Independent Medicines and Medical Devices Safety Review: Sodium Valproate

Debate between Lord O'Shaughnessy and Lord Bethell

Tuesday 2nd March 2021 Lords Chamber

[Lord O'Shaughnessy]

To ask Her Majesty’s Government, further to the report by the Independent Medicines and Medical Devices Safety Review First Do No Harm, published on 8 July 2020, what plans they have to bring forward a redress scheme for women and families who have been harmed by sodium valproate.

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

My Lords, the Government plan to respond further to the Cumberlege review later this year, as I committed in my recent Written Ministerial Statement. In the meantime, we are carefully considering the recommendation regarding a redress scheme for those harmed by sodium valproate, and measures are in place to limit the prescribing of this drug.

[Lord O'Shaughnessy (Con)]

I am grateful to my noble friend for his Answer. Since my noble friend Lady Cumberlege published her landmark review, another 150 babies have been born suffering harm from in utero exposure to sodium valproate, to add to the 18,000 children—18,000, my Lords—who have been harmed in this way since the 1970s. These children belong to families whose lives have been turned upside down, and who often cannot afford the costs of caring for their damaged children. They need and deserve a redress scheme now. Why can the Government not move faster?

[Lord Bethell (Con)]

My Lords, I pay tribute to those who have put together the valproate registry scheme that became live on 11 February. My noble friend is entirely right. There are 22,095 people on the registry; 462 of them had 490 conceptions, and 180 women were prescribed in a month when they were pregnant. A redress scheme is not necessarily the correct solution to this problem. We are considering it extremely carefully, and when we publish our overall response to the Cumberlege review we will include our considered response to the redress suggestion

Covid-19: Over-75s

Debate between Lord O'Shaughnessy and Lord Bethell

Tuesday 9th February 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I pay tribute to all those elderly carers, who, as the noble Baroness quite rightly points out, provide a huge service to society, to their loved ones and to the community. We have put in place a tremendous amount of support for carers, including PPE support. We have changed the arrangements for domiciliary care so that we can restrict the spread of the virus, and we have changed the way in which domiciliary care is paid for. The noble Baroness is entirely right: we should not forget the considerable contribution made by a large number of unpaid carers, many of whom are themselves elderly.

[Lord O’Shaughnessy (Con) [V]]

My Lords, as well as the direct health impacts that the pandemic has brought on older people, there are the indirect effects of increasing loneliness and isolation, which can have a devastating impact too. As the country emerges from lockdown, will my noble friend ensure that the right support for mental health and other support is in place for this group, including better access to their families and loved ones through more flexibility in the use of support bubbles?

[Lord Bethell (Con)]

My Lords, my noble friend is entirely right about the massive mental health challenge and, if not the challenge to mental health, that of the isolation and loneliness felt by many who are shielding or isolated. Seven hundred and eighty thousand individuals over 70 are considered clinically extremely vulnerable. We have changed the terms of the shielding arrangements to give them more flexibility, and we have published the well-being and mental health support plan relating to Covid-19, which sets out steps to strengthen the support available for those who are struggling. But my noble friend is entirely right: we must do more to support and help voluntary organisations, which play a critical role, as do local authorities.

Covid-19 Update

Debate between Lord O'Shaughnessy and Lord Bethell

Thursday 4th February 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, the noble Lord alludes with characteristic insight to one of the great frustrations and mysteries of Covid. It seems to me, a lay person and a neophyte in this area, that understanding the body’s immune response to something as simple as a virus such as Covid should be straightforward, but it is one of the unlocked mysteries of Covid. We are working extremely hard to unlock the mystery of it all. We have invested a huge amount in immunology and the detection of antibodies in the British public. I pay tribute to the UK Biobank study, a massive survey which has been going on for six months. It has found that 8.8% of the UK population had been infected by December 2020; 40% of them did not have a single classic symptom of Covid, and a quarter of those with antibodies were completely asymptomatic. We are doing other assessments as well—through the ONS, REACT, blood donors, the RCGP and others—and I would be very pleased to meet Professor Akbar to discuss this work further.

