Medicines and Medical Devices Bill

Baroness Bennett of Manor Castle Excerpts

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

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, many noble Lords, including the noble Baronesses, Lady Andrews and Lady Walmsley, have made reference to the extremely strong—you might almost say scathing—report of the Delegated Powers and Regulatory Reform Committee. It is worth going back to its conclusions, in which it states that Ministers are

“given very wide powers to almost completely rewrite the existing regulatory regimes for human and veterinary medicines and medical devices”.

This Bill sees the Government seize control, rejecting the oversight and scrutiny of the elected Members in the other place and the technical experts here. In the best Trumpian style, it declares that the rules will be whatever they want them to be. Forget checks and balances, forget consultation and careful consideration; let Ministers rip. Indeed, that is what the Minister suggested he wanted in his opening remarks, focusing on speed of action, which would happen with scant parliamentary scrutiny. What he is suggesting is something new and radical.

Yet, as the Delegated Powers and Regulatory Reform Committee points out, the Government claim elsewhere that this is like-for-like replacement of existing powers. The Government cannot have this both ways: it is either new and radical or just more of the same. However, the Minister is clearly right: this is new and radical, because what exists now is

“a mechanism for transposing into UK law EU rules on medicines and medical devices ... The new powers are subject to no such constraint”.

The answer here is not to concentrate power in the hands of the Government. The current system is clearly not good enough, but the answer is not to take away controls and oversight but rather to strengthen them through democracy, openness, a focus on the patient experience and independent expertise. As the Cumberlege report suggests, a commissioner for patient safety is crucial, and I am pleased to offer the Green group’s support for the noble Baroness’s proposed amendment, which she just outlined. We need a more democratic, listening approach, as the noble Baroness, Lady Cumberlege, demonstrated so effectively, not a centralised, unchecked one, in which few have input.

Let us consider what the UK regulation might look like if the Bill goes through. We will have a Minister who will be bombarded by well-funded industry lobbyists on what the new rules should look like. A pharmaceutical company or a device manufacturer has not taken the Hippocratic oath. Their job—their legal obligation, in fact—is to maximise profits, and their profits are very large. As the former editor of the New England Journal of Medicine suggested, an appropriate metaphor for the pharmaceutical industry is an 800-pound gorilla. “What does that do?” he asked rhetorically. Whatever it likes. Your Lordships’ House might like to contemplate the image of Matt Hancock up against that gorilla.

We have already seen drug companies flexing their muscle in the notable case of Selexipag—also known as Uptravi—using a patient representative group as cover for a massive lobbying effort. We know that pharmaceutical companies are lining up for a post-Brexit bonanza, increasing the price that the NHS pays for drugs. As the noble Lord, Lord Alton of Liverpool, made clear in his excellent speech, there is a huge problem in our system with conflict of interest, which is only likely to grow.

I am most often talking about the disastrous model of US healthcare in the context of the rush to privatise our NHS, but a significant contributor to its disastrous and highly expensive outcomes is the political power of the pharmaceutical companies. This Bill is not “take back control”. This is “abandon control” and, when you are talking about medicines and medical devices from the industry that gave us thalidomide, the US opioid epidemic, Primodos and pelvic mesh, that is a frightening development.

Smoking

Baroness Bennett of Manor Castle Excerpts

Monday 20th July 2020 Lords Chamber

[Lord Bethell [V]]

I take a different view from the noble Baroness on the success of pubs’ efforts to introduce social distancing. I spent the weekend in a number of pubs and I was extremely impressed by the measures that publicans have put in place. That is why we support the role of local authorities in judging the right measures for the right pubs and why we will support the government amendment.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I am sure that the Minister is aware that the rate of smoking among adults in Blackpool is almost double that of Westminster. Given the Government’s levelling-up agenda, plus the fact that we know that smoking is related to illnesses that amplify the impact of Covid-19, and indeed threaten greater rates of death, why have we not seen emergency legislation to bring in a smoke-free 2030 fund, which has already been well explored and set out?

[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.

