Independent Medicines and Medical Devices Safety Review

Baroness Ritchie of Downpatrick Excerpts

Thursday 9th July 2020 Lords Chamber

Asked by

[Baroness Ritchie of Downpatrick]

To ask Her Majesty’s Government what assessment they have made of the report by the Independent Medicines and Medical Devices Safety Review, First Do No Harm, published on 8 July.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

While the NHS is a beacon of brilliant care and safety in the majority of cases, we must do better, as this report demonstrates. I apologise in full on behalf of the healthcare system to all the families affected in this report for the time it has taken to listen and respond to their concerns. I salute their courage and persistence in coming forward to make these concerns known. Much has already changed. We are introducing major advances in legislation, but we will respond further. In the meantime, I pay tribute to patients who bravely shared their experiences to inform this important report.

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, I thank the Minister for his fulsome apology on behalf of the Government to all the victims—all the women and all the families. The first duty of any healthcare system is to do no harm, and the damning report from the noble Baroness, Lady Cumberlege—whom I congratulate—into the use of these medical devices and medicines, including pelvic mesh, reveals shocking failures in this duty of care. What further urgent action will the Minister, along with his colleagues in the department of health, now take to implement the review’s nine recommendations, including a task force and an exhortation to the devolved nations to implement and act on those recommendations?

[Lord Bethell]

My Lords, much has already happened, and I point to the appointment of a national patient safety agency, run by Dr Aidan Fowler, whom I know and to whose fine work I bear testimony. Much is due to happen shortly: I emphasise the introduction of a registry amendment to the Medicines and Medical Devices Bill, which is due to be debated in this House shortly. But there is more to be done. The Government must consider the report’s recommendations, on which we will return shortly.

Health Protection (Coronavirus, Restrictions) (England) (Amendment) (No. 3) Regulations 2020

Baroness Ritchie of Downpatrick Excerpts

Thursday 25th June 2020 Lords Chamber

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, yet again we are dealing with statutory instruments in retrospect, and that could in many ways be considered undemocratic. We are, however, dealing with a very peculiar situation in peculiar times. People are understandably worried that an easing of these restrictions will increase their vulnerability and it is vital that the wider public are reassured. Only two days ago, the Prime Minister announced further relaxation and it seemed that the Chief Medical and Scientific Officers were quite cautious about the recent changes and the removal of the two-metre rule. Just how aligned are they with Ministers and their political advisers? What progress has been made with research and clinical trials and the provision of a vaccine? There was reference yesterday in the media to many people being involved in trials of a particular vaccine. Will those people eventually be categorised and selected according to their medical background, their age and their job groups? What further progress has been made on track, trace and isolation?

I realise that there are a lot of questions there, but people require reassurance. They have been through a lot and made significant sacrifices in a very difficult time. Will the Minister also tell us what further medications may be available, apart from the one already specified? What stage are those clinical trials at? In conclusion, what provisions have been made, and will continue to be put in place, to protect residents and staff in care homes, to ensure that they do not become further susceptible to catching this virus?

Personal Protective Equipment

Baroness Ritchie of Downpatrick Excerpts

Wednesday 24th June 2020 Lords Chamber

[Lord Bethell [V]]

The noble Lord is entirely right that public confidence is important here. I emphasise that huge progress has been made. We have signed contracts for over 2 billion items of PPE with over 20 UK-based manufacturers alone. The progress made on face masks, visors, gowns, aprons and so forth is enormous, and the accounting for that will continue through the usual channels of government procurement publication.

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, to what extent are the Government engaged in the procurement of PPE in a collective effort with the devolved institutions, and what discussions are taking place to ensure that every region is well equipped with adequate PPE and will have long-term infection control in place over the next 90 days and beyond?

[Lord Bethell [V]]

My Lords, we have had regular engagement with the devolved Administrations and have discussed how we manage cross-border services. The balancing of stockpiles of PPE around the nation is something that we are very much focused on. We have moved from the supply of PPE to a few NHS trusts to nearly 55,000 individual users of PPE. This is a massive undertaking that has hugely expanded the scope of our PPE supply.

Covid-19: Response

Baroness Ritchie of Downpatrick Excerpts

Tuesday 19th May 2020 Lords Chamber

[Lord Bethell]

My Lords, I do listen to “More or Less”. I absolutely love it, and it is a shame that I did not hear the episode to which the noble Lord refers because I would have reprimanded them greatly. The 100,000 tests a day are done very clearly. I would be glad to take the noble Lord, Lord Rennard, to visit our Lighthouse Labs to see the remarkable automation and robotics that achieve that remarkable effect. On the care home figures, we work hard in order to create prompt, immediate, daily figures. Those are then verified and put into the official national figures that are curated by the ONS. Having operational figures that are delivered quickly is important for decision-making. Having figures officially verified by the ONS to audit those results is an entirely appropriate way of doing things. It is a system that works, and we currently have no intention to change it.

