Social Care Funding (EAC Report)

Baroness Wheeler Excerpts

Thursday 28th January 2021 Grand Committee

[Baroness Wheeler (Lab)]

My Lords, I too congratulate the committee on its excellent report. We have waited a long time for this debate and, of course, for the Prime Minister’s ready plan for social care that he said he had when he took up office 18 months ago, just after the report was published. I also thank the noble Lord, Lord Forsyth, for his strong advocacy and efforts to keep the report alive and kicking, his continued pressure on Ministers on the need for urgent and long-term action, and his pushing for this debate.

Noble Lords have stressed the devastating impact of Covid-19 on social care. As October’s annual CQC State of Care report said:

“Social care’s longstanding need for reform, investment and workforce planning has been thrown into stark relief by the pandemic”,


thrusting a long-recognised crisis into public consciousness and, with it, awareness of the quality of care, unmet needs, the pay and conditions of social care staff and the lack of co-ordination between NHS and care providers. Age UK has described the “battering” of the social care system from Covid 19, which it was in no position to receive. It stresses that social care staff and the services they deliver are being stretched appallingly thin, with older and disabled people and their families left to pay the price.

Noble Lords have today brought their expertise and experience to the range of issues covered by the report in respect of both Covid-19’s impact and what needs to be done to address the current crisis and build a long-term, sustainable social care system. I want mostly to reinforce some of the issues raised about domiciliary and residential care. Let me first stress our strong support for the report. Eighteen months on from its publication, it remains a solid basis and stepping-stone for moving forward and breaking the cycle of chronic underfunding of social care, of unmet need and of the unfairness and disparity in entitlement to care in the NHS and the adult social care system.

The fundamental principles espoused by the committee have widespread support among the social care stakeholders and community: funding social care largely from general taxation; the top priority of restoring local authority funding for social care to 2010 pre-austerity levels; ending councils’ dependence on locally-raised financing for social care; a new, £7 billion-a-year system for providing free personal care to help people with basic daily needs; and major investment in a new deal for the social care workforce and joined-up workforce planning with the NHS.

Most of all, the report plays a vital role in setting out the scale of the funding required, based on Health Foundation, King’s Fund and ADASS research, just to begin to address current and unmet need and future demand. We have heard the figures repeated this afternoon: £1.5 billion extra this year to maintain the levels of service provision of five years ago and £2.4 billion extra to local authorities just to stop the funding gap from widening even further. The Minister well knows this, so I hope that his response will not just restate the Government’s cash injections into the social care system. Extra cash is always welcome but, to emphasise, periodic cash injections, announced mostly during a crisis and too late, buy only a few months of shoring up already fragile services.

Proper funding and support for domiciliary care must be an essential part of a sustainable system. It is social care’s front line, and its scale and reach are often not widely recognised. If residential care during the pandemic played a grim catch-up to NHS services, then domiciliary care was often an afterthought even to care homes. Its dedicated, low-paid care workers, nearly 700,000 of them in England, visit people’s homes daily, moving from client to client and providing a vital link with the outside world on which they depend, particularly if clients are without family or carer support and especially during the pandemic when most have been unable to leave their homes, or their daycare or support clubs, while community services have been shut down. As a carer myself, regularly in touch with many local carers, I fully support the committee’s recognition of the huge further burden that underfunding of services has placed on unpaid carers.

As with residential care, during the pandemic there have been widespread reports of desperate agency care managers ringing around to try to get the PPE they need. Government recognition and funding are needed to cover the extra costs involved in this, as well as the staff shortages and absences arising from a combination of positive Covid cases following PCR testing, self-isolation following contract tracing, shielding and childcare responsibilities. What additional funding has been provided specifically for domiciliary care, PPE, testing and additional staffing costs in 2020? ADASS estimates that an additional £480 million funding is needed in England now to increase the provision of care at home for older and disabled people so they can live independently, with good care, and be kept out of hospital.

On the key issue of free personal care noble Lords, including my noble and good friend Lord Lipsey, will be well aware that we have long advocated it as a basic entitlement for people with substantial and critical levels of need for help with washing, toileting and other daily living needs that will enable them to live safe, independent lives in the community. We applaud the committee’s recommendation on this vital issue. As it points out, free personal care is fair and better aligned with NHS entitlement than the current system, and it would help keep people more mobile and active in the community rather than needing residential or hospital care.

In England, more than 350,000 older people are currently estimated to use home care services, 257,000 of whom have their care paid for by their local council. The United Kingdom Homecare Association estimates that 249 million hours of home care are delivered each year. It is a service which a further 1.6 million older people should receive but do not, because they do not meet current eligibility criteria or there is just not the funding for it. Does the Minister acknowledge that the domiciliary care service needs urgently to be substantially expanded to meet current and future demand?

We know that there has been deep concern about the Care Act easements arising from the Coronavirus Act during the pandemic. Seven councils used this provision in the first wave, mainly to relieve them of duties to carry out care and financial assessments and care planning reviews and visits. The CQC website has not been updated since last July, so can the Minster tell us whether any further councils have used the easement during the second wave? Will the Government provide a full breakdown of the services or activities affected by them? Age UK’s November survey showed that one in seven of those receiving care before the pandemic have since seen a reduction in their care; that is, 210,000 people either receiving less care or no longer receiving any.

On residential care, the Minister is on record as saying that he sees nothing wrong with the current business model, yet he will know that one of the “big four” independent care home providers, Four Seasons, is riddled with some £50 million worth of debt and that, in any event, the big four—the others being HC-One, BUPA and Barchester—cover only around 15% of the overall market. The bulk of England’s 15,600 residential homes are small, privately owned or voluntary sector-run. Although LaingBuisson reports that no home closures were triggered by Covid-19 through the first lockdown, occupancy fell by 8%. Care England has referred to occupancy rates as “historically low”. As the property agency Knight Frank predicts, small, older care homes will be most affected, as they will find it harder to cope with this. Moreover, of more than 6,500 care homes which have 40 beds or fewer, half do not have facilities to support care during a pandemic. Future care home design will need to provide wider corridors to enable social distancing, larger rooms with full en suite and wet-room facilities as standard to promote residents’ safety and isolation, adapted fixtures and fittings to limit touch points, and safer, more separate visitor areas with enhanced communication systems.