Independent Medicines and Medical Devices Safety Review

Baroness Bennett of Manor Castle Excerpts

Wednesday 15th July 2020 Lords Chamber

[Lord Bethell]

The noble Baroness is entirely right. The report must not be left on the shelf. We have already done much, and in the Medicines and Medical Devices Bill we will do more. The other recommendations will be taken extremely seriously.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, this wonderful but deeply disturbing report has so many points to make, but one point that has not been brought out in coverage as much as it might have been is the noble Baroness’s recommendation that the responsibility for ensuring transparency of interests should fall not only on the medical profession but also on manufacturers, who must take responsibility for ensuring that, where they are creating potential conflicts of interests with medical professionals and researchers, they show that. Can the Minister tell me what plans the Government have to make sure that manufacturers are being open, honest and transparent in all their dealings and that, should they not act in that matter, action is taken?

[Lord Bethell]

The noble Baroness is entirely right that transparency is essential in order to have a fair and equitable healthcare system. The GMC has already considered these areas and has moved a long way. The world has changed considerably since many of these horrific events took place, but I am sure there is more to be done and this recommendation, like others, will be considered seriously by the Government.

Food: Fruit and Vegetables

Baroness Bennett of Manor Castle Excerpts

Monday 6th July 2020 Lords Chamber

[Lord Bethell]

The noble Baroness is right about the effects of diabetes, and the impact of Covid on those with diabetes has been profound. It is described well in the PHE report and is a source of enormous sadness. The Government are looking at ways to react to the Covid pandemic, but my instincts are to regard it as an inflection point for the nation’s health. The Government will look at ways to mark this moment with a suitable campaign to encourage healthy eating.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, the Minister may be aware of the pioneering work of the American nutritionist Clara M Davis, in the 1920s, who found that just-weaned infants, allowed to choose their own food from a range of healthy natural options, chose a balanced highly nutritious diet and enjoyed it. But our children see a continual parade on their screens and in the shops of highly processed food of low nutritional quality. Does the Minister not think that we need to create space, in their stomachs and minds, to allow the healthy fruit and vegetables in?

[Lord Bethell]

The noble Baroness does me a great service to point out the good work of Clara M Davis, who I was not aware of previously. She makes a very good point: the effect of advertising on children in school is profound—and not just on children but on adults, as well. The danger of ring-fencing children is that they do not learn how to make proper choices in the long term. That is why the emphasis of our work is on ensuring that children learn the difference between good and bad food, learn how to make the right decisions and learn the habits that can set them up for a lifetime.

Ultra-processed Foods

Baroness Bennett of Manor Castle Excerpts

Thursday 2nd July 2020 Lords Chamber

Asked by

[Baroness Bennett of Manor Castle]

To ask Her Majesty’s Government what plans they have to reduce the amount of ultra-processed foods available for purchase in the United Kingdom.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con) [V]]

My Lords, to address the consumption of food and drinks high in fat, sugar and salt, Public Health England oversees the sugar reduction and wider reformulation programme on behalf of the Government, as set out in the three chapters of the child obesity plan and the 2019 prevention Green Paper Advancing our Health: Prevention in the 2020s. In addition, the Government provide healthy eating advice through the Eatwell Guide, social marketing campaigns and food procurement and catering guidance.

[Baroness Bennett of Manor Castle (GP) [V]]

I thank the Minister for his Answer, but I am disappointed that he did not use the term “ultra-processed foods” in it, which represent 57% of the calories in the British diet. In the past couple of years, we have seen three studies which I shall quote from briefly. The first is from the US, which said that

“Ultra-processed foods cause excess calorie intake and weight gain.”


A French study states

“a 10% increase in intake results in a 14% increase in death,”

and a UK study says that

“a 10% increase in intake results in an 18% risk of increase in obesity in men.”

This is a relatively new area of science, but do the Government not understand that we have to acknowledge that these ultra-palatable foods that are designed not to satisfy have to be part of what the Prime Minister has said is going to be a new focus on tackling obesity?

