Covid-19: Wuhan Institute of Virology

Baroness Blackwood of North Oxford Excerpts

Wednesday 30th June 2021 Lords Chamber

[Lord Bethell (Con)]

I entirely agree with the noble Baroness. It is extremely frustrating that we do not know the steps of evolution that this virus went through. It has come to us completely out of the blue. That leaves us in a vulnerable state when we are preparing for the next pandemic. It is absolutely essential, as any epidemiologist will say, that one knows and understands where the virus came from—whether that is the water pump handle for an outbreak of cholera or a virus from China.

[Baroness Blackwood of North Oxford (Con)]

My Lords, the situation could not emphasise more clearly the need for genuine global participation in transparency in surveillance and pathogen sequencing to respond to future pandemics and epidemics. I was pleased to see the progress at the G7 on this but, if the global anti-pandemic action plan is to have any teeth, we will need to ensure that countries such as China contribute trustworthy data to global surveillance in the future. What steps does the Minister envisage to ensure that this happens?

[Lord Bethell (Con)]

I completely agree with my noble friend. The international health regulations need to be amended in that respect. It was one of the aspects of the pandemic preparedness treaty that was brought to Carbis Bay for the G7 earlier this year. We are working extremely hard, through our G7 chairmanship, to ensure that this relatively obscure but absolutely critical international treaty has the teeth it needs to do the work on genomic sequencing and pathogen identification that needs to be done.

Covid-19 Update

Baroness Blackwood of North Oxford Excerpts

Thursday 10th September 2020 Lords Chamber

[Lord Bethell (Con)]

The noble Lord is right to be concerned about false positive results. However, our experience, our piloting and the emerging technologies suggest that that will be the case in a relatively small proportion of the tests and is entirely manageable within a mass population testing system. With regard to the idea that we can somehow identify vulnerable groups and target them pre-emptively, I wish that that were true, but this disease constantly confounds expectations and turns up in places where we least expect it. If we could tell people that they were going to get the disease, we would not have this problem in the first place.

[Baroness Blackwood of North Oxford (Con) [V]]

I thank the Minister for his answer, but those who were formerly shielding, those whom we had identified as being most at risk, will be watching the rise in cases and some of this debate with anxiety. There were a number of problems with the rollout of the shielding programme the first time round, and we have new evidence about who is most at risk from Covid. Has there been a reassessment of the criteria for those who might need to shield this winter? If so, what is the Minister doing to ensure that this is communicated early and much more clearly to both those who will not need to shield this winter and those who might need to, so that we can reduce anxiety among those groups and protect the most vulnerable?

[Lord Bethell (Con)]

I completely recognise the problem identified by my noble friend. I reassure her that the expert sub-group NERVTAG is developing a predictive risk model to enable a more sophisticated approach to clinical risk and to identify more clearly those who need to shield. The model incorporates known relevant risk factors, such as age, sex, BMI and ethnicity. We are working at pace and will continue to engage patients, those on the shielding list, healthcare professionals and the voluntary sector as we embed this important insight into what we do.

Folic Acid

Baroness Blackwood of North Oxford Excerpts

Thursday 3rd September 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, I am not aware of any conclusive scientific evidence that contradicts the benefits of folic acid. As I said, the demographic data would seem to suggest that experiences in other countries have been benign. Longitudinal studies take a very long time to emerge and, therefore, we are not expecting a massive change in that data. However, back at the department, I will ask if any science has emerged and I will write to the noble Baroness if I can put my hands on anything.

[Baroness Blackwood of North Oxford (Con) [V]]

I of course join other noble Lords in pressing the Minister to implement mandatory fortification as soon as possible—it really is time—but if he needs additional motivation, can I point to the potential wider benefits in addition to vital prevention of NTDs: reducing anaemia caused by folic deficiency in older adults, for example? Given the inequalities associated with these deficiencies, is the Minister confident that such wider benefits have been fully considered? If not, will he commission the relevant research as a matter of urgency?

