Health and Care Bill

Debate between Baroness Thornton and Baroness Penn

Lords Hansard - Part 1 & Report stage
Monday 7th March 2022 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, it is a great pleasure to speak about reciprocal healthcare, which is not how I felt several years when we dealt with this exact issue in your Lordships’ House, as many noble Lords might remember. It was with some trepidation that I and these Benches looked at this part of the Bill, because we were so concerned and had to do so much work to protect our NHS in the passage of the 2019 Act.

I am very grateful to the Minister and the Bill team for engaging with us so thoroughly to take on the board our concerns, which needed to be built into this part of the Bill. I say particularly how impressed I am by the noble Lord, Lord Sharkey, and how grateful I am to him for his understanding and persistence—and his ability to read long, complex documents, understand them and then translate them so that other people can understand them too. That is a great talent.

From these Benches, with the idea that the affirmative resolution will be agreed, we are very happy indeed.

[Baroness Penn (Con)]

My Lords, I too thank noble Lords for their helpful engagement on this matter over the last few weeks and for bringing forward the debate on this issue today. It is important that the results of those discussions are on the record, so I hope that noble Lords will forgive the length of my response.

I am pleased that we agree on the overarching benefits of having reciprocal healthcare arrangements with countries across the world, which would provide support to UK residents when travelling abroad and can be particularly valuable to those with long-term health conditions. Such arrangements can also support enhanced healthcare co-operation with our international partners. It is for these reasons that the Government have negotiated new arrangements with the EU and Switzerland and now wish to refresh arrangements with countries outside Europe and with our overseas territories and Crown dependencies. This policy is fundamentally aimed at assisting UK residents to access healthcare abroad.

Turning to the amendments tabled by the noble Lord, Lord Sharkey, I start by making some assurances to him and to the House over the policy intentions of the international healthcare arrangement clause in the Bill. To be clear, this legislation is not about the negotiation of international healthcare agreements. Those agreements are negotiated using prerogative powers. This clause and the 2019 Act that it amends simply ensure that the Government have the powers to implement international healthcare agreements. Healthcare agreements contain substantive provisions, such as eligibility criteria and which treatments will be covered. New Section 2(1) gives us the power to implement those healthcare agreements; for example, by putting in place administrative arrangements and conferring functions on public bodies to deliver our reciprocal healthcare commitments. We could, for example, set out which public body will administer the global health insurance cards. It is anticipated that any regulations made under new Section 2(1) will be materially the same as the current Healthcare (European Economic Area and Switzerland Arrangements) (EU Exit) Regulations 2019 No. 1293.

The department has been undertaking careful analysis of how to take forward international healthcare agreements, balancing the benefits for citizens when abroad with the Secretary of State’s duties in the NHS Act 2006, which apply when exercising functions in relation to health services, for example, the duty to continue the promotion in England of a comprehensive health service. Our analysis to date shows that there are clear benefits to be derived from state-to-state reimbursement models, but that these will generally work only with countries with public healthcare systems.

I recognise the noble Lord’s concerns about the breadth of the powers, and I reassure him that Clause 151 narrows the powers under the Healthcare (European Economic Area and Switzerland Arrangements) Act 2019 to better reflect what is necessary now that the UK has left the EU and has reciprocal healthcare arrangements in place through the trade and co-operation agreement. It does this by revoking existing powers in Section 1 of the 2019 Act, which currently enable the Secretary of State to pay for unilateral healthcare policies in the EEA and Switzerland; enabling payments to be made for treatment outside the scope of a healthcare agreement only if exceptional circumstances justify the payment; allowing the payment power to be exercised only if authorised by regulations. and limiting the Secretary of State’s ability to make regulations in areas of devolved competence.

Our approach follows concerns raised by noble Lords in the original Bill debates in 2019 about the breadth of the unilateral payment and regulation-making power. Under the current Sections 1 and 2, the wide powers given to the Secretary of State to fund healthcare in the EEA and Switzerland were intended to cover various EU exit options and ensure that UK nationals were not left in a cliff-edge situation in the EEA and Switzerland in the event of a no-deal scenario. There was limited additional scrutiny for the payment power in the original 2019 Act due to the circumstances at that time. We consider that this power is no longer appropriate or necessary now that the trade and co-operation agreement is in place.

Amendment 126A would limit the exceptional payments power so that it is exercisable only after the Secretary of State has set out reasons for, and details of, any payments made before Parliament. However, I do not believe that this would work in practice. The policy intention is that the exceptional payments power will be used in circumstances where an individual falls marginally outside of the scope of a healthcare agreement. We have, for example, used discretionary payment powers under the 2019 Act to provide crisis mental health support to a minor in the EU who was not covered under the European health insurance card scheme due to the structure of the member state’s healthcare system. These circumstances are often where an individual has a very serious and urgent medical need, and it remains essential that the Government are able to move quickly to support that person and ensure their welfare. An amendment where this power is exercisable only after the reasons and details of payments have been laid before Parliament could severely hamper our ability to act quickly—something that I am sure is not the intention. Furthermore, the Government are already obliged under Section 6 of the 2019 Act to lay before Parliament an annual report outlining the payments made pursuant to the Act. This ensures that there is transparency and will continue to apply following amendments made by this Bill.

