Independent Medicines and Medical Devices Safety Review

Baroness Thornton Excerpts

Wednesday 15th July 2020 Lords Chamber

[Baroness Thornton (Lab) [V]]

My Lords, I thank the Minister for the Statement. I start with the words of the chair of the review, our colleague, the noble Baroness, Lady Cumberlege, who said when she launched the report last week that she was shocked by the sheer scale and intensity of suffering. She said:

“I have conducted many reviews and inquiries over the years, but I have never encountered anything like this … Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself.”


I congratulate the noble Baroness on conducting an inquiry over the last two years that has been praised by everyone concerned, particularly the patient groups and those affected.

Some of us have been discussing the problems addressed in this report for many years. We have heard about the hormone pregnancy test Primodos, the anti-epileptic drug sodium valproate and, in recent years, use of vaginal mesh in surgery. It is important to pay tribute to the bravery and persistence of the patients and patient groups, but also to the parliamentarians whose work helped to persuade the Government to establish the inquiry two years ago. The All-Party Groups have been vital, as have Yasmin Qureshi MP, Norman Lamb MP, Owen Smith and Sharon Hodgson MP, to name but a few.

On the surface, the three medical issues are separate. What links the medicines and devices is that they were all taken or used by women—in two cases, by pregnant women. As my honourable friend Alex Norris MP said last week in the Commons,

“these cases reek of misogyny from top to bottom—and ageism and ableism as well.”—[Official Report, Commons, 9/7/20; cols. 1148-49.]

We also have to look at the reaction of the healthcare system, which, according to the report, failed to monitor the use of these medicines and medical devices, then failed to identify and acknowledge the things that had gone wrong, then failed to work to improve. The review sets out the missed opportunities when something could or should have been done to prevent harm. Instead, there was a culture of denial, disjointedness and defensiveness that failed to listen to patients’ concerns.

Our NHS failed to protect these women and their families. It is therefore right and welcome that the Minister’s first reaction has been immediately to offer an unqualified apology, which is the first of the nine recommendations in the report. The Secretary of State said that listening and humility are in order. That is right, but it now needs to be followed by action to make the process worth while and to address the suffering. I hope that in this discussion the Minister will be able to outline what the Government will do to implement the rest of this report and to what time- scale. The most sensible way forward is the ninth recommendation, which is to set up a task force to implement the other recommendations. Will this be done, and by when?

On recommendation 2, I can see that progress has already been made. But can the Minister explain what legislative underpinning would be needed for a patient safety commissioner? Some of us are very puzzled as to where the delightfully named HSSIB is—the patient safety Bill—and whether that would have been a good complementary vehicle.

Recommendation 3 calls for:

“A new independent Redress Agency for those harmed by medicines and medical devices”


to create a new way of delivering redress in future. It suggests that manufacturers and the state should share the costs. Would the Minister care to tell us how that might be achieved?

Recommendation 4 suggests:

“Separate schemes … for each intervention—HPTs, valproate and pelvic mesh—to meet the cost of providing additional care and support to those who have experienced avoidable harm”.


How might that be achieved? I also have one question relating to mesh and all other implants. How will the Government ensure that they are safe to use? A register is obviously a good step forward and is in the Bill that we will discuss in the next few months, but why do the regulations on implants not provide for trials, as with medicines?

On recommendation 6, will the Minister commit to amendments to the Medicines and Medical Devices Bill to strengthen the Medicines and Healthcare products Regulatory Agency’s regulatory regime? On these Benches, we are committed to implementing the nine recommendations in this excellent report. We will seek to use the forthcoming MMD Bill to do so, and we wish to work with the Government to explore how best to achieve that.

[Baroness Brinton (LD) [V]]

My Lords, on behalf of the Liberal Democrat Benches, I too thank the noble Baroness, Lady Cumberlege, and her team for such an outstanding report. It is not only comprehensive but blunt in its language, so that no one can misunderstand the failings of all levels of the healthcare system, whether in our NHS or other health and research settings, over many years. We too pay tribute to those women, and their children and families, for continuing against all the odds for years when too many ears, including the Government’s, were deaf. I also pay tribute to the many parliamentarians, including Norman Lamb, who over the years supported them. They pushed for this review in Parliament and raised it in any way they could.