[Lord O’Shaughnessy (Con) [V]]

My Lords, in asking my noble friend the Minister about schools, I declare my interests as set out in the register. Last week, Public Health England confirmed that the health risks to and from the primary school population were very low, and that teachers are not at greater risk than the rest of the population of getting Covid or suffering its consequences. Other countries with similar case rates, such as the Netherlands, are planning to reopen their primary schools next week. Does the Minister agree that the toll of school closures is particularly acute on younger children and their parents, because those children often are unable to work independently, while the health benefits of these closures are minimal? Should the primary schools not be the very first institutions to open on 8 March?

[Lord Bethell (Con)]

My noble friend hits the nail on the head. Nothing could be a greater priority to the Government than the opening of all schools, and primary schools are at the top of the list. I pay tribute to all those parents and, if I may be so bold, particularly the mums, who have taken on the bulk of the work in dealing with young children at home while juggling other commitments to care and work. This is one aspect of one of the greatest emotional tolls on the British public. My noble friend is entirely right that the opening of schools is a massive priority. It hits hard those communities that depend on schools for care, and those that do not have the resources for at-home teaching. I completely agree with his assessment and assure him that it is a primary priority of the Government.

Medicines and Medical Devices Bill

Debate between Lord O'Shaughnessy and Lord Bethell

3rd reading & 3rd reading (Hansard) & 3rd reading (Hansard): House of Lords
Thursday 21st January 2021 Lords Chamber

[Lord O’Shaughnessy (Con) [V]]

My Lords, there is not much more to say that has not already been said by other noble Lords. I just wanted to use this opportunity to thank and pay tribute to particular groups. The Bill team and private office, which have worked so hard to produce this legislation, are amazing in what they do and often unsung. It is important we recognise them.

Secondly, I thank those patients and patient groups who have provided so much moving information and testimony that has informed our work. After all, we serve them, and I hope and believe that we have served them through improving this Bill in this House in the way we have.

Thirdly, I pay particular tribute to my noble friend Lady Cumberlege. When I was in government and we commissioned her report, I could not have dreamed that she would have done such a thorough job and carried it with her customary tenacity, to the point where we have, on statute, the commitment to a patient safety commissioner. It is such an important step forward and it will make a massive difference to the lives of hundreds of thousands of people in this country. For that, we should all be proud of this step—and she in particular should be.

Finally, I thank the Minister—my noble friend Lord Bethell—the noble Baroness, Lady Penn, and the noble Earl, Lord Howe, but particularly the Minister; he has performed with absolute aplomb in the difficult 10 months since he became a Minister. He has so much on his plate, yet throughout this process he has listened, engaged and acted in a way that does him enormous credit, and I really want to pay tribute to him for everything he has done.

I share the Minister’s optimism that, having produced this Bill, we can produce a regulatory system for the UK outside Europe that is the envy of the world, that makes sure that every company, every charity and every researcher who wants to bring a transformative therapy into a health system will come to us because of what we are able to do and how we are able to bring them through into mainstream treatment, just as we are doing with vaccines and have done with the recovery trial. That is the template, and I look forward to working with my noble friends and other noble Lords to make that happen in the months to come.

[Lord Bethell (Con)]

My Lords, I am extremely touched by the kind words of noble Lords and pay tribute once again to the hard work of all those concerned. I look forward to the future—to, as my noble friend Lord O’Shaughnessy said, the opportunity for patient safety and innovation to be enhanced by this Bill. In that spirit, I beg to move.

Health: Brain Tumours

Debate between Lord O'Shaughnessy and Lord Bethell

Tuesday 19th January 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I have had three meetings, particularly with the Tessa Jowell Brain Cancer Mission, which has been extremely constructive and brought with it clinical expertise, patient groups and policymakers. Together we have worked on a plan, which I articulated in my opening remarks. It has emerged that it is not a question of the quality of the research applications. The quality of research in this area is fantastic. The problem is that we need to have better basic science at the very early stage of the pipeline in order to guide the later operable research suggestions. That is why we have organised the workshops, are feeding back to the applicants in the previous round of research and are actively engaged in this area.

[Lord O'Shaughnessy (Con) [V]]

My Lords, I declare my interest as a patron of the Tessa Jowell Brain Cancer Mission. I thank my noble friend for his sincere engagement with the challenge of improving the quality of brain cancer research since my Oral Question last year. He has taken the bull by the horns and I think we have a plan that is going to make a difference. I wonder if he might also comment on the difficulties that medical charities, which are such an important part of the funding landscape, are having at the moment because of the Covid crisis. This particularly affects hard-to-treat cancers such as brain tumours. Are the Government willing to give more support to these charities to ride out the difficult times they face at the moment?