I confirm that the amended definition of a “healthcare agreement” in this Bill is materially the same as the current 2019 Act definition. Both cover commitments between the UK and a country, territory or international organisation for healthcare provided outside the UK in whatever form. Making reference to “other commitment” is a drafting change to make it clearer that the regulation-making power can be used to implement non-legally binding arrangements, such as memoranda of understanding. This ensures that implementation of reciprocal healthcare arrangements made with close partners, such as the overseas territories and Crown dependencies, are in scope of the 2019 Act, as they do not have the authority to become parties to treaties in their own right. They can, therefore, enter only into non-legally binding arrangements.

Amendment 184ZC would make regulations subject to the affirmative resolution procedure. With thanks to the noble Lord, Lord Sharkey, for his constructive engagement, the Government are content to accept this amendment and, as the noble Lord is aware, may amend it further to ensure that the drafting is optimal for our shared objective.

The purpose of the 2019 Act and the provisions that we have put forward in Clause 151 is not to implement trade deals. The Government have categorically stated in their manifesto that the NHS is off the table when we are negotiating agreements with our international partners. To be clear, it is important to state that reciprocal healthcare agreements that we agree with other countries do not relate to the commissioning and provision of services for the NHS. The policy intention in that reciprocal healthcare should cover publicly available healthcare.

This legislation narrows the scope of the powers compared with the 2019 Act and is tailored to negotiate more comprehensive healthcare agreements with our closest partners, as well as provide support to our citizens when they need it most. For that reason, I ask the noble Lord to withdraw this amendment and not move Amendments 126B to 126G. I confirm the Government’s support for Amendment 184ZC.

Health and Care Bill

Debate between Baroness Thornton and Baroness Penn

Lords Hansard - Part 1 & Report stage
Thursday 3rd March 2022 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, the noble Lord, Lord Lansley, has once again put his finger on an issue that the Government need to take seriously and which, as the noble Lord, Lord Scriven, said, has run through our debates at Second Reading and in Committee. What is the role of the ICPs’ joint working and what should a place board be doing? As I said during the previous day’s debate on Report, we need also to treat place boards—or any commissioning body—in the same way as we do the ICBs.

The noble Lord, Lord Lansley, is right. If the Government do not address this issue in the next few weeks by putting something in the Bill, we may well find ourselves back here in two or three years’ time, doing exactly what we are doing now.

[Baroness Penn (Con)]

My Lords, this has been an important discussion about place and joint working, and although the Government are unable to accept my noble friend’s amendments, for reasons I shall touch on, I hope I can reassure him that the questions which he and other noble Lords have raised have been considered in the Bill.

England is so large and diverse that a one-size-fits-all approach will not be right for everyone, and that is why we have been flexible about the requirements for integrated care partnerships and joint working arrangements. We fundamentally believe that, if integration is to work, we must allow local areas to find the right approach for them.

As my noble friend will appreciate, our provisions on integrated care partnerships build upon existing legislation, particularly in the case of health and well-being boards. We know that health and well-being boards have played an incredibly important role in the last decade, and this legislation intends to build on their success. We will be refreshing the guidance for health and well-being boards in the light of the changes that this Bill proposes, in order to help them understand the possibilities of these arrangements and their relationships with ICBs and ICPs, so that they can find the most appropriate model for their area.

Fortunately, this Bill and existing legislation already provide the framework to do what these amendments intend to achieve. Two or more health and well-being boards can already jointly exercise their functions, and where the local authority area and ICB area are the same, there is no reason why the health and well-being board and the ICP cannot have the same membership. The ICP is intended as an equal partnership between the local authorities and the ICB. By restricting the right of the local authority to nominate a member who they see fit and requiring them to do so through a committee with a potentially wide membership, including the ICB, risks undermining that equality. Local authorities may ask their health and well-being board to nominate those members. However, we do not wish to restrict their options and unintentionally prevent better collaboration and integration by adding further requirements to the Bill.

I turn to the joint working arrangements. The Bill also provides for the ability to establish place-based committees of ICBs and to set them out clearly in their constitutions. I assure my noble friend on this point that the legislation allows the flexibility to establish these committees, so we should not find ourselves in the situation that he talks about. ICBs will be able to enter arrangements under new Section 65Z5, which allows an ICB to delegate or exercise its functions jointly with other ICBs, NHS England, NHS trusts, foundation trusts and local authorities, or any other body prescribed by regulations. Under these powers, a committee of an ICB could be created to look at population health improvement at place level and could consider entering an arrangement under Section 65Z5 to work jointly where appropriate.

The membership of that committee can be decided locally by the ICB, and it is entirely open to the ICB to seek views from other organisations as to who best to appoint. I hope that reassures my noble friend that there is already the legal framework for ICBs to look at population health improvement at a place level. We are trying to protect the ability of ICBs to determine the structures that work best for them. To help them to do that, NHS England has the power to issue guidance to ICBs on the discharge of their functions. The flexibility that we have set out in the Bill makes my noble friend’s intentions possible. However, our provisions also give a degree of flexibility, so that areas can take control, innovate, and adopt what works best for them, rather having to meet prescriptive top-down requirements.

