Health and Care Bill

Debate between Baroness Penn and Baroness Wheeler

Lords Hansard _ Part 1 & Report stage
Wednesday 16th March 2022 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, we had a good debate in Committee on the issue of self-care and the management of health conditions, particularly on its importance as a key part of the primary care pathway. This was underlined in diabetes care and, as I also emphasised, in the care and treatment of people with rare diseases, most of whom are living with lifelong conditions. As vice-chair of the Specialised Healthcare Alliance of charities supporting this key group of patients, I know that they often do not feel sufficiently supported in terms of care and support and health and system information, and with physical and daily living.

As the two noble Lords have stressed, the Health Foundation’s research on the effective self-management by patients has shown a significant reduction in the need for emergency admissions to hospital and in A&E attendances, and fewer GP appointments. In this context, Amendment 165 makes a great deal of sense. If patients with, for example, rare diseases receive appropriate support to manage their less intensive care needs, then promoting self-care has the potential to help them prevent their conditions from deteriorating, to improve their lives and to reduce demands on the NHS, as the noble Lords have stressed.

We therefore strongly support the need for the development of a national self-care strategy, starting with awareness raising among primary and secondary children on how to self-care, and with appropriate staff and management training of healthcare professionals. Improved technologies, as underlined by the noble Lord, Lord Clement-Jones, especially those developed during the pandemic, will have a key role in broadening access to effective self-care and ensuring the better support from primary and community pharmacists that we all want to see. I hope the Minister will respond positively to this amendment.

[Baroness Penn (Con)]

My Lords, I thank the noble Lord, Lord Hunt, for bringing forward a debate on this issue. I reassure him and other noble Lords that the Government absolutely agree that supporting people to maintain their health and well-being and to manage self-treatable conditions is a vital part of delivering a comprehensive health service. Indeed, much of what the amendment seeks to achieve is already government policy. However, I do not agree that requiring the Secretary of State to prepare a single national strategy would add value. Instead, we are threading self-care through a wide range of work, reflecting the range of areas that it impacts upon.

A good deal of work is already under way. The community pharmacy contractual framework for 2019 to 2024 five-year deal sets out how community pharmacy will support the NHS long-term plan. Community pharmacies, which provide easy access to the NHS, are already required to support patient self-care, signpost to other parts of the NHS and local services as necessary, and help people to live healthily.

I am especially aware of the interest the Proprietary Association of Great Britain has shown in this area. The Department of Health and Social Care officials have met with it to discuss its blueprint for a self-care strategy in England and will continue to engage with it about further supporting self-care throughout our healthcare system.

We do not think placing an additional duty on the Secretary of State would be the right way to support this work, as it would take it out of the NHS long-term plan, where it belongs as part of a holistic approach to the provision of a health service. It could risk making it more disjointed rather than integrated in its approach, but noble Lords made a really important point about demand on our health service and the role that self-care has in this. Prevention was a key theme of a speech by my right honourable friend the Secretary of State last week and, clearly, elements of self-care and prevention go hand in hand with each other, particularly in the use of new technology.

Noble Lords also made an important point about how we can use self-care, particularly at community pharmacies, to reduce pressure on GPs and A&E departments. All community pharmacies are required, as I said, to provide support for self-care. To ensure that people get directed to the right support for their health needs, we have introduced referral systems from NHS 111 and GPs to pharmacies for advice and treatment for minor illnesses. We are also exploring expanding referrals from other settings, including urgent treatment centres and A&E to community pharmacies.

I hope that gives noble Lords some reassurance that we place an importance on self-care, as part of our health service. That will only increase in future and work is under way in multiple areas of the health service to do that. I hope, therefore, that the noble Lord is able to withdraw his amendment.

Health and Care Bill

Debate between Baroness Penn and Baroness Wheeler

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

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister and welcome these government amendments in response to the key concerns raised in Committee about the crucial importance of including the NHS’s duties on climate change and working towards net-zero emissions in the Bill, and the excellent supportive speeches today.

The amendments take on particular significance in the light of the stark warning in today’s UN report that climate breakdown is accelerating rapidly and there is only a brief and closing window of opportunity to minimise its catastrophic impacts. The duties rightly go across the roles of NHS England, integrated care boards, NHS trusts and NHS foundation trusts in relation to the Climate Change Act 2008 and the Environment Act 2021, and address the need for those bodies to have regard to the need to contribute towards compliance with government climate change and environment targets. Of particular importance is the duty of each body to adapt to current or predicted impacts of climate change and, in Amendment 7, recognition of the importance of NHS England guidance on how the climate change responsibilities are to be discharged within the promised 12 months of Royal Assent.

My noble friend Lady Young sought reassurance that the guidance on procurement will cover not just the need for the NHS supply chain to reduce emissions but also include the key environmental targets. I hope the Minister will be able to reassure her on that.

