Medicines and Medical Devices Bill

Baroness Thornton Excerpts

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

[Baroness Jolly (LD) [V]]

My Lords, I particularly welcomed the remarks of my noble friend Lady Burt, as they took me back to the days in the 1990s when I taught IT. I taught A-level students the differences between databases, tables and registers. I totally support these amendments about registries and databases relating to medical devices. They form one of the key recommendations of the review of the noble Baroness, Lady Cumberlege, in light of the scandals relating to, for example, vaginal mesh.

A huge number of patients have been affected by these incidents, and introducing registries allowing the use of implantable devices to be tracked, and allowing patients to view information relating to the data stored, would make a huge difference. Amendment 95, from the noble Baroness, Lady Finlay, changing “may” to “must”, is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill setting up the new information system envisaged by Clause 16.

Amendment 96, in the name of the noble Baroness, Lady Thornton, is a probing amendment seeking clarity about whether the Government intend to track all medical devices used in the UK, rather than a selection. Amendment 99, in the name of the noble Baroness, Lady Finlay, seeks to make mandatory the list of specified issues for regulations to cover. Her Amendment 100, to which I have added my name, would allow for the creation of a system of information regarding implants, with appropriate consents and oversights. It would also allow a patient’s experiences to be reported and stored; they should be subject to oversight. The noble Baroness, Lady Finlay, has also included the point about patient experience in her Amendment 101.

Amendment 104, in the name of the noble Lord, Lord Lansley, would require regulations under this section to have regard to the Caldicott principles. It was just over 20 years ago, when I was a non-exec director in a local NHS trust, that these principles were first introduced. I can remember the way that clinicians—in particular, senior clinicians—really welcomed the new measures. They certainly changed the way that clinicians thought about information and data. We are now moving through a different step change.

Finally, my noble friend’s Amendment 107 would require the introduction of a registry for patients who have had surgical mesh implanted. Though I appreciate that this looks retrospective, there should be data held in hospital databases that could be imported into the new registry. It would then give a complete overview of surgical mesh implantations. It would require the Secretary of State to report on progress towards creating databases relating to other devices or implants and how they would lead to the creation of registries.

Like other noble Lords, we favour registries as opposed to databases because, according to the Cumberlege review, registries act as a repository for more complex patient-related information datasets, enabling research and investigation into patient outcomes. A database is really just a three-dimensional table held in store, but a registry is a richer, more useful resource than a database. However, often a database is required before a registry can be created, which is why our amendment is framed in that particular way.

[Baroness Thornton (Lab)]

My Lords, this group concerns the need to set up information systems—registries—which will serve the purpose of tracking medical devices. I thank the Minister and the Bill team for their very enlightening and useful presentation this morning. The noble Baroness, Lady Finlay, and other noble Lords have already explained to the Committee how these registries and databases might work. The key point, which was made by the noble Baroness, is that they should be mandatory rather than permitted. Changing “may” to “must” so that the Secretary of State has to produce the information system envisaged by Clause 16 is a small but vital change. The Minister will need to explain to the Committee why, at this stage and after the experiences expressed and covered in the report of the noble Baroness, Lady Cumberlege, there should be any discretion in this matter.

The other amendments seek to ensure that patients have a direct route to report their experience to any information system established. Again, after the dismissal of so much patient experience over so many years in the cases outlined in First Do No Harm, it would seem to be the only way to guarantee that patient experience can be heard and registered.

Amendment 96 in my name is a probing amendment which seeks clarity about whether the Government intend to track all medical devices used in the UK, or just some of them. As other noble Lords have pointed out in the course of this Committee, if supermarkets have the technology and wherewithal to track the provenance of every single food product from anywhere in the world, we would need to understand why this would not be possible for medical devices.

Amendment 107 specifically addresses the issue of surgical meshes, and requires the production of a registry for patient safety. I hope that the Committee will be seeking to discuss registries and how they are linked. On Amendment 104 on the Caldicott principles, I do not see how anybody could possibly object to that.

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

My Lords, we had an excellent debate last week on the subject of medical device information systems at Clause 16, which is critical for how we will go forward on these points. The noble Baroness, Lady Finlay, seeks in Amendment 95 to confirm that the Government will make regulations to establish the system, not that they might. We will introduce this system; the noble Baroness provides no timescale attached to the obligation she introduces. It is essential that the regulations are informed by consultation. The discretion that “may” provides allows for this consultation to be conducted. We want the regulations to be right, not rushed.

I spoke last week on Amendment 96, in the name of the noble Baroness, Lady Thornton. Devices have varying levels of risk profile; it is our intention in the first instance to use the power in Clause 16 to require all implanted devices to be recorded in information systems. Implanted devices pose the greatest risk to patients and it is right that these should be prioritised. Consultation will help us to determine which devices ought to be captured by the information system.

On Amendment 99 in the name of the noble Baroness, Lady Finlay, we recognise the importance of all the issues in Clause 16(2): that is why they were explicitly referred to. However, there may be occasions where the inclusion of provisions in regulations on all four of the issues listed here is not appropriate or necessary. For example, in future we might wish to update the types of information in Clause 16(2)(a) to include, perhaps, a new way of recording a procedure or a device. We might have no immediate need for further provision under 16(2)(b) to 16(2)(d). Without the flexibility afforded by the current drafting, we would be prevented from making proportionate regulation limited to what was necessary.

On Amendment 100 in the name of the noble Baroness, Lady Finlay, the drafting of Clause 16(2) is sufficiently broad as to say, “among other things”. Regulation is not limited to the four suggested areas for provision at subsection (2)(a) to (d).

The noble Baroness suggests mandating recording of information on any medical device implanted into the human body and the information related to any other medical device as considered necessary for patient safety. Clause 16(2)(a) is sufficient for both these matters. While they are clearly important, the addition is unnecessary.

The noble Baroness adds a requirement of patient consent for the information to be recorded in the information system. I hope that the assurances that I provided to my noble friend Lady Cumberlege last week gave her some comfort on this point. I am happy to write further on this, but the noble Baroness will know that the information systems are conditional on regulations, on which we must consult.

The noble Baroness adds in her amendment expert oversight of any information system established under Clause 16(1). I do not think this is necessary. The information system acts as a database. Where expert oversight is needed is in the assessment of patient outcomes, where information is reviewed by clinical registries operated by experts in their field.

I understand the intent behind Amendment 101. I pay tribute to the noble Baroness, Lady Masham, and my noble friend Lady McIntosh, who put it very well. The patient voice is very important in the assessment of the efficacy and safety of medical devices, but I do not wish to confuse the purpose of the information system. It is a hub; it is not a decision-making tool. There are existing routes to raise specific concerns and experience of devices.

The yellow card scheme allows patients to complete and submit reports themselves. This gives a single, clear route for patients to avoid confusion about who to tell and how, and to ensure that all necessary parties receive all data relating to patient concerns. However, data used for analysis needs to be consistent in format and terminology to ensure that comparisons can be drawn and to maximise the ability to spot common themes and issues.

Amendment 101A in the name of the noble Baroness, Lady Finlay, is unnecessary. Even though the overarching objective of the information system is medical device safety, and therefore a reserved matter, I have made it clear that I am committed to ensuring early and ongoing consultation and engagement with colleagues in Scotland, Wales and Northern Ireland as we look to develop a UK-wide system. I say for the record that it is of great importance to us all that we work together to improve the safe use of medical devices across the four nations. I strongly agree that there is a need for a centralised approach to address the existing gaps in the traceability of medical devices placed on the market. The Government have already introduced Amendment 126 to Clause 41. Therefore, it is neither necessary nor appropriate to set out the engagement or working arrangements between the four nations in regulations.

