Health Service Safety Investigations Bill [HL]

Baroness Finlay of Llandaff Excerpts

2nd reading (Hansard): House of Lords
Tuesday 29th October 2019 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, I am delighted to follow the noble Lord, Lord Ribeiro, who has covered a large part of my concerns about some of the Bill’s powers relating to coroners. I will return to those. I declare my interests as in the register, particularly as president of the Chartered Society of Physiotherapy, as vice-president of Marie Curie and of Hospice UK, and as a clinician in Wales. I know that Wales is outside the Bill’s remit, but I will come to the cross-border flow issue.

I have a concern, from recognising that the Bill is based on aviation, rail and marine and their investigative processes, as to whether the body will be underresourced in the long term because of the complexity of the NHS. There has been pressure for an open culture of learning. There are death reviews and notification of serious incidents within hospitals, which has been pushed for some time, but unfortunately we do not have the culture of learning that is being called out for loud and clear. The reality works against it. The British Medical Association’s chairman, Chaand Nagpaul, said in the BMJ this week that the NHS now has a culture,

“where blame stifles learning, contributing to the vicious cycle of low morale so staff leave. This unsafe, underfunded environment is as damaging for patients as it is for doctors”.

In an article on fear and medical practice, David Oliver, who is a consultant in geriatrics and acute medicine, describes:

“A continually under-resourced, short staffed system, increasingly unable to meet rising demand”,


that “begins to feel unsafe”. He continues:

“The sheer number of patients … means corner cutting and workarounds. We have to accept, balance, and mitigate risk to patients, even as systems outside hospital are under even more strain. We work on wards facing epic nursing shortfalls, often with inadequate IT or logistics. Even if our … decisions and communication are sound, there’s much else we can’t control”.


I do not want to sound like a whingeing doctor on behalf of medicine, but I am really concerned that, unless that culture of fear and blame is addressed head on, this proposed organisation will not be able to extract much-needed learning.

I am unclear from the Bill what the threshold will be to trigger an investigation, given that the investigations are meant to be thematic rather than going into an individual case. If we are to have a thematic investigation it has to go across boundaries. I echo the concern of several noble Lords about the private sector, where NHS patients might be treated in the private or voluntary sector, such as hospices. If we cannot investigate the whole part of an organisation we would be ring-fencing a patient who goes into that sector and then saying, “All these other problems might have been contributed to on the other side the line, therefore we don’t have the powers to look at it”. If we are to look at thematic change, I do not see how, when we are commissioning services across the nation from non-NHS providers, we can then exclude them from the criteria we are asking for.

My other concern is how recommendations will be audited. How will we know that recommendations made for thematic improvements have been implemented and what are the levers if they are not? It might be that I have missed that, but I do not feel that I am clear on it.

Maternity services have been under HSIB for some time now. There was initially great resistance, but I understand that things have actually been going well and that the trust and confidence of staff and patients have developed so that they feel able to undertake it. In its maternal critical care report, the Royal College of Anaesthetists brought together anaesthetists, obstetricians, midwives, intensive care medicine and the Intensive Care Society. They are very clear that you cannot take maternity services in isolation because they are an integral part of a whole system. They depend on the anaesthetic department being immediately available, on the laboratory infrastructure, on radiology and so on. It cannot be viewed as separate to a whole system. If we are going to have whole system improvement, we must look at it thematically.

In working with others and working across borders, can the Minister tell me whether the memorandum of understanding with Wales has already been written? I have not been able to unearth it. This becomes very important because we have a lot of patients who go from Wales to England for treatment, and a small number who come in the other direction, but for people on the border, thematic changes become very important.

Turning to the safe space concept, this is essential in many ways. In Wales, our revalidation system in medicine is called MARS, spelled like the planet but fortunately not as far away from the realities of this earth. In it, we are asked to describe personal constraints and practice constraints on their practice of medicine. These are visible to the responsible officer in each hospital, who can then analyse them and pick up trends. Everyone was very nervous about this at first, but it provides the beginnings of a safe space, because people are disclosing early warning signals before an incident has happened, rather than once there has been a problem, and they are describing constraints which mean that they are not practising as well as they feel that they should.