Strengthening the law to integrate an active response to climate change through every layer of the NHS has been welcomed by the UK Health Alliance on Climate Change, representing more than 900,000 healthcare professionals. Noble Lords made clear in Committee that omitting sustainability requirements from the Bill would have been a missed opportunity to enshrine and enforce the NHS’s historic commitment to reaching net-zero targets by 2040, and we are pleased the Government have recognised that.

As we heard from all speakers, the NHS has made huge progress, but this is just the start and there is much more to do. The amendments reinforce the importance of action in those areas, particularly for the new bodies and processes the Bill creates, and that progress will need to be managed, delivered, tracked and reported at every level.

My noble friend Lady Young’s point, reinforcing that guidance on duties across NHS bodies must include not just climate change but also the improvement of the natural environment, is well made. I look forward to the Minister’s response on that.

In relation to reporting, raised by the noble Baroness, Lady Walmsley, I understand from the contributions of the noble Lord, Lord Kamall, in Committee that progress is being made. He referred to NHS England’s green plans, and we are told that every NHS trust and interim care system is expected to have prepared a green plan and had it endorsed by its governing body. For trusts, the deadline for submission to ICSs was 14 January, so it would be good to know how they have done so far and how many trusts have submitted such plans. The next stage is for ICSs to develop “consolidated system-wide plans” by the end of the month, which will be

“peer reviewed regionally and published”.

Are we confident that ICSs will meet that deadline, and what is the expected assessment and timescale for ICSs to report back to NHS England and, subsequently, more widely on this vital issue?

[Baroness Penn (Con)]

My Lords, I thank all noble Lords for their welcome for the government amendments, and for setting the challenge for the Government that there is always more to do.

I agree with the noble Lord, Lord Stevens, on the additional points that he set out about the importance of decarbonisation, not just for the climate but for health, security and humanitarian reasons. I reassure the noble Baroness, Lady Young, and others, that I did not say that decarbonisation was there to exclude other issues; it is just that that particular point related to that.

I say to the noble Baroness, Lady Hayman, that it is a pleasure to work with her on these issues when we look at Bills, including the Financial Services Bill as it went through, but I have noted her and other Peers’ points about the reactive or proactive nature of the Government’s approach to these issues in legislation.

I can provide the noble Baroness, Lady Young, and others, with the reassurance that they seek that the NHS will have to have regard to wider environmental objectives in developing the guidance, and this includes, for example, biodiversity. That applies to procurement and any other guidance NHS England issues to the system using the new power. In my examples, I mentioned enhancing biodiversity and adapting to climate impacts, so I hope I was not inadvertently too narrow in how I spoke to the amendments.

The noble Lord, Lord Scriven, is right that decisions are being made all the time that will have a longer-term impact, so although I cannot go further than the 12-month commitment, I am sure that the NHS will want to work as fast as it can to bring out the guidance within that.

The noble Baronesses, Lady Walmsley and Lady Wheeler, asked about reporting, both on how the NHS will fulfil its obligations under these duties, and specifically under the green plan. NHS England will report on carbon emissions and progress against its wider objectives. The noble Baroness, Lady Wheeler, asked me a number of more specific questions; if I have not addressed them, and those asked by other noble Lords, I will seek to write after today.

Covid-19: Hospital Patient Referrals

Debate between Baroness Penn and Baroness Wheeler

Monday 28th June 2021 Lords Chamber

[Baroness Penn (Con)]

My Lords, I will absolutely take that point away. My understanding is that there is the Public Health England report, while a number of other retrospective studies in Scotland and Wales have looked specifically at the impact of discharge policies. Although there has been a slight variation in the policies implemented across the four nations and the evidence is not as yet conclusive, the studies have indicated that discharge policies were not responsible for a significant number of outbreaks in care homes in the UK. We look at a number of pieces of evidence and we always look to make sure that that evidence is up to date. I will take back the noble Baroness’s specific point on the revision of that data and see what I can write to her in response.

[Baroness Wheeler (Lab)]

My Lords, we know that the Government’s interpretation of throwing a protective ring around care homes is not what most of us would see as protection, nor was there upfront recognition from the start of the pandemic of the vulnerability of care home residents. The extra resources from the infection control fund have been crucial in helping care homes to keep going and deal with their extra PPE, staffing and huge administrative costs, but it runs out on Wednesday, as the Minister will know, with only an obscure notice on the government website on 15 June to announce its demise. What are care homes to do now with their ever-escalating costs, infections increasing and a minority of care home workers not vaccinated?

[Baroness Penn (Con)]

My Lords, we continue to support the social care sector in its efforts to control infections. The noble Baroness raised the question of vaccinations, which will be crucial in protecting care homes. We have laid the statutory instrument that will require all members of staff working in CQC-approved care homes to get their vaccination.

