Folic Acid

Lord Patel Excerpts

Thursday 3rd September 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, I completely accept the urging of my noble friend Lord Balfe on this matter. He is entirely right. There is very strong scientific evidence in this area; the Government accept that, and this is why they have launched a consultation, which was due to be published earlier this year. However, Covid has blown us away and that is why the announcement has been delayed. The Government have listened to the scientific evidence, which is very persuasive, and the decision will be made when the time is right.

[Lord Patel (CB) [V]]

My Lords, this is the fourth occasion that I have supported this Question put down by the noble Lord, Lord Rooker. Every time, there has been a disappointing Answer. As an obstetrician, I have seen many, many pregnancies result in serious spina bifida and anencephaly. Previously, the Government have used the excuse that overdosing might result if we put folic acid in flour. Would the Minister confirm that the recent research does not support that view?

[Lord Bethell (Con)]

My Lords, the consultation on the proposal to fortify flour ran for 12 weeks from 13 June to 9 September 2019 and was undertaken on a UK-wide basis. The pilot ran extremely successfully; the use of the supplements by the flour manufacturers was affordable and their implementation of the pilot was achieved without much disruption, and it was an encouraging experience that gives us good evidence for taking this matter forwards.

Medicines and Medical Devices Bill

Lord Patel Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord Patel (CB) [V]]

My time limit curtails me from commenting on the Minister’s or other speeches, so I shall get on.

I know that the Government feel that this is a simple Bill that is needed to implement EU laws in UK legislation in relation to medicines and medical devices, but the implications of it go far beyond that. The Cumberlege report has added the need to strengthen the Bill in relation to patient safety.

In Part 1, the Government set out their ambition to have a world-class regulatory authority for medicines and medical devices that puts patient safety at the forefront and promotes innovation by making the UK “attractive” to investors. I cannot complain about that.

The Government have stated their ambition to make the UK a science superpower in which life sciences and the development of new medicines will play a crucial part. This Bill offers the Government an opportunity to say how they plan to do this but fails to do so. As the Science and Technology Committee report on life sciences indicated, the UK leads in life sciences research, but it is not very successful at taking research to innovation and commercialisation. The stated aim in the Bill to make the UK attractive is presumably to address this deficit, but it gives no definition of “attractiveness”, although the Minister referred to it in his speech. I hope that he will clarify it in more detail in Committee and even define “attractiveness”.

The Bill falls short of identifying how it will achieve its objectives, except that the Secretary of State will take wide powers to do it. Let me highlight the areas of my concern which I wish to explore in Committee. The Bill gives broad delegated powers to the Secretary of State to amend or supplement regulations. As the Delegated Powers Committee and the Constitution Committee—already referred to several times—recognise, some delegated powers may be necessary, but the Bill grants powers far wider.

Furthermore, the Bill adds to the complex regulatory regime rather than simplifies it. Clarification is needed as to how it intends to prioritise patient safety, even when there might be conflicting interests, such as “attractiveness” for investors. The findings of the Cumberlege review, that patients’ concerns were ignored, need to be addressed in the Bill. While the creation of a registry of devices is welcome, their safety and efficacy need to be addressed. I hope that my noble friend Lord Kakkar takes up this cause. If he does, I shall certainly support him.

Why will the MHRA be the regulator that licenses devices and maintains the register, but any new information systems are to be held by NHS Digital, referred to in the Bill as the information centre? What pre-market processing will there be for devices prior to approval for usage?

Clarification is needed from the Minister on the powers that the Secretary of State will have in emergency situations and on the removal of the duty of confidentiality and privacy afforded to patients. I want to explore how the Government plan to make the United Kingdom a prime destination to conduct clinical trials, an area of considerable concern for a wide sector of pharma. The Minister may well remember the debate at the time of the withdrawal Bill on clinical trials and making the UK a prime destination to conduct trials. The key point in being able to do this was the ability for the MHRA to have a close relationship with the EMA. What discussions are going on currently to enable this to happen? Regulations for medicines is a devolved issue for Northern Ireland, a potential area of divergence in the future from the rest of the UK. The implications of this need to be clarified in the Bill.

In conclusion, I am able to support much of the Government’s ambitions through this Bill to make UK regulations in medicine world-leading. Having said that, I will support amendments that allow for greater scrutiny of the powers of the Secretary of State, place greater emphasis on patient safety and give a clear commitment to allow the MHRA to make strong partnerships with other regulators. I look forward to Committee.

Covid-19: Response

Lord Patel Excerpts

Monday 27th July 2020 Lords Chamber

[Lord Bethell [V]]

The noble Baroness is entirely right that these local outbreaks create invidious choices for local authorities, and the fine tuning of the boundaries is an important part of the lockdown process. We saw that in Leicester, where the boundaries of the lockdown were changed for the very reasons that she outlines, both to preserve trust and in order to be effective. However, I remind the noble Baroness that the movements of people within areas mean that the disease can spread. Therefore, the lockdowns do not necessarily apply only to those areas with high prevalence in any one period, and sometimes buffers need to be put around the infection area, which is why these areas can seem to be either unfair or overextended.

