(3 years, 10 months ago)
Lords ChamberMy Lords, I declare my interest as advising the board of the Dispensing Doctors’ Association, and I would like to focus on the rollout of the vaccinations. Does my noble friend the Minister share my concern that a delivery of over 1,000 vaccines to a rural practice in Suffolk was cancelled at less than a week’s notice? This is happening across the country—in Devon the same as in Suffolk. Dispensing doctors are the ideal vaccinators for the elderly and stand prepared to play their part. Yet notice and certainty of delivery are essential, mindful of the distances and needs of patients in far-flung rural areas to reach the surgery.
It seems that successful vaccination sites are being prevented from getting more vaccines, possibly because they are considered to have successfully vaccinated a greater percentage of patients than neighbouring sites. Yet there are media reports that an internet pharmacy—Pharmacy2U—is to be allowed to vaccinate people in supermarket car parks. Where is the infrastructure to support this? A GP practice wanting to operate vaccinations from a car park would currently be prevented from doing so. Remote NHS management teams seem to be dictating how much can be supplied rather than allowing individual practices to request what they require for their population. Thus, there is no certainty of supply and an inability to plan clinics efficiently and effectively. Those with proven expertise in the provision of vaccinations are being prevented from doing their job.
I also raise the concern that over-65s will not be vaccinated before the middle of February, which appears to be a slippage in timing. Yet this age group is as likely to require hospitalisation as those in the four priority groups. Equally, a change to the date and timing of the second dose of vaccination is not supported by the pilots, on the basis of which regulatory approval was given, and flouts the recommendation of all scientific authority, not least the World Health Organization.
(3 years, 10 months ago)
Lords ChamberMy Lords, I join my noble friend in thanking all the NHS staff who worked over Christmas and who will work over the new year. I applaud the approval of the Oxford AstraZeneca vaccine.
Will my noble friend ensure that the double dose of whichever vaccine is used is rolled out as it was originally believed that it should be, so that both doses will be given to the most vulnerable as a priority, and to NHS staff, many of whom have not yet been vaccinated, to protect NHS beds and staff as best we can? Will he tackle, as a matter of urgency, the apparent hurdle to enabling GPs and other recently retired staff—here I declare an interest, as my brother falls into this category—who are willing to serve but appear to have a problem with indemnity and face other barriers? That seems inconceivable, given that they are prepared to swing into action to roll out vaccinations and presumably help with triage at hospital admissions.
As the noble Lord, Lord Scriven, mentioned, will my noble friend look carefully at the role that secondary schools in England appear to be playing in the recent rampant spread of this latest mutant infection? Will he consider taking actions such as Wales and Scotland have to delay the return of schools by more than the two weeks envisaged?
Finally, my noble friend said—I think I am quoting him correctly—that, economically, the restrictions set out today will be beneficial in the longer term as they will enable us to get back to normal sooner, yet there is very real concern in the hospitality industry that many establishments will simply not be in a position to reopen. Will additional support be considered at this time, as a matter of urgency?
(3 years, 11 months ago)
Lords ChamberMy Lords, difficult decisions have to be made by everyone in this. The JCVI has looked very carefully indeed at the challenge of how to prioritise this vaccine, taking representations from a large number of groups. Ultimately, its priority is to protect life and the NHS, and its clear decision has been to have a prioritisation based on age because this is the greatest driver of mortality.
My Lords, I add my congratulations to my noble friend, the MHRA and everyone associated with producing this vaccine in such record time; it is a great tribute to our health service. I will focus on the fact that the flu jabs for the over-50s are still being distributed, and there is a reluctance among some—perhaps as many as two-thirds of the over-50s—to take up the flu vaccine, as they would like to wait for the Covid vaccine, which, of course, defeats the purpose of offering them the flu vaccine. Is this something that my noble friend is aware of, and is it something that he could address? I echo the remarks of the noble Lord, Lord Clark, and ask that specific regard be had to the challenges of administering the vaccine in rural areas. Will my noble friend use, as far as possible, the dispensing doctors in this regard? I pay tribute to them and the work I do with them.
