Independent Medicines and Medical Devices Safety Review: Sodium Valproate

Baroness Jolly Excerpts

Tuesday 2nd March 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, as I explained a moment ago, there is an annual risk acknowledgment form signed by the prescriber and the patient, and that is shared with the patient’s GP. GPs should check that the patient has signed an up-to-date annual risk acknowledgment form each time a repeat prescription is issued. We have instituted a valproate safety implementation group that analyses, along with the MHRA, compliance with this plan. We acknowledge the review’s recommendation to introduce an indicator on safe prescribing in pregnancy for future iterations of the quality outcomes framework, and we will respond on that with the rest of the response to the review.

[Baroness Jolly (LD) [V]]

My Lords, redress is important, but so too is patient support. Could the Government confirm that they are considering the recommendation that a network of support centres should be set up to support those women who have been affected by Primodos, sodium valproate or vaginal mesh?

[Lord Bethell (Con)]

My Lords, I completely acknowledge the noble Baroness’s point. Support is incredibly important and our hearts go out to all those who have been hit by any of the three conditions covered by the review. We are absolutely looking at those recommendations to see how they may be implemented to provide the support that the noble Baroness rightly points out.

Covid-19: Brazilian Variant

Baroness Jolly Excerpts

Tuesday 2nd March 2021 Lords Chamber

[Lord Bethell (Con)]

The noble Baroness is entirely right: this is not the first case of P1 in Europe. As of 11 February, P1 has been identified in 17 countries, with 200 cases reported globally. In the EU, 30 cases have been identified in five countries and areas. We keep the red list under permanent review and have an ongoing process of keeping it up to date. The fact that we have a red list and a managed quarantine programme makes further expansion of the red list possible. It puts our borders and our vaccine under a programme where we can control things, which is to be applauded.

[Baroness Jolly (LD) [V]]

How confident are the Government that our vaccines will cope with the Brazilian variant of the Covid virus and that the passenger from Brazil, who is somewhere in south Gloucestershire, will be traced? What measures are now in place to ensure that an incoming passenger is not lost again?

[Lord Bethell (Con)]

We are uncertain on the vaccine. There is a huge amount of speculation, but I would recommend that noble Lords take it with a pinch of salt because we cannot know for sure how the virus will behave with those who have been vaccinated until we have much better and clearer data. Regarding the current managed quarantine arrangements, I pay tribute to the teams which have stood up the system extremely quickly and well. The south Gloucestershire and Aberdeen arrangements have been incredibly impressive. It is extremely frustrating to all concerned that one person did not fill in the form and slipped through the net. But overall, the programme has shown itself to be extremely robust and we have an enormous amount of confidence in it.

Covid-19: Vaccination Programme

Baroness Jolly Excerpts

Wednesday 24th February 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, teachers are a priority in as much as they are on the prioritisation list along with other key workers, but the honest assessment of the JCVI is that teachers are not at accelerated risk of increased sickness or hospitalisation over any other member of the public. We are enormously grateful to the teaching profession for the role it is playing in getting schools back and in testing but, in terms of sickness and mortality, teachers are in the right place in the JCVI prioritisation.

[Baroness Jolly (LD) [V]]

My Lords, NHS England has told GPs to use their clinical discretion on vaccines for adults with a learning disability—although I am pleased that the Minister says that this is no longer the case. What percentage of adults with a learning disability have been called for their first jab and, if it is not 100% at this stage, why not?

[Lord Bethell (Con)]

I do not have the precise figure to hand. Those in group 4 will include those with Down’s syndrome and other CEVs; those with severe or profound learning disabilities will be in group 6. As we know, group 4 has had an extremely high conversion rate and, although I do not think it is exactly 100%, it will be an astonishingly high amount and, if those figures are available, I should be glad to write to the noble Baroness with them.

Dentists: Covid-19

Baroness Jolly Excerpts

Thursday 11th February 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I do not necessarily accept the dichotomy the noble Baroness refers to. I think it is reasonable for dentists to triage patients between those who can be treated with either advice, analgesics or antibiotics, and therefore do not need face-to-face contact, and those who need to be prioritised to, for example, the urgent dental care centres. I commend the dental profession for making good choices in that area. With regard to the treatment of children using anaesthetics, those are not statistics I have to hand, but I would be glad to write to the noble Baroness with whatever information we have.

[Baroness Jolly (LD) [V]]

My Lords, when I inquired, none of the dentists in north and east Cornwall was able to offer an appointment for NHS dentistry, so I know to my cost that private treatment is expensive. Would the Minister tell the people of Cornwall, whose earnings are below both regional and national averages, what should be done about this lack of NHS dentists in remote areas, leaving patients untreated, in pain and often resorting to self-care?