[Lord Patel (CB) [V]]

My Lords, Amnesty has reported that the UK has had 540 deaths among health and care workers, second only to Russia. Compare that to Spain, which has had 63 deaths. Have the Government carried out a root-cause analysis to find out the causes of these deaths, and will they publish the results? If the Government have not carried out such an analysis, will the Minister agree that one should be carried out with some urgency in case there is a second wave of infection?

[Lord Bethell [V]]

My Lords, local trusts have been urged for many months now to undertake a profound risk assessment of workers, particularly BAME workers, in order to understand where infection may have come from. Infection control teams in individual trusts are charged with the responsibility for delivering infection control plans. It is at that level that we can understand the detailed causes of infection because in each trust those causes can be quite different.

Independent Medicines and Medical Devices Safety Review

Lord Patel Excerpts

Thursday 9th July 2020 Lords Chamber

[Lord Bethell]

I thank my noble friend for his comments and for his role in commissioning this important report. His point on the safety commissioner is extremely well made. I am not ruling out anything whatever, but we need time to study the report before we can make any commitments.

[Lord Patel (CB) [V]]

My Lords, I thank the noble Baroness, Lady Cumberlege, and her team for what is a hard-hitting report, and rightly so. Reading it, I felt anger and shame—anger that so many women patients were treated with such disdain and felt that they were not listened to; and ashamed that members of a profession I belong to showed such ignorance, arrogance, duplicity and callousness towards the very people who put trust in them. As a member of that profession, I apologise wholeheartedly to women who suffered and I hope that the profession takes heed of them. Much of the report draws on narratives from women, and I was struck by one who called herself

“an unsuspecting, unwilling participant in a cruel experiment”.

No patient should ever feel that. I hope this report is a wake-up call for the professional organisations too, to take charge and become more patient-focused, rather than professional-focused, and to deliver the care that patients deserve. I am a long-time supporter of the charity Epilepsy Action. It has welcomed the report and hopes that action will be taken soon, particularly for women and mothers in relation to sodium valproate. I support the questions asked of Ministers and I hope we will soon see action.

Covid-19 Update

Lord Patel Excerpts

Wednesday 1st July 2020 Lords Chamber

[Lord Bethell]

I reassure my noble friend that anyone who has reason to believe that they may have been infected by the virus is eligible for the test. The resources we have put into testing are now enormous. There are nearly 300,000 tests a day. Those in Buckinghamshire who are too far away from the drive-in testing facility should apply for an at-home testing kit.

[Lord Patel (CB) [V]]

My Lords, I agree with much of what the noble Baronesses, Lady Thornton and Lady Brinton, had to say. In response to them, the Minister said the dashboard will provide data about the infection rate to local authorities and local healthcare. If that is so, I welcome it. Does that mean a change in policy towards greater involvement of local public health directors in managing this pandemic?

[Lord Bethell]

To be clear to the noble Lord, the dashboard was made available on 22 June. It has a very large amount of local information, including information from 111, hospitals and the test and trace programme. The analysis of the data will be enhanced using the latest technology in order to give the most granular information possible. Those enhancements will be rolled out very shortly.

Covid-19: Test and Trace App

Lord Patel Excerpts

Monday 22nd June 2020 Lords Chamber

[Lord Bethell]

My Lords, I completely endorse the noble Lord’s point. We have followed the principle of working in parallel in all cases possible. However, I should explain that pressure is incredibly intense, and one cannot focus on everything all the time. I understand the point that he makes, but I suggest that, at some points, one has to focus on one part at a time. That is what we have sometimes needed to do, but we have remained in contact with all players at all times.

[Lord Patel (CB) [V]]

My Lords, I have one question in two parts. First, in the event of a substantial increase in the number of new infections, what plans do the Government have to manage such an increase, and will they publish them? Secondly, what plans do they have to use antibody screening of the population?

[Lord Bethell]

My Lords, our plans for the winter are in development and I look forward to their publication. The noble Lord is entirely right to prioritise antibody screening. We have invested considerably in antibody testing from a number of suppliers, including Roche and Abbott. As he knows very well, the science remains ambiguous, but we are optimistic. That is why we are putting our best minds to understand it better, and we are world-leading in that respect.

Contact Tracing: Personal Privacy

Lord Patel Excerpts

Thursday 11th June 2020 Lords Chamber

[Lord Bethell [V]]

My Lords, we are currently assessing the value of a specific Isle of Wight update and whether it would be worth while before we move on to issuing the full app. When we have finished that assessment, I would be glad to answer the questions asked by my noble friend.

