Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

Lord Goddard of Stockport Excerpts

Wednesday 2nd December 2020 Lords Chamber

[Lord Goddard of Stockport (LD) [V]]

I do not intend to take up too much of the time of the House, but I want to make a couple of comments and ask the Minister three questions about the SIs and the context in which they sit. These instruments are technical in nature, but the subject area—the regulation of medicines and medical devices—is a key issue for millions of people across the United Kingdom.

It is clear that in a no-deal EU exit scenario, the UK’s current participation in the European regulatory network for medical devices would end. The MHRA would then take on the responsibility for the UK market currently undertaken through the EU system, to ensure the continued safety of patients. The instruments are designed to enable the regulation of medical products and devices across the UK to be continued beyond the implementation period, so the regulations need maximum scutiny.

The EU and the UK markets for medicines and medical devices are closely linked, and enormous numbers are involved. I doubt whether the general public have any idea of the scale. According to the Association of the British Pharmaceutical Industry, every month at least 45 million packs of medicines are exported from the UK to the EU, and 37 million packs are supplied from the EU to the UK. The UK still also relies heavily on the EU for its supply of medical devices, with more than half its £5 billion budget for imported medical technology being spent on devices originating from the EU.

From January 2021, changes to legislation on these issues will no longer flow through from updates at EU level. I therefore hope that the Government will explain clearly how this vital supply chain will be not only maintained but improved. A number of issues in relation to the Medicines and Medical Devices Bill have raised concerns about the Government’s approach to the future regulation of medicines and medical devices. I will pick out just three for the Minister to consider.

The first issue is patient safety. There is a balance to be struck between innovation and patient safety. The Government need to provide assurances that patient safety will be an overarching consideration in their approach to new devices, some of which have been controversial in the past. The scandal of the women affected by mesh implants is an obvious example of where things have gone wrong.

The second issue is about alignment and collaboration. The EMA centralises the process for licensing and the monitoring of drug safety. Pharmaceutical companies could prioritise the EEA market over the UK market if the processes diverge too far, leading to delays in medication and medical devices being available in the UK.

The third issue—to me, possibly the most important—is patient data. The Government need to provide assurances that patient data will be protected and used appropriately. That should be front and centre of their approach, to give confidence that patient data will be protected and will not be shared with third parties.

Covid-19: Charitably Funded Hospices

Lord Goddard of Stockport Excerpts

Wednesday 28th October 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, I completely recognise the note of urgency in the noble Lord’s comments. I also recognise that, as we go into a Covid winter, the hospice movement, which has contributed so much to our response to Covid and brought valuable capacity to the care of the elderly and the vulnerable during the first wave, needs answers. I recognise the funding gap that he describes, in particular the collapse in retail income that many depend on, but I assure the noble Lord that the meeting on 4 November will have these issues on the agenda. The movement should look forward to that meeting as an opportunity to discuss the issues he describes.

[Lord Goddard of Stockport (LD)]

My Lords, in my home town of Stockport, St Ann’s Hospice is about to celebrate its 50th anniversary. It is one of the largest and oldest hospices in the country. It has been looking after people across Greater Manchester for half a century, delivering world-class specialist palliative and end-of-life care for thousands of people. St Ann’s Hospice must raise £20,000 every day from voluntary contributions to top up the value of the clinical commissioning group contracts, which provide only a third of the funding. What will the Government do to ensure the levelling up of fair funding in the contract arrangements with local clinical commissioning groups while protecting the all-important charitable status that hospices value so much?

[Lord Bethell (Con)]

My Lords, the noble Lord is right that 70% of hospices are funded through charitable income with only 30% coming from CCGs. That is why we put in more than £150 million during the first wave and why we have a discussion about future support on the agenda. I reiterate absolutely the points that he made about the contribution of hospices during the first wave and the innovation that many of them brought to the response. I have before me tributes paid to the Mary Ann Evans Hospice in Warwickshire and the St Elizabeth Hospice in Ipswich, which were case studies in bringing in fresh thinking and changes to work practices to support people during the Covid first wave.

