Medicines and Medical Devices Bill

Debate between Baroness Finlay of Llandaff and Lord Ribeiro

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

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

My Lords, this is a large group of amendments relating to expert registries. I have Amendments 95, 99, 100 and 101 and support the others in this group.

First, I welcome Clause 16, which the Government added during the Bill’s passage in the other place. The clause is a clear step in the right direction. Amendment 95, like Amendment 96, would build on this to ensure efficacy by tracking the use, and the outcomes from the use, of all medical devices rather than just a select few. We must not forget the conclusions of the Cumberlege review that registries are too

“few and far between and all too often prompted by catastrophe”. 

The Bill provides a prime opportunity to move away from that position. Without tracking all devices, we will allow another scandal, involving an as-yet-unknown device, to emerge undetected until many have been affected. A proper warning system is essential.

Amendment 99 seeks to make the list of objectives for regulations listed under Clause 16(2) mandatory rather than permissive. These should be minimum standards against which to hold any regulations the Government publish, not just aspirations.

Amendments 100 and 101 then seek to add to that list of standards. In doing this in Grand Committee, I would welcome some commitments from the Minister, setting out where the Government share the objectives in those amendments. In essence, the difference between the Government’s approach and mine is that the Government foresee a future in which some medical devices continue not to be tracked, hoping that their outcomes will be audited. I strongly believe that this is a mistake. 

Registries, which track patient outcomes through proper monitoring and audit, are an essential component of post-market surveillance and a prerequisite for patient safety. They should be the rule, not the exception. This is a principle that the Royal College of Surgeons of England strongly supports too. Indeed, its former president, Professor Derek Alderson, made this clear in his evidence to the review of the noble Baroness, Lady Cumberlege. As he put it

“a registry of its own right does not create patient safety; it’s just a list. The registry must contain information that can be audited”.

Essentially, as the Cumberlege review acknowledges, a registry is a registry only if it contains patient outcomes, which are then subject to expert oversight. To that end, Amendment 100, which is at the core of this group of amendments, sets out the following principles.

First, the use of all implantable devices should be recorded in a registry. That goes to the heart of the issues explored by the Cumberlege review and is surely the central lesson that must be learned from the unnecessary—and unnecessarily long—suffering of thousands of women whose experiences with mesh were horrific.

Secondly, other devices used in the course of operations should similarly be subject to outcomes tracking. I raise this in particular because it is not just devices left inside people that can later cause problems. We know, for example, that machines used in the heating and cooling of blood during open heart surgery can cause a Mycobacterium chimaera infection. The NHS now warns people of this risk, but it seems clear that the Bill should put in place measures to ensure that the use of particular machines is tracked, and that where infections develop later, a flag can be raised against that machine. To be clear, the machines involved do not actually make contact with the patient or their blood. The heater-cooler units contain two water tanks and tubing. One water tank uses warm water, which, through indirect thermal transfer, keeps the patient warm during the surgical procedure, often through the use of a warming blanket. The second water tank contains cold water, used, again indirectly, to cool the cardioplegic solution that slows or stops the patient’s heart to allow the surgical procedure to proceed. It is thought that where Mycobacterium chimaera develops in these machines, it can escape as aerosol—a fine spray—into the surgical area and thus cause infection from there. I raise the example simply to illustrate that medical devices are not only about what is left inside people, or even what comes into contact with people. The new provisions for information systems need to be flexible in recognising that.

The third provision of Amendment 100 is that information systems must be subject to expert oversight. That is to deal with the central point raised by the Royal College of Surgeons of England, which is that without this oversight a registry is just a list—not really a registry at all. A good example of a registry in action is the National Joint Registry, which is overseen by a steering committee of experts. The expert committee monitors outcomes achieved in joint replacement surgery, analysing procedures by brand of prosthesis, hospital and surgeon. Instances where performance falls below expected levels are highlighted to ensure appropriate investigation and follow-up. This is a standard we need to see replicated across surgical specialities and across the NHS.

Fourthly, and perhaps most critically, the amendment seeks assurances from the Minister that information systems set up under the Bill will provide a direct route for patients to report their own outcomes. Clinicians, of course, want to assume the best about the treatment they have commissioned and undertaken for a patient. It is a natural and not ignoble instinct to try to reassure a patient who presents with a problem following a procedure. There is human nature in a clinical transaction. When a problem emerges, patients are often reassured that they “need to give it more time” or “things will settle down”. Each GP may see only one or two patients who have been subject to a particular device or procedure. With follow-up appointments decreasing, these patients with problems can become invisible to secondary care. Yet the patients know that they feel worse, feel that they are not being properly listened to and speak to others in online communities, discovering a specific pattern of concerns.

The yellow-card notification scheme is greatly underused, and patients do not know how to self-report on it. For that reason, we need two ways for information to reach a registry. We hope that a majority will be tracked from patients, through clinicians. Where there are multiple instances of concerning outcomes, these should be flagged through expert monitoring, but there must be a failsafe for patients to approach the holders of the registry directly to have their outcome reported and considered in its monitoring. The fourth limb of Amendment 100 seeks to achieve this objective and Amendment 101 reflects the same principle. Together, the measures in Amendments 100 and 101 seek to implement this key conclusion of the Cumberlege review:

“A central patient-identifiable database should be created … This can then be linked to specifically created registers to research and audit the outcomes in terms of both the device safety and patient reported outcomes measures.”


That surely is the goal to which we must all aspire.

