Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022
Lord Brougham and Vaux Excerpts(1 year, 10 months ago)
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Lord Grade of Yarmouth (Con)
My Lords, the health or otherwise of independent community pharmacies can be judged by the rate of closures, which has been increasing over the last few years for a number of reasons, not least the overall deal with the NHS. That deal requires, for example, an individually owned community pharmacy to be deemed to have received the same discount on the purchase of drugs that Boots and the other big chains get on volume discounts. There is a serious crisis in this sector. Can my noble friend the Minister give us some idea of the rate of closure? If he does not have the statistics today, perhaps he could place them in the Library. Closure is an upward trend.
The Deputy Speaker (Lord Brougham and Vaux) (Con)
The noble Baroness, Lady Brinton, will be taking part remotely and I call her now.
Baroness Brinton (LD) [V]
My Lords, I thank the Minister for his introduction to this Order and the noble Lord, Lord Hunt of Kings Heath, for explaining his amendment. First, as others have said, it is important to recognise the contribution pharmacists in our health service have made for many years—long before the NHS was created. Too often we talk about clinical and health care professionals and do not raise the vital contribution made by pharmacists. Covid-19 has really demonstrated in a number of ways that they are not only a cornerstone of the NHS and our healthcare system. In the pandemic, and lockdown especially, they also stepped up, took on extra responsibilities and became a new frontline service for people concerned about minor symptoms that they would normally have taken to their GPs, while their GPs were overrun with many more serious cases, including Covid cases.
I too thank the PSNC for the pharmacy advice audit it sent through earlier this week. We now know that nearly a quarter of a million consultations a week—that is 65 million informal healthcare consultations a year—are still being carried out in community pharmacy because patients are unable to access another part of the healthcare system. We should not forget, either, that the pharmacy database was used as the basis for the NHS app because it already had direct links with GP records, prescriptions and vaccinations that were delivered by pharmacists in their pharmacies.
Turning to the SI, which clarifies the governance of, and sets out the roles of, responsible pharmacists and superintendent pharmacists, the brief summary by the Secondary Legislation Scrutiny Committee raises some key issues. The Minister is right: although there are only three paragraphs, its report is certainly worth reading. It says in paragraph 14:
“several proposals were not popular with respondents to the consultation exercise on the grounds that they may reduce patient safety, particularly provisions allowing Superintendent Pharmacists to cover more than one firm and Responsible Pharmacists to cover more than one pharmacy or to operate remotely. We also note significant levels of distrust from the profession that the regulator, the General Pharmaceutical Council … would be able to set standards and rules appropriately.”
Worryingly, the committee goes on to say:
“We found the response of the Department of Health and Social Care … to these concerns, as set out in the Explanatory Memorandum, unconvincing.”
In the next paragraph, it says:
“In supplementary material, DHSC told us that to counter the concerns the GPhC will be required to consult on any proposed rules, which will provide the profession with an opportunity for scrutiny and comment. In addition, any changes to professional rules made … would need to be made by a statutory instrument following the negative resolution procedure in Parliament.”
Although this extra information to the Secondary Legislation Scrutiny Committee is reassuring, I still want to ask the Minister what the timescale is likely to be before such an instrument is laid before Parliament for scrutiny, explaining those concerns outlined by the committee and how they will be alleviated.
I thank the General Pharmaceutical Council for its briefing, which sets out the safeguards in the draft order to consult on the rules and report back. I know we look forward to seeing the detailed responses to the consultation and how they might affect the resulting resolution. With any change in responsibility, trust is absolutely critical, and this is on top of the increase in community consultations and referrals to other parts of the healthcare system that pharmacists throughout the UK are now carrying out. This is the real change already happening in our primary care system that Ministers say we should be looking for, and the public have taken to it.
The All-Party Pharmacy Group notes that the new demands on pharmacists have been coupled with a real-terms decrease in funding over the last eight years. Despite their desire to help, many pharmacies have had to limit or reduce their offerings and, as the noble Lord, Lord Hunt, has said, some pharmacies are closing. It is in this context that the noble Lord has brought forward his amendment, asking your Lordships’ House to consider that
“the Order does not make provision about the wider workforce challenges facing the community pharmacy sector”.
Health and Care Bill
Lord Brougham and Vaux ExcerptsWednesday 9th February 2022
(2 years, 2 months ago)
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Baroness Cumberlege (Con)
My Lords, Amendment 284 would implement one of the major recommendations of the Independent Medicines and Medical Devices Safety Review. I will say from the start that I so welcome the government amendments. I thank the Minister and the civil servants for crafting them in such a thorough way.
There is one glitch, however, about which I have given the Minister forewarning. All the government amendments say that the Secretary of State “may”—and of course that is a very sneaky word. What we want to see is a more robust word: the Secretary of State “shall.”
However, I do not want to detract in any way from the burden of my amendment, which is that relationships between the pharmaceutical and the medical device industries on the one hand, and the hospitals, medical research institutes and individual clinicians on the other, can be a huge force for good. Industry collaborating with doctors, researchers and scientists working in the NHS, academia or elsewhere has led to great breakthroughs and great treatments that we have been able to introduce. No one should want to stop that happening—but we do have a right to see where the money goes. Despite all the undoubted good that collaboration between industry and the rest of healthcare brings, we know that there are long-standing concerns about undue influence.
We need transparency so that trust can be rebuilt where it has been undermined in the past. Voluntary arrangements are all well and good, but they have a drawback: they are voluntary; they are not a requirement; they carry no teeth. So I am encouraged to see that the ABPI, which represents many pharmaceutical companies in the UK, agrees. It is supportive of moving to mandatory disclosure.
Amendment 284 would make it a requirement for payment by the industry to teaching hospitals, research bodies and individual clinicians to be published by the companies themselves. Such legislation exists and works very effectively in the United States. It is called the Physician Payments Sunshine Act, and it has been in existence since 2010. All the information is held on a public website. Americans can see at a glance which pharmaceutical or device companies have made payments to physicians or others: when, why and how much. It is not just the US which benefits from this level of transparency; various European countries have similar legislation in place, and we should not be the poorer cousin.
I of course welcome the Government’s own amendments that are grouped with mine and very much look forward to what the Minister has to say about them. I hope we can all agree that transparency, trust and good, safe care go hand in hand. That is why the amendments are so important.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
My Lords, I invite the noble Baroness, Lady Brinton, to speak remotely now.
Baroness Brinton (LD) [V]
My Lords, this amendment is a companion piece to the previous amendment on declarations of interest that we believe should be made by doctors and other regulated healthcare staff, and ensures that any companies involved in the production, buying or selling of pharmaceutical products or medical devices must publish any payments made to teaching hospitals, research institutions or individual clinicians. Whether someone wants to know about a doctor working with a pharma company, or the other way around, we need a system that provides a golden thread of transparency and accountability.
