Medicines and Medical Devices Bill
Lord Hunt of Kings Heath ExcerptsWednesday 2nd September 2020
(5 years, 5 months ago)
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Lord Hunt of Kings Heath (Lab)
My Lords, I thank the Minister and declare my interests as a member of the GMC board and as president of GS1, the barcoding organisation responsible for the Scan4Safety programme. The Bill is of great importance for patient safety, but also for the health of the life sciences sector, yet it is striking for its brevity and, as the Minister acknowledged, for the extensive powers given to Ministers without the exceptional justification required for the skeleton approach taken. The Minister said he was listening, but he will know that both the Delegated Powers Committee and the Constitution Committee were highly critical, and I believe there is a strong argument for the Bill’s powers in relation to medicine and medical devices regulation to be subject to sunset clauses.
Leaving the EU’s regulatory regime brings significant risks that companies will choose somewhere other than the UK to trial and launch medicines. At the moment we are nowhere near knowing whether our new regulatory system is to be aligned with the rest of Europe—the policy statement published yesterday by MHRA on devices and clinical trials regulation from 1 January 2021 is silent on this. I have to say to the Minister that I am not impressed that his department thinks it is acceptable for such a publication to be produced hours before our Second Reading debate. There is certainly no room for complacency. The European Medicines Agency covers 25% of global pharmaceutical sales; the UK on its own makes up just 3%. The odds are that companies will want to submit applications for new drugs to the EMA before the MHRA, meaning that the UK will lose its advantage and UK patients will risk getting slower access to the latest medicines.
As Sarepta pointed out to me, for many companies the attractiveness referred to in the Bill equates to speed of decision-making at every stage. That means being able to approve clinical trials faster than in the EU, maintaining swift decision-making on medicines approvals and getting approved medicines to patients faster. Yet the Minister will know that the NHS record in uptake of new medicines is very poor indeed, and I would like to hear from him what is going to be done to improve access for NHS patients to these new medicines.
On patient safety, Ministers are silent on whether they will accept many of the recommendations of the Cumberlege review. In particular, will the Minister support the appointment of a commissioner for patient safety, which the noble Baroness, Lady Cumberlege, argued for very persuasively in her report?
Finally, I turn to the abhorrent practice of forced organ harvesting taking place in China today, and to the importance of ensuring that the UK is not in any way complicit in these crimes. In a letter to me last night, the Minister referred to the World Health Organization’s view that China is implementing an ethical voluntary organ transplant system. That is simply not credible, and in fact it is based on a self-assessment by China itself. A much more objective assessment comes from the China Tribunal, which concluded:
“Forced organ harvesting has been committed for years throughout China on a significant scale.”
At the moment, human tissue and organs can be imported into the UK from countries such as China without traceability, documentation or consent. Marie Rimmer MP tabled an amendment in the Commons to deal with this. A similar amendment will be tabled here and I very much hope that the Government will agree to it.
Health Protection (Coronavirus, Restrictions) (Leicester) Regulations 2020
Lord Hunt of Kings Heath Excerpts(5 years, 6 months ago)
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Lord Hunt of Kings Heath (Lab) [V]
My Lords, I thank the Minister and refer him to the report of Sir David King and colleagues in Independent SAGE, who concluded that:
“The situation in Leicester was both predictable and avoidable.”
This derived from the premature lifting of lockdown restrictions when the virus was still circulating widely in some areas, when there was no functional system of find, test, trace, isolate and support, and when the Prime Minister then sent an implied message that things were getting back to normal. Independent SAGE further stated:
“The current situation arose out of a failure to respond to the increase of infections in Leicester … at an early stage and before they reached crisis levels. This was a result of several factors”,
including
“excessive centralisation and unavailability of data”.
The Minister said just now that megabytes of data were given to local directors of public health, but why did it take so long for all the data to be given to Leicester’s director of public health?
On Monday in his Covid-19 Statement, and he repeated it today, the Minister was very clear that the Government were in constructive dialogue with dozens of directors of public health. If that is the case, can he explain why, on the test and trace system, directors of public health have expressed frustration that local expertise has been sidelined? Of course, he is right in saying that data alone will not deal with the virus and that what counts is local action. However, does he not agree that for local action to be effective, you have to trust people locally and give them the full facts?