Ministers have apologised for these failings, including for the system not listening and for not acting soon enough, over the decades since patients first started to raise the problems with these three medical interventions. Last week, when I asked the Minister about the timetable for implementing the recommendations, he said that

“it will take some time for the Government to study these recommendations … and to come back on the timetable”.—[Official Report, 9/7/20; col. 1224.]

The noble Baroness, Lady Cumberlege, says in her letter introducing the report:

“Over the past two years we have found ourselves in the position of recommending, encouraging and urging the system to take action that should have been taken long ago.”


She also said:

“Implementation needs to be approached with a new urgency and determination, founded on the guiding principle that our healthcare system must first do no harm.”


When the interim report was published, leaving this House in no doubt about the direction in which the review group was proceeding, many people expected action at that point.

I am grateful to Epilepsy Action for its briefing, which demonstrates exactly why urgent action must be taken now. Epilepsy Action, the Epilepsy Society and Young Epilepsy jointly surveyed over 500 women and girls who had taken sodium valproate since the pregnancy protection plan was introduced two years ago. One in 10 were unaware of the possible risks of birth defects. Almost half said that they had not discussed the risks of taking medicine with their health professional in the last 12 months, and only four in 10 said they had signed the annual risk acknowledgement form. For patients and families who have suffered as a result of these interventions, urgent action needs to be taken on government departments such as the DWP regarding the way it assessed the damage caused, and on how government as a whole compensates them for this gross injustice.

So I ask the Minister again: when will the Government return to those affected and to Parliament with clear recommendations and a timetable to do honour to the report and to all those affected? And when will the various bodies in our healthcare sector be set a deadline to publish the list of recommended actions that they will take that will not need parliamentary action? Last week, the Minister told your Lordships’ House that the Government had moved ahead on one of the recommendations—the creation of a patient safety commissioner—but their version is not independent, as asked for in the report.

So much of this report is about changing cultures: we still have not learned from Mid Staffordshire, East Kent and Shrewsbury maternity care, all of which Ministers have rightly been appalled by. For all the excellence and commitment of the individuals who, singly and collectively, provide our unique healthcare in the United Kingdom, there remains an unhealthy culture in some parts that does not listen to patients, does not understand conflicts of interest and resists change. That must change, it must change soon and it must be led from the top by the Government.

The report quotes Professor Ted Baker, chief inspector of hospitals for the CQC:

“I have to say 20 years later it is very frustrating how little progress we have made. It’s clear to me we still have not got the leadership and culture around patient safety right. As long as you have that culture of people trying to hide things, then we are not going to win this.”


Armed with this blunt and excellent report, I hope that the Minister can demonstrate the Government’s support with firm actions and dates, and not just with warm words that will drift away. The hopes of patients and their families and the future safety of our healthcare system depend upon it. When, Minister, when?

Medical Teaching and Learning: Ethnic Diversity

Baroness Thornton Excerpts

Tuesday 14th July 2020 Lords Chamber

Asked by

[Baroness Thornton]

To ask Her Majesty’s Government what steps they are taking to ensure that ethnic diversity is fully reflected in all aspects of medical teaching and learning.

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

My Lords, the Government understand the importance of racial equality and diversity within the NHS and are committed to ensuring that this is reflected in medical training. We think we could do better, which is why the General Medical Council sets standards to ensure that students and doctors in training have the opportunity to understand the needs of patients from diverse social, cultural and ethnic backgrounds. That is why Health Education England provides a learning module on equality, diversity and human rights for all health and social care staff.

[Baroness Thornton (Lab) [V]]

Thank you, my Lords. I thank the Minister for that Answer. We live in a multiracial society; our NHS serves everyone and is staffed by everyone. However, the training of our doctors, nurses and medical technicians appears not to reflect this fact. We do not know whether current clinical language and learning has exacerbated the dangers to patients from a BME background during the pandemic, for example.

