Medicines and Medical Devices Bill

Baroness Redfern Excerpts

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

[Baroness Walmsley (LD) [V]]

My Lords, I add my voice to those of the noble Baroness, Lady Finlay, and the noble Lord, Lord Ribeiro, on their Amendments 86, 88 and 102, about having unique identifiers for medical devices. In these days of barcodes, this should not be too difficult nor add much, if any, cost for the manufacturers. Indeed, it has been proved to work with medical devices, as the noble Baroness explained.

It is important that products found to be faulty are speedily traced. If my digital radio can be recalled speedily because it might burst into flames, surely a medical device implanted in someone’s body must also be able to be recalled speedily. Recall could also be useful when something better comes along; it could be vital for the future treatment of the patient.

There are occasions when an individual product develops a fault, although the majority of products of that model are perfectly okay. If we are to learn lessons and improve products, as the noble Baroness, Lady Cumberlege, has just pointed out, it would be essential to know where they are and how the receiving patient has reacted to them. A unique identifier could facilitate that, and also provide some protection for the patient concerned, especially in the case of a recall.

I look forward to the Minister’s answers to the questions that the noble Baroness, Lady Cumberlege, asked about patient consent. It is vital that patients have confidence in the system. Confidence in their own privacy is part of that, and patients can have that confidence only if they know what is being shared, and by whom.

[Baroness Redfern (Con) [V]]

My Lords, I am pleased to speak to this group of amendments, and to thank the noble Baroness, Lady Cumberlege, who has been so diligent in her review in proposing such needed changes, and making good for the recipient and building user confidence in the devices offered. It is a pleasure to follow the noble Baronesses, Lady Finlay and Lady Walmsley, and the noble Lord, Lord Ribeiro—as well, of course, as the noble Baroness, Lady Cumberlege.

I spoke on Second Reading in support of an extensive programme for medical devices, to provide for high standards of safety and to share vital information, with data central to effectiveness. The noble Baroness, Lady Cumberlege, in her review, regarded being able to track which treatments and implants people have had as being of particular importance. A barcoded wristband, with equipment used in treatment, including implantable medical devices, being scanned and tracked to a patient’s record, would save much precious time for product recalls, and reduce drug errors.

This means knowing who has had a device used in their treatment, so that they can be swiftly notified if there is a problem. Having unique device identification is therefore very important. The noble Lord, Lord Ribeiro, said—and I agree—that we must consider tracking all medical devices used in the UK, rather than a select few.

[Baroness Jolly (LD) [V]]

My Lords, we support the amendments in the names of the noble Baroness, Lady Finlay of Llandaff, and the noble Lord, Lord Ribeiro, and Amendment 103 in the name of the noble Baroness, Lady Cumberlege. Registers are a tool that helps clinicians to track devices and those who have the devices fitted or implanted, and to use the data for research and to aid patients to seek redress.

The noble Baroness, Lady Finlay, explained clearly how the amendment would work to help to change a medical device that no longer functions. By citing the recall mechanism for a faulty domestic product, she illustrated what is required of a device register.

The amendments in this group relate to the tracking of medical devices, and the information stored. Amendments 86, 88 and 102 would allow regulations to provide for the tracking of all devices, as they are used, via a unique device identifier, with the information recorded either in registries or through hospital episode statistics data.

Amendment 103 is an important amendment, tabled by the noble Baroness, Lady Cumberlege, that seeks to clarify which information held by the healthcare system requires the consent of the relevant patient. Data is powerful, and should be kept appropriately. The governance of data has been a key issue in the NHS for more than 20 years.

Health Protection (Coronavirus, Restrictions on Gatherings) (North of England) Regulations 2020

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Friday 25th September 2020 Lords Chamber

[Baroness Redfern (Con) [V]]

My Lords, I shall speak to the health protection coronavirus restrictions on gatherings regulations, laid before the House on 4 August.

Any restriction on people’s freedom is regrettable, but we are facing an epidemic the likes of which we have not seen before, with epidemiological data showing growing high transmission rates of Covid-19. Therefore, it follows that it is necessary to impose restrictions which prevent the spread of the virus and reduce public health issues but which are proportionate to what they seek to achieve at the time. I welcome the areas where easements are made, but everything remains very fluid.

