Independent Medicines and Medical Devices Safety Review: Sodium Valproate

Lord O'Shaughnessy Excerpts

Tuesday 2nd March 2021 Lords Chamber

Asked by

[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

Lord O'Shaughnessy Excerpts

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

Lord O'Shaughnessy Excerpts

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

Lord O'Shaughnessy Excerpts

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

[Lord Patel (CB) [V]]

My Lords, I am delighted to have this opportunity to express my thanks to the Minister—the noble Lord, Lord Bethell—the noble Baroness, Lady Penn, and all the other noble Lords who have been taking part in this legislation, in particular those who spoke to and supported my amendments from all sides of the House.

Much has already been said about what we have achieved. I know that time is running short, so I will try and be brief. Of course I congratulate, first and foremost, the noble Baroness, Lady Cumberlege, for achieving what I had tried before—getting patient safety on statute. I did not have her tenacity or clout. So, many congratulations to her and, I believe, the commissioner for patient safety, who will make patient safety stronger in the whole of the health service.

I am very grateful to the Minister, the noble Lord, Lord Bethell, to the noble Baroness, Lady Penn, and to the noble Earl, Lord Howe, for the many meetings they arranged with us to hear our concerns and find solutions. I know it is a privilege for me to speak in person, but I hope all my colleagues on the Cross Benches—more than 12 of them—who took part in the Bill will feel I can speak on their behalf to thank Ministers and all other noble Lords.

I am also grateful to members of the Bill team, who were very helpful at the many meetings that the Minister arranged. And I am grateful to outsiders, in particular the University of Birmingham faculty of law, which worked very hard to produce the details of the legislation. Thank you all.

[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

Lord O'Shaughnessy Excerpts

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.

Medicines and Medical Devices Bill

Lord O'Shaughnessy Excerpts

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

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

My Lords, it is a privilege to be able to support and put my name to the amendment in the name of my noble friend Lady Cumberlege. As has so often been the case in this Bill, where she leads, others follow, and I entirely endorse everything that she and the noble Baroness, Lady Bennett, have said. My reason for supporting the amendment is simple: as my noble friend made clear today, there are tens of thousands of women, men and their families who are suffering from the impact of licensed medicines and medical devices that have been wrongly used.

My noble friend’s landmark review gives voice to so many people who have been ignored for too long; that is what gives it such moral power and makes the force of its arguments so irresistible. Within the final report of her review is a clear recommendation for ex gratia redress schemes to be established for those affected by the HPT, mesh and valproate scandals. To my mind, this recommendation is neither radical nor extraordinary: such schemes have been set up in the past—for the victims of thalidomide and contaminated blood. Indeed, this is a common-sense proposal, and it is urgent—because the suffering of so many continues to this day, as my noble friend pointed out.

I have spoken in the past of two women—Janet Williams and Emma Murphy—whose lives, and whose children’s lives, have been changed for ever by in utero exposure to sodium valproate. They were interviewed as part of a recent Channel 4 documentary on the challenges they face in day-to-day life, the guilt they have been made to feel and their struggle to be heard. Janet and Emma’s honesty and tenacity have been an inspiration to me since I met them, and I defy anyone to watch that programme and not be moved to tears.

I was also contacted recently by another lady, who has been harmed by mesh. Her name is Susan Morgan, and, with her permission, I convey her story. She described to me being on,

“a hideous journey that was thrust upon me without consent”,

suffering grievous, painful and irreparable damage due to a mesh that can now never be removed. Sadly, she has lost nearly everything in dealing with the consequences of this terrible, avoidable injury, and she asks only that

“the burden of fear and worry be removed so that I can find some peace”.

Therefore, I ask my noble friend the Minister: are the redress schemes proposed in the review of the noble Baroness, Lady Cumberlege, under serious consideration, as my honourable friend Nadine Dorries said in the other place earlier this week? I hope so. If so, when will they be introduced? Only a robust answer will be enough to satisfy those supporting this amendment. I close by imploring my noble friend to move quickly: these victims cannot wait any longer—their pain is real, and their need is urgent. Of course, a redress scheme will not change or right every wrong that has been done to Susan, Janet, Emma and thousands like them, but perhaps it might bring them some peace.

