Covid-19: Transparency and Accuracy of Statistics

Baroness Hollins Excerpts

Monday 9th November 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, my noble friend is entirely right: statistics are critical and very important to public trust. No one takes them more seriously than this Government. However, I remind him that it was not the statistics that the Office for Statistics Regulation expressed concern about; it was about material being used in press conferences that has not been published at the press conferences as they happened. That was a function of the speed at which that press conference was turned around, but he is entirely right that that chart had a presentational error in it, which was corrected. It was published as a result of the publication of the data behind it. I reassure him that the data upon which decisions were made and the data that went into the central case of that chart was correct, and the fact that we have changed it demonstrates that we are committed to transparency in all these matters.

[Baroness Hollins (CB) [V]]

My Lords, my question is about when Her Majesty’s Government will make accessible communication a priority. The Prime Minister’s press conference was like a scientific symposium, except that the slides were presented too quickly, with too much information. It felt as if we were being blinded by science. Does the Minister agree that providing information that is accessible to all viewers would be a more effective public education strategy, and that that means using everyday language?

[Lord Bethell (Con)]

On the manner in which the information was delivered, I take the noble Baroness’s comments completely on board. While it is not my role to be in charge of the presentation of No. 10 presentations, I think a lot of people would agree with her that there were a lot of slides, which were very detailed and not all formatted for the TV screen. However, we are trying our hardest to share with the public as much of the insight and science as we possibly can, and we are trying to hit that balance between too little and too much information. We are trying to publish data as soon as it can be reasonably verified. There will be some scratchiness around the edges on that, and I take the noble Baroness’s points about last Saturday completely on board. However, the commitment to transparency and open debate on these issues is sincere.

Medicines and Medical Devices Bill

Baroness Hollins Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Lord Patel (CB) [V]]

My Lords, as I was not able to get in following the comments made by the noble Earl, Lord Howe, I say that, as a Cross-Bencher, I was irritated that we were not involved in the communication, I am glad that the statement has been made and I concur with most of the comments of the noble Baroness, Lady Thornton. I hope that from now on the procedure will be better. I had threatened to negative the amendments, but I will not do so now.

I speak in strong support of Amendments 10, 12, 74 and 75 tabled by the noble Baroness, Lady Cumberlege, to which I have added my name. I concur with all that she and other speakers have said. So far as her findings were concerned, I will repeat what I said when we debated her report. The profession needs to hide its head in shame that such trauma was inflicted on women and that such harm to unborn children was caused by disregard for guidance. As an obstetrician, I have never used mesh; I am one of those old-fashioned surgeons who did not use any artificial devices, but then I was not regarded as an avant-garde or fancy surgeon in that respect. Her report is a salutary lesson about the importance of patient safety. I will confine my remarks to medicines and medical devices, and the importance of embedding patient safety.

The noble Baroness’s report is entitled First Do No Harm. I say with humility that the motto on my coat of arms is “Primum non nocere”. I am privileged that the shield that bears it will hang for ever in the chapel of St Giles’ Cathedral in Edinburgh. I took that motto not because of the medical oath, which of course is correct, but because I was at the time chairman of the National Patient Safety Agency of England, an organisation that the noble Lord, Lord Hunt of Kings Heath, had chaired before me. It no longer exists, but its aim was to establish the whole concept and methodology of patient safety in the NHS in England. The NPSA, as it was then known, had developed a confidential reporting system for incidents relating to patient safety for healthcare staff and patients. Nearly 40% of the large number of reports—we used to get as many as 200 confidential reports a day—were related to medicines, medicines delivery and devices.

The concept of the safety of medicines is not new, and the experience of over a century has framed laws, regulations and amendments to make medicines safe and effective. In 1937, more than 100 deaths were reported in relation to sulfanilamide. They were due not to the medicine itself but to the solvent, diethylene glycol, which was added to the active ingredient. This led to regulations requiring testing of medicines in non-clinical and clinical settings prior to their being licensed for therapeutic purposes. Is it not ironic, especially in the context of the report of the noble Baroness, Lady Cumberlege, on Primodos, that the drug thalidomide, used as an antiemetic in early pregnancy, was not licensed in the USA due to animal studies that had shown some deformities in animal embryos? The USA therefore avoided the harm that the medicine caused to unborn children and a condition called phocomelia. It was accepted in a large part of the world, including the United Kingdom, and resulted in tens of thousands of children being born with such deformity.

