Botulinum Toxin and Cosmetic Fillers (Children) Bill

Baroness Wheeler Excerpts

2nd reading
Friday 16th April 2021 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I too congratulate the noble Baroness, Lady Wyld, on sponsoring the Bill and on her excellent introductory speech, which clearly set out the overwhelming need for urgent and longer-term action to bring the regulation of botulinum cosmetic fillers for under-18s in line with other appearance-related procedures, such as tattoos and sunbed use, for which there is already a statutory minimum age of 18. This is what we know the public would expect and, as we have heard, mostly assume we already have.

Like other noble Lords I was shocked to realise that this crucial area is as unregulated as it is and that in 2018 an estimated 100,000 under-16s underwent cosmetic enhancements. It is also important to note that Sir Bruce Keogh’s 2013 review was also shocked, and that shock was reinforced by the 2017 Nuffield Council on Bioethics review, which highlighted major safety concerns. Everybody has been shocked ever since then, but now we are at last able to begin the process of remedying this deeply worrying situation,

Progress is obviously due to the tireless work and determination of Laura Trott MP in the Commons and the Bill’s many supporters, in particular the co-chairs of the All-Party Group on Beauty, Aesthetics and Wellbeing, Carolyn Harris MP and Judith Cummins MP. They have highlighted the lack of age restrictions for these procedures and concerns about advertising and social media promotion that leave young people at risk. The APPG’s inquiry is ongoing and has brought together people from across the sector to talk about the lack of robust, consistent and enforceable standards. It is a tribute to the cross-party work that has taken place across both Houses on these vital issues, and when it reports it will be a valuable tool to build on the initial measures in the Bill.

Like other noble Lords, I pay tribute to the pioneering Save Face charity for its campaigning and awareness-raising, its voluntary register and its work to build the necessary standards and safeguards through its accreditation with the Professional Standards Authority for Health and Social Care.

The Bill is an important step forward and fully supported by Labour. It is welcome because it prohibits specific procedures being performed on young people under the age of 18, except under the direction of a registered health professional, and prevents businesses arranging or performing procedures on under-18s on their premises. Most importantly, its provisions do not affect the vital medical use of Botox or fillers by appropriately qualified medical practitioners, such as Botox treatment for conditions such as Bell’s palsy, which will remain available where there is an assessed need.

During the course of the Bill and in today’s speeches we have heard about the horrific consequences for vulnerable young people when procedures go wrong, including the worst-case scenarios of infection, permanent scarring and tissue death, as well as serious psychological and mental health problems for young people whose lives have been seriously impacted by botched procedures undertaken by unqualified and improperly trained staff who bear no responsibility or accountability when malpractice occurs.

As the British College of Aesthetic Medicine stresses:

“Dermal fillers in particular are plain dangerous in the wrong hands”.


Its call for

“a wider regulatory regime, which supports controlled access to prescription medicines, and which differentiates aesthetic medicine from beauty therapists, spas and salons”

is the vital work that will need to follow from the Bill.

Noble Lords, especially the noble Baroness, Lady Bull, have spoken movingly of the pressure on young people to conform to the body images they see around them, especially on social media, which holds so much power over today’s youth and is flooded with adverts for treatments claiming to make them look younger, thinner and prettier. The Childline, Mental Health Foundation, YoungMinds and Save Face surveys all show an alarming picture of the impact of all this on young people’s sense of self-worth and their physical and mental health. The thousands of young people who view procedures such as lip fillers as easy, temporary and comparable to getting a haircut or manicure are deeply concerning when the results can have a profound and extensive impact on so many lives.

Under Clause 4, there are significant new responsibilities for local authorities to reinforce the provisions of the Bill using their powers available under Schedule 5 to the Consumer Protection Act, which we welcome as local councils are best placed to monitor local businesses and developments. The Explanatory Notes to the Bill acknowledge that it may result in an increase in revenue support under the Local Government Finance Act 1988, and the Commons has agreed a money resolution to give effect to any decision on this. Noble Lords have expressed serious concerns, which we echo, about what new money will be made available to local authorities to meet these responsibilities in the light of the huge funding cuts they have faced in the past decade. Can the Minister reassure the House that new money will be made available to implement the provisions of the Bill? Without additional funding it is hard to see what local authorities will actually be able to achieve.

