Medical Devices (Northern Ireland Protocol) Regulations 2021
Baroness Ritchie of Downpatrick Excerpts(3 years, 5 months ago)
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Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, I thank the Minister for his explanation of these regulations. I accept what the statutory instrument is intended to do. However, I have some questions, as I want to see streamlined processes with no impediments to the supply of medical devices into Northern Ireland or to those that are currently under construction. There are about 500,000 medical devices, ranging from sticking plasters to dental implants to hip replacements, so they have many forms and functions. We are trying to achieve pragmatic solutions under the protocol to ensure that there are no impediments to their supply.
I have several questions for the Minister. Does the existing legislation on medicines and medical devices, which was approved in Parliament last year, have corresponding legislation in Northern Ireland to ensure that people with particular mesh problems will have a resolution and see an improvement to their health?
Furthermore, on the protocol, what discussions are taking place in the joint committee and the specialised committee with the EU on the exportation issues relating to the transfer of medical devices and medicines, to ensure that they will all continue to be supplied post December 2021? For example, the Royal College of Podiatry and the Ethical Medicines Industry Group are seeking mutual recognition agreements for the supply of those medicines and medical devices post 2021 as part of the protocol. What progress has been made in this regard? What evidence is there of working together to arrive at a long-term solution that avoids unnecessary regulatory complexity and duplication?
Given that the risk of medicines leaking into the EU single market from Northern Ireland in an unregulated manner is very slim, an agreement that permits medicines licensed for use in GB to be supplied to Northern Ireland only without additional checks would deliver on both sides’ needs. What steps are being made in this regard by UK and EU negotiators?
Do the common frameworks on blood safety and quality, on organs, tissues and cells, and on public health intersect with the protocol? What pressure can be brought to bear on the Northern Ireland Executive to sign off on these common frameworks, which deal with technical and policy divergence between Whitehall and the devolved Administrations? I look forward to the Minister’s responses to these issues on this important matter for the people of Northern Ireland.
Covid-19 Update
Baroness Ritchie of Downpatrick Excerpts(3 years, 5 months ago)
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Lord Bethell (Con)
We have committed to issuing guidelines for the vulnerable and immunosuppressed before 19 July. I cannot share with the noble Baroness at this stage exactly what those guidelines will say, but her points are very well made. We have not made a decision on antibody testing yet, but she raises an important point. We have a number of therapeutics and antivirals that may provide either prophylactic protection or support in the case of infection. Knowing whether somebody has antibodies before they go into the winter is one of the things that should really help to provide reassurance as well as important clinical data on how treatment might pan out. We are looking at the use of antibody tests for that reason.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, the Statement says that there are currently no plans to vaccinate the under-18s. Can the Minister indicate what the possible timeframe could be for reversing that decision and vaccinating that cohort, taking on board that around 0.5% of pregnancies are to girls aged under 18? Will he further elaborate on the fact that the Prime Minister indicated that there will be deaths—quite a large number—when we open up? What level of deaths do the Government consider acceptable?
Lord Bethell (Con)
My Lords, the vaccination of children is something that we are looking at; it is with the JCVI at the moment, I understand. I do not have the precise timetable at my fingers. What I will say is that we of course need to vaccinate as many adults as we can and will therefore move to children after that, because they are the ones who least need that protection. My nephew has been vaccinated in another country; I have spoken to him about it and it is very touching to hear him describe how he now feels that he can visit relatives who might be vulnerable or have co-morbidities. He sees it as a contribution to the national well-being. That is exactly the spirit in which we go into this but, as I say, it is up to the clinicians to make their pronouncement. We wait to hear from them before we can make a decision.
Women’s Health Outcomes
Baroness Ritchie of Downpatrick Excerpts(3 years, 5 months ago)
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Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, I commend the noble Baroness, Lady Jenkin, for securing this important debate and for depicting the lifecycle of women, with its many challenges. There are life challenges, societal challenges and, above all, gynae- cological challenges, which we have all faced in our lives.