[Lord Bethell (Con)]

The noble Baroness is entirely right to explain and expand on the wider benefits, but the benefits in respect of NTDs are extremely persuasive in themselves and the consultation focuses on them. I understand that it is an analysis of those benefits that will form the basis of our decision-making.

Medicines and Medical Devices Bill

Baroness Blackwood of North Oxford Excerpts

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

[Baroness Blackwood of North Oxford (Con)]

My Lords, I refer to my interests as declared in the register.

I pay tribute to all those who have worked tirelessly to deliver lightning-fast and globally important Covid trials, including RECOVERY, REACT and the Genomics England genomic host sequencing study. These have been a clear demonstration of the strength of the MHRA and UK life sciences. However, surely none of us can read my noble friend Lady Cumberlege’s heartrending report or watch the race to a Covid vaccine without knowing that we have more to do. Therefore, although this Bill has been triggered by Brexit, it is in fact timely regardless of Brexit.

A great deal has been said regarding the delegated powers—I note my noble friend Lord Lansley’s comment regarding framework Bills—and we will have time in Committee to cover all this, but I add that while current frameworks governing MMD will be retained, the loss of the ECA Section 2(2) power causes specific challenges for operating a safe and responsive regulatory regime. By its nature, MMD regulation requires frequent, prompt updating. The Human Medicines Regulations 2012 have been updated 11 times using Section 2(2). Over and above this, as has been mentioned, we have significant decisions to come on MDR, CTR, in vitro diagnostics and much that is as yet unknown.

Passing this Bill will mean that we will be able to shape our MMD regulatory environment in a far more tailored way. We may well choose to mirror upcoming EU regulations. The MHRA has been clear that we want a seamless process for multisite clinical trials not just across Europe but globally. However, there are other areas, such as genomics and cell and gene therapies, where innovative regulation may be highly desirable for novel trial design or surrogate end points, for example.

From Genomics England to Wellcome Sanger and Biobank, we have a unique concentration of institutions, skills and industry that puts us at the forefront of this field. This is a position that we must maintain. Furthermore, genomics drives two of our most highly skilled and high-growth sectors: life sciences and data science. These are critical to our economic recovery. However, primarily, these technologies should be assured and accelerated due to their promise for patients: more accurate diagnostics, personalised medicines, and screening tools that may even help prevent certain diseases altogether. The value of knowing that you carry a faulty BRCA1 gene and therefore have an increased risk of ovarian or breast cancer is well known. However, combining this genotyping with emerging tech such as polygenic risk scoring can sharpen that risk profile and prevent inappropriate interventions. The same is true of familial hypercholesterolaemia, promising to improve care of the highest-risk CVD patients.

We know that gene editing tools are producing entirely new casts of medicine, including cell and gene therapies such as the blood cancer drug Kymriah. It was the UK that struck the first full-access deal in Europe for this breakthrough CAR-T therapy, and there is promise of much more, with 12% of global ATMP trials happening here. The benefit of cell and gene therapies is patient-specific treatment with curative potential. The challenges include cost, complex manufacturing and short shelf lives. This Bill would help, enabling approved therapies to be processed at the bedside, and much more.

Genomics and other such tech generate vast swathes of data, and none of us needs to be reminded of the challenge and urgency of regulating the intersection of novel medicines, medical devices and health data. This Bill would help us develop a future-proof health data regulatory framework that could unlock the potential of ML in healthcare while maintaining the highest ethical and data standards. But align or innovate, it will be our decision. Clause 41 makes it clear that these decisions will be fully consulted on and largely subject to the affirmative procedure, but it would be helpful for the Minister to clarify the points raised by the noble Lord, Lord Sharkey.