The report strongly underlines the unsustainability of the current system of residential care, particularly fears that the number of publicly-funded care places will decline if care homes are driven to market just to self-funders because councils are unable to meet the real costs of providing care. Does the Minister agree that any future model for residential care will be sustainable only if councils are adequately funded to meet the full costs of care?

The actions proposed in this report enjoy widespread support, as today’s debate and the submissions from key stakeholders have clearly demonstrated. As a starting point, it sets out fully-costed proposals that would begin to restore social care funding to pre-austerity levels, ensure that local government was fully funded for providing care, and address the truly urgent need for people to get free personal care support to meet essential daily living needs. Noble Lords have commended the recognition that a new deal is desperately needed for health and social care staff. That is surely no longer in doubt for anyone who has seen their selfless, remarkable and dedicated response to the pandemic.

Health: Brain Tumours

Baroness Wheeler Excerpts

Tuesday 19th January 2021 Lords Chamber

[Lord Bethell (Con)]

My noble friend alludes to a situation that is grave and concerning. Hundreds of millions of pounds have disappeared from medical research charity income, particularly through the closure of second-hand clothes shops, which provide an enormous amount of income for British medical research. I pay tribute to the massive contribution of medical research charities in trying to move forward the science of medical research. This is an area we are deeply concerned about, and colleagues at BEIS and the Treasury are actively engaged with it. My noble friend is right that this a knotty situation to solve that we need to look at very carefully indeed.

[Baroness Wheeler (Lab) [V]]

My Lords, I was very privileged to be present in the Chamber when my noble friend Lady Jowell made her plea to improve brain tumour treatment, research and survival. The work since her death of the Tessa Jowell Brain Cancer Mission, referred to by the Minister and other noble Lords, on the new national strategy has been inspirational. The mission has developed clear practical steps and pathways to build the quality, quantity and diversity of research that the UK needs, such as addressing delays in opening clinical studies, programmes to train the UK’s first generation of brain tumour-specific positions, and dedicated brain tumour centres. What steps are the Government taking to make sure that the NIHR, the MRC and the UKRI work together to ensure that the progress we need comes about? What will happen to the NIHR funding money put aside for brain tumour research in 2018 that remains unallocated at the end of the five-year window announced three years ago?

[Lord Bethell (Con)]

My Lords, I also pay tribute to the Tessa Jowell Brain Cancer Mission and all its work in putting together a really thoughtful strategy for tackling this most difficult issue. NIHR cancer research expenditure has risen from £101 million in 2010 to £138 million in 2019-20, and its settlement in the recent spending review was generous. I am optimistic that there are more resources there. I reassure the noble Baroness that, although the £40 million for brain tumour research has not all been allocated yet, it is not going anywhere and we are working as hard as possible to ensure that the right kinds of research project are put forward for that money. I would like to see it allocated as soon as possible.

Medicines and Medical Devices Bill

Baroness Wheeler Excerpts

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

Moved by

[Baroness Wheeler]

51: After Clause 18, in subsection (1), leave out “may” and insert “must”
Member’s explanatory statement
This would require the Secretary of State to make regulations to creating a statutory committee to provide advice in relation to medical devices.

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for moving Amendment 50 enabling regulations to be made to establish the medical devices advisory committee to advise the Secretary of State and to place the existing Devices Expert Advisory Committee on a statutory footing. We welcome this proposed new clause to the information system requirements as an important step towards bringing more transparency to the devices system and ensuring that the regulator seeks independent expert advice on the safety of devices.

As will be seen from Amendments 51, 52, and 53, however—I am moving Amendment 51 on behalf of my noble friend Lady Thornton—we want the requirement on the Secretary of State to establish the MDAC as a “must do” commitment, rather than the “may” in proposed new subsections (1), (2) and (3) of the amendment in relation to: the need for the regulations; providing advice; and making key provisions, such as how independent members should be from the Secretary of State. I know that numerous debates have been held during the course of legislation going through this House about the differences between “must” and “may”. However, “must” is surely the necessary language to require the Secretary of State to establish the committee and ensure its independence.

The Government’s briefings on the amendment—and the Minister today—as well as referring to the committee providing independent expert advice, emphasise that this will include “the views of patients”, complementing the work of the patient safety commissioner and giving patients a voice within the system of regulating medical devices. Through every stage of the Bill, noble Lords have underlined the importance of consultation with patients and end-users of medicines and medical devices. Can the Minister explain the thinking behind not including a subsection in the amendment which underlines the importance of the patient’s voice and perspective? I would also be grateful if he could tell the House what he considers will be the impact on the advisory role and scope of the change to a statutory footing for the committee.

We acknowledge the need for the two technical government Amendments 64 and 96. On Amendment 64, I note the explanation from the Minister today, and in his briefing letter to Peers of 5 January, of the need to reinstate provisions in the Medical Devices Regulations 2002 extending time limits for bringing proceedings in relation to medical devices offences. Amendment 96 is a necessary consequential amendment in relation to the added clause on the MDAC under Clause 18, bringing the whole clause into force two months after the Bill is passed.

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

My Lords, I am glad to be able to take part in this debate, which allows the House to have a preliminary discussion about the future of medical devices regulation. I certainly welcome the establishment of an advisory committee, but I also welcome my noble friend’s amendment which makes sure that the rather tentative “may” is replaced by “must”. The Minister’s amendment is rather open-ended. It does not specify what matters it will advise the Secretary of State on, nor does it give any indication of the likely balance of membership. This is important because, as I have said, there has been some concern over quite a few years that the regulation of medical devices is not up to the mark, nor sufficiently protective of patient safety. The report by the noble Baroness, Lady Cumberlege, has identified some weaknesses. In that regard, I declare my interest as president of GS1 UK, the bar-coding association.

We received a very helpful briefing from Professor Muireann Quigley and colleagues at the University of Birmingham, pointing to the rather confused state that medical devices regulation is in. The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 came into force at the end of the EU exit transition period. These amend the Medical Devices Regulations 2002 to mirror key elements contained in EU regulations 2017/745, on medical devices, and 2017/746 on in vitro diagnostic medical devices. The aim of that was to make sure that there was good regulatory alignment between the UK and EU, as well as between different parts of the UK’s own regulatory framework. This Bill, when enacted, will provide an opportunity to mandate a more streamlined legislative approach. That would benefit all stakeholders, including industry, businesses and patients.