Reporting payments or benefits in kind by the relevant organisations and individuals receiving them ensures that the links between donors, recipients and their respective interests are always visible. Although it is, we hope, rare, this is more than just transparency. As in any walk of life, occasionally there is malpractice and fraud, which needs to be prevented. A register such as this helps to remind all those concerned of the rules.
I echo the comments made by the noble Baroness, Lady Cumberlege, that “may” is not strong enough: “shall” is important here. The noble Baroness also referred to the USA Sunshine register; and, as I said on the last group of amendments, we definitely need the disinfection of sunlight. Can the Minister say whether any such regulations on industry reporting might be published and brought into force?
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
My Lords, I invite the noble Lord, Lord Howarth of Newport, to speak remotely now.
Lord Howarth of Newport (Lab) [V]
My Lords, I thank the noble Baroness, Lady Cumberlege, for tabling Amendment 284. If we are to avoid the risk of corruption and maintain full public confidence, it is vital that there should be full disclosure of payments by commercial interests to hospitals—I would have thought to all hospitals, not just teaching hospitals—research institutions and clinicians. It is a good maxim to follow the money and to be able to do so.
In regard to research, there has long been public concern about business interests suborning researchers whose judgments and pronouncements influence public understanding, sometimes with important implications for public health. Corrupt scientists certified that DDT and pesticides used in agriculture were not harmful to public health. Exposure of that by Rachel Carson in her book Silent Spring did not end the mischief. Bogus research evidence was paid for for decades by the tobacco industry in a rearguard action to persuade Governments and the public that tobacco was not harmful to human health.
Today, firms in the food industry deploy spurious evidence and arguments about the damage certain foods do to human health. They have lobbied Government with considerable success to the terrible detriment of human health—it is good that the Bill limits the advertising of unhealthy foods. Scientists, paid by energy firms, have abetted those who deny that climate change is manmade.
Disclosure payments in regard to research will help, but more is needed. The noble Baroness might have considered—and may yet consider—tabling another amendment needed to underpin research ethics. The data on which research conclusions are based should be held independently. The Engineering and Physical Sciences Research Council rightly now requires researchers to deposit data connected to the research they have funded.
There is huge pressure, in a competitive environment, on scientists to publish research, and there have been notorious instances of fake science—scientific discoveries announced that were made up and whose results could not be replicated by other researchers. A paper entitled Fake Science and the Knowledge Crisis published by the Royal Society said,
“it is especially important that the scientific world as a whole upholds the highest standards of ethical behaviour, honesty and transparency, aiming to sustain the gold standards of research integrity and validated information.”
However, the authors go on:
“Sadly, a range of forces are working counter to this aspiration.”
It is good that the pharmaceutical industry in the United Kingdom supports the transparency that the amendment calls for. We should certainly match the best standards and practice in the USA and Europe.
The NHS holds huge budgets for drugs, medical equipment and hospital building; big commercial interests are at stake. There is scope for corruption if the system is weakly regulated. The scandal of PPE contracts has led to widespread anxieties about the integrity of procurement. The public want to believe that the NHS is free of corruption, and I am sure it mainly is, but reassurance is needed. As the noble Baroness, Lady Brinton, reminded us. in the old saying, sunlight is the best disinfectant. We need the transparency that the amendment would secure.
The government amendments are, certainly at first blush, welcome. But, as the noble Baroness, Lady Cumberlege, noted there is a conspicuous difference in language between her amendment, which says that companies “must” publish payments, and the Minister’s amendments, which say that the Secretary of State “may” require or regulate. That slide of language is liable to weaken public confidence. I hope the Minister will explain why he has used the word “may” and not “shall” or “must”.
The government amendments are as elaborate as the noble Baroness’s is simple, and they prompt some questions. In the Government’s Amendment 312B, subsection (6)(b) states:
“The regulations may … create exceptions from requirements to publish or provide information.”
What would those exceptions be? Subsection (8) states that the Secretary of State may,
“grant an exception … in a particular case.”
What sort of case? Earlier in Amendment 312B, subsection (1)(a) refers to “payments or other benefits”. I ask the Minister whether the disclosure requirements he envisages cover benefits in kind, including donations to political parties. whether made by big pharma or small local donors.
I do not want to be cynical. How can the Minister reassure those who are?
Baroness Chakrabarti (Lab)
My Lords, Amendment 292 is in my name and that of my noble friends Lady Lawrence of Clarendon and Lord Boateng, and the noble Baroness, Lady Bennett of Manor Castle. I thank noble Lords from across the Committee and the People’s Vaccine Alliance—Saoirse Fitzpatrick of STOPAIDS, in particular—for their advice.
Last year, the Prime Minister lauded the successes of the UK’s vaccination programme as a result of “greed and capitalism”, but the virus-busting vaccines, treatments and tests were in no small part funded by taxpayers, supporting the work of scientists at universities, research institutions and small-scale biotech companies across the world. Over €93 billion of public money has gone into developing vaccines and therapeutics. The AstraZeneca vaccine developed at Oxford University was over 97% publicly funded.
Public investment at the beginning of the research process assumes the biggest risk at the point when there is no certainty that a product will be successful. It is only when effectiveness is clearer that big pharma swoops in and uses exclusive intellectual property rights to hold a monopoly over that product in the market. The risk is socialised but rewards are privatised and, crucially, monopolised. The NHS is paying twice for medicines: once for research and again through procurement.
Some estimates show the public paying for up to two-thirds of drug development, including research and clinical trials. Drugs are getting only more expensive, with estimates that the NHS procurement bill increased by nearly 10% over the last couple of years, to £20.9 billion. Yet there is still no guarantee of production at the volumes required to meet demand or that patients will be able to access health technologies at affordable prices, nor that scientists will be able to make use of the data, knowledge and technologies generated in the research process to develop improved follow-on products. Due to the opaqueness of the pharmaceutical industry, it is very difficult to track public funding. The terms of agreement, actual costs and prices charged—all these are kept behind closed doors.
The amendment seeks to change that for health technologies developed with public funding, as well as to define emergency procedures to expedite a sharing of research, data and intellectual property in the case of a pandemic. By adhering to the “public health condition”, the Secretary of State and all public authorities would ensure that
“a proportionate share of any intellectual property resulting from the public funding … is subject to Crown ownership and openly licensed … a proportionate share of any private profit from public funding is re-invested in further public health-related research, and … public funding is published and taken into account in … the setting of reasonable prices for the public procurement of medicines domestically and internationally.”
Open licensing would allow production in a competitive generic market, bringing down the price of medicines. A study published in the BMJ showed how the price of oncology drugs could decrease by between 75% and 90%. We saw this with ARVs for HIV/AIDS, and how crucial that was in fighting that pandemic by reducing costs from over $10,000 per person per year to under $100. Reinvesting a proportion of profits could ensure that they go towards health priorities rather than financialised practices or the development of me-too drugs—sufficiently different to obtain patent protection but without added therapeutic value, compared with existing products.
