Medicines and Medical Devices Bill

Baroness Altmann Excerpts
Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021

(3 years, 10 months ago)

Lords Chamber
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Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, I think I am back now. I apologise: I have no idea what happened then, but the trusty old iPad is coming in useful. I think that when I lost my link I was talking about media companies, so I will pick up with that.

Despite the Government’s and social media companies’ announcement last week of new measures to tackle the issue, dedicated anti-vaccine groups with hundreds of thousands of members on social media are still churning out disinformation—100,000 Facebook users and 180,000 on TikTok. Although the Government have talked about online harms for a long time, it is unlikely that that legislation will have Royal Assent in time to help with this.

Finally, the situation was made clear in the Question in the House yesterday from my noble friend Lady Lawrence about the BAME community and the vaccine being rolled out. She said:

“I have heard messages from the black community about their mistrust of and lack of confidence in the vaccine. I ask Her Majesty’s Government: what proportion of those taking part in the vaccine trials were black, Asian or from ethnic minorities before the rollout?”—[Official Report, 13/1/21; col. 725.]


That was amplified by the noble Baroness, Lady Warsi, who made the point that, although BAME communities were initially less likely to accept a Covid vaccine than white communities, when they had the opportunity to discuss their concerns with healthcare professionals, they were more likely than white communities to be persuaded to have the vaccine. Is the noble Lord familiar with that polling, and will he follow it up? I beg to move.

Baroness Altmann Portrait Baroness Altmann (Con) [V]
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My Lords, first, I apologise to the House because this is the first time I have spoken on this Bill, so I will not detain the House long. However, I support the aims of the amendment. This is something I have felt strongly about for some years.

Tackling anti-vax disinformation can be life-saving, and continuing to promote anti-vax messaging can be so damaging to public health as well as individual health. As the noble Baroness, Lady Thornton, rightly said in her excellent introduction—I am grateful to her for tabling the amendment—the online anti-vax messaging problem is growing. It is not just from a tiny minority in any one country; there could be systemic efforts to damage public health in our country and others. Given that those minority views can be spread, potentially to the severe detriment of the public and those who perhaps tend to support those views, believe them or be convinced by them, I should be very grateful if my noble friend would explain to the House the Government’s position. What do they believe they can do to combat the anti-vax messaging, not least as we are in the middle of this dreadful pandemic, for which the way out seems to me and many others to be to vaccinate as much of the population as we can, as soon as we can, to enhance their protection? Therefore, this is a very important and live issue, given the dreadful consequences that the pandemic is having not only on health through the virus itself, but on other aspects of public health and the country’s wider ability to support our beloved NHS.

Baroness Masham of Ilton Portrait Baroness Masham of Ilton (CB) [V]
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My Lords, I am speaking on the telephone, as something went wrong with my iPad.

I support Amendment 16, which is tackles anti-vaccination disinformation. For some years, this has created a problem. For example, there has been an epidemic of measles in many countries because many people, including the growing number of vegans, mistrust vaccines. Clear messages should go out about the benefits of vaccines and how they work. Some vaccines are very complicated and difficult to develop, but they are desperately needed for diseases such as HIV, TB and malaria.

Regarding these important coronavirus vaccines, I hope that the Government will be very careful that disinformation is not going out to the public about the Pfizer vaccine. Many health workers and elderly vulnerable people have had one dose, and the second dose should be given in three weeks’ time. People have signed up to that, as there are written instructions to do so, but the Government are trying to delay the second dose by up to three months, which is not recommended by Pfizer-BioNTech or the regulator.

There is a risk that with only one dose, people may become carriers and the virus may become resistant to the vaccine. The Doctors’ Association is not happy about the Government’s idea of a three-month delay. More careful monitoring and research is needed, but these mixed messages are extremely unhelpful. I hope that the Government will realise that people need to trust the information they receive.

Covid-19: Vaccinations

Baroness Altmann Excerpts
Wednesday 13th January 2021

(3 years, 10 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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That is a gruesome prospect and not one that I like to see in a debate like today’s, where there is so much positivity. However, the noble Lord is entirely right that mutations may go that way. The good news is that the current round of mutations that have been seen in Kent, South Africa and Brazil seem to be about transmissibility, not escapology. It is as though the car had driven into the pits and had a turbo attached to it, but not camouflage equipment. But that could happen, and if it did, we would indeed have to look at much more emphatic and systematic long-term vaccination programme.