As my noble friend the Minister alluded to earlier, the Government are working with local authorities to develop dedicated local outbreak plans to help manage Covid spikes, with all authorities having to submit their procedures. There is an urgent need for good data, and of course clarity is essential in order to be able to take people with you. I stress the importance of having local volunteers and using council employees to fill the role of Covid marshals and help deter people gathering in larger numbers. Local knowledge is invaluable.

The restrictions on gatherings are eminently sensible and appropriate, as is lifting the regulations as soon as conditions are safe. Those conditions are changing on a nearly weekly or—dare I say?—daily basis. I support the regulations.

Covid-19 Update

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Monday 14th September 2020 Lords Chamber

[Lord Bethell (Con)]

I thank the noble Baroness for her testimony, which completely resonates with me. The current national prevalence is around one in 1,500, so there is a strong likelihood that, in a school with 1,500 kids, one of them will turn up with Covid. We are aware of the challenge of febrile children who have a temperature, as children often do, and are naturally anxious to get a test. We therefore provide kits of tests to schools, but we are not able to turn schools into testing centres—I do not think that parents, teachers or schoolchildren would like us to do that. We have also prioritised social care, the protection of hospitals and the asymptomatic testing of key workers over schoolchildren for the moment. As our capacity increases, that will be reviewed.

[Baroness Redfern (Con) [V]]

My Lords, this virus has shown it is extremely difficult to eradicate or keep under control until a vaccine is produced. I ask the Minister about people being asked to isolate because data has shown that some are facing real hardship. We are told that this is a central reason for people sometimes ignoring advice. Are Ministers looking at the possibility of helping with extra financial support?

[Lord Bethell (Con)]

The noble Baroness is entirely right that the isolation protocol is extremely onerous for some people and has a huge impact on their life, mental health, income and social life. I completely understand the point she is making. We are keeping the question of financial support under review and will continue to look at this important subject.

Medicines and Medical Devices Bill

Baroness Redfern Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Baroness Redfern (Con) [V]]

I congratulate the Minister on introducing this important Bill and the review team, led by my noble friend Lady Cumberlege, on its commitment to patient safety.

This Bill delivers an extensive programme for the regulation of medicines, veterinary medicines and medical devices in the UK, and provides for a high standard of safety. To capture the fast pace of innovation in these areas within a regulatory legal framework, it is important to share vital information and be responsive and flexible, while being less complex and unwieldy, with data central to effectiveness. Can the Minister say how the duty to consult on regulations about human medicines will be carried out and which stakeholders will be involved?

I am pleased to see the Bill upholding and enhancing of the attractiveness of UK life sciences, as mentioned by previous noble Lords, while not hindering its ability to continue to provide for these important innovations for patients. It demonstrates a wish to make clear the importance of commitment to the life sciences sector, which is worth over £75 billion to our economy. We all know and acknowledge that enhancing continued collaboration of technical and scientific expertise is of significant importance to the UK going forward, but it should not be put before patient and user safety.

There is also a government commitment to a world- leading regulatory system, enhancing us as an attractive destination for clinical trials; to allowing strong collaboration, not just across the EU but maintaining alignment with global standards on the different routes to accessing innovation; to supporting patients’ access to innovation, creating more opportunities as we leave the EU; to maintaining and strengthening our position as a global player in the world of R&D; to allowing the removal of barriers to hub and spoke dispensing, giving smaller community pharmacies the same opportunities as large pharmacies; and to extending low-risk drug prescribing to other healthcare professionals.

An area of concern in the dispensing of medicines is oversupply, particularly in repeat prescriptions. Unused medicines have an environmental impact, so I would like to know how that can be responded to. How, too, can regulations be made to provide for a database of information on medical devices, to be established and managed by the Health and Social Care Information Centre?

As with human medicines regulations, the framework in the Veterinary Medicines Regulations 2013 upholds the safety of veterinary medicines by having a robust system for their availability, development and supply. Changes making prescribing professionals for veterinary medicines as accessible as possible, without compromising animal safety and while ensuring that the person administering the medicine is protected, are to be welcomed.

