Medicines and Medical Devices Bill

Lord Russell of Liverpool Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

In that regard, could the Minister explain where the anxiety is in terms of giving safety a priority above the other two important elements, which are availability and attractiveness? Is it because clinical trials methodology—[Inaudible.]

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

We seem to have lost the noble Lord, Lord Kakkar.

[Lord Kakkar (CB) [V]]

Or is it that in some way—

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

Lord Kakkar, please keep going. We lost you for a minute.

[Lord Kakkar (CB) [V]]

Is the Minister able to indicate why there might be anxiety about giving priority to safety? Is it because methodology by way of clinical trials evaluation is not sufficiently well developed to make that a statutory principle for the availability of medicinal products or medical devices? Is it that there might be some basis for legal challenge that would make this ill-advised? If not, it appears that putting safety at the forefront is in the interests of patients, our healthcare system, clinicians and the standing of our country as a place to lead in the development of the life sciences.

Medicines and Medical Devices Bill

Lord Russell of Liverpool Excerpts

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

[Lord Mackay of Clashfern (Con) [V]]

My Lords, the Bill will confer a power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices. I respectfully submit that a power to create a system to protect the public in relation to all three, but particularly two of them, is well within the scope of the Bill.

When I first read the report of my noble friend Lady Cumberlege, I was extremely upset by what it disclosed. When the noble Lord, Lord Hunt, followed me last time, he said that doing so was a privilege. I want to say that following him is a tremendous privilege because he knows much more about the internal structures of the health service and its related services than I do.

I was privileged to represent the Medical and Dental Defence Union of Scotland for a good number of years before I joined the public service. The work was concerned primarily with mistakes of one kind or another that doctors or dentists had been involved in, but the need for safety was absolutely clear in most of the cases I was involved in. The first time I ever came to the House of Lords was on the instruction of the Medical and Dental Defence Union of Scotland, but of course, that was long ago. The case concerned the safety of a patient.

The message that cries out from the report of the committee chaired by my noble friend Lady Cumberlege is that people are suffering considerable harm as a result of treatments given in the health service, but they have no one to turn to. There is no direct public voice for patients to come to and discuss the matter. It is essential to have someone to whom patients can bring their concerns, which may not always be complaints. It may start as something much less than a complaint—a concern that becomes a complaint if not attended to in any way.

It is essential that somebody with authority and complete independence of the health service be put in place now who is able to listen to what any patient may want to say in connection with the treatment he or she has received. There is a huge deficiency, as has been exposed clearly by the examples given in the report. Therefore, there is an urgent need for Her Majesty’s Government to deal with that immediately. It is all very well to say that it is not this or that, but the truth is that this is urgent, because people are suffering and have suffered from the absence of anybody to whom they can turn in situations such as those described in the report. The Government would be heavily at fault if treatments and difficulties of this kind emerged in the future without them having done anything about it.

The setting up of a patient safety commissioner seems to require in the first instance the appointment of a completely independent person who would be a voice for patients, with a knowledge of the service but independent of it. He or she could bring a patient’s question or trouble to the attention of the part of the service that was intimately concerned with it and do something about it. The report makes it clear that the full powers that a patient safety commissioner should have is a matter for detailed work by a taskforce, but in the meantime statutory authority should be given to an independent person to listen to those suffering in some way from a difficulty in relation to the health service so that it can be brought to people who understand the nature of the subject. The independent person could bring it to the appropriate authority. It is a serious matter that should be dealt with straightaway.

I am very impressed by the example of the Children’s Commissioner, which has been referred to. In the recent discussion about whether to keep schools open, the Children’s Commissioner could not be said to be an organ of the Government, of the trade unions, or particularly of children; she stood independently in a relationship that considered all three parties. That gave her tremendous authority in a very difficult situation, which remains difficult. She was able as an independent person authoritatively to say that children should come back to school. Of course, it was necessary to take effective steps to protect them, but I believe that she was influential in bringing that about. In Scotland also, that has been an important area in delivering people from the stringency of the lockdowns.

So that is a very good illustration of what an independent person can do. I strongly hope that the Government will put forward an amendment to deal with this matter in the simplest possible terms at present, but with the possibility of enlargement as time goes on. Indeed, I suggested some time ago to the Department of Health that it would be useful for it to consider an amendment that would give effect to the report—but I gather that nothing has happened in that direction so far. So we might have to think about amendments to try to deal with some of those matters, as well as the present one. But I strongly support the essence of the present amendment, and I strongly support it happening now.