Medicines and Medical Devices Bill

Debate between Baroness Penn and Baroness Wheeler

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

[Baroness Penn (Con)]

My Lords, we now turn to the way in which reports are prepared and made on the exercise of the regulatory-making powers in the Bill.

Amendment 69 in the name of the noble Baroness, Lady Thornton, would make changes to the existing requirement to report, introduced in Grand Committee. It proposes that an additional report be made by the Secretary of State to Parliament, this time on regulatory divergence with Northern Ireland introduced as a consequence of future regulations. I understand the noble Baroness’s intent. I heard the concerns raised in Grand Committee about the potential impact of regulatory divergence. The Government take that seriously. However, I will explain why this amendment is not necessary to address it.

As a reminder, the amendments made in Grand Committee provided for a reporting obligation on the operation of regulations made by the Secretary of State under Clauses 1(1), 9(1) and 14(1)—one that was both forward- and backward-looking. Those reports must include any concerns raised or proposals for change made by anyone consulted by the Secretary of State in the preparation of the report, and the response to these. It will necessarily draw Parliament’s attention to regulations that have been made.

Parts 1 and 2 of the Bill relating to human and veterinary medicines are matters transferred to Northern Ireland. As such, legislative consent was secured for the Bill earlier in its passage, but as amendments were made during Grand Committee, further legislative consent was sought. At Northern Ireland’s request, government Amendments 75, 76, 79, 80, 81, 82 and 85 in this group replicate the existing reporting obligation for Northern Ireland. This means there will be a report laid in Parliament every two years on what new regulations have been made and any plans to make further related regulations. A separate report will be laid before Northern Ireland. Between our report and the report laid before the Northern Ireland Assembly, any areas of regulatory divergence between the UK and Northern Ireland regulatory regimes will be made clear. Therefore, it would be duplicative to require the Secretary of State to lay additional reports specifically on regulatory divergence for human and veterinary medicines and medical devices.

In addition, where there are concerns about the implementation of the protocol and its impact on patients and animals in Northern Ireland, there are formal channels in place. Officials meet regularly in the Ireland/Northern Ireland Specialised Committee. The Specialised Committee reports to the Withdrawal Agreement Joint Committee and provides advice on decisions to be taken by the Joint Committee under the protocol.

Before the end of the transition period, we raised with the EU through its specialised committee the issue of the falsified medicines directive and regulatory importation requirements for medicines moving from Great Britain to Northern Ireland after 1 January. We agreed with the EU a pragmatic one-year, time-limited approach to implementing these regulations that ensures no disruption to the flow of medicines to Northern Ireland. I say this to reassure noble Lords as to the effectiveness of those mechanisms under the protocol.

Noble Lords made a number of comments on the issue of regulatory divergence and I thought I would dwell on it briefly. The noble Lord, Lord Patel, gave a good description of future provisions regulating devices between Northern Ireland and Great Britain. He is wrong to say that the Bill lays out Northern Ireland separately because of this. It does so because medicines and veterinary medicines in Northern Ireland are the responsibility of the Northern Ireland Assembly and are therefore devolved. However, divergence may be an issue for the future, not least because the EU may change its own regulatory regime under the protocol that Northern Ireland will follow, and the UK may make changes here as well.

To reassure noble Lords, we have agreed a standstill period of two years for medicines and veterinary medicines and two and a half years for devices, during which we will continue to recognise EU regulations in these areas. This means that there is time for adequate consultation on regulations made under this Bill, for consultation on any future changes and for these mechanisms to operate properly. Divergence may be a matter for the future, but we have reporting to Parliament and public consultations on any regulations made under this Bill to address those questions.

The noble Lord, Lord Hunt, asked how we ended up here. I think that question is slightly wider than the purview of this Bill. I have quite a lot of lived experience of how we ended up here and I do not intend to recount that now.

I hope the amendments I have referred to in the name of my noble friend Lord Bethell, coupled with these other, existing arrangements, make the amendment tabled by the noble Baroness unnecessary.

Government Amendments 77, 83 and 84, also in the name of my noble friend, are made in the same light of expanding reporting obligations. In the interests of transparency and scrutiny, amendments have been made to extend the obligation to include regulations made under Clause 18—the regulation-making power in relation to the medical devices information system. We have made this change to make clear our absolute commitment to transparency, to giving Parliament continued visibility, to understanding the assessment made of any proposals or concerns raised as to how the regulations have been working, and to ensure that the regulation-making powers specifically containing provisions that may ensure or affect device safety and post-market surveillance are treated equally.

