Health Protection (Coronavirus) (Restrictions) (England) (No. 4) Regulations 2020

Lord Bethell Excerpts

Wednesday 4th November 2020 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 3 November be approved.

Relevant document: Instrument not yet reported by the Joint Committee on Statutory Instruments

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

My Lords, we have come to a critical juncture. Incidence rates are growing, and the NHS is under increasing pressure. The ONS now estimates that approximately 568,100—one in 100 people—in England have Covid-19. That has risen from one in 2,000 in July, and one in 240 at the beginning of October.

The Prime Minister explained things very clearly in the other place. The R number is above one in every part of England, the virus is spreading even faster than the reasonable worst-case scenario, there are already more Covid patients in some hospitals than there were in the first wave, and, even in the south-west, current projections mean that we will start to run out of hospital capacity in a matter of weeks. The chief executive of NHS Providers, the membership organisation for NHS trusts, said:

“Looking forward, there is a clear and present danger that the NHS will not be able to treat all the patients it needs to in the best and most timely way.”


The modelling presented by our scientists suggests that, without action, we could see up to twice as many deaths over the winter as we saw in the first wave.

I recognise that some noble Lords are sceptical about whether the full range of measures in these SIs is needed right now, or whether they are needed at all. I acknowledge the concern that perhaps the cure does more damage than the disease itself, but that is not the belief of the Government. Without action, the NHS will be overwhelmed, which could put life-saving procedures, cancer therapies, emergency services and diagnostic investigations at risk.

It is true that we are much better prepared than before, with large stockpiles of PPE and ventilators, the Nightingales on standby and 13,000 more nurses than last time. However, the virus is growing exponentially, far faster and heading far further than we could ever conceivably add capacity for. Even if, by some incredible national effort, we doubled capacity, that gain would be consumed in one gulp of the virus doubling once.

Meanwhile, the scientific evidence shows us that the measures have worked and lives have been saved. The analysis of my department, the Office for National Statistics and the Government Actuary’s Department has shown that the mitigations we have put in place have prevented more than 500,000 deaths, and our previous sacrifices and efforts have therefore saved us all from untold personal heartache, civic pressure and economic disruption.

However, we recognise that these interventions are difficult for many people, and that is why we have evolved our approach from the first wave and the previous lockdown. I will say a few words about this. For the first lockdown we paused non-urgent care to stop the NHS being overwhelmed. This time, we are maintaining as many NHS services as possible. In response to arguments made forcefully by noble Lords in this Chamber, we are prioritising education—doing everything we can to keep open schools, colleges, universities, childcare and early years settings.

We have taken steps to mitigate the impact on the vulnerable: the new lockdown measures include allowing support and childcare bubbles, support groups and unlimited outdoor exercise, for instance, to continue. We have amended guidelines to suggest that the clinically vulnerable and the over-60s should minimise their contact with others, and the clinically extremely vulnerable should work only from home, rather than asking them and their households to shield themselves, as we did for the first lockdown. On funerals, we have changed the Covid-secure guidelines to allow up to 30 people to attend.

Lastly, we have improved how we work with local authorities to support them in responding to this crisis. My department has regional teams made up of PHE regional directors, Contain regional convenors and Joint Biosecurity Centre regional leads, who work continuously with local authority chief executives, the directors of public health and local resilience forums. I pay testimony to all those noble Lords who have brought this challenge to our attention. These groups attend local incident management meetings and outbreak boards as well as meeting more informally. They also organise meetings at a regional level to share good practice and help areas support each other through mutual aid.

In relation to those who are less privileged and in the area of financial support—another subject raised by noble Lords—we completely recognise that these measures are difficult for the general public and business, which is why we will provide support to protect jobs and get people through the crisis. This includes extending the furlough scheme until the end of November, helping with mortgages, helping the self-employed—as the Prime Minister outlined earlier this month, we are doubling our support from 40% to 80% of trading profits—extending the deadline for applications to the Covid loans schemes, cash grants of up to £3,000 per month for business premises closed as a result of the national lockdown, additional funding worth £20 per head to enable local authorities to support other business affected by the lockdown, and other measures.

