Medical Devices (Northern Ireland Protocol) Regulations 2021
Debate between Baroness Healy of Primrose Hill and Lord Bethell(3 years, 5 months ago)
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, the statutory instrument that we are discussing today relates to the regulations for medical devices within Northern Ireland. It reflects the application of EU regulation 2017/745 on medical devices, which I will hereafter refer to as the EU medical devices regulation, under the terms of the Northern Ireland protocol. As noble Lords will be aware, the protocol agrees to continue applying certain EU rules in Northern Ireland to recognise the unique status of Northern Ireland within the UK and to uphold the Belfast/Good Friday agreement. It is important to remember that this instrument does not apply the EU medical devices regulation within Northern Ireland. That legislation took automatic effect in Northern Ireland from 26 May this year, under the terms of the Northern Ireland protocol.
The EU medical devices regulation contains some flexibility areas, where states have the discretion to make policy decisions and adjustments. This instrument therefore makes provisions to apply in Northern Ireland where it serves to align Northern Ireland policy with Great Britain. This is to deliver the Government’s commitment to the pragmatic implementation of the Northern Ireland protocol. In creating the provisions in this instrument, we are minimising the impact on economic operators and the public in Northern Ireland, as the Northern Ireland protocol pledges.
The Medical Devices Regulations 2002, hereafter referred to as the 2002 regulations, will continue to be the relevant regulations for in vitro diagnostics in Northern Ireland, and will operate alongside the EU medical devices regulation and this instrument on the regulation of medical devices and active implantable medical devices.
I shall give some background. This instrument achieves the Government’s commitment to align Northern Ireland with Great Britain, where permitted, in four areas. First, it implements national adjustments for Northern Ireland in areas where the EU medical devices regulation grants member states the ability to make national policy decisions. This has been done in a way that will align with policies in place in Great Britain. Secondly, it sets out the fee structures that keep fees aligned with those applied in Great Britain. Thirdly, it sets out the enforcement regime for activity and violations under the EU medical devices regulation in Northern Ireland. Lastly, it makes amendments to existing regulations, to take account of the application of the EU medical devices regulation in Northern Ireland.
I will first describe areas of national flexibility where this instrument makes provision to change default positions under the EU medical devices regulation to maintain Northern Ireland policy with that of Great Britain. The Government currently permit the remanufacturing of single-use devices, which the EU refers to as reprocessing, so long as the remanufacturer adheres to strict requirements. The default position of the EU medical devices regulation is not to permit remanufacturing unless there is national legislation in place to support it. This instrument does just that. This means that the remanufacturing of single-use devices can continue to take place in Northern Ireland, as well as in Great Britain, so long as requirements under the relevant legislation are followed.
The instrument also introduces provisions so that the MHRA can continue requiring custom-made devices, ranging from dental appliances to orthopaedic moulds, to be registered before being placed on the Northern Ireland market. Provisions are also contained in this instrument that uphold our national requirements for clinical investigations, which are crucial for ensuring that the safety of participants is protected. They do so by maintaining the MHRA’s ability to authorise clinical investigations for all risk classes of medical devices before they can commence. Furthermore, it upholds the requirement for all clinical investigations for custom-made devices to be subject to MHRA assessment. The Government remain committed to delivering improvements to patient safety, and this instrument means that we can respond proactively to any concerns.
By amending the Consumer Rights Act 2015 and the Medicines and Medical Devices Act 2021, this instrument provides the MHRA and district councils in Northern Ireland with inspection powers and powers to serve enforcement notices for breaches of the EU medical devices regulation within Northern Ireland. This will ensure that the MHRA has the enforcement powers it needs to ensure patient safety is prioritised and high standards are maintained for the people of Northern Ireland.
The MHRA charges fees to cover the costs associated with certain aspects of the regulation of medical devices. This instrument details fees which may be charged for activity under the EU medical devices regulation in Northern Ireland, keeping them identical to those charged in Great Britain under the 2002 regulations for similar services. This upholds the Government’s commitment to ensure that there are no disadvantages to economic operators in Northern Ireland as a result of the Northern Ireland protocol. This instrument does not introduce any fees for new requirements under the EU medical devices regulation.
Finally, this instrument makes technical amendments to other legislation, including the 2002 regulations, to reflect the application of the EU medical devices regulation within Northern Ireland. This will ensure the regulatory landscape operates effectively in Northern Ireland. Officials in the Northern Ireland Executive have been kept informed of the progress of this instrument and I am hugely grateful for their continued collaborative approach. As the nature of the changes in this instrument are technical in many instances, the impacts of the instrument do not meet the threshold for impact assessments, hence these are not provided.