[Baroness Jolly (LD) [V]]

Amendment 68, in the name of the noble Baroness, Lady Cumberlege, requires the Secretary of State

“to create redress schemes for those who have already suffered avoidable harm”

related to hormone pregnancy tests, sodium valproate and pelvic mesh. The Minister has told us that there will be no redress agency. The noble Lord spoke passionately about suffering without redress. A significant amount will need to be paid through NHS Resolution to the women affected by these three interventions. Who will ensure that the women affected receive proper recompense? As the noble Baroness, Lady Cumberlege, has said, they have had to pay out for travel for treatment and payment for carers, and they are seriously out of pocket for what they originally thought was standard, straightforward NHS treatment.

I fear that, if there is no scheme, the NHS will have to pay more than it would through a properly managed redress scheme. This and the previous amendment are powerful signals to the Government that they must act on this issue of redress. I hope that, in summing up, the Minister will be able to share the Government’s plans with us. If they have no plans, what would he suggest that these women should do? The noble Lord, Lord O’Shaughnessy, put the case very powerfully.

Medicines and Medical Devices Bill

Lord O'Shaughnessy Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, these amendments are a testament to the incredibly hard work and perseverance of the noble Baroness, Lady Cumberlege, the Minister and the noble Baroness, Lady Penn. They have all worked hard to get to this point. The report, First Do No Harm, must be a turning point in driving up better outcomes.

I hope that in the response to these proposals it will be helpful to have reassurance that the new post will be adequately resourced, the timeframe for fulfilling the appointment is rapid, and, subsequently, regulatory requirements can be defined and relevant statutory instruments drawn up. The independence of the post-holder is crucial. The person must be able to work across all the different and varied organisations and structures that have responsibility for patients, directly or indirectly. That will require promotion to all organisations that they have a duty to co-operate and collaborate with the commissioner to ensure that early warning signals are picked up and heeded through processes that are light on bureaucracy yet rapidly responsive in order to pick up signals. We cannot have years of accumulation of distressed patients. When things start not to be right, those amber warning lights must start flashing.

I urge the Minister to ensure that the remit of the commissioner is as wide as possible. For example, the coroners’ reports that the noble Baroness, Lady Cumberlege, referred to have not had adequate enforcement by others sometimes. The reports made powerful recommendations but it was found that those responsible for enforcing them have been so slow to act that the proposals have effectively gathered dust.

In previous debates, I raised the need for the yellow card scheme to be updated—opened for easy use by patients themselves, who may wish to report adverse outcomes. The wording of the Bill that I found most helpful and welcome is the part stating that the role

“does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue”.

Can the Minister make sure that the reporting mechanisms are open to patients and do not hit a hurdle when they try to report to a clinician who does not recognise the full import of they are saying?

To conclude, I reiterate my congratulations to all, particularly the noble Baroness, Lady Cumberlege, and her team, and look forward to the next phase of working with her and others as this important development moves forwards.

[Lord O'Shaughnessy (Con)]

My Lords, I join other noble Lords in expressing my sincere thanks to my noble friend the Minister for the progress that we have made. In all fairness to him, he said that since Second Reading he was listening, but we all know that it is sometimes possible to listen and not hear, let alone act. On this occasion, he heard and acted. I join other noble Lords in expressing my sincere gratitude for that.

I also pay tribute to my noble friend Lady Cumberlege. No one doubted her tenacity but it has been on display in bucketloads, and she has made the progress that her superb report deserves. More than anyone, I pay thanks to the army of campaigners; many of us have met them, and they could not help but move us with their stories. This legislation is ultimately for them and a tribute to them.

I had a close look at my noble friend the Minister’s amendment and compared it to that of my noble friend Lady Cumberlege. Clearly, there is a specific issue about where the organisation, the commissioner, should sit, but there is a precedent for doing that in the way in which the Minister suggested. I take confidence from his determination to give proper independence to the role. A lot will depend on the kind of person recruited, how they are recruited and to whom they are accountable. I should like him to say a little more about how he envisages that happening.

We also need to hear more detail on the timetable. The Minister will know that when one makes big commitments of this kind, they are staging posts—never the destination. There is still some way to go in making sure that we get there quickly. That is important, as my noble friend pointed out. However, the powers in the amendment are important to recognise. On the ability to demand information from relevant persons, as other noble Lords have said, we need to hear a little more about who they are and the consequences of non-compliance. However, they are powerful ways in which the commissioner can act and create change in the system. I have no doubt that they will be effective.