I understand that the aim of Amendment 104 in the name of my noble friend Lord Lansley is to ensure that organisations protect any information that could identify a patient, such as their name and their records. I reassure him and others who have spoken to the amendment that this information is used and shared only when it is appropriate to do so.

On the Caldicott principles and guardians, I am sure that these matters will be brought forward by others in consultation. That is the forum for addressing these points. Adherence to the Caldicott principles is expected of all NHS organisations, including—some would say most of all—NHS Digital. The Caldicott principles have been developed into the national data guardian principles that apply in England. GDPR also requires that personal information be treated in this way. All data collected by the information system will be subject to GDPR. The intention is that the medical device information system should hold patient-identifiable information. Information that is de-identified will be shared with the relevant organisations to ensure the protection of that patient. It is unlikely that there would be any requirement to share patient-identifiable information with other organisations. MDIS would be programmed to know, when provided with notices by MHRA or others, that action needed to be taken and which patients it applied to.

Parliament oversees data protection legislation. The standards are very high, and we have no intention of lowering them. I do not think, therefore, that having regard to the Caldicott principles is necessary or would add anything material to the legal constraints that would apply to this information. Of course, we have no intention of doing anything contrary to those principles through this legislation. Regulations under Clause 16 will be subject to public consultation. Under GDPR, they are also subject to the requirement to consult the Information Commissioner’s Office. We have already begun discussions with the Information Commissioner’s Office on this basis.

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[Baroness Jolly (LD) [V]]

I support Amendment 108, led by the noble Lord, Lord Patel, which would place a duty on the Secretary of State to disclose information they hold

“relating to a medical device where there is a clear threat to public safety.”

Amendment 114, also in the name of the noble Lord, Lord Patel, would retain Regulation 3B of the Medical Devices Regulations 2002, which was inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 and, among other things, requires the 2002 regulations to comply with the Data Protection Act 2018.

I support these amendments but wonder what might be the process to contact patients in the event of a fitted medical device fault, which might lead to a threat to public safety if it was more than just one. Would it be the same sort of process as that for recalling certain faulty domestic appliances, which, by law, also need to be recorded? Noble Lords may chuckle, but there is a system there. Where the patient has a medical device implanted, who is responsible for taking patient contact information?

More importantly, how does the patient ensure that their contact data is up to date? Will it link, using the unique patient reference number: their 10-digit NHS number? It would need the patient to ensure that their personal data is kept up to date via the website or app. Many do use the NHS app, but, given the patient demographic, I would not be that confident in relying on that mechanism. I am not sure that the general public are ready for that requirement or, in many cases, have the capacity or devices to fulfil it. Could the Minister clarify this for me?

[Baroness Thornton (Lab)]

I am very grateful to the noble Lord, Lord Patel, and the noble and learned Lord, Lord Mackay of Clashfern, for bringing these amendments to the Committee. They are quite different, although linked. On Amendment 108, which would place a duty on the Secretary of State to

“disclose information … about concerns relating to a medical device where there is a clear threat to public safety”,

the noble Lord, Lord O’Shaughnessy, absolutely got it when he said that this is not a “may” but really is a “must”. The thing about this that would interest me most, because it is an important duty, is how it could happen: what would trigger such a disclosure, where would it come from and how would it be handled?

The only thing I would ask about this issue is whether a Secretary of State is the right person to do that. I have in mind someone who is now a respected noble Lord of this House, who fed his daughter a burger to show us that beef was safe during the BSE outbreak, which led to the creation of the Food Standards Agency as an independent organisation that would say, “This food is actually unsafe”, to the Government. It quite rightly has the powers to bring about a closure or recall. This is exactly the right place to be on patient safety. The only question I would pose is: is that the right person to do it?

Amendment 114, on Regulation 3B, worries me enormously. I would need to have an explanation from the Minister as to why he would remove confidentiality and seemingly protect commercial interests. It is very worrying, and the Committee needs to know the justification for that because it looks to me like it probably needs to remain in place.

[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.

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

I have received a request to speak after the Minister, so I call the noble Baroness, Lady Thornton.

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for her explanation in response to Amendment 114. My desire to explore the issue slightly more is partly a result of what the noble Baroness, Lady Cumberlege, and others have said. It is also partly a result of the very helpful discussions this morning about the time that it is going to take to get the protection on devices in place. If we have another mesh situation, will that be able to emerge in this period of time? If so, who will be responsible for saying that it is not a safe device?

[Baroness Penn (Con)]

I believe that responsibility will continue to lie with the MHRA. We have existing systems, such as the yellow card reporting system. The report by my noble friend Lady Cumberlege will have made an important difference; as we discussed earlier and in other sittings, not just the systems but the culture will need to change. That culture change has begun already.

We must get the systems right so that they operate as intended and deliver the results that we all want, but the noble Baroness, Lady Thornton, is right: in the space that there will be while we implement these changes, we need to be extra vigilant about these potential issues.

As I have already said, adverse incidents involving medical devices are published on the MHRA website. The job is to take all that information and make sure that it is not just dispersed but that people can build the bigger picture. That is what we are working towards.

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[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.

[Baroness Thornton (Lab)]

The last remark of the noble Baroness, Lady Jolly, was very pertinent indeed.

After this debate, I probably need to say only that, from these Benches, we support the noble Baroness, Lady Cumberlege, in her proposal to establish a patient safety commissioner on a statutory basis. We have heard powerful contributions from the noble Baroness, Lady Cumberlege, herself, the noble Lord, Lord Patel, and my noble friend Lord Hunt. I always thought, when I was a Minister and since, that you should always listen when the noble and learned Lord, Lord Mackay of Clashfern, says that, in his “respectful submission”, something is a good idea; it is always a good idea for the Minister to take note of that.

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[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?

[Lord Bethell (Con)]

I take the encouragement of the noble Baroness to heart. I would be very happy to think further on it. She makes a very good point: we know about the terrible incidents of the past and the very substantial responses that they had. I share with her the frustration that these problems continue to arise. For that reason, as I said, we are looking for a really thoughtful, considered response to the review overall. As I said in my earlier remarks, the case for a patient safety commissioner is one that we are looking at. I listened to absolutely everyone who has spoken in its advocacy, but we do not regard it as a silver bullet or a single point of catalysis, which I do not think the noble Baroness was alluding to. We are looking for a broad response to the review that would ultimately take on all the different points that the noble Baroness and her review team have made.

Reciprocal and Cross-Border Healthcare (Amendment etc.) (EU Exit) Regulations 2020

Baroness Thornton Excerpts

Monday 16th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

I thank the Minister for his introduction. I also thank all noble Lords who have taken part in this debate, raising an unenviable number of questions that the Minister will need to answer. I want to be clear that I understand the situation here. I am a veteran of this debate. I had a look and I have had this debate in one form or another at least four or five times in the last three years. This is the third Minister I have had dealing with it, so I hope noble Lords will pardon me for my sense of déjà vu.

My understanding is that we are all okay for the next six weeks while we are still covered by the transitional agreement, but on 1 January we are okay in terms of healthcare and other provision only if it already exists. If it does not exist and you are not resident in a European Union country—or, presumably, a European Union resident in this country—you will have to make new arrangements.

I remember being in a meeting with one of the noble Lord’s colleagues, probably about two and a half years ago, who assured us that, if necessary, we would have 27 absolutely rock-solid agreements on reciprocal healthcare, and that it would be okay. I have to say that I greet some of this with a certain amount of scepticism because I feel as though I have been led up this particular mountain at least three or four times in the last few years. I would like to know whether my assumption is right: that those of us who do not live in Spain, have not paid into the Spanish system and are not eligible to do so but who might want to retire there next year, will have to make our own arrangements. I suggest to the Minister that the way people will feel about Brexit will be judged partly on how this works, because healthcare and access to healthcare across the European Union is very personal to all of us.