[Lord Bethell (Con)]

My Lords, as I said earlier, 88% of NHS dentists are open. I was at an NHS dentist earlier today, and I pay tribute to all those dentists that are open. I do not know the specific situation in north and east Cornwall, but those in acute pain have access to the 695 urgent dental care centres, which are around England. I have enormous sympathy for those who have painful teeth, and I urge them to hunt down an appointment at one of those centres, where the service is excellent.

Covid-19: Self-Isolation

Baroness Jolly Excerpts

Wednesday 10th February 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, in terms of the numbers or proportion of those isolating, a large number of figures is being bandied around. Some apply to last year and some to this year. I raise doubts as to whether anyone truly knows what the behaviours of people are, but I reiterate that UCL reports that 80% are self-isolating for the recommended 10 days or more, and that figure has some authority. In terms of the support that we are offering to people, we have taken on board the recommendations of noble Lords on the Opposition Benches and local authorities are using targeted support that suits the communities in which they work to provide that kind of support. We have provided substantial financial funding and resources for local authorities to provide the support needed.

[Baroness Jolly (LD) [V]]

Despite local authorities doing their best to support those self-isolating, good examples from Germany show that integrated health and care teams that visit people daily are vital to support people’s health and well-being in self-isolation. What has stopped the Government fully financing this integrated model across England?

[Lord Bethell (Con)]

We are hesitant to send teams of healthcare workers to people isolating because of the fear of infection. Obviously, having people attend those who have either tested positive or are the contacts of those who have tested positive does not comply with the latest hygiene protocol, but the noble Baroness is entirely right, and one way in which we could work harder is to use volunteers and community groups to provide pastoral and practical support for those isolating.

Hotel Quarantine for Travellers

Baroness Jolly Excerpts

Wednesday 3rd February 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I entirely agree with the noble Lord. He is right that additional vigilance is required. The advent of new variants that could have higher transmissibility or escape the vaccine is a complete game-changer, and that is why we have changed our approach to border management. We have upgraded our border control measures, and there will be further government announcements on that. We have introduced red lists of countries where there are variants of concern, and we have implemented Project Eagle, the tracing project to track down those who have tested positive in genomic sequencing for variants of concern.

[Baroness Jolly (LD) [V]]

My Lords, the Minister will be aware that Australia is imposing a two-week quarantine for all travellers flying in from abroad, with no exceptions. My son, who has dual nationality, is flying out in March to take up a job. He must have a negative Covid test result before flying and stay in a hotel for two weeks at his own expense. Australia has shown the way; when does the Minister expect the UK to follow?

[Lord Bethell (Con)]

The noble Baroness is completely right to cite Australia, and we take our hat off to its remarkable achievement in using its island status to protect itself against the virus. We are responding to the challenge of new variants by upgrading our measures, and announcements on this will be made shortly. The CMO’s view on the variants of concern so far is that we should have a proportionate system, which means an upgrading and not necessarily an Australia-style system. But we are putting in place the kinds of measures that could be upgraded to an Australia-style system were there to be a threat of significant magnitude.

Medicines and Medical Devices Bill

Baroness Jolly Excerpts

Consideration of Commons amendments & Ping Pong (Hansard) & Ping Pong (Hansard): House of Lords
Tuesday 2nd February 2021 Lords Chamber

[Lord Patel (CB) [V]]

My Lords, I am extremely grateful for the amendments that the Government have brought from the Commons. I am grateful to the Minister and his team for working so diligently with the rest of us, and to all noble Lords who supported my amendments. It is not unusual—but it is infrequent—for the votes that the Government did not get through in the Lords to be reconsidered in the Commons and brought back as government amendments. I am very content that the amendments that the Government have brought are very satisfactory and I congratulate them. I thank the noble Lord, Lord Bethell, the noble Baroness, Lady Penn, the noble Earl, Lord Howe, and the legal team for working with us throughout the Bill. That is all I am going to say.

[Baroness Jolly (LD) [V]]

My Lords, I too shall be brief and I too am grateful to the Minister and his team for giving Peers an opportunity to see the Commons amendments to the Bill before they were tabled, so that we might give some feedback. One of the things that has made this Bill a pleasure to work on is the open way in which political parties and Cross-Benchers have worked together, as well as the way that the Minister and his team have worked with us. We particularly welcome the clauses that have come to us from the Commons; they make the Bill a more explicit and effective piece of legislation than when it was debated either in Committee or on Report in this House.