Covid-19: Response
Lord Hunt of Kings Heath Excerpts(5 years, 6 months ago)
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Lord Bethell [V]
My Lords, the relationship with local authorities is extremely good, and I recommend that noble Lords do not believe everything they read on this subject. I completely commend those who work closely with PHE, the test and trace programme, the joint biosecurity team and all the sectoral parts of government that reach out to local authorities, DPHs and local infection teams. A very strong bond is forming, and we have a very large number of outbreaks up and down the country that you never read or hear about, and which are not celebrated either for being good or bad because that partnership works well. The intelligence and data are put into the hands of the people who need them, and the teams move quickly and effectively to deal with the outbreak. I am extremely grateful for this; a huge amount of progress has already been made, and we continue to invest in those relationships.
Lord Hunt of Kings Heath (Lab) V
My Lords, it is clearly good to hear that the relationship with local government is on a good level, as the Minister has said. However, why is it that directors of public health have been complaining for weeks about the lack of information? The Minister says that they are getting all the information they need, but this has occurred only in the last few weeks. If it is a question of data protection legislation, why was emergency legislation not put through in the spring to enable local authorities to have all the information they clearly need?
Lord Bethell [V]
My Lords, it is put to me week in, week out that our relationship with directors of public health is in some way troubled. I reassure noble Lords that, every single day of the week, we are in contact with dozens of directors of public health in amicable, constructive dialogues that lead to concrete action, local interventions and sharing of data. These conversations happen in a cordial and friendly fashion. The message may have got through to some noble Lords that there is some huge acrimony and difficulty between us, but that is not the perspective that I have. The data has got through. It is a hell of a thing to have put up a huge track and trace system in a few months. That we can get such detailed data to a large number of people within the envelope of reasonable data security legislation is nothing short of a miracle. I am extremely proud and pay tribute to those involved.
Health Protection (Coronavirus, Restrictions) (No. 2) (England) Regulations 2020
Lord Hunt of Kings Heath Excerpts(5 years, 6 months ago)
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Lord Hunt of Kings Heath (Lab) [V]
My Lords, I know we are working under difficult circumstances, but to have one minute to debate these important regulations does not do them justice. We need more time to consider these regulations in a more timely fashion. Even now, further regulations have been made: SI 750, made on 17 July, enables local authorities to restrict access to close premises events; and SI 754, made on 20 July, amends the Leicester lockdown arrangements, which we have not even debated yet. We still have not debated two regulations on the restrictions on people travelling to this country, SI 567 and SI 568. As the Minister said, new regulations on lockdown generally were laid on 23 July. Last month, the Secondary Legislation Scrutiny Committee pleaded with the Government to ensure that legislation more closely follows any announcement. We really must do better.
Health Protection (Coronavirus, Restrictions) (England) (Amendment) (No. 3) Regulations 2020
Lord Hunt of Kings Heath Excerpts(5 years, 7 months ago)
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Lord Hunt of Kings Heath (Lab) [V]
My Lords, we are once again in the unsatisfactory situation of debating regulations that are already in place and, following the Prime Minister’s announcement early this week, now somewhat academic. I listened very carefully to what the Minister said in opening this debate. We are, of course, in exceptional circumstances and the Government have had to act very quickly, but I would draw the Minister’s attention to the report today of the Secondary Legislation Scrutiny Committee, which urges the Government to ensure that legislation follows on more closely from any announcements they make. As the committee says, even a short gap between regulations being laid and their coming into effect would better enable those affected to prepare, having seen the law’s actual, detailed requirements, rather than just the headline announcements.
Public confidence would also be enhanced with the timely publication of the full scientific advice available to Ministers. When the crisis first occurred, Ministers were very fond of saying that they were following the science. This was much in evidence in the Downing Street briefings, with the presence of the Chief Medical Officer and Chief Scientific Adviser. They have been less in evidence recently, although they did come to the last briefing in Downing Street this week.