[Lord Bethell (Con)]

My noble friend alludes to a situation that is grave and concerning. Hundreds of millions of pounds have disappeared from medical research charity income, particularly through the closure of second-hand clothes shops, which provide an enormous amount of income for British medical research. I pay tribute to the massive contribution of medical research charities in trying to move forward the science of medical research. This is an area we are deeply concerned about, and colleagues at BEIS and the Treasury are actively engaged with it. My noble friend is right that this a knotty situation to solve that we need to look at very carefully indeed.

Brain Tumour Research

Debate between Lord O'Shaughnessy and Lord Bethell

Thursday 19th November 2020 Lords Chamber

[Lord O’Shaughnessy]

To ask Her Majesty’s Government what financial support they are providing for research into therapies and treatments for people with brain tumours.

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

My Lords, in 2018, the Government announced funding of £40 million over five years for brain tumour research as part of the Tessa Jowell Brain Cancer Mission, through the NIHR. We are relying on researchers to submit high-quality research proposals in this very difficult area. To encourage such applications, in April 2018 we released an NIHR highlight notice on brain tumour research asking research teams to submit collaborative applications, building on recent initiatives and investments.

[Lord O’Shaughnessy (Con)]

I am grateful to my noble friend for that Answer. Nearly three years ago, this House was witness to one of the most courageous and moving speeches in its long history when Baroness Jowell argued for better support for people who, sadly, like her, die from rare cancers. We have made progress since then; fluorescent dye to aid surgical accuracy has been rolled out and new specialist brain cancer centres have been set up across the NHS. However, funding for research is lagging. Of that £40 million promised by the NIHR, only £6 million has been allocated. Can my noble friend tell the House what the department is doing to address this issue and is he prepared to meet with representatives of the brain cancer research charities in order to think of a way forward?

[Lord Bethell (Con)]

My Lords, the memory of Baroness Tessa Jowell has had a huge impact in this area. I remember well her testimony from these Benches and the mood of the House then. It was an extremely moving and impactful occasion and we remember her very fondly indeed.

My noble friend is entirely right that it is extremely frustrating that not more of this money has been spent. You will not catch me saying that very often at the Dispatch Box, but in this case, it is true. Managing the pipeline of research submissions through the process to the NIHR is a challenge. The NIHR has very high standards for the allocation of research grants and to date, it has struggled to find the number and quality of grants to support. That is why we will put a renewed focus on supporting the drafting of better grants, and I would be pleased to meet with the charities recommended by my noble friend in order to discuss the ways we can do that.

Medicines and Medical Devices Bill

Debate between Lord O'Shaughnessy and Lord Bethell

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Lord O’Shaughnessy (Con)]

I thank my noble friend for addressing the point about therapeutic use, but I think I am slightly more confused now than I was before. He talked about NICE, but of course, NICE does not assess every medical device and assesses from a health economics perspective, as opposed to a purely regulatory, safety and efficacy perspective. It is not something that need detain us, but perhaps he could follow up afterwards with a bit more detail.

[Lord Bethell (Con)]

I would be happy to conduct that follow-up.

Independent Medicines and Medical Devices Safety Review

Debate between Lord O'Shaughnessy and Lord Bethell

Thursday 9th July 2020 Lords Chamber

[Lord O’Shaughnessy (Con) [V]]

My Lords, as a former Health Minister I add my apologies to these women on behalf of the Government I served. They were let down over many years and I pay tribute to their courage in coming forward for this review. I also pay tribute to my noble friend Lady Cumberlege and her review team for a superb, landmark piece of work. I want to press my noble friend the Minister on one issue: he mentioned that Aidan Fowler is the national director of patient safety in NHS England. That is quite right and very welcome, but the report recommends that somebody from outside the system—someone whose first loyalty is to patients themselves, not to the NHS—should be the gateway, the representative on behalf of patients. I know my noble friend wants to consider these recommendations carefully, but will he not rule out the idea of a new, patient-focused commissioner simply because there is someone leading on patient safety in NHS England already?

[Lord Bethell]

I thank my noble friend for his comments and for his role in commissioning this important report. His point on the safety commissioner is extremely well made. I am not ruling out anything whatever, but we need time to study the report before we can make any commitments.