In conclusion, this instrument upholds the Prime Minister’s commitment to the Northern Ireland protocol and to minimise the impact on the activities of economic operators and the public in Northern Ireland. The significance of our public healthcare system has never been clearer than during the Covid-19 outbreak, and this instrument will ensure that the UK’s exceptional standards of safety are maintained within Northern Ireland. This is something we must support. I commend the regulations to the Committee.
The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)
The noble Lord, Lord Hunt of Kings Heath, has withdrawn, so I call the next speaker, the noble Lord, Lord McColl of Dulwich.
Body Mass Index
Debate between Baroness Healy of Primrose Hill and Lord Bethell(3 years, 8 months ago)
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, I too am enormously grateful for the successful efforts of the noble Lord, Lord Addington, in securing this important and insightful debate. Any debate on our weight, health and fitness is extremely personal and bound to arouse emotions. It certainly does in my household, and so it does in this Room. I very much welcome, though, a national conversation about these issues. It is the right time to be having it.
As noble Lords have pointed out, we face two major challenges. The first is that too many people are overweight or living with obesity. I have already spoken this week about this grave challenge faced by this country, which was clearly outlined by the World Obesity Federation report on Covid death. That is a real wake-up call. The Government have already swung into action to a degree. More is planned. We are trying our hardest to address the knotty problem that few countries have ever completed successfully.
The second issue that the country faces is that too many people have eating disorders that make their lives a misery and threaten their health. I am grateful to noble Lords who have spoken movingly on this subject. Although she did not speak this afternoon, I reference the noble Baroness, Lady Bull, who recently arranged a stakeholder session with me that gave me first-hand testimony from those seeking to address these important issues.
I fear that poor old BMI, the much-maligned metric and subject of this debate, has in some ways become a surrogate and a scapegoat in a battle between two groups that see these two big issues—obesity and eating disorders—as somehow in conflict with each other. I do not want to take sides in any such battle. While I always welcome policy dialectic and the battle of ideas to hammer out the most sensible policy on complex issues, I do not think this should be a zero-sum game with winners and losers on opposing sides. Instead, I would like to work towards finding a way through, because it is imperative that, as policymakers, government Ministers understand the impact of our policies in one area on our policies in another area and somehow find a way of tackling them both in a complementary fashion.
Before I try to do that, let me say a few words in defence of the poor old maligned metric, BMI. It is, as noble Lords have pointed out, a very simple calculation—body weight divided by the square of height. It has been used by the National Institute for Health and Care Excellence, the World Health Organization and countless health organisations around the world for decades as just this: a simple first step to establish if individuals might be carrying too much or too little body fat for their long-term good health. To answer the noble Lord, Lord McNally: as risk assessments go, BMI has proven value year after year, study after study, in countries around the world, for predicting premature death and many chronic diseases, including type 2 diabetes, some cancers and some heart disease. As my noble friend Lady Jenkin rightly pointed out, it is simple to measure and highly reproduceable. It does not require specialist equipment or clinical training, unlike many methods of assessment noble Lords mentioned.
None the less I recognise, as the noble Lord, Lord Addington, pointed out, that it is not perfect for all people. Muscly athletes are considered too fat, and it is problematic for the very old. It is not unique, and, as the noble Lord, Lord Thomas, pointed out, a measuring tape around the waist is also very insightful. But it works for most people very well. The reality is that most people who have a high BMI are also at risk of ill health and premature death. When establishing an individual’s health risk, the noble Lord, Lord Brooke, is right: health professionals must use follow-up measures and assessments as well, such as waist circumference. NICE is crystal clear about this and, as my noble friend Lady Wheatcroft pointed out, BMI is just the recommended first step in the assessment pathway.
I hear the noble Baroness, Lady Parminter, loud and clear. I have read the stories to which she referred. I am extremely disappointed by them. It is not right and it is not recommended in the eating disorder commissioning guide. I agree that we need to listen to patients much better. I agree completely with my noble friend Lady Altmann that, in such cases, mental health assessments are absolutely essential. Similar safeguards apply to assessing whether someone is underweight, and of course it is absolutely true that conditions such as anorexia and other eating disorders require specialist assessment. NICE is looking at ways to improve the metric for ethnicity and other factors. None the less, given the large international evidence base underpinning BMI, its simplicity and its wide international use, I do not see it as likely that there will be wholesale change.