My final points are on the steps out of this lockdown. I stress that these restrictions are time limited: after four weeks, on Wednesday 2 December, they will expire, and we will return to a tiered system on a local and regional basis according to the latest data and trends. As the Prime Minister set out in the other place, the best way to get R down now is to beat this autumn surge and use the breathing space to exploit the medical and technical advantages we are making to keep it low.

Our doctors and scientists have led the way in improving how we treat people with Covid, work continues to progress on developing a vaccine and we are working to continue to increase our testing capacity, most notably with cheap, reliable and rapid-turnaround tests with results in minutes. As the Prime Minister outlined, plans are already in place for the deployment of these quick-turnaround tests, which we will manufacture in this country and apply in an ever-growing number of situations to allow us to beat the disease.

By way of conclusion, I acknowledge that these measures are difficult for us all. There is not one of us who does not regard them with a heavy heart, but I know that the general public will continue to come together, as they always have done. Together, we can protect the NHS and the vulnerable, and save lives. We must place difficult but time-limited curbs on our freedom in the short term so that we ensure greater freedom and prosperity in the long term. If we act now to suppress the virus and support the economy, education and the NHS, we can restore those cherished freedoms more quickly and get closer to the lives that we all want to be living. We cannot do this with the virus growing exponentially so we must all make sacrifices now for the safety of all. It will not be easy, I know, but in a pandemic the effective steps are not always easy. We are called on to make fundamental changes to how we work, live and interact with each other, in pursuit of a common cause. I beg to move.

Amendment to the Motion

Moved by

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, this has been a hard-hitting debate. I thank noble Lords for their clarity and candour. In honesty, I do not agree with everything that has been said, but I share the frustration expressed by noble Lords in the Chamber and I absolutely recognise the seriousness of the issues that have been raised.

Before going further, I reiterate noble Lords’ thanks to those NHS, social care and ancillary services for their ongoing work to tackle the virus, and to the public for the sacrifices that they have already made. I also thank the usual channels for allowing this debate to be scheduled before the regulations we are debating come into effect. I recognise that the delay in holding debates has been a concern for a number of Members, as has been raised many times in this Chamber, including by the noble Baroness, Lady Jolly. We have listened and will continue to value noble Lords’ scrutiny as we respond to the Covid crisis.

I completely hear the concerns of my noble friends Lord Robathan, Lord Forsyth and Lady Noakes and others that we have not published an impact statement. This is a temporary piece of legislation; there is no requirement to publish an impact statement. However, there has been a very large amount of published data, shared analysis and debate on these subjects. My noble friend Lord Mancroft put it very well with his characteristic colour. With NHS data, test and trace data, PHE data, SPI-M data and SAGE papers, a colossal amount of scientific data has been published into a vigorous debate. It is impossible to generate a scientific consensus; that is not what science is about. It is up to the politicians to make the decision. It has been the Government’s decision to go into these measures, and we stand by them, but in doing so we welcome the scrutiny of this Chamber and Parliament. I welcome the fact that we are debating these regulations today.

Noble Lords have raised a number of issues about the regulations. I would like to reference them, even if I do not have the time or capacity to offer answers to each and every one. A lot of them are about how we mitigate the lockdown measures. As I said in my opening words, we have already done a lot but there is more that we can do.

The noble Baroness, Lady Meacher, made a very good point about vape shops; I am happy to take that back to the department.

A number of Peers, including the noble Baroness, mentioned tennis and golf; that has been discussed and is the subject of a high-profile petition. I will take that back to the department as well.

The noble Baroness, Lady Bonham-Carter, and others mentioned rehearsals and live events, a subject that I care about enormously.

In terms of the relatives of those in care homes, particularly those visitors who provide an enormous amount of service and support for their loved ones, we are working really hard to get the testing capacity and systems in place to change the situation. The noble Baroness, Lady Walmsley, and the noble Lord, Lord Rooker, raised this.