However, the concept of a safe space, and access to information in it, must, as the noble Lord, Lord Ribeiro, has so clearly said, be set against a very high bar, with only a High Court judge able to rule that on balance in this exceptional circumstance, such information should be available. Coronial inquests are terrifying for those appearing before the coroner who do not know what is coming, replicating a sense of fear and blame. That has all been worsened by the concepts and accusations of gross negligence manslaughter, for which many of the referrals to the police have come from coroners. That is also aggravated by the fact that there is not a clear definition of what is or is not gross negligence manslaughter. The Williams review asked for it to be clarified. Unless the coroner is undertaking a clean investigation, de novo, and asking questions, if they cannot unknow information that they may have somehow gained from whatever has been in the safe space, they will then be owners of that information, and I fear that what they do with it will completely erode trust in the safe space concept. It sets the safe space up to fail, because those people who have been referred for investigation of gross negligence manslaughter are often so traumatised, having been suspended for one to three years, that they leave medicine, or certainly never practice as thoroughly and as well as they did before.

Therefore, the public interest in having thematic investigations that work well is essential. If I may turn in the last moments to medical examiners, I am glad to see them in place and on a statutory footing. Personally, I wonder whether the Wales system of them being employed through shared services at a national level is going to work better, because they cannot be deemed to have any vested interest in the organisation, the hospital trust or the health board in which they are working. Time will tell. That is going to be one of those interesting experiments where we see what happens across borders with slightly different healthcare systems.

Overall, I welcome this Bill. We have a lot to discuss, and I am glad that it looks as though we will have quite a lot of time to do that in, because we have to get it right.

Drugs: Methadone

Baroness Finlay of Llandaff Excerpts

Monday 28th October 2019 Lords Chamber

[Baroness Blackwood of North Oxford]

No, the Government are suggesting that a PHE review in 2017 found that drug and alcohol treatment services are currently as good as or better than international comparators. They are cost-effective and the outcomes are good. However, we recognise that the number of deaths at the moment is too high, which is why the Home Office has commissioned a review of drugs policy by Dame Carol Black, and there will be a summit in Glasgow before the end of the year to find out what more can be done to improve these services.

[Baroness Finlay of Llandaff (CB)]

My Lords, do the Government recognise that methadone, apart from being an opioid substitute, is therapeutically a useful drug because it hits a different set of receptors from many other opioids? Each individual opioid is unique in its pharmacological profile and action, so there are real dangers in labelling methadone as only an opioid substitute. Patients who need it for symptom control can worry that they are stigmatised by being prescribed methadone, and there can be difficulties in supply therapeutically. In addition, any review of addiction and addiction services cannot look only at substituting one drug for another but must also look at the fundamental underlying drivers to the addiction that has occurred. It must give support in the long term, because these people remain at risk of returning to their addictive habits.

[Baroness Blackwood of North Oxford]

The noble Baroness in her question has outlined her expertise in this. She is quite right that the evidence base for the effectiveness of methadone is robust. It is provided for by NICE guidance and UK drug misuse and dependence treatment guidelines. Those have recently been updated in the Orange Book, which provides clinical guidance to clinicians and was published in 2017. There is also an update coming to NICE guidelines on how to manage drug dependency, which will be published in 2021. Therefore, up-to-date guidance is available for clinicians which ensures that they are able to provide both therapeutic and dependency management to those on prescription but also on withdrawal treatment. I therefore reassure the House that this is being taken extremely seriously by the Department of Health and Social Care, and by all related departments.

Sexually Transmitted Infections: England

Baroness Finlay of Llandaff Excerpts

Thursday 5th September 2019 Lords Chamber

[Baroness Blackwood of North Oxford]

The noble Lord is of course an expert in where we should target our research. The NIHR is a £1 billion fund which is not targeted specifically. However, it is right that we should target research into STIs to ensure our response to the challenges. We know that STIs are increasing so we should include research into them.