There are patient groups to whom regulators need to pay special attention when approving medications, such as pregnant women, children and older people. We will come to amendments later on alluding to this. There are many examples of medications that are withdrawn from the market because of patient harm, emphasising the importance of a secure system of post-licensing surveillance. Some 1.1 billion prescriptions are supplied every year in primary care. Furthermore, a mid-sized hospital supplies about 50,000 doses a day. A study in 2018 showed that 237 million medication errors occurred every year in England, of which 68 million caused some degree of harm. While the harm may appear in one part of the system, the solution often lies across it. Much can be learned from a well-run and monitored national reporting and learning system, particularly as to which medicines are commonly involved in errors and hence patient harm. A single change that would make a big difference is a system that recognises and establishes the greater involvement of patients in their own care.

A healthcare system that wants to achieve a significant reduction in patient harm from medications will need a national programme in which different parts of the system work together. The amendment in the name of the noble Baroness, Lady Cumberlege, may be a start to that, and I commend her for it.

Unlike with medicines and the EMA, even at EU level, there is no agency for the safety of medical devices. Regulation relating to medical devices or standards is often a voluntary process and is not governed by national or international standards unless recognised by a regulator as mandatory. The list of what constitutes a medical device is long and ranges from machines and in vitro reagents to software. As the UK leaves the EU, it has an opportunity to devise a system of regulation focused on safety. In 2017, there were more than 16,000 device-related reports of harm. Following the publication by investigative journalists of a series of reports on medical devices known as “The Implant Files”, there has been a demand from doctors and others for greater transparency from manufacturers of devices, particularly regarding safety. The same stringent regulatory process, including disclosure of data related to adverse events, should be part of a market approval process.

I know that several amendments coming up are related to safety and licensing, which currently does not exist in the UK for medical devices. The amendment in the name of the noble Baroness, Lady Cumberlege, in relation to patient safety, including medical devices, will go further than current requirements for market approval. Information and data related to safety, both short-term and long-term, may well be a requirement for market approval. Why is it necessary to have full safety data to license a cardiac drug but not for an implanted pacemaker? As an example, a device called Nanostim was withdrawn from the market three years after safety approval due to the alarming number of patients to whom it was causing harm, by which time 1,400 patients had had it implanted. The noble Baroness is right to highlight the need for more effective regulation for safety of medical devices and medication overall. I am pleased to support her amendment.

[Baroness Hollins (CB) [V]]

My Lords, it is a pleasure to follow my noble friend Lord Patel. I commend his work on patient safety over many years. I strongly support the amendments in this group, which are intended to improve patient safety—in particular, Amendments 10 and 12 tabled by the noble Baroness, Lady Cumberlege. I withdrew my own, very similar amendment and added my name to that of the noble Baroness.

In the present drafting, as the noble Baroness has explained, there is no explicit hierarchy of the three stated principles: safety, availability and attractiveness of parts of the UK as a place to conduct clinical trials or supply medicines, yet this Bill could be so much more effective if it was more explicitly about patient safety. These amendments put patient safety first, as so clearly called for in the noble Baroness’s shocking recent report First Do No Harm. I quote from that report’s foreword:

“The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns.”


I simply stress that safety must apply across all aspects of the development and provision of human medicines with respect to both mental and physical illness. Noble Lords may be unfamiliar with the national STOMP programme, launched in 2016—STOMP stands for stopping over-medication of people with a learning disability, autism or both. Public Health England says that, every day, between 30,000 and 35,000 adults with a learning disability take psychotropic medications when they do not have the health conditions the medicines are for—they are also prescribed to children and young people—yet such medicines may have serious side effects, including adverse effects on their mental and physical health.

I do not wish to speak at length about this or other aspects of these amendments other than to stress that patient safety must be the foremost consideration in this Bill.

Covid-19: People with Learning Difficulties and Autism

Baroness Hollins Excerpts

Monday 5th October 2020 Lords Chamber

[Lord Bethell (Con)]

My noble friend Lady Stroud speaks very movingly of the tough figures around the prevalence of disability among those in poverty. I completely take on board her recommendations about training in education. The Prime Minister spoke last week about the opportunity that Covid presents for a reboot around skills. That reboot will include provisions for those with learning difficulties and disabilities. I would be glad to inquire at the department exactly how developed those plans are and to update the noble Baroness with the information that I have back at the department.

[Baroness Hollins (CB) [V]]

My Lords, a ministerial response in the other place last week stated that only some supported living settings would be able to access asymptomatic testing. People with learning disabilities have had excess death rates higher than over-65 year-old care home residents, and many live in supported living settings. When do the Government intend to extend regular asymptomatic testing to all supported living settings, where the majority are still effectively shielding, and thus perhaps also enable day centres to open?