The noble Baroness, Lady Thornton, again seeks to test us on the preparation of the reports with Amendment 78, which would add a list of stakeholders to be consulted under the obligation. Again, this is unnecessary. If her concern is that the stakeholders listed may be ignored, I reassure her that the reports must summarise concerns raised, or proposals for change made, in relation to regulations enforced during the reporting period. That information will come from engagement with relevant stakeholders. Therefore, I do not think it necessary or proportionate to add a list of specific stakeholders to be consulted for each report, which will be a summary of public consultation that will already have been responded to.

I must say to the noble Baronesses, Lady Jolly and Lady Wheeler, that the Government will not return to this issue at Third Reading, so if they wish to press it, now is the moment. However, with the number of avenues already available, I hope that they are reassured that their amendment is not needed and will not wish to press it.

[Baroness Wheeler (Lab)]

I thank the Minister for her response. I shall not go into details now, but we know that there will be significant issues of regulatory divergence, as the noble Lord, Lord Patel, my noble friend Lord Hunt and the noble Baroness, Lady Jolly, have stressed. We know that it is an issue about which we will have to be very watchful. In the circumstances we currently face, an annual report would have aided the process of working through the issues and encouraged understanding of the plans to address them and the progress being made.

On Amendment 78, the Minister is obviously not going to oblige me with a tidying-up amendment at Third Reading to underline the importance of the patient voice. I think that is a mistake; it would have been helpful. However, I beg leave to withdraw Amendment 69.

Medicines and Medical Devices Bill

Debate between Baroness Penn and Baroness Wheeler

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I too congratulate the noble Baroness, Lady Sheehan, on another important speech on this key issue and the dogged way she has pursued her arguments and key questions to the Minister. I thank her for sharing her response letter of 7 January to the Minister, which clearly sets out the issues she is still pressing the Minister to address, and I am looking forward to the response from the noble Baroness, Lady Penn, on these matters. I also welcome the very expert and thoughtful contributions from other noble Lords both today and in Committee on this issue, drawing on their extensive professional and international experience and knowledge.

As my noble friend Lady Thornton made clear in Committee, we support this amendment. The reassurance from the Minister during Committee about the Government’s commitment to collaborating with public and private partners in the UK and globally to promote affordable access to vaccines and medicines for all is welcome. Also, we are grateful for their continued commitment to the UK’s obligations on the WHO TRIPS agreement and the DOHA declaration, which provide important flexibilities that support access to medicines and are especially vital during public health emergencies such as the Covid-19 pandemic that is so engulfing us today.

Noble Lords are right to underline the deep concerns of patient groups on the issue of fair and free access to medicines. I remind the House that the Royal College of Physicians, the Faculty of Pharmaceutical Medicine, the British Association of Dermatologists and other key stakeholders have called for a review of the processes for issuing sole manufacturing licences and consideration of the use of price control mechanisms in relation to costs of production to increase access to medicines at fair prices. The Government’s assertion that non-exclusive voluntary licensing provides incentives for developing new medicines and health technologies is not borne out by recent evidence on newly patented drugs, as the noble Baroness, Lady Sheehan, has pointed out.

On vaccines, and our participation as a country in the global sharing and effort, access to the Covid-19 tools accelerator COVAX advance market commitment needs continuing support from the UK and wealthier nations. The promise was for matched funding if the £1 billion target was reached by the end of last year. Can the Minister update the House on this, and what will be the UK’s contribution? Is there any further information on the role the UK will play in the WHO’s proposed Technology Access Pool, C-TAP?

Finally, on funding of research and development, a number of noble Lords raised the issue of the absence of analysis of, and data on, how much public and private money goes into the development of new vaccines and medicines. The Minister referred to the VPAS voluntary pricing scheme negotiated with the industry, which runs alongside the statutory pricing scheme, the NICE appraisal process and the commercial NHSI arrangements. The scheme is designed to support patient access to innovative medicines and expires next year, so these coming months will provide a crucial opportunity to commence a detailed review on how the research and development of medicines are actually funded. This would not only strengthen the Government’s negotiating position but lead to greater transparency in the UK’s future relationship with the pharmaceutical industry, which we all want to see.

[Baroness Penn (Con)]

My Lords, first, I would like to address the issue of patient and clinician access to affordable medicines in the UK. Patient and clinician access to affordable medicines is at the core of the NHS and this country’s healthcare policy. This Bill will not diminish that. Indeed, a safe and innovative regulatory regime for medicines and devices will support that outcome, although patient access is not dealt with directly in this Bill. The Government have recourse to a number of mechanisms to ensure that patient and clinician access to affordable medicines is upheld. For example, the price of branded medicines is controlled by the 2019 voluntary scheme for branded medicines pricing and access. The National Institute for Health and Care Excellence also continues to ensure cost-effectiveness for medicines purchased by the NHS.