[Baroness Finlay of Llandaff (CB)]

My Lords, how much is the Department of Health and Social Care doing with the Department for Education to ensure that in schools young people are aware of the emergence of antimicrobial resistance among STIs and to make the use of condoms more fashionable? Many young people feel that they are not the things to use, when they are actually the best form of protection.

[Baroness Blackwood of North Oxford]

The Government have made it clear that we want all young people to be happy, healthy and safe, especially when it comes to relationships. That is why we are making relationship and sex education compulsory for all secondary-age pupils from September 2020. That is intended to equip young people with the skills to maintain their sexual health and overall well-being. The noble Baroness is absolutely right that that will be effective only if it is cool and works well in terms of communication with young people.

NHS Pensions: Taxation

Baroness Finlay of Llandaff Excerpts

Tuesday 9th July 2019 Lords Chamber

Asked by

[Baroness Finlay of Llandaff]

To ask Her Majesty’s Government what action they are taking to tackle the 50% increase in waiting times for NHS patients due to the changes in rules on pension contributions for consultants which affect the number of clinical hours they are able to work.

[Baroness Finlay of Llandaff (CB)]

My Lords, I beg leave to ask a Question of which I have given private notice.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, we will be consulting shortly on proposals to make NHS pensions more flexible for senior clinicians in response to evidence that shows that pension tax charges as a result of the tapered annual allowance are having a direct impact on retention and front-line service delivery. These proposals aim to maximise the contribution of our highly skilled workforce, who are crucial to delivering the NHS long- term plan.

[Baroness Finlay of Llandaff]

My Lords, I declare my interest as a past president of the BMA. Can the Government state exactly when the consultation will begin, how long it will run for, how it will be organised and when it will report? Do they recognise that, of 4,000 consultants recently surveyed, 60% said that they would retire at or before 60 years of age, and over half of those cite the sudden unexpected tax bills as a reason? This is particularly urgent because in August we have new graduates starting, who need additional supervision as they begin to get used to working in the clinical arena, yet we are already seeing consultants dropping sessions, which will adversely impact on clinical services. Doctors seem to have only two options now: to retire or to leave the NHS pension scheme, and until they can do that, they are financially penalised for working. One paediatric intensivist I was talking to said that he is £300-plus out of pocket by working a weekend.

[Baroness Blackwood of North Oxford]

I thank the noble Baroness for her important Question, which she has asked before. Retaining and maximising the contribution of our highly skilled clinical workforce is crucial to the delivery of patient care. We are preparing to provide pension flexibility that appropriately balances the benefit of new flexibilities with their affordability. We have listened, and we are discussing the issue with the Treasury. As a first proposal, the consultation will set out a potential 50:50 option, offering 50% pension accrual and halved contributions. The BMA requested this as an option earlier this year and has welcomed it as a step in the right direction. The consultation will be an opportunity to listen to a range of views and will be genuinely flexible and open; we will bring it forward as a matter of urgency. I hope that that is a reassuring answer for the noble Baroness.

NHS Long-term Plan

Baroness Finlay of Llandaff Excerpts

Monday 1st July 2019 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare my interest as a past president of the BMA. It will take some years for the new workforce plan to come through. Given that the current NHS medical workforce crisis involves consultant and GP staff having to drop clinical sessions to avoid huge tax bills, what consideration is being given to abandoning the concept of annual allowance in relation to defined benefit pension schemes, and allowing tax relief to be limited by the lifetime allowance? The current situation means that people are dropping sessions. Combined with the GMC regulations around retirement and revalidation, this is forcing clinicians into permanent retirement, rather than coming back to work additional sessions, which would relieve the pressure on waiting lists in clinics, would help with teaching and supervision, and would offer experienced surgical hands in operating theatres to assist in complex operations.

[Baroness Blackwood of North Oxford]

The noble Baroness, as ever, asks a very perspicacious question. She will know that as part of the GP contract negotiations, pensions and other issues were raised, and are still under discussion. Similarly, issues around secondary care doctors are in discussions with the Treasury. These discussions are quite technical but the issues are under consideration. I am unable to give her a complete answer now, only to tell her that we are very alive to the issue and trying to find a way through.