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

Before I call the next speaker, could I request that the noble Lord, Lord Patel, mutes himself?

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[Lord Blunkett (Lab)]

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

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

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

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

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

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

The noble Baroness, Lady McIntosh of Pickering, has scratched from this group, so we move on to the noble Baroness, Lady Ritchie of Downpatrick.

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, it is a great pleasure to follow the noble Lord, Lord Blunkett, on this group. I pay tribute to the noble Baroness, Lady Cumberlege, for her report and for introducing this proposed new clause, which I feel the Minister should accept.

I apologise for not participating on previous days but I was involved in debates in the Chamber, so I ask your Lordships to accept my apologies.

I fully accept the need for this new clause. At Second Reading, I indicated that the recommendation of an independent patient safety commissioner, on a statutory basis—one of the central recommendations in the report of the noble Baroness, Lady Cumberlege, and her team—should be given legislative effect. The provision of high-quality healthcare in which all citizens can have confidence defines any nation. For me, that is why this Bill is so important and why it should be amended to include this proposed new clause, among others. Our ethical practices are of the highest standard, and any medical product available in the UK, or indeed anywhere, must be rigorously tested and be shown to be safe and effective. That also goes for the Covid vaccines which are currently under investigation and awaiting licence.

I have long campaigned to get justice for pelvic mesh sufferers who have been left with internal damage and intense, chronic pain. They were failed by an appalling culture of mismanagement, ignorance and apathy within the health system. These victims deserve better justice and we must ensure that this sort of systemic failure never happens again. I remember, as a Member of the other place, meeting many constituents —in the main, women—who had a pelvic mesh inserted and suffered immeasurable pain. They were trying their very best to have it removed.

The recent report by the noble Baroness, Lady Cumberlege, First Do No Harm, on surgical mesh and other medical interventions, was scathing in its assessment of the failure of a disjointed and defensive health system to listen to and address patient concerns. Much of the suffering, it concluded, was entirely avoidable. As I said, I met victims of this appalling mismanagement when I was a Member in the other place. I learned at first hand of the pain they had been forced to endure and the impact that it had on the quality of their lives and those of their families. Therefore, I am pleased that the report was commissioned and I am happy to support the recommendation for an independent patient safety commissioner, as per the proposed new clause. It should be placed on the face of the Bill. I believe that, if the Government are serious about that report and about the Bill, this recommendation should be given legislative effect, and I urge the Minister to accept the amendment.

It would be vital for the commissioner to lead with full patient group engagement, and be accountable to Parliament. Patient groups should also be involved in developing a set of better patient safety principles that would govern the way the commissioner fulfilled her or his remit.

As other noble Lords have referred to, we now have experience of the work of various commissioners. I can speak about those that exist in Northern Ireland. There is now a Veterans Commissioner, a Children’s Commissioner and a victims’ commissioner. They all do good work, acting as advocates for people in their specific fields, and bring forward recommendations to the devolved Administrations. In this particular instance, there is absolutely nothing to suggest that this commissioner, if established through this legislation, would not do likewise. They would be a listening ear and would seek to improve existing health service regulations and practice, particularly in the area of medical devices.

Therefore, I am very happy to support this proposed new clause, and I urge the Minister to accept it.

[Lord Sheikh (Con) [V]]

My Lords, I commend my noble friend Lady Cumberlege on putting forward this important amendment, which has my full support.

I referred to this issue when I spoke at Second Reading. At the outset, I congratulate my noble friend on her thorough and excellent review, including the bravery of its participants. The Cumberlege review was clear that there is an urgent need for action. I welcome this Bill, which aims to put patient safety first.

We need to listen to the review’s recommendations and create an independent patient safety commissioner through the enactment of this amendment. This commissioner would be a trusted voice for patient safety and would ensure that the Primodos, valproate and mesh scandals, or any other previous scandals, are not repeated. As the Cumberlege review shows, the harm caused should have been avoided—and could have been, if patients’ concerns had been properly listened to and acted on.