It is for these reasons that I hope that my noble friend feels able to withdraw his Amendment 61 and not move his Amendments 95 and 96 when they are reached.

Health and Care Bill

Debate between Baroness Thornton and Baroness Penn

Lords Hansard - Part 1 & Report stage
Tuesday 1st March 2022 Lords Chamber

[Baroness Thornton (Lab)]

I absolutely concur with the noble Lord, Lord Crisp, and the noble Baroness, Lady Walmsley, and congratulate the Minister on a concise and accurate proposal of these amendments. Long may this continue.

[Baroness Penn (Con)]

My Lords, this has been a welcome, consensual and short start to Report stage, which I am sure we will continue through future groups. I am not sure there is much to add, so therefore I ask that these amendments be agreed.

Deprived Areas

Debate between Baroness Thornton and Baroness Penn

Thursday 1st July 2021 Lords Chamber

[Baroness Penn (Con)]

My Lords, I had the pleasure of sitting in on an excellent debate on a similar subject last week. Unfortunately I do not lead the House’s timetable, but I will make the submission on behalf of the right reverend Prelate.

[Baroness Thornton (Lab)]

I am very pleased to hear that the Government have noted the report, but I would like the Minister to confirm whether the Government have actually consulted or used Sir Michael Marmot, who is the UK’s foremost academic in the field of health equity or lack of it. His research is being used, so I would like to know: when did the Government, or representatives of the Government or the Minister’s department, meet Sir Michael Marmot and his team? Are the findings of this research and the research from last year being taken into account with the levelling-up plans?

[Baroness Penn (Con)]

My Lords, on the specifics of any meetings, I am happy to write to the noble Baroness. I point to the creation of the new office for health promotion and the fact that the guiding mantra that sits behind it is very much aligned with the agenda Sir Michael Marmot has set out. I know that is a key priority for the Chief Medical Officer as we come out of the pandemic and take this work forwards.

NHS Test and Trace

Debate between Baroness Thornton and Baroness Penn

Monday 28th June 2021 Lords Chamber

[Baroness Penn (Con)]

My Lords, my understanding is that the Innova test has passed the UK’s assessment process and that ongoing assurance work is conducted in labs and in the field to ensure that the tests consistently perform to the required standard. My understanding is also that the latest evidence suggests that Innova lateral flow devices have a specificity of around 99.97%.

[Baroness Thornton (Lab)]

My Lords, this morning it was announced that Serco had been awarded a new contract with the Department of Health and Social Care worth up to £322 million to continue providing Covid test-and-trace services. Will the Minister justify this just days after the NAO review found that 600 million tests were unaccounted for, and that the £22 billion scheme was still missing targets and was wracked with problems? Can the Minister explain why more taxpayers’ money is being handed out to what has been found to be an ineffective and inefficient company instead of supporting local public health teams to do this work?

[Baroness Penn (Con)]

My Lords, more than 80% of the budget for test and trace goes towards the testing part of that programme. That has proved highly effective. The programme is working to increase its partnership with local authorities and local directors of public health. We are also reducing our reliance on private sector contractors by around 17%, but we recognise the work that those partners have done with us in building up the system over the past year and continue to work with them where it is in the best interests of the country.

Sudden Adult Death Syndrome

Debate between Baroness Thornton and Baroness Penn

Wednesday 9th June 2021 Lords Chamber

[Baroness Penn (Con)]

I reassure the noble Baroness that awareness of CPR is now part of the national curriculum in secondary schools for teenagers. Other work is also being done with partner organisations such as the British Heart Foundation and GoodSAM to improve the co-ordination of first responder activities and defibrillation skills for adults and passers-by who may need to respond in that kind of situation.

[Baroness Thornton (Lab)]

My Lords, I found the websites of SADS UK, the British Heart Foundation and CRY useful in the information, advice and practical support they offer people about the various conditions which cause sudden adult death. Are these important organisations being supported by the NHS and the Government, and in what way? Secondly, can the Minister inform the House whether any research is being carried out into age, gender, race or other characteristics that will shed light on which groups are most vulnerable and carry the genetic disposition to SADS?

[Baroness Penn (Con)]

Perhaps I may reassure the noble Baroness that the NHS engages with a number of charities involved in SAD, including the sudden arrhythmic death syndrome charity SADS UK. That organisation in particular is helping scientists and clinicians understand and combat a rare condition called “short QT syndrome”, which is associated with an increased risk of sudden cardiac death. On other factors that may put people at an increased risk, gender is one that seems to increase the risk for men rather than women. However, I am sure that there is further work and research being done in this area.

Drug-related Mental and Behavioural Disorder Hospital Admissions

Debate between Baroness Thornton and Baroness Penn

Wednesday 17th March 2021 Lords Chamber

[Baroness Penn (Con)]

Absolutely. Part 2 of Dame Carol Black’s review of drugs, which should report to the Government shortly, is expected to include recommendations on what can be done nationally and locally to tackle drug and substance misuse and the support needed for those who face addiction and mental health issues.