People with Disabilities: Reporting Abuse

Baroness Finlay of Llandaff Excerpts

Monday 17th June 2019 Lords Chamber

[Baroness Blackwood of North Oxford]

Absolutely. The right reverend Prelate makes a very sensible, common-sense point: this is exactly why work is going on between the NHS and the ombudsman to ensure that, within the NHS, there is a sensible and consistent complaints process that is accessible to all who try to make a complaint within the system, no matter their circumstances.

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare my interest as chair of the National Mental Capacity Forum. Do the Government recognise that many people are frightened of reporting any form of abuse, because of recriminations? Even when they do, they are asked for evidence of the abuse and it may be very difficult for them to provide any kind of objective evidence. Therefore, within the whole care sector we need a change in culture: we need staff to learn ways of dealing with some of the most challenging behaviours that they may face, recognising those and differentiating them from other forms of aggression, which may be drug- or alcohol-fuelled, or whatever. That requires investment, so that the CQC and other organisations, in inspecting, will look at the quality of education provided to staff at every level. It is often the lowest-paid staff who need the most education and they cannot access it.

[Baroness Blackwood of North Oxford]

As ever, the noble Baroness speaks with experience and wisdom. Speaking up and raising concerns where there has been abuse or where something has gone wrong should be straightforward and met with openness and a desire to get to the bottom of the problem. She is absolutely right that there is often a cultural barrier—a fear of aggression or recrimination. A patient or carer making a complaint should feel that they will be listened to and believed, but a staff member raising a concern should also feel that there are safe avenues for them to do so. That is why we have put in place the national guardian and the “freedom to speak up” guardian. When it comes to carers and patients, that is also why we are working with the ombudsman to ensure that there are clear routes of complaint across the whole NHS so that it is straightforward for people to make complaints and they feel that these avenues are protected for them.

NHS: Shortage of GPs and Nurses

Baroness Finlay of Llandaff Excerpts

Wednesday 8th May 2019 Lords Chamber

[Baroness Blackwood of North Oxford]

The noble Baroness is right that driving out variation within the NHS is one of the key commitments of the long-term plan: it can be seen as a priority throughout every commitment within it. One of the ways in which we intend to do this is through the new undergraduate medical school places; the expansion in medical schools has been targeted specifically to address that. Those medical schools will be placed in key areas—Sunderland, Lancashire, Chelmsford, Lincoln and Canterbury—to ensure that we recruit doctors from right across the nation. That is something that I think she will welcome.

[Baroness Finlay of Llandaff (CB)]

My Lords, I declare an interest as the author of Medical Generalism, a report for the Royal College of General Practitioners some years ago. Do the Government recognise that while their moves to increase supply are admirable and welcomed by everyone, the problem is retaining staff? We have an increasing number of medical and nursing staff who, for reasons to do with taxation, their pensions and their revalidation processes, find that it is just not worth their while to carry on with the onward, uphill struggle to carry on providing services. I recently met some who have dropped off the medical register simply because the revalidation processes were just too cumbersome for them. These are good clinicians, whose skills are now being lost. Their skills are also being lost from the pool of people to teach the next generation of doctors coming through the system. These pressures are now having a knock-on effect in emergency departments, where waiting lists are going up inexorably, and we know that that is being reflected in the four-hour waiting targets. Talking to staff in emergency departments, they are routinely seeing situations that used to be unusually busy.

[Baroness Blackwood of North Oxford]

I thank the noble Baroness, who is very expert in this area. She is absolutely right that there is no point in our bringing new trainees into the system if we do not retain the expertise and the teaching quality within the system. We can be very proud of the quality we have within the system, which is why we have put in a number of programmes to address this. We have put in a targeted, enhanced recruitment stream to attract doctors into parts of the country where there have been consistent shortages. We have put a broad offer of support for GPs to remain within the NHS, including GP Career Plus, the GP Retention Scheme, the Local GP Retention Fund and the national GP Induction and Refresher Scheme. We have also put in place a number of schemes for nurses, including a scheme that will attract nurses into specific, targeted areas, such as mental health, learning disabilities and district nursing, where we believe we should make the career more attractive. We recognise that there is more to do, and in areas such as pensions, which the noble Baroness rightly raised, we are taking that issue up with the BMA and the Treasury.