My Lords, as few will be surprised to know, the rollout of the flu vaccine has been hugely successful this year; the take-up has been massive. I am not aware, from the stats that I have seen, of any slowdown in the take-up of the flu vaccine, but the point my noble friend Lady McIntosh makes is understandable—I am happy to check it out. I also encourage anyone who is thinking about deferring the flu vaccine until they get the Covid vaccine to think again because it is a massive priority to get vaccinated for both.
The noble Baroness and I have talked before about dispensing doctors, whose role is very important. There is a challenge with the distribution of the Pfizer vaccine because of cold storage and the large number of shots in each vial. I am not sure whether that means that rural dispensing doctors can play the important role that they might do at this stage of the distribution, but I reassure the noble Baroness that they will play a role in the national distribution as it pans out over the next few months.
(4 years ago)
Grand CommitteeMy Lords, I am delighted to follow the noble Lord, Lord Hunt of Kings Heath, and support the noble Baroness, Lady Cumberlege, in her amendment, to which I have added my name.
The report that the Government commissioned and appointed the noble Baroness, Lady Cumberlege, to do on these issues of medicines and medical devices made nine very clear recommendations in July. One central recommendation in that report, First Do No Harm, was the need for a task force to oversee the implementation of the recommendations from the report —hence this amendment today.
If the Government, the Minister and his colleagues, are serious about the recommendations and recognise that there is an issue and a problem in relation to certain medicines and medical devices, they should see fit to implement all nine recommendations. I think back to when I was doing some research on this. An eminent QC, Lauren Sutherland, said that the Government should not ignore these recommendations—they should implement them.
I made the request, along with many other noble Lords, for the implementation of the task force during Second Reading in early September. I said that it should be set up without delay to oversee progress, and I believe that, if the Government are to take this report seriously and ensure that such failures do not happen again, that needs to happen. What better way to have an implementation group than by the task force that is already in existence, because it was independent of government, has worked on these issues for two years and is fully acquainted with all the matters, problems and challenges met by many people, who have suffered indignity and immeasurable pain as a result of the imprecision in relation to medical devices? To ensure proper implementation and oversight of the recommendations, a task force is a necessary prerequisite and needs to be placed in the Bill. The first remit or task of such a task force should be to set a timeline for its work and delivery of the review’s recommendations. The only way for that to work is if the implementation task force is put in the Bill.
As the report states, the task force should be made up of representatives of the various arms of the healthcare system that have a recognisable role to play in delivering patient safety—in other words, people acquainted with the issues and who have knowledge and expertise. Those responsible for implementation need to know that their work and progress will be monitored and they will be accountable. Supporting the implementation process should be a reference group made up of a range of patient interests going far wider than the groups the report members dealt with. Yet again, such a reference group would consist of people with direct experience, and ongoing daily experience, of the impact of such medicines that have been specified, as well as other types of medicines, where there have been side effects, and the medical devices that have caused so many problems to so many women and men.
We need a system and task force that listens, hears and acts with speed, compassion and with proportionality to prevent further avoidable harm—hence my support for the amendment in the name of the noble Baroness, Lady Cumberlege, to establish such an implementation task force without delay in the Bill.
My Lords, I congratulate my noble friend Lady Cumberlege on the work that she and her able team have done on the report, First Do No Harm. I entirely support the amendment, and I am delighted to follow in this the noble Baroness, Lady Ritchie, who has pointed out that by definition it will have only a limited life. Its main work will be to ensure that the functions of the report and all the recommendations are followed through. However, I take this opportunity to ask both Ministers if they are minded to support this. Possibly, when my noble friend comes to respond, we might hear what the nature might be of the budget allocated to the task force, as well as to whom, if at all, the oversight governance board in subsection (2)(b) of the proposed new clause might report, and whether it is intended that Parliament might have an overview of the work of the task force.
In establishing the task force, it is absolutely vital that there is a body that has the role, as is intended in this amendment, of implementing the recommendations set out in the report of the Independent Medicines and Medical Devices Safety Review. I would personally favour the mechanism in this amendment that a task force should be set up for this purpose, limited in time with a specific view. I would be interested to know what budget might be allocated, and from which budget this would come, and also if there was a mechanism to keep Parliament informed of the work of the task force for its limited life.
