Medicines and Medical Devices Bill

Baroness Bennett of Manor Castle Excerpts

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

[The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)]

I have been made aware that a Division may happen in the course of the next contribution. I apologise in advance to the noble Baroness, Lady Bennett of Manor Castle, should we have to suspend the Committee. I now call the noble Baroness, Lady Bennett.

[Baroness Bennett of Manor Castle (GP) [V]]

It is a pleasure to follow the noble Lord, Lord Sharkey. I share his concerns about the quality, depth and effectiveness of far too many consultations. As he was speaking, I was looking at an editorial article in the British Medical Journal, which says:

“The medical-political complex tends towards suppression of science to aggrandise and enrich those in power.”


That is a powerful message.

I will speak specifically to Amendments 105 and 132, in the name of the noble Baroness, Lady Thornton, to which I have attached my name and which have been ably introduced by the noble Baroness, Lady Wheeler. I do not feel the need to speak at great length—maybe I will manage to beat the bells, but we shall see. However, I want to reflect on the fact that both Amendment 105, in addressing information systems and Amendment 132, in addressing regulations, specify full consultation with the devolved Administrations. As the noble Baroness, Lady Finlay, noted in her summing up on the previous group, the Government’s attitude towards devolution is a little uncertain. It would seem that the Prime Minister’s view changes from one hour to the next, according to recent reports, but it is terribly important that we see in the Bill an absolute commitment and requirement to consult the devolved Administrations.

In his comments on the initial group, the Minister noted that data needs to be consistent. Speaking as someone who has occasionally been forced to manipulate databases and work with Excel spreadsheets, although that is certainly not my favourite thing, I think we all know the problem with inconsistent data and the kind of outcomes that it can produce. It is crucial—

[The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)]

I am afraid I have to interrupt the noble Baroness, Lady Bennett, because we are now about to have that Division.

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[Baroness Bennett of Manor Castle (GP) [V]]

Thank you. I will not go back to the beginning but I was speaking about the need for consistent data, which the Minister referred to in his earlier summing up. We have, of course, diverging systems and that is the point of devolution: it is for the devolved nations and Administrations to be able to go their own way and end up with quality, easily comparable data. It is obvious that there will need to be very tight consultation and working together. Amendments 105 and 132 would put this into the Bill, Amendment 105 being particularly important in terms of data.

I will also refer briefly to the other amendments in this group. As the noble Baroness, Lady Wheeler, said, government Amendment 126 is an improvement. Any kind of strengthening of consultation, as in the references to the public and devolved Administrations, is good but it is only partial. I can only commend Amendments 127 to 130 for pushing further on these issues. We know from the report of the noble Baroness, Lady Cumberlege, that so much needs to be done better. Transparency, openness and consultation are clearly key to all of that.

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

My Lords, I join my noble friend Lady McIntosh of Pickering in apologising for having my name to amendments here while I have found myself in proceedings on another Bill which was fairly encompassing in the sense that it required a good deal of attention to understand what was going on. We were not able to achieve the result that the noble Baroness, Lady Finlay, managed of being in both places at once. However, I am glad to be here on this occasion and I am particularly interested in Amendment 117, which we may reach later.

In this group, I particularly support Amendment 127, which the noble Lord, Lord Patel, has carefully referred to already. I generally support all that has been said by others before me on this group of amendments, especially the reference of the noble Lord, Lord Sharkey, to the need to keep in mind the medical charities. I think particularly of Cancer Research, but it applies equally, as he said, to all of them.

I wondered whether the government amendment made unnecessary some of our amendments, but I really wonder about that, because a public consultation is not specifically targeted, and I think the groups that we have represented—particularly in relation to Amendment 127—require to be consulted more directly. I do not know how your Lordships feel about consultations, but I often find that I did not know that there was a consultation at all until the time allowed for it was well passed. That is no doubt due to my lack of efficiency, but I suspect that a lot of patients will not know that a public consultation is happening unless it is drawn specifically to their attention. It is important that the consultation, public as it is, has direction as well. Therefore, I think that Amendment 127 and the other specific amendments are well worth considering in relation to the new government amendment.

I am also extremely anxious that the devolved Administrations should be properly consulted. Of course, devolution and independence are different things, and we are talking about devolved institutions at present. This group of amendments is important, and I agree with most of what has been said about them. Therefore, I do not need to say any more on this occasion.

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

I understand that there was an error, and the noble Baroness, Lady Bennett, was not called, so I call her now.

[Baroness Bennett of Manor Castle (GP) [V]]

Thank you, Madam Deputy Chairman; I resisted the urge to leap in. My contribution, anyway, will be brief. I want to build on my remarks in the previous group and, in particular, to address Amendment 108 in the name of the noble Lord, Lord Patel. I referred then to the article in the British Medical Journal about the medical-political complex. We have seen over the decades, again and again, in respect of medicines, pesticides and herbicides, situations where there has been growing concern about a particular chemical. Critics have come under tremendous pressure, including critics often from Governments—critics in official positions—from very large, powerful commercial interests to remain silent.