As the noble Baroness, Lady Sheehan, has noted, in line with the flexibilities in the TRIPS agreement, the Government also retain the right to order Crown use of patented medicines under Section 55(1)(a) of the Patents Act, where collaborative approaches are not successful or we determine that it is in the public interest. I should emphasise that this would be used only in very narrow circumstances, such as an emergency. The UK has an internationally renowned IP system, which cultivates an innovative pharmaceutical sector, attracts generics manufacturers, and ensures that the NHS has access to the most cost-effective options. We will continue to work with these stakeholders to provide cost-effective access to Covid-19 therapies and vaccines, in the UK and globally, on a voluntary basis.

Medicines and Medical Devices Bill

Debate between Baroness Penn and Baroness Wheeler

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[Baroness Penn (Con)]

To address the noble Lord’s question about when the statutory instrument was laid, I believe it was on 20 October. I think the statutory instrument laid on 20 October, which we shall debate, is not the Government’s approach to an answer on how we deal with the future issues of regulating medicines, medical devices and vet meds in Northern Ireland and Great Britain. What I was trying to express to the noble Lord is that we have a mechanism that means the Minister will report to Parliament every two years, both looking forward to prospective changes and back at any changes that may have been made. Of course, where new regulations are proposed there will be public consultation on those, but there will also be reports to Parliament ahead of that about the intentions, and those reports will provide a mechanism, which I think the noble Lord wants, to ensure that these issues are discussed properly in Parliament in future.

[Baroness Wheeler (Lab)]

I thank the Minister for her response. Due to the break in the group since Tuesday, we have all had the advantage of being able to have a closer look in Hansard at the speeches made by the noble Lord, Lord Patel, and the noble Baroness, Lady Ritchie. If we had managed to squeeze in the Minister’s response, that would have been perfect; I could then have responded having read it all very closely.

Anyway, I thank the noble Lord, Lord Patel, both for his support of our amendment and his very detailed considerations and questions on the MHRA guidance on Northern Ireland-Great Britain regulatory diversion on medicines and medical devices. His speech was very much a tour de force on the whole situation, understating how confusing the situation is in relation to the distinction the MHRA guidance makes between the EU market, the GB market and the market for Northern Ireland. We will need to read Hansard carefully but, despite the Minister’s best endeavours, I cannot see that she has managed to clear up for us exactly how the whole confused system will work in the future.

Moreover, as the Minister and the noble Lord, Lord Patel, mentioned, we do have the draft regulations. My attention has been drawn to them only this week. I thought they were published on 13 November, not in October, but that may be just me not reading them properly. Both regulations deal with Northern Ireland and Great Britain regulatory diversion issues, so this debate will be paused until we have considered those regulations and come back to the main Bill, and while we see what outcome there will be on the adoption of the Northern Ireland protocol.

The noble Baroness, Lady Ritchie, underlined the need for monitoring, oversight and accountability on this issue, and the importance of reporting to Parliament, and we obviously strongly agree with that. I did not specifically hear a response to her question on what internal discussions there have been between the noble Lord, Lord Bethell, and the Minister in the Northern Ireland Executive with responsibility for the NI Department of Health. If the Minister could write to her and put a copy in the Library, so that we can see what progress the discussions have made so far, that would be really helpful.

On the issue of reporting to Parliament annually—as in the amendment in the name of the noble Lord, Lord Patel—and not every two years, as the amended legislation provides for, I think the annual report called for by the noble Lord will be very much needed as all the problems and issues underlined by him and others in this debate are being worked through.

The issue is vital, and many issues are still to be identified, considered, worked through and resolved, which will mitigate and minimise the potential for regulatory divergence in human medicines and medical devices between Northern Ireland and Great Britain. In that expectation, I beg leave to withdraw the amendment.

Medicines and Medical Devices Bill

Debate between Baroness Penn and Baroness Wheeler

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

[Baroness Penn (Con)]

My Lords, I am grateful to the noble Baroness, Lady Wheeler, for raising the important issue of the prescribing cascade, as put forward in Amendment 62. I recognise the desire to ensure that the use of the cascade continues to be regulated. It is an important tool for veterinary surgeons, as they can access a wider range of medicines to treat animals under their care and avoid unacceptable suffering. However, I reassure the noble Baroness that this amendment is not necessary. The Bill already confers discretionary powers that will allow the appropriate authority to decide, following public consultation, if and how the existing cascade provisions in the Veterinary Medicines Regulations 2013 should be amended.

The existing provisions for the prescribing cascade are well used and well understood by veterinary surgeons who are responsible for their prescribing decisions. The provisions were so well described by the noble Baroness that I shall not repeat them here.