[Baroness Thornton (Lab)]

My Lords, in 2019, five out of 12 English regions did not have a doctor training to specialise in addiction psychiatry. Indeed, funding for addiction services in England fell by 29% in real terms from 2013 to 2020—and we can add to that the fact that virtually all services and treatments available have been disrupted by the Covid-19 epidemic. Do the Government have a plan to address the regional disparities of drug misuse and drug-related mental and behavioural disorders?

[Baroness Penn (Con)]

My Lords, the noble Baroness is absolutely right that we need to do more in this area and that Covid has made it harder. That is one reason why the Government have announced an additional £500 million for 2021-22 to support NHS mental health services to recover from the pandemic, address wait times and invest in the NHS workforce.

Medicines and Medical Devices Bill

Debate between Baroness Thornton and Baroness Penn

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

[Baroness Thornton (Lab) [V]]

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

[Baroness Penn (Con)]

The noble Baroness is correct that Amendment 27 is consequential to an amendment agreed on day 1 of Report, so she may wish to move it.

[Baroness Thornton (Lab) [V]]

I think Amendment 26 is similar, possibly. We may need some guidance from the clerk. Was Amendment 26 also related to the group of amendments that were agreed on Tuesday? I apologise; it is always difficult to do these things when you are not actually in the Chamber.

[Baroness Penn (Con)]

My understanding is that Amendment 26 is also consequential to amendments passed on day 1 of Report, so we may wish to ask the noble Lord, Lord Patel, whether he wishes to move his amendment, which is consequential to previous amendments agreed.

[Baroness Thornton (Lab) [V]]

That is what I thought

--- Later in debate ---

[Baroness Thornton (Lab) [V]]

The noble Baroness, Lady Jolly, is quite right: two of our health big thinkers have laid out the issues here. My noble friend Lord Hunt gave a wonderful introduction to Amendment 66, which covered the reasons why it is important and what it will do. The noble Lord, Lord Lansley, took us on a journey through how health inequalities can be addressed. The point, and the reason the amendment is on the Marshalled List today, is that it does not always work like that. Implementation is key. As the noble Baroness, Lady Jolly, said, requiring NICE to support NHS access to new medicines and medical devices seems kind of obvious. The challenge for the Minister here is how to use this legislation and this discussion to make what we think is obvious work better.

[Baroness Penn (Con)]

My Lords, I know the noble Lord, Lord Hunt of Kings Heath has a long-term interest in and commitment to the work of NICE and, as such, will know that NICE’s remit is set out in other legislation. I do not intend to rehearse the arguments on why we do not see that as strictly for this Bill. Instead, I hope to provide some reassurance on the issues he raises with his amendment.

The noble Lord will be aware that NICE’s methods and processes for assessing the cost-effectiveness of medical technologies are internationally respected and have been developed over almost 20 years through periodic review, including extensive engagement with stakeholders, and the latest iteration of that process of periodic review of its methods is ongoing. NICE finished the first phase of its consultation on the case for change to its methods on 18 December 2020. There will be a second consultation on the case for change to its processes in the spring. The result of those will inform the final consultation on the updated methods manual in summer 2021. I hope that the noble Lord is reassured by the consultative nature of that process in considering the issues he raised.

Subsection (1)(a) of the new clause proposed in his amendment would require NICE to address the implications of health inequalities when assessing the cost effectiveness of medicines and medical devices. Subsection (1)(b) would require NICE to accept a greater degree of uncertainty and risk in recommending their use. I reassure the noble Lord that NICE is already considering both of those as part of its review, and they were both consulted on as part of the consultation on the case for change that ran from 6 November to 18 December 2020.

In that consultation, NICE noted that there may be a case for a modifier that considers health inequalities. However, further work is needed to explore how this could be defined and implemented in a health technology evaluation, and under which circumstances. This will be done in NICE’s second consultation running from February to March. Such a modifier could consider the types and sources of inequality, as well as how a modifier should be applied—qualitative or quantitative. It could also consider whether such a modifier covers technologies that directly reduce inequalities—for example, by specifically targeting or providing additional benefits for a disadvantaged group; or whether indirect effects might also be considered—for example, if a technology has uniform benefits across groups, but the condition disproportionally affects a disadvantaged group. At this stage, it is not clear that there is sufficient evidence for a health inequalities modifier, but it is being explored, and will be explored further in the second stage.

I hope that level of detail on the consideration that NICE is undertaking helps to reassure the noble Lord, but of course it would not be appropriate to pre-empt that review, and we want to encourage all stakeholders to respond to it.

In addition, I remind the noble Lord that a requirement to have regard to reducing health inequalities is already imposed on NICE under Section 1C of the National Health Service Act 2006. This applies to NICE as a non-departmental public body of the Department of Health and Social Care.

Proposed new subsection 1(c) would require NICE to have regard to the need

“to ensure patients with rare diseases have access to medicines and medical devices”.

The noble Baroness, Lady Wheeler, noted some concern during Grand Committee as to why NICE did not propose a rarity modifier in its methods review. A rarity modifier was considered by NICE prior to publication of the consultation document. However, stakeholders noted that rare diseases would be covered by the proposed severity modifier, which more accurately reflects society’s values. Although there is of course overlap between severity and rarity, not all rare conditions are severe and some severe conditions are more common. Of course, the consultation was an opportunity for all stakeholders to express their views on this point. As noted previously, NICE is also consulting on changes, such as a more accepting attitude towards uncertainty in some situations, which should benefit medicines for rare diseases.