Baroness Altmann Portrait Baroness Altmann (Con) [V]
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My Lords, I too congratulate the Government and the Minister on all the tremendous work that has been done, especially on the vaccine. Can he say what the hold-up would be for a 24/7 programme, what the scale of supply is, and when a supply chain might be available that could deliver 24/7 vaccination? The scale of damage to other aspects of the health of our nation as well as to the economy is unsustainable. This is like a war effort but we absolutely need to be rolling out this vaccine as quickly as we possibly can.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I completely hear my noble friend’s encouragement, and her advocacy on behalf of business and a return to normal is heard loud and clear. The deployment is happening literally as quickly as we can possibly make it. I suggest to her that even NHS workers have to sleep, they have families, and it is not possible to run operations through the night on a mass scale. You cannot force people to turn up for a vaccine. I am not sure that the idea that millions of people will turn up at 4 o’clock in the morning for a vaccine is entirely realistic. However, my noble friend’s point about scale and whether we can move faster and turn around the situation more quickly is extremely well made. I reassure her that we are doing everything we possibly can.

Health Protection (Coronavirus, Restrictions) (Self-Isolation and Linked Households) (England) Regulations 2020

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Thursday 7th January 2021

(3 years, 10 months ago)

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Baroness Altmann Portrait Baroness Altmann (Con) [V]
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My Lords, yet again we are rubber-stamping regulations imposing draconian restrictions aiming to protect the country in a war that has already caused countless casualties. Despite ever stricter lockdowns, the virus has accelerated. People are not objects that can be put in a box and locked away. Where is the impact assessment on human lives, or a matrix that demonstrates how each element works? Why are we not pulling out all the stops to win this race? Test and trace is not doing the trick. Winter pressures and an ageing population are against us, and serious staff shortages have reduced NHS capacity below normal winter levels, with Nightingales underused. Can my noble friend explain precisely how the Government are removing bureaucratic delays preventing retired NHS staff returning?

It is almost beyond belief that we do not require a negative Covid test before UK entry. The only way forward seems to be vaccination. We keep hearing about delays in training, approvals or distribution logistics, but Israel has managed to get moving much faster than us. Its medical and military operations have left the UK and EU countries lagging behind.

My mother is 88, with COPD, heart problems and other risk factors, but has not been called. All military medical support units, pharmacies, dental staff, first aiders and any others trained in administering injections must be fully mobilised. Also, the virus does not stop spreading at night, so where are the plans for 24/7 vaccinations? Could we consider vaccinating all care home residents through the night in those homes and free up daytime hours for other vulnerable individuals? Medical staff, care home staff and teachers should all be receiving vaccines. We must win this war. We cannot keep halting cancer treatments and other urgent treatments and throwing money at people and businesses that are paralysed by this virus. We have a vaccine, and nothing is more important than doing everything possible to deliver it.

Health Protection (Coronavirus, Restrictions) (All Tiers) (England) (Amendment) (No. 2) Regulations 2020

Baroness Altmann Excerpts
Wednesday 30th December 2020

(3 years, 11 months ago)

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Baroness Altmann Portrait Baroness Altmann (Con) [V]
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My Lords, I too welcome the approval of the Oxford AstraZeneca vaccine, and commend the work of scientists and those on the social care and NHS front lines.

I ask my noble friend the Minister—whose dedication and courtesy I always appreciate—whether he can confirm, as was suggested by my noble friend Lady McIntosh of Pickering, the stories of medical and nursing staff who have volunteered to return from retirement but who are unable to get to work due to various bureaucratic delays. Without extra staff, clearly the automatic response of calling for ever-tighter restrictions will not cease. We have Nightingale hospitals that cannot be used and we need vaccines to be administered.

Yet again, we are debating retrospective legislation which has imposed further draconian restrictions on people’s lives without trusting them to be responsible. Yes, some are being irresponsible, but that is a small minority. Yet against the backdrop of Covid cases rising and winter pressures on the NHS, plus our ageing population, clearly there are reasons for concern. But as many noble Lords have stressed, recent history and examples from around the western world suggest that lockdowns and tiered restrictions have not defeated this virus. In Wales, the two-week circuit breaker has not defeated the virus, as my noble friend Lord Robathan said.