I want finally to address Amendment 104, to which I have added my name. The noble Lord, Lord Lansley, draws attention to the balances we have to get right in collecting all this data in the name of patient safety. As I said on a previous group of amendments, I hope and expect that dealing with consent to recording this data could and should be dealt with as part of shared decision-making between the clinician and the patient at the point of agreeing to a procedure. Of course, it should be open to a patient to have a procedure without the data being recorded, but they would have to be made aware of the increased risk to their own health if problems with a device used in the operation were later to arise.

I have sought to reflect this point in Amendment 100 by making clear that collecting data should be subject to patient consent. None the less, the noble Lord, Lord Lansley, offers another way to deal with the issue by putting in the Bill that regulations under Clause 16 should have regard to the Caldicott principles. I do not see how the Minister could argue with that and I hope he will be able to give a positive response.

This group of amendments is designed to assist the Government and to catalyse faster movement on their part. I understand that Ministers see tracking and auditing the outcomes from the use of all medical devices as the right direction of travel, but as yet we do not have a destination or an estimated time of arrival. We need to hear both from the Minister this afternoon. I beg to move.

[Lord Ribeiro (Con) [V]]

My Lords, I thank the noble Baroness, Lady Finlay, for introducing this group. As a surgeon, I will focus on the registries and, in particular, the National Joint Registry—the NJR—and the Breast and Cosmetic Implant Registry. The noble Lord, Lord Hunt, was Parliamentary Under-Secretary of State when the NJR was introduced in 2003, with the aim to

“improve surgery through learning from best practice, and … improve the quality of care to patients.”

The NJR is the largest of its kind in the world, with data from 3 million hip, shoulder, knee, elbow and ankle replacements. In the last year before Covid-19, nearly 200,000 hip and knee replacements were recorded. By analysing this information, surgeons are supported in choosing the best artificial joints for their patients. It helps surgeons decide whether their patients need to return to hospital by flagging up problems with a particular type of implant. I was lucky enough to have bilateral metal-on-ceramic hip implants. Had I received a metal-on-metal implant, I would be concerned, as the NJR in 2010 identified higher than expected revision rates for metal-on-metal implants, with metal debris damaging patients’ soft tissue and causing pain and loss of function. Without the NJR’s comprehensive registry, hospitals would be unable to track their patients’ progress and identify problems early. Similarly, the Breast and Cosmetic Implant Registry records implants used in patients, along with the surgeon and organisation responsible for the procedure, allowing patients to be traced in the event of a safety concern or product recall.

Medicines and Medical Devices Bill

Debate between Baroness Finlay of Llandaff and Lord Ribeiro

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

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

My Lords, I will speak to Amendments 86, 88 and 102, standing in my name, and in support of Amendment 103 in the name of the noble Baroness, Lady Cumberlege.

My purpose in this group is to underscore the critical importance of unique device identifiers in maintaining patient safety. Fundamentally, I ask your Lordships to reflect on the systems we have in this country more broadly, say in retail, for product recall where a safety issue arises. Let us say that a tumble dryer is found to be a fire risk, or a washing machine is liable to flood people’s homes: it is dealt with by a media campaign urging people who have the product, with the relevant model number and bought at the relevant time, to contact their retailer and the manufacturer directly. We may examine, as the Fire Safety Bill presently before the House illustrates, whether this system is adequate for domestic electrical products, but that is for another day.

This afternoon, I hope that we can agree that devices left inside human beings and used in their medical treatment should be subject to a more rigorous and effective product recall system than tumble dryers. Tracking is absolutely essential in order to ensure that, if a product is discovered to be faulty or to have adverse effects of some kind, others who have had that device used in their treatment can be contacted and, if necessary, examined.

What is more, we already have the technology in place to make this a reality. In July this year, Scan4Safety published an evaluation of six pilot sites where a system of scanning and tracking was used. At these Scan4Safety sites, all patients have a unique GS1 barcode on their wristband, which is scanned before a procedure. The system also involves scanning all equipment used for the procedure, including implantable medical devices, and the location in which the procedure takes place. At some trusts, staff have barcodes on their badges that they can scan prior to a procedure. The result is full visibility of what has been done to which patient, when and where. To quote the noble Lord, Lord Prior, who as chair of NHS England wrote a foreword to the report, this system means:

“The time taken to recall products falls to hours from days or weeks, clinical time is freed up—significant as the NHS continues to face workforce challenges—and effective stock management becomes straightforward.”


The system is good both for patient safety—providing complete traceability, speed and accurate recall, alongside reductions in drug errors and those terrible “never events”—and for cost and efficacy. It leads to cost-effective product ordering, more efficient staff with better staff well-being, the creation of accurate patient-level costings, and reductions in unwarranted variation. Across the six trusts, the pilot produced £5 million in recurrent savings and £9 million in non-recurrent ones. Perhaps more importantly, the system is said to have released 140,000 hours of clinical time back to patient care.

The purpose of my amendments is to adduce from the Minister—who I hope will be willing to help—an absolute commitment that the Government see rolling out Scan4Safety as the future of medical device use in this country, and that we will not have devices put inside people without a clear record, including of which surgeon put in the device, when, where and so on. We will come back in the group starting with Amendment 87 and Amendment 95 to talk about registries that track outcomes. They are an absolutely essential part of this picture. However, the bare minimum for registries to function is to have a full and accurate database of what devices have been used in procedures, and on which patients.