My Lords, when I was preparing for today’s debate and I saw where I was in the speaking list, I anticipated that there would not be much left to say by the time we got to me. I was wondering what I might be able to add to support my noble friend Lady Cumberlege in the very powerful argument she made about the need to set up the task force in recommendation 9 from her review.
I went to look at the latest data on the use of valproate in girls and women in the UK, and I declare my interest as a vice-chair of the APPG that looks at these issues. The MHRA publishes a regular report and its version 4, which tracks the data from 2010 to 2019, was published earlier this year. From that I draw two lessons that are very germane to this debate. The first—which the noble Lord, Lord Hunt, alluded to—is that there is this fear of independence, but there is also something else that perhaps goes on, which is almost a sense of helplessness: well, harm is going to happen in practice, there are things you can do, but it is something we are always going to have to accept. The positive message that comes from the work of the noble Baroness, Lady Cumberlege, and her review, is that we can make a difference. If you look at the prescribing of valproate in pregnancy, you see that it fell by 78% from 2010 to 2019 on the back of concerted action from many people—clinicians, officials, Ministers, patients of course, patient campaigning groups particularly, and many others. It halved, year on year, from 2018 to 2019. So we can make a difference through concerted action.
The other data point I take out of it is that even now there are still 200 babies exposed each year to valproate and, as we know, half of them will experience physical or mental harm. That is 100 babies whose lives, and whose families’ lives, are going to be irreparably changed because of that exposure, when everybody accepts that exposure to valproate in pregnancy should be zero, or as close to that as humanly possible.
It is the point about urgency that I want to get across to my noble friend the Minister. I do believe that he is deeply sympathetic to the findings of the review and the need to move forward, but we cannot wait any longer, because these harms are going on. They are going on every day and we can do something about them—and the recommendations in my noble friend’s review are precisely the way we can do something about them. As my noble friend Lady Cumberlege said in her opening remarks, this is not the kind of thing on which you really want an amendment. It is not the kind of thing that should require legislation, but the reason there is such support for it is the sense that nothing is happening when there are harms going on that could be prevented if we took the concerted action that is necessary. That is why I am speaking in support of the amendment today.
(4 years ago)
Grand CommitteeThis string of amendments all talk about recording information, and I broadly agree with all of them. I particularly mention Amendment 104, in the name of the noble Lord, Lord Lansley, because of the mention of the Caldicott principles. Many people, particularly noble Lords in the Liberal Democrat party, jealously guard our right to privacy—hence the promissory tone of Amendment 100 in the name of my noble friend Lady Jolly.
The purpose of the proposed new clause in Amendment 107, to which I have put my name, is slightly different from that of the other clauses because it seeks to ensure that a proper systematic analysis is made of the effectiveness of mesh implants through registers. The Cumberlege review notes that registries are
“few and far between and all too often prompted by catastrophe”
in relation to transvaginal mesh and PIPs. This is obviously a good phrase because the noble Baroness, Lady Finlay, has already picked it out of the report.
This clause proposes a register. It requires the Secretary of State to report on progress towards creating databases relating to other devices. I appreciate that there are many databases out there—far more than I anticipated when first became involved in this Bill. The idea of the registries is to draw all this information together. As the Cumberlege report says,
“a ‘registry’ … would act as a repository for more complex patient related information datasets enabling research and investigation into patient outcomes.”
This would be more holistic and far more useful than just a database, enabling any adverse outcomes to be spotted early and not allowed to fester, literally, for years before defaults are spotted.
Patient groups must be consulted on devising the register. Time and time again, victims reported that they had not been listened to, despite the fact that the mesh felt “like razor blades” inside them. Never again must a patient feel patronised, unheard or left to suffer in silence. Of course, those healthcare professionals at the coal face, as it were, of the issues must have their say. We know that some registries exist today, but this database would bring everything together, instead of the piecemeal system we have at the moment.