The balance to be struck is articulated in all three sections, which call for Ministers to consider safety, access and attractiveness of UK life sciences. Of course, patient safety is paramount, but a sick patient is not safe if they cannot access the treatment they need, and they will not be able to do that if the UK becomes an unattractive environment to trial and launch the best treatments. This requires rigour and prompt intervention to ensure the highest standards of patient safety, yes, and I fully support the patient safety commissioner and an effective devices register, but it also requires addressing barriers to access and uptake and creating certainty and right-touch regulation that limits bureaucracy and takes a proportional approach to fostering innovation in life sciences. That way, not only will UK patients get the best and safest care but we will ensure our life sciences sector remains one of the most productive in the country and one of the most innovative in the world.

Smoking

Baroness Blackwood of North Oxford Excerpts

Monday 20th July 2020 Lords Chamber

[Lord Bethell [V]]

I completely agree with the noble Baroness that there is a massive health dimension to the levelling-up agenda. Health inequalities affect families the hardest and the Government are highly focused on them. However, it is not our style to introduce emergency legislation, because we believe that prevention is better than cure and that people have rights and choices to make for themselves.

[Baroness Blackwood of North Oxford (Con) [V]]

My Lords, I welcome the publication of the draft guidance on pavement licences in time for the debate this afternoon. However, I note that, while local authorities are to consider public health when setting local conditions, Section 5.2 fails to reference the smoking reduction targets set out in the tobacco control plan or the ambition for a smoke-free England by 2030. These would be a helpful addition, so will the Minister consider including them as the guidance is finalised?

[Lord Bethell [V]]

It is not my role to comment on the drafting of legislation in the manner that my noble friend describes. However, I resolutely repeat the Government’s commitment to a smoke-free 2030 and the tobacco control plan, both of which are absolutely essential to our tobacco policies.

Covid-19: Mental Health

Baroness Blackwood of North Oxford Excerpts

Wednesday 1st July 2020 Lords Chamber

[Lord Bethell]

The right reverend Prelate is entirely right to be focused on the support offered to both NHS and social care staff. There is considerable potential trauma in this area, and those who have been on the front line are under more pressure than one could possibly imagine. We have put in place schemes specifically targeted at both NHS and social care staff, and I reassure the right reverend Prelate that there is parity between the two sectors.

[Baroness Blackwood of North Oxford (Con) [V]]

My Lords, the first UK study of neurological and psychological complications of Covid-19 was published last week. It found that 31% of patients developed an altered mental state arising from both neurological and psychiatric diagnoses. This is a relatively small cohort study, but the breadth and prevalence of the complications uncovered mean that larger studies are crucial to truly understand the scale of the challenge. With recovery, we have proven our capability to run outstanding trials at pace, so can the Minister please outline his plans for research into the acute and longer-term mental health effects of Covid?

[Lord Bethell]

The noble Baroness is entirely right to emphasise the importance of longitudinal studies. The UK household longitudinal study data, which analyses the GHQ-12 scores, has been upgraded. We will continue to invest in that, and Public Health England has been tasked with monitoring the development of mental health issues across the country.

Personal Protective Equipment

Baroness Blackwood of North Oxford Excerpts

Wednesday 24th June 2020 Lords Chamber

[Lord Bethell [V]]

My Lords, we have had regular engagement with the devolved Administrations and have discussed how we manage cross-border services. The balancing of stockpiles of PPE around the nation is something that we are very much focused on. We have moved from the supply of PPE to a few NHS trusts to nearly 55,000 individual users of PPE. This is a massive undertaking that has hugely expanded the scope of our PPE supply.

[Baroness Blackwood of North Oxford (Con) [V]]

My Lords, I was pleased to hear the Minister’s ambitions for a 90-day stockpile. NHS Providers has now stated that most trusts are receiving the right PPE when they need it, but it highlights the need to move from a crisis day-to-day supply to secure access to 14 days’ worth of all PPE. Obviously this is important for planning, restarting elective care safely and especially for patients being asked to isolate for surgery. When will a 14-day supply of PPE at trust level be achieved?