The noble and learned Lord, Lord Mackay of Clashfern, asked how anyone could not speak out in a situation where they saw that there was a danger or a serious cause for concern. We have seen again and again, however, situations where people, including Ministers in Governments, have come under tremendous pressure. Does the Minister not think that an amendment such as that proposed by the noble Lord, Lord Patel, would protect the Government, the individual and the public if she or one of her successors were in a situation where there was grave cause for concern but also very powerful multinational company forces at play?

[Baroness Penn (Con)]

My Lords, I thank the noble Lord, Lord Patel, for his amendment, designed to ensure that the public are always warned about concerns relating to a medical device where there is a clear threat to public safety. The Government agree that sharing information with the public—as well as the healthcare system—is important. Safety information is provided already to relevant special interest groups and through social media channels to ensure that messages are accessible and reach those affected who need to be aware or take action. This can include patients, healthcare professionals and members of the public. For example, MHRA recently urged users of Safe and Sound Infrared Ear Thermometers to check their product code and lot number due to a voluntary recall of specific lots because of a two-degree temperature overreading fault. This is a safety concern for members of the public who are monitoring their temperature, particularly in view of the pandemic. However, noble Lords are correct that it is critical that we do more to improve transparency and share more safety information to support patient safety. This has been made even more apparent in the findings of the report by my noble friend Lady Cumberlege.

Clause 35, along with Clause 13(1)(h)(iii), is designed to ensure that in future we can share information with key parts of the healthcare system, academia and the public in a considered and effective way. Under the current medical device legislation, MHRA does not have a clear legal basis to report all incidents involving medical devices occurring in the UK. By contrast, this has been common practice in the USA, via the FDA’s MAUDE database, and in Australia, via its DAEN database. Medicines legislation already enables MHRA to provide its interactive drug analysis prints, or iDAPs. It is therefore right that, via the information-sharing powers in this Bill, we are able to disclose in an appropriate manner all medical-device serious incidents. This will provide greatly improved transparency about the safety of medical devices in the UK.

Amendment 108 would place a legal requirement on the MHRA to disclose information to the public to warn them about concerns relating to a medical device where a clear threat to public safety had been determined. The amendment is unnecessary, as the MHRA would always share safety information with the public where it was necessary to do so. However, issuing warnings and safety information to the public needs careful management, a good understanding of the situation, full verification of the data and consideration of wider complexities. There is a high risk that mandating the disclosure of clear threats to public safety would commit MHRA to regular disproportionate direct communication to the public about safety issues that the public cannot act on.

The great majority of MHRA’s medical device safety alerts require healthcare workers, not members of the public, to take action to remove a public health threat. For example, MHRA’s national patient safety alert of 23 September 2020, addressing a clear threat to public health, instructed all hospital trusts and other healthcare providers on actions to be taken to avoid potential unexpected shutdown, leading to a complete loss of ventilation, when using the Philips Respironics V60 ventilator. Such messages should not be targeted and promoted to the public but should be made available passively to the public; for example, via access to a website. Otherwise, this would likely create unwarranted anxiety in the public about safety issues that they themselves could address because they required the intervention and clinical support of healthcare professionals.

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[Baroness Masham of Ilton (CB) [V]]

My Lords, I would support an independent patient safety commissioner, as its aim would be to

“promote and improve patient safety with respect to the use of medicines and medical devices,”

which is vital. In the past years there have been some tragic cases: patients have been left in long-term pain after operations with medical mesh; pregnant women have taken medicines that have caused disabilities in their children; and people have died due to the wrong dose of morphine or potassium chloride by the wrong button being pressed on the infusion pump.

I hope that, if established, the patient safety commissioner would be able to help patients from the private health sector as well. There have been some unfortunate incidents in plastic surgery, for example.

I would like to ask a few questions, but I do not know whether it is the noble Baroness, Lady Cumberlege, or the Minister who can answer them. The NHS is so huge and has so many different bodies and groups. Many people get confused about who does what. Would the patient safety commissioner co-operate with the Healthcare Safety Investigation Branch and the Citizens’ Partnership, which will work with HSIB on healthcare safety investigations?

AvMA—Action against Medical Accidents—which works for patient safety and justice, would be happy to work with an independent patient safety commissioner. Would that be helpful? Many all-party groups take evidence from patients and experts on safety issues. Would the safety commissioner be interested in collecting the data and promoting what is appropriate? A great deal of time, energy and experience goes into producing these reports.