There is recent precedent for more transparency and conditionality around public funding in Italy and France, while the European Union is looking at how to track public funding and measure societal impact. Even our Government are beginning to think about public interest conditions for future pandemic tools to ensure access in low- and middle-income countries. This is a recommendation of the UK’s pandemic preparedness partnership’s 100 Days Mission report, published during the UK’s G7 presidency.
There are also circumstances where there has been no public funding but the price or volume restrictions of a product are preventing widespread access. In that case, the amendment calls for a recommitment to the use of pre-existing public health safeguards within the Trade-Related Aspects of Intellectual Property Rights—TRIPS—Agreement. These flexibilities include the use of compulsory licences when intellectual property monopolies prevent access to a medicine. They enable a Government to license another manufacturer to produce a generic or biosimilar version of a patented health technology at a much lower price. These can be used at any time by any WTO member; they have already been implemented more than 100 times between 2011 and 2016.
The need to use flexibilities has never been greater, with ever more drugs coming to market with a price tag of over £1 million per dose. For example, the NHS is currently paying a list price of £1.795 million for a single dose of Zolgensma to treat spinal muscular atrophy—SMA. It is the most expensive drug in the world, despite public and philanthropic funding. A Crown-use licence would permit the Government to allow a third-party manufacturer to make a biosimilar version at a discounted price.
We must also stand with other countries in the face of huge and unconscionable pressure from big pharma when TRIPS flexibilities are used. In 2007, we supported the Thai Government when they applied for a compulsory licence to produce a more affordable antiretroviral drug to treat HIV and were met with a threat from the pharmaceutical company AbbVie that they would lose access to all its other products. We could show leadership and solidarity again. Multinational corporations, whether tech, pharma or other corporations that noble Lords have considered in your Lordships’ House in recent times, warrant international democratic governance, regulation and restraint. Hence the last part of the amendment.
In future pandemics, we must not remake the continuing mistakes of this one. Monopolies which profiteer from poverty and sickness are bad enough at the best of times. But in a global emergency, when so many ordinary citizens, health workers and ethical businesses have sacrificed so much by way of livelihoods, liberties and lives, such conduct is totally amoral. Pharmaceutical companies’ refusal to share manufacturing know-how has led to grotesque vaccine inequity. Only 10% of people in low-income countries have received a single jab. So the amendment stipulates immediate action as soon as the World Health Organization declares a pandemic. The temporary—I stress, temporary —waiver of UK registered patents, industrial designs and other intellectual property rights relating to undisclosed information necessary for combating a pandemic, and emergency compulsory directions to enable domestic manufacturing, would mean that any company within the UK with the capacity could be making these products. It would allow products to be shipped internationally and allow companies across the world access to the critical data and rights to produce pandemic tools at scale for their own people.
The Indian and South African proposal to temporarily waive the TRIPS agreement is supported by more than 100 countries. It is only opposed by the European Union, Switzerland and our own Government. The waiver could allow the 100-plus potential mRNA producers across Latin America, Asia and Africa access to critical clinical data and manufacturing know-how required to make mRNA vaccines, without fear of litigation in the worldwide race to beat variants of the virus.
New treatments are in high demand, and high-income countries have already brought up the lion’s share. We will be facing a treatment apartheid on top of a vaccine one if the United Kingdom and others do not shift their position urgently. Just last week, it was reported that the director-general of the WTO, Ngozi Okonjo-Iweala, was hopeful of a breakthrough in the long-standing waiver discussions. However, it is incredibly important that any compromise is not overly restrictive geographically or in terms of products or types of intellectual property.
The UK Government must stop saying that a waiver will take too long to implement while simultaneously blocking its agreement. They should end their group hug with the EU, Switzerland and big pharma and start embracing and empowering the global south and wider world. The line that temporarily waiving TRIPS will stifle future innovation ignores the public money that funded the riskiest parts of developing vaccines and treatments, and how innovation works. Sharing research data and clinical trials results with great minds around the world creates the conditions for competitive collaboration, vying to have the best results but also sharing lessons learned and supporting each other. This is how we have made great leaps in the past, as with the human genome project, where public funding supported a global collaboration which has changed modern science.
This is about improving access to affordable, life-saving health technologies for our NHS and the world to combat pandemics and improve health. It is about ensuring that we get the best from our biomedical innovation, especially when we are investing so much money and expertise and putting human beings through clinical trials. In a global health emergency, not sharing life-saving knowledge is as wicked as blocking access to emergency exits from a crowded building in a raging fire. I beg to move.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
My Lords, I call the noble Baroness, Lady Brinton, who is taking part remotely.
Baroness Brinton (LD) [V]
My Lords, I am a former trustee of UNICEF UK and, before that, Christian Blind Mission, a global disability charity. I have seen first hand the two-tier system of access to global vaccines and medications. It is a pleasure to hear the noble Baroness, Lady Chakrabarti, set out how, through her Amendment 292, the UK can fulfil its global public health responsibilities for investment in research into vaccines and other health technologies and how, in an emergency, companies developing these goods would also be required to help. She has introduced it in her usual effective and persuasive way. I suspect I am not alone in valuing her contributions to your Lordships’ House.
Throughout this pandemic, the Government have rightly congratulated themselves on their investment in research on the range of vaccines developed in rapid time and also the extensive, rapid clinical trials assuring their safety prior to approval. However, less satisfactory has been the UK Government’s view about their international moral responsibilities as a member of the OECD and one of the high-income countries with access to much-respected vaccination and pharmaceutical research. The World Health Organization has said right from the start of the pandemic that no country is safe until all are safe, but low and middle-income countries have not just not had the advantage we have; we have reneged on our promises to them over the last two years.
The UK Government repeatedly tell us that they have donated cash to Gavi and COVAX, but the reality is that we need to help those countries now to become able to manufacture their own medicines and vaccines in the light of emergencies such as future pandemics. The old adage of “Give a child a fish, feed them for a day. Teach a child to fish, feed him for ever” is so true. Here, the fishing rod is the skills to manufacture and sell medications in a future pandemic.
The TRIPS waiver, or intellectual property waiver, is supported by the World Health Organization and many large charities and countries, including the USA and others. However, as we have heard, the EU, the UK and Switzerland are not in that bracket. Its intention is to increase vaccine production in developing countries by sharing intellectual property for vaccines publicly for the period of that pandemic. It is needed because the data for November 2021, nearly a year from the first vaccine being delivered, showed that just 4.2% of people in low-income countries had received their first Covid vaccine. Across Africa, 6.3% are now fully vaccinated. COVAX has shipped just one-third of what it had expected would be available by the end of October—those expectations were based on promises from high-income countries. Export bans, manufacturing delays and bets on vaccines that have not received regulatory approval have also held up deliveries. Worse, we know that in this country we have thrown away vaccines rather than redirect them if we chose not to use them at a particular time.