I also seek clarification about the scope of the Bill. As I understand it, the Bill applies only to procedures carried out in England, reflecting the fact that public health is devolved. In so doing, it amends the Consumer Rights Act and the Human Medicines Regulations 2012, both of which have wider England and Wales or UK territorial scope. The Human Medicines Regulations also cover Northern Ireland. I would be grateful if the Minister or the noble Baroness, Lady Wyld, could confirm whether this would be solely for the purpose of making consequential amendments and what work and consultation with appropriate devolved bodies is envisaged in this respect.

As we have said, the Bill is a welcome first step to address the growing threat of unregulated cosmetic treatments to young people’s mental and physical well-being, but it is just that: a start which lays the groundwork for future change. We strongly support the Bill and look forward to the Minister’s response to noble Lords’ questions on how its provisions are to be taken forward, the timescales for implementation, the proposals for the review of regulations and guidance that has been spoken about, and the next steps that need to be taken to ensure effective future monitoring and regulation.

Crohn’s Disease and Ulcerative Colitis

Baroness Wheeler Excerpts

Thursday 15th April 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I agree with the noble Baroness. A lot of late diagnoses are caused by the kind of delicacy the noble Baroness refers to. My noble friend talked about the challenge of diagnosis, which is made more complex by patients finding a lot of these subjects extremely delicate. The approach taken in primary care to handling such delicate issues has improved dramatically over the years. We are working with GPs and clinicians to make their bedside manner more delicate, so that they are able to broach such delicate issues more sensitively. That, I believe, is at the heart of the problem.

[Baroness Wheeler (Lab)]

My Lords, Covid-19 has widened the huge cracks in the quality of IBD care, with patients facing even longer waits for elective care, surgery, investigations and a personalised care and support plan to support their daily lives. Surveys have shown nearly one in five IBD patients have suffered a flare-up crisis during the pandemic because they were unable to obtain specialist advice. We know that many have had to continue shielding because Crohn’s disease compromises the immune system and they have to wait for their two vaccines. What recognition and support of their particular care needs is being given at primary care and community level?

[Lord Bethell (Con)]

I completely sympathise with all those with IBD and associated conditions. The situation the noble Baroness described is exactly right and it is extremely challenging. I have particular concern for those shielding for a very long period, although I hope many of them will not be waiting long for their second vaccine. Those with all conditions have endured some waits because of Covid, but the NHS is working incredibly hard on the catch-up. Huge progress has already been made and there is a massive focus on diagnosis in particular, to ensure that we catch up with all those presenting with problems who need diagnoses.

Folic Acid

Baroness Wheeler Excerpts

Tuesday 23rd March 2021 Lords Chamber

[Lord Bethell (Con)]

The noble Baroness’s figures are not quite the same as the ones I have in front of me. The mandatory fortification of bread flour with folic acid in Australia resulted in a 14.4% overall decrease in NTDs—although that is still a really important number, and if we are running at 1,000 a year in the UK, 50% of which are due to unplanned pregnancies, there are clearly important grounds for this measure to be considered seriously.

[Baroness Wheeler (Lab)]

My Lords, last year, a year after the consultation deadline closed, the Minister repeated his promise that, despite seriously delayed government decision-making, major efforts were being made to step up the raising of awareness of the importance of taking folic acid supplements, particularly among at-risk groups such as Afro-Caribbean women and women under 20. Can the Minister tell the House what actions have been taken? What measurable impact has awareness raising had among these at-risk groups and on ensuring that women whose pregnancies are unplanned—as we have heard—are not missing out on these vital nutrients in the early stages of their pregnancy?

[Lord Bethell (Con)]

I am grateful to the noble Baroness for reminding me of my words on that matter. I will endeavour to find an answer to her very particular question. I worry that the very large amount of engagement we have had to do on Covid, particularly around marketing, has drowned out some of the messages that we have put through to people on these very specialist issues. I will find out from the department what progress has been made and will be glad to update her.

Osteoporosis: Treatment

Baroness Wheeler Excerpts

Tuesday 9th February 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, the CMO has recently issued new guidance on the consumption of vitamin D and there has been widespread discussion about its dosage level. My understanding is that we are leaving the matter at that for the moment. I am not aware that the mandatory application of vitamin D to food is on the runway at the moment, but I am happy to check that point and write to the noble Baroness.