There are still cover-ups and fears about reporting safety issues. Patients and their supporters need to feel that their voices are heard and will be acted on independently, and that they will stay safe and not be victimised for reporting patient safety matters. I thank the noble Baroness, Lady Cumberlege, for her report and for bringing this subject up the agenda to where it should stay, with the lead of a patient safety commissioner.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I can only begin this contribution, as I did at Second Reading, by paying tribute to the power and importance of the report by the noble Baroness, Lady Cumberlege, as so many other noble Lords have. I also note that the length of the list of Peers speaking to this amendment reflects the fact that this is perhaps the most important element of her recommendations, or certainly the most easily and directly deliverable through legislation.

When thinking about how I could contribute within this long list of speakers in a positive way, I decided to go back to the noble Baroness’s report and to the patients who spoke to her. If I were delivering this as a public speech, I would at this point deliver a trigger warning: what I am about to say is very disturbing. That needs to be said now.

I will quote three of the patients quoted in the noble Baroness’s report. The first is identified as a mesh-affected patient who said:

“I have had a constant battle to get the help and treatment I needed with my mesh complications. ‘Gaslighting’ and a ‘fobbing off’ culture appears to be rife”.


The second quote is from a former GP and mesh-affected patient:

“I do … believe there is a huge unconscious negative bias among you all towards middle aged females in chronic pain.”


Finally, the third quote is from Teresa Hughes, from Meshies United:

“They would tell you there is nothing wrong with you and that you are just a hysterical woman”.


It is worth reflecting briefly on the history of medicine and the medical profession. The idea of a wandering womb—with strange afflictions supposedly affecting women, particularly those of reproductive age—goes back to the ancient Greeks. We have something here that has been embedded for literally millennia. If we look to more recent history, it was the book on hysteria by Edward Jorden in 1603 that really pinned down in English something that became medical doctrine for centuries. This treatment of female patients has a very long and embedded history.

If we look back at the 1960s and 1970s, up until that point in time the culture of medicine was very much one of paternalism. The doctor, who was most often a male, knew best; the patient was told what they should do and how they should be treated. The doctor knew what was best for them and the patient had very little say or control. We can credit the women’s movement as an important part of the forces driving for change in the medical profession. We have seen change, but medical habitus does not change quickly in its practices and culture. It is clear from those quotes I just read out that there is still a long way to go. There is a strong gender aspect to this, but many male and child patients were affected by it as well.

A patient safety commissioner could be someone to go to: someone who knows the system and has sufficient technical support to understand the issues, and to see where systematic breakdowns are happening and act on them. The Children’s Commissioner is a wonderful example—the noble Baroness, Lady Cumberlege, referred to it—and by chance I was referring to that commissioner approvingly in this very same Room yesterday.

We have already seen action on the recommendation for a patient safety commissioner in Scotland, and I am proud that the England and Wales sister party, the Scottish Greens, was very strong in supporting that. With this amendment, your Lordship’s House has a real chance, as we have been doing with so many Bills lately, to insert an important and key improvement.

I hope that, if not today then sometime very soon, the Government might see the sense of following the Scottish lead and the recommendations of the report of the noble Baroness, Lady Cumberlege. However, if that is not the case, I can certainly offer the Green group’s very strong support for pushing this further—as far as it needs to be pushed—to deliver this vital figure.

[Baroness Jolly (LD) [V]]

My Lords, Amendment 117 would establish the independent patient safety commissioner on a statutory basis, as recommended in First Do No Harm, the report of the Independent Medicines and Medical Devices Safety Review. As the noble Baroness, Lady Cumberlege, said, it is a future-facing amendment towards a proposed organisation. It has not been a surprise that all noble Lords who have spoken have been hugely supportive of her report. This recommendation from the Cumberlege review was overwhelmingly supported by the House at Second Reading and is vital to ensure that the interests of patients are represented, to try to prevent scandals such as that regarding mesh implants from recurring. We support it wholeheartedly, and I was delighted to add my name to the amendment.

At present, there is no one to listen to the voice of patients, act on concerns, gather data and put together a clear picture to report back to the department. Commissioners can bring a fresh pair of eyes to an area but also a strong voice for patients. Of course, as the noble and learned Lord, Lord Mackay of Clashfern, said, they bring independence too. In addition, they will have unique statutory powers and responsibilities, such as powers to get access to data, and investigatory powers, with power of entry if necessary. Of course, patients’ voices would need to be heard, so in all probability, there would be a helpline, as well as email access and access via a website and by letter.

The noble Baroness, Lady Cumberlege, spoke of the Children’s Commissioner, and she was not alone. It has been a great success. The commissioner knows her remit and, as the noble Lord, Lord Hunt of Kings Heath, said, she speaks with no vested interest except in children, and she stays within it. She champions children and, as has already been said, this has given her authority. As a consequence, the organisation is hugely respected.

I have heard the criticism of the cost of such a body as the patient safety commission, and I feel sure that the noble Baroness would have squared off the funding for a commissioner and their office with the Cabinet Office, which would be the funding vehicle. However, compared with similar commissions, it would amount to less than £1 per head of population per year—less than tuppence per person per week. I defy anyone to claim that that is excessive. This is indeed of value, and patients of course deserve it.