[Lord Bethell [V]]

My Lords, the noble Baroness has made her point well. When the pandemic began, the national food strategy team were investigating the health risks associated with a diet heavy in ultra-processed foods. The team is in the process of restarting its work and will return to the question of ultra-processed foods in its final report, which it currently plans to publish over the winter.

Exercise Cygnus

Baroness Bennett of Manor Castle Excerpts

Tuesday 9th June 2020 Lords Chamber

[Lord Bethell [V]]

The noble Baroness is in danger of misrepresenting the situation. The whole point of running a trial such as operation Cygnus is to probe the system and to find weaknesses. That it identified areas for improvement is entirely appropriate and is exactly why we run such projects. As I have explained, the exercise identified key areas where developments were made, and those developments helped us in our preparations for Covid.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, does the Minister agree that Exercise Cygnus warned, and Covid-19 has demonstrated, that we were profoundly unprepared for the pandemic shock that we knew was coming? Does he agree that it demonstrates that a focus on so-called efficiency—that is, profit maximisation for contractors and cost minimisation for Governments under austerity—is incompatible with resilience? The whole model of outsourcing and privatisation is not fit for the 21st-century age of shocks.

[Lord Bethell [V]]

The noble Baroness will not be at all surprised to learn that I do not agree with her analysis in any way. Operation Cygnus demonstrates that we did have robust systems in a great many areas and I am grateful to it for identifying some areas that we went on to improve. As for working with the private sector, I bear testimony to its enormous contribution to our Covid response. I do not agree with her characterisation of the profit motive.

National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) Regulations 2020

Baroness Bennett of Manor Castle Excerpts

Monday 8th June 2020 Lords Chamber

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I thank the noble Lord, Lord Hunt of Kings Heath, for his Motion and express the Green group’s strong support for it. “Regret” is the right word to use when we are talking about policy around care homes and funding. Indeed, it is rather like the rotten onion that you find neglected at the bottom of the sack. When you peel it, the centre is rotten and the tears are flowing. This is a great gaping hole of unmet needs and human suffering.

I am picking up on points made earlier by the noble Baroness, Lady Tyler of Enfield, and the noble Lord, Lord Sheikh, about the 84% of care homes which are privately owned and what you find when you peel back the layers of that. I first got interested in these issues in 2016 when I read a brilliant report by the Centre for Research on Socio-Cultural Change called Where Does the Money Go? Financialised Chains and the Crisis in Residential Care. It exposed for the first time to full public view the way in which large numbers of care homes are owned by offshore-based companies with complex financial structures which extract 12% or even more annually in effective profit, however it is structured, while ensuring that little or no tax is paid and loading companies up with debt. All that provides care of a sort for our most vulnerable and often frail citizens while the work is done by lowly paid and often insecurely employed staff, treated with scant respect.

It is worth peeling into the onion and looking back to where this started in the 1980s. Until then, the UK had been a world leader in the provision of care, particularly for older people, but the NHS started to withdraw from that, leaving it to charitable and then for-profit providers. Some of the move had good intentions to allow people to live in the community, but the effect was a massive privatisation. The number of private residential homes rose from 44,000 in 1982 to 164,000 in 1994, almost quadrupling in little more than a decade. This shifted the costs of ill health and frailty on to individuals.

Now we have coronavirus, and again we have care home owners saying that they cannot afford to pay the costs. Is the Minister looking into what is happening and where the money is going now? Is 12% still being taken out? Are the Government looking for an entirely new, different, non-privatised, non-financialised structure?

David Lloyd George said:

“How we treat our old people is a crucial test of our national quality.”


We are failing the Lloyd George test for our elders and many other vulnerable citizens very badly.

Covid-19: Response

Baroness Bennett of Manor Castle Excerpts

Wednesday 3rd June 2020 Lords Chamber

[Lord Bethell]

The arrangements for local lockdowns are not fully in place. In fact, the policy around them is in development and a full decision has not been made on what arrangements we will make for lockdowns. The joint biosecurity centre will be absolutely central to those arrangements. It is the hub into which the intelligence on prevalence and infectiousness comes and which pushes that information out into the local area to help advise directors of public health, local authorities and other local services on local arrangements. I believe that it will develop the expertise and the co-ordination role which the noble Lord asks about.