[Baroness Wheeler (Lab)]

My Lords, your Lordships’ House recently discussed the importance of medical research and government financial support for the fundraising and work of key charities on new brain tumour research treatments. With an estimated 3.5 million people aged over 50 currently affected by osteoporosis, many suffering chronic pain and disability, research on this is also vital. What resources does the NHS currently spend on osteoporosis research? Will the Minister undertake to consider the financial support, including match funding, that the Government can provide to the Royal Osteoporosis Society’s newly launched research academy and its potentially game-changing road map, which charts the key steps for researching a cure for this extremely debilitating disease?

[Lord Bethell (Con)]

My Lords, I do not have the figures for the precise amount that the Government spend on osteoporosis research at the moment, but I am happy to write to the noble Baroness with them if they are available. We are enormously grateful to the Royal Osteoporosis Society for its contribution to medical research. I can confirm that it has received a grant of £258,000 to support important work providing support for the vulnerable during the pandemic. That comes out of the package of £750 million that the Chancellor of the Exchequer announced to support the charity and voluntary sector during the Covid pandemic.

Hotel Quarantine for Travellers

Baroness Wheeler Excerpts

Wednesday 3rd February 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I share the noble Lord’s pride in that measure and concern that we extend a warm hand of friendship to those from Hong Kong. He raises the point extremely well. I would like to think that any system we put in place would be resilient to surge demand of the kind he indicates, but I will take his point back to the department and check that everything is being done accordingly.

[Baroness Wheeler (Lab) [V]]

My Lords, UK borders have knowingly been left open and potentially exposed people to new strains of the virus, rather than the implementation of the prompt, concerted action advised by SAGE and a comprehensive hotel quarantine system brought in for all UK arrivals. Does the Minister accept that the current 10-day self-isolation system has failed? If so, why is the policy still being pursued for the majority of travellers? We have been promised that hotel quarantine will be implemented for some countries as soon as possible, with some reports suggesting that this will not be enforced until the week of 15 February. Can the Minister confirm whether this is the target date? Will additional measures be in place for travellers from the red list of countries in the interim? Finally, does he accept that a partial quarantine is doomed to fail, given that global travellers may move across many countries during their journey, passing through multiple travel hubs and departure lounges while encountering and spending time close to many other travellers along the way?

[Lord Bethell (Con)]

My Lords, I acknowledge the detailed and perfectly reasonable questions raised by the noble Baroness, but I am unable to answer them all in detail. A Statement will be forthcoming from the Government on exactly those questions. I remind her that travel has come down by 90% in a comparative period. She is entirely right that travel patterns are complex; any measures we put in place will recognise that many travellers leapfrog from one country to another, brushing against others, and that the spread of the virus cannot be narrowly contained to travel corridors in the way one would sometimes like to hope.

International Year of Health and Care Workers

Baroness Wheeler Excerpts

Monday 1st February 2021 Lords Chamber

[Lord Bethell (Con)]

I take this opportunity to confirm to the noble Baroness that all NHS staff qualify for the vaccine. I would be very grateful if she could communicate to me any incidents where an NHS trust has said otherwise. We are enormously grateful in this country to all those who migrate to support our social care services. We are profoundly grateful for those efforts, and I want to ensure that everyone is treated well in their workplace. Generally, those in the social care workplace are treated well; there are exceptions, and we crack down on those exceptions extremely hard.

[Baroness Wheeler (Lab)]

My Lords, I express our strong support for the WHO statement in recognition of the selfless dedication of health and social care staff to providing care during and despite Covid-19. Following on from the comments of my noble friend Lady Pitkeathley, the WHO statement draws attention to the importance of workforce readiness, education and learning to manage the pandemic and its consequences. Will the Minister explain how the Government are ensuring that both health and social care staff on the front line of social care—particularly care staff, providing vital domiciliary care in the home and in the community—are being given this key support?

[Lord Bethell (Con)]

The noble Baroness is right. Those involved in domiciliary care, particularly part-time, make an extremely important contribution. We are naturally concerned about how they are contracted and their educational needs supported. We would like to think more about how part-time domiciliary care staff in particular, who make such a valuable contribution, can be further supported.

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?

--- Later in debate ---

[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.