The noble Baroness, Lady Wheeler, is right that the second option under the cascade is the use of human medicine authorisation in the UK or a veterinary medicine authorised in an EU member state. She and the noble Baroness, Lady Jolly, asked what will happen after the end of the transition period. On 1 January, the second option will be extended to encompass the importing of veterinary medicines from any other country, rather than only EU member states. This is being provided for through secondary legislation taken through last year, I believe.

The Veterinary Medicines Regulations 2013 also set out additional conditions that need to be met when a product is prescribed under the cascade for use in food-producing species. These conditions help protect the safety of consumers of produce from treated animals. The conditions state that the pharmacologically active substances contained in the medicines must have a maximum residue limit, an appropriate withdrawal period must be specified, and specified records must be kept. These conditions help protect the safety of consumers of produce from treated animals. We do not plan to significantly diverge from the current prescribing cascade for veterinary medicines.

The new EU regulation 2019/6 on veterinary medicinal products will apply in the EU from January 2022. This regulation introduces changes to the cascade, such as separate cascade structures for food producing and non-food producing animals. It includes provisions on the use of antimicrobial medicines under the cascade. For example, the European Commission may, by means of implementing Acts yet to be adopted by the EU, establish a list of antimicrobials which shall not be used under the cascade and a list of antimicrobials which shall be used, subject to certain conditions for cascade use. If it is in the best interests of the UK, we can make provision corresponding or similar to those in EU regulation under the powers in the Bill.

The UK Government and animal sectors have already shown their commitment to tackling antimicrobial resistance and the sectors have substantially reduced their use of antimicrobials in food-producing species—a 53% reduction in sales between 2014 and 2018. The Government will consult on proposed changes to the VMR, including changes implementing our priorities on antimicrobial resistance.

The amendment that the noble Baroness has proposed would obligate the Secretary of State to make changes to the regulations on the use of the cascade. I hope I have reassured her that the cascade remains of vital importance, and it is right that we have the option to amend the regulations when it is appropriate and necessary, subject to consultation, rather than being obliged to do so.

I will write to the noble Baroness, Lady Jolly, on her question about trade deals.

In the light of that response, I ask the noble Baroness, Lady Wheeler, to withdraw her amendment.

[Baroness Wheeler (Lab)]

I thank the noble Baroness, Lady Jolly, for her support and the Minister for her response. As I said, I have learned a great deal about this valuable procedure. I am grateful for the Minister’s reassurance on the Government’s continued support for and commitment to the cascade. I will certainly read her comments carefully. I did not hear any reference to the VICH, but if she would write to me on that that would be very helpful. With that, I withdraw the amendment.

Medicines and Medical Devices Bill

Debate between Baroness Penn and Baroness Wheeler

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

[Baroness Penn (Con)]

My Lords, the commitment on the consultation is that it would be a public one, in line with the government amendment on what type of consultation we need to undertake for regulations made under the Bill. That would therefore include patient groups. On the content of the consultation, I understand that when it first took place it was very open, to hear from the sector how it would want to make use of the powers. My understanding is that we have heard the need to have a more structured conversation on the framework for how these powers could deliver the benefits which people think they could. Maybe I could undertake to write to the noble Lord with some more detail on that.

[Baroness Wheeler (Lab)]

Some of the points I was going to come back on have been raised pertinently by the noble Lord, Lord Clement-Jones, and my noble friend Lord Hunt. I too thank the Minister for her full and comprehensive response, and I thank all noble Lords for their contributions. Between us, we have covered a pretty comprehensive range of the issues and concerns around this. However, the Minister has not really made the case that warrants the use of the delegated powers contained in the Bill, nor met the criteria of the DPRR Committee—in particular, that the use of secondary legislation needs to be justified. The words of the DPRR were that the department should “acknowledge the breadth” and depth of the powers proposed and justify them. I do not think that has yet been done.

My noble friend Lord Hunt raised the complex issues on funding, as have other noble Lords. There is much to be achieved in putting funding on a stable footing for community pharmacists. The Minister was unable to answer the specific questions on the £370 million that my noble friend raised, but there needs to be recognition of extra costs. That point has been made forcefully in the House, in questions to the Minister, and I hope that the Government will make that response.

Overall, the Minister has not fully answered the key question of how these proposals fit into the longer-term NHS plan for transforming pharmacy as an integral part of primary care. There are a number of issues around that, which is why we particularly wanted to see a comprehensive plan going forward. Where is the overall strategy and plan for this?

The noble Lord, Lord Clement-Jones, raised a number of issues about how we want to take the development of pharmacists forward. The prescribing powers set out in the Bill are obviously the road to that, but I still do not have a comprehensive picture of how all this fits together. It comes back to the fairness of hub and spoke. Yes, of course the legislation is permissive, and community pharmacies will not have to join hub and spoke arrangements if they do not want to, but the complexity of some of the models proposed and the power of the large-scale providers really make the level playing-field so important—and important to the survival of community pharmacists—that we need to be much clearer about how it is going to work out.