Furthermore, Sir Cyril Chantler, one of the review’s panel members, rightly said that if such a commissioner had existed before, there would have been no need for this latest inquiry as the Primodos, valproate and mesh scandals would have been dealt with at an early stage, thus preventing the high number of patient incidents that were allowed to occur. Instead, thousands of patients and their families suffered for many years. Many of them were not listened to even though they were right. If this Bill is to succeed in its goal of promoting patient safety, we must accept this amendment.

Patients should not have to fight to be heard. They should not be made to feel that they are in the wrong. Patients and their families need to be consulted, listened to and given a voice. Through this amendment, the patient safety commissioner would be that voice. As is stated in the amendment, the commissioner would

“promote the views and interests of patients”

and would be able to

“receive direct reports from patients and other members of the public”.

This way, all concerns will be listened to and properly acted on. The amendment also states that the commissioner will be able to produce

“reports regarding patient safety … with respect to the use of medicines and medical devices.”

This information will be essential in making patients aware of any potential risks or harms so that they can make fully informed decisions about their treatment. I am glad to see that the commissioner would be independent so that the public know that any information is accurate and unbiased.

Our healthcare system is one of our greatest assets. I would like to state my gratitude for all the marvellous work that the NHS has done and continues to do. As we have seen during this pandemic, NHS staff have done sterling work and work effectively as a team. Unfortunately, some key workers have paid the ultimate price and we are for ever grateful to them.

The NHS is a very large organisation that does many great things but it cannot do everything right. Sometimes it is better when activities are undertaken by outside bodies that have specific duties and expertise. This is where a patient safety commissioner will play an important role in overseeing the whole system. Furthermore, as in this amendment, an advisory board will support the commissioner in their work, using its wide range of experience.

Our current complaints system is too complex and there have been issues with reports being misplaced and poor co-ordination between the different departments and actors. As the commissioner would be constantly reviewing patient safety and be completely aware of any potential issues, they would be able to keep the Minister and the Cabinet Office informed, for the benefit of patients. The commissioner will be able to join the dots in our big healthcare system so that nobody gets lost, and will provide a more straightforward direction.

I am also supportive of this amendment because it requires the commissioner to publish an annual business plan. As a businessman, I know how important this is in creating a clear strategy to bring together different stakeholders and respond to current issues. This annual plan, alongside establishing and updating the principle of patient safety, will help guide the whole healthcare system. I am also glad to see that subsection (6) of the proposed new clause means that these principles must

“be drafted in consultation with the public.”

This will make them more accurate, and help build public trust.

Unfortunately, the Primodos, valproate and mesh scandals are not the only cases of a lack of patient safety and we must learn from previous historic mistakes. In 1958, Distaval was licensed in the UK. It was sold as a wonder drug for insomnia, coughs, colds and headaches. It also gave many women relief from morning sickness symptoms, but this drug contained thalidomide and had not been tested on pregnant women.

In November 1961, it was withdrawn from sale and, in May 1962, the Government released an official warning against its use by pregnant women. Thalidomide harmed the development of unborn babies, causing serious life-threatening birth defects, and affected 10,000 babies worldwide, and many more are thought to have died before birth. The drug led to the arms or legs of the babies being very short or incompletely formed, as well as causing deformed eyes, ears and hearts. In the UK, more than 400 adults are still living with these consequences.

In 1968, the UK producer Distillers paid 62 families of thalidomide-affected babies compensation amounting to 40% of assessed damages. A similar amount was paid to a further 367 children in 1973. However, it later became clear that these settlements were not large enough to support those affected in their day-to-day lives. Only in the last 10 or 15 years since the scandal have significant settlements been made and provided by Distillers, now part of Diageo, as well as by the UK Government.

Although there have been many improvements in drug testing since the thalidomide scandal, the delays in dealing with potential risks and proper compensation were totally unacceptable. I comment again that, if there had been a patient safety commissioner, the scale of harm would have been limited, action could have been taken more quickly and compensation may have been paid earlier.

It is imperative that we learn from these historic scandals and the more recent scandals related to Primodos, valproate and mesh. Therefore, we must have a patient safety commissioner. We have to support this amendment, and I welcome its objective to lay reports before Parliament and committees. It is important to take quick and appropriate action against any harmful medicines or medical devices before they become a scandal. It also means that the correct bodies and people can be held to account so that the right improvements can be made.