I put on record some of the concerns that have been raised with us by a range of patient groups and healthcare organisations, who feel that the regulations do not go far enough in protecting the rights to healthcare of British citizens who travel in the European Union. As other noble Lords have said, this could leave some people with underlying health conditions not completely covered. The noble Baroness, Lady Ludford, used an example from Kidney Care UK that 30,000 people on dialysis can currently travel through Europe and receive their dialysis free of charge because of EHIC, even though dialysis for life-sustaining treatment for kidney failure is not covered by travel insurance; without reciprocal healthcare arrangements, it may cost up to £1,000 per week. I would like the Minister to answer the question of what will happen to people who receive dialysis after 1 January. How many more thousands of people with pre-existing health conditions will not be able to get insurance and could be put in the same situation if the Government fail to reach a deal?

If they fail to reach a deal in the next two weeks, will there be 27 agreements in existence? Are they there and ready to run? I would really like to know. The Brexit Health Alliance—a group of organisations that want to ensure that the views of healthcare users and providers are reflected in the Brexit negotiations, including the Academy of Medical Royal Colleges, NHS Providers, the Richmond Group of Charities and the Association of the British Pharmaceutical Industry—says:

“The current arrangements involve minimal bureaucracy for patients and healthcare providers, underpinned by well-established systems for reimbursement between member states. The NHS will face unwelcome increased resourcing burdens, if it is required to handle new, more complex administrative and funding procedures when providing care to EU citizens in future.”


The British Medical Association says that failure to reach a deal would,

“lead to significant disruption to … individuals’ healthcare arrangements, an increase in costs of insurance, and uncertainty regarding accessing healthcare abroad. Moreover, the NHS would face a drastic increase in demand for services, which could dramatically increase its costs and place greater pressure on doctors and clinical staff.”

I said those words to the Minister’s predecessor about two years ago. I said if we do not sort this out, there will be increased pressures on the NHS. Two years later, having increased pressures on the NHS is even more serious than it was.

Those organisations have been completely consistent in what they have been saying to the Government about this issue for the last three to four years and here we are now, weeks from possibly falling off a cliff. It is very important that the Minister not only answers some of the very relevant questions he has been asked by other noble Lords but seeks to reassure us that we are not all going to find ourselves faced with huge costs and, possibly, not being able to travel at all in Europe because we have failed to reach an agreement.

European Qualifications (Health and Social Care Professions) (EFTA States) (Amendment etc.) (EU Exit) Regulations 2020

Baroness Thornton Excerpts

Monday 16th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

Many of the issues I wanted to raise with the Minister have been raised by the noble Baroness, Lady Jolly. I accept that we will be supporting this regulation and that it is necessary as a tidying-up exercise.

As we know, nationals of the EU and other countries make up 9.1% of doctors in England’s hospitals and community services. They account for 6% of all nurses and 5.8% of scientific, therapeutic and technical staff. As the noble Baroness, Lady Jolly, says, we have 106,000 vacancies across the NHS, including—according to my figures—44,000 nursing vacancies. And we have about 120,000 vacancies in social care. My question, echoing that of the noble Baroness, Lady Jolly, is: what will happen if we have no deal? What will happen to the ability of people to come to this country and work?

When we debated the previous regulations more than 18 months ago, we asked the then Minister what assurances could be given that the NHS would be able to stem the huge losses of those important health and social care staff. Given the numbers I have mentioned, can the Minister confirm whether any study has been made of the costs and barriers that might prevent applicants from the EEA and Switzerland entering the country and the possible impact on the health service? This might be a good opportunity to ask for progress and an update on the issue of the social care workers with which the Government agreed during the course of the immigration Bill.

It is clear that the regulations are temporary, but there is no clarity about the plans to introduce sustainable, long-term arrangements for registering and licensing EEA and Swiss nationals. Will the Minister give us some further information about what longer-term plans there are in the current timeframe and the four-year period provided by this statutory instrument?

Medicines and Medical Devices Bill

Baroness Thornton Excerpts

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

Moved by

[Baroness Thornton]

49: After Clause 6, insert the following new Clause—
“Extending prescribing rights
The Secretary of State must, within three months of this Act being passed, lay before each House of Parliament proposals and a timetable for extending prescribing rights to additional healthcare professionals under section 2(1)(n).”Member’s explanatory statement
This new Clause requires the Secretary of State to publish proposals and a timetable for additional healthcare professionals to be given appropriately restricted prescribing rights.

[Baroness Thornton (Lab)]

My Lords, I said at Second Reading that we on these Benches are supportive of the extension of prescribing rights to additional health- care professionals, including radiographers, dietitians, orthoptists and speech and language therapists. It is time that this issue was resolved and that is our intention in tabling this amendment. The new clause would require the Secretary of State to publish proposals and a timetable for additional healthcare professionals to be given appropriately restricted prescribing rights. I thank my noble friends Lord Bradley and Lord Hunt, and the noble Lord, Lord Ramsbotham, for their support and I look forward to hearing their remarks.

The background to this issue is that, in February 2020, in response to a Parliamentary Question tabled by my honourable friend Geraint Davies MP, the Government said:

“Subject to Parliamentary approval, the Medicines and Medical Devices Bill currently before Parliament will give the Government powers to extend prescribing responsibilities to new professional groups where it is safe and appropriate to do so.”


We support that extension and our proposed amendment to the Bill will expedite that, resulting in better outcomes for patients and the system as we face a surge in demand on health services both now and in the future due to the Covid-19 pandemic.

The extension will build on the groundwork already undertaken by the NHS England scoping exercise over the past few years on extending prescribing rights to members and professionals. Extending prescribing rights would help to deliver better support and more timely care for patients. It would improve patient safety, as allied health professionals with appropriate expertise would be able to make decisions rather than relying on junior clinicians signing off clinical management plans. It would decrease the number of patient group directions needed, thus reducing the time spent on development, use and training, and it would bring prescribing expertise closer to the patient. It would reduce the pressure on other stretched professionals, including GPs, and it would improve system efficiency by reducing the duplication of work among health professionals, with a potential result of significant time and resource savings. The extension of prescribing rights to these professionals and others would make a significant and positive difference to those professionals and to the ability of the wider health system to respond as swiftly and efficiently as possible to the post-Covid-19 surge in demand on health services, including the rehabilitation and recovery of post-Covid-19 patients.

It is important to recognise the impact of Covid-19 and how it has emphasised the urgency of taking action. When we discussed these issues before the Bill came before the House, representatives expressed their frustration at how long it seemed to be taking to get approvals to work their way through the system. Given that we have managed to shortcut various systems because it has been necessary to do so with Covid-19, it seems that this is one that presents itself and needs a positive response. It will benefit the NHS, patients and expert health groups. I beg to move.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I support my noble friend’s amendment and the potential for increasing prescribing responsibilities. The noble Baroness, Lady Cumberlege, was a huge champion of prescribing rights for nurses. I was able to extend that to community pharmacists and I want to see us now build on that by extending it to other professions in healthcare. Dietitians, occupational health therapists, orthoptists, radiographers and speech and language therapists all have a hugely important role to play and giving them prescribing responsibilities would help to deliver safer, better and timelier patient care.

We have seen already how dietitians have hugely expanded their role in the treatment of diabetes, gastroenterology, bariatrics, metabolic conditions and oncology. Orthoptics has seen its roles expand in stroke management and neuro-rehabilitation and neuro-ophthalmology, in particular among children with SEN and for paediatric ophthalmology. Diagnostic radiographers are increasingly performing routine interventional procedures under imaging control, while speech and language therapist roles have developed in respiratory care, ear, nose and throat services, critical care and end-of-life care. Occupational therapists have increased their advanced practitioner roles and are demonstrating a hugely beneficial impact across all areas of the NHS.