I pay tribute to Malone Mukwende, a student at St George’s, University of London, who published Mind the Gap as guidance for healthcare professionals, showing how skin conditions manifest on darker-skinned patients. This is a question of medical training, not a question of options that people might opt in to. We have to integrate these issues into our medical training to ensure that all healthcare professionals are able to recognise, diagnose and treat all our citizens from all ethnic backgrounds. Are the Government going to act on that?

[Lord Bethell]

My Lords, I welcome the noble Baroness’s point. She is entirely right that we live in an extremely diverse community, and this has an impact not only on the way people present their disease but on how they could and should be treated. This is why we build diversity awareness into our training and why we will build extra programmes into the People Plan that will be published shortly, and that is why we remain committed to this agenda.

Independent Medicines and Medical Devices Safety Review

Baroness Thornton Excerpts

Thursday 9th July 2020 Lords Chamber

[Lord Bethell]

Health records are absolutely key—that is why we have tabled an amendment on them. That amendment enjoys the support of the Government and of me personally.

[Baroness Thornton (Lab) [V]]

I think we can see that we need a longer discussion on this report. It is quite clear that some of its excellent recommendations will require primary legislation and I hope the Minister may have identified them already. We on these Benches are keen to co-operate with the Government and across the House to bring forward the necessary amendments to the Medicines and Medical Devices Bill.

[Lord Bethell]

The HSSI Bill is an incredibly important part of our agenda. It is not currently on our schedule, but we hope to bring it back at some date, or incorporate its contents in another vehicle.

Social Care

Baroness Thornton Excerpts

Wednesday 8th July 2020 Lords Chamber

[Lord Bethell]

My Lords, the precise remit of any review will be the choice of those doing the review when it comes, but I entirely endorse the noble Baroness’s sentiments that the social care workforce is worthy of our respect, particularly for its hard work and commitment during the epidemic. Workforce remuneration has improved since the introduction of the national living wage in 2016. Flexible contracts suit many workers, so a blanket commitment to annual wages is not necessarily suitable, but I endorse a focus on solutions that encompass all aspects of the social care industry, including the workforce.

[Baroness Thornton (Lab)]

My Lords, following on from what the noble Baroness, Lady Brinton, said, the Minister’s party has form for not honouring cross-party co-operation on this issue. To mitigate that, given that the Prime Minister has said that he is currently finalising plans, perhaps the Minister could commit the Government to setting a firm date and a timetable that could be published before the House rises for the Summer Recess? Does he accept that we need a plan to be delivered within a year?

[Lord Bethell]

The noble Baroness is kind to think that I am in a position to articulate a timetable from the Dispatch Box—that is beyond my abilities. However, she is entirely right to focus on the urgent need to focus on this area. The Prime Minister and the Secretary of State could not have been plainer that when the time is right and we have dealt with the epidemic, social care reform will be uppermost in our mind and will be the focus of our attention.

Covid-19

Baroness Thornton Excerpts

Wednesday 8th July 2020 Lords Chamber

[Baroness Thornton (Lab)]

Last Wednesday, the Minister advised noble Lords that the lockdown in Leicester was being carried out under the Public Health (Control of Disease) Act 1984 and that regulations would not be brought to the House. However, on Friday, Leicester regulations were laid. Can the Minister clarify that and explain why there was some confusion and whether this has any practical consequences for implementation and enforcement in Leicester? Will this apply to other cities such as Bradford, Barnsley or Oldham? At Prime Minister’s Questions just now, the Prime Minister stated that the risks associated with asymptomatic transmission were unknown until recently. This is not the case. I am very happy to provide the Minister with SAGE minutes from 4 February, for example, when precisely that was recorded. Can the Minister clarify that statement for the House?

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

My understanding regarding the 1984 Act is that the regulations are published under the appropriate section. They have been published as is appropriate, but they are not brought to the House for debate. If I am wrong, I will be happy to write to the noble Baroness.