[Baroness Thornton (Lab)]

My Lords, I am very grateful to the Minister and his team for the manner in which they have engaged and worked with us throughout the passage of this Bill, particularly at this final stage. The amendment in lieu is a good compromise that reflects the need for scrutiny to be at the heart of the Bill. It provides a mechanism to examine the powers of the Act in five years’ time and will open the door for the restructuring and consolidation of the post-Brexit medicines and medical devices regulatory regime. We believe that this will prove both desirable and necessary, and look forward to working with the Minister on such issues when the time comes.

We welcome the requirement that the Secretary of State must specifically consider whether this should be in the form of primary or secondary legislation and hope that this will lead to policy being put into a future Bill rather than scrolled away in regulations. The Secretary of State will also have to take account of all parliamentary committee reports. This would include post-legislative scrutiny undertaken by a Select Committee, as well as the DPRRC and Constitution Committee, whose oversight played a crucial role in reshaping a skeleton Bill into a framework Bill; I thank the noble Lord, Lord Lansley, for explaining that to us all. I hope the Minister can assure me that stakeholders will also be consulted. I am sure that that will be the case. It is very important, given that they are the end users of the legislation, and for the report to have value and credibility it must reflect the experience of regulators, industry, patients and medical professionals.

Finally, the tidying-up amendment that retains the requirement to share information in the public interest is an important provision because it will allow for substantive and ethical issues relating to the sharing of public data to be considered. This is of the utmost importance, given the role that the NHS and patient data may have in future trade deals.

Social Care Funding (EAC Report)

Baroness Jolly Excerpts

Thursday 28th January 2021 Grand Committee

[Baroness Jolly (LD) [V]]

My Lords, social care funding for older people or those with a disability has been put in the “too difficult” or “too expensive” box for as long as I have been involved in health and care policy—about 20 years. At every general election since 2010, there has been a promise to fix it, and, sure enough, after the 2019 general election, as we have heard, Prime Minister Johnson joined his predecessors and promised to address the issue “once and for all”.

State provision of social care is not easy, it can be expensive and there is no right way to do it. The German and Japanese models are often quoted; they involve members of the public contributing to an insurance system that will pay for their care once they need it.

England has no state provision of social care. We have a system whereby the person’s needs are addressed and, after a means test, they will find if they are eligible for financial support from their local authority. This will go some way towards the provision of their social care, either in their own home or in a residential setting, but not accommodation costs.

Local authorities pay out at different rates. I sat on the joint scrutiny committee for the Care Bill 2014. We heard of families moving to a neighbouring county to ensure that they were eligible for a more generous provision. Sometimes there is a need to top up from savings or by selling or remortgaging the family home. Some with long-term care needs might, for many years, face care costs that seem reasonable at the outset but will quickly erode savings. So the proposed cap is welcome.

The proposal to introduce free personal care over the next five years should be adopted. This would require an immediate investment of £8 billion—the estimate from the King’s Fund and the Health Foundation.

The other part of the care system is for those adults with disabilities; the majority—1.5 million—have a learning disability. Until last year I was chair of a charity which cared for over 2,000 adults with a learning disability. With help, such people can lead a fulfilling life. Many are in residential care or supported living. The funding from this comes from local authorities, which hold the responsibility for their care. Each year the conversations with commissioners become more difficult, as local authorities’ budgets are stretched and the costs of caring rise.

As the noble Baroness, Lady Kingsmill, said, care workers are paid poorly, and should be receiving the real living wage of £9.50 per hour but many do not. Those who work in the care of either older people or those with a learning or physical disability are not unionised, as nurses are. They are not regulated; nor are they required to have formal qualifications, but many would take the care certificate. Someone who has been fired for negligence or worse can walk out and get a job straightaway. This should change.

Whichever way you look at it, the current system is no longer fit for purpose. There is a sustainable solution. The report of the Select Committee of the noble Lord, Lord Forsyth, offers a route map for the department. Mencap estimates that £3.2 billion would stabilise the system. So, when they have a moment, the Prime Minister, the Chancellor of the Exchequer and the Secretary of State for Health and Social Care should read this report, and do what successive Governments have promised to do: fix the funding of the care system. This would be welcomed by so many older people and their children.