It is time that the UK took a leading role in fulfilling the World Health Organization’s call. Now is the time to make all countries safe, not just for Covid but in preparation for whatever future pandemics may occur, and make sure every country is safe in the future.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
The noble Lord, Lord Howarth of Newport, is also taking part remotely. I invite the noble Lord to speak.
Lord Howarth of Newport (Lab) [V]
My Lords, this amendment raises major issues which warrant full debate outside the confines of the Health and Care Bill, but I am most grateful to my noble friend Lady Chakrabarti for providing us with this opportunity to consider them. I support the principle of the public health condition, as articulated in the amendment and as she described it.
The inflexible application of the intellectual property regime during the pandemic has been unconscionable. Huge numbers of people have died unnecessarily in low-income countries. Rich countries not only pre-empted and hoarded supplies beyond their reasonable needs but refused to relax the intellectual property regime to enable free manufacture of vaccines in low-income countries. South Africa and India led the appeal, on behalf of low-income countries, to the World Trade Organization to waive IP protections—patents, copyright, trade secrets. That appeal was rejected contemptuously and cruelly. The UK is among the culprits; the US and France support the waiver, but we do not.
The statement by the United Kingdom Government to the TRIPS council on 16 October 2020 is a piece of Mandarin cant: amoral, inhuman and disconnected from the realities of life and death for billions of people. Let me quote from it:
“Beyond hypotheticals, we have not identified clear ways in which IP has acted as a barrier to accessing vaccines, treatments, or technologies in the global response to COVID-19.”
The Covid crisis is not hypothetical. The refusal to support the free production of vaccines in low-income countries has had catastrophic consequences, yet still government Ministers repeat this theme.
The Government also said in their statement:
“A waiver to the IP rights set out in the TRIPS Agreement is an extreme measure to address an unproven problem.”
The pandemic is an extreme situation and the problem is staring at us—howling at us. At least 350 million cases of Covid have been confirmed globally, and estimates of the number of deaths from Covid range from 5.75 million to much higher figures.
The Government stated that:
“Multiple factors need to be considered … These include increasing manufacturing and distribution capacity”.
Indeed. But the response to this challenge by our Government was to cut aid funding massively, from 0.7% of GDP to 0.5% of a declining GDP.
The Government then said:
“The world urgently needs access for all to … vaccines … which is why a strong and robust … IP system … is vital.”
That is a non sequitur to end all non sequiturs.
The last quote I will give from the Government’s statement to the TRIPS council is this:
“The UK has played a leading role in … ensuring no-one is left behind”.
Do the Government really believe that? It seems to me to be beyond satire.
If we refer to Our World in Data, a website from the University of Oxford, for up-to-date figures, we find that in low-income countries 10% of people have had at least one dose of vaccine, while in high-income countries the figure is 78%. Africa has been most wretchedly left behind: on the continent of Africa 15.2% of people have had one dose and only 28% are fully vaccinated, whereas in the United Kingdom 78% of people have had one dose and 73% are fully vaccinated. It is not surprising that African leaders have complained bitterly of vaccine apartheid. How does the Minister refute that charge?
I feel profound shame at the behaviour of our Government; not only have they been morally purblind but they have been recklessly imprudent. Consider the economic consequences. The IMF has downgraded African economic prospects. Do we gain from the impoverishment of Africa? Think only of the implications for migration. Consider the diplomatic consequences. Africa has turned to China. How does our vaccine nationalism assist post-Brexit Britain to develop relationships around the world? Consider the health and economic consequences for ourselves. If we do not tackle Covid globally, we risk continuing damage to our economy, and our physical and mental health, as we reel in and out of lockdowns and restrictions. Consider the consequences for the world. Professor Sarah Gilbert has warned that the biggest threat is Covid spreading and mutating uninhibited in unvaccinated countries. No one is safe until we are all safe. Dr Hans Kluge, the World Health Organization regional director for Europe, last week demanded a drastic and uncompromising increase in vaccine sharing across borders. He stated:
“We cannot accept vaccine inequity for one more day—vaccines must be for everyone”.
The United Kingdom has not paid its fair share of funding to the WHO accelerator programme. The UK committed to donating 100 million doses through COVAX, but what we have actually done falls far short of that; at the end of 2021, the figure was 30 million doses. Does the Minister accept that our Government have acted appallingly? Will he accept Amendment 292 and will the Government incorporate its principles, wherever relevant, in policy and legislation?
Health and Care Bill
Lord Brougham and Vaux ExcerptsTuesday 11th January 2022
(2 years, 3 months ago)
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The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
My Lords, before I call Amendment 5, I advise the Committee that the noble Lord, Lord Howarth of Newport, will be speaking remotely.
Amendment 5
Health Protection (Coronavirus, Wearing of Face Coverings) (England) Regulations 2021
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Lord Kamall (Con)
The UK Health Security Agency continues to monitor the situation closely in partnership with scientific and public health organisations across the world. Covid-19 is not going away and so we are likely to keep seeing new variants emerge. If we want to learn to live with the virus, we must follow the scientific evidence and advice and act in a proportionate and responsible way if a variant has the potential to thwart our progress. As we do this, we are taking a well-rounded view, looking not just at the impact of these measures on the virus, but on the economy, education, and non-Covid health, especially mental health. I am confident that the responses we set out today are balanced and responsible steps that are proportionate to the threat we face.
The Deputy Speaker (Lord Brougham and Vaux) (Con)
I call the noble Baroness, Lady Brinton. No? I call the noble Baroness, Lady Thornton.
Baroness Thornton (Lab)
I was happy to wait for the noble Baroness, Lady Brinton, to speak before me. I thank the Minister for introducing and explaining the content of these statutory instruments. As we discussed on Monday, the omicron variant is a sobering reminder that this pandemic is not over. I think we all agree that we need to act with speed to bolster our defences to keep the new variant at bay and to keep each other safe through the difficult winter period.
We on these Benches were critical of the Government’s slow response to the delta variant—slow to protect our borders, slow to act to reduce transmission in the community—so we welcome swifter action regarding this variant. It is right to be acting urgently given the seriousness of the threat. While it is sad to be debating these statutory instruments after the fact again, it is definitely an improvement on discussing them after Christmas or weeks later.
Turning to the regulations and starting with the Health Protection (Coronavirus, Wearing of Face Coverings) (England) Regulations 2021—I still have a problem with all the numbers on these, but this is number 1340—as I said on Monday, it is right to reintroduce masks on public transport, in shops and other settings including banks, hairdressers and post offices for those who are not exempt. However, we believe this measure should never have been abandoned. While mask wearing in public spaces forms part of the Government’s plan B, as far as we are concerned it should have been part of plan A rather than an emergency measure, as should encouraging working from home.