There is a problem. It has been reported that the current ability of these professions to administer medicines to support patients through patient group directions and/or patient-specific directions is apparently becoming increasingly difficult. They are either taking longer to secure or they are being more restrictive, to the detriment of patient care and safety. I ask the Minister why this is. I refer to his interesting comment on Second Reading, when he said:

“NHS England and NHS Improvement are considering across all non-medical groups, influenced by learning from the Covid-19 pandemic, where there is a need to consider undertaking formal consultation on potential amendments to prescribing responsibilities for several professional groups.”—[Official Report, 2/9/20; col. 432.]


This is very welcome—and, of course, implied in that statement is a recognition that during the past six months we have had to rely on professional and other staff adding to their responsibilities and going beyond the extra mile. By extending prescribing rights, we would be recognising that fact and recognising that many of our professionals can do more, if they are given the ability to do it.

Provided that this happens within safe bounds—and so far, prescribing for non-medics seems to have worked very successfully—we have a total win-win situation, in which patients will benefit and the professional development and satisfaction of many of our staff groups will increase. I believe that my noble friend’s intention is to give the Minister all support for charging on with the extension of prescribing rights, and I hope that she will embrace that support and get a move on.

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[The Deputy Chairman of Committees (Lord Bates) (Con)]

I have received no requests to speak after—

[Baroness Thornton (Lab)]

I actually just sent in my name.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

Oh, right. I have received one request to speak after the Minister. I call the noble Baroness, Lady Thornton.

[Baroness Thornton (Lab)]

I am sorry; it was possibly delayed. It was really just to ask the noble Baroness: when is the earliest she thinks there will be change? Are we looking at three months, six months or a year?

[Baroness Penn (Con)]

I might need to pick this up with the noble Baroness in writing afterwards. The consultation will close in December and, obviously, work has to be done after that—but it is probably safest to write, if that is okay.

[Baroness Thornton (Lab)]

If these were normal times, I would have just popped up and asked that question.

I thank my colleagues—my noble friends Lord Hunt and Lord Bradley. My noble friend Lord Bradley is one of my roommates here. I have not seen him since March and I am missing him very much. So it is very nice to see him, even on the screen, and he made a very powerful case. I also thank the noble Lord, Lord Ramsbotham, who has enormous expertise in the very important areas of speech and language therapies. I also thank the noble Lord, Lord Balfe, and the noble Baroness, Lady Jolly.

Given the promise that we might actually, at some point, have a date, I beg leave to withdraw the amendment.

Amendment 49 withdrawn.

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[Baroness Jolly (LD) [V]]

My Lords, the amendments in this group relate to technologies. Amendment 83, from the noble Lord, Lord Freyberg, to which I have added my name, seeks to improve how the Bill addresses new technologies which have significant potential for harm, and it aligns with and improves on the EU and US equivalents. The critical issue is: what is a medical device? Amendment 113, also from the noble Lord, Lord Freyberg, and my noble friend Lord Clement-Jones, updates the definition of a medical device to bring it in line with the EU and US regulation, acknowledging the progress of technology beyond the Medical Devices Regulations 2002, which, in the world of programming, is very nearly the dark ages. I wonder if noble Lords remember ALGOL, FORTRAN and BASIC.

I support Amendment 83, to which I have added my name, and received a very helpful letter about Amendments 112 and 113 from the noble Lord, Lord Freyberg. I listened very carefully to both him and, of course, my noble friend. I am happy to support their arguments and their amendments.

[Baroness Thornton (Lab)]

My Lords, the noble Lords, Lord Freyberg and Lord Clement-Jones, have done the Committee a great service today. I was fascinated by the speech from the noble Lord, Lord Freyberg, which set the tone for this discussion. I welcome his main points and his knowledge. He knows that I am a supporter of his work in this area, particularly on the protection of patient data.

It is a constant source of concern that either through carelessness, lack of expertise, unscrupulousness or policy fragmentation, our NHS will not benefit from AI and the use of patient data. I see this amendment as part of that discussion and that effort to decide what happens. The noble Lord, Lord Freyberg, has asked some very pertinent questions about algorithms, how they change and how they develop. Our job, surely, during the course of this Bill, is to find legislation that is ahead of the technology for once, not behind it. I was particularly struck by what the noble Lord, Lord Freyberg, has to say about GOQii and the MHRA, and the definition for medical devices and algorithms. The use of AI and algorithms is not impartial. We know that, particularly given our recent experience with A-levels, which was mentioned by the noble Lord, Lord Clement-Jones.

The Minister has to find a way of ensuring that this Bill reflects the modern situation and does not stop innovation. I really hope that she is not going to say that those of us who are asking these questions are opposed to innovation, because that is absolutely not the case. These are very important questions indeed for the future, as we find ourselves between the FDA and the European Union, and we make our way in this particular world.

[Baroness Penn (Con)]

My Lords, all the amendments in this group deal with the important matter of forward-thinking regulation—regulation that evolves as technology evolves. I say to the noble Baroness, Lady Thornton, that all the questions raised in this debate are very pertinent and are pro-innovation, not anti-innovation questions, concerned with ensuring that we can regulate this area properly.

As my noble friend the Minister said in previous communication to the noble Lord, Lord Freyberg, artificial intelligence is already in use in medical device technology and is already regulated—for example, Babylon’s mobile application Healthcheck is software that provides a general health assessment to users. That application is registered as class 1 medical device by the MHRA. We are also working on equipping our regulator for these products. The MHRA secured £740,000 from the Regulators’ Pioneer Fund to work with NHS Digital on developing a pilot in order to test and validate algorithms and other AI used in medical devices. There are other works in train to get the benefit of artificial intelligence in the health service. The Artificial Intelligence Award is run by the Accelerated Access Collaborative in partnership with NHSX and the National Institute for Health Research. It is making £140 million available to accelerate the testing and evaluation of the most promising AI technologies that meet the strategic aims set out in the NHS Long Term Plan.

I recognise that the intention of Amendments 83, 112 and 113 is to address the potential to cause harm to patients without appropriate regulation of these technologies. I can reassure noble Lords that software used for the application of medical devices falls within the definition of a medical device under the EU medical device directive, transposed into UK law through the Medical Devices Regulations 2002. Artificial intelligence and algorithms are encompassed within the term “software” where they have a medical purpose, and I can reassure the noble Lord, Lord Freyberg, that this covers static and dynamic algorithms.

In addition, within 12 months of this Bill gaining Royal Assent, we will start to develop new medical device regulations. The development of these regulations will include a full consultation on any changes proposed. I can commit here that the consultation will conclude within 12 months and will include the definition of a medical device, with particular reference to algorithms and methodologies used for the interpretation of data and associated technical architecture used within medical devices. This process will allow members of the public, patients and industry bodies—as well as perhaps noble Lords in this Committee—to help shape the future of regulation in the UK and the terminology that we use to describe what is captured by those regulations.

The amendments are accordingly unnecessary, as the outcome sought will be achieved under the umbrella of the wider-scale review of medical devices regulation in the UK, which will take place during a similar window as that sought by the amendment and will address the specific questions that it raises. So I hope that I have reassured the noble Lord, Lord Freyberg, that the existing definition covering both dynamic and static algorithms is sufficient and, if I have not, that he will take satisfaction from the Government’s commitment that, within 12 months, we will have concluded a consultation—to which I hope the noble Lord will contribute—that will include the definition of a medical device and specific reference to algorithms and methodologies used for interpretation of data.