[Baroness Ritchie of Downpatrick (Non-Afl)]

Is the Minister confident that the public health surveillance system in the UK is able to detect and manage cases and their contacts and identify at-risk cases—that is, test, track and trace?

[Lord Bethell]

I am afraid I did not hear the full question from the noble Baroness, but if I understood her correctly, she referred to track and trace. I reassure her that we are putting a huge amount of resources into that surveillance. It is true that surveillance does not currently exist. We do not have the facilities that some Asian countries, such as Taiwan and South Korea, had following SARS, about which we now know so much. We are putting the correct resources in place, and we hope very much to have a detailed local and demographic understanding of where and how the disease is progressing. That information is essential to beating it.

Covid-19: Testing

Baroness Ritchie of Downpatrick Excerpts

Thursday 14th May 2020 Lords Chamber

[Lord Bethell]

My Lords, I pay tribute to those BME workers on the front line. There is no doubt that their courage and bravery in the face of heightened risk is one of the things that has kept the NHS and our care service working and we owe them a huge debt. That debt will be paid by providing testing for anyone who needs it. To answer the noble Lord’s specific question, we started rolling out asymptomatic testing throughout the NHS and care service last week. The results of that will be published by the NHS shortly.

[Baroness Ritchie of Downpatrick (Non-Afl)]

My Lords, the Minister will be aware that, to be effective, testing in care homes of residents and staff needs to be done continuously. Can he confirm when this testing system will be established and then achieved?

[Lord Bethell]

Testing in care homes is absolutely a number one priority. We have massively ramped up testing: we are now running it at 30,000 tests a day. We will test 300,000 care home residents and 500,000 care home staff before mid-June. That will make a massive difference, but we will not stop there. The ongoing and regular testing of both residents and staff will be a core part of our test and trace programme.

Covid-19: Contact-tracing App

Baroness Ritchie of Downpatrick Excerpts

Wednesday 6th May 2020 Lords Chamber

[Lord Bethell]

My Lords, it is not a go-it-alone app; others are following our lead on this. It is interoperable, and we are working with other countries to make sure it is. Testing with the public has turned out to be extremely positive and we look forward to publishing the audit shortly.

[Baroness Ritchie of Downpatrick (Non-Afl)]

My Lords, the importance of track, trace and isolate is beyond doubt, but what assurances can the Minister give to your Lordships’ House that this data, as part of data-sharing with the NHS, will be anonymised and protected to prevent information being used by others?

Covid-19

Baroness Ritchie of Downpatrick Excerpts

Thursday 23rd April 2020 Lords Chamber

[Lord Bethell]

I have not seen the piece in the FT, so cannot comment on the noble Lord’s remarks. All I would remind him, as I have said in previous answers to similar questions, is that false reporting of a death is an offence. Doctors are required to make a clear report of a death. If it is associated with Covid in any way, the word “Covid” will be in the death certificate. If it is in the death certificate, it will make its way through the CQC to the ONS figures. There should be no ambiguity about this at all.

[Baroness Ritchie of Downpatrick (Non-Afl)]

Will the Minister provide an assurance that there will be rigorous tracking, tracing and isolation of those in care homes, including the staff and residents? Through its European director, the World Health Organization told us today that there were significant deaths across Europe, including in the United Kingdom and Ireland, and that there is a need to address this.

[Lord Bethell]

The noble Baroness, Lady Ritchie, addresses a very difficult problem. The programme we are looking at, announced earlier today with the change to our guidelines, is the testing of asymptomatic carers and residents in care homes. It is a natural and growing concern that the disease may be present in an asymptomatic form. We are determined to get the infection out of our care homes and the NHS.

Dementia: Accident and Emergency

Baroness Ritchie of Downpatrick Excerpts

Wednesday 11th March 2020 Lords Chamber

[Baroness Ritchie of Downpatrick (Non-Afl)]

My Lords, will the Minister consider a meeting of the British-Irish Council to deal specifically with the rising level of dementia cases throughout our devolved institutions, as well as England, with special reference to social care and the need for investment in it? It is urgently required.

[Lord Bethell]

The noble Baroness is quite right that this issue is not limited to England. The devolved Administrations are very much focused on it. I will look into the relevance and possibility of the kind of meeting she describes.

Rare Diseases Strategy

Baroness Ritchie of Downpatrick Excerpts

Tuesday 28th March 2017 Westminster Hall

[Ms Margaret Ritchie (South Down) (SDLP)]

It is a pleasure to serve under your chairmanship, Mr Pritchard. I congratulate the hon. Member for Bath (Ben Howlett) on his thoughtful contribution and on securing this important debate. He has given leadership on the issue, drawing on his professional field and as chair of the all-party parliamentary group, for which we are particularly grateful.

