Medicines and Medical Devices Bill

Debate between Baroness Wheeler and Lord Hunt of Kings Heath

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

[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.

Medicines and Medical Devices Bill

Debate between Baroness Wheeler and Lord Hunt of Kings Heath

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Baroness Wheeler (Lab)]

I am pleased to move Amendment 46 in the name of my noble friend Lady Thornton, which, alongside other amendments in this group, amends provisions in Clauses 6 and 15 and removes provisions for the disapplication of regulatory provisions in an emergency to be made subject to conditions set out in a protocol published by Ministers.

We understand why the Bill confers emergency powers on the Government to disapply existing health medicine regulations in circumstances which give rise to the need to protect the public from a serious risk to public health. However, we are concerned that the disapplication authorised in the regulations can be subject to conditions specified in the regulations, or conditions set out in a protocol published by the public authority. Furthermore, no formal requirements are set for the form, publication or dissemination of a protocol. It may simply be a document published on a website by the appropriate authority. This is completely inappropriate and unsatisfactory.

The Minister will be very aware that both the Delegated Powers and Regulatory Reform Committee and the Constitution Committee raised concerns about this provision. The Constitution Committee noted that:

“In other bills emergency powers are time-limited and there are often requirements for periodic reviews of their use”,


and yet

“No such constraints or safeguards exist in this Bill. These powers are subject only to the negative resolution procedure and can be adjusted by the amendment of a protocol which is not subject to parliamentary scrutiny”.


As the DPRRC commented at paragraphs 39 and 42:

“On a number of occasions, we have drawn the attention of the House to provision in Bills which enables Ministers to make what are, in effect, legally enforceable rules under the radar of the Parliamentary scrutiny that is afforded to primary and secondary legislation … Allowing regulations to make the disapplication of legislation subject to conditions set out in a ‘protocol’ is yet another example of ‘camouflaging legislation’ … we consider that, where those powers are to be used to provide for legislation to be disapplied in an emergency, any conditions to which disapplication is to be subject should be set out in the regulations themselves and not in a ‘protocol’ which is not subject to Parliamentary scrutiny.”


The Constitution Committee concurred and recommended that

“the use of these powers should be time bound, subject to periodic review and that any conditions on the disapplication of legal provisions should be set out in regulations.”

Although the Government have yet to publish their full response to those reports, as we know, the Minister has tabled, and indeed moved, a number of amendments in Grand Committee which are intended to address the concerns of the DPRRC and the Constitution Committee. This amendment provides an excellent opportunity for the Minister to explain to the Committee exactly why he has not therefore tabled an amendment ensuring that the disapplication of legal provisions is invariably set out in regulations, as recommended. I beg to move.

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

My Lords, I am very glad to support my noble friend Lady Wheeler. I will not repeat what she said, because I thought she put across the points very powerfully. She quoted extensively from the Delegated Powers Committee, which complains that no justification whatever has been given for what the Government seek to do.

It is worth saying that the committee has drawn the attention of the House to this kind of mechanism being adopted in a number of Bills over the past few years. I was very struck by the assurance it sought from the Government that they would not continue the practice of what it called “camouflaging legislation” as guidance. In response to the committee’s report on both the Ivory Bill and the Mental Health Units (Use of Force) Bill, the Leader of the House, the noble Baroness, Lady Evans, wrote:

“As you will be aware, it is Government policy that guidance should not be used to circumvent the usual way of regulating a matter. If the policy is to create rules that must be followed, the Government accepts that this should be achieved using regulations subject to parliamentary scrutiny and not guidance”.

NHS: Wound Care

Debate between Baroness Wheeler and Lord Hunt of Kings Heath

Wednesday 22nd November 2017 Lords Chamber

[Lord Hunt of Kings Heath]

To ask Her Majesty’s Government what plans they have to develop a strategy for improving the standards of wound care in the NHS.

[Baroness Wheeler (Lab)]

My Lords, in my noble friend’s unavoidable absence, I shall ask the Question standing in his name on the Order Paper. Wound care is a massive challenge to the NHS, but it currently lacks priority, investment and direction. This debate is designed to press the Government to recognise the need for urgent action and for the development of a strategy across care providers for improving the standards of wound care.

I am delighted that so many noble Lords with expertise on this highly important matter have put their names down to speak. It will ensure that we can cover a wide range of issues across medical, nursing and patient care and the quality of medical supplies. It will also give the Minister the stepping stone for developing the national strategy that I hope he will recognise is sorely needed.

A staggering 2 million patients are treated for wounds every year at a cost of more than £5 billion. The overwhelming majority of this figure goes towards paying for nursing care costs rather than products such as bandages. In other words, the cost is more than, for example, we spend on tackling obesity, which is the centre of major national campaigns. Treatment costs include more than 700,000 leg ulcers and 80,000 burns. Pressure sores also feature highly, with estimates of an 11% increase overall each year.