The standing down of the Chief Nursing Officer when she would not endorse the behaviour of Dominic Cummings was a standout moment that did great credit to the Chief Nursing Officer—rather less so to Downing Street. Scientists are not above criticism, but surely, we are entitled to see the full advice going to Ministers. In the case of the ludicrous 14-day quarantine period for visitors to this country, we are still awaiting even a summary of the advice. Will the Minister say when it is going to be published? Would he accept that, if the public are to regain confidence in the Government, the full advice should be published?
Covid-19: Test and Trace App
Lord Hunt of Kings Heath Excerpts(5 years, 7 months ago)
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Lord Bethell
My Lords, the decision to change strategy was taken ultimately on operational grounds. The regulatory environment was not necessarily relevant for that. We cannot avoid the fact that there have been technical issues with both the Apple and the NHS apps. We are still some way from resolving those issues, but we hope to overcome them, in partnership with Apple, and the House will be updated when we do.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, the SAGE minutes of 1 May indicate that 80% of contacts should be isolated within 48 hours of the original case becoming ill. The SAGE meeting on 19 May included the summary point that a test, trace and isolate system would be necessary, though not sufficient on its own, to allow changes to distancing measures without pushing R above 1. Given the failure of the Government’s app, and their intention to reduce the two-metre social distancing rule, has SAGE now changed its mind?
Lord Bethell
My Lords, the Government have the two-metre rule under review, but no decision has been made on it. Enormous progress has been made on reducing the turnaround times of tests. A large proportion of them now take place within 24 hours and we remain focused on this important index.
Health Protection (Coronavirus, Restrictions) (England) (Amendment) (No. 2) Regulations 2020
Lord Hunt of Kings Heath Excerpts(5 years, 8 months ago)
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Lord Hunt of Kings Heath (Lab) [V]
My Lords, debating these regulations, which came into effect on 13 May, does seem a little academic because further easements have already been brought in, with more on the way, as the Minister has kindly explained. One can only wish that we could see that as part of a coherent strategy, but the contrast between the opening of shops and zoos today and the scaling back of school opening before the summer holidays, along with the introduction of a 14-day quarantine period for all new arrivals, is striking and difficult to fathom.
Nowhere is this more apparent than in the 14-day quarantine policy, which was described in the Sunday Times on 7 June as
“one of the most economically damaging policies the Government has yet unveiled. It cuts the travel industry off at the knees and makes the country look isolationist and ridiculous.”
As Professor Michael Baker, Professor of Public Health and adviser to the New Zealand Government has said,
“The UK’s new 14-day quarantine rule only makes sense if you go for elimination of the virus as your goal”,
and all the necessary measures are in place. But the Government are now removing many of those measures.
The confusion is being compounded by the continuing failure of the Government to publish the evidence to justify their decisions. All we have been promised in relation to the 14 days is a summary at some point in the future. As Sir Paul Nurse and the noble Lord, Lord Saatchi, said last week,
“Trust has to be earned if the public are to have confidence in their political leaders and the scientists advising them. Trust is only possible if the scientific advice given is open, transparent and properly communicated.”
Unfortunately, much government activity is more about managing the media, polling and focus groups than anything else.
The so-called review of the two-metre rule announced yesterday is a case in point, since it appears to be a softening-up process designed to legitimise a decision which has already been made. As the respected Professor Sir Chris Ham, the former director of the King’s Fund, wrote this morning,
“Boris Johnson was complacently late to grasp the gravity of the crisis and then animated by a panic-driven urge to try and impress the public by throwing out pledges he could not deliver.”
That typifies the Government’s whole approach: slow into lockdown; the sacrificing of the care sector; the shortages of PPE; the dubious testing targets and the world-beating app that never quite appears. When will the Government get a grip?