At present, the MHRA has no involvement in the pre-market phase of medical device development and there is a question as to whether it ought to have. Birmingham University colleagues are certainly proposing a proactive regulatory role for devices that is more akin to that for medicines. This would be clinically focused and, as they say, at least as stringent as the new EU medical devices regulations. Under that proposal, manufacturers could be required to apply to the MHRA before marketing their device. The MHRA could also assess the application in a way that is proportionate to the risks. It is proposed to take account of relevant factors, such as evidence-based supply, approvals in other jurisdictions and post-marketing surveillance plans. I know that that view may not necessarily be shared by industry, which would, perhaps, be concerned about the cost and delay in achieving licensing. However, we can expect a pretty intense debate about medical device regulation in the future.

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[Lord Bethell (Con)]

My Lords, I am enormously thankful for that constructive debate. This change to the Devices Expert Advisory Committee should be welcomed. It provides for if not equivalence then equality between the medicines and medical devices regimes. It provides for transparency, which we value enormously, and it indicates our direction of travel, the step change and the commitment to patient safety that the MHRA will enshrine.

As has been noted, the committee already exists. It currently meets, and it has an impact and an effect, but these measures mean that it will be strengthened. This change is put forward not solely by the Government; it was a recommendation in the review authored by my noble friend Lady Cumberlege. It adds to the collective picture of improvements that we are making, from future regulation of devices to the medical devices information system. I reassure my noble friend Lord Lansley that we have a profound commitment to creating a regulator in the MHRA that has international influence. I say to the noble Lord, Lord Hunt, that patient representatives are already on the DEAC. As Dr June Raine made clear in her briefing to noble Lords, she and the MHRA are massively committed to the patient safety agenda and to mobilising the patient safety voice through instruments such as the DEAC but not solely through it.

It is a delegated power, but one that I hope noble Lords agree is contained. It will allow us to ensure that the structure and focus of the committee can be kept under review to make best use of its impact, and the regulations will be subject to public consultation and all the steps therein.

The noble Baroness, Lady Thornton, has tabled Amendments 51 to 53 to the government amendment, which would change the nature of the regulations such that they “must” rather than “may” be made. However, as I have set out, the committee already exists; it functions now. It will be strengthened by the regulations. We are committed to a more structured decision-making process that improves transparency. There is no equivocation or doubt; these regulations will be made.

The powers provided by Amendment 50 in my name will enable movement towards a more transparent, proactive, whole-life cycle approach to vigilance. Fundamentally, they will make a difference in the oversight of medical devices to the benefit of patients and patient safety.

I am grateful to noble Lords who have continued to shine a light on the importance of device safety. I hope that this additional tool in the arsenal demonstrates continued commitment and that I have provided sufficient reassurances for the noble Baroness to feel able to withdraw the amendment.

[Baroness Wheeler (Lab)]

I thank the Minister for his response and all noble Lords and noble Baronesses who have taken part in this useful debate. The points made by my noble friend Lord Hunt and the noble Lord, Lord Lansley, about the future role of regulation were particularly pertinent, and we look forward to seeing how it develops.

I understand the Minister’s response in relation to “may” or “must” and heard loudly his reassurance that there is no doubt that the committee will be established or be upgraded. That being the case, I am happy to withdraw the amendment.

Amendment 51 (to Amendment 50) withdrawn.

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Moved by

[Baroness Wheeler]

57: Clause 37, page 22, line 3, at end insert—
“( ) Where information is disclosed in accordance with subsection (5) such disclosure will only be permitted where—(a) it is required as part of international cooperation in monitoring the performance and safety of medical devices; or(b) it is in the public interest.” Member’s explanatory statement
This amendment would allow a relevant authority to disclose information to a person outside the UK where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicine provided it is within the public interest to do so.

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Moved by

[Baroness Wheeler]

63: After Clause 39, insert the following new Clause—
“Requirement for draft consolidated legislation: medical devices
The Secretary of State must, within the period of three years beginning with the day on which this Act is passed, publish draft legislation consolidating the regulatory regime as it applies to medical devices.”Member’s explanatory statement
This new Clause, and the other consolidation amendments in the name of Lord Patel, would require the Secretary of State to publish draft consolidated legislation within three years to streamline the existing regulatory framework. These amendments are linked to the amendment providing for a three year sunset provision in the name of Baroness Thornton.

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Moved by

[Baroness Wheeler]

69: After Clause 40, insert the following new Clause—
“Northern Ireland and regulatory divergence
(1) The Secretary of State must make an annual report to Parliament on areas of regulatory divergence between Northern Ireland and the rest of the United Kingdom in matters covered by this Act.(2) Where the Secretary of State has identified areas of potential regulatory divergence between Northern Ireland and the rest of the United Kingdom, the Secretary of State must set out plans to mitigate the adverse effects of such divergence in the annual report.” Member’s explanatory statement
This new Clause would require the Secretary of State to report on regulatory divergence between Northern Ireland and the rest of the UK.

[Baroness Wheeler (Lab)]

My Lords, I am moving the amendment in the name of my noble friend Lady Thornton, which revisits the issue of regulatory divergence between Northern Ireland and the rest of the UK in matters covered by the Bill, and the need for an annual report to Parliament on this matter. The amendment also places an obligation on the Secretary of State specifically to report on plans to mitigate its adverse effects.

The Government will know that there is huge concern on this issue, strongly reflected in our Committee debates through our amendment and an amendment from the noble Lord, Lord Patel, calling for an annual report. The issue was also raised in consideration of the medicines and medical devices statutory instruments before Christmas and in the deliberations on the Northern Ireland protocol and the Trade Bill.

However, I welcome the Government’s amendments in this group to Clause 44, which extend reporting obligations to apply in respect of regulations made by a Northern Ireland department and to regulations under Clause 18 on the health and social care information systems. In particular, Amendment 85 specifies a Northern Ireland department and the Northern Ireland Assembly as an appropriate legislature and relevant authority in relation to regulations made under the Act.

We also welcome the Government’s acceptance of the arguments put forward by noble Lords and the Delegated Powers and Regulatory Reform Committee on the need for parliamentary scrutiny before and after delegated powers are exercised, and the introduction of a two-yearly reporting requirement in large parts of the Bill. I note that government briefings commit to the reports containing a summary of how the regulations have operated over the period under consideration, including any concerns from stakeholders and the Secretary of State’s response, as well as outlining plans for further changes.