In conclusion, I make a couple of comments provided by the ABPI’s briefing. They relate to further questions around the nature of the relationship between the commissioner and the MHRA and other bodies, how the four nations of the UK will act together on patient safety, given that we are a single market, and ensuring diversity of patient voice.

I would also add one more thing to that. Patient safety is not just about finding out when medicines and devices go wrong; it is also about access to them. Will the patient commissioner have a remit to investigate these kinds of issues?

However, these questions are for tomorrow. Today, we want to recognise the progress that has been made and the amendments put down in the name of my noble friend. I thank him sincerely for them and I thank my noble friend Lady Cumberlege for her dedication to this particular cause.

[Baroness McIntosh of Pickering (Con) [V]]

My Lords, I, too, add my congratulations to my noble friend the Minister and pay particular tribute to the tireless work of my noble friend Lady Cumberlege in bringing us this far. I welcome government Amendments 1 and 54.

I want to take this opportunity to mention two specific issues that we focused on in Committee and seek confirmation on where we are in this regard. I want in particular to look at the right of patients to report directly on their own experience, rather than waiting for the patient safety commissioner to investigate. I would welcome hearing that my noble friend the Minister imagines that the commissioner should have this power. If not, would he consider introducing such a measure at the first available opportunity? It is so important that the voice of patients is heard. I remember the accounts that my noble friend Lady Cumberlege gave in Committee of her work and that of her team in producing the report, First Do No Harm; that will be a lasting legacy. Allowing patients the right to report directly, without necessarily waiting to be asked, would cut through many of the difficulties with medicines and medical devices, and would enable the patient safety commissioner to report directly to the Government in this regard.

The only other point that I wish to make at this stage is that of the regulations that my noble friend envisages in the government amendments in this group. Can he confirm that these will be discussed and agreed with the devolved Administrations at the earliest possible stage? Can my noble friend assure us that if the devolved Administrations raise any significant issues or highlight any problems that they have with the draft regulations, these will be acted on before the regulations are adopted and sent to each House of Parliament?

We are in a very good place. I congratulate my noble friend Lady Cumberlege and her team on bringing us here, and I pay special tribute to my noble friend the Minister for listening to the concerns of so many people, over so many years, to bring us to where we are today. I wish the amendments godspeed.

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[Lord Sharkey (LD) [V]]

My Lords, I welcome the amendments in this group. They add clarity to the obligations laid on the Secretary of State in making regulations under Clause 1(1) and its counterparts.

I particularly welcome Amendment 12 in the names of the noble Baroness, Lady Thornton, and my noble friend Lady Jolly, as it seems particularly important. It requires the Secretary of State to publish the criteria used in determining the benefits and risks caused by regulation and to set out how they have been weighed against each other. This amendment touches on the whole issue of transparency in devising regulations. The level of transparency that Amendment 12 requires should certainly apply to the factors listed in the Minister’s Amendment 9. These factors, which the Secretary of State must have regard to, are the safety of human medicines, the availability of human medicines and the likelihood of the relevant part of the United Kingdom being seen as a favourable place in which to carry out research related to human medicines, conduct clinical trials, or manufacture or supply human medicines. These are all clearly important, and I am glad that the Minister has added manufacturing to this list, as I suggested in Committee.

The list contains three rather vague notions: “likelihood”, “favourable” and “being seen as”. For all these terms, we need to know what definitions will be used and what evidence will be required in support. For “being seen as”, the question arises: being seen as by whom? What weight will be given to different views from different sectors? If, for example, it turns out that academic researchers and pharma companies have different views about the favourability of the UK, how are they to be weighted? On “likelihood”, could the Minister say whether he considered the word “desirability” instead, which seems closer to what we want here?

I hope the Minister is able to give reassurance on the points I have raised and that he accepts the merits of Amendment 12 and its counterparts.

[Lord O'Shaughnessy (Con)]

My Lords, I will make three quick points about the government amendments in this group, which I broadly welcome. The first relates to Amendments 4 and 42, where the Minister has clearly listened carefully to the forceful arguments made by my noble friend Lord Lansley, the noble and learned Lord, Lord Woolf, the noble Baroness, Lady Jolly, and others in Committee. I am delighted that he has.

For those of us who have not been involved in the discussions, and following on from the points that the noble Baroness, Lady Thornton, made about why language from the European regulation has been adopted—“safeguarding public health”—it would be helpful if my noble friend could explain, on the record, why that language has been chosen. That is particularly the case given that he expressed some reluctance in Committee, bearing in mind that the regulations being referred to also had some relevance to operating the internal market, not simply medicines safety. It would be good to hear from him on that.