Amendment 86 addresses this issue directly by stipulating that the provision about unique device identifiers—barcodes—must be included in regulations on medical devices made under Clause 12 of the Bill and should be part of the thinking when it comes to packaging and labelling. Amendment 102 seeks to strengthen the later Clause 16 by making the regulations about unique device identifiers mandatory.

I will briefly address Amendment 103 on patient consent. The noble Baroness, Lady Cumberlege, and I are broadly aligned on this. Her report recognises the GDPR issues around recording data on patients and storing it in a database. She distinguishes between database, the subject of this group, and the registry, which is more complex and useful, and which we will discuss in a later group. There is an issue as to whether the database we are discussing here is subject to the same level of patient consent as a registry. In a registry, patient outcome data will be recorded, in addition to the simple fact of a device having been used. I will be interested to hear the Minister’s position on that, and I strongly support the idea in Amendment 103 that any distinction should be set out clearly in the regulations under this Bill.

For my own part, I would hope that the consent process and shared decision-making that are used between surgeons, radiologists and so on and their patients in deciding to go ahead with a procedure, could be used both to set out a routine action to make an entry in a database and to participate in more complex registries. We will examine the purpose of registries more thoroughly in subsequent groups. For this group, I hope that the Minister will respond by confirming a shared belief in Scan4Safety and set out a timetable for an equivalent scheme to be rolled out across the NHS. It is an approach which has the strong support of the Royal College of Surgeons and whose broad use around the country is long overdue.

I hope that the Minister will also ensure full consultation with the devolved Administrations to ensure that a system of coding is compatible with all systems across the UK. I beg to move.

[Lord Ribeiro (Con) [V]]

My Lords, it is a pleasure to follow the noble Baroness, Lady Finlay, who made a powerful case for knowing what happens to medical devices once they have been inserted. This was at the very centre of the Cumberlege review and to which I am sure my noble friend will draw our attention again, as well as to the key findings in this respect. Amendment 86 draws attention to the need for unique device identification information to be added to all packaging of medical devices, while Amendment 88 deals with the tracking of devices once inserted, as Clause 13(1)(h)(ii) requires information relating to the use of medical devices in individual procedures to be tracked and entered in a register or within hospital episode statistics data.

In my speech at Second Reading, I referred to Scan4Safety, which the noble Baroness, Lady Finlay, has just noted. In 2016, the Department for Health and Social Care awarded a total of £12 million to six hospital trusts in England for Scan4Safety demonstrator sites to investigate how the consistent use of point-of-care barcode scanning might improve efficiency and safety within the NHS. The noble Baroness also outlined the benefits of the GS1 barcodes. The result of the GS1 is a comprehensive, real-time view of stock, including that which is about to expire, as well as a complete audit trail. An audit trail is key to identifying problems with devices when they occur and to keep track of them in the future, as it may be many years before complications occur. Total hip replacements are one example. I have two of them, so I have a vested interest in knowing about the long-term future of those prostheses.

In June 2020, Scan4Safety published a report entitled A Scan of the Benefits. It gave two examples that are worthy of note and of repeating. In the North Tees and Hartlepool NHS Foundation Trust hospital orthopaedic department, barcodes helped to ensure that the correct patient is listed for the correct operation on the correct side. All items and implants are scanned before use. If the incorrect prosthesis is selected, for example a right knee implant for a patient who is supposed to be having an operation on the left knee, the barcode scanner buzzes and flashes, immediately notifying the potential error. At Leeds Teaching Hospitals NHS Trust, following the introduction of Scan4Safety, the average time taken to recall a product has fallen from 8.33 days to less than 35 minutes. The organisation reported £84,411-worth of staff efficiency savings on recall between January 2016 to December 2017 alone.

In Clause 16 on information systems, while I welcome the provisions, surely they are worthy of being strengthened by not using “may” so often. We need to move away from “may”, and its implied “perhaps”, to “must” and the implication that it will actually happen.

I shall end by restating my comments at Second Reading. The Government must undertake to mandate the tracking of all medical devices that are used in the UK, rather than a select few. I hope that these amendments will provide a means to do so. The Cumberlege review rightly recommended that a central patient identifiable database should be created, collecting key details of the implantation of all devices at the time of the operation. In the light of this, we strongly urge the Government to apply the powers provided for in Clause 16 as well and as widely as possible.

To give assurances in the context of this amendment, the Royal College of Surgeons believes that the Government should publish their intended regulations under Clause 16 in draft before Report, as they have for the various regulations on medicines. Early sight of the regulations would establish whether the Government intend to apply the powers covered by Clause 16 widely enough to satisfy the recommendations of the Royal College of Surgeons and those of the Cumberlege review.

In closing, perhaps the Minister would update us on the future of the medical devices information system and its application to the private sector.

European Union (Withdrawal) Bill

Debate between Baroness Finlay of Llandaff and Lord Ribeiro

Committee: 6th sitting (Hansard): House of Lords
Monday 12th March 2018 Lords Chamber

[Lord Ribeiro (Con)]

My Lords, I support the amendment because I think it is very important after all the points that have been made by previous speakers.

In my Second Reading speech, I referred to something slightly different: a loss of some £32 million to nuclear research, which would have gone to 25 university institutions, as a consequence of leaving Euratom and the Horizon 2020 project. The key benefits of the CTR are the improvement in collaboration, information sharing and decision-making between member states, as well as maintaining high safety standards for all participants in EU clinical trials. Withdrawing from these arrangements will have a negative effect on UK research and clinical trials.