I echo the calls of my noble friend Lord Shinkwin for the Government to ensure more engagement with Parliament, and those of my noble friend Lord Balfe for better data, and context for that data, to allow relevant comparisons, and for a proper cost-benefit analysis, including impacts on other forecast deaths resulting directly from the tier restrictions, such as from cancers left undetected or inadequately treated, strokes, heart problems or suicide.

I am delighted that places of worship have remained open, and I have tremendous fears about the impact of school closures on younger people if that is decided again.

Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020

Baroness Altmann Excerpts
Thursday 10th December 2020

(3 years, 11 months ago)

Grand Committee
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Baroness Altmann Portrait Baroness Altmann (Con)
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My Lords, I thank my noble friend for his clear explanation of the two SIs. Like the noble Lord, Lord Hunt, I completely understand that there is urgency in trying to ensure that we have adequate but safe testing capacity. I want to ask my noble friend a few questions in the time available.

First, I note that the instrument applies only to England. What is the position on testing in Scotland, Wales and Northern Ireland? Secondly, the Explanatory Memorandum says that it could take up to 10 weeks to register with the CQC if large numbers try to register at the same time. What timeframe does it take at the moment? Might the new system speed things up, and by how much?

The United Kingdom Accreditation Service end-to-end testing regime for Covid-19 will require extra resourcing, staffing and capacity, I assume. I wonder what budget has been set aside for that. We are told that the cost will be lower for the UKAS. Do we have an idea of how much might be saved by this alternative system? I believe that guidance will be issued for prospective providers. Could my noble friend give us an idea of when that guidance might come through?

I confess that I have some concerns about the potential quality control in the new system. Coming from the pensions world and having seen so many scams, I fear that we may be opening ourselves up for an opportunity for fraudsters to make a lot of money on these testing regimes. I note that much of the system is self-assessed, which does not fill me with enormous confidence that there will be the necessary medical director, clinical scientist or systems. How will it be monitored and enforced?

The 2014 regulations have a statutory review clause, but today’s regulations do not. Why is that? Might it be wise for them to do so, given that this is potentially such a large issue?

Health Protection (Coronavirus, Restrictions) (All Tiers) (England) Regulations 2020

Baroness Altmann Excerpts
Tuesday 1st December 2020

(3 years, 11 months ago)

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Baroness Altmann Portrait Baroness Altmann (Con) [V]
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My Lords, I thank my noble friend for his opening remarks, and for his passion for and dedication to his role. I understand that none of these decisions is easy and that nobody would have wished us to be in the position in which we currently find ourselves. Of course the Government must protect their citizens as best they can. They must make tough choices on behalf of the wider public and lead the country responsibly.

However, to make those choices it is vital to have the best information from a wide range of sources, not just one perspective. We all want to see success in our stewardship of the health, well-being, prosperity and security of our citizens. I want to see the Government make the right choices. However, while I have listened to the reasons given for the detailed measures we are debating, and the dramatic intrusions into people’s most personal lives contained in this 75-page document, we have still not been provided with any proper analysis to justify them.

My problem revolves around the lack of clear evidence for such confusing, seemingly illogical and draconian measures. I hope the Government can be persuaded to do better to ensure that measures are based on solid evidence, rather than apparently continuously erring on the side of caution with respect to one illness and its possible impact on the NHS, while risking many more lives that have already been and will continue to be lost from other illnesses, whether strokes, heart problems, suicide or cancer. We simply do not have the numbers to show how many people are forecast to die of, for example, undetected or untreated cancers that have already occurred since March 2020, as well as those yet to occur, but which are directly or indirectly attributable to the ongoing interruption of normal NHS services. I deeply regret the position we are in, but we need to be satisfied that the costs of these measures do not outweigh any benefits we are likely to see. Thus far, we simply have not been provided with such evidence.

