Medicines and Medical Devices Bill

Baroness Ritchie of Downpatrick Excerpts

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

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

My Lords, like many noble Lords who have spoken today, I agree that the provision of high-quality healthcare in which its citizens can all have confidence defines any nation. That is why this Bill, with all its warts, is so important.

We must always ensure that our ethical practices are of the highest standard. Any medical product available in the UK, or indeed anywhere, must be rigorously tested, safe and effective. That is also particularly true of any future vaccine for Covid-19.

However, I want to focus today on one aspect of this Bill, that relating to medical devices. I have long campaigned on the issue of winning justice for pelvic mesh sufferers, who have been left with internal damage and intense, chronic pain. They were failed by an appalling culture of mismanagement, ignorance and apathy within the health system. These victims deserve justice, and we must ensure that this sort of systemic failure never happens again.

The recent report by the noble Baroness, Lady Cumberlege, entitled First Do No Harm, on surgical mesh and other medical interventions was scathing in its assessment of the failures of a disjointed and defensive health system to listen to and address patient concerns. Much of the suffering, it concluded, was entirely avoidable. As someone who met victims of this appalling mismanagement when I was a Member in the other place and learned at first hand of the pain they had been forced to endure and its effect on their quality of life, I am pleased that this review was commissioned and am happy to support the noble Baroness in her proposals. I am pleased, too, that it was able to be so honest in its findings.

I am further pleased that the Minister, the noble Lord, Lord Bethell, provided an apology in your Lordships’ House on the 9 July to all the people who have suffered as a result not only of pelvic mesh issues but of certain medications. I am now going to ask the Minister a direct question. Will the recommendations of the noble Baroness, Lady Cumberlege, be reflected in this Bill through government amendments in Committee? I refer in particular to the implementation task force, which must be set up without delay to oversee progress. Like other noble Lords, I believe that that recommendation should be given statutory effect if the Government and Parliament are to take this report seriously. That goes also for the recommendation that a commissioner for patient safety be created.

In relation to Northern Ireland, there is also the issue of potential regulatory divergence. As medicines are a devolved power but medical devices are not, the Bill in its current form raises the possibility of future regulatory divergence between Northern Ireland and the rest of the UK. That matter requires clarification in relation to the report of the noble Baroness, Lady Cumberlege, and this Bill. Can the Minister provide that? There is no doubt that such assurances are very necessary, but they should not and will not close the door on the past.

Health Protection (Coronavirus, Restrictions) (No. 2) (England) Regulations 2020

Baroness Ritchie of Downpatrick Excerpts

Friday 24th July 2020 Lords Chamber

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

My Lords, I thank the Minister for his explanation of the statutory instruments—although we are approving some of them retrospectively.

I will ask the Minister one question. With the easing of restrictions, anxiety is emerging among people wanting to know about progress in relation to the development of a vaccine. Can the Minister provide us with an update on the development of a vaccine and an indication of the method of distribution? Will it be England first and then the devolved regions, and which groups will be considered eligible for vaccination?

Pharmacies

Baroness Ritchie of Downpatrick Excerpts

Monday 20th July 2020 Lords Chamber

[Lord Bethell [V]]

My Lords, the role of pharmacies in the administration of vaccines is critical. Not only will the standard flu vaccine be coming up shortly, but, if today’s news is to be taken on the level, the possibility of a Covid vaccine is at some point on the horizon. That is why we are talking to the sector about the role that community pharmacies can play in the greater administration of vaccines, both of flu and of Covid.

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

My Lords, will the Minister indicate what further discussions will take place with the National Pharmacy Association to ensure that community pharmacies become the front line for giving out services that would normally have been dealt with by GPs and emergency departments, to ensure that they take the flak and slack off the National Health Service and continue to provide an essential service to the wider community?

[Lord Bethell [V]]

As the noble Baroness is probably aware, the Secretary of State for Health and Social Care spoke at the annual conference of the National Pharmacy Association, at which he reiterated his commitment to the sector. The noble Baroness puts it well: pharmacies have something very special and valuable because of their trusted role. We very much want to see an enhanced role for pharmacies in the delivery of healthcare.

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.