It is quite clear that research has found a gender health gap in the UK, where many women receive poorer healthcare than men. This poses the question: why has this been the case and what measures will be taken to rectify the situation at governmental level, working with communities and the voluntary sector?
Many of the challenges facing women’s healthcare have already been raised in the Paterson Inquiry, and the First Do No Harm report, which found that the healthcare system was
“disjointed, siloed, unresponsive and defensive.”
The Saving Lives, Improving Mothers’ Care report said that, between 2016 and 2018, 217 women, or 9.7 women per 100,000, died during pregnancy or up to six weeks after childbirth
“from causes associated with their pregnancy”.
In academic research, Caroline Criado Perez, to whom the noble Baroness, Lady Jenkin, has already referred, has argued that women have been considered less important in healthcare as far back as ancient Greece. Arguing that the problem still exists due to a patriarchal worldview being prevalent in our healthcare system, she said that women are routinely under- represented in clinical trials and that medical research proposed by women is not allotted the same funding as medical research proposed by men for men. I am not sure about that, as somebody who is on a clinical trial—a double-blind trial for breast cancer.
Research and observations would show that, in many societies, women have provided the caring at the expense of being cared for, thus placing their health needs as secondary to those of men. I look at research from Northern Ireland and a matter that has already been referred to by the noble Lord, Lord Rooker. It shows that women have a 70% chance of providing care, compared with 60% of men. By the time they are 46, half of all women have been a carer—11 years before men. I look forward to the Minister’s response.
Covid-19: Vaccines and Pregnancy
Baroness Ritchie of Downpatrick Excerpts(3 years, 6 months ago)
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Lord Bethell (Con)
My Lords, when it comes to conspiracy theories, we have found that the best people to communicate on that are those who women and mothers trust and are dealing with during their pregnancy, typically their nurses and doctors. We have ensured that all the right materials are there, so that difficult questions can be answered in a collaborative dialogue. That is the most effective way of dealing with this.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, can the Minister comment on or indicate the extent of the level of co-operation between the UK Government and the devolved Administrations regarding vaccination take-up and pregnant women?
Lord Bethell (Con)
My Lords, the vaccine programme has worked extremely well across all the nations of the UK, and there is a huge amount of collaboration, particularly between the CMOs. Material is routinely shared between all the countries, and I am not aware of any differential outcomes in any particular part of the UK.
Covid-19 Update
Baroness Ritchie of Downpatrick Excerpts(3 years, 6 months ago)
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Lord Bethell (Con)
My Lords, I pay tribute to my noble friend for his advocacy on behalf of Nepal; we are all extremely moved by the stories from Nepal and the challenge that it has had from Covid. We are extremely supportive of his initiative for both medical supplies and the vaccine but, as I said, there is a sequencing challenge here. Our priority as a Government is the British people. It is important that we see the job through. As the noble Baroness, Lady Brinton, pointed out, there is a threshold to which we need to get the British public to ensure that the R rate remains below one and that the new India variant, or any other variant, does not run amok and drive up hospitalisation in the UK. Until we have reached that point, we must focus on the job at hand. In the meantime, and in parallel, we are doing absolutely everything we can to grow global manufacture of the vaccine and ensure that countries such as Nepal receive secure and reliable supply. My noble friend should be reassured that we are absolutely firm in that commitment.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, we have often heard it said that we will not all be safe until the whole world is safe. Today, UNICEF, the children’s charity, is lobbying the G7 Ministers, asking for an ongoing distribution of vaccines to poor and developing countries, rather than supplying surplus vaccines at the end of our programme, because they may not be able to use them in the best possible way at that stage. Will the Minister, further to the answers he has already given, go back to his ministerial colleagues and the Prime Minister and urge them to please undertake that global vaccination programme, along with other G7 countries, now? The WHO said yesterday that inequitable vaccination is a threat to all nations.