This is an incredibly important debate. This is an emerging area of technology and, while we are reassured that the current regulations capture what they need to, we also need to look to the future, which is what the consultation can do. I hope that the noble Lord will feel able to withdraw his amendment.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

I have received a request to speak after the Minister from the noble Baroness, Lady Thornton. I now call the noble Baroness.

[Baroness Thornton (Lab)]

I thank the noble Baroness the Minister. This is such an important issue, with the potential for huge benefits and huge harms. I regard it slightly like the sort of issues we dealt with in relation to the Human Fertilisation and Embryology Authority and the Human Tissue Authority—this is very important and runs very deep into our humanity. So the question I need to ask the Minister is: when the consultation is over, will we be looking at primary legislation, because I am not sure that regulation will quite do?

[Baroness Penn (Con)]

My Lords, the consultation will look at the specific issue of medical device regulation that takes place through secondary legislation. However, the noble Baroness is right in that this is not the only aspect of this issue that we are looking at and working on. There is work across government on a number of areas where this technology comes up, and we have established a number of bodies to help us in our work, such as the Centre for Data Ethics and Innovation. So, although the specific issue about the definition of a medical device and medical device regulations will take place under this Bill—subject to public consultation —there is a broader landscape that we will also address across the board and across government.

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We welcome the amendments. In his closing remarks, would the Minister confirm that registers would be accessible to the private sector as well as to the NHS?

[Baroness Thornton (Lab)]

My Lords, I have greatly appreciated this debate, the expertise, and the explanations we have been given as to why the amendments are important. I particularly enjoyed the remarks by the noble Lord, Lord Ribeiro, about his hips: very important they are indeed.

Perhaps we should remind ourselves that Clause 16 was inserted in the Bill during the Commons stages after a cross-party effort involving the Labour Front Bench working with the Government. It provides for a data system to be set up by regulations to assist in tracking devices once they are implanted, so that safety performance and clinical effectiveness can be better monitored. The intention is that in the long term, that would support future device registries, allowing problems to be spotted earlier and patient harm to be prevented.

The amendments would tighten up that clause. The amendments tabled by the noble Baroness, Lady Finlay, are concerned with the operation of the tracker, using the devices’ unique identification. Currently, Clause 16 provides that unique device identifiers “may” be recorded as part of the data system. Quite rightly, the amendment would change that “may” to a “must”. So much of our work revolves around changing “may” to “must”.

Amendments 86 and 88 would amend Clause 13. Amendment 86 would require that UDIs should be considered as part of the packaging information on medical devices, and Amendment 88 would require that tracking devices used in individual procedures should be part of the Government’s consideration when regulating device registries. These amendments raise questions about the detail of device tracking. How will the unique identifiers be recorded and used? Those questions were raised by both the noble Baronesses, Lady Finlay and Lady Cumberlege. Will it be mandatory to record the unique device identifier in every procedure, and feed that into the data system? How can we ensure that that data is secure, and that it is recorded in the appropriate place? The Minister has those questions to answer at the end of the debate.

The noble Baroness, Lady Cumberlege, rightly addressed the issue of patient consent. She also underlined the fact that there is an opportunity in the Bill to get the law and the framework right. Amendment 103 would add to Clause 16 a requirement that the regulations must specify what information held by a data system is subject to a patient’s consent. The intention is that data held under the system should be used and shared to identify trends and trigger regulatory and clinical action where it is needed.

In her report, the noble Baroness cites the difference between a database and a registry. She is right to do so. The amendments explore the importance of the registry and the database, and the importance of patient consent —and whether we return to the subject at a later stage will depend on what the Minister now has to say.

[Lord Bethell (Con)]

My Lords, I am enormously grateful for that really important discussion of these critical amendments and provisions. I will take a moment to run through them in some detail. Device safety is absolutely critical to patient safety, and that is why the Government amended the Bill to include Clause 16. I pay tribute to my noble friend Lady Cumberlege, whose team helped inspire that amendment, and to the noble Baroness, Lady Finlay, who has participated in discussions on this clause. We have the benefit of her insight now.

Amendment 86 in the name of the noble Baroness, Lady Finlay, would add the unique device identifier number to the provisions in Clause 13(1)(g). These provisions currently allow the Secretary of State to make regulations about package labelling, provision of information and instructions for medical devices. UDIs would be one of the matters included within regulations made in reliance on Clause 13(1)(g), as drafted. It is therefore our belief that the amendment is not necessary.

The noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro made important and fascinating remarks on Scan4Safety. I will limit my comments, which could be extensive, to the importance and value of that scheme. We are extremely supportive of the principle of fast and accurate traceability. Scan4Safety is not the only scheme of its kind, but it is a particularly good one. It is the hope that any UDI created by these regulations will empower these valuable services. We have a session on medical device information systems coming up in the diary, when I hope very much that we can discuss how that might work. If the concern of the noble Baroness is whether we intend to make provision to require manufacturers to provide a UDI, I reassure her that that would be a condition for being placed in the UK market.

Amendment 88 to Clause 13, as the noble Baroness, Lady Finlay, has indicated, is intended to support the tracking of devices used in medical procedures by recording the UDI in a register provided for in Clause 13 or within hospital episode statistics. I completely acknowledge the noble Baroness’s intent, but there is a difference between a register at Clause 13 and a database at Clause 16, or a registry. Clause 13 provides for a register or a number of registers. The register or registers we intend to create under Clause 13 will be a list of medical devices for sale on the UK market, held by the MHRA. It will not include the individual product identifier part of the UDIs and it will not contain data or monitoring information related to individual devices. The register forms part of wider market surveillance and vigilance activity. Regulations will be able to make provision requiring information to be entered into a register, such as the unique device identifier, which all manufacturers will be required to put on their devices. Amendment 88 is therefore unnecessary.

While the registers will enable some device identification to track individual devices, it is the information system, created under regulations made under Clause 16, which will ensure that devices and procedures are tracked in the event of a concern being identified, through which patients can be contacted and appropriate action taken in each case. The use of MDIS, which I will come on to, could prompt the MHRA to use the information in the register established under Clause 13 to identify the manufacturer and take action.

Amendment 102 would add information to be recorded in any information systems established under Clause 16. All the information set out in Amendment 102 can already be required under regulations made under Clause 16, but the regulations do not have to set out all those matters and can set out other descriptions of information.

A UDI may not always be available, such as for a custom-made device, so it may not always be possible for the providers to capture this. Amendment 102 would also require the recording of every procedure that related to a medical device. I have spoken before about the number of different medical devices on the market and that they vary greatly in risk profile. It would not be necessary or cost-effective to record every procedure related to a medical device, but they could be recorded in one of the registers provided for by regulations under Clause 12, as being on the UK market.

Amendment 103 in the name of my noble friend Lady Cumberlege deals with the important issue of patient consent. It would introduce an obligation that regulations made under Clause 16 would require the Secretary of State to set out the categories or types of information that are subject to patient consent that are held by the Health and Social Care Information Centre, otherwise known as NHS Digital, or by other persons.

My noble friend has raised this with me and with officials, and she is a tireless champion of patients. I am moved and affected by the accounts she has heard. As the testimony in her review shows, the absence of data in the healthcare system is absolutely medieval, and it is exactly the purpose of the Bill to fix that. Before any data can be collected relying on the provisions at Clause 16, regulations must be made. Those regulations are subject to consultation, as at Clause 41. It is absolutely right that the system is informed by patient views, and that the process is one where it is easy to engage, to understand what we want to do and to build consensus that it is the right thing.