While 60% of all wounds heal within a year, a huge resource has to be committed to managing unhealed wounds. The NHS response is very variable. Healing takes far too long; diagnosis is not good enough; and inadequate commissioning of services by clinical commissioning groups compounds the problem, with undertrained staff and a lack of suitable dressings and bandages. There has also been a very worrying drop in the number of district nurses, whose role in ensuring safe and effective wound care in the community is crucial.

Ideally, 70% of venous leg ulceration should heal within 12 to 16 weeks and 98% in 24 weeks. In reality, however, research shows that healing rates at six months have been reported as low as 9%, with infection rates as high as 58%. Patients suffer and the cost of non-healing wounds is substantially greater to the NHS. The failure to treat wounds swiftly and effectively can lead to more serious health problems, such as sepsis, which is often the result of an infected injury; we also know that foot ulcers on diabetics can lead to amputations if they are not dealt with properly.

The situation will only be turned around with a nationally agreed strategy to reduce variation, prevent wounds getting worse and improve outcomes. Wound care therapy strategies are needed and national care pathways for wounds must be established to cover the complexity and variety of wounds, using evidence-based health economic data and academic and clinical expertise. The Bradford study and survey that is summarised in the Lords’ Library brief for this debate—a good brief but sadly received only yesterday—underlines the point about the importance of evidence-based care, with nearly one-third of patients interviewed in the study failing to receive an accurate diagnosis for their wound. As the study puts it:

“Wound care should be seen as a specialist segment of healthcare that requires clinicians with specialist training to diagnose and manage. … There is no doubt that better diagnosis and treatment and effective prevention of wound complications would help minimise treatment costs”.


Dedicated wound clinics in the community are also needed, alongside a co-ordinated treatment plan to achieve best outcomes for patients. A focus on the prevention of wounds, as well as treatment and healing of wounds, is also very important. The NHS must also invest in high-quality bandages and dressings, in contrast to the current skimping that takes place in many areas. We know, however, that with the NHS as financially hard pressed as it is, there is huge pressure to reduce the costs of medical equipment and clinical supplies such as dressings. The result is that in the procurement of dressings and other forms of treatment, there is not enough emphasis on the cost of patient care and too much focus on the unit cost of products. Not only does this lead to poorer and more costly outcomes for patients but there are a number of unwelcome side-effects. Products will be less innovative and effective; a reduced amount of educational support will have a detrimental effect on patients; there will be fewer appropriate treatments available; and all this will lead to job losses if there is less sourcing from high-quality British suppliers and manufacturers.

With cost as the primary driver, suppliers to the NHS will have a race to the bottom, compromising quality. Poor-quality dressings simply cannot withstand the rigour required to produce effective healing. It is massively counterproductive. Reduction in the availability of clinically appropriate dressings, which comprise only 10% of costs, will result in patients suffering as wounds take longer to heal. An increased burden on the NHS will follow and the result is longer hospital stays, particularly for the elderly, more readmissions, compromised quality of life and repeated visits to GPs and community services.

Of course, we fully support improvements in the way that medical equipment and other supplies are procured. I am not sure whether, in his absence, I have to declare my noble friend Lord Hunt’s interest and commitment to these matters as president of the Health Care Supply Association but I am sure he will value it being mentioned. We also support the work of my noble friend Lord Carter and his 2015 review on how the NHS can avoid unwanted and unnecessary variations in the cost of supplies. The overall aim of his review was to see how the NHS could reduce spending by £5 billion by the 2020-21 financial year. It proposed £600 million in savings for supplies, half of this to be saved before October 2018; limiting the NHS to 40,000 products instead of 300,000, with an overwhelming majority of this—80%—going towards a newly revised supply chain process; as well as replacing local formularies with a national formulary.

Although we welcome the report’s efforts at saving the NHS money, we need to ensure that any shift in focus to the short term will not lead to the knock-on effect of costs rising in other clinical areas. There is also strong concern that the short-term focus could lead to a scarcity of supplies in the future. I would be grateful to hear reassurances from the Minister on the steps being taken to guard against these two unwanted outcomes. Evidence clearly shows that the current problems can only worsen. The average number of adult wounds that every CCG will have to manage is expected to rise from 11,200 in 2012-13 to 23,000 in 2019-20.

The Government urgently need to get a grip, with a nationally driven strategy. Without it, patients will receive worse care for their injuries and the financial burden on other parts of the NHS will continue to increase because patients will develop chronic wounds or catch an infection that could lead to potentially life-threatening illnesses. I look forward to the contributions of noble Lords to this very important debate and to the Minister’s response.