I would understand that these measures could potentially be justified if we were dealing with a disease that killed 50% or 80% of those infected, but this unprecedented deprivation of liberty and intrusion into people’s everyday lives and family relationships, as well as the destruction of good people’s livelihoods, which will leave permanent scarring on our future growth, seems to be based on conjecture and warnings about future scenarios from people whose previous forecasts have been shown to be inaccurate. The quantitative modelling and analysis is simply nowhere to be found. How can we properly assess these measures without such evidence? Cost-benefit analysis is normally essential, yet the so-called Analysis of the Health, Economic and Social Effects of COVID-19 and the Approach to Tiering, published last night, contains no rigorous cost-benefit analysis in any formal, recognisable sense. My noble friend Lady Neville-Rolfe is absolutely right. Yet this omission seems to be excused by the statement that,

“it is not possible to forecast the precise economic impact of a specific change to a specific restriction with confidence”.

So, none is provided.

Figure 2 of last night’s document shows that, thankfully, the numbers of weekly deaths, each one of which is a tragedy, are way below the numbers in April this year. Yes, the numbers of deaths are rising but, as we go into winter, that is not surprising. Where is the context? What is the normal number of deaths from all causes at this time of year?

The document states that,

“the alternative of allowing COVID-19 to grow exponentially is much worse for public health.”

However, as other noble Lords have said, no one is suggesting that this is the only alternative. We have treatments for this illness. We also have a population that could decide for itself what is needed to be able to live with this illness. Most of the population is trying hard to be cautious and is keeping social distancing, and I believe we should trust them. There is significant behavioural evidence that compulsion and draconian restrictions are not the best way to control people’s behaviour. I also understand the sentiments of my noble friend Lady Noakes about the inconsistency of areas such as Kent, with its different tier restrictions that seem to bear no relation to the underlying data.

My feelings are of regret rather than of anger. I agree with the amendments in the names of my noble friends Lord Cormack and Lady Neville-Rolfe. Indeed, I have some sympathy with my noble friend Lord Robathan’s amendment. Without an analysis that quantifies the costs and impacts of the measures we are debating tonight rather than just bold statements that they will save lives and stop the NHS being overwhelmed, I do not believe we are in any position to judge these serious measures.

Covid-19: Dental Services

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Tuesday 10th November 2020

(4 years ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the noble Baroness refers to the prioritisation of patients in the constrained appointment flow of dentists. She is entirely right that those who have vulnerabilities, disabilities or other disadvantages should be prioritised: that is the objective of the prioritisation process. She makes the point extremely well and I am happy to take on board any points on where she thinks the system is not working as well as it might do.

Baroness Altmann Portrait Baroness Altmann (Con) [V]
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My Lords, will my noble friend the Minister tell us what lessons have been learned from the initial response to the Covid pandemic and the blanket closure of dental practices? Does he have any estimates of the number of cancers of the head and neck that might not have been detected because people have not had regular dental check-ups?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, my noble friend is right to allude to the confusion around the closure of dental practices. We have made it crystal clear that in the second lockdown all dental practices—both NHS and private—should remain open; that is part of our commitment to try to clear the backlog. I also acknowledge her concerns about the diagnosis of cancers. I do not have the figures for which she asked, but we certainly appreciate the role that the dental sector plays in detecting many cancers, including oral cancers. Dental services are open to those seeking urgent care and we hope that those urgent care clinics to which I referred earlier can provide some diagnostic analysis in urgent cases.

Health Protection (Coronavirus) (Restrictions) (England) (No. 4) Regulations 2020

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Wednesday 4th November 2020

(4 years ago)

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Baroness Altmann Portrait Baroness Altmann (Con)
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My Lords, it is a pleasure to follow the noble Baroness, Lady Smith of Newnham, with whom I normally agree; I do on this occasion, in many ways. I do not underestimate the challenges faced by the Government and have enormous sympathy for my noble friend the Minister, but I believe that the measures in these regulations, which we are being asked to approve as a whole—with the dramatic consequences they will have on millions of people’s lives, physical and mental health, personal safety and livelihoods—are flawed. We still have not been presented with an impact assessment, a cost-benefit analysis or alternative scientific views—of which there are many suggesting that these measures are based on questionable data and invalid assumptions.

I find myself agreeing wholeheartedly—unfamiliarly, perhaps—with my noble friends Lord Robathan, Lord Forsyth, Lord Lilley and Lady Noakes. We need to prepare proper analysis and present it to Parliament, with full transparency on all the assumptions, and have an opportunity to amend these measures in the light of evidence.