Lord Bethell (Con)
I completely endorse the sentiments of the noble Baroness and can absolutely reassure her that this is top of the agenda for the G7 leaders’ meeting later this week. The Prime Minister will absolutely be ramming home the message that she put extremely well. Roughly 1 billion vaccinations have been done around the world so far; that leaves another 7 billion or 8 billion to do. We need manufacturing on a scale that the world simply does not have today to see that job through. That is why the UK has contributed so much through the AstraZeneca vaccine, which is a wonderful, portable, cheap and flexible platform for creating vaccines for the world. We are ensuring that that magic source is available to all those who can contribute vaccine manufacturing capacity anywhere in the world. In the meantime, we will ensure that any capacity that we have after we have done the British public is made available, but we have to see the job through here in the UK. It would be utterly counterproductive if the UK, having got so far, tripped over at the last hurdle.
Covid-19 Internal Review
Baroness Ritchie of Downpatrick Excerpts(3 years, 7 months ago)
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Lord Bethell (Con)
I am enormously grateful to the NAO for the powerful report that it has published. It said many complimentary things about the Government’s handling of the pandemic. I am grateful to noble Lords for the counsel and challenge that they have given here in this Chamber. I point out the vast amount of data and information that we have published, which is at the disposal of the public and parliamentarians. However, confidential advice from officials to Ministers on a means-of-working review is not the kind of thing that I think adds to this sort of debate, and for that reason it is most appropriately kept confidential.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, this morning on BBC News there has been a suggestion that the Indian variant has been due in large part to ineffective track and trace. Would the Minister like to comment on that?
Lord Bethell (Con)
My Lords, I do not think that is correct. The noble Baroness is right to ask the question because we should always challenge our systems, but track and trace has really delivered for the country when it comes to the containment of the variants. We were extremely concerned about the Manaus variant. That was why we instigated Project Eagle, an intense application of testing in communities on a very large scale and forensic tracing, putting huge resources into tracking down the movements of those who tested positive with a VOC. We then had the South African variant, which has been successfully contained. We could not have imagined that an Indian VOC of this kind could make its way into this country with such high transmissibility, and I pay tribute to those working in track and trace who have bought us an enormous amount of time so that we can bring in surge testing and surge vaccination to contain and minimise the spread of this variant.
Osimertinib Cancer Treatment
Baroness Ritchie of Downpatrick Excerpts(3 years, 7 months ago)
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Lord Bethell (Con)
My Lords, I reject the accusation of complacency. We have worked unbelievably hard with Northern Irish stakeholders, the pharmaceutical industry and EU colleagues to ensure the smooth running of the supply of medicines in Northern Ireland. The facts speak for themselves: so far, they have run extremely smoothly indeed. I reassure the noble Baroness that the UK Government are committed to parity of access to medicines across the UK, including Northern Ireland. Despite different approval routes, we have ensured that all patients have access to medicines at the same time, and we will maintain that commitment.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, will the Minister commit to meet the pharmaceutical industry, otherwise known as PAGB, which I met several weeks ago and which told me about problems that could ensue from 1 January next year in relation to the availability of over-the-counter medicines in Northern Ireland, due to the requirements of the protocol? Will the Minister undertake to meet this organisation to ensure that there are immediate discussions between the UK and the EU to resolve any ongoing difficulties and impediments?
Lord Bethell (Con)
I note the point made by the noble Baroness. As I mentioned in relation to the point made by the noble Baroness, Lady Jolly, on this issue, it is not one that I am not aware of, but I would be pleased to meet with the party she described in order to understand it better.
Social Care: Person-centred Dementia Care
Baroness Ritchie of Downpatrick Excerpts(3 years, 7 months ago)
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Lord Bethell (Con)
My Lords, the noble Baroness puts the case for supported housing social care for those with low levels of dementia extremely well. It is slightly beyond the purview of the Department of Health, but the case she makes is strong. I would be glad to go back to the department and find out if any measures are taking place.