The challenge faced by special needs children whose schools have been shut was well raised by the noble Baroness, Lady Walmsley. There will be challenges around riding schools for the disabled, but I am happy to take that back to the department. The noble Lord, Lord Knight, and the noble Baroness, Lady Jolly, mentioned children playing together, a situation that I am very aware of and one that I can definitely look into.

Private music teaching, raised by the noble Earl, Lord Clancarty, and the noble Lord, Lord Berkeley, swimming in pools, raised by the noble Baroness, Lady Altmann, and affordable food, raised by the noble Baroness, Lady Boycott, are all subjects that I am happy to take back to the department and write to noble Lords on.

Most powerful and emphatic was the point on freedom to worship, which my noble friends Lord Cormack and Lord Moylan, the right reverend Prelate the Bishop of Winchester and the noble Baroness, Lady Altmann, all raised. It is a very touching and important issue. I am happy to take it back to look into it further and, if possible, seek some sort of mitigation.

The noble Lord, Lord Desai, put it well when he described the “luxury” of six Motions on this SI; it is not something that I have come across before. I will try to enjoy the privilege in addressing them.

The concern of my noble friend Lord Lilley that the regulations were laid under the Public Health (Control of Disease) Act 1984 has been raised a number of times in the Chamber. I have answered it a few times before but will do so again. His point is that this Act does not give specific powers to Her Majesty’s Government to impose restrictions on uninfected persons. However, the Government’s view is that this legislation does provide those powers. I am happy to take up his points on the Civil Contingencies Act with him. It has been looked at by the Government, but our very strong advice is that it could not be used on this occasion.

In relation to the concerns of my noble friends Lord Shinkwin and Lord Cormack, I do not agree that we compare unfavourably with totalitarian regimes. This virus can infect everyone, and the only way to protect our loved ones is by taking the necessary steps to bring down the R number. Our measures have been applied largely through consent and enjoy enormous popular support.

I completely agree with the concerns of the noble Baroness, Lady Meyer, on the impact of the lockdown on mental illness and other long-term psychological harm. The Government share these concerns and we have taken a huge number of steps to reduce the risk, which include providing exemptions to stay-at-home guidance and supporting the charities concerned.

A number of noble Lords including the noble Lord, Lord Scriven, raised NHS Test and Trace and the challenge around tracing. I agree that the regulation provides breathing space for us to upgrade the tracing service and build the capacity of the testing service. Noble Lords mentioned the work we are doing on that in Liverpool; that will be an enormously impactful pilot and experiment which, if it proves successful, could have a transformative effect on the way in which we manage this pandemic.

The noble Lord, Lord Boateng, referred to the challenge faced by those from a BAME background. I reassure him that staff who are potentially at greater risk of serious illness from Covid have been protected. Over 95% of BAME staff in the NHS have received risk assessments and, where necessary, agreed to mitigating measures.

As I said before, no Government would want to take these measures. However, if we do not take them now, we will not make use of the hard work and sacrifices that we have all made. We do not seek to repeat the mistakes of the past, but to demonstrate that we have a plan and are serious about beating this virus. As the Prime Minister said in the other place, although scientists are bleak in their predictions in the short term, we are unanimously optimistic about the medium and long terms. The noble Baroness, Lady Thornton, asked about the exit strategy. The ongoing work on vaccines and test and trace will, I believe, allow us to beat this virus.

I will quite happily come back to the House when these regulations are near their expiry, if not before, to update your Lordships on our next steps. I believe that the case is proven, and that the necessity and urgency of these measures have been put forward by the Government. For that reason, I respectfully ask that my noble friends Lord Robathan, Lord Forsyth, Lady Noakes, Lord Shinkwin, Lady Meyer and Lord Lilley withdraw their amendments to the Motion. I hope that I have addressed noble Lords’ questions, and beg to move.

Medicines and Medical Devices Bill

Lord Bethell Excerpts

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Baroness Jolly (LD) [V]]

I should apologise to noble Lords: my noble friend Lord Clement-Jones is unable to be part of today’s Committee, so I will be speaking on his behalf—at some length but without, I suspect, his bravura.