I will go back to the lady whose poignant testimony I quoted at Second Reading, whom I called Jane. Jane had an estimated five pieces of mesh inside her, although the health professionals treating her maintained that there were only two. How can this be? I leave noble Lords to speculate but, in my view, this is a sharp indictment of the state of the service our health service gives to patients in this area. Unless we have a proper register of everything that is inside a patient, when it was inserted and what its performance record is, how are we going to enable them to be given the appropriate treatment when problems arise? The Royal College of Surgeons endorses this view—it wants all medical device implants overseen by registries.
Finally, I express my gratitude to the noble Lord, Lord Bethell, for the briefing this morning. I was very heartened to learn of the hard work going on in this area and the aspiration that a register for vaginal mesh implants could be up and running in only a year. I wish the Bill well.
My Lords, first, I apologise for not being able to participate at earlier stages of the Bill because of the clash with speaking in the Chamber. I congratulate the noble Baroness, Lady Finlay, on introducing these amendments and, especially, my noble friend Lady Cumberlege for all her work in preparing her report in advance of this. I also thank the Minister, my noble friend Lord Bethell, for briefing us this morning. I will particularly speak in favour of Amendments 100 and 101.
I hope that my noble friend the Minister will look favourably on patients being able to report directly to the register. The testimony that my noble friend Lady Cumberlege and others heard in the context of her report was very moving. As my noble friend Lord Ribeiro said, it is absolutely essential that the voice of patients is heard. This absolutely goes to the heart of medical and surgical treatment. We must ensure that, whether they have had a good or a bad experience, patients are able to place their experiences on the record. Amendments 100 and 101 go some way to achieving that. Were my noble friend not to like those amendments, I hope that the Government would come forward with a similar provision to put our minds at rest. I thank the noble Baroness, Lady Finlay, for these amendments, and I lend my support to them.
My Lords, Amendments 100 and 101 make clear that there should be means by which patients can report into registries directly so that they can be heard even if there is divergence of opinion with their clinician. Patients need to be protected. I support all the amendments in this group and thank those who tabled them, giving extra thanks to my noble friend Lady Finlay, who works so hard.
This is exceedingly important for many patients who have rare and complicated conditions. I speak from experience, as a high-lesion paraplegic. Many GPs and general doctors or surgeons may not be familiar with several of the peculiarities and may not understand the patient’s needs. For people with spinal injuries, for example, the three Bs are very important: bowels, bladders and bedsores. If not treated by specialists, patients can get into serious problems. Severely disabled people use all sorts of complicated devices that need to be kept on a register and to be easy to track if they go wrong. Suitable mechanisms should be found for the variety of needs, which can be inside and outside the body. This is particularly difficult in this time of Covid-19.
My Lords, it is a great pleasure to follow the noble and learned Lord. I have added my name to that of my noble friend Lady Thornton to Amendment 128, which was introduced by my noble friend Lady Wheeler. This regards the organisations to be consulted—other noble Lords have already referred to this—and concerns the provisions of Clause 41 for consultation on Parts 1, 2 and 3 of the Bill. As noble Lords have said, at the moment, it is entirely up to the Secretary of State who is consulted, other than the clarification the Government have brought in relation to the devolved Administrations.
The context of this amendment is the extensive power given to Ministers under the Bill. We have debated this before, but it is worth reminding the Committee that the Delegated Powers Committee in its report on the Bill was highly critical of Ministers for failing to provide sufficient justification for parts of the Bill adopting a skeletal approach. As the committee said, the Bill gives Ministers wide powers to almost completely rewrite the existing regulatory regime for medicines and medical devices.
It is also worth reminding the Committee that the Constitution Committee described the Bill as
“a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made using the powers.”
It went on to say:
“The Government has not provided the exceptional justification required for this skeleton approach.”
The case for a sunset clause is readily apparent, but in its absence, the way in which consultations are done assumes more importance than normal. It is very surprising that the duty to consult is open-ended and simply leaves it to Ministers to decide who to consult. The Minister may say that he does not like lists of organisations to be consulted, but legislation is littered with lists of organisations because it is important to reflect the range of bodies that ought to be consulted. Discretion is always given to Ministers to add to those lists of organisations.
