NHS Covid pass for both domestic and international travel purposes.
The Deputy Speaker (Baroness Fookes) (Con)
We now come to the 30 minutes allocated for Back-Bench questions. I ask that questions and answers be brief so that I can call the maximum number of speakers. I understand that the noble Baroness, Lady Watkins of Tavistock, has withdrawn so I call the noble Baroness, Lady Stroud.
Covid-19 Update
Debate between Lord Bethell and Baroness Fookes(2 years, 9 months ago)
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, I am enormously thankful to the noble Baronesses, Lady Thornton and Lady Brinton, for such thoughtful questions. I will certainly try to address as many of them as I can.
In reply to the noble Baroness, Lady Thornton, on the advice we get, I am afraid, as I said last time, that we of course draw on lots of advice from lots of people. I completely acknowledge, as she rightly pointed out, that no decision in this pandemic is risk-free. She set out the list of possible risks very well. There is always the possibility that there will be new variants. We are extremely concerned about the existing 1 million people who have self-diagnosed with long-Covid symptoms; the possibility that that number may rise is very much on our minds, and we are putting in place NHS provision to assist in diagnosis and treatment of that.
We are extremely concerned that test and trace resources will be stretched. We are therefore looking extremely closely at the policy around testing and isolation, while providing test and trace with the resources it needs to get through any increase in the infection rate. I also completely acknowledge the concerns of the NHS Confederation on hospital beds and hospitalisations —although the statistics on those today are extremely encouraging.
Those are all acknowledged concerns that we keep close track of, while putting in place measures to mitigate and minimise their impact. However, the noble Baroness, Lady Thornton, half-answered her own question, because she is entirely right: we need to focus on getting the NHS back to speed in order to address the very long waiting lists and to get elective surgery back on track. It is very difficult to find an answer to the question, “If not now, when?” That has been tackled by the CMO and a great number of people. It must surely be right that we take the inevitable risks of restarting the economy and getting people back to their normal lives at the moment of minimum risk from the virus, which has to be in the middle of summer. Assessing those risks precisely is incredibly complex. Impact assessments of the kind that we would normally associate with legislation are the product of months of analysis. They often identify one relatively straightforward and simple policy measure. We are talking here about a machine of a great many moving parts.
I cannot guarantee that any model anywhere could give us accurate projections of the exact impact of what is going to happen this summer. We are, to a certain extent, walking into the unknown: the Prime Minister made that extremely clear in his Statement. As such, we are ready to change and tweak our policy wherever necessary in reaction to events. However, what we know very well now on the basis of our assessment of the data, and because of the pause we put in place to give ourselves breathing time to assess and additional time to roll out the vaccinations, is that that direct correlation between the infection rate and severe disease, hospitalisation and death has massively diminished. There is a relationship, but it is a fraction of what it used to be.
We can therefore look at a period where those who are at extremely low risk of any severe disease may see an increase in the infection rate, because we know that those in the highest-risk groups have been protected by two doses of the vaccine, and two weeks, and because we are working incredibly hard to get as many in the high-risk groups vaccinated as possible—half a million a day—and to roll out the vaccine to younger cohorts. That is the balance. I cannot deal in certainty here, because certainty does not exist. Balance is key, and I believe the balance we have here is the right one.
The noble Baroness asked specifically about the NHS Covid app. It is in some ways emblematic of the kind of decisions we are making at the moment. She is entirely right: the anecdotes are loud and clear. The app is pinging loudly around the country as the infection rate moves up. To clarify the legal point, as noble Lords probably know, the app protects privacy. We do not know the identity of the person who has the app. In fact, we have no information about people who have the app at all because it has such rigorous privacy protection. As such, the ping from the app is advisory but a telephone call from test and trace is mandatory. That has a legal status and a breach of that advice could lead to an FPN or a knock on the door. It has a different status in that respect.
Given the large number of infections and the large number of pings, we clearly need to review the way in which the app works. The Prime Minister talked about this earlier today. He talked about moving from a quarantine-and-isolation approach to more of a test-and-release approach. We are not quite there yet but we are clearly well on the way. Therefore, I would be glad to clarify how we have made those decisions once they have been announced.
The noble Baroness, Lady Brinton, talked about the plight of the immunosuppressed. I am grateful to her and to Anthony Nolan, Cancer UK and others who were on the call yesterday. I express complete sympathy with the point made by the noble Baroness. If you are at home and your immune system does not work as well as other people’s, and you see the rest of the country opening up, you will feel extremely uncomfortable, as though the world has moved on and that you have perhaps been left behind. Those were the feelings described to me by the experts I met yesterday. On an emotional level, I completely sympathise with that. There are some people in this country whose immune systems do not protect them from flu and contagious diseases that would have no impact on those with a fully functioning immune system. We have complete sympathy for those people.