I certainly welcome the commitment on consultation. That is so vital and, as everybody has said, the 2016 consultation was never really completed. As the Minister explained, there was neither the time nor the follow-through for it. I hope that this one will be comprehensive. I would have liked to have heard some kind of timescale but that is obviously yet to come. Much remains unanswered, which we may need to come back to on Report. We will look carefully at Hansard, but meanwhile, I beg leave to withdraw my amendment.

Medicines and Medical Devices Bill

Debate between Baroness Penn and Baroness Wheeler

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

[Baroness Wheeler (Lab)]

My Lords, we are grateful to the noble Lord, Lord Lansley, and my noble friend Lord Hunt for amendments that would ensure that the future role and funding of NICE are placed firmly in the Bill. Amendments 17 and 79 to Clauses 1 and 13 —in the name of the noble Lord, Lord Lansley—underline for both human medicines and devices the importance for the appropriate authority making regulations under the Bill to consider the ability of the NHS to meet the needs of patients and ensure consultation in accordance with Clause 41.

Amendment 85 to Clause 13, in the name of the noble Lord, Lord Lansley, and Amendment 124 in the name of my noble friend Lord Hunt, which proposes to insert a new clause after Clause 38, deal with the funding mandate to the NHS, the availability of human medicines and medical devices, timescales, and ensuring effective monitoring and reporting arrangements by the Secretary of State to both Houses of Parliament.

Noble Lords speaking to this group, particularly those with experience as former Ministers, have made powerful arguments based on their expertise. Those speeches have been very illuminating. I hope, therefore, that the Minister will respond in a positive way that reflects these concerns and these amendments’ intentions.

My noble friend Lord Hunt’s amendment, in particular, places a duty on NICE to take account of the availability of innovative medicines and medical devices for human use on the NHS. It also requires the Secretary of State to report to Parliament on the anticipated impact of new medicines and devices on inward investment and the attractiveness of the UK life sciences sector, whose vital importance to patients and the UK economy we all recognise fully.

As we have heard, my noble friend’s Amendment 24 is very much embedded in the current review of the methods and processes of NICE, amid widespread concerns that despite its recognition as a world-class institution, there is still a major problem with the take-up of new medicines by the NHS, with many CCGs financially or structurally unable to deliver the innovation that NHS patients deserve and must have. The recent report from the cancer charities showing how UK patients are missing out on new innovative treatments that are readily available in any other comparable country shows that stark reality. The NHS’s record on implementation of technical appraisals of new drugs by NICE says it all.

We must therefore ensure that the review of NICE’s methods, which is under consultation until the end of the year, and the consultation on changes to NICE’s processes, which is due to follow early next year, deliver real and effective change, and are open and transparent. The Bill should set out clear responsibilities for both NICE and the Secretary of State on their role in funding; they will be more important than ever in getting that change and innovation.

My noble friend expressed a genuine fear, which is shared across the NHS, about the de facto rationing of innovative medicines and the role that NICE often ends up playing in this without having the clear funding mandate from the NHS that these amendments would provide. His amendment is important because it would inject some parliamentary oversight into the review of NICE’s methods and process, which many consider as having been progressing very much under wraps for a while.

I declare an interest as vice-chair of the cross-party Specialised Healthcare Alliance. We have heard worrying noises about the rarity modifier consideration on rare diseases being removed. I have heard real concerns from rare disease charities among our 100-plus members that the review could be taking a worrying turn in terms of impeding access to treatments for rare diseases. This remains to be seen but it would certainly be a retrograde step; I hope that the Minister will provide me and rare disease charities with some reassurance on it today. I hope that the Minister will at least commit to more parliamentary scrutiny of the review’s work as it reaches its conclusions over the coming months. It is crucial for NICE to be obliged to improve, rather than frustrate, access and for Parliament to be given a view on these matters.

Amendment 85 in the name of the noble Lord, Lord Lansley, would ensure that the NHS has to implement NICE’s recommendations on medical devices as swiftly as for medicines. It is squarely in line with the Government’s stated aims, in so far as the Government have promised a medtech funding mandate of the kind referred to by the noble Lord himself and the noble Lord, Lord O’Shaughnessy.

However, the reality of the Government’s limited proposals—which are now delayed until next year at the earliest—is rather different. Many of the SHCA’s charities represent patients who have already had to shield this year, and now have to do so again, and the newest medtech innovations stand to help them care for themselves at home better. Does the Minister acknowledge that the Government’s medtech funding plans need to be expanded and accelerated rather than delayed? I hope that the Minister will commit to this important issue.