Where there is uncertain evidence relating to a medical technology—I appreciate this can be a challenge for rare diseases—NICE and NHSE&I have developed managed access agreements. NICE has already recommended six topics for use subject to a managed access agreement outside of cancer. NHSE&I continues to use its sophisticated commercial capabilities to negotiate deals with industry that enable patients to access the most innovative new medicines and ensure that the NHS gets good value.

Proposed new subsection 1(d) would require NICE to have regard to supporting

“the use of curative therapies involving medicines and medical devices.”

The word “curative” should be used with caution, as there is no standard definition of what might be meant by it. For example, in some cases it may mean a significant amelioration in symptoms, in others that the treatment pathway is different or more tolerable.

While I appreciate that recently launched advanced therapy medicinal products hold great promise by targeting the specific cell or genetic defect, the data on long-term effectiveness is often immature at the time of marketing approval. Further, we need flexibility to respond quickly and effectively to developments in life sciences. We want to avert a situation whereby an effective therapy is not guaranteed funding because it did not meet the legal definition of a “curative therapy”. However, I think that the noble Lord was more trying to get at our support for some of these innovative approaches. Again, this is being looked at in the review of NICE’s methods.

NICE’s working group has explored whether there is a case for changing the approach to discounting, which the noble Lord asked about, in particular the impact on technologies with long-term benefits such as one-time gene therapies. This is a complex area that needs to take into account the policy-level need to support particular types of technologies or circumstances, the limitations of the current criteria for non-reference case discounting, and the effects and any accompanying policy and affordability challenges of any change. This will be covered by the second stage of the NICE methods review. Again, while we would not want to pre-empt that review, all stakeholders are encouraged to respond to it.

Briefly, proposed new subsection (2) would require the Secretary of State to lay a report and impact assessment before both Houses of Parliament, setting out how NICE has implemented its duty under proposed new subsection (1). As I said in Grand Committee, NICE will publish its revised methods and process manual, including its impact assessment, on its website for all to access, including parliamentarians, once the process has been completed. That is the correct forum.

I will briefly address Amendment 46 in the name of the noble Baroness, Lady Finlay, which touches on similar issues—the importance of access to medical technologies, the future medical devices regulatory regime, and the critical nature of medical device safety. I pay tribute to the noble Baroness’s work through her engagement with Ministers and our officials in developing government Amendment 45, which provides greater clarity on the types of activity we would intend to encourage through appropriate regulation. That includes, in respect of medical devices, carrying out research, developing medical devices, or manufacturing and supplying medical devices.

The Government support the agenda for early access to medical devices for NHS patients, as demonstrated through other mechanisms such as the rapid uptake products programme, managed by Accelerated Access Collaborative, and the medtech funding mandate, due to launch in April.

The second stated purpose of the noble Baroness’s amendment—to allow monitoring of the safety and efficacy of medical devices in real-time use—is already achieved by regulations that may be made under Clause 15(1)(i) and (j), so the mechanism to deliver this is already in place. In addition, Clause 18 empowers the Secretary of State to make regulations for the establishment of a medical device information system by NHS Digital, which will support the monitoring of patient outcomes and patient safety.

The noble Baroness also asked about the timeframe for future devices regulation made under the Bill. I assure her we will consult on this issue this year.

I hope the reassurances I have provided, here and during Committee, are of comfort to noble Lords and that the noble Lord, Lord Hunt of Kings Heath, feels able to withdraw his amendment.

Medicines and Medical Devices Bill

Debate between Baroness Thornton and Baroness Penn

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

[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.

Medicines and Medical Devices Bill

Debate between Baroness Thornton and Baroness Penn

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

[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.

--- Later in debate ---

[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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[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.

Medicines and Medical Devices Bill

Debate between Baroness Thornton and Baroness Penn

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

[Baroness Thornton (Lab)]

This is a slightly strange time to be making this speech, because it seems likely that we will not hear the Minister’s speech until we reconvene in a week’s time. If that is the case, I would like to register that I will probably want to ask a question after the Minister speaks, if that is where we finally end up.

I am very grateful to the noble Lord, Lord Patel, and my noble friend Lord Hunt for the way in which they spoke at the beginning of this debate. The noble Lord, Lord Patel, went into a level of detail about the effects of the government amendments that was absolutely right and accurate. It also lies at the heart of my remarks. I need to make it clear from the outset that we on these Benches regard the government amendments to this part of the Bill as dangerous, sloppy and possibly sinister. The Minister must be aware, because we have discussed it with the Bill manager, that we regard the use of “a person” in Amendment 48 as something that should set alarm bells ringing right across the House.

I am getting a feeling of déjà vu. The Bill mentioned by the noble Baroness, Lady Jolly, started its life as the international healthcare arrangements Bill and ended it as the European Union and Swiss healthcare arrangements Bill, because it cast its net so wide. One of the giveaways is what the Government say in their description of their amendments:

“This new Clause makes clear that information held by the Secretary of State or the Department of Health in Northern Ireland in connection with human medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.”