I hope that the Minister will be prepared to take this back because in the end, certainly in the absence of a sunset clause, we have to beef up the provisions on consultation.
My Lords, I support in particular Amendments 105 and 127 in this group, but I shall speak briefly to Amendment 105 and thank the noble Baroness, Lady Wheeler, for introducing this short debate on it. In the context of the proposal for a requirement to consult the devolved Assemblies, I share the concern expressed by my noble and learned friend Lord Mackay of Clashfern: it is essential that we keep all the devolved Assemblies in tune with Westminster thinking as the Bill and the regulations under it progress.
(4 years ago)
Lords ChamberThe noble Lord is completely reasonable in his concerns but that is not the approach we are taking at the moment. Actually, public support for the lockdown measures—the wearing of masks, social distancing and restrictions on travel—has been amazing. Lockdown has been largely by consent and extremely well supported by the public in their behaviour. We are extremely proud that in Britain we do not need the Army on the street with their guns or the police fining people on the street, as they do in other countries. I pay tribute to the British public for the way in which they have gone along with those measures. The noble Lord makes the point that some people have been in breach of the rules and there have been prosecutions and fines. However, they have been minimal and have had their effect. We will continue to operate at the kind of level at which we have been operating to date.
My Lords, my noble friend will be aware of my interest in the Dispensing Doctors’ Association. Will he update the House on where we are with the vaccination programme for the over-50s? What use will be made of dispensing doctors in rural areas to dispense the Covid-19 vaccine? I hope he will rely on them fully because they have the network to provide it in much the same way as the noble Lord, Clark, explained.
My noble friend will be aware of the prioritisation list published by the JVCI. I am afraid that the over-50s, of which I am a member, are not highest on the list, but they are at least halfway down. Prioritisation starts with the over-80s and works down from there. I completely endorse my noble friend’s comments on dispensing doctors. We will be relying on all parts of the healthcare ecology to deliver the vaccine. It will be a massive national project. Getting to hard-to-reach rural communities is incredibly important, particularly people in those communities who are older and perhaps do not travel. Dispensing doctors pay a pivotal role in that, and I pay tribute to their contribution to the vaccine.
(4 years, 1 month ago)
Lords ChamberIt is a pleasure to follow the noble Baroness and to join others in congratulating my noble friend on his stamina and energy in pressing these regulations.
I ask my noble friend to address a number of practical problems and limitations with the app and the track and trace system. On a practical issue, how can we advise people who are working away from home to self-isolate at home, which may be some distance away, without putting others at risk? This is a perennial problem and normally flagged up when it is a high-profile individual who is deemed to have fallen foul of the rules.
I want to address the issue of the app not necessarily updating sufficiently. It has also come to the attention of many that it drains the battery enormously, which is a disincentive to those who are using their mobile phone for other purposes during the course of the day to rely on the app, because they simply do not have enough battery usage left.
I know that there has been a lot of criticism of consultants being paid £7,000 a day, but I would like to understand what particular role the consultants played to justify what seems like an extraordinarily high fee. I welcome the fact that we are now using unqualified people to work track and trace; presumably they have been trained up at high speed. This is very welcome, and I wonder why we have not been using them earlier. I welcome this opportunity to address these issues and ask my noble friend as far as possible to find solutions to the issues that I have identified here.
(4 years, 1 month ago)
Lords ChamberMy Lords, I add my congratulations to the noble Baroness, Lady Fox of Buckley. I welcome her to the House and wish her a very happy and successful time in this place. I also add my congratulations to my noble friend the Minister for his stamina and patience in once again coming to present these regulations to the House.
It is not that I do not support regulations—I do—but I make a plea to my noble friend that the guidance could be much clearer. In particular, for example, when reference is made to “linked households” and “bubbles”, my noble friend referred me to the app, so I took his advice and went on the app, but it is not immediately clear where to find this guidance. When you look up “linked households”, it comes up with general advice about coronavirus, about household antibacterial chemicals linked to weakened bones and something about house dust linked to obesity, which I do not think is what my noble friend intended to direct me to.