The PM’s speech has been mentioned. It is worth reading because this is perhaps about holding her to account. She said:

“We will … explore … terms on which the UK could remain part of EU agencies such as those that are critical for the chemicals, medicines and aerospace industries”.


There is an opportunity here to hold her to account because it sounds as if the decision that was made early on to withdraw from Euratom was rather hasty and the consequences of it are only now beginning to dawn. The amendment is essential to re-establishing the research collaboration that we need with the EU, which has benefited us greatly in the past.

[Baroness Finlay of Llandaff (CB)]

My Lords, much has been said in support of the amendment. I do not see how the Government can argue against us going along with the flow of modernising regulation.

I hope that in responding the Minister might consider what we will lose if we do not go down this route. Quite apart from losing the ability to attract pharma here and so on, it is important to record that many research groups that currently collaborate with European researchers know that their only future to pursue research—and want to do so under the new, better framework—means that they will effectively have to move, either to Dublin or Amsterdam. Those are the two main university hubs currently being looked at, although others in other parts of Europe are too. It becomes very easy for very high-powered researchers to move into different academic units, yet if we do not have biological and life sciences research here as new discoveries are made, we will not reap any economic rewards from those discoveries—quite apart from then not having the industries to produce whatever has been discovered.

I hope the Minister will consider very carefully that the amendment is absolutely essential going forward. Irrespective of what we think of Brexit, we need to be part of this group. If we are not, we will massively become a loser.

Health and Social Care (Safety and Quality) Bill

Debate between Baroness Finlay of Llandaff and Lord Ribeiro

Friday 13th March 2015 Lords Chamber

[Lord Ribeiro]

My Lords, I thank the Minister for clarifying the issues around the consistent identifier. It is interesting that the use of the consistent identifier and the sharing of information was welcomed at Second Reading by the noble Lords, Lord Turnberg, Lord Willis of Knaresborough and Lord Hunt of Kings Heath. The noble Lord, Lord Hunt, confirmed that the Opposition were very supportive of sharing a patient’s information, which, as he said, was,

“clearly in the best interests of their patients”.—[Official Report, 6/2/15; col. 961.]

That slides me very easily and comfortably into Amendment 5 and the question of best interests, which, again, has been addressed. I must confess that I have always used, and continue to use, the term “best interest” without assuming that this can be used only about those without mental capacity, as defined by the Mental Capacity Act 2005. It is my understanding that in these clauses the phrase “best interests” assumes its general meaning and provides a relevant person with a duty to act in the individual’s best interest when providing information for direct patient care. That is my understanding of the term.

As regards Amendment 6, patient control and choice about how their information is used is the subject of wider government policy. I believe that what needs to be done in that respect has already been illustrated. It is about empowerment of the individual and giving them control over their own information. I also welcome the intervention of the noble Baroness, Lady Hollins, in highlighting a key piece of information in patient care. Her description of a patient who died after surgery for want of the right word when asked a question—the patient answered incorrectly, which led to a fatal outcome—was truly revealing. In my experience, it is critical that if an individual has particular communication needs, those who provide care or treatment should know about them beforehand.

I am confident that the requirements to share information in support of direct care in the Bill already encompass communication needs. The Minister commented that Mencap has sought reassurances that health professionals should become more aware of the ways in which people can communicate their health and care needs. I am sure that, from his statement earlier, work on this will take place to ensure that those concerns are met. With those comments, I hope the noble Baroness will be happy to withdraw her amendment.

[Baroness Finlay of Llandaff]

My Lords, I am grateful to the Minister for being so clear in addressing the issues that I have raised and for the supportive further clarification sought by the noble Lord, Lord Hunt, of Kings Heath. It will ensure that the term “best interests” is attributed only its ordinary meaning and not misinterpreted for the purposes of this Bill as meaning “best interests tests” as outlined in the Mental Capacity Act. I am also grateful that the guidance and the Explanatory Notes will be amended as both noble Lords have outlined. I appreciate the welcome of the noble Lord, Lord Ribeiro, for how the debate has gone and what has happened. I therefore beg leave to withdraw my amendment.

--- Later in debate ---

[Lord Ribeiro]

In following the Minister, perhaps I may deal, first, with “well-being”. At paragraph 3.20, the Law Commission’s report states:

“We disagree with the criticism of ‘well-being’. This term has already been incorporated without difficulty into the main duties or objectives of many of the regulators”.

Within that context, it feels strongly that that term cannot be misinterpreted.

The Bill introduces consistent objectives for the PSA and the regulators based on the proposals of the Law Commission’s review last year. Most of the professional regulators have some form of main objective. Although they are not consistently expressed they are generally to protect, promote and maintain the health and safety of the public. It is the health aspect with which the noble Baroness, Lady Pitkeathley, was particularly concerned at Second Reading. I think that that concern has been allayed today.

It is clear that public protection—by “public” I of course include patients—is sufficiently important that it should be adopted expressly in legislation. Defining public protection in terms of these three elements to be pursued by the regulators and the PSA as their overarching objective enables public protection to be considered in its fullest sense. That should give comfort and reassurance to the noble Baronesses who have spoken. With that, I hope that the noble Baroness will agree to withdraw the amendment.

[Baroness Finlay of Llandaff]

My Lords, I am most grateful to the noble Baroness, Lady Pitkeathley, for having expanded on and brought better definition to the points that I was trying to make on the amendments and for the clarification that we have had from the Minister and the noble Lord, Lord Ribeiro. I therefore beg leave to withdraw the amendment.