Independent commissioners have been incredibly valuable in certain areas; for example, the Children’s Commissioner, which was established in 2004. Since the start of the pandemic, 14 different reports and policy briefs have been produced by the Children’s Commissioner. They have provided key information on how children are affected, different vulnerabilities and how the Government—

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

My Lords, excuse me. The Grand Committee will adjourn for five minutes because there is a Division. We will reconvene at 6.16 pm.

--- Later in debate ---

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

My Lords, the Grand Committee will reconvene again, and I call upon the noble Lord, Lord Sheikh, to finish his contribution.

[Lord Sheikh (Con) [V]]

Thank you. My Lords, I have nearly finished. I conclude by saying that a patient safety commissioner will be a champion to mobilise changes and deliver necessary improvements. This is vital for creating a healthier system that works for everyone because it can listen to everyone. We must ensure that historical or recent scandals are not repeated, and we must therefore accept this amendment.

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I am very grateful to my noble friend Lady Cumberlege, to the noble Lords, Lord Patel and Lord Hunt, and to the noble Baroness, Lady Jolly, for tabling their amendment. However, with the utmost respect to them, the Government are unable to accept it for the reasons I have outlined. I therefore hope the noble Baroness feels able to withdraw her amendment.

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

I have received one request to speak after the Minister. Baroness Thornton.

[Baroness Thornton (Lab)]

I am grateful to the Minister for that detailed answer, but as far as I can see, it underlined the point about the fragmentation of patient safety. He is undoubtedly right about the need to change culture. Will the Minister look at this again, because I mentioned the three inquiries in the past 20 years that I knew about very well, and every one of them said very similar things to what the Minister has said? None of them has produced the kind of support that one would want for patients or been the catalyst required here from the patient safety commissioner. Will the Minister go back and think about this again?

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Amendment 118 not moved.

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

We now come to the group beginning with Amendment 119. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.

Amendment 119

Moved by

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[Baroness Penn (Con)]

My Lords, we have unfortunately come to the end of our allotted time for this Grand Committee. I am afraid that I will need to adjourn our debate for today.

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

That concludes the work of the Committee this afternoon. I remind Members to sanitise their desks and chairs before leaving the Room.

Committee adjourned at 7.30 pm.

Medicines and Medical Devices Bill

Lord Russell of Liverpool Excerpts

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

19: Clause 7, page 5, line 8, at end insert—
“(4A) Nothing in this section authorises a disclosure of patient information without the consent of the individual to whom that information relates.”Member’s explanatory statement
This amendment and the amendment in the Minister’s name to add a definition of “patient information” to Clause 7 prevent Clause 7 authorising the disclosure of information from which patients can be identified without their consent.

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

Does the noble Lord, Lord Clement-Jones, wish to move Amendment 20, as an amendment to Amendment 19?

[Lord Clement-Jones (LD) [V]]

[Inaudible]—very much about informed consent, but, nevertheless, I will not move the amendment.

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Amendment 25 agreed.

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

Does the noble Lord, Lord Patel, wish to move Amendment 26?

[Lord Patel (CB) [V]]

No.

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

Does the noble Baroness, Lady Thornton, wish to move Amendment 27?

[Baroness Thornton (Lab) [V]]

I thought these amendments were part of the group that was passed on Tuesday?

--- Later in debate ---

[Baroness Thornton (Lab) [V]]

That is what I thought

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

I will go back to Amendment 26. Does the noble Lord, Lord Patel, wish to move Amendment 26?

[Lord Patel (CB) [V]]

I do not wish to move the amendment.

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

Does the noble Baroness, Lady Thornton, wish to move that amendment?

[Baroness Thornton (Lab) [V]]

Yes.

Amendment 26

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[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

My Lords, I should inform the House that, if Amendment 45 is agreed to, I shall not be able to call Amendment 46 by reason of pre-emption, and that the debate on the group beginning with Amendment 46 will be postponed and take place on Amendment 66.

Amendments 42 to 45

Moved by

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Amendment 49 agreed.

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

We now come to the group beginning with Amendment 50. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in this group to a Division must make that clear in debate.

Amendment 50

Moved by

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Amendment 67 withdrawn.

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

We now come to the group consisting of Amendment 68. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this amendment to a Division must make that clear in debate.

Amendment 68

Moved by