[Lord Bethell (Con)]

We are seeking to extend asymptomatic testing as widely as we possibly can and as soon as we possibly can. At the moment, our focus for testing is on residential social care, where we have committed to 100,000 tests a day. That is where the greatest threat comes from. But as the number and range of tests increase, we hope to be able to roll out asymptomatic testing to a much broader set of user cases, and the kind of care centres that she describes will surely be near the top of the list.

Coronavirus Act 2020: Temporary Provisions

Baroness Hollins Excerpts

Monday 28th September 2020 Lords Chamber

[Baroness Hollins (CB) [V]]

My Lords, a public health crisis needs a public health response, not a discourse about discipline and punishment or jokes about “not getting caught”. Public health includes public education to ensure that people understand why this virus is so dangerous and how each of us, of any age, can keep ourselves and our friends and family safe until there is an effective vaccine. There are of course other aspects to staying safe which do not mean staying at home, because domestic abuse and child maltreatment have been increasing. There is also concern about the lack of support provided to new mothers and babies during the pandemic. One survey found that only one in eight pandemic-era new mothers had seen a health visitor. There is concern about it being harder to uphold human rights during the pandemic.

We also know that mental health has deteriorated, and people with a learning disability have been disproportionately affected and impacted by Covid-19. The CQC reported a 134% increase in the number of death notifications in this group compared with the same period last year. The learning disabilities mortality review programme found that on average they were younger than other people dying in this period. Day centres have closed and most remain closed. Some have found virtual ways to support people, but people with a learning disability are less likely to own a smartphone or a tablet, or to have internet connectivity, than the general population, making maintaining contact so much more difficult.

Mencap surveyed over 1,000 family carers. As my noble friend Lady Campbell noted earlier, seven in 10 respondents said that their relative’s social care had been cut or reduced at this time, despite us being told that the easements had been little used. Eight in 10 family carers, often elderly and at risk themselves, had no choice but to provide the care themselves because of a shortage of care staff. Three-quarters of respondents said that they are scared of further cuts. Can the Minister assure this House that the Government are committed to reinstating the full powers and responsibilities of the Care Act as soon as possible? Rather than the spectre of six more months of easements, people requiring social care support deserve reassurance that their needs will be met.

Can I suggest that, instead of easements to the Care Act and the Mental Health Act, a stimulus package of support for the social care sector is needed? In its April Covid-19 action plan for adult social care, Her Majesty’s Government’s ambition was to attract 20,000 new people into social care jobs over the following three months. Can the Minister update the House today on the progress that has been made? A stimulus package could include recruiting and retraining staff made redundant from other sectors, such as the refreshment and retail industries. Staff are desperately needed in care and supporting health, to prevent isolation and loneliness, to reduce the digital gap, to reduce the disability employment gap, to avoid the mental health crises that can lead to people with a learning disability ending up in in-patient units, to support informal carers and so on. The voluntary sector has done so much during the pandemic within local communities, but it cannot replace the duties of the Care Act.

In conclusion, I return to my first request that, instead of more regulations, we should have a consistent and understandable health education message and that its effectiveness is checked. Do people understand this dangerous virus and how to keep each other safe? My informal inquiries suggest that they do not. Compliance depends more on understanding than on discipline.

Medicines and Medical Devices Bill

Baroness Hollins Excerpts

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

[Baroness Hollins (CB) [V]]

My Lords, I refer to my interests in the register and congratulate the noble Baroness, Lady Cumberlege, on her review, which, as we have heard, was asked to look at three interventions in particular detail: hormone pregnancy tests, the use of sodium valproate in pregnancy, and pelvic mesh implants. The connection between these was not lost on the review, which noted that each of them are

“taken or used by women and, in the cases of valproate and hormone pregnancy tests, usage is during pregnancy.”

The review found a litany of failures in the system to monitor harmful effects and heard about: patients not being provided enough information to make informed choices; a lack of awareness as to how to raise complaints; struggles to be heard; not being believed; dismissive attitudes by clinicians; and life-changing consequences due to the harms that ensued.

For women, there seemed to be a confounding factor, which the report described as

“the widespread and wholly unacceptable labelling of so many symptoms as ‘normal’ and attributable to ‘women’s problems’.”

In my field, we call this diagnostic overshadowing. The review described the stories of adversity and harm it heard as being “harrowing”. This is what happens when a group is not believed and when systematic prejudices diminishes a speaker’s credibility. This stark example of epistemic injustice should serve as a reminder to all of us of the harms of ignoring the voices of the disfranchised. Of course, there are many groups whose voices are not heard and have, for too long, proved to be too easy to ignore. These include, for example, the voices of some patients detained under mental health legislation.