Secondly, on Amendments 8 and 44, unlike other noble Lords I did not believe that there was a suspect motivation behind the use of the word “attractive” by my noble friend and the Bill team, or any desire to reduce stringency to attract investment. But I would be grateful if my noble friend could confirm that the Government remain as determined as ever, if not more so, to grow the UK’s life sciences sector, and that it was never their intention to lower regulatory standards to achieve this.

Thirdly, on Amendments 9 and 45, I commend my noble friend on the subtle but important changes already referred to by the noble Lord, Lord Sharkey, in Clauses 1(3)(c) and 14(3)(c), especially the inclusion of manufacturing and broader medical research. The salience of these two parts of our overall supply chain has come to the fore during the pandemic, which has demonstrated our strengths in basic science but, unfortunately, exposed our weaknesses in manufacturing resilience. It seems right that this should be explicitly recognised in the Bill and I commend my noble friend for making those important changes and for demonstrating, once again, his ample appetite for listening and acting.

Brain Tumour Research

Lord O'Shaughnessy Excerpts

Thursday 19th November 2020 Lords Chamber

Asked by

[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

Lord O'Shaughnessy Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[Baroness McIntosh of Pickering (Con) [V]]

My Lords, I congratulate my noble friend Lady Cumberlege on the work that she and her able team have done on the report, First Do No Harm. I entirely support the amendment, and I am delighted to follow in this the noble Baroness, Lady Ritchie, who has pointed out that by definition it will have only a limited life. Its main work will be to ensure that the functions of the report and all the recommendations are followed through. However, I take this opportunity to ask both Ministers if they are minded to support this. Possibly, when my noble friend comes to respond, we might hear what the nature might be of the budget allocated to the task force, as well as to whom, if at all, the oversight governance board in subsection (2)(b) of the proposed new clause might report, and whether it is intended that Parliament might have an overview of the work of the task force.

In establishing the task force, it is absolutely vital that there is a body that has the role, as is intended in this amendment, of implementing the recommendations set out in the report of the Independent Medicines and Medical Devices Safety Review. I would personally favour the mechanism in this amendment that a task force should be set up for this purpose, limited in time with a specific view. I would be interested to know what budget might be allocated, and from which budget this would come, and also if there was a mechanism to keep Parliament informed of the work of the task force for its limited life.

[Lord O’Shaughnessy (Con)]

My Lords, when I was preparing for today’s debate and I saw where I was in the speaking list, I anticipated that there would not be much left to say by the time we got to me. I was wondering what I might be able to add to support my noble friend Lady Cumberlege in the very powerful argument she made about the need to set up the task force in recommendation 9 from her review.

I went to look at the latest data on the use of valproate in girls and women in the UK, and I declare my interest as a vice-chair of the APPG that looks at these issues. The MHRA publishes a regular report and its version 4, which tracks the data from 2010 to 2019, was published earlier this year. From that I draw two lessons that are very germane to this debate. The first—which the noble Lord, Lord Hunt, alluded to—is that there is this fear of independence, but there is also something else that perhaps goes on, which is almost a sense of helplessness: well, harm is going to happen in practice, there are things you can do, but it is something we are always going to have to accept. The positive message that comes from the work of the noble Baroness, Lady Cumberlege, and her review, is that we can make a difference. If you look at the prescribing of valproate in pregnancy, you see that it fell by 78% from 2010 to 2019 on the back of concerted action from many people—clinicians, officials, Ministers, patients of course, patient campaigning groups particularly, and many others. It halved, year on year, from 2018 to 2019. So we can make a difference through concerted action.

The other data point I take out of it is that even now there are still 200 babies exposed each year to valproate and, as we know, half of them will experience physical or mental harm. That is 100 babies whose lives, and whose families’ lives, are going to be irreparably changed because of that exposure, when everybody accepts that exposure to valproate in pregnancy should be zero, or as close to that as humanly possible.