Covid-19: Contact-tracing App

Debate between Lord O'Shaughnessy and Lord Bethell

Wednesday 6th May 2020 Lords Chamber

[Lord Bethell]

My Lords, the app works by using the Bluetooth tags which are shared once you have declared symptoms or you have had a positive test. It does not rely on GPS tracking. If the terms and conditions are broader, that is because we want to try to provide the most thorough set of conditions that encompass all the data provided by the user’s telephone. However, I can reassure the House that it is Bluetooth tagging that is used by the app and the surveillance system.

[Lord O’Shaughnessy (Con)]

My Lords, what work is going on to make sure that the app that NHSX is developing is interoperable with other countries’ apps? Clearly we all want to get back to a situation where people can move freely from one country to another for business or leisure, so interoperation is important. I will be grateful if my noble friend can update us.

[Lord Bethell]

My noble friend Lord O’Shaughnessy is entirely right. We all wish to move as quickly as possible back to normal, but I am afraid that travel will be one of the aspects of our former lives that will be slowest to return. That said, we are working extremely hard with other countries to make sure that interoperability can be baked into our arrangements. Of course, the app has not yet been launched and few other countries are ahead of us. We sat with the Irish Government on 24 April in order to work out interoperability protocols since that border is the most important and proximate to us.

Covid-19: Critical Care Capacity

Debate between Lord O'Shaughnessy and Lord Bethell

Monday 23rd March 2020 Lords Chamber

[Lord Bethell]

My Lords, the bravery and commitment of our front-line staff are to be commended. I think I speak for all of us when I pay tribute to everyone who has put their safety and health on the line. There is no doubt that those in the NHS who are working with those affected with Covid-19 are taking a huge risk, and it is our commitment to support them where we can. Hotel rooms are being booked for NHS staff who are reluctant to return home and who would quite wisely prefer to seek alternative accommodation. Tests are absolutely essential in order to get not only front-line clinical and ancillary staff but the whole country back to work. The Government are committed to finding a way to roll out a testing programme that gives British people confidence that we can beat this virus.

[Lord O’Shaughnessy (Con)]

My Lords, can the Minister be a bit more specific on the diagnostic front? The deal with the private sector is incredibly welcome, and the situation with Northwick Park demonstrates how important it is. However, it is not just about beds and ventilators but people. We know that staff are having to self-isolate because someone at home seems to be ill but they themselves may not be. What kind of numbers are we talking about? The Prime Minister has talked about getting up to 25,000 a day; there are 65 million people in the country. What is the ambition, not just in four weeks but in eight and 12 weeks, of what we might get to and how we will get there?

[Lord Bethell]

My noble friend Lord O’Shaughnessy asks entirely reasonable questions, and he is quite right to press me for numbers. The tests we are talking about for this virus are new—some of them are only a few weeks old. It requires the tests to be tested to ensure that they are delivering accurate results, and for that reason it is difficult to commit to the kinds of numbers my noble friend searches for. However, it is very much the Prime Minister’s desire to have testing as a central part in our battle against the virus, and that is why we are putting enormous resources into it.

Coronavirus

Debate between Lord O'Shaughnessy and Lord Bethell

Thursday 12th March 2020 Lords Chamber

[Lord O'Shaughnessy (Con)]

My Lords, I am grateful to my noble friend for repeating that Statement and providing that reassurance. We all respect that this is an incredibly difficult and finely balanced decision, and, to some degree, we all need to trust in the process and those who are leading it. We have great scientists who are doing so.

Will my noble friend do two things? First, can he talk a little about the welcome funding that was in the Budget yesterday to support the economy and the health system through this outbreak? What exactly will that be spent on and what can be spent quickly to good effect? Secondly, to pick up an issue that was raised by the noble Baroness, Lady Thornton, but was also mentioned yesterday about capacity in the system, particularly in care homes, I am very worried about vulnerable people who require domiciliary care whose workers might get sick. Who will care for those people? We may need to think completely out of the box in how we do this. Can we stand up a volunteer army of post-infected people who have DBS checks to take on these kinds of responsibilities? Going about things in the ordinary way will not deal with the consequences of this crisis when it really hits. I would be grateful if my noble friend could expand on some of the plans the Government are making for these consequential impacts, which are not to do with the virus, but are very much to do with the impact on the health system.