My noble friend Lady Cumberlege has views on what data should be subject to opt-out versus opt-in. Privacy is a higher-order value that we should protect. The question of patient consent is really important. The noble Baroness, Lady Finlay, campaigned on the importance of opt-out organ donation and I congratulate her on her contribution to the recent change to organ donation privacy protocols, which are widely supported by the public and will save thousands of lives. She knows as well as I do that choosing to opt into measures is not as comprehensive as choosing to opt out. It is important to have enough data to draw conclusions.

Consent will not be required to input information about the surgical procedure and the UDI of the implanted device, linked to the patient, into the information system. The medical device information system is about protecting all patients who have had similar procedures, not just a particular patient. The detail of the specific device inserted, the procedure information and, if necessary, the effect that device has caused is what will be necessary for the information system to work. If there is no adverse report made by the clinician on behalf of that patient, that data acts as a control sample. It allows for other patients’ reports, where there have also been adverse reactions, to be understood as part of a wider data picture.

In her report, my noble friend raised the recommendation that detailed data should require consent in order that the data collected is necessary and proportionate. I reassure her that all data collected for the system will be necessary and proportionate. Data held by clinicians should be shared only under those circumstances, and data shared by the information system with, for example, a clinical registry for clinical assessment of whether there is an issue, should be only that which is necessary.

The intention is, that in the event there is a reported adverse reaction with a device, the medical device information system would send a report to a clinical registry. That report, suitably anonymised and stripped of patient-identifiable information but including the device UDI, would have the detail of all procedures, not just those involving adverse reactions, to further anonymise the incident. A clinical assessment would be conducted and, if it is concluded that the device is the issue, only relevant and necessary information would be sent to the MHRA to conduct its own tests.

This is a very important paragraph and one that I will emphasise. We do not need patient-identifiable information to determine whether compliance or enforcement action needs to be taken, but device information. There are routes to identifying that there are issues with adverse reactions when a clinical registry is not present, such as manufacturers’ reports or Yellow Card reports.

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[The Deputy Chairman of Committees (Lord Lexden) (Con)]

I have received a request to speak after the Minister from the noble Baroness, Lady Thornton, on whom I now call.

[Baroness Thornton (Lab)]

Can the Minister run it by me again how this will protect patients? I heard a lot being said about physicians and their reporting. I am not sure that I understand how this will avoid the problems with valproate and all the other situations with mesh unless “must” is used rather than “may”.

[Lord Bethell (Con)]

I can give a couple of illustrative examples if that would be helpful, but to run through the whole philosophy and system is probably beyond my ability or the time afforded by this Committee. In essence, the challenge identified by my noble friend Lady Cumberlege is that individual reports of adverse signals are not easily connected, unless those reports are somehow sent to a central registry and analysed by the kinds of experts who can spot mistakes and the connections made between those signals. This is how any problem identification system works. To do that process, you do not have to share personal details. You do not need the telephone numbers or personal identities of those concerned, but you need the clinical details and the full context in which signals have occurred. This pattern identification is often missing in the instances on which my noble friend reported. Having this information system, and analysis connected to it, will enable us to spot problems at a much earlier stage. Necessary interventions based on analysis and understanding will be much prompter and the connections made much more emphatic.

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[Baroness Jolly (LD) [V]]

My Lords, the amendment from the noble Baroness, Lady Finlay of Llandaff, would require the Secretary of State to introduce a scheme to promote the availability of innovative medical devices for human use within the NHS. The scheme would be known as the NHS innovative medical devices fund.

The Secretary of State is charged with providing the funding and I welcome that approach. She has explained that custom-made devices are both difficult and expensive to fund, especially for the subsequent development of innovative devices with repeated trials. It can also be frustrating. A medical devices fund could take an innovation from concept through its development to production and then be rolled out widely, with any gains being returned to the fund or to the NHS organisation hosting the work. Clearly, flesh needs to be put on to those bones, but as I explained in an earlier Committee session, there is a fund that is particular to orthopaedics which is managed by a charity. In effect, every year it calls for bids, often from start-ups. It supports a certain number of the bids and any profits come back to the charity, which can also choose to be a partner in the venture. Some of the bids come from academia and others from within the NHS, but it works.

[Baroness Thornton (Lab)]

This amendment is interesting and certainly worthy of consideration. The innovative medical devices fund would insert a new subsection into the National Health Service Act 2006. Section 261 provides powers for the Secretary of State in relation to voluntary schemes to control the cost of medicines. The section describes these as schemes that are joined voluntarily and limit the price that may be charged on the profits that may accrue from the manufacture and supply of health service medicines. The scheme also provides for manufacturers and suppliers to pay the Secretary of State an amount of money if the agreed limits are breached. Amendment 91A would create a voluntary scheme under Section 261 which would be specifically for medical devices to give them equal treatment as innovative medicines. The Minister will have to explain why that would not be a good idea.

In her speech at Second Reading, the noble Baroness, Lady Finlay, talked about making the UK a medical devices development and production hub. Too often the UK effort has been bought out by overseas manufacturers who then market the devices back to the NHS at great profit.

[Lord Bethell (Con)]

My Lords, Amendment 91A seeks to replicate the innovative medicines fund with a comparable fund for medical devices called the innovative medical devices fund. We have had a terrific debate on this. The ideas and insights shared by noble Lords have been extremely powerful, but perhaps I may address the points in turn.

The goal that is shared wholeheartedly by the Government is that we recognise the huge benefits that medical devices can deliver. My noble friend Lord Lansley and the noble Lord, Lord Hunt, put that particularly well. We recognise the astonishing pace of innovation and development that is creating new healthcare options for patients across the UK. In fact, that is one of the reasons we are considering this Bill. We are extremely ambitious and are determined to capitalise on the opportunities presented by new medical technologies to ensure that the best innovations are adopted and spread across the NHS.

Devices, like medicines, are key to ensuring patient health, but they are different and it is not necessarily helpful to use a system that was developed for medicines to be used for devices. For example, the primary purpose of the innovative medicines fund is to cover the cost of managed access agreements where NICE feels that there is insufficient evidence to give a positive opinion and asks for further evidence to be collected before the product is re-evaluated.

Devices are not assessed by NICE in the same way and we do not consider that mirroring the provisions for medicines would necessarily be beneficial. In particular, unlike medicines where, once licensed, they do not change, medical devices are constantly evolving. New iterations of medical devices are developed quickly, their impact on patients changes, often rendering earlier iterations completely obsolete within relatively short periods of time. That gives rise to the potential for funding mandates to be in place for devices that are no longer the best or most cost-effective in their category. Requiring the mandatory purchase of all but the most innovative devices by commissioners would not be a sensible use of NHS funds. We therefore need to find different systems of process to ensure that innovative and effective devices, along with other medical technologies such as digital, find their way to the NHS and to patients.

That is why we have boosted the remit of the Accelerated Access Collaborative. It will bring together leaders from across Government, the NHS, regulators and industry to address the underlying challenges that delay patient access and uptake.

As chairman of the AAC, the noble Lord, Lord Darzi, has been able to bring his world-leading expertise to bear to deliver a host of successes in recent years. Indeed, almost 750,000 patients have benefited from access to AAC-supported innovations in recent years, including more than 315,000 patients who have accessed new technologies supported through the innovative technology payment programme. The AAC is going further to deliver the commitment in the NHS Long Term Plan to accelerate the uptake of proven, affordable innovations with the introduction of a new medtech funding mandate. The mandate will ensure that all patients have faster access to selected cost-saving devices, diagnostics and digital products approved by NICE, via medical technologies guidance and, when available, NICE diagnostic guidance for innovations.