Mental Capacity (Amendment) Bill [HL]

Baroness Finlay of Llandaff Excerpts

Ping Pong (Hansard): House of Lords
Wednesday 24th April 2019 Lords Chamber

[Baroness Murphy (CB)]

My Lords, I do not really share the enthusiasm or optimism of the noble Baroness, Lady Tyler, although I often shared her views on what needed to be done at earlier stages. We are all rather tired of this Bill and I see nothing to be gained from hindering its passage, but I cannot let it pass without expressing my profound misgivings. We—the Members of this House—have failed to do what we were supposed to do. Our task was to make the deprivation of liberty safeguards—now the “liberty protection safeguards”—more practical, more focused on those at risk, more cost-effective and safer, and we have allowed the Bill to disintegrate into a sprawling, all-encompassing bit of a nightmare. The procedures may be simpler—we have cut out one layer of bureaucracy—but we have allowed these provisions to be extended even further than Cheshire West, even pursuing people in their own homes in a way which I do not think many families will appreciate.

The one thing everyone, including the JCHR, was hoping we would do was to introduce a realistic definition of a deprivation of liberty. In the end, we in this House just copped out. We could not agree; we got into a mess; the lawyers could not agree either; so we have just said, “No, let us put it all in a code of practice”. As many noble Lords will know, I wrote some of the early codes of practice for the Mental Health Acts, and I know that codes of practice suffer from mission creep—they get more and more stuff in which is quite difficult for people outside in practice who will implement it, and do not get updated very regularly because it is difficult to do so. Indeed, if there is no clause in statute, which most codes are fixed around—and there will not be, of course, as is intended—it will have to be arranged around Article 5. That will leave a situation in which the lawyers will have a field day, and in which we will still be waiting for case law to give us some guidance.

Meanwhile, the numbers are going up. My latest count was 140,000—I think the official number a couple of months ago was 125,000. There will be a lot more soon. About a third—it may be even more than that—will be waiting for over a year, and 75% of them are elderly people with dementia, who will probably die before they get their rights looked at. Will it make any difference to them? Generally, it will not make one whit of difference. If we had done our job properly, the numbers would have gone down, and there is a chance that those at greatest risk—for example, people with severe dementia who are kept in locked units, who never see the light of day, and people with severe disabilities in residential care—would have been seen sooner and would have had their care plans addressed in respect of their freedoms.

Meanwhile, these last three years have seen an industry grow up around the implementation of DoLS. It is now called DoLS by everybody out there—I am not sure that most people know what that means. A costly public service has developed which has a life of its own, and which, as we have seen, takes money directly out of care budgets. When Staffordshire quite sensibly tried to call a halt and said, “Hang on a minute, let’s go for the worst cases: those most at risk, those with the most profound disabilities or where there is a disagreement”, somebody complained, and they were told in no uncertain terms by the Local Government Ombudsman to get on with it and to get back to doing everybody. So the waiting list grew yet again. Of course, many other county councils and metropolitan councils were making similar decisions, but they have all had to go back to compiling the waiting list, which grows and grows.

The other people who will love the Bill are the lawyers. Just imagine how you will be able to debate the nuances of Article 5 meanings when the code of practice fails to live up to expectations.

This Bill should be a lesson to us all. It is legislation which arose from a Supreme Court judgment—an impeccable theoretical case, made without any thought to the practicalities that would affect 2 million people. The Law Commission was as tied up in knots as everyone else and could not see a way through. My goodness, it worked long and hard on it in an admirable way, but it could not get beyond the problems of having to satisfy Cheshire West and the Supreme Court’s judgment. This House’s inability to grasp the Bill will not provide any more than a hit-and-run assessment of one patient’s disabilities and whether they are deprived of their liberty. It will not provide any more care for people, and it will be a bit of a disaster.