I do not believe that these regulations had been sufficiently broadly considered. They are not based on rigorous analysis. For example, there is no evidence to suggest that banning communal worship will impact the spread of the virus, especially after churches, synagogues and other religious venues have spent so much to ensure that they are Covid safe, as the right reverend Prelate the Bishop of Winchester rightly said. Where is the evidence that outdoor sports such as golf and tennis, or swimming in a chlorinated pool, are dangerous?

These measures need to be amended, but we are not able to do that. Yet surely we have a duty to satisfy ourselves that they are based on robust data. As an economist, I have plenty of experience of flawed models that assume away the real world or depend on incorrect assumptions. Selected statistics, presentation out of context and failing to consider issues broadly are classic errors. I feel that we are in danger of being misled. Of course I am concerned about the economic impacts of the measures we are being asked to approve, but I am even more concerned about the effect on broader national health, particularly mental health, to which my noble friend Lady Meyer refers in her amendment to the Motion, and the impacts on family life, people in care homes and people missing cancer, heart, stroke or other diagnoses and treatments.

These measures have been hastily put together and I believe they are dangerous. Policy devised in panic is not good policy. Can we not take some extra time—even just a few days—to consider them more carefully, gather more evidence, and produce a proper cost-benefit analysis and impact assessments to allow a more cogent set of measures to be laid before us?

Health Protection (Coronavirus, Restrictions) (Self-Isolation) (England) Regulations 2020

Baroness Altmann Excerpts
Thursday 22nd October 2020

(4 years, 1 month ago)

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Baroness Altmann Portrait Baroness Altmann (Con)
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I thank my noble friend, for whose stamina, good humour and diligence I have enormous respect, for introducing these regulations. He certainly received the hospital pass. He says that the aim of this SI is to make it crystal clear to the public that people should stay at home and self-isolate but, as the noble Lords, Lord Rooker and Lord Hunt, and the noble Baroness, Lady Meacher, and others have said, for how long? Should it be for 14 days or 10 days, and from when—five days before what? It is convoluted. This SI is part of a broad effort to simplify and clarify the rules, but they have ended up being highly confusing, with huge fines.

With such penalties, it is particularly regrettable that there has been no proper parliamentary scrutiny of these measures. They were not debated in the Commons, even though they were announced about a week before they came into force, and we are now debating them well after commencement. The SI states, for example, that parents are responsible for ensuring that children under 18 self-isolate. Can my noble friend confirm that a parent could be fined thousands of pounds if their rebellious 16 year-old persistently sneaks out of the house to go to the gym? What advice does the Government have for effective restraints or solitary confinement methods for individual homes?

I recognise that my noble friend believes that these measures are designed to protect individuals and their loved ones, but isolation itself costs lives. Psychological damage, collapsing cancer tests and other treatments, and the lack of exercise, as my noble friend Lord Moynihan, has said, have already caused thousands of deaths as a direct or indirect result of lockdown. The poorest groups are the hardest hit, as the Secondary Legislation Scrutiny Committee warns, including so many of the young.

Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 5) Regulations 2020

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Tuesday 20th October 2020

(4 years, 1 month ago)

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Baroness Altmann Portrait Baroness Altmann (Con)
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My Lords, I have sympathy with my noble friend on the Front Bench and I have great admiration for the work that he is doing in this area. But I also have sympathy with the statements which have already been made by other noble Lords. I have continually asked for a broad impact assessment of the damage being caused by these measures. How does the 10 pm curfew work? Why can cinemas stay open after 10 pm but not other hospitality venues?

We seem to have a hokey-cokey policy here. One minute, Durham is in while Gateshead is out, and Newcastle is in and Northumberland is out. On 22 September, Merseyside and the majority of Lancashire were in, and then on 26 September Blackpool went in as well. How are ordinary people who are living in these areas meant to keep up with all of this?

The ONS estimates that 85,400 people have died at home in England and Wales this year, some 25,000 more than the five-year average. That represents around 500 people a day. We seem to be trading off cancer deaths against Covid deaths, with bowel cancer endoscopies running at only 12% of their usual levels. Other checks, such as people not seeing their dentist, mean that head and neck cancers, breast and oesophageal cancers are not being spotted. This will lead to thousands of deaths.

I understand that the Government are facing difficulties in the current situation and that the desire to lock down is great, but just hiding people away is not necessarily the answer to solving the problems we are facing as a country not just from one illness but from all the other dangers that are around us.