I make a plea that there should be a one-stop shop, where those who are the target and recipient of the restrictions in these regulations can go for very clear, specific guidance. A specific example that received great notoriety was when Dominic Cummings visited the north-east, a place in County Durham, right at the outset of the original lockdown. Giving him the benefit of the doubt—perhaps he did not understand the rules—where would he look to find these rules in a very simple way, so that he could understand, as we could all understand as the recipients of these regulations, what, for example, constitutes a bubble and what constitutes a linked household?
(4 years, 1 month ago)
Lords ChamberMy Lords, I will speak to the regulations relating to the north-east of England, particularly those that prohibit people in those areas gathering with one or more people from a different household, apart from linked households in a private dwelling, whether inside or outside the protected area.
It is very clear, and I share the frustration that I am sure Ministers and the general public feel about this, that Covid is not acting as one would expect it to. However, the communication and understanding that flow from the regulations which the Government are bringing forward are clearly key to enabling those in the north-east of England to follow the letter of the regulations before us this afternoon.
My particular concern relates to the fact that urban areas such as the Tees Valley were initially left out of the regulations, whereas deeply rural areas such as Teesdale, with a population of 25,000, and Weardale, with a population of just over 8,000, were included, lumped together with the whole of the city of Durham and other more urban parts of County Durham. This must be a feature of unitary government, and it is one I deeply regret. It leads to perverse consequences; I am not convinced that, when these regulations came into effect, the level of the virus in the rural areas was high enough to justify the draconian regulations that were introduced.
I will ask my noble friend a specific question, because I am being asked it by those I know living in County Durham. It relates in particular to linked households under SI No. 1010—Regulation 7 on page 6—and paragraph 7.2 on page 3 of the Explanatory Memorandum to the SI No. 1012 correction regulations. What does my noble friend understand exactly by a “linked household”? Is it just for the householders to agree or do they have to notify the authorities, or only if they were challenged in that purpose? Also, can my noble friend explain what a support bubble is? How many people can form one? If I can learn that from my noble friend, I can go on to explain what it is to others who are asking. Other noble Lords have expressed concern about the extent of the measures before us today, so can my noble friend explain what balance has been reached regarding the mental health and well-being of—and the feeling of isolation experienced by—those living in a single household who may not be part of a linked household or a bubble, or who may not quite understand the extent to which they are? They may take a complete turn for the worse in those circumstances. Physical conditions such as cancer and others itemised by my noble friend Lady Altmann are also important, as the timing of diagnosis and treatment is a particularly critical factor.
I have a general question for my noble friend in connection with the regulations before us. I know he said that consultations were held with the leaders of councils, so presumably that included the leader of Durham County Council. However, with particular regard to my concerns about the rural area of Teesdale and Weardale, what consultation and discussions were held with councillors elected to represent those areas?
Finally, what is the relationship now between the regulations before us and the new tiers announced this afternoon by the Prime Minister? What will happen if, even in spite of the new, even more draconian, measures announced along with the tiers this afternoon, there continues to be a rise in infection? What further action might my noble friend and the Government consider taking if such a course of events transpires?
(4 years, 1 month ago)
Lords ChamberMy Lords, I completely endorse the noble Lord’s points. There is robust evidence that the FHRS has driven up hygiene standards in food businesses, thereby reducing the risk to consumers. It was identified by the Royal Society for Public Health as one of the top 20 public health achievements of 21st century. We have received a case for a statutory scheme in England, and Ministers have given a commitment in Parliament to consider the scheme in due course.
My Lords, I pay tribute to the local authorities, not just in connection with this scheme but in connection with the testing that they do, particularly environmental health officers. They are at the front line of keeping us all safe from food poisoning and food fraud. But does my noble friend share my concern that, while some individual councils have an excellent track record of testing, others do hardly any at all? Is he concerned at the lack of resources that cash-strapped councils might face at this time to prevent food fraud occurring?
My Lords, the pattern of food inspection rates across the country is uneven, as my noble friend points out. However, the costs of implementing this scheme should not and might not be a hurdle for implementation. We believe that it would actually serve as a potential encouragement for those doing food inspections to see the results of their work published in a mandatory fashion.