I am speaking also on Amendment 78, in the name of my noble friend Lady Thornton, supported by the noble Baroness, Lady Jolly, which in Committee we submitted for inclusion in the provisions under the previous Clause 41 on consultation but which now amends the reporting requirements in Clause 44. Our amendment specifies cohorts that must be consulted in preparation of a report to Parliament, including patients and their representatives, and other key industry stakeholders from healthcare, pharmaceuticals, veterinary and medical research organisations, and healthcare providers and regulators.

Once again, we come back to the importance of ensuring that patients and end users are part of and involved in consultation and reporting relating to existing and potential new medicines, veterinary medicines and medical devices. The stark lessons from the Cumberlege review, the Ockenden review and many other reviews that we have had are that patients’ voices must be heard.

For the record, we feel that the Government’s reporting requirements amendment falls short of providing the reassurances that we sought in Committee, because the relevant authority still has ultimate discretion over whom it consults. This could mean that any report could be skewed or biased by those chosen at the discretion of the Government. That is why our Amendment 78 details the key stakeholders that should be consulted.

In response to that amendment, I am sure that the Minister will come back to the often stock response to the inclusion of specific stakeholders in the Bill, namely that this would be too rigid and burdensome, and would inadvertently rule out contributions from those accidentally not listed. However, in the context of a very complex Bill and the history of often poor communications with stakeholders, I urge the Minister, if she is not happy with our list, to consider a broader amendment at Third Reading that would provide the reassurance that is clearly needed.

I come back to the key issue of regulatory divergence between Northern Ireland and the UK and reporting on this matter. Marketing, authorisation and trading processes on medicines and medical devices between Northern Ireland, the EU and the UK are complex issues, and many remain unclear. The Northern Ireland protocol and the provision for ongoing discussions to resolve key issues mean continued uncertainty for businesses, health services and patients. In this context, an annual rather than a two-yearly report to Parliament would have been more appropriate, particularly highlighting the problems arising from regulatory divergence, and the plans and progress on addressing them.

This is not the time or occasion to go into detail on the issues covered in Committee. However, in Committee the noble Lord, Lord Patel, highlighted many key matters and concerns arising from the MHRA’s guidance on regulating medical devices from 1 January 2021, issued in September 2020, before Committee. I know that the MHRA has been pretty busy of late with the vital Covid-19 vaccination authorisation, but can the Minister tell us when it is envisaged that the MHRA guidance will be updated and reissued?

We have sought and been given reassurances from the Minister that the MHRA’s staffing, resourcing and capacity have been substantially increased to meet its new obligations. It is a much-respected body, but, as we have said, it faces huge challenges under its new role, and we suspect that the £13 million additional funding provided to it by the Government up to the end of March 2021 will be just a pump-priming starter in the light of all that needs to be done. The Minister’s reassurances over the MHRA’s strategic development plans and the Government’s commitment to further funding are welcome, but this is something that we will need to keep a close watch on. I beg to move.

[Lord Patel (CB) [V]]

My Lords, from the outset it has been clear that there was a potential for regulatory divergence in Northern Ireland from the rest of the UK for medicines and veterinary medicines, since they are referred to separately in the Bill as reserved matters in Northern Ireland. However, it has been made clear in the last quarter of 2020 that interaction with the Northern Ireland protocol makes that divergence inevitable for medical devices as well.

Guidance published by the MHRA in October, which I referred to previously, and statutory instruments laid before Parliament in the final months of 2020, set out two different systems of market authorisation and registration, among other issues, and distinguished between the Northern Ireland and Great Britain markets for medical devices and medicines alike. The Northern Ireland protocol requires that EU regulations relating to medicines, veterinary medicines and medical devices apply to Northern Ireland, while CE marks will cease to be recognised in the Great Britain market from July 2023 unless the products in question are from manufacturers based in Northern Ireland.

There are essentially two paths for manufacturers based in Northern Ireland to bring a medical device product into the Great Britain and Northern Ireland markets. The first is to go through UK-based approved bodies for their assessment and market authorisation, which will be approved for both the Great Britain and Northern Ireland markets but will not be recognised in the EU. The second is to submit an application to approved or notified bodies in the EEA to gain a CE mark and thus access to the markets of Great Britain, Northern Ireland and the EU without further needing to apply to a UK body for approvals for the Great Britain market.

By contrast, manufacturers based in Great Britain will need approval from UK-based bodies to place their products on the market in Great Britain and Northern Ireland, but will need to undertake the separate task of setting up an EU-based responsible person and apply separately for a CE mark in the EU. It appears that the recognition of a CE mark on a medicine or device coming from Northern Ireland provides easier access for Northern Ireland-based manufacturers to both the UK and EU markets. What is not clear is the extent to which this dual system between Northern Ireland and the rest of the UK will diverge in substance.

For these reasons and many others, the Government should clarify the position. The amendment would provide greater transparency on potential regulatory divergence, with a commitment to mitigate it where possible. Of course, I will not be surprised if the Minister does not accept the amendment, and neither do I think the noble Baroness will divide the House on it, but whether we agree with it or not, I hope the Minister will agree that somebody has to have some way to recognise what this divergence will do. Who will that be? Would she agree that this will be needed in due course?

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[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.

Amendment 69 withdrawn.

Medicines and Medical Devices Bill

Baroness Wheeler Excerpts

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

[Baroness Jolly (LD) [V]]

My Lords, the purpose of this amendment, tabled by my noble friend Lady Sheehan, with cross-party support, is to ensure that fair and affordable access to medicines for all must be a consideration when regulations are made with respect to human medicines. This is key for two reasons. The first is to ensure that medicines, including on the NHS, are available at a fair price. We know that the NHS buys medicines at an industrial scale and is very able to be tough in its bargaining to get a good deal for the taxpayer. The second is that the British Government used to play a pivotal role, through DfID, in helping many across the world in the eradication of polio and other life-changing or life-threatening diseases. Will the Minister outline what criteria are used now that DfID has been subsumed by FCDO?

On Covid-19, collaboration on the production of vaccines is critical. What is being done by the Government to collaborate in this life-saving mission? Time is of the essence. Can the Minister tell us where we are now and outline what support is going to those who have neither the contacts nor the money to fund these vaccinations? Our economy has taken a serious hit, but we have a moral duty to support those with no industry, and so no income. I endorse all the comments from the noble Lord, Lord Crisp, who has many years’ experience of these issues—many more than I have. I would be grateful if the Minister could answer my questions.

[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.