Assisted Dying Bill [HL]

Debate between Baroness Finlay of Llandaff and Lord Ribeiro

Friday 7th November 2014 Lords Chamber

[Lord Ribeiro (Con)]

My Lords, I should like to speak as we have heard many noble Lords speaking but we have not heard from the medical profession. Noble Lords will have heard that the majority of doctors are not supportive of being involved in the decision-making process. The reason is very clear. I, as a surgeon, on more than one occasion had to deal with children and adults—but children particularly—whose parents were Jehovah’s Witnesses. If an operation was needed that required transfusion there was a dilemma between my opinion that surgery and transfusion were necessary to save that child’s life and the parents’ decision that under no circumstances was a transfusion to be given.

What has made life easier for doctors is that we can now go for a judicial decision, made by the judges as to what should happen. That happens when, as was mentioned earlier, you have to divide a Siamese twin, to which the noble Lord, Lord Pannick, referred, or when you have to switch off the machine. These are important life and death decisions. Surgeons have always been referred to as people who play God and carry out life and death decisions, but the fact is that this is a situation in which they feel comforted that the decision is taken outwith their domain and taken by the judiciary. The same principles apply here, in this case.

I am slightly varied in terms of whether I support the noble Lord, Lord Pannick, or the noble Lord, Lord Carlile, but, in either case, doctors should be as far removed from decision-making as possible. If it is decided that assisted suicide should then happen, the mechanism and how it is done and whether it involves the medical profession is something to which we can then apply our minds. But the initial decision must be underpinned by the judiciary.

[Baroness Finlay of Llandaff (CB)]

My Lords, as another doctor I follow the noble Lord, Lord Ribeiro, who has explained so clearly why doctors do not feel that they should be involved in this. Indeed, my feeling is that the noble Lord, Lord Pannick, has made a very important first step, but I worry that his amendment does not go far enough. For that reason, the amendment tabled by the noble Lord, Lord Carlile, about which we will hear more in further groupings, is the way forward.

I reassure all Members of this House that compassion is at the heart of those who do not support this Bill. My objection is on public safety to protect those who are vulnerable. I declare an interest, having looked after these patients for more than a quarter of a century. I have looked after thousands of people—I have had hundreds of conversations with people who wanted their lives to end. Then we have done things, and they have not persisted with those requests.

I address very briefly the issue of finance. Please do not forget that many people who are dying are already reliant on charitable funds of different sorts to support them. I do not believe that it is beyond the wit of our society to find a way of having pooled funding that can be drawn on to support the fees for a legal process where it is absolutely right to go through one, and society deems that it is. It is dangerous to have the illusion that money would get in the way.

I address a couple of points that have already been raised in the previous excellent and outstanding debates, when examples were given of poor pain control. As a clinician, I was horrified at the bad care. There is no excuse for not redoubling efforts to relieve symptoms or to withhold analgesia from someone who needs it; even if you know that you are taking a risk and you are clear with it, there is absolutely no excuse, and our law does not require doctors to withhold all efforts to relieve distress. But doctors have to look after patients, and we are often in a difficult situation.

The noble Baroness, Lady Mallalieu, laid out very clearly the problem of coercion and coercive pressures, and I completely agree with her. There are external pressures, and pressures now coming from healthcare. Sadly, it is true that not all doctors are good doctors. At a meeting this week, we heard from the CQC that 2% to 3% of general practices will probably have to go into special measures and that 20% to 30% are below substandard. Yet the Bill without these amendments leaves decision-making in the hands of people—we know not what. We will go on to address all the inadequacies in the Bill.

There are families where there is carer fatigue—they are worn down. I have had families refuse to take patients home because they are fed up with their relative. That is a really difficult conversation to have with anybody. Indeed, I have had relatives pressurise me to give something to end a life and get it all over with—yet the patient has not wanted their life to be ended. As I have already explained to your Lordships, I discovered later, after the birthday of one female patient, that it was her fixed-term life insurance policy running out that drove the request to push up the drugs. After her birthday, they did not get the extra money and they visited less. I am afraid that I was taken in before I knew that, and I have been taken in time and again—because, while most parents love their children, sadly, not all children love their parents. It is difficult to detect coercive pressures, but then there is also the selflessness that patients may feel when they know that they are imposing a burden on their family.

Let me give a cogent example. I was asked to see a man by a GP who said that the man was a clear case for euthanasia or assisted suicide but that he could not give him a lethal injection. That was the only reason the GP was referring him. The consultant surgeon, oncologist and GP all thought that the man had a life expectancy of three months. His wife had just given birth to their third child. There was a small baby there. I went straight out and I was there until 11 o’clock that night. The distress was overwhelming. Weeks later, the distress was calming down. Much later, when I had conversations with that man, he said that the pain had been overwhelming and the prospect of becoming paraplegic and wheelchair-bound was overwhelming and terrifying but that also at the back of his mind he wondered how his lovely, beautiful postnatal wife could cope with their three children, particularly the new baby, and look after him as well. He felt that it might be best for everybody if he was not there. I spoke to him this morning. He said that I could relate his story. He can see the dangers of what is proposed because he lived way beyond three months. We will discuss prognosis and the difficulty of determining who is terminally ill later.