It is the point about urgency that I want to get across to my noble friend the Minister. I do believe that he is deeply sympathetic to the findings of the review and the need to move forward, but we cannot wait any longer, because these harms are going on. They are going on every day and we can do something about them—and the recommendations in my noble friend’s review are precisely the way we can do something about them. As my noble friend Lady Cumberlege said in her opening remarks, this is not the kind of thing on which you really want an amendment. It is not the kind of thing that should require legislation, but the reason there is such support for it is the sense that nothing is happening when there are harms going on that could be prevented if we took the concerted action that is necessary. That is why I am speaking in support of the amendment today.

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That is my contribution on these amendments. I want to take a second, if I may, because this is my final contribution on the Bill, to say that, particularly due to the clashes with the internal market Bill, we have been a very small group of people carrying an enormous load. I attempted to make my very small part a contribution towards that with my particular interest coming from the environmental side, the feminist side and a concern about patients and patient safety that reflects my personal experiences and my family background. I thank all noble Lords for their contributions and for their patience with me. I am aware that I have been in your Lordships’ House for only about a year, so I still very much feel as though I have my learner plates on. I am working my way through and trying to work out the best way to contribute. I thank all noble Lords. I would love to say that we will not need to be back again, but I fear we will.

[Lord O’Shaughnessy (Con)]

I shall speak to the amendments in reverse order, starting with Amendment 123 in the name of my noble friend Lady Cumberlege. As she said, these amendments deal with the here and now and with the future, and it is important that we start with the here and now. The perspective I bring to this is again informed by my work with valproate charities through the all-party group and by reflecting on the evidence compiled by charities such as INFACT and others and presented in my noble friend’s report. Historically, some 20,000 babies were exposed to valproate in the UK and half suffered harm. The disorder recognising those harms, foetal valproate spectrum disorder, was fully recognised only in 2019, although the drug was known for decades to have effects of that kind.

It must now be the case that for those families and others we put in place a proper redress scheme. They have had to battle to be recognised. They have had to battle to change clinical behaviour. They have had to battle red tape and a lack of understanding in personal impact payment schemes and in the education and health assessments carried out for young children. This is not only a historical problem; it is true today. We need a solution in the here and now. We do not need to spend huge amounts of time creating a new agency or anything else—I will come to that in a moment—but we need to address that and their harms today. I hope my noble friend will be sympathetic to that spirit.

Amendment 122 is in the name of the noble Lord, Lord Hunt. He is quite right to want to look at this structurally, given all the scandals over the years, including thalidomide, contaminated blood, which I dealt with briefly when I was a Minister, breast implants and many others. It was quite right that my noble friend Lady Cumberlege talked in her report about creating an agency and a proper redress scheme for clinical negligence. Indeed, she has been promoting such an idea since her work on maternity safety, where, as we know, are the largest financial claims and some of the most heart-breaking. I do not think any of us can deny that the system is currently broken. The noble Lord, Lord Hunt, talked about some of the data points from NHS Resolution’s annual report. The annual cost is now nearly £2.5 billion and there are total liabilities of £84 billion because of clinical negligence. A lot of that is the cost of care for people who have been harmed, but a lot of it is the frictional cost—the legal and other costs of going through the process—let alone the uncounted cost to families, especially as the average number of days to settle claims has been increasing over the past decade. There is a very strong case for acting in a big structural way to do something about this.

Having said all that, and having been responsible for this policy area as a Minister, it is a very complex situation. There is undoubtedly a case for moving to a less confrontational and swifter approach. This is not a new idea, as the noble Lord, Lord Hunt, pointed out. We have been thinking about this and legislating for this purpose for at least the past 15 years. There are good examples of no-fault compensation schemes that work in New Zealand and across Scandinavia, which generally satisfy all the participants and, importantly, change clinical behaviour, which is so important in reducing the cost. However, the truth is that this is tied up in broader tort reform, which I am definitely not expert enough to discuss, and in considerations attached to other legislation. A good example is Section 2(4) of Law Reform (Personal Injuries) Act 1948, which has been discussed in this House before and concerns the entitlements of people who have suffered from clinical negligence, but inevitably affects other people who have been harmed.

It is also true that these kinds of schemes do not necessarily save money. Indeed, the modelling I saw when I was a Minister suggested that they could end up being more expensive. That is the challenge and we have to be realistic. It might be deserved, but it is a challenge in moving from one scheme to another.