[Baroness Bennett of Manor Castle (GP)]

My Lords, in answering the question of the noble Lord, Lord Turnberg, the Minister said that a test is available to anyone who wants one, and that this is being advertised on the M4. I am looking right now at the nhs.uk website page headed “Ask for a test to check if you have coronavirus”. Highlighted on that page, it says:

“Please help the NHS by only asking for tests for people who have coronavirus symptoms now.”


Can the Minister explain that? Also on that page, it lists the three symptoms for which it suggests we should have a test. Yet when I go to the Centers for Disease Control and Prevention website—the US body—it lists 11 lots of symptoms, including: fatigue; muscle ache; headache; sore throat; congestion; nausea or vomiting; and diarrhoea. Have the Government considered expanding the list of symptoms, and if they have not, why not?

[Lord Bethell]

If I was not clear, I hope the noble Baroness will forgive me. The test is open to anyone in the population. It is not restricted to key workers or those who are over five, as it once was. However, the clinical advice is that you should seek a test only if you show symptoms, partly because the test will not necessarily work if you do not have symptoms. That remains the case.

With regard to expanding the list of symptoms, we changed the symptoms about two weeks ago. We have done a huge amount of work to understand the best way of recommending symptoms. This is an amazingly complicated area. A lay person like me would think it was not too difficult to define symptoms for an important disease, but actually it is an extremely contested area. We have broadened it, we keep it under review, and if what we have done is not working well enough, we will update it again.

Covid-19: Response

Baroness Bennett of Manor Castle Excerpts

Tuesday 19th May 2020 Lords Chamber

[Lord Bethell]

The noble Baroness raised the data protection impact statement, which I have read. I did not find it confusing; I thought it was extremely straightforward and it has been welcomed by a large number of the privacy groups I have spoken to.

[Baroness Bennett of Manor Castle (GP)]

A few minutes ago, responding to the Front-Bench questions the Minister said that the heart of the Government’s message was that

“people who have symptoms must isolate themselves”.

How does the Minister square this with what he said to me last Thursday? He said:

“No one working in the NHS should go to work if they feel ill or have a temperature”


but that this

“is not necessarily true for people who work in normal workplaces.”—[Official Report, 14/5/20; col. 806.]

We were of course at that point talking about care homes. If we look at the Government’s launch last Tuesday for the document Our Plan to Rebuild, this says:

“If a negative test is returned, then isolation is no longer required.”


If the Government’s position has changed, should this not be made clear to the public?

[Lord Bethell]

The noble Baroness undoubtedly knows that anyone who is ill with anything whatever should not go to a hospital. Being ill is not the same as having the symptoms of Covid-19. Anyone who has the symptoms of Covid-19 should isolate immediately.

Care Homes: Covid-19 Testing

Baroness Bennett of Manor Castle Excerpts

Thursday 14th May 2020 Lords Chamber

[Lord Bethell]

I completely acknowledge that one of the most horrible aspects of this disease is that it targets those who are most vulnerable and live closely to each other. Care homes are therefore a priority. I also acknowledge that we started with a very low base of diagnostic testing and have had to work extremely hard to build that up. But now that that capacity is there, we are focusing it on care homes and using innovative methods to get those tests directly to people. We could not be working harder to get the right people tested in the care home sector.

[Baroness Bennett of Manor Castle (GP)]

NHS England recommends to staff that if they have symptoms after a negative coronavirus swab test they do not return to work, given the estimates of false negatives of up to 30%. But the Government’s official advice to someone with a negative test, in Our Plan to Rebuild, says:

“If a negative test is returned, then isolation is no longer required.”


What is the Minister’s advice to care home workers after a negative coronavirus swab test?

[Lord Bethell]

No one working in the NHS should go to work if they feel ill or have a temperature. That is true for anyone working on the front line, but it is not necessarily true for people who work in normal workplaces.