BMI is an essential tool in our battle against obesity. We have a huge problem in this area: six out of 10 adults and more than one in three children aged between 10 and 11 are overweight or living with obesity. In my briefing, I have page after page on the impact of obesity on the lives and futures of British families. It has a huge impact on the NHS, the causes of cancer and the causes of diabetes. It has an impact on women: obese women are 12.7 times more likely to develop type 2 diabetes and three and a half times more likely to have a heart attack than women who are a healthy weight. I could go on and on.
As the noble Baroness, Lady Redfern, rightly explained, it is children who are overweight or living with obesity who are sometimes affected the most. In particular, many experience bullying, low self-esteem and a lower quality of life. They are more likely to continue to be overweight or living with obesity into adulthood, which in turn increases their risk of type 2 diabetes, cardio- vascular disease and other chronic illnesses. We must do something to address this issue.
As the noble Lord, Lord Brooke, and my noble friend Lady Jenkin rightly said, during the pandemic we have seen a stark illustration of the impact of living with obesity. That is why we are acting. To answer my noble friend Lord Bourne, we are tackling the nation’s obesity with a new strategy. Published in July last year, it set out measures to get the nation fit and healthy, protect against Covid-19 and protect the NHS.
As my noble friend Lady Jenkin pointed out, there are many nudges in shops, on TV, on computers and on phones that encourage us to buy less healthy food. The Government are committed to restricting further the advertising of less healthy food on TV, and we are considering online restrictions on the promotion of less healthy food in shops. We are also committed to calorie labelling in restaurants and improving front-of-pack labelling on pre-packed foods. These actions are about helping people to make healthy choices.
At the same time, there is another issues that we must face: the national crisis around body identity and self-confidence, which, in some, manifests itself as extreme eating disorders or as mental health challenges. The Women and Equalities Committee report put it extremely well. Acute anorexia is a particularly distressing mental health condition that can ruin lives and cause horrible worries for the families of those concerned. That is why our mental health recovery plan is putting £500 million into work to ensure that we have the right support for people with mental illness, and I am encouraging further policy on positive body imagery.
I want to make my point clearly: I am concerned that there is a perception that these two agendas are somehow at odds with each other—that if we put calorie counts on menus, we will somehow trigger mental health episodes for those with eating disorders or reinforce a damaging body image culture, or that if we push our message on healthy lifestyles too much, we will stigmatise those with sensitivities about their body image. I simply do not accept that this needs to be the case. While I do not discount people’s lived experiences, it is important that we know what we are buying. The calorie count of everyday food available in fast-food chains is often absolutely shocking. The food we grab on the go or have delivered to our homes is now a big part of our diet, yet there is huge ignorance about what that food contains.
Collectively, we need to somehow work a way through this. The maths of it are really simple: there are 725,000 people with eating disorders in the UK. That number may be higher, as I recognise that some struggle to seek support and are not included in the figures. We must do everything we can to bring them the clinical support they need to address their significant mental health issues, so that they can live resilient lives and deal with the stresses of everyday living. At the same time, there are millions of schoolchildren and young people living with poor mental health. My DCMS colleagues are doing everything they can to address the challenges of social media in their lives.
In addition, there are 28.9 million adults in England who are either overweight or living with obesity. Somehow, we need to inspire those people to take on board a healthy lifestyle, which means changing their diets and taking more exercise. These are tough decisions that people can only make for themselves. It is not our business to deal in shame; we are dealing in honesty. That is where the BMI comes in, because it is a simple, unequivocal and, for most people, accurate predictor of risky lifestyles.
It is not beyond our intellectual capabilities to find a way through this conundrum. I am hugely grateful to the noble Lord, Lord Addington, for bringing us the opportunity to debate these sensitive subjects, and I hope very much that we can work together to find an answer to this challenge.
The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)
The Grand Committee stands adjourned until 3.30 pm. I remind Members to sanitise their desks and chairs before leaving the Room.
Covid-19: Response
Debate between Baroness Healy of Primrose Hill and Lord Bethell(4 years, 6 months ago)
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Lord Bethell
I thank the noble Baroness for her question, which I think I understood. If I understand correctly, she is asking about those who live in social care and residential care. I commend the work of Helen Whately, the Social Care Minister, who has been an amazing champion for social and residential care. She holds our feet to the flames daily to ensure that more work is being done. Testing is one area where we have made huge progress. The provision of PPE, raised by the noble Baroness, Lady Brinton, is another, despite everything noble Lords might have read. I pay tribute to my noble friend Lord Deighton, who has brought about a huge amount of manufacturing in the UK. There is, however, more that we can do and we are working as hard as we can.