I am definitely a supporter of action on this front, and I would very much like to hear from my noble friend that work is going on. I worked closely with my noble and learned friend Lord Keen, when he was at the Ministry of Justice, on this programme, and I hope it has continued. I am not sure that this can be dealt with in the way suggested, with a clause dropped into the Bill, because of all the consequential changes and the very difficult issues that it raises, but it is unbelievably important. The cost—that liability of £80 billion—is two-thirds of annual spending on the NHS and we simply cannot go on taking on these liabilities to future tax- payers, let alone to those people who have been harmed. We need to see a more robust policy response from the Government in general on this.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

The next speaker on the list, the noble Baroness, Lady McIntosh of Pickering, has withdrawn, so I call the noble Lord, Lord Lansley.

Medicines and Medical Devices Bill

Lord O'Shaughnessy Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I understand that the noble Baroness, Lady McIntosh of Pickering, has withdrawn, so the next speaker will be the noble Lord, Lord O’Shaughnessy.

[Lord O'Shaughnessy (Con)]

My Lords, I will speak to Amendment 108. In doing so, I remind noble Lords of my interests as listed on the register and my membership of the First Do No Harm All-Party Group, set up by my noble friend Lady Cumberlege. It seems that the debate and discussion on this issue revolve around the use of “may” or “must”, as is often the case in legislation —we are all familiar with this. I fully understand why the Bill uses the word “may” in relation to concerns as set out currently in the clause because, as described, they involve ambiguity. That is implicit in the way the clause is framed. It therefore requires judgment about the balance of risks, which is difficult to prejudge.

It seems that Amendment 108 is a build, as they say, on this and an elegant solution to the existence of a higher-risk category of the kind that the noble Lord, Lord Patel, my noble and learned friend Lord Mackay and my noble friend Lady Cumberlege have talked about. It would leave “may” in place for when ambiguity exists, but would introduce “must” when, in their words,

“there is a clear threat to public safety”,

which is the highest category of risk. It seems unconscionable to think that, when there is knowledge of such risks, they should not be communicated; indeed, there should be, if there is not already, an obligation to do so. Consequently, I feel that this amendment improves on the Bill. It seems perfectly logical and rational to me, and I hope my noble friend the Minister will be sympathetic.

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I next call the noble Baroness, Lady Jolly, and I dare say that there will be a little pause before she speaks.

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[Lord O’Shaughnessy (Con)]

My Lords, it is a pleasure to follow my noble and learned friend Lord Mackay of Clashfern in talking to my noble friend Lady Cumberlege’s important amendment. It is impossible to match the passion and forensic skill with which she introduced her amendment—no one can make the case better and I will not try—but I offer her my deepest support for what she is trying to achieve through it.

The review that my noble friend carried out is quite simply one of the most remarkable of its kind, detailing as it does the extraordinary harm done to patients, mostly women, because of an inadequate safety regime that was too lax on products coming into the market, not capable of fully monitoring the adverse effects of products while they were used in the health system, and unwilling to heed the voices of those crying out in agony because of the harm being done to them and their families.

The First Do No Harm report is full of arresting facts: the 11-year delay between the first statistically significant evidence of the links between hormone pregnancy tests and malformations in babies; the lack of clinical evaluation of the use of mesh—a supposedly inert and harmless device—in the treatment of pelvic organ prolapse in tens of thousands of people; and the 20,000 people exposed in utero to sodium valproate in the UK, around half of whom have been affected physically or mentally, often very severely. But its true power comes from the testimony of those women whose lives were turned upside down by the adverse effects of these tests, pelvic mesh, sodium valproate and other medical scandals.

It was a privilege to hear this testimony at first hand when I was a Minister in the department, and I pay tribute to those brave women who led delegations to bring their message of pain and sorrow, and of being patronised by those who claimed to care for them, to us. Marie Lyon, Kath Sansom, Emma Murphy, Janet Williams—women like them are the reason why Ministers, and ultimately the then Prime Minister, asked my noble friend to carry out her review. It is to tens of thousands of women like them and their families that we owe a duty to implement the findings of that review.

There are many excellent proposals in the report, and it is my sincere wish that my noble friend Lord Bethell and his colleagues at the department will implement its recommendations as soon as possible. However, one recommendation stands out: the proposal for a patient safety commissioner, which is the subject of the amendment. Having served in government, I know that there is often internal resistance when a review proposes a new arm’s-length body or something of that kind, so I will explain why I believe that this one is so important and why there is a strong precedent for a Conservative Government introducing one.