However, if the court were to receive evidence from experts, not the doctors described in the Bill, and assessment of capacity were done properly by experts, the court could make a balanced decision and that would not contaminate the way that clinicians behave. It would not put clinicians under a lot of pressures which are difficult to untangle and it would maintain their prime duty to relieve the distress of the patient in front of them, and to help the family and carers cope and redouble their efforts when they fail. It is for that reason that I think the Bill is wholly inadequate without such a control.

Children and Families Bill

Debate between Baroness Finlay of Llandaff and Lord Ribeiro

Wednesday 5th February 2014 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, it has been an enormous privilege to be part of the movement across all Benches in this House to do something about controlling the use of tobacco, particularly in relation to child protection. Tobacco control has for many years been something that medicine, the discipline from which I come, has been arguing and pushing for. It is with a great sense of relief that I see these amendments before us today.

I thank everyone who has contributed to these and previous debates, but I especially thank the noble Earl for the way in which he has remained in contact, listened to discussions, been very open to suggestions and has really taken on board a rapidly changing landscape in the atmosphere of this House, which has supported these moves. I would have added my name to the other amendments had I not been so busy checking the one to which I did add my name before the time ran out.

The issue of e-cigarettes is really important; they have crept up on us rapidly. They give a bigger nicotine hit, so users say, than cigarettes and they have flavourings that are likely to attract young people. So, moves towards controlling them as well are really important. I know that the Chief Medical Officer has looked at this carefully and is concerned. I share those concerns, as do many others in my discipline of medicine. I hope that in the years ahead we will see a drop in cigarette and tobacco-related diseases presenting in our A&E departments, GP surgeries and hospitals.

[Lord Ribeiro (Con)]

My Lords, I add my appreciation to my noble friend the Minister for getting us to the point where we are today. Little did I wonder when I introduced my Private Member’s Bill way back in July 2012 that we would actually be at this position. As the noble Baronesses, Lady Finlay and Lady Tyler, rightly said, this has been a cross-party initiative right across the House. I am grateful for the conversations that I have had with my noble friend and for the way in which the Government have shifted their position both publicly and privately. That is very rewarding.

Thanks to the Tube strike today, I came in by taxi. The best way to find out what the average member of the British public thinks about anything is to ask your taxi driver. I noted that he had a no-smoking sign in his cab. I asked, “What do you think about this Bill on smoking in cars that we might be able to resolve today?”. He held up a packet of cigarettes, to my surprise, and said, “I’m a smoker. I don’t smoke in the cab, I go outside to smoke. Why would anybody want to smoke in a car with children present? Why would they?”. That was his reaction. When we know that 85% of smokers think that it is bonkers to smoke in a car when children are present, we realise that we have finally made the point that this is more about child protection—protecting young children with young lungs, who are likely to end up with long-term respiratory problems—than it is about removing personal liberties.

I hope that the Government will continue to re-energise this educational programme because it is that 15% of the public who do not recognise the importance of not smoking in cars that we need to get at. I have every confidence that the Government will do so. Legislation can always be used as a blunt instrument but it is interesting that, since the seat-belt legislation was brought in, the current compliance rate is more than 90%. Some 95% of people who clunk-click would never even think of driving off without putting their seat belts on. In years to come, I hope that people will wonder why they ever smoked in cars with children present.

Children and Families Bill

Debate between Baroness Finlay of Llandaff and Lord Ribeiro

Wednesday 29th January 2014 Lords Chamber

[Lord Ribeiro]

I greeted that event with jubilation. I would not want that grandson to go through life having his young lungs damaged by cigarette smoke. I am concerned about that. Cigarette smoke contains a cocktail of carcinogens: arsenic, cadmium, formaldehyde, benzene and in particular the fine particulate matter that comes out of cigarettes when they are smoked. This can cause long-term damage and illnesses.

My Amendment 62, which mimics the Private Member’s Bill that I took through this House in 2012, serves to make parents and the public aware of the risks and to provide educational programmes to rehabilitate them through smoke-free driving awareness courses. I believe strongly in education and behavioural change, rather than the imposition of punitive measures. It is about providing incentives to change behaviour, not dissimilar from the police driving course which noble Lords may have been offered if they have ever been unfortunate enough to have been caught speeding. There may be some in this Chamber who can endorse the benefits of that.

In that sense, my amendment is exploratory, seeking to obtain answers from the Government on two specific issues. The first is education to change behaviour, as I explained. Here, I applaud the Government for their successful advertising campaign launched last year, with its graphic films of children assaulted by smoke in the back of cars while parents in the front are oblivious to the damage being done behind them, probably because the driver has a window open and therefore assumes that all the smoke is going outside. I should like assurances from my noble friend that the Government will repeat that successful campaign and undertake an extensive evaluation of its effects. We must know that behavioural change is happening.

I am sure that the Government have taken note of the Welsh Government’s Fresh Start Wales campaign. I made reference to this at Second Reading and asked whether the Government would again consider mirroring what the Welsh Government were doing. That Government are due to report in the spring on the result of their campaign, following which they reserve the right to introduce legislation if no improvement in behaviour is apparent.

My second question to the Government relates to a national consultation, which should involve the public, the profession and the retailers, to decide whether legislation or non-legislative measures are required to protect children from smoking in confined spaces. I am pleased that my noble friend has asked Sir Cyril Chantler to undertake an independent review of the public health evidence on standardised tobacco packaging and its effects on public health. Might he perhaps also consider asking Sir Cyril, at the conclusion of this review in March, to undertake a similar review of the effects of second-hand smoke on children travelling in cars? There is plenty of evidence out there but what is now needed is the clinical evidence that shows that smoke causes long-term damage. We know that the long-term sequelae from smoking in adults are quite severe. If we can demonstrate that they start at a very early age, that will be very good evidence for taking action now rather than later.