Finally, the threat to the UK life sciences industry from leaving the EU, and the steps that must be taken by the Government to ensure that the NHS does not start to lose its reputation as a global leader in medical science and innovation, have been fully explored. They are a constant theme from these Benches and across the House on the Brexit legislation that we have considered so far. A statutory duty on NICE to take account of the need for improved availability of innovative medicines and medical devices for NHS patients, with a duty on it and the Secretary of State to work together to ensure that the latest medicines are able to provide the care and treatment that patients need and deserve, will be a key part of supporting a world-leading life sciences sector in future.

[Baroness Penn (Con)]

My Lords, if the noble Lord, Lord Blunkett, speaks with temerity given the other speakers on this group, I ask noble Lords to consider how it feels to be the Minister responding.

I assure the noble Lord, Lord Patel, that Health Ministers may not be completely transformed on leaving government, but discussions that may have taken place in private can become much more public once they are on the other side of the fence.

I turn to Amendment 17, with which it may be convenient to take Amendments 79, 85 and 124 in the names of my noble friend Lord Lansley and the noble Lord, Lord Hunt. On the first half of Amendments 17 and 79, my noble friend conceded that the Bill likely already delivers what is within its scope to deliver. The consideration of the availability of medicines and medical devices when making regulations is relevant. This is what sits behind the ability of the NHS to meet the needs of patients, where it relates to regulation. The Bill simply does not deal with matters related to the NHS supply chain. It supports it by ensuring that medicines and medical devices that are safe are available on the UK market. As my noble friend knows, and has referred to, these matters are set out in other pieces of legislation. NICE was established as a statutory body by the Act that he took through as Secretary of State. I know that his Amendment 85 also probes on issues to do with the NHS supply chain.

I was interested to hear my noble friend Lord Lansley’s fuller explanation of the intention behind the amendment: to enable access to innovative medicines in the NHS. I know that he has done a huge amount to improve such access in the NHS. Although the Government do not think that this amendment is necessary to achieve his goal, I hope that when we come to debate later groups of amendments, including on the Innovative Medicines Fund, I can provide him with further reassurance on this matter.

On the second parts of Amendments 17 and 79, which deal with the results of the consultation on subsequent regulations that flow from the Bill, my noble friend Lord Lansley may have noted government Amendment 126, which we shall reach in a later group. This would add to the consultation requirements in the Bill. On the result of any consultation, I assure him that there is already case law requiring that consultation responses are taken into account. This is reflected in the Cabinet Office consultation principles, which require the Government to explain the responses that have been received from consultees and how these have informed the policy. A public consultation must be formally responded to. Not only that, the Explanatory Memorandum that must accompany a statutory instrument must explain the consultation outcome. Between these various documents, the Government must not only take into account the consultation but set out what has changed as a consequence of that consultation. I therefore think that the amendment may render these changes unnecessary, as the requirement to respond and explain is already there.

My noble friend Lord Lansley also tabled Amendment 85. While I understand his interest in ensuring that we have the appropriate funding and frameworks in place so that NICE-approved devices are made available to patients—an issue already touched on in the previous discussion on attractiveness—he may have anticipated my saying to him, once again, that the Bill is not necessarily the appropriate vehicle.

None the less, my noble friend and other noble Lords have raised an incredibly important issue. I reassure him and others that the NHS medtech funding mandate will be launched in April 2021. It will get selected NICE-approved, cost-saving devices, diagnostics and digital products to patients more quickly and ensure that specified innovations are funded locally. In advance of the mandate’s launch and to support adoption of relevant technologies, the NHS standard contract has been updated to include reference to the medtech funding mandate. I hope that that provides my noble friend with the reassurances that he seeks from me. We are on the way. This Bill is not the means to the end, and I hope he feels sufficiently assured to refrain from pressing his amendment to a Division, when we reach it.

NHS: GP Vacancies

Debate between Baroness Penn and Baroness Wheeler

Thursday 8th October 2020 Lords Chamber

[Baroness Penn (Con)]

The noble Lord is correct that the numbers are calculated at full-time equivalence. There may be more individual GPs working, because one trend we have seen is that with increased workload, people with families to look after, or who are either at the end or the start of their career, are choosing not to work full-time. With the retention programme, we are looking at both freeing up time and workload pressures on those GPs and providing specific support with childcare and costs to those looking to join or return to general practice.

[Baroness Wheeler (Lab)]

My Lords, analysis by the Health Foundation think tank has found that people in the most deprived communities are less well served by GPs, who are struggling to cope with shortages of doctors and receive less funding per patient than those in more affluent areas, despite the fact that people living in poorer areas have greater healthcare needs. What action are the Government taking to tackle the lack of doctors and the funding disparity between poorer and wealthier communities? Is not addressing the inequalities of provision in general practice the key to tackling health inequalities, which have worsened because of the coronavirus pandemic?