Those who suffer from rare diseases struggle for recognition, funding and resources, but rare diseases collectively are not rare; there are over 6,000 of them, and many Members here have constituents who are among the 3 million people throughout the UK affected by such diseases. The range of rare diseases is wide, but they have in common an impact on the lives of those who suffer from them and on those of their families and carers. In October last year, I chaired the annual general meeting in Northern Ireland on Behçet’s disease, a very rare disease that affects suffers with listlessness and muscular atrophy. They cannot get close to a level of diagnosis that comes with a clear medical plan for dealing with their particular disease.

Having a rare disease presents its own unique challenges. The testing experience of ill health is exacerbated by the difficultly of diagnosis and the subsequent struggle to access medicine and treatment. Other sufferers of rare diseases in my constituency have told me of the need for a co-ordinated approach to diagnosis and implementation of a treatment plan across all medical disciplines, which is sometimes sadly lacking.

I come to the issue from a Northern Ireland perspective. The hon. Member for Bath referred to an implementation plan for the nations and regions within the UK. A constituent who has a rare disease, as does her son, suggested to me that they originally received a considerable level of co-ordinated treatment here in Great Britain, but not in Northern Ireland. That issue must be addressed under our own singular plan.

Of course, proving the safety and effectiveness of treatments and medicines is an added difficulty in rare diseases with complex data, or perhaps even a dearth of data. I echo the vision of the Northern Ireland Rare Disease Partnership: no one should be disadvantaged because of the rarity of their condition. People with rare diseases should be able to expect access to the safe, effective and affordable drugs and treatments that they need.

Other hon. Members have mentioned muscular dystrophy in their interventions, specifically Duchenne muscular dystrophy, which affects more than 2,500 children and adults in the UK. Assisted ventilation is required to help older Duchenne patients to breathe, which necessitates 24-hour care, and some patients undergo a tracheostomy procedure. I have heard worrying reports that medical centres that conduct clinical trials for Duchenne muscular dystrophy and other muscle-wasting conditions are facing a lack of capacity and resources and are having to turn studies away, which risks thwarting the development of promising new drugs and the search for effective treatments that the hon. Member for Bath referred to.

As a Member of Parliament who represents a constituency in Northern Ireland, I was pleased that the then Northern Ireland Executive published their rare diseases implementation plan in October 2015, some two years after the report here was published. The plan identified four priorities: Northern Ireland’s participation in the 100,000 Genomes Project; a commitment to review communications and information; a review to establish a Northern Ireland rare diseases registry; and training needs analysis for medical professionals. The next steps, of course, are to monitor the outcomes of those reviews and to listen closely to the people who are directly affected by the actions of the Department of Health. One of my principal regrets is that we do not currently have a Northern Ireland Executive; civil servants are monitoring the issues but do not have the authority or directives to drive policies forward.

The founding principles of the NHS—that care should be free at the point of delivery and in accordance with need—must be observed. This debate is important because we need to find ways to ensure that those who suffer from rare conditions, for which proving safety and effectiveness is not easy, are not disadvantaged simply because their condition is rare or because the statistics are complicated. The Northern Ireland Rare Disease Partnership told me yesterday that it is not convinced that the latest efforts in that regard from NICE and NHS England are the final answer or even a good answer. It wants NHS England and NICE to look at the testimony of patients who are directly affected, and think about what “need” actually means in today’s world. It cannot just mean paracetamol for headaches; it must mean life-saving or life-altering treatment.

I fear that delays in the progress of implementation will be another unacceptable result of the political situation that we currently face. It is important that we have a political driver—a political authority—to implement our rare diseases strategy fully. I will continue to be guided by the judgment and first-hand knowledge of constituents who have a rare disease, and to measure the success of our local strategy by their experience of how it is implemented.

Oral Answers to Questions

Baroness Ritchie of Downpatrick Excerpts

Tuesday 21st March 2017 Commons Chamber

[Mr Hunt]

My hon. Friend speaks very wisely on this matter. In the end, schools are a vital place in which to spot mental health conditions early. We know that around half of mental health conditions become established before the age of 14, and this will be a big part of the Green Paper that we publish later this year.

[Ms Margaret Ritchie (South Down) (SDLP)]

Does the Secretary of State recognise the ways in which poverty, the associated financial strain and deprivation intersect with mental health; understand the need for him to work with the Secretary of State for Work and Pensions to ensure that mental health is properly recognised in personal independence payment assessments; and recognise that the problem is more acutely affected if people have to travel out of their area of residence?

[Mr Hunt]

I can reassure the hon. Lady that I have had a number of discussions with the Secretary of State for Work and Pensions. Indeed, we are producing a joint Green Paper on health and work precisely to make sure that we address those issues.