Covid-19: One Year Report
Baroness Ritchie of Downpatrick Excerpts(3 years, 8 months ago)
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Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, it is a pleasure to follow the noble Baroness, Lady Walmsley. In this instance, I am supporting the regret Motion in the name of the noble Baroness, Lady Thornton. I thank the Minister for the explanation of the regulations and the note on what has happened in the past year. I pay tribute to all those nurses, doctors, ancillary staff and carers, as well as the scientists who brought us the vaccination programme. Who would have thought it? If any of us could have imagined a year ago that more than 126,000 people in the UK would die with Covid and that there would be 4.3 million cases, we would rightly have been dumbstruck.
This Government have made very serious errors in the intervening period. They have taken too long for lockdown and wasted vast amounts of public money on their failed test and trace scheme and unsuitable PPE equipment. Therefore, I agree with the noble Baroness, Lady Andrews, and many others that there is a need for a public inquiry into the handling of this pandemic by the Government. A year is a long time in politics and it is a long time with coronavirus for the many people who have lost loved ones, who have suffered from Covid themselves and who have been isolated and marginalised because they have had to shield.
Thankfully, we now have a vaccination programme under way and, by Tuesday of this week, 41% of the population had received a first vaccination. Credit where it is due: that is a very good start. However, do not lose sight of the fact that just 3.3% had received both shots by that date, which makes the row over the supply and use of the AstraZeneca vaccination even worse than it first seems. Concentration on the vital issue of getting people across the globe vaccinated would be a good idea because we are all in this together, right across the world. Therefore, why are we wasting time and effort on a row that could cost lives?
London has laid claim to millions of doses of the Oxford/AstraZeneca Covid-19 jab, produced in a Dutch factory, sparking a fierce battle with the European Commission, which says that they should be used in the EU. I note that, as of last night, there was an indication from both the UK and the EU that they would work together—perhaps, in the wind-up, the Minister could provide us with an update on that. I will not try to go into the details of the opposing sides, but I stress that the Covid virus does not respect borders. France and Germany have had fresh outbreaks and, in spite of regulations, it will inevitably reach these shores. We ignore this at our peril.
If different nations fail to work together, we will all suffer. Fighting over a fair distribution of the different vaccines is humiliating and embarrassing. This is not some blame game of who claimed this or that; this is not just about health in the UK. It is about global health and our global interdependence. Vaccinations will be a part of our lives for some time and we are very thankful for the vaccines, but we need to move away from the notion that protecting people is merely a local, or even national, matter. It is an international matter, because a vaccinated world protects us all.
Health and Social Care Update
Baroness Ritchie of Downpatrick Excerpts(3 years, 8 months ago)
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Lord Bethell (Con)
My Lords, the noble Lord puts the situation well. I do not agree with every aspect of his assessment, but his concerns are shared by the Government. We keep the whole situation under review, but the bottom line is that we do not know the impact of the variants of concern on the vaccine and vice versa. We keep the situation very closely monitored. The measures in place are entirely proportionate to the threat we face but, should that escalate, we will not hesitate to take the necessary decisions.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, in commending the rollout of the vaccination programme, could the Minister indicate whether the Government have made arrangements for its continuation in subsequent years? What discussions have there been and potential arrangements made with the devolved Administrations on this?
Lord Bethell (Con)
My Lords, we very much hope that the vaccination programme being delivered today will lead to an inflection point in the whole country’s approach to vaccinations overall. That is not just for Covid, but for flu, HPV and other prophylactics. We are on the brink of a massive change in our mindset regarding preventive medicine. There is an opportunity here for us to completely change the way in which we do healthcare—from an emphasis on late-stage and acute medicine to preventive early-stage medicine. The stakes are enormous. We are determined to grab this opportunity with both hands and we will take our friends in the devolved authorities with us.