Women’s Health Strategy
Debate between Lord Bethell and Lord Kakkar(3 years, 1 month ago)
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Lord Bethell (Con)
I pay tribute to my noble friend for his campaigning on this important cause. It is not the specific focus of the health strategy but it will play a part in it, and I encourage my noble friend to submit the characteristically detailed evidence, for which he is so well known, to this important evidence-gathering process.
Lord Kakkar (CB) [V]
My Lords, I draw attention to my declared interests. In taking forward an initiative for clinical research as part of their G7 health agenda, how do Her Majesty’s Government propose to ensure alignment of the clinical research regulatory framework so that the approval of innovative devices and therapies is predicated on clinical trial and registry methodologies with appropriate representation of women, including those from ethnic minorities?
Lord Bethell (Con)
The noble Lord makes a really good point. I am not sure whether we have considered the gender aspect of the clinical trials work programme in our G7 agenda. It has been very much about pandemic-preparedness and ensuring that next time we are able to share clinical trial information. Of course, we pat ourselves on the back for our own vaccine clinical trials in the UK, which, I think, have met a new standard for gender representation. He makes a good point, however, about making that case in our G7 work programme, and I will take it back to the department for further consideration.
Future of Health and Care
Debate between Lord Bethell and Lord Kakkar(3 years, 2 months ago)
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Lord Bethell (Con)
The noble Baroness is right that there are distinctive qualities to social care and medical care, but the lived experience of most patients and residents is that those living in social care are very often heavy consumers of the NHS. As far as most of them are concerned, the support and treatment they are given needs to be much more closely linked. For instance, it is a strange anomaly that many living in residential social care have a completely different budget and sometimes completely different staff providing their medical treatment and their care treatment. This is not a functional distinction that we are seeking to overturn; what we are seeking is to get those teams of people and the decisions made about the care of individuals working much more closely together. We are not seeking to introduce a revolution in the funding of social care, and the financing of social care by local authorities and private individuals will continue, but we would like to see the distinction between social care and NHS medical care become more seamless, more joined up and, therefore, more effective.
Lord Kakkar (CB) [V]
My Lords, I draw attention to my registered interests. The justification for any reorganisation of the health and care system must be to improve patient and population outcomes. The current system, which has been unable to deliver the benefits of integrated care, is heavily regulated on the basis of distinct institutional boundaries and care settings. How do Her Majesty’s Government propose to address the regulatory impediment to the successful delivery of integrated care as part of the proposed reorganisation?
Lord Bethell (Con)
My Lords, the noble Lord is entirely right that the regulation of both clinical care and social care is critical and key not only to good performance by both sectors but to the way in which they work together. That is why we will look at the CQC and its role in social care regulation. We will seek to enhance the way in which the CQC can look deeply into social care to set higher standards and to ensure that, when it comes to integrated care, social care is stepping up to the challenge as best it can.
Covid-19 Update
Debate between Lord Bethell and Lord Kakkar(3 years, 7 months ago)
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Lord Bethell (Con)
My Lords, the noble Baroness raises an important point about the rollout in the devolved Administrations. I do not have the details in my brief but I would be glad to write to her with them.
Lord Kakkar (CB)
My Lords, I draw the House’s attention to my registered interests. The Minister has alluded to the strategy, announced by Her Majesty’s Government earlier this month, of moving to mass population testing for citizens, regardless of symptoms. This is clearly predicated on having capacity for high-frequency testing, rapid reporting of results and a minimum threshold of accuracy for the test used. What assessment have the Government made of the threshold of accuracy in relation to sensitivity and specificity required to ensure that the mass testing strategy is successful—which is essential if we are to not only implement public health measures but save our economy?
Lord Bethell (Con)
My Lords, the user cases for different tests are being drafted and interrogated as we speak. The user case, for example, of an anaesthetist going into a delicate operation would be very different from the asymptomatic testing of a large school, or of people thinking about going to the pub in the evening. Matching the tests with the user cases is an important and necessary step. Once that is agreed with all relevant scientific committees, we will publish those user cases so that manufacturers can make the tests according to the required dimensions and specifications.