Now we have the issue of building confidence for compliance in the new law. The guidance will be important. When will the guidance about wearing of face masks be issued? USDAW, for example, the shopworkers union —in fact, the union I was a member of when I worked for the Co-op—said:
“Shopworkers aren’t police officers and shouldn’t be expected to act like them. They’re key workers who have kept our country going during these tough times. They deserve our respect.”
I also congratulate my friend and Co-operative colleague Paul Gerrard, who was on “Good Morning Britain” yesterday. He said on Twitter:
“We’ll make sure customers know rules & we’ll help them to follow them but we won’t put colleagues at risk”.
The Co-op is a responsible retailer, as are most of our retailers, but they all need the Government’s support. Have the guidelines been issued yet and what are the Government’s plans to support retailers?
As I said, we think these regulations are too modest and will not provide the protection the Government have described. For example, you will wear your mask to go into the off-licence to get some booze, and then you will go to a party indoors where no one will be wearing a mask. If you attend the theatre, you may get a taxi to the theatre and will wear your mask, and in the theatre some of the people in the audience may be wearing a mask but some will not. Will the Minister explain the scientific justification for those differences?
Social Care Funding: Intergenerational Impact
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Lord Sikka (Lab)
My Lords, I thank the noble Baroness, Lady Greengross, for this debate. Nearly 50% of social care expenditure is on working-age adults in this country, and every one of us is just one event away from the need for social care—so it is an issue not just for the elderly but for the whole society. With 18.4 million individuals on an annual income of less than £12,500 and median gross household savings in this country of only £11,000, hypothecated taxes, a higher basic rate of national insurance for the masses or insurance for the benefit of the rich property owners is not really the answer.
The best legacy that we can give future generations is a system in which social care is free at the point of delivery. Governments have bailed out banks, provided £895 billion of quantitative easing to speculators, thrown billions at contracts for cronies and continue to give billions in subsidies to railway, gas, oil and other companies. The Government can surely find resources to improve people’s welfare, too.
If the Government want to think in old-fashioned ways of tax and spend, they still have plenty of options without increasing the basic rate of income tax or national insurance contributions for the masses. Redistribution, as earlier speakers mentioned, is the key. Here are some things that the Government could do.
By taxing capital gains at the same marginal rates of tax as earned income, some £17 billion in tax, plus another £8 billion in national insurance, can be raised. Taxing dividends as earned income can raise £5 billion plus nearly £600 million in national insurance. By abolishing the current regime of tax reliefs on pension contributions, which mainly benefits the 40% and 45% taxpayers, and instead giving all pension savers a flat rate of 20% relief, another £10 billion can be raised. Currently, 12% national insurance is levied on earned income below £50,284, and only 2% is levied above that—a highly regressive practice. An additional £14 billion a year can be raised by extending the 12% rate to all income. However, the Government do not wish to inconvenience their rich friends.
Those proposals redistribute income and wealth by removing anomalies and tax perks for the few. They do not impose higher taxes on the young or most workers. There are no shortages of resources for free universal social care; there is only a shortage of political will to improve social welfare.
The Deputy Speaker (Lord Brougham and Vaux)
The noble Baroness, Lady Brinton, is taking part remotely. I invite her to speak.
Flu Vaccination and Blood Test Cancellations
Lord Brougham and Vaux Excerpts(2 years, 7 months ago)
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Lord Bethell (Con)
My Lords, I hear loud and clearly the very obvious feedback from noble Lords about cancelled appointments. It is not the same as the guidance that I have been given, but I will look into it when I get back to the department and will be happy to write to the noble Baroness with an update on them. With regard to test tubes, I reassure her that guidance was issued to the NHS and GPs recommending actions for medical directors, nursing directors, GPs and pathology laboratories. It required refinements that had an impact, but those with an acute need for blood were accommodated and a COBRA meeting was not needed.
The Deputy Speaker (Lord Brougham and Vaux) (Con)
I call the noble Baroness, Lady Stuart of Edgbaston.
Lord Bethell (Con)
My Lords, my understanding is that patient safety has not been at stake, but the noble Lord makes an extremely good point. I am not sure it is my role to instruct HSIB on this, but I will look into whether investigation is necessary. I reassure him that these shortages have not had a profound impact. We have marshalled the use of the tubes extremely carefully and have pushed back some routine blood-taking. That will have a small impact but we have put in place provision for a catch-up.
The Deputy Speaker (Lord Brougham and Vaux) (Con)
We now come to the noble Lord, Lord Young of Norwood Green.
Calorie Labelling (Out of Home Sector) (England) Regulations 2021
Lord Brougham and Vaux Excerpts(2 years, 9 months ago)
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Baroness Bull (CB)
My Lords, I share government’s commitment to addressing obesity. My concern with these regulations is not their underlying intent; it is that they will have limited impact on reducing obesity while causing real harm to people with eating disorders.
If body weight was entirely under volitional control, this measure might be the answer to the obesity challenge, but obesity is more complex than that. Metabolism, poverty, environment and psychology all play a part, while hundreds of different genes influence our propensity to gain weight. The assumption that voluntarily eating less and/or exercising more can entirely prevent or reverse obesity is at odds with a definitive body of evidence developed over decades. They are not my words, but those of 100 obesity experts in a statement co-ordinated by the World Obesity Federation. Yet government’s obesity strategy turns a blind eye to this evidence and to the complex interface between obesity and mental health. I am astonished that the Minister did not mention this.
Eating disorders affect 1.25 million UK citizens and have the highest mortality rate of all mental illnesses. While some manifest in low body weight, others, such as binge-eating, lead to obesity. Obesity is not a mental illness, but the two often co-exist, with 30% of the extremely obese having a diagnosable eating disorder. Obesity measures will work only if they take these interactions into account. These regulations do not. While the impact assessment admits the poor quality of the studies supporting calorie labelling, the evidence for harm is strong. It drives people with anorexia or bulimia to eat less and those with binge-eating disorders to eat more. It leads to unhealthy weight control behaviours such as laxative use or vomiting, and it increases disorders in the wider population.
Calorie counting is an all-consuming obsession and a common trait in eating disorders. One person described her disorder as thriving off counting calories, while another said it ruined their life. Recovery is possible but fragile, with learning to eat in public a key part of the pathway. The affordable chains that these regulations affect are exactly the places where this happens. One sufferer described overcoming a terror of restaurants but said, “With calorie counts on the menu, I don’t think I’d have coped”. Given the complex and secretive nature of eating disorders, it is unduly cruel to insist that restaurants provide label-free menus only on request. Will the Government reconsider this, and can the Minister confirm that daily calorie requirements in the guidance now match what the NHS recommends?