Independent Residential Care

Baroness Thornton Excerpts

Tuesday 7th July 2020 Lords Chamber

[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.

[Baroness Thornton (Lab) [V]]

My Lords, I return to the question raised by my noble friend Lady Armstrong and the noble Baroness, Lady Brinton, because, while it is obviously welcome for the Minister to thank those who work in care homes for the sacrifices that they have made, he needs to acknowledge the hurt that the Prime Minister has caused with his words. Will the Minister clarify which procedures care homes are accused of disregarding? Are they procedures related to the Government’s policy of allowing hospital patients to be discharged without testing, to the failure to provide the required PPE or, perhaps, to setting up the testing programme so late?

Medicinal Cannabis

Baroness Thornton Excerpts

Monday 6th July 2020 Lords Chamber

[Lord Bethell]

The noble Baroness will not be surprised to learn that I have just spent three and a half months looking at drugs that might make a difference to Covid, only to find that many of them are not helpful and often quite dangerous, so I do not share the optimism bias that many have towards unlicensed drugs. We remain conservative in our approach to clinical trials. I agree with the noble Baroness and others who have suggested that progress on this should be quicker, and I am leaning into the subject to try to bring that about as soon as we can.

[Baroness Thornton (Lab)]

My Lords, it is deeply concerning that no new NHS prescriptions for full extract cannabis oil have been issued since the medicinal use of the drug was legalised more than 18 months ago. This leads to a health inequality: 313 private prescriptions for unlicensed cannabis medicine items, including full extract oil, have been issued. Does the Minister share my concern that only wealthy families and those who can successfully raise funds in the region of £2,000 a month have access to cannabis medicines, while children from poorer families who are unable to afford the prescription are going without? What does he think needs to happen next?

[Lord Bethell]

The noble Baroness shines a spotlight on an uncomfortable but realistic fact of life in our medical service: those with money are able to pay for treatments beyond the reach of those who rely on the NHS for absolutely everything. Another area that concerns me is that those who have relied on fundraising have found that Covid has restricted the amount of money coming from donors. That is why we have put money into medical research charities and support charities that can help support those fundraising for their medicine.

Covid-19: Mental Health Services

Baroness Thornton Excerpts

Thursday 2nd July 2020 Lords Chamber

[Lord Bethell [V]]

My Lords, I am as concerned about the over-prescription of anti-depressants as the noble Earl and would much prefer people to take cognitive therapies than drugs wherever possible. As I mentioned earlier, we have invested in two major rounds of support for community groups to help those struggling with their mental health, and we are reviewing additional funding for those schemes. We will keep a careful eye on the prescription of anti-depressants, which we are all concerned about.

[Baroness Thornton (Lab)]

My Lords, health and social care workers battling through the coronavirus pandemic are paying a heavy mental and emotional toll and will continue to do so. Yet the current mental health support available is not adequate. Will the Government commit to appointing a new independent national well-being guardian to co-ordinate and oversee a proper mental health support package for all NHS and care staff?

Covid-19: Mental Health

Baroness Thornton Excerpts

Wednesday 1st July 2020 Lords Chamber

[Baroness Thornton (Lab) [V]]

I return to the Question asked by my noble friend Lord Bradley. We know that around a third of schools currently do not provide school-based mental health support and that many young people struggling to cope will not meet the criteria of the NHS mental health services in their area. Will the Minister consider the request of Young Minds for the Government to provide ring-fenced funding to ensure that schools can bring in the extra support needed to help their children?

[Lord Bethell]

I should be very glad to look at that request and would be grateful if the noble Baroness would forward it to me. The Young Minds movement is very important. I would say that young people, particularly girls, have been a focus of mental health issues. That has come out in the figures and it is a situation that concerns us.

Covid-19 Update

Baroness Thornton Excerpts

Wednesday 1st July 2020 Lords Chamber

[Baroness Thornton (Lab) [V]]

My Lords, I thank the Minister for providing the Statement.