Medicines and Medical Devices Bill

Baroness Jolly Excerpts

3rd reading & 3rd reading (Hansard) & 3rd reading (Hansard): House of Lords
Thursday 21st January 2021 Lords Chamber

[Baroness Jolly (LD) [V]]

My Lords, Bills come and go. This Bill started its life as one to tidy up regulatory issues to do with the new post-EU world. In 10 years’ time, the Medicines and Medical Devices Bill is one I may not list as one of the most important I have worked on; I hope that the forthcoming mental health Bill will fit that spot. If remembered at all, it will be for the introduction of a commissioner for patient safety, born out of the First Do No Harm report by the noble Baroness, Lady Cumberlege.

There will need to be changes in the House of Commons to make the Bill really fit for purpose. The Minister has indicated the Government’s intention to lay amendments, and I am grateful to him for involving Peers in that process. When does he anticipate Second Reading in the Commons?

As the Minister and the noble Baroness, Lady Thornton, said, many people make a Bill, and they do not all sit in the Chamber. In particular, I thank both the Minister and the noble Baroness, Lady Penn, for giving us time to talk to the Bill team and allow them to explain new government amendments. Of course, I should not forget the noble Baroness, Lady Thornton, and her team; the noble Lord, Lord Patel; my noble friend Lord Sharkey; staff in opposition offices; and others who certainly made the Bill better, turning it into a workable piece of primary legislation.

[Baroness Cumberlege (Con) [V]]

My Lords, I could not let this opportunity pass without expressing my gratitude to all those who have played such a vital part in drafting, scrutinising and improving this important Bill. I know that it will now return to the other place. I wish it a fair wind and hope that we will soon see it enacted.

Throughout, noble Lords from all sides of the House have, quite rightly, focused on using the Bill to strengthen patient safety. Safety is now threaded throughout the Bill. I do so welcome that; it is something that the noble Baronesses, Lady Thornton and Lady Jolly, have both just mentioned. We have enshrined a very important safety recommendation in the Bill: we will now have a proper database to record the medical devices that are used and on which we and patients will be able to track their outcomes and detect safety more quickly. I cannot overstate just how important that is. Without this data, the healthcare system has been flying blind.

I have been very touched by the kind and thoughtful expressions of support from so many noble Lords in general debates and, in particular, for my amendments, which were triggered by the recommendations in First Do No Harm. The report enshrined in me that, at every opportunity, we must be reminded that the NHS is run for the people and is paid for by the people. Right now, the NHS is demonstrating a total commitment to saving lives and defeating this deadly virus—a virus that, as it sweeps around the world, devastates lives, livelihoods, education, personal budgets and a national aspiration for a better world.

In the dark days of the Second World War, Beveridge was preparing for a better Britain. In these dark days, there is a need to make plans—not just to return to what was there before but to look forward to something better. I believe that the patient safety commissioner will provide something better and will improve patient safety and healthcare as a whole. I was thrilled that so many of your Lordships lent me their support in calling for this; I know that their voices made all the difference. I thank the Minister and the noble Baronesses, Lady Thornton and Lady Jolly, for their generous remarks today.

Covid-19: Vaccination

Baroness Jolly Excerpts

Wednesday 20th January 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, there have been glitches; I do not know whether there are lessons learned. However, I can share with the noble Lord that the practicalities of getting the Pfizer vaccine in particular—which, as he knows, requires deep-cold storage—into every part of the country are quite challenging, and we are trying to reach not only the big mass centres but community pharmacies and GP surgeries. The delivery of the vaccine to thousands and thousands of locations will always be a little uneven, and there have been occasions where we have deemed it the correct procedure to have people stood up for their vaccination even though we were not 100% sure of the delivery of the vaccination. That does create concern but I think has been the right approach to take.

[Baroness Jolly (LD) [V]]

My Lords, my question follows that of the noble Lord, Lord Anderson of Swansea. For many in isolation, the appointment for their first jab is all that has kept them going, and the certainty of timing of the second has changed since the introduction of the vaccine regime. Can the Minister tell us whether that is to do with the region—there seem to be problems in the south-west—or is it demand, logistics or science?

[Lord Bethell (Con)]

My Lords, if I understood the noble Baroness’s question correctly, I reassure her that absolutely everyone’s details are registered in the national immunisation database, so everyone will receive an invitation for their second dose, as I mentioned earlier. However, the reason for having this longer period before the second dose is completely pragmatic. Every 250 doses saves a life, so it is absolutely essential that we get the maximum number of first doses out as quickly as possible. The MHRA, the JCVI and others have looked at the safety and efficacy of this approach, and they have found reassuring evidence that this will work extremely well. I take great joy in the fact that we have found a way to get the highest number of doses to the greatest number of people as quickly as we possibly can.