I have been as guilty as everyone here because I was not here for Report, when perhaps I should have been here to say this more clearly—I am sure that my colleagues quite often feel cross with me when I am not here, and I apologise for that. However, I am not blaming the Ministers either, who have, unfortunately, changed during the passage of the Bill, which has taken a lot longer than it should have done. They have struggled as best they can with a complex, technical Bill; nor am I blaming the team at the Department of Health, because Sharon Egan and her team have been squashed between the lawyers, the DoLS industry, the obvious need to make things viable and less depleting of care budgets, and the impossibility of satisfying everyone.

The only flexibility left—because we will pass the Bill—is that before the Bill is commenced, the Government should pause and do a few more sums; otherwise, we shall be back here in another three years, looking at how we can make this legislation more viable. Many more millions of hours of care staff time will have been wasted in failing to improve the care of mentally incapacitated people. Their rights need protecting, but this Bill will not do it.

[Baroness Finlay of Llandaff (CB)]

My Lords, I have taken a slightly different view. I declare my interest as chair of the National Mental Capacity Forum, and I am grateful to my leadership group in that forum for their comments, constant advice and constructive criticism. I am also most grateful to the Bill team, the noble Lord, Lord O’Shaughnessy, and the Minister for having listened. We have certainly given the Bill what we could term a bumpy ride. I think that needed to happen and do not apologise for it at all. From what I understand, the way the code of practice is now being developed will result in a far better situation.

Access to Medicinal Cannabis

Baroness Finlay of Llandaff Excerpts

Tuesday 9th April 2019 Lords Chamber

[Baroness Blackwood of North Oxford]

The noble Lord is right that it is important that guidance is provided. The point of bringing the guidance forward is to look at the most up-to-date evidence available across the country. The challenge with medicinal cannabis is that the evidence base is developing. Currently, more than 100 clinical trials are ongoing worldwide. We are bringing the NICE guidance forward in the autumn to take all that clinical evidence into account in the most up-to-date guidance, so that patients can benefit and clinicians can have more confidence in prescribing. The NIHR call for clinical trials has been brought forward so that the evidence base can be strengthened even further as we go forward because, in the long term, the only way for us to move from an unlicensed prescribing route, which is where we are now, to a licensed route is through clinical trials and a greater evidence base. That is what the Government are keen to encourage.

[Baroness Finlay of Llandaff (CB)]

Do the Government recognise that, whenever patients take part in a clinical trial, there will also be some patients who access the medication outside that trial? Are the Government establishing a confidential database to monitor the outcomes of every child who is prescribed a cannabinoid to look at its efficacy and any harms reported, so that we can get a cross-population database of the effects that could then feed into the evidence-accruing processes? It may be that a royal college such as the Royal College of Paediatrics and Child Health would be able to assist the Government by providing a confidential haven for such clinical data to be collected.

Safety of Medicines and Medical Devices

Baroness Finlay of Llandaff Excerpts

Thursday 28th February 2019 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, like others I congratulate the noble Lord, Lord O’Shaughnessy, on securing this debate, and welcome the illuminating contribution from my noble friend Lord Carrington in his maiden speech.

I will focus in this debate on the role of the National Institute for Health and Care Excellence, which is building on its 20 years of experience, and will look forward to what needs to be done. I declare that I am vice-chair of a guideline review group on ME and chronic fatigue syndrome, a review that was precipitated by patient voices and has good patient representation on it. I should also declare that my husband has done a great deal of work on patient and family-reported outcome measures, which may be relevant here.

NICE guidance covers, as we all know, the safety and efficacy of interventional procedures and the managing of specific conditions and medicines in different settings. Its technology appraisals of new pharmaceutical and biopharmaceutical products, procedures, devices and diagnostic agents are recognised around the world. Any device under consideration must have a valid and current certification, which comes from the EU at the moment, and be registered with the Medicines and Healthcare products Regulatory Agency. But the EU certification process itself seems at times to be flawed.