Care Quality Commission Report

Baroness Wheeler Excerpts

Tuesday 15th December 2020 Lords Chamber

[Lord Bethell (Con) [V]]

I am not sure that I completely recognise the numbers given by the noble Baroness. In August, there were 365 instances of seclusion and 10 instances of segregation of those with autism and learning difficulties, but I would be glad to correspond with the noble Baroness to clarify those things.

I reassure the noble Baroness that the progress that we are making to create the pathways to which she rightly alludes is very much the focus of the department. Earlier this morning, the Minister for Social Care chaired the first Building the Right Support delivery board, in which she brought together representatives of the NHS, LGA, ADS, DfE and MHCLG to make progress on exactly what the noble Baroness is talking about. I reassure her that funds of £74 million have been put in place to help those with autism and learning difficulties who are being discharged into the community.

[Baroness Wheeler (Lab)]

My Lords, the 66 case studies across hospitals and community settings in this very shocking report were of extremely vulnerable people who have all been badly let down by the health and social care system. Most depressing of all is that the actions promised after Winterbourne View and similar appalling situations in the past, which we hoped would lead to major changes in treatment and understanding in the care and support of autistic people and those with learning difficulties, have just not happened. Once again, there is a litany from the patients themselves, and from their families and carers, saying that, if they had received help and support earlier, or when in crisis, they may not have needed hospital care. What are the Government doing to ensure that the right community support is in place for people with autism or learning difficulties in every local area?

[Lord Bethell (Con) [V]]

I completely endorse the noble Baroness’s observations. She is entirely right that the 66 case studies in the report make very harrowing reading. That is why the report was commissioned in the first place, as an acknowledgment that the current state of affairs is not acceptable and needs to improve. Overall, £4.5 billion is going to primary care and community health services, and that is additional money to be committed by 2023-24. It is part of the Government’s overall commitment in this area, and we look forward to publishing a White Paper on mental health shortly.

Puberty-blocker Drugs

Baroness Wheeler Excerpts

Thursday 10th December 2020 Lords Chamber

[Lord Bethell (Con) [V]]

My Lords, I salute the court’s thoughtful and lengthy judgment, which brought enormous clarity to an area which is very important but which has also caused concern and ambiguity. The court has made it clear that children under a certain age are not ordinarily able to make the kind of decisions that have previously been asked of them, but there are openings. No one under the age of 16 can now be referred on to puberty blockers unless a court rules that it is in the child’s best interest. These are helpful clarifications and we look forward to further work to clarify this area.

[Baroness Wheeler (Lab)]

My Lords, the mental health and well-being of young children and teenagers who present with gender dysphoria are paramount. Given the NHS England announcement on puberty blockers, what support are the Government giving to children and teenagers affected by the revised guidelines and their families and schools? On medical matters, will a young person under 16 concerned about gender dysphoria who approaches a GP continue to be covered by the duty of doctor-patient confidentiality?

[Lord Bethell (Con) [V]]

I reassure the noble Baroness that patient-doctor confidentiality remains paramount and is respected. To update her, the Tavistock has immediately suspended new referrals for puberty blockers and cross-sex hormones for under-16s. In future, they will be permitted only where a court specifically authorises it. I reassure the noble Baroness that those already on the programme will continue their medication until the review has been finalised.

Coronavirus Vaccine

Baroness Wheeler Excerpts

Thursday 3rd December 2020 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for the Statement. Yesterday’s great news about the Pfizer/BioNTech vaccine and the MHRA’s clinical authorisation was the breakthrough that we all hoped for. We on these Benches join in with the heartfelt thanks to the dedicated scientists and those who have taken part in the trials, testing and validation process. Coming with the absolute assurance from the MHRA that no corners have been cut by it in the speeding-up of the vaccine, and that safety of the public has rightly remained paramount, the news is especially welcome.

Hospital trust staff will receive the vaccine first. This is a massive logistical challenge given the size of the workforce, the temperatures that this vaccine must be stored at and the two doses needed. We understand that 50 hospitals are already set up and waiting to receive the vaccine. How many NHS staff are expected to be vaccinated by January? When will mass-vaccination centres start opening in our communities?

On care homes, today we have the reality of the difficulty of ensuring that the vaccine can be delivered safely and quickly to them, in the light of its low temperature requirements and because of the fragmented social care system, involving thousands of predominantly small providers employing permanent and often frequently changing temporary staff. The Joint Committee on Vaccination and Immunisation’s Covid-19 priority lists advises that care homes residents and the staff who treat them should be first in line to be inoculated. We now understand that only care home staff will be among the first to be vaccinated, travelling to an NHS centre. While this and readiness in parts of the NHS to administer the vaccine are welcome, can the Minister update the House on how the Government will ensure that in the rollout of this essential vaccine, that hopefully will help to protect thousands of care home residents, they do not find themselves at the back of the queue once again? Care home managers are demanding clarity over this issue and have warned of confusion and raised expectations among vulnerable people.

Overall, we have historic strengths with vaccination, but in recent years we have lost our measles-free status, and we know that vaccination rates can often be lower in poorer and more vulnerable communities. While Covid-19 has affected everyone, the burden of the pandemic has disproportionately impacted the poorest, who are more likely to die than the richest. Can the Minister ensure that there is a health equality strategy, so that black and ethnic-minority groups, and the poorest and most vulnerable, do not miss out on this vaccine?

I also make a special plea for unpaid carers. Carers UK is deeply disappointed that carers are not on the priority list for the vaccine in England. Can the Minister explain the thinking behind this by the JCVI or the Government? They were prioritised for the flu vaccine, as it was recognised that if they get flu, the loved ones they care for are at risk and cannot be properly cared for. As a carer myself, I am in touch with many local carers, who play a vital role in keeping older, disabled and seriously ill people safe during the pandemic.

On the supply of vaccines, the UK has promised 40 million doses by spring, which is estimated as enough to give the required two jabs to health and care workers and everyone over 65. Nevertheless, in the first few weeks of winter, our ability to vaccinate could easily outstrip supply. Current figures are that there will be 800,000 doses in the country within days, with several million more to follow in weeks. I understand that the jabs are being manufactured in Belgium. What assessment have the Government made of the impact of Brexit on importation? Can the Minister reassure the House that supplies will not be disrupted, deal or no deal? We all understand that the restrictions will remain in place for some time but in the meantime, if someone is vaccinated, will they still have to isolate if contacted by test and trace, or are they now released from that obligation?