[Lord Bethell]

I thank my noble friend for those questions. In terms of funding, the Treasury has provided immediately a £5 billion contingency fund to ensure that not only the NHS but local authorities have the resources necessary for both clinical and social care. The kinds of items that the money can immediately be spent on include boosting staffing, particularly in the NHS, which might include re-employing retired doctors and nurses and recruiting and offering compensation to volunteers who agree to help provide health and social care services full-time for the period of surge.

The precise arrangements for how that volunteering army can be put together will have to wait until we have the legal provisions for that army because there are important questions of indemnity, legal registration and DBS checks, all of which have been raised in this Chamber previously and which we take very seriously. But it would be premature to describe plans that are being worked on at the moment until we have tabled the sorts of legal requirements that we will need.

Funding will also ensure that we have the right drugs, supplies and equipment. Lastly, there will inevitably be a backlog of care after the virus has passed. We are conscious that this backlog will put a long-lasting strain on our medical and social care arrangements, and we are putting in the resources today to ensure that the backlog can be addressed in the future.

Wuhan Coronavirus

Debate between Lord O'Shaughnessy and Lord Bethell

Wednesday 26th February 2020 Lords Chamber

[Lord Bethell]

The noble Baroness asks a detailed question on an important part of our response. British scientists have done an enormous amount to investigate an antidote to the virus; £20 million has been put into research into those arrangements. We are absolutely at the forefront of trying to find some kind of antidote. The regulatory arrangements for that are not in my brief, so I cannot answer her question directly. I reassure the House that British scientists are absolutely working hard; they are well resourced, and any regulatory arrangements that are needed to find the right medicines for this virus will be put into place.

[Lord O'Shaughnessy (Con)]

My Lords, I thank my noble friend for the authoritative way he has given this Statement and provided reassurance to the House. I join other noble Lords in recognising the efforts of many health and non-health staff in dealing with this, not just in the UK but abroad.

I want to ask a specific question about the advice being given to schools. The Statement said that schools should refer, if they are unsure, to regional schools commissioners. He will know that such commissioners were not set up to provide public health advice but to supervise the structure of the school system. What access are they getting to advice from Public Health England and its equivalents across the UK to make sure that they are getting the right advice, and not closing when they should not close or opening when they should not open? I declare my interest in and involvement in schools as a concerned parent.

[Lord Bethell]

My noble friend asks a characteristically detailed question. There has been a huge hunger on the part of schools over the last few days for more accurate information about how to respond. As a result, the Department for Education has put in place a regular email directly to the schools themselves—to headmasters and governors. This is currently planned to happen weekly, but that will change as events progress. The email refers to the provision of further information on the DfE website. Arrangements for hotlines and follow-up information are being put in place.

NHS: Data

Debate between Lord O'Shaughnessy and Lord Bethell

Tuesday 28th January 2020 Lords Chamber

[Lord Bethell]

The noble Baroness is absolutely right to emphasise the value of the data. We are blessed in Britain with one of the largest datasets in the entire world. Enormous work has been put into crafting the frameworks, ombudsmen, regulations and oversight necessary to make best use of this data. The Government are investing in projects such as the NHS artificial intelligence lab, which will put government money to work. We are working with partners who will share income from the use of this data.

[Lord O'Shaughnessy (Con)]

My Lords, I declare my interests as set out in the register, including as a board member of Health Data Research UK. Data sharing between the public and private sector has always gone on in the NHS; there would be no clinical trials if that were not true. However, with new technology it is important that that data is shared not just in a safe, legal and ethical way but, as the noble Lord, Lord Clement-Jones, pointed out, in a way that continues to enjoy the trust of the public. Having the public deeply involved in setting the strategy and parameters for the kind of data sharing that goes on is absolutely essential. Can my noble friend the Minister reassure the House that, as well as legal compliance, investment of capital and all the rest of it, the Government are taking this issue very seriously? As an example of using citizens’ juries and other methods to build that confidence, I commend to him the One London programme. I have no involvement in it myself, but it is doing an exemplary work in getting people not only involved but setting strategy.

[Lord Bethell]

The noble Lord, whose experience in this matter far outweighs mine, hits upon an incredibly important point. Public trust is essential in this area. Public awareness of the use of data remains very low and recent polling evidence suggests that engagement is not at the level that is needed. This represents a danger that the Government recognise, which is why we are doing everything we can to educate the public on the use of their data and to ensure that our partners are utterly explicit about the way in which data is used.