Baroness Healy of Primrose Hill (Lab)
Could the Minister explain what changed between 12 May, when I asked him what advice could be given to those shielding and was told that they must remain inside until at least the end of June, and last Saturday evening, 30 May, when the advice suddenly changed with no warning and the clinically extremely vulnerable were told that they could go out?
Lord Bethell
The noble Baroness asks a good question. One thing that changed was that there was a large amount of representation from those being shielded that the mental health consequences of their isolation were having a profound effect. There were very touching and moving stories, and the scientific analysis of that was extremely persuasive. We have sought to be flexible, but the advice remains very clear: those who are clinically vulnerable have to take extremely good care of themselves. Even though the prevalence is lower, they have to be aware of the consequences of this awful disease.
Covid-19: BAME NHS Staff
Debate between Baroness Healy of Primrose Hill and Lord Bethell(4 years, 7 months ago)
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Lord Bethell
I reassure the noble Baroness that the data is being centrally aggregated. ONS has published figures on ethnicity and the CMO and PHE are both scrutinising them. On their list of issues to consider is the role of vitamin D, where the evidence is interesting but unproven.
Baroness Healy of Primrose Hill (Lab)
To follow further on the data, many medical bodies, and the Science and Technology Committee today, are calling for greater collection of real-time data on infection and deaths by protected characteristics, and for it to be recorded, analysed and shared so that urgent action can be taken to prevent deaths of front-line staff. What assurances can the Minister give that this work is actively underway now?
Lord Bethell
I reassure the noble Baroness that we have a large amount of data—although we could do with more and better. The collection of death certification data, for instance, has already improved dramatically and we are working hard to ensure that the evidence is there to inform our policy-making.
Covid-19: Vulnerable Populations
Debate between Baroness Healy of Primrose Hill and Lord Bethell(4 years, 7 months ago)
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Lord Bethell
The noble Baroness, Lady Bull, asks a searching question. On whether the Mental Health Act easements of which she speaks have already been enacted, I will have to find out exactly what those arrangements are and write to her. However, I assure the House that the care of the most vulnerable is absolutely the Government’s number one, top priority. It is true that some of those caring and providing important pastoral care for the most vulnerable have been worst hit by Covid—the examples she gives are really good ones—but we are absolutely putting the care of the most vulnerable at the top of our priorities.
Baroness Healy of Primrose Hill (Lab)
Yesterday, the Prime Minister said of his road map:
“it is a plan that should give the people of the United Kingdom hope.”
But on examination of the plan, I see no hope offered to the clinically extremely vulnerable, who are just told that they must continue to shield beyond June. The Government offer only a future review into the effects on their well-being. Can the Minister say how and when this review will be conducted, and by who?
Lord Bethell
My Lords, the advice from the Government is that the clinically extremely vulnerable should continue to be shielded until the end of June. That is under review at the moment. We are seeking to have more refined and more targeted guidance after the end of June, and we will publish that before the end of that month.
Covid-19: Removal of Restrictions
Debate between Baroness Healy of Primrose Hill and Lord Bethell(4 years, 8 months ago)
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Lord Bethell
The noble Lord, Lord Patel, asks an incredibly perceptive question. The ultimate decisions will be made by the CMO, who, as noble Lords know, has enormous experience in this exact area. Serology tests play an extremely important role in this by giving an indication of the number of antibodies there are, whether people have a degree of immunity and therefore a sense of how far the virus has spread through the community. However, we are aware of reports that there are recurrences of the virus in people who have emerged and recovered. That creates a great sense of concern around our serology tests.
Baroness Healy of Primrose Hill (Lab)
Will making face masks compulsory form part of the exit-from-lockdown strategy? Other countries have implemented it.
Lord Bethell
The noble Baroness is entirely right that the use of PPE—certainly in the workplace and, more commonly, in other parts of our life—is likely to be part of our lives in the forthcoming period. However, to date, the British Government have been sceptical about the efficacy of face masks. We do not want to be in a position of misleading or providing false reassurance for the public when there is not sufficient scientific evidence for the relevance of face masks. However, should that evidence emerge and should the guidance change, we will of course follow the science and make the recommendation if it is helpful.