The Bill is an important piece of legislation for the regulatory system for medicines and medical devices, and for enabling new developments, but it must always display safety front and centre. The Government have stipulated that they do not intend to make any bold policy changes without full consultation, and that is to be welcomed.

[The Deputy Speaker (Baroness Garden of Frognal) (LD)]

The noble Lord, Lord Gadhia, has withdrawn from the debate, so I now call the noble Baroness, Lady Sheehan.

Covid-19: Mental Health Services

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Thursday 2nd July 2020 Lords Chamber

[Lord Bethell [V]]

The right reverend Prelate makes a good point, and I thank very much indeed those from all faith groups who have provided important pastoral support during this difficult time. On a practical matter, the funding for the mental health projects from our £5 million fund has gone to 130 different charities through the coronavirus mental health response fund. We are assessing the impact of those and we look forward to the recommendations of the Mind and mental health consortia which are behind that fund.

[Baroness Redfern (Con) [V]]

Mental health community projects are supporting people during coronavirus, and the Government’s announcement in May of £5 million of additional funding marked the first round of funding to be allocated to the sector. When will the second wave of projects receive funding, and will that include extra training for staff and to recruit more to service the 24/7 helplines?

[Lord Bethell [V]]

I pay tribute to charities and other community projects which have contributed to a wide range of projects across mental health, learning disabilities, dementia, isolation, befriending, domestic abuse, women’s issues and BAME groups. As I mentioned earlier, the Mind and mental health consortia are making recommendations about the progress of the fund. I look forward to their recommendations and we will act on them wherever we can.

Covid-19: Cancelled Medical Operations

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Wednesday 10th June 2020 Lords Chamber

[Lord Bethell [V]]

The noble Baroness, Lady Jolly, is right to emphasise the importance of safe spaces. Cancer surgery requires a completely hygienic environment for those who have immune challenges. Safe spaces are found for all those who need to have cancer practices. They may not be in absolutely every hospital, but if one hospital cannot make that kind of offer, an adjacent or nearby hospital will be found to provide the kind of safe spaces that are needed to carry out the procedures she described.

[Baroness Redfern (Con) [V]]

When will treatment begin for post-operative patients who are waiting for chemotherapy, do we have instances where chemotherapies have been halted during their term of treatment, and will these therapies recommence? Do we know whether trusts are beginning to do this?

[Lord Bethell [V]]

The noble Baroness is entirely right to focus on those who are the most vulnerable. Data for March 2020 shows that cancer referrals began to drop although treatment levels did remain high, with 15,363 patients starting treatment following an urgent referral. That is the highest figure on record in a single month. So, although some treatments may have been cancelled, as she rightly describes, what I would like to convey is that a large number of treatments did continue, and we will be working hard to address any backlog.

Health: Vaping

Baroness Redfern Excerpts

Tuesday 14th January 2020 Lords Chamber

Asked by

[Baroness Redfern]

To ask Her Majesty’s Government what assessment they have made of the effect of vaping on public health.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)]

My Lords, despite reductions in smoking rates, smoking remains the leading cause of preventable death in England. E-cigarettes are not risk free but are less harmful to health than smoking tobacco. Each year, more than 50,000 additional people who would not have quit through other means quit smoking through e-cigarette use. We continue to monitor the evidence base on e-cigarettes. The next Public Health England annual review is due in February 2020.

[Baroness Redfern (Con)]

I thank the Minister for her response. Does she agree that people who vape and struggle to quit should be given the same support and access to NHS services that is offered to regular smokers?

[Baroness Blackwood of North Oxford]

The Government have consistently highlighted that quitting smoking and nicotine use completely is the best way to improve health. Although they are not risk free, research shows that e-cigarettes are effective in helping smokers to quit. That is why we committed in the long-term plan to roll out “stop smoking” services in the NHS, to support improvements even on our smoking cessation rates—smoking is now at its lowest level on record, down from 18.4% in 2013 to 14.4%.