As we have heard, the Bill we are debating today grants wide-ranging powers to the Government—and, indeed, the Minister—in relation to medicines and medical devices, with a large number of putative regulations subject only to the negative procedure. Will Her Majesty’s Government commit to using this timely opportunity to implement the recommendations of the noble Baroness, Lady Cumberlege, in the framework of the present Bill?

There were nine recommendations, which included appointing a “patient safety commissioner” and the formation of an independent “redress agency”. Another was, quite simply, for the Government to apologise to all the women who have suffered lasting harm. I hope the Minister will inform the House of Her Majesty’s Government’s specific intentions with respect to patient safety.

The report suggests that the MHRA’s yellow card safety-monitoring scheme is poorly sensitive to adverse treatment outcomes and that the MHRA needs “substantial revision”. Will the Government commit, in this Bill, to a far greater emphasis on post-market surveillance of medicines and medical devices? In Clause 1(2), the Bill places market considerations on an equal footing with patient safety and distributive justice—namely, the availability of human medicines.

While the economic implications of the pharmaceutical and medical devices market are, of course, important, there is no implicit or explicit hierarchy in the current drafting of the Bill that would enable defence of the appropriate authority’s decision-making being based primarily on safety, or safety and availability. Will Her Majesty’s Government amend the Bill to ensure that the hierarchy of these principles is recognised in statute? I am considering such an amendment myself.

The Bill gives the Government power to extend prescribing responsibilities to new professional groups where it is safe and appropriate to do so. Can Her Majesty’s Government comment as to which professional groups they propose to extend prescribing responsibilities to and, if they do not intend to do so at the present time, when they would consider addressing this issue? What safeguards would they consider to be necessary?

Independent Residential Care

Baroness Hollins Excerpts

Tuesday 7th July 2020 Lords Chamber

[Lord Bethell [V]]

My Lords, the money that my noble friend refers to is not currently ring-fenced. Local authorities have been written to, to explain that the money should be prioritised for Covid—but, at the request of the local authorities themselves, the money was not ring-fenced.

[Baroness Hollins (CB) [V]]

My Lords, the Vivaldi project found that, in care homes where staff received sick pay, there were lower levels of infection in residents. During the next pandemic, will our priority to be to save the NCS—the new national care service—as well as the NHS, or will we have an integrated NHCS national health and care service, or, what other urgent measures are Her Majesty’s Government considering to protect care?

[Lord Bethell [V]]

The noble Baroness puts her question extremely well, but I am afraid it is beyond my ability to predict as she asks exactly what the shape of the national care provisions will be. What I can say is that the role of agency staff was always, from the very earliest stage, one of the gravest concerns we had. The CMO flagged it very early, and we moved as quickly as we could to tackle the difficult issue of itinerant staff, and to put in place both the funding and the procedures to anticipate problems of infection around staff who move from one home to the next.

Covid-19 Update

Baroness Hollins Excerpts

Wednesday 1st July 2020 Lords Chamber

[Lord Bethell]

The noble Baroness asks a sensible question. It is, however, an unfortunate truth that, by the time someone tests positive, it is likely that they may have infected other members of their household. So, our current guidelines are that anyone who tests positive should isolate themselves with all other members of their household for 14 days, thereby containing the virus and breaking the chain of transmission.

[Baroness Hollins (CB) [V]]

My Lords, are services that care for people with learning disabilities—a group with an even higher death rate than the over-65s—being provided with home testing kits? I hear of services that are having difficulty getting access to them. Secondly, what proportion of people completing a home test fail to register their test online and therefore do not receive their test result?

[Lord Bethell]

My Lords, home testing by those with learning difficulties should be a straightforward matter. Anyone seeking a home testing kit can apply for one online; we have a large supply and there is no capacity issue. The registration of home testing kits is improving all the time; we are working through a checklist of things to get that rate higher. At-home testing is a hugely valuable resource for specifically the reason that the noble Baroness alluded to, and to get the geographical spread we need if we are to make testing available to everyone in the country.

Covid-19: Response

Baroness Hollins Excerpts

Wednesday 3rd June 2020 Lords Chamber

[Lord Bethell]

I deeply regret that my noble friend had to drive from Cambridge to Stansted. We are working hard to address that and are looking at alternatives. We have now put up more than 100 sites, and I hope very much indeed that there would now be a site nearer him. We have also pioneered at-home testing, which we believe will address his key point, and we are trialling walk-in centres for city centres such as Cambridge.