The Government’s document, Community Testing: A Guide for Local Delivery, suggests that local areas can use mass testing as a freedom pass. What does this mean in practice? How will local areas enforce rules if some people are able to follow different rules based on their testing status? In the Commons yesterday, the Prime Minister suggested that people may want to take advantage of mass testing ahead of visiting their families this Christmas, but what does this mean for people in areas that do not have access to lateral flow testing? Needless to say, despite the approval of a vaccine the restrictions will need to remain in place for some time, and test and trace will be key. Can the Minister confirm that mass testing will therefore be rolled out in all areas in time for Christmas? What are the consequences of the Christmas exemption period if not?

We must not forget that the Minister’s Statement also announced the welcome news that family visits can now take place in care homes, subject to visitors testing negative for Covid-19. However, the increase in staff and resident testing, alongside the introduction of visitor testing, must be backed up by additional resources to make this possible. What extra funding is being made available to care homes to meet the costs of additional testing, cleaning, PPE and visitor administrations that they will incur?

Today’s focus is on the vaccine and how it will be distributed. However, for the record, in response to the Secretary of State, Matt Hancock, claiming that the process of vaccine approval has been one of the early benefits of leaving the EU, the MHRA has today made it clear that the process for developing and authorising the vaccine has been undertaken under the terms of European law, which remain in force until the completion of the Brexit transition period at the end of the year. In other words, Matt Hancock’s assertion is simply not true.

[Baroness Jolly (LD) [V]]

No one can deny that the news about the Pfizer-BioNTech vaccine is just what we need as the days get shorter and Christmas still seems some way off. The technical achievement is enormous, and I am happy to congratulate all those involved in the creation of the vaccine, in the lightning regulation process and in its manufacture. The logistical challenge is next, and I feel sure that, again, the armed services will figure highly here.

Some time ago, I asked the Minister who might carry out the vaccinations. There are not enough NHS staff free to do it. Is there a plan to train others? The training is very short and needs no clinical background whatever. I seem to remember that student friends, when training to be doctors, would practise their technique by injecting oranges. I understand that it will be at least Easter before all the population has received the first round of the Pfizer vaccine and midsummer before we have all had the two jabs.

Can the Minister clarify what sort of immunity someone would have if they failed to get the second jab? What is the timescale of the availability of the other vaccines that we know are in the pipeline? When do we expect all the population of the UK who are willing to be vaccinated to have received their vaccine, and does he have an indication of how many will refuse it?

Vaccine is not a magic bullet—yet. Those of us who will not get it for some time will have to be careful and adhere to the rules outlined by the Government. We might be surprised that not everyone is aware of the symptoms of the virus—the cough and the loss of taste and smell, along with flu-like symptoms. They have not been part of the messaging but, on prevention, we all know “hands, face, space”. Was there a reason that the messaging did not include symptoms? I appreciate that if you are an avid follower of the PM’s No. 10 virus briefings, all that information is at your fingertips, but for many these are not required viewing. How much is the department using Instagram, Facebook and Twitter to get these messages out? If it is not using them, why not? For months to come, people will be testing positive, and anyone who does will still be required to quarantine.

I would like to spend the rest of my time addressing some issues relating to self-isolation that have come from research by King’s College London, based on surveys carried out by the Department of Health and Social Care. Many of us who have been in this situation isolate, as that is doing our bit to prevent the spread of the virus. King’s found that intentions to isolate were high but, when it came to sticking to it, the numbers were low. It found that there were both practical and psychological barriers to an effective isolation system. Practically, there is the issue of finance. The evidence suggests that those of a lower socioeconomic status with dependent children or older relatives struggle financially or lose their pay if they self-isolate, and they choose to ignore the advice.

The £500 grant has not been available since the onset of the lockdowns, and £250 does not cover all the costs for a family for a week if you lose your wage. If a child has to go into quarantine, there is no eligibility for support, yet in all probability a parent will have to take time off work to care for the child. Not all employers continue paying a salary to those isolating or caring for someone who is isolating.

The data that I referred to came from a series of surveys carried out by the department. Is that data in the public domain? It would be really interesting to see the breakdown by geography and demography.

Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

Baroness Wheeler Excerpts

Wednesday 2nd December 2020 Lords Chamber

[Baroness Wheeler (Lab)]

I thank the Minister for introducing the regulations, and other noble Lords for their contributions and key questions on these two important instruments. I also thank my noble friend Lord Blunkett for the speech he decided not to make. As noble Lords have said, it is timely to discuss these instruments now, as we take stock of the Medicines and Medical Devices Bill Committee discussions and outcomes, await Report dates and deliberations, and meanwhile continue the so far helpful discussions on a number of key issues taking place between the Minister, ourselves and other noble Lords involved with the Bill.

For the record, the Bill has changed substantially as a result of government amendments agreed in Committee —not by consensus among participants, as we normally would have expected, but by the Government’s insistence that it was necessary to agree the amendments in Committee to comply with the requirements and timescales for consultation on the Bill with the Department of Health in Northern Ireland and the Northern Ireland Assembly.



We are now working our way through the “new” Bill to assess the full impact of this departure from established procedure and, in particular, the response from the Government to the deep concerns of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee on the use of delegated powers across a range of provisions in the Bill. I note that the Government have not formally responded to these committees, as is also usual practice, other than broadly commenting in the course of their response on individual proposed amendments, or in general correspondence from the Minister in his letter to Peers of 13 October and to the noble Lord, Lord Lansley, of 18 October. Can the Minister tell the House if he plans to respond to the committees, explaining not only how their concerns have been addressed but by which specific government amendment? This information is pretty crucial to all involved as we continue to discuss the Bill with Ministers prior to Report.

The regulations today are confirmed through the affirmative procedure instruments. I would be grateful if the Minister can today confirm that the Government will use this procedure in all regulations on human medicines and medical devices, as also promised in his letter of 13 October.

We have had a good, if short, debate on these SIs, which are long, complex and technical, but which we recognise as a necessary step towards ensuring that people are kept safe when using medicines and medical devices after the end of the implementation period for exit from the EU. I will not repeat the content and purpose of the regulations, which have been well explained by the Minister and other noble Lords and also documented in the very helpful Explanatory Notes and Library briefing, and by the most helpful summary of all, in my view, the Commons Minister Edward Argar’s bullet-points letter of 20 October. In the main, the key issues are the ones we have closely examined in Committee, and which continue to be under discussion.