The final criteria to be used in the mandate will be announced in the consultation response to be published in December this year, and the mandate will take effect from April 2021. Additional steps are being taken to ensure that the mandate translates to front-line improvements in patient access. The NHS standard contract has already been updated to state that the relevant parties must comply with their obligations under the mandate guidance, and technologies receiving the mandate will benefit from dedicated support via the regional academic health sciences network to help drive local adoption and spread.

NICE also recognises the need to ensure its methods for assessing innovative medical technologies continue to support our ambition for the NHS to provide world-leading care that delivers value to patients and the NHS. The NICE methods review is therefore under way, with extensive input from industry and patient representative groups. The consultation on the case for change to existing NICE methodology is open until 18 December, and I encourage all those interested to submit their views.

Finally, it is also important to note that in her amendment the noble Baroness, Lady Finlay, stated that moneys should be paid to the Secretary of State under Section 261(9) of the National Health Service Act 2006 in order to support an innovative medical devices fund scheme. However, Section 261 of the National Health Service Act relates only to voluntary schemes agreed with pharmaceutical manufacturers which control the prices charged, or profits accrued, by manufacturers and suppliers of health service medicines. The vast majority of medical devices would not therefore be within the scope of such a scheme.

I trust that I have been able to reassure the noble Baroness that the funding of medical device technology in the NHS in England is of great importance to the Government and that we are actively putting in place mechanisms to support it. On this basis, I hope very much that the noble Baroness, Lady Finlay, will feel able to withdraw her amendment.

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[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

We do not seem to be able to contact the noble Lord, Lord Norton of Louth, so I call the noble Baroness, Lady Thornton.

[Baroness Thornton (Lab)]

I thank my noble friend Lord Field—he may not technically be my noble friend, but he is really—for bringing this issue to the Committee at this stage. He probably knows that he is not the only parliamentarian who has been driven to cannabis products for similar reasons, but my lips are sealed about who the others might be.

The noble Baroness, Lady Meacher, is absolutely correct. She and I have form. I have been supporting her from the Front Bench on this issue for quite a long time. While the debate was going on, I looked to see what Hansard had to say about this. The last time, I think, that we discussed this was in March 2019. At that time, the framework and law had been changed the previous November, so that is two years ago. At that point four people had managed to get cannabis products prescribed. When the noble Baroness put the question to the House, it was answered by the Minister’s predecessor. Will the Minister say how many more people there are now? I think it is probably not that many more, and I see this amendment as a scream of frustration about this issue. There is justifiable frustration that we have not managed to regulate this product in a way that makes it accessible to people who need it most. It also exacerbates the inequalities in our health system because, as the noble Lord, Lord Field, said, he can afford to buy it, but there are thousands of people who need it and cannot afford to buy it. I support this amendment, but I am really much more interested to see what on earth the Government are going to do to make progress with this.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I am now able to call the noble Lord, Lord Norton of Louth.

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[Baroness Penn (Con)]

I thank the noble Baroness for her comments. I emphasise that there has been a great deal of discussion in the debate about the use of evidence. That is what will guide the Government and the MHRA in this, and that is why we are supportive of these RCTs taking place.

[Baroness Thornton (Lab)]

I have two brief questions. I agree with the noble Baroness, Lady Walmsley, in what she said about 200 being two a week. That is really pathetic in terms of what the need is likely to be. I wondered if the problem was because early on, there was a certain nervousness among GPs and clinicians in terms of the legal issues as regards prescribing cannabis products. Is that still an issue? The other thing I want to ask the Minister about is whether the MHRA is drawing on international experience because some countries are much further ahead on these issues than we are.

[Baroness Penn (Con)]

The MHRA is very clear about its desire to be an international regulator and engage with other regulators across the world on all issues regarding the regulation of medicines and medical devices, so I am sure that it is working in this area. On the point the noble Baroness has made about the nervousness of clinicians on the legal status, this is not something that I am aware is still an issue, but I am happy to take the point away and look at it again.

Covid-19: Vaccine

Baroness Thornton Excerpts

Wednesday 11th November 2020 Lords Chamber

[Lord Bethell (Con)]

The noble Lord is entirely right that we have to approach the prospect of a vaccine in a measured way. There remain considerable imponderables about the effectiveness, longevity, impact and side-effects of a vaccine. These are things that we do not know yet, and we have to keep our eyes open to the limits of what the vaccine may or may not be able to do. That said, the initial data from Pfizer is incredibly encouraging. We have taken a measured approach in our communications to date. Jonathan Van-Tam, the Deputy Chief Medical Officer, is the face of the vaccine, as it were; he is the member of the Vaccine Taskforce who has brought the clinical perspective to its work, and he will remain an important voice in all this.

[Baroness Thornton (Lab)]

It is good news indeed. I would like the Minister to share how the Government are preparing to build public confidence in the vaccine and counter the anti-vax campaigns. Following my noble friend’s question earlier, I would be grateful if the Minister could share with the House the plans for reaching harder-to-reach communities, so they can get the information they need and access to the vaccine when the rollout starts.

[Lord Bethell (Con)]

The noble Baroness is right that we face a challenge. While there will be millions of people who will come forward emphatically to have the vaccine, there will be some who are either disengaged with the British Government or actively hostile to the thought of a vaccine, and we take seriously the disruption caused by those who seek to profit either financially or politically from the confusion and distress caused by anti-vax campaigns. It is not appropriate for me to discuss at the Dispatch Box the detailed measures we are putting in place to deal with the anti-vax message, but I can reassure the noble Baroness that they are focused, energetic and proving to be effective.

We also take seriously our efforts to reach hard-to-reach communities—those who might not have confidence in the Government or we might not have the right connection with. Those communities are exactly the ones we need to vaccinate, and we are making them an enormous priority in our efforts.

Covid-19: Dental Services

Baroness Thornton Excerpts

Tuesday 10th November 2020 Lords Chamber

[The Lord Speaker (Lord Fowler)]

I make the point that I say at the beginning of every Question Time that two points are the maximum that should be made.

[Baroness Thornton (Lab)]

In my view, the Government have offered little support to dentist practices: not exempting them from business rates, even though book- makers and vape shops are exempted, and not offering them key worker status, which has caused problems with childcare. Can the Minister commit to early access to Covid-19 vaccines for all high-street dentists who are NHS contractors, rather than employees? Can the Minister give them key worker status?

[Lord Bethell (Con)]

My Lords, one area where the Government have made a big commitment to dentists is in PPE. As of Wednesday 4 November, over 5,000 dental and orthodontic providers in England had registered with the PPE portal and over 36 million items of PPE had been delivered. In terms of the commitment to workers, I will have to come back to the noble Baroness.

Covid-19 Regulations: Assisted Deaths Abroad

Baroness Thornton Excerpts

Tuesday 10th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I think it is to be welcomed that the response to the Urgent Question last week was that travelling for the purposes of an assisted death would be exempt from lockdown travel restrictions. However, there are concerns that this Statement did not go into detail about whether family members could accompany people. Legal constraints mean that it is not clear whether the exemption applies to them. Presumably, they would have to demonstrate their reasons for travel and might, in the course of doing so, incriminate themselves for assisting a suicide. So can the Minister clarify that family members accompanying someone travelling for an assisted death will not be vulnerable in this way? If the Minister does not know the answer in detail to this important question, please would he seek to find out from the Ministry of Justice, write to me, and put the letter in the Library?

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

The noble Baroness is entirely right on the question of travelling abroad for the purpose of assisted dying. It would be regarded as a reasonable excuse, and therefore anyone who did would not be breaking the law. In answer to the noble Baroness’s question, under Section 2(1) of the Suicide Act 1961, a person does commit an offence if he or she

“does an act capable of encouraging or assisting the suicide or attempted suicide of another person”

and that act

“was intended to encourage or assist suicide or an attempt at suicide.”