Many in Leicester are wondering why it has taken so long to act, when authorities knew that there was a surge of Covid-19 cases in early June and the Health Secretary called it “an outbreak” a fortnight ago, on 18 June. Why did it take so long for pillar 2 information to be shared with the council and public health leaders in Leicester? Is the Minister aware that published data for Leicester recorded just 80 new positive tests between 13 and 26 June, but the Secretary of State has revealed that the complete figure for that period was 944?

In the last 30 minutes, a leading respiratory doctor and consultant at Glenfield Hospital has confirmed what my right honourable friend Sir Keir Starmer said at Prime Minister’s Questions an hour ago—that the true numbers and demographic data were not shared. Why is the Prime Minister trying to pretend that the information was made available when the truth is that it was late? Given that the Minister is in charge of testing in the UK, he might owe Leicester an apology for this disrespectful and dangerous treatment. Does the Minister agree that areas that see flare-ups will need a faster response?

This is important, because new statistics show that coronavirus cases have increased in 36 parts of England; Bradford, my home city, is number two. I learned from the Public Health England website that many of the places on the list with increased infection rates have large BAME populations, so why are PHE’s recommendations regarding the disproportionate effect of Covid-19 on our BAME populations not in play here? Given the diversity of a city such as Leicester, why have none of the PHE recommendations that have been implemented included the mandatory collection of ethnicity data?

Can the Minister confirm whether the Government anticipate announcing further local lockdowns in the coming days? The Prime Minister has used the rather ridiculous and flippant words, “whack-a-mole” strategy, regarding tackling local outbreaks. If that means moving quickly and firmly, then frankly it is of no use to the people leading the response on the ground, including Public Health England local leaders, if they are not given the most accurate, up-to-date data possible as soon as it is available. Does the Minister agree? Can he ensure that it happens without centralised bureaucracy getting in the way?

Leicester City Council has been waiting to be given pillar 2 data from commercial labs that process at-home and drive-through tests for many days, and the mayor, Sir Peter Soulsby, said that he was only given access last Thursday after he signed a data protection agreement. A data protection agreement? Why have local authorities not routinely been given pillar 2 information about their residents who test positive? Will the Government confirm why a data protection agreement needed to be signed and whether there is a data-sharing exemption for public authorities on public health grounds? Do the issues go beyond the availability of the data and also concern its quality and the speed with which it is disseminated? I note that data flows more quickly in Wales where the Welsh Government publish both pillar 1 testing data from hospitals and pillar 2 data from commercial labs on a daily basis. Will the Government commit to publishing this data for England moving forward?

It was not until after 9 pm on Monday that we and the people of Leicester learned that there would be an increased lockdown with non-essential shops prohibited from opening with immediate effect. In fact, the mayor got an email about the strategy at 1 am on Monday morning. The Health Secretary said that the decision had been taken in the last two hours, which is why people were given such little notice.expand-col2 That is wholly inadequate. Many businesses and communities on the Leicester boundaries are unsure about whether they and their staff are permitted to work. It was not clear until 9.30 am on Tuesday which areas were included in the lockdown, by which point some businesses had just minutes’ notice that they would have to close again. It was not until Tuesday afternoon that the Government confirmed that those workers who had previously been furloughed would have access to the scheme again.

Will the Minister explain why the decision was taken so late in the day, given the mounting evidence of rising cases? Why were key details, including boundaries and furlough eligibility, not confirmed immediately, leading to further confusion and anxiety? Will he confirm whether people are permitted to travel to work in other cities from Leicester because of the lockdown and, if not. whether they will be eligible for support too?

The situation may have been clearer had the regulations been laid immediately alongside the announcement, so will the Minister confirm when the regulations relating to Leicester will be laid? Given that the Government have long been advised to prepare for local spikes and first floated the idea of local lockdowns in May, why are we still waiting for these regulations? We are also waiting for the latest coronavirus regulations to be laid, which concern changes due to come into effect on Saturday 4 July. Is it true that accident and emergency departments have been told to treat Saturday evening as if it were New Year’s Eve? What on earth do we think we are doing? Again, it is very disappointing that the Government have yet to lay these regulations, which were first announced three weeks ago.