The same explanatory statement follows the other government amendments in this group and tells us what the purpose of these amendments is. This underlines why we on these Benches will ask the Delegated Powers Committee to have another look at the Bill. These amendments fundamentally change the purpose of the Bill. It is not the same Bill that it looked at when it did its first report in July.

One of the reasons why this discussion—I am afraid I do not use the word “debate” about these proceedings—is so important is the read-across to the Trade Bill, to which I moved an amendment in Grand Committee a few weeks ago. It is about scrutiny and accountability. Amendment 45 is about fees: accountability and transparency and setting the level of fees. I would like the Minister to address that issue, which is fairly straightforward.

Amendment 118 in my name concerns international agreements. In terms of its policy content, it is probably the opposite of government Amendment 48. There is a policy clash here and I need to be clear that I am very unhappy about the fact that we have to agree to amendments that are unacceptable to us because of the time problems that the Government face on the Bill. We will be looking very carefully indeed at these sections of the Bill and will be seeking to amend them at the next stage.

The read-across we need to look at is to do with the trade negotiations with the United States, the EU and elsewhere, where we have to have systems of transparency and scrutiny about trade deals. The House of Lords passed an amendment to a previous Trade Bill on parliamentary scrutiny, but the Government have not made good their promises to give Parliament a say in new trade deals. I am concerned about the threat to our NHS and public health from these amendments, and about the misuse of information. We are concerned that, at present, Parliament does not have adequate powers to guide and scrutinise either the trade negotiations or the issues that will arise out of the Bill. We will need to look at this very carefully when it moves to the next stage.

[Baroness Penn (Con)]

My Lords, I am responding as a Whip, rather than as a Minister. I understand that this is not the ideal moment to break, but I believe that noble Lords would wish to hear a full response to the issues raised. I therefore beg to move that the debate on this amendment be adjourned.

Medicines and Medical Devices Bill

Debate between Baroness Thornton and Baroness Penn

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Baroness Thornton (Lab)]

I do not think that I need to say much in response to the remarks that were, I think, unanimous in their support for my amendment and the other amendments in the group. The cap on the sentence is not a good enough response by the Government. Earlier in our debates, I made a remark about amendments designed to circumvent; I am afraid that the government amendments before us are exactly that kind of amendment. They will not serve, I am afraid.

Unless the Government are prepared, as I hope they are, to table amendments that actually solve the problems and address the issues raised by the Constitution Committee and the Delegated Powers and Regulatory Reform Committee—they could not have been clearer on this issue: in this country, we do not set up criminal offences and their sentences by delegated legislation—there is nothing more for me to say, other than that I hope the Government will think again.

[Baroness Penn (Con)]

My Lords, it is perhaps appropriate if I begin by speaking to the government amendments—Amendments 43, 44, 64 and 65 in the name of my noble friend Lord Bethell —in this group. In doing so, I thank my noble friend Lord Blencathra for his committee’s report. As previously noted, we have listened to that report, and the changes that we propose through these amendments are intended to address the specific concern in that report regarding penalties for existing criminal offences.

As drafted, Clause 5(1)(b) already provides a restriction limiting the maximum penalty to imprisonment for two years when creating a criminal offence. The DPRRC asked us to explain whether the penalties for existing offences could be amended when there was no maximum specified in the Bill. I want to be clear that we do not intend to increase the penalties for existing offences.

Amendments 43 and 44 would work together to amend Clause 5. They make it clear that, under Clause 1, we may not make regulations that provide for a criminal offence to be punishable by more than two years’ imprisonment. This will apply to both new and existing criminal offences. For veterinary medicines, Amendments 64 and 65 seek to achieve the same by amending Clause 10.

The government amendments will, I hope, remove any concern that powers in Clauses 1 or 8 could be used to make regulations extending sentences for existing offences beyond two years’ imprisonment.

I now turn to Amendment 4 and the other amendments in this group to which noble Lords have spoken. The ability to enforce breaches of the regime governing medicines is a power originally conferred on the Secretary of State in the interest of protecting public health. This was introduced by the Medicines Act 1968 and provisions around offences are found throughout the Human Medicines Regulations 2012. They are also contained in the Veterinary Medicines Regulations 2013.

Offences deter potentially harmful activity and make it possible to take punitive measures against those whose actions put people, animals and the environment at risk. As we make necessary updates to the regulatory requirements, we must be able to remain consistent with the current enforcement regime, which already imposes criminal sanctions. It would not be right that a person may face a criminal sanction for breaching current requirements but not for breaching new regulatory requirements, for example relating to novel technologies and medicines. As with other changes to provisions, making changes to offences will be subject to the draft affirmative procedure, and we will make offences proportionate and necessary. It is imperative that we are able to balance novel regulation with enforcement of that regulation.