Covid-19: Rise of Positive Tests
Debate between Lord Bethell and Lord Kakkar(3 years, 7 months ago)
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Lord Bethell (Con)
Testing arrangements for care homes have, as the noble Baroness, Lady Jolly, alluded to, risen dramatically. Testing is done in a large variety of ways. For large care homes, mobile testing facilities are put in place; for care staff, facilities at local NHS hospitals are in place; and we invite visitors to have tests in advance of visiting their loved ones. This is all overseen by the NHS Test and Trace programme, and the CQC remains the auditor of the care sector.
Lord Kakkar (CB) [V]
My Lords, I draw noble Lords’ attention to my registered interests, in particular my membership of your Lordships’ Science and Technology Committee. In his appearance before that committee in July, the Government’s Chief Scientific Adviser suggested that the higher the number of cases in circulation at the beginning of winter, the greater the likelihood of a significant peak of disease. What assessment have Her Majesty’s Government made of scientific evidence on the threshold at which the number of new cases might suggest that we can no longer be confident that the NHS will have sufficient capacity to deliver both its routine winter service and manage resurgent Covid-19 admissions?
Lord Bethell (Con)
My Lords, we are well within the threshold that the noble Lord, Lord Kakkar, alludes to, but we are concerned about winter. That is why we are putting in place new restrictions and new arrangements to stop the spread of this disease, protect the NHS and save lives.
Independent Medicines and Medical Devices Safety Review
Debate between Lord Bethell and Lord Kakkar(3 years, 9 months ago)
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Lord Bethell
I thank the noble Lord for his searching questions. The role of the MHRA on both medical devices and medicines has been massively upgraded, and the review process for new medical devices has been improved. However, medical devices have different criteria from medicines.
One of the most important things that we have sought to do is to include a registry of the medical devices themselves and a registry of the medical devices inserted into individuals. Compliance with both procedures are the most important steps for clinicians embarking on new products.
Lord Kakkar (CB) [V]
My Lords, I thank the Minister for answering questions on this Statement and in so doing remind noble Lords of my registered interests. In her excellent report, the noble Baroness, Lady Cumberlege, identifies concerns about the lack of evidence that is required prior to the granting of marketing authorisation for many medical devices, where all that is often required is demonstration of equivalence to an already marketed product. The noble Baroness highlights the striking difference that exists with regard to the situation for medicinal products, where robust evidence of efficacy and safety is required before a medicinal product can be marketed. Are Her Majesty’s Government content with this situation—this difference between the level of evidence required before a product and a device can be marketed as regards patient safety? If there are concerns, what approach do Her Majesty’s Government propose to take with regard to ensuring that there is proper evidence of both the safety and efficacy of a device prior to its broad marketing and use in large populations of patients?
Lord Bethell
The noble Lord alludes to an extremely difficult balance that we have to seek to make. He is entirely right that medical devices and medicines operate on different criteria. The most important thing is that the MHRA resources for focusing on the approval of medical devices have been improved and the procedures enhanced. However, medical devices remain an important area of potential innovation, and we are concerned not to suffocate this area of potential improvement as it has been suffocated in other areas. At present, the Government believe that we have struck the right balance, but we remain keenly focused on it and it is under constant review.
Contraceptives and Hormone Replacement Therapy Drugs
Debate between Lord Bethell and Lord Kakkar(4 years, 1 month ago)
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Lord Bethell
The noble Baroness is entirely right to express her frustration. It is enormously frustrating for those concerned and for our medicine supplies. Medicine production is a long-term business. There was a point when HRT consumption went down, but then demand grew exactly when some production facilities had backed off their supply. It was an incredibly unfortunate combination of events that has led to this situation, but I reassure the House that we are working extremely hard to provide alternatives and to replace those most favoured products that are in short supply at the moment.
Lord Kakkar (CB)
My Lords, I remind noble Lords of my declared interests. Has thought been given to whether novel therapies that might soon become available from research elsewhere in the world might be applied to the management of patients infected with coronavirus in our own country? Is the Minister content that the current regulations that govern the use of medicinal products in man are sufficiently flexible to allow for drugs that not only currently exist but might be repurposed for this, and for novel and innovative therapies, neither of which might be licensed for use in the United Kingdom at the current time, to be made available without further impediment if that was thought to be a useful intervention?