I acknowledge the noble Baroness’s point that there is a need for clear advice because the immunosuppressed are a highly diverse group. There may be people recovering in hospital with a completely flatlined antibody system, compared to someone who has rheumatoid arthritis but is otherwise living at home and is mobile. It must be right that that communication is done on a tailored basis through the healthcare system. We will look at ways in which we can ensure that GPs are informed and have the right information in order to give that bespoke advice.
The dissonance is hard to bear. I recognise the noble Baroness’s point but I do not necessarily have a suite of answers for absolutely everyone in this condition. We have large investments in antivirals and in therapeutic drugs, including some of the monoclonal antibodies that may offer some protection to some people in this situation, but it is not going to be a blanket measure. As a result, we are putting a huge amount of investment in the OCTAVE study, which looks specifically at ways in which vaccines, boosters or therapeutics can be used to protect those whose immune systems are not right. Ultimately, it is going to be down to the vaccine. The vaccination of a large proportion of the population, including the carers who look after the immunosuppressed, is how we will offer protection to these people.
On the noble Baroness’ question about the LFT system being dismantled, I do not recognise those press reports. On the provision of PCRs by the private sector, she asked how prices are determined. The answer to that is through the market. The marketplace introduces competition and innovation. I am pleased to say that the price for tests is coming down and will come down further. The one provided by Chronomics for TUI is now £30; that is a very encouraging sign that there is more to go.
The Deputy Speaker (Baroness Fookes) (Con)
We now come to the 30 minutes allocated for Back-Bench questions. I ask that questions and answers be brief so that I can call the maximum number of speakers. I call the noble Baroness, Lady Nicholson of Winterbourne.
Covid-19: Brazilian Variant
Debate between Lord Bethell and Baroness Fookes(3 years, 1 month ago)
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Lord Bethell (Con)
My Lords, I remind my noble friend that we have some mandatory vaccination already in place in the health service; those who perform operations and other intimate health interventions are required to have hepatitis and other vaccinations, for instance, so there is a precedent for what he talks about. However, it is a huge step, which impacts people’s personal liberty and choices, to make vaccination mandatory for more than a million social care workers. My noble friend makes a persuasive argument, which is why the Cabinet Office is looking at exactly this sort of matter; there is a strong public health argument for mandatory vaccination. Given that we have not rolled out vaccination across the whole population yet, it is premature to make that decision today, but we are considering it carefully.
The Deputy Speaker (Baroness Fookes) (Con)
My Lords, the time allowed for this Question has now elapsed. I apologise to those Members whom I was not able to call.
Covid-19: Vaccines
Debate between Lord Bethell and Baroness Fookes(3 years, 2 months ago)
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Lord Bethell (Con)
My Lords, I congratulate the noble Lord on having his vaccine so early, and I share his concern on this matter because those who had their first dose early received a leaflet of exactly the kind he described, and, since then, the CMO’s advice has changed. I reassure him that, using data for those cases observed between days 15 and 21, efficacy against symptomatic Covid-19 for the Pfizer vaccine was estimated at 89%. Those kinds of statistics reassured the CMO to change the date to three months, and I reassure the noble Lord that he is in safe hands.
Baroness Fookes (Con) [V]
My Lords, I am perfectly happy with waiting for the three months, but I am concerned about people over the age of 80 who are living in their own homes, rather than retirement homes, who I understand are not yet receiving the vaccine. I can understand that it would be difficult to go to individual homes, but can my noble friend tell me what the position is?
Lord Bethell (Con)
I reassure my noble friend that we have put in place a systematic arrangement to visit care homes and those living at home with domiciliary care in order to bring the vaccine to their homes. That system includes GPs, community pharmacists and, where necessary, mobile vaccination units. It is proving to be extremely effective. The big numbers will be delivered by the mass vaccination centres, but we will not overlook those who cannot move from their home.
Ockenden Review
Debate between Lord Bethell and Baroness Fookes(3 years, 4 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
Debate between Lord Bethell and Baroness FookesTuesday 17th November 2020
(3 years, 5 months 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 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.
Covid-19: Response
Debate between Lord Bethell and Baroness Fookes(3 years, 9 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
Debate between Lord Bethell and Baroness Fookes(3 years, 9 months ago)
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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.