Public health always involves trade-offs, with small harms to a few the price of gains for the many. The risk of my mammogram is worth it because I am screened for a disease to which I am vulnerable, but can it be justified for a public health measure to hurt people with no risk of the disease? If labelling was really going significantly to impact obesity, this prioritisation of physical over mental health might be justified, but evidence suggests it will not. We need instead an integrated approach to weight-related issues across the spectrum, recognising the co-occurrence and shared risk factors for obesity and eating disorders, and involving both fields from the outset. These regulations are not that. Given the high levels of concern, I ask government to commit to reviewing their impact not just on obesity but on any rise in the rate of eating disorders.
My regret today is genuine. I regret the limited effect that the regulations will have on obesity and the distress they will cause to those with eating disorders, and I deeply regret that we have failed in our efforts to protect them. I regret that, despite so many people bravely speaking out and despite the efforts of charities and clinicians, it has not been possible to work together on a public health approach to obesity, an approach that would more effectively support one part of the community without causing lasting collateral damage to another.
The Deputy Speaker (Lord Brougham and Vaux) (Con)
I remind noble Lords that the time limit for speeches is four minutes. I call the noble Lord, Lord Brooke of Alverthorpe.
Baroness Wheatcroft (CB)
My Lords, it is a pleasure to follow the noble Baroness, Lady Bennett of Manor Castle, and her sensible comments on nutrition.
I support the amendment tabled by my noble friend Lady Bull. She is absolutely right: these regulations are misguided and will be counterproductive. If calorie labelling were an effective way of curbing obesity, sales of crisps would not have grown by 4.6% in volume last year. Neither would biscuit manufacturers have been able to enjoy a bumper year, with sales up 7.2% to almost £3 billion. Among the top 10 biscuit brands, only two failed to register growth—they were the ones in the healthier category. The best seller, McVitie’s chocolate digestive, has 86 calories. That may not sound a lot, but those prone to obesity find it hard to stop at a single biscuit.
These regulations are intended to hit in particular those who frequent fast-food outlets, but no one in Britain can be unaware that a Big Mac and fries will not win favour at Weight Watchers. In fact, together they add up to 845 calories. Throw in a caramelised frappe and you have 1,164 calories. Spelling it out on the menu will not reshape the eating habits of those intent on a quick and relatively cheap hunger fix, and it is the cheapness that is important. Obesity is strongly linked to poverty. A study of children in 2018-19 found that the incidence of childhood obesity was more than twice as high in the most deprived areas of the country as in the least.
Insisting that calorie numbers are on the menu will not deal with the obesity problem, but it will feed the problems of those suffering from eating disorders, the numbers of which are rapidly increasing. Only today it has been reported that hospitalisations of young people with eating disorders rose by 50% last year, and many more are queueing up to try to access treatment. Someone with anorexia nervosa will be as fixated on these calorie lists as a heroin addict on getting the next fix.
The regulations will make the struggle of trying to persuade an anorexic to eat something—anything—even harder than it is now. I know this because I spent many hours trying to persuade my desperately sick daughter to eat. It was sometimes easier to try to do this in a restaurant rather than at home, where she could take flight to her bedroom. As the noble Baroness, Lady Parminter, said, these trips were often very stressful for the anorexic and for all concerned.
My daughter nearly died. Had it not been for the brilliant Professor Janet Treasure and a year in hospital, she almost certainly would have done. Instead, she is a happy mother who has just produced her second child. Before making this speech, I asked if she would mind me talking about her, and she was keen that I should, because she wants to add her voice to those who counsel against insisting on this calorie labelling measure. She agrees that it would have added to the agonies of those sessions when she tried to find the least worst, in her demented view, item on the menu. Anorexics see calories as the enemy. I have been so fortunate that my daughter managed to overcome this pernicious illness, but these regulations will make it harder for others to do so while achieving very little positive.
While I realise that the Minister will not be swayed from his decision to go ahead with these regulations, may I add Lucy’s plea to that of my noble friend Lady Bull that he agrees to a timely review of their effects on everybody?
The Deputy Speaker (Lord Brougham and Vaux) (Con)
I now call the noble Baroness, Lady Fall. This debate is running out of time—four minutes, please.
Health Protection (Coronavirus, Restrictions) (All Tiers) (England) (Amendment) (No. 2) Regulations 2020
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Lord Bilimoria (CB) [V]
My Lords, I congratulate the Government. The Minister just announced the MHRA’s clearance of the Oxford University AstraZeneca vaccine. I congratulate Kate Bingham and the Vaccine Taskforce on this phenomenal example of collaboration between business, universities and the Government, and of international collaboration between Sweden and Britain. India has a contract for 1 billion doses to the Serum Institute of India—the largest vaccine manufacturer in the world. Could the Minister assure us that there will be all hands on deck for vaccinators, including retired doctors and nurses, wherever we can get volunteers, and that we will use all possible premises, including workplaces, as long as they are in a safe supervisory environment?
There was an excellent article in the FT the day before yesterday on rapid Covid tests, titled:
“Rapid Covid tests are being used more widely: can they be trusted?”
Yet here we have the example of Britain and France using rapid Covid tests to unblock the 48-hour blockage of movement. Enabling the use of these tests has saved so much. Can the Minister confirm that permission was granted on Tuesday for the public to use these tests on their own? Will the lateral flow tests now be available to the public? Professor Sir John Bell, Regius Professor at Oxford University, said:
“Testing asymptomatic people is an enormous priority … If there’s no testing, they don’t get caught. Every successful positive you get is a win.”
Surely that gives validation to this, yet we have others who say that we will miss half the cases. Professor Tim Peto of the University of Oxford said:
“They’re not perfect, but that doesn’t stop them being a game changer for helping detect cases of infectious disease”.
Would the Minister agree? There is also the very clear example of Slovakia. That test was employed throughout the country and lead to a 60% to 70% reduction in the rate of infection across Slovakia.
There is no perfect test. “Everything is a compromise”, according to Jo Martin at Queen Mary University. The best will otherwise be the enemy of the good.
The Deputy Speaker (Lord Brougham and Vaux) (Con)
Baroness Royall of Blaisdon. No? I call the next speaker, the noble Lord, Lord Greaves.
Medicines and Medical Devices Bill
Lord Brougham and Vaux ExcerptsThursday 19th November 2020
(3 years, 5 months ago)
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The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
A participants’ list for today’s proceedings has been published by the Government Whips’ Office, as have lists of Members who have put their names to the amendments, or expressed an interest in speaking, on each group. I will call Members to speak in the order listed. Members are not permitted to intervene spontaneously; the Chair calls each speaker. Interventions during speeches or “before the noble Lord sits down” are not permitted.
During the debate on each group I will invite Members, including Members in the Grand Committee Room, to email the clerk if they wish to speak after the Minister, using the Grand Committee address. I will call Members to speak in order of request and will call the Minister to reply each time. The groupings are binding and it will not be possible to de-group an amendment for separate debate. A Member intending to move formally an amendment already debated should have given notice in the debate.