[Lord Bethell [V]]

My noble friend is entirely right that having adequate stocks on hand is important, but having line of sight is also important. Individual trusts are able to make their own decisions on whether they wish to have stockpiles on the premises or a flow of supplies from their suppliers. At present we are working on supporting the trusts in their decisions on this matter.

Covid-19: Track and Trace System

Baroness Blackwood of North Oxford Excerpts

Thursday 18th June 2020 Lords Chamber

[Lord Bethell [V]]

My Lords, the epidemiological maths is as the noble Baroness describes, but our focus on symptomatic cases does not mean that the system does not work. Taking out more than a quarter of infected cases is a massively important and impactful event. Asymptomatic testing has started in healthcare and social care workers. It is making a big difference in both those forums, where prevalence is higher than the community prevalence, and we will be learning lessons from those schemes.

[Baroness Blackwood of North Oxford (Con) [V]]

My Lords, a key priority of “track and trace” is to monitor the emergence of localised hotspots and intervene before wider community transmission can occur. Local authorities and public health officials have expressed concerns that they do not have the powers to deliver swift local interventions and that a top-down approach might be too slow. Can the Minister say what process is in place to prevent community transmission when “track and trace” finds evidence of such localised hotspots?

[Lord Bethell [V]]

My noble friend is entirely right that local action is central to an effective response to Covid-19. We are working extremely hard through the JCVI to take the intelligence from our testing programme to identify hotspots when they occur and to move resources to those areas to support local directors of public health and local infection officials with the resources they need, whether in terms of testing or surge control of the disease.

Contact Tracing: Personal Privacy

Baroness Blackwood of North Oxford Excerpts

Thursday 11th June 2020 Lords Chamber

[Lord Bethell [V]]

My Lords, the evidence before me suggests that the British public have an enormous amount of support for the app. Recent research by Johnson and Lubbock partners for ITV showed that 59% of British adults report that they would download the app. We remain committed to reassuring all British people that the app is safe. I take completely on board the noble Baroness’s recommendations to engage with community and faith leaders who may have particular misgivings; it would be worth engaging with them on a particular basis.

[Baroness Blackwood of North Oxford (Con) [V]]

My Lords, I understand that a second version of the tracing app is now undergoing testing and that, following the outcome of this trial, the plan is to issue the new version to Isle of Wight residents as an update. Is this the case? If so, what are the differences in the information gathered between the first and second versions? Will Isle of Wight residents have to consent to any update or does their original consent include all future updates?

[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.

Covid-19: Cancelled Medical Operations

Baroness Blackwood of North Oxford Excerpts

Wednesday 10th June 2020 Lords Chamber

[Lord Bethell [V]]

My Lords, the impact on the over-75s is, as has been described, profound. We have worked hard to try to protect those who are shielding. The reopening of GPs’ surgeries is a priority but, at the moment, we are not encouraging those who are over 75 to make the journey to surgeries that are a potential source of infection. Therefore, we will not be taking the steps the right reverend Prelate described.

[Baroness Blackwood of North Oxford (Con) [V]]

My Lords, as the waiting lists caused by Covid create huge pressures, harder-to-treat patients must not be left behind. Last month, Eurordis released a survey which included UK rare disease patients and found that nine out of 10 had experienced disruptions in care, while more than half who needed surgery had had it cancelled or postponed. Many rare disease patients are in the shielding group and many have degenerative conditions. Can the Minister set out the plans to improve access to care and communications about care for rare disease patients, and can he please undertake to meet with patient groups about this?

[Lord Bethell [V]]

The work of my noble friend Lady Blackwood on rare diseases is well known and acknowledged in the House. Those with rare diseases are in exactly in the kind of vulnerable groups that are being hard hit by Covid. They are given particular access to local support systems and they should have access to home testing services if they feel vulnerable to the effects of Covid. Further, I am happy to undertake a commitment to meet with the relevant stakeholder groups to discuss how we could be working harder to support them.