I want to reinforce and add to the questions raised by some noble Lords. First, on the landmark Cumberlege report, I referred earlier to the helpful discussions taking place on the implementation of this vital review, in particular the establishment of a patient safety commissioner. The Minister referred to these discussions, but he knows that a clear statement of commitment from the Government is needed on this and is long overdue. Can he update the House further on the progress of the discussions? The Minister in the Commons promised strengthened regulations to do more to protect patients, and to use the powers in the MMD Bill for this. He said that plans are in development which will take into consideration both international standards and global harmonisation in the establishment of our future system. I look forward to further information from the Minister about these budding plans and the timescale for when we can expect information and consultation on them.

My noble friend Lord Blunkett touched on the powers of the MHRA in relation to vaccines, and the powers generally in the Bill. There have been deep concerns about how the MHRA is to be staffed and resourced to meet the huge challenges of its future role as the UK regulator of all medicines coming into Great Britain and Northern Ireland. It is a much respected body, but its capacity and expertise will need to be hugely expanded to meet its new obligations and duties. The £13 million in additional funding from the Government up to the end of March 2021 will, I suspect, be just a pump-priming starter. Can the Minister tell the House the planned annual budget for the MHRA up to the end of year three of its operation under its extended remit?

The conformity assessment—the UKCA mark—will be available for industry to use for medical devices placed on the market in Great Britain from the end of the transition period. Is the Minister confident that manufacturers have been given sufficient time and guidance to prepare for the UKCA marking?

What assessment have the Government made of the impact these new regulations could have on the number of approved medical devices in the next few years? According to GlobalData’s pipeline products database, there are more than 17,000 active medical devices currently in the pipeline, with approximately 42% of these devices in the early stages of development. The high proportion of products being developed in the EU and UK indicates that a vast majority of devices will be caught in transitioning approval processes, which may lead to a temporary decline in the volume of approved devices—and, indeed, to the delays that noble Lords have talked about. Many companies are already struggling with the demands of the medical device regulations, including the increased costs. Does the Minister share my concern that this, coupled with the additional authorisation process required to reach the UK market, may lead to delays or deter companies from selling their products in the UK altogether?

Under these regulations, the UK will continue to recognise the CE marking on medical devices and in vitro diagnostic devices which have demonstrated their conformity with EU regulatory requirements, until July 2023. Will the UKCA marking be recognised by the EU? Can the Minister confirm whether the EU falsified medicines directive, referred to by the noble Baroness, Lady Bennett, will apply in the UK after Brexit? If not, packs of medicine intended for the UK that are not compliant with the directive may not be lawfully dispensed in Northern Ireland.

The complexities businesses face are considerable and have been exacerbated by the Northern Ireland protocol, which requires companies seeking marketing authorisation to be able to sell a new medicine in the UK to continue to follow EU procedures in respect of Northern Ireland. Can the Minister confirm whether a single marketing authorisation will suffice or whether new companies will have to obtain a double “EU plus UK” marketing authorisation to sell throughout the UK?

For those of us deeply concerned about the risks of regulatory divergence on medicines and medical devices between Great Britain and Northern Ireland, can the Minister tell the House about the specific work that is being done, in response to the Bill and these regulations, to mitigate the adverse consequences of possible divergence in the medium and longer term? One has to look only at the timely and expert analysis of the noble Lord, Lord Patel, of the MHRA guidance on this issue in Committee to see that there are key issues that remain unclear and unresolved, and deep confusion around how the dual systems will work in the future.

Medicines and Medical Devices Bill

Baroness Wheeler Excerpts

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.

Amendment 119 withdrawn.

Medicines and Medical Devices Bill

Baroness Wheeler Excerpts

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

Moved by

[Baroness Wheeler]

105: After Clause 16, insert the following new Clause—
“Requirement for consultation with devolved authorities
(1) Before making regulations under section 16 that contain provision which is within the legislative competence of a devolved legislature, the Secretary of State must consult the relevant devolved authority on that provision and have regard to the views of that devolved authority.(2) In this section—“devolved authority” means the Scottish Ministers, the Welsh Ministers, Northern Ireland ministers or a Northern Ireland department; and“devolved legislature” means the Scottish Parliament, Senedd Cymru or the Northern Ireland Assembly.(3) A provision is within the legislative competence of a devolved legislature if—(a) it would be within the legislative competence of the Scottish Parliament if it were contained in an Act of the Scottish Parliament;(b) it would be within the legislative competence of Senedd Cymru if it were contained in an Act of Senedd Cymru (including any provision that could only be made with the consent of a Minister of the Crown); or(c) the provision, if it were contained in an Act of the Northern Ireland Assembly—(i) would be within the legislative competence of the Assembly, and(ii) would not require the consent of the Secretary of State.”Member’s explanatory statement
This new Clause would require the Secretary of State to consult the devolved administrations before making regulations concerning UK-wide information systems.

[Baroness Wheeler (Lab)]

My Lords, I am moving Amendment 105 on behalf of my noble friend Lady Thornton; it leads the group of amendments following Clause 16, which provides the legal framework for the medical devices information system. I will also speak to our other amendments in this group—Amendments 128, 130 and 132—and on the remaining amendments, including government Amendment 126.

The number of amendments in this group shows the strength of feeling on this issue. Key issues raised last week and in debate on Clause 16 earlier today are also relevant here. As we have all stressed, First Do No Harm, the landmark report by the noble Baroness, Lady Cumberlege, very much places the importance of the MDIS system centre stage. The complete lack of safety data and record-keeping on pelvic mesh implants in thousands of women—including basic details about the patient’s name, medical history and health problems, and manufacture and supply information for these devices after implantation, which would have enabled patients to be traced and treated—reinforces the need for MDIS and its future role as both an information and tracing system.

Amendment 105 would add a new clause after Clause 16 to place a statutory requirement in the Bill that the devolved Administrations in Scotland, Wales and Northern Ireland must be consulted before regulations on the MDIS are laid and that the Secretary of State must have regard to the views of the devolved authority. Government Amendment 126 and Amendments 105, 127, 128, 129 and 132 all aim to strengthen consultation provisions, including public consultation before making regulations under any provision of Parts 1, 2 or 3 of the Bill or under Clause 16(1).

This focus on the importance of consultation and ensuring that NHS Digital—with its existing remit and expertise limited to England—fully engages in meaningful and active collaboration with the devolved authorities is absolutely crucial for the UK-wide development of MDIS. If the system is to be fit for purpose, the work to deliver it must be informed by and responsive to the local requirements and realities across the devolved Administrations. The devolved nations must be fully involved in the system’s design and modelling, have equal access to MDIS data analysis and sharing, have a governance structure for MDIS that includes representatives from all the devolved authorities’ institutions, and have parity of funding across the four nations.