As my right honourable friend Jeremy Hunt said when he first launched the medicine and medical device safety review in February 2018, it is the responsibility of the Government to listen, hear and act with compassion, speed and proportionality when things are going wrong. As the exhaustive findings of my noble friend’s review show, this did not happen, time and again, over many decades—and it must.

Whose responsibility, then, should it be? I, like other noble Lords, have great confidence in the NHS, the MHRA, the DHSC and other bodies, but we must be honest that none of them has consistently lived up to the maxim propounded by the former Secretary of State. More importantly, too many patients have had negative experiences interacting with these organisations when they were seeking help, so confidence in their ability to act in patients’ interests is not robust.

As the review continued, it became clear to me, as it did to my noble friend Lady Cumberlege, that there was a need for an entirely independent body that could act as the patient’s friend on safety in the system, a gateway and a support mechanism where those who were not being listened to could go—if you like, a conscience for the system. This would benefit the health system too, providing aggregated access to new information on safety issues and a potential to spot emerging concerns. Nothing that currently exists could perform both these essential functions in a way that carries the support of patients.

These are precisely the roles that the patient safety commissioner is proposed to play. There are different ways it could be implemented, of course, but it must be independent of the department and the NHS, as other noble Lords have said, and it must be patient-facing in all it does. We already have examples of how this could and should work. Many noble Lords have referred to the excellent work of the Children’s Commissioner. I also point to the Victims’ Commissioner, a role fulfilled until recently with great expertise by my noble friend Lady Newlove, and the new independent office of the Domestic Abuse Commissioner. It is absolutely right that these new positions have come into being, and I am proud that it was a Conservative Government who created them.

So once again I throw my weight behind the proposals of my noble friend Lady Cumberlege. I am sure that my noble friend the Minister is highly sympathetic to this cause. For the sake of all those women—and the men and children who have also been harmed—I hope that we can work together to make it happen.

[Lord Blunkett (Lab)]

First, I declare a tangential interest in the sense that I am patron of the Society of Occupational Medicine and, together with the faculty, it obviously has a real interest in this area, as well as its broader remit. I apologise to the noble Baroness, Lady Cumberlege, and the Committee for not being in my place at the beginning of her incredibly powerful speech, and I endorse what people have said already about not only the speech but the incredible work and reflections in the report.

The history that the noble Lord, Lord Patel, gave us, indicates very clearly the challenges that have been faced in this area. I am the first Member to speak who, as a former Member of Parliament, had people at my surgery bewildered, frustrated and not in a position, as they were in America, to go down the litigious route to get any satisfaction. But, of course, down the road and down the line is, as the report of the noble Baroness, Lady Cumberlege, indicates, is too late. Having someone who can intervene to prevent misery, hurt and, for many, terrible trauma for life is really important.

When you have the noble and learned Lord, Lord Mackay, and a former Health Minister, the noble Lord, Lord O’Shaughnessy, on your side, you are on a winner, and I hope that the noble Lord, Lord Bethell, will be able to indicate that he is prepared to go back to what we used to call the Legislative Committee—difficult as that is, because there is enormous resistance in government, as the noble Lord, Lord O’Shaughnessy, will remember and my noble friend Lord Hunt will be painfully aware, to having substantial amendments to Bills and to conceding that measures were not thought of first within the department. But I hope that on this occasion it will be possible to do so.

Reference has been made to other commissioners, and I endorse what the noble Lord, Lord O’Shaughnessy, said about the noble Baroness, Lady Newlove, and the powerful work that she did. I respect her greatly, as I do Anne Longfield, the Children’s Commissioner. I say to my good friend and noble friend Lord Hunt that I like to think that some of us in the political arena played a bit of a part in getting the schools reopened as well as the commissioner, but she did a phenomenal independent job in that area. I hope that the commissioner recommended by the noble Baroness, Lady Cumberlege, would be able to do the same in this sometimes forgotten area.

I am not sure that she will thank me for this, but perhaps the noble Baroness will accept that there may be a connection with the Health and Safety Executive, because the research and testing facilities it has may have a relevance here, and some connection with the commissioner that she has recommended may be sensible. My noble friend Lord Hunt and I shared an interest in this when we were both at the Department for Work and Pensions and the HSE reported to us. We had a number of ideas which, because we had both moved on, did not come to fruition—but here we are, all those years later, with an opportunity to do something that would be of great benefit to many people—mainly, as the noble Lord, Lord O’Shaughnessy, said, women—who have suffered so grievously and did not need to.