It cannot be ignored that crime involving medicines is increasing. Furthermore, criminal activities adapt to new environments and technology. In recent months we have seen opportunistic criminals selling online unauthorised and unapproved medicines and devices for the treatment, prevention or diagnosis of Covid-19, including antimalarials, self-testing kits, “miracle cures” and “antiviral misting sprays”, which could cause harm and unnecessary stress to patients. Enforcement capabilities must be able to keep pace with criminal exploitation. Delegated powers afford us our continued ability to enforce the regulatory requirements for medicines and devices for public protection. To be effective, they must be enforceable.

The Veterinary Medicines Regulations 2013 contain numerous criminal offences for breaches of the regulations; again, this is for the purposes of enforcement. The Veterinary Medicines Directorate’s enforcement strategy is risk-based; it focuses on proportionality, consistency, transparency and targeting. The VMD works with businesses and individuals to assist them in complying with the legislation through the provision of advice and guidance. However, where necessary the VMD will use more formal means of enforcement to secure compliance. It is critical that we have the delegated powers to enforce this.

We have always been clear that we are trying to provide greater clarity on how to enforce the regulations on medical devices. The regulator’s ability to have teeth when we are looking to raise medical device safety standards in future is essential. The report from my noble friend Lady Cumberlege tells us that.

The Bill is also clear on the maximum time limit for imprisonment, which applies to any new criminal offence introduced. This limit matches the current system for devices, where criminal offences for medical devices are already punishable for up to six months. The devices regulations are in place to protect public health; breaches of those regulations put people at risk and can cause significant harm. It is only appropriate that there is a clear consequence for any such actions, including potential criminal prosecutions. We will of course have regulations subject to the duty to consult at Clause 41, which will mean the public have the opportunity to comment on the necessity and proportionality of the approach.

I hope the necessity of enforcing the new regulations, and the safeguards the government amendments have provided, persuade the noble Lord to withdraw his Amendment 4 and others not to move theirs.

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[Baroness Thornton (Lab)]

My Lords, I thank the noble Lord, Lord Sharkey, for his comprehensive introduction to this group of amendments, particularly those that he is supporting.

We are minus at least four noble Lords from this debate because of the clash with the other Bill. I have certainly made my view known to the usual channels in the next booth that we cannot continue to discuss this Bill in those circumstances because we will be missing too many people who have a stake in the Bill and amendments down. I cannot imagine what the noble Lord, Lord Forsyth, is saying to his own Benches about this—actually, I probably can, and it will not be polite, I suspect. He put his name down to this amendment and, presumably, found out that he was not allowed to speak in both the Second Reading debate and in this Committee at the same time. I can see why that rule is there, but we are finding that this really does not work.

While the affirmative procedure offers nothing like the scrutiny given to a Bill, which typically goes through several substantive stages in each House and can be amended, we agree wholeheartedly with the DPRRC’s view that Clauses 1, 8 and 12 contain inappropriate delegations of power. We are where we are, and we therefore take the view that the affirmative procedure should apply. Amendment 134 provides for all regulations to be made subject to the draft affirmative procedure rather than the negative procedure and for urgent regulations to be subject to the made affirmative procedure rather than negative procedure.

Both the DPRR Committee and the Constitution Committee have expressed considerable concern at the inappropriate use of the negative procedure in this Bill. For example, Clause 2(1)(n) provides that regulations under Clause 1 may make provision about prohibitions relating to the supply of human medicines. Clause 42(9) provides for such regulations to be subject to the negative procedure. The explanation given for this in the memorandum, which I think I referred to in the very first debate in this Committee, is as follows:

“proposals to make changes to existing provisions, or to introduce new provisions enabling the supply, administration or prescribing of medicines are made to reflect shifts in best practice following extensive consideration and scrutiny by the relevant professional bodies.”

The DPRRC found this an unconvincing explanation. I probably do as well. It noted:

“It isn’t clear why consultation with relevant professional bodies lessens the requirement for scrutiny in Parliament. Indeed, if proposed changes are sufficiently important for there to be extensive consideration and scrutiny by professional bodies, this supports requiring the higher level of scrutiny in Parliament that the affirmative procedure affords. Furthermore, the prohibitions to which clause 2(1)(n) applies are sufficiently important that breach of them is a criminal offence (punishable, in the case of 4 of the 5 prohibitions, by imprisonment for up to two years). Even accepting the appropriateness of the delegation of powers in clause 1, we take the view that the affirmative procedure should apply. The consultation requirement imposed by clause 41 of the Bill is to be welcomed but we are concerned at consultation being presented as a substitute for Parliamentary scrutiny. On the contrary, if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”


The committee also highlighted and raised concerns about Clause 9(1)(f), which provides that regulations under Clause 8 may make provision about the categories of person who may apply for veterinary medicines. The EM states:

“any proposals to make changes to existing powers or to introduce new powers for veterinary professionals to supply, administer or prescribe medicines will be subject to extensive consideration and scrutiny by professional bodies”.

Again, the committee found this unconvincing for the same reason, and took the view that the affirmative procedure still applies. I must say, I wholeheartedly agree with its assessment. As it says,

“if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”

My amendment also addressed the egregious provisions of Clause 42 that provide that where any such regulation needs to be made urgently to protect the public from imminent risk of serious harm to health, the negative procedure applies instead. The Government’s justification for departing from the affirmative procedure was that:

“It is appropriate for regulations made in these circumstances to be subject to the negative resolution so that they can come into force immediately and provide an efficient means of addressing an imminent serious public health risk. We expect that such regulations would only need to be in place for a very short period of time, potentially shorter than it would take to schedule and hold debates”.