My amendment provides the Government with measures to change behaviour. They may have started with good intentions—and I am sure that they have. Standardised tobacco packaging will reduce the risk of smoking and its damaging effects on children. I hope that the Government will take the view that legislation, although difficult, may need to be considered. However, for legislation to work, I understand that it must be proportionate and enforceable. In this respect, my amendment is probably defective, as it will be difficult to police and to enforce, much in the same way, I suppose, as is the case with the mobile phone offence, which is legislated for but is difficult to police.

I hope that my noble friend will provide me with some of the concessions that I seek. I do not think that they are small ones but they will help to ensure that over the next year, and certainly over the next three months when we hear the results of the Welsh review and Sir Cyril Chantler’s review—and it is to be hoped that he will extend that further—we will have more information on which to make a decision as to whether we should introduce legislation or non-legislative measures.

[Baroness Finlay of Llandaff (CB)]

My Lords, I have put my name to Amendments 60 and 62. I will first address Amendment 60 on standardised packaging and move on to the amendment to which the noble Lord, Lord Ribeiro, has spoken so eloquently. I hope to avoid covering the ground that has already been covered. In terms of standardised packaging, those of us who contributed in Committee to a very powerful and widely supported debate across the House are grateful to the Government for having done exactly what they said they would; namely, take the proposal away and look at it. They have returned with an elegant amendment. Before finally legislating, it seems wise to have an independent review by Sir Cyril Chantler.

This is definitely a public health and a child protection measure. I should like to address that briefly but not repeat what was said previously. The Minister has already said how many children start smoking before the age of 18. That figure is particularly high in looked-after children, where about one-third report that they are current smokers. However, when looking at children in residential care, the figure rises to more than two-thirds. There is a real problem with very vulnerable children.

In 1999, the tobacco industry’s magazine, World Tobacco, said that,

“if your brand can no longer shout from billboards … it can at least court smokers from wherever it is placed by those already wedded to it”.

The problem is that we know that tobacco is a highly addictive substance, and that the products of tobacco damage health and do not have any positive benefit. Recently, a study published in the European Journal of Public Health has shown that,

“the removal of brand imagery from tobacco packaging reduces the appeal of tobacco products, including perceptions of brand attractiveness and smooth taste and perceptions of lower tar or lower health risk”.

Those perceptions are an illusion. The study was in the UK, and I am sure that it will be considered in the evidence review and that Sir Cyril will be an independent reviewer in every sense.

It is worrying that it has taken us so long to get to this point. Like other noble Lords who have put their name to this amendment, I sincerely believe that the day will come when we will see standardised packaging. That day is not far off, because research study after research study reports are reinforcing that standardised packaging is making cigarette packs less attractive to young people.

I have had discussions with Her Majesty’s Customs as regards illicit trade. It pointed out that it is not that difficult to detect counterfeit standardised packaging, just as it is not difficult to detect other counterfeit packaging. Indeed, the cover marks, number codes and security marks are the clue, rather than the bald, external appearance of the pack. It also is well aware that tobacco firms have been producing and exporting cigarettes far in excess of any known demand in a stated target market abroad, knowing that this excess production will be smuggled back into the UK. The tobacco companies appear to have been complicit with what has been termed the illicit trade. It seems logical that this move and the government amendment are because of child protection issues and the importance of preventing children from starting to smoke.

On tobacco and smoking in cars, the British Lung Foundation study, which was addressed by the noble Lord, Lord Hunt, included another set of figures which I hope the House will consider. One has to remember that the children responding in the study were of an age at which they could answer competently. When asked about being a passenger in a car, 31% said that they had asked someone to stop smoking but 34% said that they had not dared to ask because they were too frightened or too embarrassed. The child in the back seat, belted in, is effectively imprisoned in the vehicle for their own safety while travelling. They are stuck there. They have no control over what the adults do, and it is worth remembering that they do not feel able to do anything about it either. As was pointed out by the noble Lord, Lord Hunt, if they are in a house, they can move to another room or another area and the volume of space is much greater than in a car.

Health and Social Care Bill

Debate between Baroness Finlay of Llandaff and Lord Ribeiro

Wednesday 8th February 2012 Lords Chamber

[Lord Ribeiro]

My Lords, I follow the noble Baroness in saying that I am speaking not because I see this as an amendment that should be pushed to a vote, but rather because I see it as a probing amendment that would allow the Government and the Minister to listen to the arguments being put today.

The whole thrust of the reforms is to provide care right across the community—secondary care, primary care and, let us not forget, social care. The mental health institutions started to be closed some 30-odd years ago, and care moved into the community. The ability to identify, diagnose and treat patients admitted into accident and emergency departments, often with psychotic diseases, is a major challenge. It certainly is for surgeons—for me in particular. As more psychiatrists are diverted to care in the community, the diagnosis and treatment of patients who appear in A&E departments is a challenge. It is quite difficult for those of us who have not had psychiatric experience. I was very fortunate that my house officer rotated through a psychiatric firm, so I had the benefit of somebody who was able to identify patients with psychotic illnesses and could advise me how best to deal with them.

It is important to identify the difference between physical and mental illnesses. I feel that this amendment would make a difference by clearly stating that there is physical illness and mental illness in this section. I very much hope that the Minister will listen to the strength of the debate and come back with some answers.