Exercise Cygnus
Lord Hunt of Kings Heath Excerpts(5 years, 8 months ago)
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Lord Hunt of Kings Heath
To ask Her Majesty’s Government what action they took following Exercise Cygnus to prepare the United Kingdom for responding to a major pandemic.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con) [V]
My Lords, Exercise Cygnus addressed the greatest risk in the National Risk Register of Civil Emergencies: a flu pandemic. All the recommendations from Exercise Cygnus were accepted and taken on board. Many of these proved invaluable for informing the response to Covid, including plans for legislation that would assist in response measures, for bringing back retired clinical staff, for flexing systems beyond normal capacity and for establishing a group of expert advisers on moral, ethical and spiritual issues.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, if the Minister is so confident that the lessons from Exercise Cygnus informed the UK’s preparedness, why was the care sector so neglected? To deal with the surge of NHS patients expected in the event of a pandemic, the exercise identified that extra capacity would be required in care homes. Why was that not heeded and why, as Martin Green, chief executive of Care England, put it, was PPE redirected away from care homes and the NHS given a clear instruction in March to send people to care homes despite no testing for infection being available?
National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) Regulations 2020
Lord Hunt of Kings Heath Excerpts(5 years, 8 months ago)
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Lord Hunt of Kings Heath
That this House regrets the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) Regulations 2020 (SI 2020/469) and the lack of a long-term plan to ensure the financial sustainability of care homes.
Relevant document: 14th Report from the Secondary Legislation Scrutiny Committee
Lord Hunt of Kings Heath (Lab) [V]
My Lords, the care sector has never been more in the eye of the storm than during the Covid-19 pandemic. I pay tribute to all in the sector for the care they have given to so many people, under huge pressure and at no little risk to the workforce. As my mother is in a care home, my tribute is personal and based on first-hand experience.
There is no denying that care homes have been dealt a poor hand during the crisis, which unfortunately is consistent with the long-standing neglect of the sector. We must do better and ensure that as we come out of the crisis, we bring long-term sustainability to care homes and peace of mind to those who live in them. This SI does not aim to do that. None the less, I welcome the proposed increase in the rate that the NHS pays to care homes to cover the cost of services carried out by a registered nurse.
The new rate follows a Supreme Court judgment in Wales, with implications for England. It has also been influenced by a challenge to the 2019-20 rate and the 3.1% efficiency gain assumed within that rate. The 2019-20 rate was subsequently revised and the rate for 2020-21 is built on that revision. Can the Minister explain what efficiency rate had been built into the new rate and whether it is realistic to expect care homes to meet those efficiency savings at this time, when their costs are going well above the inflation rate?
This is borne out by many in the sector. As Richard Adams, the chief executive officer of Sears Healthcare, a small group of care homes, reported to me:
“We are seeing people coming into our nursing homes much later in their life course. Their health care needs are multiple and complex and require very specialised nursing care in order for them to be able to continue to live and to die well.”
Unfortunately, there is very little recognition of this in the contract arrangements in place with clinical commissioning groups. Will the Minister review these contracts and ensure that care homes are adequately recompensed to provide this type of care?
Of course, care homes were already under significant pressure when the pandemic hit us. Covid-infected patients were moved from NHS beds with no consideration of whether the care homes they were sent to would be able to cope. The care sector was clearly a long way down the chain of command, as illustrated by the lack of priority given to it in relation to PPE, testing and the recording of deaths. The absence of reliable figures for deaths in care homes for many weeks was indeed telling.
At times the care sector felt deserted by the Government. The Association of Directors of Adult Social Services has said that the national handling of protective equipment for care workers was “shambolic”, with early drops of equipment “paltry” and more recent deliveries “haphazard”. Martin Green, the CEO of Care England, put it even more explicitly:
“From the start the NHS was prioritised … PPE was redirected away from care homes ... There was a clear instruction to empty hospitals in March to send people to care homes despite no testing for infection.”
When it comes to funding, £3.2 billion has been made available for local authorities to help respond to the Covid-19 pressures across all services, including adult social care, but a report from Care Providers suggests that funds are not making it to the front line in some areas, with learning disability services facing particular problems. As Care England has documented, overheads are rising as occupancy falls, with serious cash-flow implications. There is a risk that providers may become insolvent and collapse, or alternatively raise fees considerably. Over the weekend Age UK reported that some residents were paying a Covid-19 surcharge of up to £150 per week to cover extra costs. Does the Minister agree that this is a massive hike, and that it is unfair as self-funders are in effect subsidising council-funded places?