The 1961 Act provides no exceptions to the prohibition on assisting suicide. The maximum penalty, as noble Lords may know, is 14 years, and there is nothing in the Coronavirus Act or any recent legislation that in any way changes that.

Covid-19: Transparency and Accuracy of Statistics

Baroness Thornton Excerpts

Monday 9th November 2020 Lords Chamber

[Lord Bethell (Con)]

On the manner in which the information was delivered, I take the noble Baroness’s comments completely on board. While it is not my role to be in charge of the presentation of No. 10 presentations, I think a lot of people would agree with her that there were a lot of slides, which were very detailed and not all formatted for the TV screen. However, we are trying our hardest to share with the public as much of the insight and science as we possibly can, and we are trying to hit that balance between too little and too much information. We are trying to publish data as soon as it can be reasonably verified. There will be some scratchiness around the edges on that, and I take the noble Baroness’s points about last Saturday completely on board. However, the commitment to transparency and open debate on these issues is sincere.

[Baroness Thornton (Lab)]

When will the Government start sharing data and having meaningful discussions before decisions are taken? Given that public confidence in these decisions is crucial for them to work, will the Government start working with the opposition parties, which they expect to—and which have—supported the lockdowns and proposals, as Keir Starmer and others have been offering for months?

[Lord Bethell (Con)]

The noble Baroness is right to pinpoint the sharing of data as being very important, and we have been as open and transparent as we can be. We publish an enormous amount of data. Just before this debate, I tweeted three of the main portals to the data, which there is not only an unprecedented quantity of but which is more up to date than could reasonably have been expected a few months ago, when such data was not available. Some of these decisions are made extremely quickly because the data changes so quickly. Sometimes, one believes that we are on track for one thing, and then the virus changes course and we have to change our policies accordingly. That is simply a fact of the challenge of fighting this virus: speed is of the essence, and sometimes it has been extremely difficult to do the kinds of consultation that the noble Baroness quite reasonably describes.

Health Protection (Coronavirus) (Restrictions) (England) (No. 4) Regulations 2020

Baroness Thornton Excerpts

Wednesday 4th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

Like the noble Baroness, Lady Jolly, I will actually be addressing the statutory instrument, the Minister will be pleased to hear. In a way, these Benches are probably the least of his problems tonight. I do not expect that he is thanking his clutch of colleagues who, for one reason or another, are trying to stop these important regulations or have regrets. Of course, most of the regrets are perfectly legitimate questions to be asked and concerns to be raised, which is actually the point of the debate. Putting down an amendment to the Motion to double your speaking time seems a bit iffy to me.

On behalf of these Benches, I will not be commenting further on the amendments to the Motion, which I think are based mostly on internal Conservative Party arguments. We will abstain if any of the five noble Lords move to a Division. As for the noble Lord, Lord Robathan, we know that he has form—possibly a quasi-herd immunity supporter, I wonder, who disregards the science which at present tells us that such abandonment of restrictions might mean many deaths until we have a cure or a vaccine. We know the noble Lord’s intemperate views are not those of his own Government. If he tests the opinion of the House tonight, we will vote against his amendment. Frankly, this is too important for the whole country to play games, like the noble Lord, Lord Robathan, and those who support him.

As my right honourable friend Sir Keir Starmer and my honourable friend Jon Ashworth have made clear in the past few days, these Benches have major concerns over the Government’s decision-making, communications and messaging, and it is of the greatest importance that we have far more clarity about what is to be done during lockdown II and its exit route, as my noble friend Lord Rooker said.

We have been offering to work with the Government for months. Indeed, yesterday in the House of Commons my honourable friend Rosena Allin-Khan MP asked the Minister Nadine Dorries five or six times about working together to deal with the mental health pandemic. She got a very rude brush-off from that Minister—not at all the kind of behaviour we would expect from our Minister.

This afternoon, the House is invited to endorse the Prime Minister’s decision to impose upon the whole country a deep, restrictive lockdown for which the exit strategy is still unclear. As the Chancellor of the Duchy of Lancaster confirmed on Sunday, it could stretch beyond four weeks. On these Benches, we have argued very strongly that the previous lockdown was the time when we could have got the vital systems, particularly test and trace, in place and rebuilt the vital local capacity that has been so foolishly run down by years of cuts and hostility to local government. This time we hope that the Government will not only recognise the crucial role of local knowledge and expertise but will fund local authorities as they have promised. We have at least to flag up that one day there will have to be a reckoning for the absurd way that contracts have been handed out to private organisations in a manner more reminiscent of a banana republic.

As Keir Starmer has made clear, Labour supports the introduction of national measures to slow down the spread of the virus. This is an approach that he made weeks ago on the emergence of evidence on 21 September, as my noble friends Lord Hunt and Lord Knight said, and for which he and the Labour Party received abuse from the Government and some of their supporters in the media. I think we are entitled to point out that the initial reaction of the Government was to do too little, too late; their shambolic press conference on Sunday was a graphic illustration of that. The cost of inaction is an inevitable harder lockdown now, as my noble friend Lady Andrews said.

Labour will support what the evidence required all along. Of course, here and in the other place, the details will be subject to scrutiny, which is our job. As the noble Baroness, Lady Jolly, said, we are at least debating these regulations four or five hours before the lockdown into comes into place, which is definite progress. We will join the Government in delivering the message that everyone has to play their part, abide by the rules and bring the rate of infection down. The Government are rightly saying that lockdown II may not end on 2 December but, like other noble Lords, I ask the Minister: what is the strategy for exiting this lockdown? Are we really going to go back to the three tiers that did not appear to work in the first place?

Above all, we have to have ready a proper world-class find, test, trace, isolate and support system. There have been so many months of unfulfilled promises on this, but it will have disastrous implications if we do not get it right. It is that case that our hospitals are filling up. Almost 11,000 people are now in hospital. Does the Minister feel that that will end if we bring the nationwide R rate to less than one?

I make a final plea for those who have people in care homes. Mistakes were made in the first wave of the pandemic. Families will be anxious to know that their loved ones in care homes will be protected as infections rise, but keeping care home residents safe should not mean locking residents up and keeping them away from the people who care about them, so can the Minister guarantee that families will be able to visit care homes during this lockdown and that they will be treated as key workers with access to regular testing so that they can visit their loved ones safely?

Covid-19: Contracts and Mass Testing Programme

Baroness Thornton Excerpts

Wednesday 4th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, it seems to me that, however urgent the requirement for PPE and other services, transparency becomes even more important in those circumstances. The Minister will be fully aware that the Ministerial Code says that Ministers are responsible for ensuring that no conflict exists, or appears to exist, between their personal interests and their public duty. As the former chair of a procurement committee for MyCCG, I received extensive NHS training on conflicts of interest, which are defined as

“a set of circumstances by which a reasonable person would consider that an individual’s ability to apply judgement or act, in the context of delivering, commissioning, or assuring taxpayer funded health and care services is, or could be, impaired or influenced by another interest they hold.”

Perception is as important as reality. Has the noble Lord declared the interests that arise out of the meetings that other noble Lords have mentioned today? Where are they recorded and published?

[Lord Bethell (Con)]

The noble Baroness is right that transparency is key. I take those principles extremely seriously, and that is why we are publishing the contracts. I encourage anyone who is interested in looking at them to look at my Twitter feed, where I published a link to the Contracts Finder service yesterday. I reassure her that, although some connections were made through networks, absolutely every contract had exactly the same technical assurance, exactly the same contract negotiation and exactly the same procurement scrutiny. Those were done by civil servants, and value for money for the taxpayer and the people was guaranteed by that process.