[Baroness Finlay of Llandaff]

My Lords, I hope that the Minister will be able to break away from his brief and accept this amendment, because it is critical. As my noble friend Lord Walton has pointed out, the first part of the amendment talks about physical and mental health, but the second part implies that prevention, diagnosis and treatment are of illness, and there is a real danger of reading that as physical illness. The most tragic situation is where physical illness is misdiagnosed as mental illness or mental illness is misdiagnosed as physical illness. The consequences of that for patients can be disastrous.

In primary care, patients present with a completely undifferentiated picture. The general practitioner has to start from scratch, sort out the different parts and then refer to or consult other parts of the service, as appropriate, if he needs to. My noble friend Lady Meacher suggested that those services are in imbalance, and I agree with her that there is a danger when funding is short that you will lose the mental health component of services and that the culture change that this Bill is meant to bring about will not happen. A culture change is needed. Stigmatising labels have been attached to people with mental illness for many years. People with learning difficulties do particularly poorly in services overall. If we are going to take the opportunities of this Bill, we have one with this amendment: to flag up that there are mental and physical components to illness that need and deserve accurate diagnosis, the one as much as the other, that they are interrelated, that one affects the other and that we cannot provide a comprehensive health service without due regard to the totality—to the holistic person who is the patient in front of us.

Health and Social Care Bill

Debate between Baroness Finlay of Llandaff and Lord Ribeiro

Tuesday 25th October 2011 Lords Chamber

[Lord Ribeiro]

My Lords, I thank the noble Lords, Lord Walton of Detchant and Lord Patel, for introducing this amendment. It highlights not only the importance of education and training in advance of the report that we will receive later in the autumn from the Future Forum group, but the fact that the Government have responded with an amendment of their own. That identifies the importance of bringing it on to the face of the Bill, so much so that it is right at the very beginning of Part 1. It is one of six duties that the Secretary of State now has to perform. That is very important.

It is quite understandable in a Chamber such as this one, full of doctors, that we tend to overemphasise the importance of medical education. As the noble Lord, Lord Turnberg, rightly said, nursing will be discussed later. However, it is not just about nursing. My wife is a physiotherapist—there are physiotherapists, radiographers and other healthcare workers as well. That is why the Government’s amendment talks about education and training without qualifying exactly which areas we are discussing. It is important that we bear that in mind.

The noble Baroness, Lady Finlay, I think, referred earlier to the independent sector treatment centres and the lack of training in that area. I must declare an interest as a past president of the Royal College of Surgeons. I had countless negotiations with the Department of Health to put into place a requirement for independent sector treatment centres to be able to train. The big issue was that all the surgeons and the ISTCs were overseas doctors. No UK doctors were allowed to train. We asked for a way in which we could introduce NHS consultants into what was effectively spare elective capacity. I fundamentally believe that we must separate emergency and elective surgery to produce the best-quality care for patients.

As a consultant, I would regularly do an out-patients’ clinic at Basildon hospital on Mondays. If I was also on call, as I sometimes was, I could be told that there was a patient in the emergency department who needed urgent treatment. That would ruin my out-patients’ clinic because I would have to go to theatre and sort out that patient. Our last assessment showed that 64 per cent of the general surgeons in Great Britain and Ireland have a responsibility to be on call while they are doing elective work. If you have that degree of commitment to doing two things, you cannot provide the best possible care for your patients. If NHS consultants could structure their work so that it was possible to work in a centre which was perhaps in the hospital—there are a few hospitals, including one in Nottingham, with elective centres within the hospital—or perhaps outside, they would be able to take their registrar and SHO to the independent sector and they would be able learn how to carry out the surgery.

[Baroness Finlay of Llandaff]

Perhaps I may ask for clarification from the noble Lord. I am not sure whether he is advocating that the duty in the government amendment should or should not be on every provider, whichever sector it is in. I tried to make it clear that I felt that the duty to provide education should be on everyone who provides patient services. I was hoping that the Minister would clarify that that was what was in the Government’s mind, so that history—what had happened before—could not be replicated.

[Lord Ribeiro]

I accept that point, although it might be difficult to implement when you consider the third sector and the voluntary sector, which may not be in a position to undertake education and training. That is a point to bear in mind.

[Baroness Finlay of Llandaff]

Forgive me but, as someone who works hugely in the voluntary sector and is a patron of many of the healthcare providers, perhaps I may point out that they carry out a great deal of education. An example is Marie Curie running NVQ courses for care assistants across the whole country. They are trying to drive up the standard of care given by people who are absolutely not at the medical end but whose care is critical to the quality of service that patients receive.

[Lord Ribeiro]

The noble Baroness makes her case but there is a wide spectrum of medical provision, and the question is whether this could be applied to every single provider. I am not clear about that but perhaps the Minister will be able to address it.

Returning to the question of training, I believe that through the Bill there is an opportunity, perhaps when the contracts for some of the independent sector treatment centres are up for renewal, to give some serious thought to whether these centres could provide the extra capacity that the NHS desperately needs if it is to go forward with the functional separation of emergency and elective care. I am of course talking about surgery and I recognise that that is a special case. None the less, we come from a history of one type of surgical provision to the situation in this Bill. If we are talking about quality as the indicator of the outcomes that we are looking for, it may well be possible to achieve this by utilising the ISTCs for NHS consultants. I shall give way if the noble Lord wishes to speak.