Independent Medicines and Medical Devices Safety Review

Baroness Brinton 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?

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

My Lords, I start by reiterating the tributes from both noble Baronesses, Lady Thornton and Lady Brinton, to my noble friend Lady Cumberlege and her team, who have worked indefatigably on a high-quality report that does justice to this important cause. Most of all, I pay tribute to the patient groups, the specialist groups and those who campaigned on these important issues and who have brought attention and a huge amount of official focus to causes that had been overlooked for years and decades. I pay tribute to their patience, their expertise and their stamina in bringing these important causes to attention. It is entirely right that the Minister, my colleague Nadine Dorries, made an apology to those groups, and I reiterate that apology on behalf of the healthcare system to all the families affected by the report, for the time it has taken to listen and to respond to their concerns.

Both noble Baronesses referred to the culture that led to these issues being overlooked. I think that that is one of the most important learnings from this report. As Nadine Dorries said, I thought very movingly, in her speech in the House of Commons, the system has to learn to listen much more clearly. Listening must happen not just from the top but also at the level at which patients engage with the system itself. I think that trying to change that culture is one of the most important challenges facing us today. It is not just a question of bringing in punishment and retribution for those in the professional world who have failed; it is trying to create a culture where mistakes are recognised and accepted and where people address and take on board the concerns of patients themselves—and on that important cause we are hugely focused.

The noble Baroness, Lady Brinton, asked what we are doing. Already, much has been done. There has been progress in lots of areas. We already have 12 different types of patient safety function in place within the NHS: the Patient Advice and Liaison Service; commissioners of NHS services; the Parliamentary and Health Service Ombudsman; Healthwatch; the NHS Complaints Advocacy service; the CQC; the NHS Friends and Family Test; the professional regulators; the Healthcare Safety Investigation Branch; the Professional Standards Authority; the National Director of Patient Safety; and the complaint systems within individual trusts.

That patchwork quilt of patient safety and patient advocacy is an enormous function within the NHS. The report teaches us that it has not been enough to identify the major themes of failures—in this case, involving medical devices—and there has not been the patient advocacy necessary to see complaints through when they have really mattered. It is that question which we are turning to: how do we make these considerable and important efforts to put patient safety at the heart of the NHS more effective?

The noble Baroness, Lady Thornton, asked about the regulatory implementation of that response. The most important legal implementation is the registry of medical devices, which was in an amendment to the Bill on Report in the House of Commons, and it has enormous support from the Government. That registry, which is an incredibly important source of accountability and of clinical information, is the key to preventing such terrible events concerning medical devices in the future.

The report was published only last week, and it will take some time to focus on all its other recommendations. I can update the House on the specialist centres that the report quite reasonably recommended should be set up: NHS England is assessing bids from NHS providers to be specialist centres for mesh inserted for urinary incontinence and vaginal prolapse.

The noble Baroness, Lady Thornton, also asked about the MHRA regulatory review. The MHRA has begun a comprehensive and far-reaching programme of change, which will include enhancing its systems for adverse event reporting and medical device regulation. The MHRA has taken important steps to put patient advocacy at the centre of the work that it does.

There is nothing we can do today to make good the harm done in the past. However, as both noble Baronesses have rightly pointed out, there is much we can do to put patient safety at the heart of the NHS and to ensure that we have the technology, the systems and the culture to make sure that these mistakes never happen again.