[Lord Patel (CB) [V]]

My Lords, we need the tracking app to succeed. For this to happen, as has already been mentioned, the Government need to make sure that they are honest and transparent with the public to gain their trust. Can the Minister say when the Government will publish the performance data from the Isle of Wight trial? Further, can he confirm that the Government have been following their own code of conduct for data-driven technologies in healthcare and in the development of the app? For example, principle 4 refers to transparency and principle 10 refers to commercial models. Can he tell us what process will determine secondary uses of the data?

[Lord Bethell [V]]

My Lords, I can confirm that the Government have been following the code of conduct, as the noble Lord suggested. I am also hungry to publish the performance data. I can confirm that, so far, there have been 73,365 users of the Isle of Wight app, 53,490 of whom were on the Isle of Wight. The user experience has been largely benign, and we look forward to publishing fuller technical and user details shortly.

Covid-19: Cancelled Medical Operations

Lord Patel Excerpts

Wednesday 10th June 2020 Lords Chamber

[The Deputy Speaker (Baroness Garden of Frognal) (LD)]

We do not seem to be able to hear the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

My Lords, I have unmuted my microphone and I hope that my voice is coming through. I am sorry for the delay.

As the Minister will know, several million patients are on waiting lists for surgery. Given the increased levels of hygiene safety that will be required, it is inevitable that productivity will be down. This means that there will be a need for the prioritisation of cases. Does he agree that the professional organisations should draw up advisory guidelines for clinicians, rather than leaving it to the individuals?

[Lord Bethell [V]]

The noble Lord may be interested to know that, frustratingly, waiting lists have gone down rather than up, from 4.42 million in February to 4.32 million in March. This is an indication of people not coming forward for operations that they may need, and it is something that we are keen to address. However, we are putting the decision-making on how to handle the lists into the hands of local clinicians, who will use a combination of clinical need and waiting list times to make their decisions.

Covid-19: Response

Lord Patel Excerpts

Wednesday 3rd June 2020 Lords Chamber

[Lord Bethell]

My noble friend makes an incredibly valuable point and I completely share her concerns, but I will share two important points, if I may. First, we cannot avoid the fact that this disease has a 14-day incubation period. It is extremely tough to protect our borders from infection by a disease that may not be detectable, even at our borders, during that period. Secondly, while the peak is raging, additional infection from foreign visitors makes only a marginal difference, whereas at this stage, when we have worked so hard to get the prevalence down and reduce infectiousness, the threat of new infection from foreign visitors is higher. That is an irony that the CMO is fully aware of, but it is entirely right that we have brought in these measures. They are constantly under review. The impact on tourism and other industries is hugely regretted, but to rid the country of Covid they are proportionate.

[Lord Patel (CB)]

My Lords, I thank the Minister for repeating the Statement. Before I ask my question, let me say this: with the greatest respect to the Minister, if he thinks that no degree of racism exists in the NHS, I suggest that he speaks to those people from ethnic minorities who work in the NHS and see how they feel. I accept his comment that examination of what has happened hitherto is for another day, but we have to examine the current strategy for suppressing the virus, which we have not done successfully. In this regard, the latest initiative is the Government’s test and trace scheme. A great degree of transparency and trust will be required to make this a success. Can I ask the Minister: what matrix will the Government use to demonstrate the success of the project?

[Lord Bethell]

My Lords, I bow to the experience and wisdom of the noble Lord, Lord Patel, particularly in the matter of racism in the NHS. I would not for a moment suggest that there is no racism at all in the NHS—or any large organisation—and I deeply regret any bad experiences he may have had. The accusation, however, was of structural racism in the NHS, and that is what I push back against. The NHS as an organisation is not racist, and I reject the suggestion that it is.

As for the matrix of success, that is an extremely perceptive question, and a bloody tough one—exactly the kind I would expect from the noble Lord. To summarise, it is to reduce R: if we can get a lid on R0 and stop the index case from spreading the disease to more people, then Test and Trace will have succeeded.

Covid-19: Testing

Lord Patel Excerpts

Thursday 14th May 2020 Lords Chamber

[Lord Bethell]

My noble friend Lady Rawlings is entirely right: we all have an important role to play. There is good evidence that personal tracing by individuals of contacts within their networks has a powerful role to play in isolating those who might have been in contact with the virus. Defeating this virus will be the responsibility of everyone in the community; we cannot rely just on digital apps and central databases.

[Lord Patel (CB)]

My Lords, what evidence do the Government use to calculate the value of R0?

[Lord Bethell]

The noble Lord will know that we have set up one of the most ambitious surveys, conducted by the ONS, to study on a weekly basis a large number of viral and serological tests. Those are used by statisticians to understand both the prevalence and the spread of the disease. Figures for that are emerging—we now have three weeks-worth of figures. They are being published regularly and I would be glad to send the noble Lord a link to the relevant data.