NICE has now gone into formal partnership with the MHRA to try to share intelligence and understanding, and to monitor key issues. However, adverse event reporting is a major problem for them in this work because it relies on clinicians notifying such events, as through the yellow card scheme. As with any voluntary reporting system, reporting is incomplete—sometimes woefully so. There is an inherent bias to report the positive benefits of interventions in research papers and underreport adverse effects. There were 62,000 adverse incidents reported over the last three years, a third of which had serious repercussions. However, this is only a small number compared with those that have happened across Europe.

In recognition of this, NICE rigorously reviews its current guidelines and seeks the sources of adverse events. Unfortunately, safety outcomes are poorly addressed in randomised trials; large numbers of treated patients are needed to reliably detect uncommon yet serious events from sources such as large case series, surveys, registers and individual case reports. Sometimes unpublished evidence is the sole source of such information. There are databases, including the US Food and Drug Administration’s manufacturer and user facility device experience database, called MAUDE. Importantly, this is available to the public and is used by sources in this country.

It is essential that safety information and evidence of harm are collected and rapidly disseminated. NICE’s medicine awareness service, with its network of prescribing associates and monthly digest of important new evidence in medicine, aims to reach out widely. But it must be strengthened, and it must have a database to draw on.

Changes to NHS structures in recent years have made dissemination more difficult because responsibility for the implementation of such guidance does not fall to any single body—hence NICE’s agreement with the four nations, a document on safely introducing new procedures. But we need to do much more to strengthen this. All NHS providers should ensure their governance structures require reporting of outcomes, including adverse events, as well as dissemination of information. Clinicians undertaking any interventional procedure, and the suppliers of devices and equipment, should be routinely asked whether any complications have arisen in the short or longer term rather than just leaving it up to them to decide whether such complications are serious enough to report. Patients must be asked too.

All this data can be entered on a mandatory relevant national register, maintained to a sufficiently high standard to deliver evidence to clinicians for decision-making and for informed funding decisions. The quality of registers at the moment seems to be disappointingly variable. Without efficacy and safety information, problems will continue to go undetected and unpublicised.

I turn briefly to another aspect of the control of medical equipment, which is the problem of purchasing. The review by the noble Lord, Lord Carter, highlighted the wastage of duplication and variable pricing—but price is not the only determinant. I will relate a simple problem that concerns syringes. The bulk buying of cheaper syringes seemed to be a good idea. However, they had to be discarded because the plunger was loose-fitting, which meant that, on injection, the contents of the syringe were bypassed and we did not know how much of the drug had been injected into the patient. Contracting had to revert rapidly to a previous, reliable supplier.

Many pieces of tubing, wiring, cannulae et cetera are used every day in clinical practice. They must be of the highest standard and must not break or fracture inside a patient, because major surgery might be required to remove them. I suggest that the light-touch regulation that we have had in the EU should be replaced by a tighter, more rigorous system, so that things are manufactured to a higher standard and we know where the components have come from.

In the last moments of my speech, I remind the House of a speech by Baroness Jowell, to which the noble Lord, Lord O’Shaughnessy, also referred in his opening remarks. She was inspiring on 25 January last year when she called for adaptive clinical trials and the right of patients to try novel therapies. The parents of Charlie Gard, who had type 2 mitochondrial DNA depletion syndrome, wanted him to try nucleoside therapy, which had been tested on type 1 but not type 2 of the condition. The drug would have been taken orally and dissolved in milk—with the only known side-effect being diarrhoea—at an estimated cost of around £5,000. Charlie died before his first birthday, having been denied the possibility of trying this, and his parents, with whom I have had several conversations, live in their bereavement with the haunting thought, “If only we could have tried it”.

In her speech calling for a new approach to novel therapies, Baroness Jowell said:

“It is about the power of kindness, support for carers, better-informed judgments by patients and doctors, and sharing access across more and better data to develop better treatments”.—[Official Report, 25/1/18; col. 1169.]


Sometimes we must allow people to take risks for the benefits of others, because data is critical. Safety sometimes means that we have to allow carefully assessed risks rather than resort to inactivity, so that we can develop new evaluation processes.