My noble friend’s last point is entirely right. You should have a test when you show symptoms, but defining the symptoms of any disease, and in particular this disease, is very difficult. We do miss some people who do not show any symptoms, and some people who think that they have the symptoms actually have the symptoms of something else. It is a real dilemma and part of the battle we face against Covid.

[Baroness Hollins (CB)]

My Lords, the Statement does not address yesterday’s report from the CQC showing more than double the expected number of deaths of people with learning disabilities during lockdown—something we were warned to expect by colleagues in Italy. Will the noble Lord explain what is being done to better protect everyone in this group, including those living in residential care, but also people made vulnerable because of visits by support staff, who often visit more than one person living in the community?

[Lord Bethell]

I thank the noble Baroness for her question, which I think I understood. If I understand correctly, she is asking about those who live in social care and residential care. I commend the work of Helen Whately, the Social Care Minister, who has been an amazing champion for social and residential care. She holds our feet to the flames daily to ensure that more work is being done. Testing is one area where we have made huge progress. The provision of PPE, raised by the noble Baroness, Lady Brinton, is another, despite everything noble Lords might have read. I pay tribute to my noble friend Lord Deighton, who has brought about a huge amount of manufacturing in the UK. There is, however, more that we can do and we are working as hard as we can.

Mental Health Services

Baroness Hollins Excerpts

Tuesday 19th May 2020 Lords Chamber

[Lord Bethell]

My Lords, I understand that it is a firm “yes”, but I will check that answer and revert to the noble Baroness if there is any different information.

[Baroness Hollins (CB)]

My Lords, yesterday the Guardian reported a study by Public Health England which showed that agency staff working between multiple care homes in London were unwittingly spreading Covid-19 during the surge of the pandemic. Given the evidence of the vulnerability of those receiving care, which includes working-age adults with mental health needs, is there really a commitment to parity of esteem between physical and mental healthcare? Why has the testing strategy not been amended properly to cover these groups?

[Lord Bethell]

The noble Baroness rightly points to one of the most difficult aspects of the Covid epidemic—the itinerant staff who pass from one vulnerable person to the next. We recognised this issue at the beginning and put money in to try to ameliorate it. When testing was expanded weeks ago to key workers, it was deliberately targeted at these staff and this continues to be prioritised.

Covid-19: Social Care Services

Baroness Hollins Excerpts

Thursday 23rd April 2020 Lords Chamber

[Baroness Hollins (CB)]

My Lords, the Covid-19 pandemic will be disproportionately felt by society’s most vulnerable people, including people living with learning disabilities. Care Act easements under the Coronavirus Act, which has been enacted by eight local authorities already, raise the bar for social care to the threshold of human rights violations. Despite government reassurances, people with learning disabilities are at real risk of seeing their care and support reduced or removed as the Care Act easements set a new high threshold for the provision of care.

For those with learning disabilities, Covid-19 has truly pulled the rug from beneath their feet. Visits are discouraged, employment and volunteering roles disrupted and day centres closed. These are not luxuries, they are essential components of keeping well in the community. For many of those with learning disabilities, this loss of routine, structure and meaningful human contact could be disastrous. For some, increased anxiety is leading to behavioural challenges that precipitate urgent hospital admissions under the Mental Health Act. Routine dental and other health appointments have stopped and people’s access to urgent treatment may even discriminate against them.

When the economy and people’s livelihoods were at risk, the Government announced unprecedented financial support. When more NHS capacity was needed, we built massive new hospitals across the country. But when vulnerable people saw their entire support network evaporate, the Government’s response was not to increase social care provision, but to watch it wither. I speak from personal experience and remind the House that I am a carer for my adult disabled son who is at home with me during lockdown. Three equally important areas—jobs, health, and supporting our most vulnerable people—have vastly different responses. This crisis adds urgent emphasis to the need for a properly funded national care service. I hope the Minister will say something positive about a future funding settlement. It is needed, and soon.

People with learning disabilities will need an increase in support to recover their confidence, meaningful occupation and friendships when lockdown ends. Can the Minister say what will be done to reverse the harm done by the loss of familiar support during this period, which for many will have been complicated further by other traumatic losses?

My noble friend Lady Masham spoke about the lack of recognition by the NHS of the respiratory risks faced by people with tetraplegia, like my youngest daughter. I share my noble friend’s and others’ concerns about difficulties recruiting to the care sector and our huge reliance on carers from eastern Europe, who are finding it more difficult to come here to work. I look forward to hearing the Minister’s response.