Lord Bethell
The noble Lord, Lord Kakkar, is entirely right to stress this point about regulation. I assure him and the House that we are working extremely closely with Public Health England and the MHRA to ensure that there will be no regulatory hurdle that prevents the swift introduction of proven, safe products into the UK market. This is a massive priority that has had great scrutiny from both the department and Downing Street. It is one that we are focused on and will continue to focus on.
Coronavirus
Debate between Lord Bethell and Lord Kakkar(4 years, 1 month ago)
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Lord Bethell
The noble Baroness is absolutely right about the importance of guidance and I reassure her that an enormous amount of work is being done to draft clear guidance for employers, volunteer groups and all parts of society, which will include case studies, FAQs and detailed recommendations. That work is being guided by the CMO and senior officials at PHE.
As for 111, we look very closely at the metrics for the return of calls. Overall, the headline figures suggest that the 111 service is bearing up incredibly well under intense pressure, but I do not deny that there must be people who have had bad experiences. These pressures sometimes lead to poor results and we will keep a very careful eye on that.
Lord Kakkar (CB)
My Lords, I declare my registered interests. Clearly, the decision to move from the phase of containment to that of delay is essential to sustaining the ability of the health delivery system to deal with this problem.
What objective criteria will be used to determine how that decision is taken? How are the behaviour and natural history of this disease elsewhere in the world being used to inform when we should move from containment to delay?
Lord Bethell
The noble Lord asks an important question. The truth is that it is more of an art than a science. Efforts were made to look at clear metrics for triggering this result, but it is a complex situation and our understanding continues to develop. It is ultimately up to the judgment of the CMO and the confidence of the Secretary of State to make that call.
Coronavirus (COVID-19)
Debate between Lord Bethell and Lord Kakkar
Lord Bethell
My Lords, the pressure on 111 has risen over many weeks. It was identified as an incredibly important part of our response to this pandemic at a very early stage. Thank goodness we have 111; without it GP surgeries would really be struggling. I can assure the House that massive resources have gone into providing additional support.
Lord Kakkar (CB)
My Lords, I draw attention to my registered interests. Is the Minister content that the current regulations governing the evaluation of medicinal products for human use are sufficiently flexible in the current circumstances, such that they will not present an impediment to the rapid testing of new therapies for the prevention and treatment of this coronavirus?
Lord Bethell
My Lords, this Government are committed to doing whatever it takes medicinally to tackle this epidemic. We will not allow regulations to stand in the way.
Wuhan Coronavirus
Debate between Lord Bethell and Lord Kakkar(4 years, 2 months ago)
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Lord Bethell
My noble friend asks a characteristically detailed question. There has been a huge hunger on the part of schools over the last few days for more accurate information about how to respond. As a result, the Department for Education has put in place a regular email directly to the schools themselves—to headmasters and governors. This is currently planned to happen weekly, but that will change as events progress. The email refers to the provision of further information on the DfE website. Arrangements for hotlines and follow-up information are being put in place.
Lord Kakkar (CB)
My Lords, I draw attention to my entry in the register of interests. The Minister, in repeating the Statement, identified the four-part plan, of which the third part is research and co-ordination with international partners. Can he reassure the House that mechanisms are in place for the early adoption, at pace and scale, throughout the NHS of any innovations in diagnosis, prevention and treatment that could have a profound impact in reducing the overall burden of this disease?
Lord Bethell
The noble Lord is right to emphasise this point. The clinical treatment of the virus is in part through the medicine itself. We have to be realistic about whether a medical solution to the virus will be found before the peak epidemic. One is instinctively optimistic that such a thing can happen, but it cannot be guaranteed. However, there are also the procedures and arrangements for nursing and looking after patients as they go through the cycle of the virus, and such best practice is absolutely the priority of the Chief Medical Officer. Arrangements have been put in place to spread that best practice through the trusts and CCGs that provide front-line care.