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

Lord Goddard of Stockport Excerpts

Thursday 25th June 2020 Lords Chamber

[Lord Goddard of Stockport (LD) [V]]

My Lords, as I have said in previous debates, this legislation is highly retrospective, and that is to be regretted. Regarding devolution, Greater Manchester has a long history of integrated partnership working across all services and sectors. Throughout this crisis, we have worked closely with government to support and develop responses to the pandemic. The Government’s response has in many ways been commendable. However, as we reach the end of this period of lockdown, it is an opportunity to reflect on the lessons learned, particularly in relation to devolved powers and funding for local and city region authorities, along with the co-ordination between national and regional government.

My noble friend Lord Scriven’s comments were right on the nail, as usual. This is about emergency legislation and, in certain cases, the misuse of it. I have heard people such as the noble Lord, Lord Naseby, who I respect immensely, talking about how the British people know best and letting the forces of nature take their course. But did he see pictures from the beaches at Brighton or Bournemouth yesterday, or the pictures from Brixton last night? That is the real problem. The noble Lord, Lord Robathan, quotes figures. Perhaps we should have T-shirts made, “I am the 0.65—one of the lucky ones”. Someone has to take control of the situation. If this is a long, hot summer and we ease the lockdown for lots of people up and down this country, it is not rocket science to understand what will happen.

The best people to deliver and control this would be local authorities, city regions and people who understand the make-up of their areas. The sooner the penny drops with devolution, that is where the real power will lie. We can control isolated outbreaks of the pandemic in isolated areas, but I do not know about the problems of Hartlepool, Southport or Plymouth. We know about Greater Manchester, and those powers should be devolved so that we can help even more to suppress this terrible virus.

Draft Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020

Lord Goddard of Stockport Excerpts

Monday 18th May 2020 Lords Chamber

[Lord Goddard of Stockport (LD)]

I too am on sound only, and some may say that that is for the better.

In my view, deemed consent legislation is long overdue. Subject to safeguards and ethical checks and balances, which I am sure finer minds than mine are addressing, we must get on with this.

I shall address my comments mainly to kidney transplants, as this is a cause close to my heart. By far the most common transplants are kidney-related, and the numbers for that particular sector are staggering: 3 million people in the UK have chronic kidney disease, including 1,000 children, while 65,000 people are being kept and treated for kidney failure by dialysis or transplant. In the UK, there are over 6,000 people on the transplant waiting list, and at least one person every day will die hoping for a kidney transplant. NHS Blood and Transplant has estimated that the change in the law has the potential to allow 700 more transplants each year by 2023, as the noble Lord, Lord Hunt, commented earlier.

To be clear, when kidneys fail there are three things that can happen: dialysis, transplant or death. Dialysis is distressing and demeaning; with four to five-hour sessions every week and dietary and fluid restrictions, people are unable to continue with work, families and relationships are strained, and depression is common. It has been reported that levels of pain are equivalent to those suffering from terminal cancer. Patients are exhausted, with aching bones, reduced mobility and constant aching.

A transplant is transformational in restoring quality and quantity of life. I commend NHS Blood and Transplant for its achievements, with over 50,000 people now alive with transplants. Kidney transplants are economically beneficial; maintaining a person with a transplant costs around £5,000 per annum, compared with over £30,000 per annum for those on a dialysis machine.

This legislation is not all about kidneys; the heart, liver and lungs are included specifically. However, other organs, such as the pancreas, the intestine and the uterus, are vital organs that can save lives and should be considered with express consent. Worldwide, the kidneys are the most transplanted organ, followed by the liver and the heart.

However, it seems that the Government have advised that it is unlikely that transplants will proceed under deemed consent during the Covid-19 pandemic, because people are distanced, and communication between relevant parties is more difficult. If this is the case, when will deemed consent actually come into force? I note that the noble Lord, Lord Bethell, stated confirmation on 20 May 2020. I hope he will clarify that later.

NHS Blood and Transplant was set up on 1 October 2005, taking over the functions of UK Transplant, founded by Dr Geoffrey Tovey in 1972. We live in unprecedented times of stress and uncertainty, and the sooner this legislation is enacted, the sooner many thousands of people will have renewed hope that their lives could be improved. It would be excellent if, less than 50 years from Dr Tovey’s initial ground-breaking work, this finally became the law.