This is wholly inadequate.

The DPRRC stated:

“We are wholly dissatisfied by departments repeatedly arguing for powers otherwise subject to the affirmative procedure to be subject to the negative procedure where there is a need to act quickly, and seeking to justify this without acknowledging the existence of the made affirmative procedure … Even accepting the appropriateness of the delegation of powers in clauses 1 and 12, if the affirmative procedure provides the appropriate level of Parliamentary scrutiny for regulations made in reliance on clauses 6 or 15 in non-urgent cases then, in the absence of cogent reasons for the negative procedure to apply in urgent cases, we take the view that the made affirmative procedure should apply in urgent cases.”


The Constitution Committee concurred, recommending that

“the emergency powers in this Bill are subject to the made affirmative procedure, rather than the negative procedure, such that Parliament is required actively to approve them.”

The Minister will be well aware that regulations under the “made affirmative” procedure can be made and laid as expeditiously as can regulations subject to the negative procedure. They can also be laid during a parliamentary recess, unlike draft affirmative instruments. Quite frankly, it is insulting that the Government have the gall to argue for emergency powers to be subject to less scrutiny under the negative procedure, especially in the current climate when hundreds of emergency regulations have been introduced with considerable haste using the “made affirmative” procedure. Can the Minister say how this dereliction ever made it into the Bill, never mind through the Commons? I imagine that the Minister might be quite embarrassed to put her name to the Bill, which is perhaps why the Government have introduced Amendment 133 at the 11th hour.

I also speak in support of the super-affirmative amendments in the name of the Lord, Lord Sharkey. They are supported by Members across the House—including my noble friend Lady Andrews who is not here to give her support although she is extremely enthusiastic about this amendment.

Given that this is a skeleton Bill, the use of the super-affirmative procedure seems a sensible and proportionate mechanism. In this case, it would allow relevant parliamentary committees, in consultation with stakeholders, opportunities to comment on proposals for secondary legislation and to recommend amendments before orders for affirmative approval are brought forward in their final form. It has been used effectively by Governments of all colours, who recognise that it allows them flexibility when they need to bring forward regulations, while consultation and scrutiny happen before any amendments come to the House by affirmative resolution.

That is particularly important given that many areas in which we expect regulations to be laid, ranging from life sciences and clinical trials to hub and spoke pharmaceutical models, could make the contents of the SIs—and, in the absence of policy details in the Bill, even examples of draft regulation that have been published in respect of other Brexit legislation—controversial. I hope that the Minister recognises the merit of this proposal.

[Baroness Penn (Con)]

My Lords, I will begin by speaking to government Amendment 133 on behalf of my noble friend Lord Bethell. It provides significant changes that I know many will welcome. We have listened to the concerns raised about parliamentary scrutiny on emergency powers. I assure noble Lords that we have carefully considered their views and the different amendments that have been put forward on this topic.

As a result, government Amendment 133 would change applicable parliamentary procedure for reactive emergency regulations to the “made affirmative” procedure. It also provides that regulations about prescribing, advertising, packaging and labelling in relation to human and veterinary medicines will no longer be subject to the negative resolution procedure, but instead to the draft affirmative procedure. Using the “made affirmative” procedure when making regulations reactively in emergency situations affords the Government the required speed and flexibility to react to emergencies while providing that Parliament can scrutinise what has been done and why. When we make the regulations proactively, we must demonstrate the need to protect the public from the risk of serious harm; these regulations will be subject to the draft affirmative procedure.

It is important to acknowledge that the emergency powers are not intended to be used. However, as the noble Baroness, Lady Thornton, said, we are in a situation where we are currently using emergency powers, so she is correct that the “made affirmative” procedure has been put to good effect during the current pandemic. None the less, these powers are a measure of last resort to protect the public from the risk of serious harm to health.

We want to avoid using the powers reactively where possible. It is already a condition in the regulations that the situation must be accompanied by a declaration of the urgent need to protect against the imminent risk of serious harm to health. I note the questions asked by the noble Lord, Lord Patel, about the definition of that statement. I will write to him further on that matter.

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[Baroness Penn (Con)]

My Lords, I understand that the need to rise at a set time is part of the needs of the hybrid House. With other Grand Committees that have taken place in this circumstance, we have made progress on groups and had to adjourn mid-group. That is incredibly important in order to make progress on legislation when we are operating to time-constrained sessions.

[Baroness Thornton (Lab)]

I have to register my objection to that. If we want a proper debate, this is not just about people making timed speeches; it is about a debate. A debate should be a coherent whole, not one or two speeches and then continuing after maybe a week’s break. Would I be allowed to make my opening speech again when we go back on the second day of Committee?

[Baroness Penn (Con)]

My Lords, we would not have a second opening speech. If the noble Baroness has strong objections, we can adjourn.

[Baroness Thornton (Lab)]

I think we should. This is an important debate and we need it as a whole debate. I would be very grateful if that could be considered. I promise to make a small speech when we restart.