Queen’s Speech

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Thursday 9th January 2020 Lords Chamber

[Baroness Redfern (Con)]

My Lords, it is a privilege to respond to the humble Address. It is ambitious to put the NHS at the heart of this legislative programme. As expressed within the gracious Speech, it is predicated on a strong, dynamic economy, so that the UK can develop more opportunities that will derive from having a new global trade policy. In a united country with renewed vigour, businesses will meet these challenges while experiencing new opportunities, and the Government will support many of our fledgling companies that will, in the future, forge inward investment.

Particularly welcome is universal coverage of broadband and digital infrastructure in all areas of the country. That is much needed, so that all will have equal access and we can make a strong pitch for the UK being the best place to invest and do business. I welcome the £100 billion to transform UK infrastructure, particularly in the north, where there has been underfunding for far too long. Businesses, wherever they are, need premises and good connectivity.

One specific business I would like to mention is British Steel in Scunthorpe. Making steel is part of our industrial heritage but, to meet our ability to produce the very best steel and be competitive, we ask for a level playing field with government support to reduce energy tariffs and rates. Steel-making is a vital part of Scunthorpe’s working life, with a skilled work force of 4,000, assisted by another 20,000 in the supply chain. All face an uncertain future. This week, Chinese business leaders are to present a business plan to revive the steel plant, so I hope for a successful outcome in 2020.

At last, we are to see more support for our ailing high streets and town centres, not forgetting our villages, where support is to be welcomed for our rural post offices, which serve the public so well. There was an announcement of the first 14 high streets that are to receive £l billion in funding to improve the UK retail sector, improve our shopping experience and complement the online sector. However, rates must be attributed and fair. It is also crucial to ensure that employees’ rights are protected and enhanced post Brexit, and to train and upskill our workforce.

The NHS is being promised more doctors, nurses and primary care professionals, and I particularly welcome that. We have debated the future of our NHS many times and this multiyear funding is, for the first time, being enshrined into law, with cross-party consensus to focus on a long-term solution for social care to provide dignity, security and, most importantly, the quality people deserve, and to make our NHS even safer for patients.

There is a requirement, too, for faster access to diagnosis. The NHS must incorporate a seamless service and remove inherent bureaucracy. Better communication and dynamic, driven management will be key in helping to drive those changes through, making life easier for staff. They need a 21st-century IT system which is fully integrated, with all areas of health talking to each other.

There is a need to reduce bureaucracy and make it easier for hospitals to manufacture and trial innovative medicines, thus helping to drive our global life sciences industries, where we lead the world. New laws will be designed to help those industries to be internationally competitive. A process for the approval of drugs and devices will minimise the risks for national pharmaceutical companies if they choose to test and roll out new inventions elsewhere.

My noble friend Lady Blackwood alluded to relatives visiting patients. I am sure that the Government’s programme to remove hospital parking charges comes as a relief to those in greatest need. The commitment to enshrine in law an NHS multiyear funding settlement, with £33 billion in cash terms by 2023-24, is a first.

Finally, a strong, dynamic and invigorating economy is the foundation. It will be the platform, in particular, for a strong, 21st-century NHS. So we begin a new chapter in driving real changes, wherever we live and work.

Antimicrobial Resistance

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Thursday 2nd May 2019 Lords Chamber

[Baroness Redfern (Con)]

I thank the noble Lord, Lord Lansley, and congratulate him on securing this debate on the incredibly important topic of addressing AMR. It is absolutely essential to see AMR as the economic and security threat that it is.

I will talk first about animal husbandry. The Government must make a clear commitment that any future trade deals will require any meat and dairy produce imported into the UK to meet at least the same standards relating to antibiotic use that apply to meat and dairy products produced in the EU, because over 40% of the UK’s total antibiotic use is in animals.

Contamination can occur from animal waste, human waste, pharmaceutical manufacturing and the use of antimicrobial pesticides on crops. There is no doubt that more funding is needed on AMR to kick-start early research into new antimicrobials and diagnostics. We must conduct in-depth research to better understand the impact of AMR pesticide exposure on humans, animals and the surrounding environment, and identify and promote best management practices to minimise exposure when applying antimicrobials as pesticides. There should also be more global transparency over antimicrobial use on pesticides, by collecting and sharing information on the amount and types used on crops each year. Sharing knowledge is so important.