Leave should be given to withdraw amendments. When putting the question, I will collect voices in the Grand Committee Room only. I remind Members that Divisions cannot take place in Grand Committee. It takes unanimity to amend the Bill, so if a single voice says “Not content”, an amendment is negatived and if a single voice says “Content”, a clause stands part. If a Member taking part remotely intends to oppose an amendment expected to be agreed to, they should make this clear when speaking on the group.
We will now begin.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
I call the noble and learned Lord, Lord Mackay of Clashfern. He is not there. The noble Baroness, Lady Jolly, is not with us either so I call the noble Baroness, Lady Penn.
Baroness Penn (Con)
My Lords, before I speak to the helpful debate we had on this group of amendments, I should like to make a correction to my response to an earlier grouping. At the time, I said that all adverse incidents with medical devices are available online on the MHRA’s website. I would like to correct this: adverse incidents with medical devices will be published online on the MHRA’s website as part of the plans to deliver increased transparency and in line with developing future legislation enabled by the powers in the Bill. However, it is not presently the case.
Turning to our present debate, I thought it might be helpful first to address the current arrangements for the regulation of medicines, veterinary medicines and medical devices in Northern Ireland. Responsibility for medical device regulation is reserved in respect of the whole of the UK. However, Part 1 of the Bill, relating to human medicines, and Part 2, on veterinary medicines, deal with transferred matters in relation to Northern Ireland. Clauses 1 and 8 set out that regulations in relation to Northern Ireland can be made either by the Secretary of State acting jointly with the Northern Ireland department or by the Northern Ireland department. This has always been the case; however, the MHRA and the VMD regulate these areas UK-wide on a day-to-day basis. After the end of the transition period, with regard to both human and veterinary medicines, as well as medical devices, under the terms of the Northern Ireland protocol, Northern Ireland will continue to follow the acquis.
Amendment 119 in the name of the noble Baronesses, Lady Thornton and Lady Ritchie of Downpatrick, seeks to ensure that, in making regulations under the Bill, the Government must minimise and mitigate the potential for regulatory divergence between Great Britain and Northern Ireland. Along with Amendment 120 in the names of the noble Lord, Lord Patel, and my noble and learned friend Lord Mackay of Clashfern, Amendment 119 seeks to establish a requirement for the Secretary of State to report to Parliament on areas of divergence between Great Britain and Northern Ireland.
I completely understand that these probing amendments seek to ensure that Parliament has proper sight of how medicines and medical device regulation develops in the future, particularly in relation to any differences between Great Britain and Northern Ireland. That is right and proper. Noble Lords will be aware, however, that the amendment in the name of my noble friend the Minister, on reporting obligations, means that the Government must already provide Parliament with a report every two years. This sits alongside the separate amendment to Clause 41 in my noble friend’s name, which requires a public consultation on any regulatory change to be made under the Bill.
That new reporting obligation on the operation of regulations made by the Secretary of State under Clauses 1(1), 8(1) and 12(1) is both forward and backward-looking. It must include any concerns raised or proposals for change made by anyone consulted by the Secretary of State in the preparation of the report, and the response to these. That may include advance notice of further regulatory change that the Secretary of State is proposing to make.
These reports, along with the public consultation on regulations under the Bill, would be the right place to deal with any issues of possible regulatory divergence raised. It would therefore be duplicative to require the Secretary of State to lay additional reports specifically on regulatory divergence for medicines and medical devices.
Noble Lords also asked a number of practical questions on how regulation will operate in Great Britain and Northern Ireland after the end of the transition period, which I will also address. The noble Baroness, Lady Wheeler, asked who would be responsible for any possible divergence between the Great Britain and Northern Ireland regulatory systems. I can reassure her that the MHRA and the VMD, reporting to their respective Secretaries of State, will continue to regulate human and veterinary medicines and medical devices for the whole of the UK, and will continue to ensure that patients and animals in Northern Ireland, just as in Great Britain, receive the safe and effective medicines and devices they need.
The noble Baroness, Lady Ritchie, asked specifically about the interaction between the UK Government and the Northern Ireland Executive on issues relating to future regulation of medicines and medical devices. I can reassure the noble Baroness that officials in the Department of Health and Social Care meet officials in the Northern Ireland Executive every two weeks to discuss the Bill and regulation of medicines and devices, and that a strong working relationship exists.
Robin Swann MLA has also given consent for the medicines day one-readiness statutory instrument, laid on 20 October, to be made by the Secretary of State for Northern Ireland as well as for Great Britain. We will continue to engage with the Northern Ireland Executive as plans for the future regulatory environment for devices and medicines develop.
The noble Lord, Lord Patel, also raised the approach to the day one readiness after the end of the transition period on which the MHRA has based its guidance to industry. I can reassure the noble Lord that, as I have just said, those regulations have been laid before Parliament, and we expect to debate them in early December.
Those regulations also require that from 1 January 2021, marketing authorisation holders must transmit all global serious reports of adverse drug reactions directly to the MHRA, to ensure that the agency has access to the totality of the information, to assess safety issues. This links to the noble Lord’s point on pharmacovigilance. I can reassure him that, following the end of the transition period, the MHRA will continue to be responsible for pharmacovigilance across the whole of the UK, and will use common processes for the assessment of safety issues in Northern Ireland and Great Britain.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
I think that the noble and learned Lord, Lord Mackay of Clashfern, is now with us. Are you there, Lord Mackay?
Lord Mackay of Clashfern (Con) [V]
Yes, I am here. My internet was turned off on the basis that I was on an aeroplane—which I have not been since March. That shows that some things are not absolutely reliable. Anyway, the noble Lord, Lord Patel, has dealt with the subject, and I do not need to trouble noble Lords any further.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
I now call the noble Baroness, Lady Wheeler. No? I gather that the noble Lord, Lord Patel, wants to speak. I call Lord Patel.
Lord Patel (CB) [V]
My Lords, I sent in a request to speak after the Minister. I am grateful to her for her lengthy response, but in a way it just shows that there will be considerable areas of divergence once we exit Europe, even after we exit Europe and the agreement with the EU has expired. What the Minister said is correct—that maybe the emergency power regulations will allow us to ask questions—but those are only emergency powers, and this is longer-term.
My amendment asks for an indication, on at least a yearly basis, of where divergences are occurring. It is interesting that the Minister said that the statutory instrument is now available and will be debated in due course. Of course it is available now—although I do not know when it was made available—and we will have an opportunity to debate it. However, the MHRA was already giving guidance on the basis of that instrument before we had seen it or debated it. The Minister’s reply did not therefore satisfy the intention behind my amendment—although I will, of course, not move it today—in terms of the necessity for the Government to produce a report of where divergences are occurring and why.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
We now come to the group consisting of Amendment 121. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 121
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, again, I thank my noble friend and her team for their work to produce the report and to ensure that patients and their families have been heard. Above all, I pay tribute to all the patients and their families who have so bravely shared their experiences to inform this important report. The report has been impactful and has already served to firmly put patient safety at the top of the agenda for all the healthcare system, and we in the Government are committed to learning from it.