I am very grateful for the helpful correspondence of 9 November from the Minister to the noble Baroness, Lady Finlay, regarding MDIS and working with the devolved Administrations. It was shared with Members, together with the 4 November letter from NHS Digital setting out its intended “collaborative approach”. These letters contain a number of assurances on both the current work being undertaken and how the future four-way relationship needs to be taken forward to develop the UK-wide system.

The remaining amendments in this group, including the government amendment, refer to the general duty under Clause 41 to consult before making regulations. Our Amendment 132 would insert a new clause on the duty to consult the devolved Administrations and “have regard” to their views. I hope the Minister will agree that that is not an unreasonable requirement.

Government Amendment 126 would amend Clause 41 to ensure consultation with the devolved authorities under Clause 16, headed “Information systems”. Although the inclusion of this statutory duty to consult as far as Clause 16 goes is a step forward, other key parts of the Bill have an impact on the devolved authorities. We want to see a general duty in Clause 41 to consult the devolved Administrations, as is common practice in a number of Bills—not just limited to consultation in relation to Clause 16. I hope that the Minister will undertake to review the Bill after Committee and consider this key point in relation to Clause 41.

In his 13 October letter to noble Lords, the Minister refers to the Government’s amendments as providing “certainty” that the Government will ensure that the devolved authorities’ views are heard throughout the development of the regulations and in their implementation. The certainty given, however, is in relation only to Clause 16 and not to the rest of the Bill, as we would like to see.

Amendment 130 is a probing amendment that would remove the permissive provision in Clause 41(3) that consultation carried out before the Act was passed could satisfy the duty to consult. This clause is very open-ended. Can the Minister provide details of the purpose and intended use of this provision? There is no explanation in the Explanatory Notes. Will there be a time limit on how up to date a consultation needs to be for it to be considered done and dusted?

--- Later in debate ---

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

I have not received any further requests to speak, so I call the noble Baroness, Lady Wheeler.

[Baroness Wheeler (Lab)]

I thank the Minister for his extensive and helpful response, particularly on the comments made by my noble friend Lord Hunt about the groups that are consulted. This has been an excellent debate and I have little to add, as noble Lords put forward the issues so ably, in particular on the importance of listening to patients and patient representatives so that the consultation is meaningful and well thought through, given the enormous powers that are in the Bill and will be set out in the regulations. It is timely for my noble friend to remind us of the context of the DPRRC and Constitution Committee reports. I asked the Minister to consider whether Clause 41 should specifically include reference to consultation with the devolved authorities. If he could come back to me on that, that would be helpful. I also asked some questions about his correspondence, which I hope he will agree to follow up.

[Lord Bethell (Con)]

On the question why the government amendment is being made to Clause 41 rather than Clause 16, which I think is what the noble Baroness is asking about, Clause 41 is concerned with consultation. It is important that consultation requirements are provided for in one place, as that assists with clarity and understanding. The legal effect is the same, irrespective of where in the Bill the obligation to consult the devolved Administrations when making regulations under Clause 16 is found.

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[Baroness Wheeler (Lab)]

I thank the Minister for that and I beg leave to withdraw the amendment.

Amendment 105 withdrawn.

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Moved by

[Baroness Wheeler]

119: After Clause 38, insert the following new Clause—
“Northern Ireland and regulatory divergence
(1) The Secretary of State must work together with the appropriate authority in Northern Ireland to minimise the potential for and mitigate against regulatory divergence in relation to human medicines, veterinary medicines and medical devices. (2) Where the Secretary of State has identified areas of regulatory divergence in relation to human medicines, veterinary medicines and medical devices between Northern Ireland and the rest of the UK, the Secretary of State must lay a report before both Houses of Parliament setting out how the divergence will impact—(a) the UK; and(b) Northern Ireland.(3) The report must set out the steps the appropriate authorities have taken to mitigate against such divergence.”Member’s explanatory statement
This Clause would require the Secretary of State to work with the appropriate authority in Northern Ireland to minimise the potential for regulatory divergence relating to medicines and devices, and report any areas of regulatory divergence to Parliament, including the impact they will have, and report on actions to mitigate against adverse consequences arising from divergence.

[Baroness Wheeler (Lab)]

My Lords, on behalf of my noble friend Lady Thornton, I am moving Amendment 119 on the important issue of regulatory divergence with Northern Ireland and reporting to Parliament. I am grateful for the support of the noble Baroness, Lady Ritchie, who raised this key issue at Second Reading, as did the noble Lord, Lord Patel, whose Amendment 120 is grouped with this amendment. I look forward to their contributions and to those of other noble Lords.

Amendment 119 would add a new clause to the Bill on the interpretation of Part 3, “Medical Devices”. It would require the Government to work with the appropriate authority in Northern Ireland to

“minimise the potential for and mitigate against regulatory divergence in relation to human medicines, veterinary medicines and medical devices.”

Where an area of divergence is identified, the Secretary of State would be required to lay a report before Parliament on the impact it will have and the steps being taken to mitigate it.

Human and veterinary medicines are transferred matters in Northern Ireland. For this reason, Clauses 1 and 8 lay out in black and white the possibility of regulatory divergence, as they give separate powers to Northern Ireland departments to make regulations relating to Northern Ireland. However, despite this being in the Bill, the rest of the legislation as drafted is completely silent on the implications this may have, or on any mechanism for dealing with them. This means Northern Ireland could end up passing different legislation.

As well as those powers in the Bill, there is the wider context of the Northern Ireland protocol, under which Northern Ireland will continue to apply certain European Union standards that will no longer automatically be part of the law governing Great Britain. For example, in the Government’s own guidance on regulating medical devices from 1 January 2021, it is stated that, unlike in Great Britain, the EU medical device regulations and the EU in vitro diagnostic medical device regulations will apply in Northern Ireland from May 2021 and May 2022 respectively.

The risks of divergence have been raised by Members in both Houses, including the risk that what may on the face of it seem to be only minor or technical differences could create a butterfly effect, leading to much larger legal and operational problems. The Bill does not itself create divergence and nor for that matter does the Northern Ireland protocol, but both permit it or create a situation in which it may arise. It is therefore vital that the implications of this are part of discussions on the Bill.