The Minister is well aware that the House and the Select Committee on Statutory Instruments have urged the Government to ensure that legislation follows more closely from any announcement that they make and that even a short gap between regulations being laid and their coming into effect would better enable those affected to prepare, having seen the actual detailed requirements rather than just headline announcements.

[Baroness Brinton (LD) [V]]

My Lords, first, on behalf of the Lib Dem Benches, I once again pay tribute to all of those who are helping to curb the coronavirus pandemic, whether in the front line or behind the scenes, and especially in Leicester. We know that there are many unsung heroes who continue to work long hours in stressful and ever-changing environments. Secondly, on behalf of these Benches, and in memory of the outstanding report by William Beveridge, I extend our congratulations to the NHS on its birthday, and note that of the five evil giants, many are still present in those most affected by Covid.

If the Minister is unable to answer all the questions asked, will he write to noble Lords with an answer? I hope that I can speak for other Members of your Lordships’ House when I say that we understand that the nature of a pandemic means that there are many questions to raise, but to repeatedly not have answers from Ministers is disappointing.

On that note, I ask the Minister for the fifth time in just over two weeks what the problem is with ensuring that every local council and director of public health has full test and tracing data as it becomes available. Over the past three weeks, it has become clear that full data has not been provided, and directors of public health, council leaders and mayors have all had to beg for data so that they can intervene early to prevent further cases, hospital admissions and deaths. Information is being dribbled out and it appears that pillar 2 testing lies at the root of the problem.

Stella Creasy MP asked a Written Question in the Commons, which was replied to by Minister Nadine Dorries on 11 June. It states:

“The contract with Deloitte does not require the company to report positive cases to Public Health England and local authorities.”


Does that remain the case, or has the contract now been varied to ensure that that information is made available immediately to key partners? The issue of why any such contract should not require positive cases to be reported is quite extraordinary but for another day; however, with low transmission, tracing pillar 2 cases is absolutely critical. Are all local authorities and directors of public health now getting full data, including pillar 2 data immediately so that they can prepare for small or larger local outbreaks? That is important because there are reports from across England of areas with increasing cases—indeed, as the noble Baroness, Lady Thornton, said, Sky News reported this morning that 35 other local authority areas may face locking down if their cases do not reduce quickly.

That raises an issue about the powers of local lockdown. It was rather strange to hear Matt Hancock saying on Monday evening that he would bring forward legislation for local lockdown, but this morning on Sky News he said that he would rather not do that by legislation but by consent. So I put what I hope is a hypothetical case to the Minister. If this Saturday a number of Leicester residents get in their cars, what powers to the police have to prevent them from going to Loughborough, Derby or Sheffield to be able to go into a pub? Clearly, at the moment, local authorities do not currently have the powers to stop them: their powers relate only to single buildings. But if the Secretary of State believed on Monday that there needed to be legislation, why not today?

This feels very much like policy by press release, and local legislation enforcers, whether they are police or local authorities, need to know what powers they have as a matter of extreme urgency. I also ask again, why will Ministers not give the powers of local lockdown to local authorities and directors of public health, obviously working with Public Health England, the NHS and Ministers? For any final decision to rest with the Secretary of State inevitably slows down processes, as we have seen in the Leicester case over the past three weeks. Above all, we must keep people safe.

Finally, will the Minister inform the House whether there is sufficient supply of PPE in Leicester and other areas where cases are increasing for hospitals, primary care, care homes and care in the community? The Health Service Journal reports today that there is still much panic buying of PPE, with some orders costing 10 times the amount that would have been paid before March.

This Saturday marks the lifting of lockdown for most of England except for those of us shielding and the people of Leicester. Will the Minister ensure that the wider public will remain safe with the increases in cases in at least 35 other local authority areas? Will the Government move much more quickly to ensure that public safety is guaranteed?