Richard Adams of Sears Healthcare has stated
“Future funding agreements for social and nursing care must include provision increased costs associated with … Purchasing additional PPE … health surveillance activities … Increased costs incurred by the need to flex staff in order meet the requirements of any self-isolation … Increased training costs in relation to infection prevention and control, correct use of PPE and outbreak management.”
Does the Minister accept this?
I am afraid that the experience of care homes in the last few months reflects the neglect that the sector has long experienced, and it is a damning indictment of this country’s failure to provide a solution to the funding of long-term care. We are in a vicious cycle: after decades of reviews and failed reforms, the level of unmet need in our care system increases, the pressures on unpaid carers grow stronger, the supply of care providers diminishes and the strain on the care workforce continues—and that is before the new immigration controls are imposed on so-called low-skilled workers at the end of the year. I want the Minister to say tonight whether the Government will soon publish their proposals to deal with the long-term challenge.
I thought Philip Collins put it very well in the Times on 14 May when he wrote:
“There are three ways to fund social care. We can wrap it into the NHS and fund it through general taxation, or perhaps a hypothecated levy. We can ask the individual to pay, drawing on savings which might be mandated through a social care auto-enrolment scheme or equity released from the family home. Or we could do some combination of those two options, which is what Dilnot suggested all the way back in 2011—the individual pays”
up to a certain level
“subject to means, and then the state steps in.”
Are the Government prepared to come forward with a concrete proposal? I certainly hope so. Fudge it, delay it, and we will continue to fail to deal with the fact of ageing and consign millions of people to a worrying and often miserable old age. We can and surely must do better than that. I beg to move.
Lord Hunt of Kings Heath [V]
My Lords, I thank all noble Lords, and the Minister for his considered response. The debate has shown the very serious situation facing many of our care homes. I heard what the Minister said about support for the social care system. However, far from experiencing a protective shield, many care homes felt abandoned by the Government and the NHS in March. They remain very vulnerable financially, and the workforce crisis in the offing because overseas recruitment will effectively come to an end at the end of this year cannot be wished away.
The Minister has reconfirmed the Government’s commitment on the long-term future. This is welcome. I also agree with the noble Baroness, Lady Wheatcroft, about the desirability of cross-party consensus. Looking back, it was a great pity when Andy Burnham’s plan was labelled a death tax by David Cameron in 2010. That has made cross-party consensus that much harder.
One thing is for sure: we owe a huge debt to care workers and carers for the fantastic work they have done over the last few months. They have responded magnificently to this huge and unprecedented challenge. We thank them all. I beg leave to withdraw my Motion.
Dental Care
Lord Hunt of Kings Heath Excerpts(5 years, 8 months ago)
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Lord Bethell
The noble Lord is entirely right that poor dental care is extremely damaging to individual health. The current situation is one that we massively regret, but the safety of patients and dental professionals is paramount. The aerosols generated by dental drilling and other dental practices leave the threat of germs in the air in a dental practice for hours to come, which could be caught by staff or future patients. It is for that reason that we have focused the infection protocols in 500 special units that have the right kit, the right training and the right arrangements.
Lord Hunt of Kings Heath (Lab)
My Lords, I declare my interest as president of the British Fluoridation Society. I recognise the work done in setting up urgent treatment centres, but they are patchy in England and many provide only for pain relief and tooth extraction. Many high street dentists are in danger of bankruptcy, because the Chancellor’s schemes to help businesses have not been applied to them. Will the Minister consider setting up a programme of work with the BDA and the Chief Dental Officer to establish a national plan to get dentistry back on track and save the profession from ruin?
Lord Bethell
My Lords, I completely understand the points that the noble Lord has made. He refers to a situation that we are fully aware of, and I completely agree with his analysis. The truth is that tooth extraction avoids some of the risks that I described, but treatment in the centres is not limited to extraction and other protocols are arranged. The Chief Dental Officer is working on a dental plan, and we are liaising with colleagues in the Treasury to see what more can be done to help dental practices.