On the amendment, if I may put this delicately, we must please remember that this is not a Bill to respond to the review. The Bill provides the powers needed to be able to update the current regulatory regime for medicines, devices and clinical trials in response to the end of the transition period, although the Bill does have the best interests of patients at its heart.
If it was not for the ongoing impact of Covid-19 on the health and care system, I believe that we would be discussing little else but patient safety. But, as my noble friend Lady Cumberlege has acknowledged in this Grand Committee, Covid has had a challenging impact on all our priorities, including on her own work on the NHS maternity transformation programme —and, of course, on the publication of her report, which was scheduled for the beginning of this year but, because of Covid, happened only 16 weeks ago.
I can assure noble Lords that much activity is already under way. Officials from across the healthcare system have been working together intensely since the report’s publication. They have been meeting weekly since August to ensure that we fully understand the report’s recommendations and the best way forward.
My noble friend has rightly mentioned the importance of listening to and involving patients in the implementation process. We absolutely recognise the need for effective patient engagement to ensure that we get implementation right. The Minister of State, Nadine Dorries, will provide an update on this and other matters related to the report in December, and I shall be very happy to report likewise to this House.
These debates have been clear, and I can assure noble Lords that, as part of our consideration of the report, we will of course want to be informed by the debates on this Bill before responding in detail to this very important report. I am very sympathetic to the desire of my noble friend and others to see the Government move quickly in responding to her report, but I do not agree that this Bill is a sensible method of delivery for that response. It is a weighty report, and our response will be rightly scrutinised when the Government responds to Parliament, but an amendment in this Bill is not the right mechanism. We should not be making policy through legislation, for that rarely makes for good government policy-making.
Therefore, I hope that this is a probing amendment, seeking some reassurance, rather than a firm request. In that spirit, I welcome the opportunity to update the Grand Committee on some of the progress that we are making to date.
Recommendation 1 has been implemented. The Government have, on behalf of the health and care sector, apologised to those women, their children and their families for the time that the system took to listen and respond.
We debated my noble friend Lady Cumberlege’s amendment for a patient safety commissioner just a few days ago, so I shall not repeat all the points raised. It was an insightful discussion, and I will think on it further, as I said during the debate.
We shall shortly be debating Amendments 122 and 123, on establishing a redress agency and redress schemes, so I will not pre-empt those discussions.
On recommendation 5, I know that my noble friend is already aware of work to establish specialist centres for mesh removal, but I would like to say a little more in recognition of its importance. NHS England is working closely with providers to set up the specialist mesh removal centres and is currently working to prepare for launch next April. The service specification for mesh centres describes how all centres must come together in a clinical summit to agree how we can develop the service moving forward, to agree standards that all centres will work to and to share data and outcomes. The first summit will take place tomorrow, 20 November. I am pleased to note that clinicians from the devolved nations are invited to that session too.
On recommendation 6, the MHRA has already begun a substantial programme of work to change the culture of the agency. Key priority areas are: first, listening and responding to patients; secondly, better utilising scientific evidence to strengthen and speed up decision-making on safety; and, thirdly, becoming more open and transparent in everything that the agency does. The MHRA is strengthening its yellow card scheme to make it easier for both patients and healthcare professionals.
On recommendation 7, as my noble friend will also be aware, we have debated Clause 16 of the Bill. Significantly, its provisions will mean that, in future, we can collect surgical implants and devices data from all NHS and private provider organisations, starting with mesh-related procedures and from that agreed next steps.
On recommendation 8, the General Medical Council already has guidance covering financial and commercial arrangements and conflicts of interest, which came into effect on 22 April 2013. In addition, the GMC’s updated consent guidance came into effect on 9 November. This reaffirms that any conflicts of interest that a doctor or their organisation may have should be shared with patients where relevant. We are considering whether these arrangements should be strengthened further.
My noble friend Lord O’Shaughnessy spoke of a worrying attitude of fatalism in the system, but I should also flag the work being done by GPs, universities and the royal colleges on long Covid and the excellent work being done to protect patients. We are listening to patients, who are presenting highly complex symptoms, including mental health, renal, cardiac, respiratory and other issues. I host a weekly round table that has full engagement with representative groups. We have mobilised a whole-system response. We are linking research with guideline writing for primary care in real time. We are using data thoughtfully, and we are mobilising networks of concerned groups around the country and around the world. This reflects the priority that we have already put on the recommendations of the patient safety report.
My noble friend Lady Cumberlege and her team took two and a half years to complete their review and present their findings, and I am intensely grateful for that. It is imperative, for the sake of patients and especially those who have suffered greatly, that we give this independent report the full consideration it deserves. I look forward to updating the House following the Minister’s Statement in the other place before recess. I therefore hope that my noble friend Lady Cumberlege feels able to withdraw her amendment.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
I do not believe that anyone wishes to come in after the Minister, so I call the noble Baroness, Lady Cumberlege.
Baroness Cumberlege (Con) [V]
I thank all those noble Lords who have spoken in this debate. I am extremely grateful to them. I have listened to what the Minister had to say, and I do not deny that meetings are taking place—I understand that they are—but I have no idea what is coming out of those meetings. But we will come to that in a minute.
The noble Lord, Lord Hunt, is quite right that actually implementing policy is the most critical thing and is extremely difficult. The Paterson report was a very interesting report on things that had gone terribly wrong with an individual surgeon who acted inappropriately, and, as I said when we debated the patient safety commissioner amendment on Tuesday, I understand that the Paterson report’s recommendations echo what our report said. What has happened to the Paterson recommendations? I do not believe that anything has happened. If things have happened, I would like to know what they are. I can show shelf upon shelf of wonderful reports that have been drawn together by people who have put their heart and soul into them, but, actually, nothing has happened. I am not going to let that happen with my report—I really am not—because there are too many people who have been so badly hurt and who deserve redress, which we will come on to in the next amendment. The noble Lord, Lord Hunt, is right that there is a missing piece in the jigsaw—the most important piece—because safety has to be a system.
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
We now come to the group beginning with Amendment 122, and we will not be interrupted by any Divisions. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 122
Covid-19: Vaccine
Lord Brougham and Vaux Excerpts(3 years, 5 months ago)
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Lord Bethell (Con)
My Lords, my understanding at the moment is that it is not necessary to take a coronavirus test before having the vaccine. This has been one of the subjects of the trials that have taken place so far. I do not believe that there is any effect at all but I am happy to check that, seeing as it is a detailed clinical point that is beyond my personal experience, and revert to my noble friend with confirmation of it.
The Deputy Speaker (Lord Brougham and Vaux) (Con)
My Lords, all supplementary questions have been asked.