We now see antibiotics reaching the environment in many ways, such as through sewage run-off and the run-off from food producing units such as farms. In particular, there is the impact of effluent from factories on our nearby water systems. Action is needed, too, so that regulators can set at least minimum standards for the treatment and release of manufacturing waste, and drive much higher standards through supply chains. It is vital that we have better commercial return on R&D; it is little wonder that firms are not investing in antibiotics, despite the very high medical needs. We need new ways to reward and enhance innovation.

What matters now is that action should support reducing the unnecessary use of antimicrobials and, I emphasise, revive investment in their development. Rapidly growing global demand for antibiotics is necessary to improve access to life-saving medicines, along with economic development. But all too often it reflects excessive and unnecessary use, rather than genuine medical need, so by reducing unnecessary consumption we can have a powerful impact on resistance. Educators, farmers, the veterinary and medical communities and professional organisations need to pledge to make better use of antibiotics and help save vital medicines from becoming obsolete.

The rise and spread of antimicrobial resistance is, as we have heard this afternoon, creating a new and potentially dangerous generation of superbugs. The UK needs to help ensure that AMR remains a global priority by continuing to lead international policy. As we have been informed, by 2050 it is estimated that AMR will kill 10 million people per year—more than cancer and diabetes combined. That is the scale of the threat that we face. The ambition for AMR is, by 2040, to have new diagnostics, therapies, vaccines and interventions in use, together with a full AMR research and development pipeline for antimicrobial alternatives, along with diagnostics, vaccines and infection prevention across all sectors.

Government and other funders must act to ensure that the market can offer sufficient commercial incentive to keep pharmaceutical companies active in this space. They should conduct studies to evaluate the effectiveness of existing wastewater treatment processing in the removal from it of antimicrobials before its discharge into environmental waters, and investigate and identify the factors that result in treatment inefficiencies and failures in processing methods, or the infrastructure failures. Studies have found APIs in rivers, treated and untreated manufacturing wastewater, and sediment downstream of industrial wastewater treatment plants.

We have evidence, too, of the clear priorities that will support greater progress in addressing antimicrobial-resistant microbes in the environment. As I mentioned earlier, high-risk areas, such as the disposal of waste from healthcare facilities and manufacturing, could be prioritised and addressed at local and global levels to reduce the potential risks to human health posed by having those microbes in the environment. Unfortunately, we have not seen a new class of antibiotics for decades, because an overuse of antimicrobials has increased the rate at which resistance is developing and spreading. Again, we lack the new drugs to challenge these new superbugs. Governments and other funders must act to ensure the antimicrobial market can offer sufficient commercial incentives to keep pharmaceutical companies active in this space. Where testing is clinically appropriate and recommended by NICE, action should be taken to address the perverse financial incentives that may discourage use. I emphasise that we must work in collaboration to improve national and international understanding. We have a major global challenge ahead of us.

NHS Funding: Mental Health Services

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Wednesday 1st May 2019 Lords Chamber

[Baroness Blackwood of North Oxford]

As usual, the noble Baroness’s expertise shines through in her question. She is right that we must ensure that the money allocated to children and young people’s mental health gets to exactly where it is intended. The dashboard is extremely valuable in tracking through the effectiveness of the funding priorities in this manner. We will be holding to account CCGs and mental health trusts in ensuring that the money allocated to trusts is spent on exactly what it is intended to be spent on.

[Baroness Redfern (Con)]

My Lords, can the Minister tell us what part of the ring-fenced mental health budget will be allocated to recruiting appropriately trained probation staff for the 39% of offenders who have mental health issues and ensuring they receive access to effective support?

[Baroness Blackwood of North Oxford]

I shall have to write to my noble friend in order to answer her question with the best accuracy possible. However, my understanding is that the ring-fenced funding will be spent on health professionals rather than probation professionals. One of the most effective measures introduced under the five-year forward view, which has delivered very effective outcomes, has been liaison services. I shall investigate the point that she has raised and come back to deliver the response that she deserves.