Amendment 30 seeks to tighten the provisions in Clause 3 to avoid the unintended consequences of data being used for purposes other than to ensure that medicines are safe. Amendment 31 also seeks to do this, by requiring a framework for data to be used as agreed in consultation with the pharmaceutical industry, and Amendment 33 places a duty on the Secretary of State to

“act with a view to”,

rather than

“have regard to the importance of”,

ensuring that information is retained securely when exercising powers.

There is no doubt that the noble Baroness, Lady Thornton, the noble Lord, Lord Hunt, and my noble friend Lord Clement-Jones are travelling down the same road, and I have very similar concerns. That is why we signed Amendment 30, and I am grateful to the noble Lord, Lord Hunt, for his support for the amendment tabled by my noble friend Lord Clement-Jones.

As explained at Second Reading, there are grave concerns about the wording of Clause 3(1)(b), relating to the development of a UK system to prevent the supply of falsified medicines. The clause refers to

“the use, retention and disclosure, for any purpose to do with human medicines, of information collected”

by such a system. This is an attempt to unreasonably broaden the original data-collection provisions of the Falsified Medicines Directive after the transition period.

The background to the current legislation is very clear. By the early 2000s, pharmaceutical companies were concerned about falsified, counterfeit products entering the legitimate medicines supply chain—especially high-value items such as Viagra. At that time, this was the only real way to distribute such products at scale. Schemes involving pack serialisation were proposed to reduce the risk of reputational and trading losses from counterfeit and falsified medicines entering the supply chain, and to reduce the potential risk of harm to patients.

A stakeholder model was established which is governed by the main groups in the supply chain and funded mainly by manufacturers—branded, generic and parallel trade—with smaller contributions to costs from wholesalers and pharmacies. These proposals became the EU Falsified Medicines Directive 2011/62/EU. In the meantime, the issue of falsified medicines had moved largely to the internet, where they are sold from trading platforms and/or unlicensed pharmacies.

So why is data use so important? As the Company Chemists’ Association has pointed out, data is a very sensitive commercial currency. All parts of the medicines supply chain need access to broad patterns of medicines usage for the purpose of planning or adjusting manufacturing, marketing, prescribing, buying and stock control. But access to pack information—who is handling which packs—could highlight purchasing decisions, the margins being made and those trading for import/export purposes.

So the principle of “Whoever generates the data owns the data” was enshrined in Article 38 of the associated delegated regulation of 2016. As a result, general access to FMD data is restricted to pack information—name, batch, expiry, serial number—and active/inactive status, with some exceptions for investigating incidents and national competent authority use for reports, reimbursement, and pharmacovigilance and pharmacoepidemiology research.

The Department of Health and Social Care already has access to a very wide range of data on the sales of medicines, and their use in the UK, under the Health Service Products (Provision and Disclosure of Information) Regulations 2018. These require manufacturers, wholesalers and pharmacies to provide summaries of products sold and prices paid. Ministers can request more detailed information if required.

Given both this access and the known sensitivities around FMD data, it is unclear why the department has included the sweeping provision of Clause 3(1)(b) on the use, retention and disclosure for any purpose of data collected under a falsified medicines system, and why this has not been discussed with stakeholders in the existing Falsified Medicines Directive scheme.

The pharmacy community has concerns not just that the department might accidentally release commercially sensitive data—this is covered by Clause 3(3)—but that it might use such data to gain unfair advantage by abusing its monopoly position as the main purchaser of medicines in the UK. Pharmacies wish to see data use under any future system being part of an agreement that has been subject to discussion with stakeholders and approved by Parliament. My noble friend understands that the department has said that the details of any proposed use under a new falsified medicines system would be contained in a statutory instrument by the affirmative procedure.

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

My Lords, I understand that the intention of Amendment 30, in the name of the noble Baroness, Lady Thornton, is to prevent the use of data for any purpose other than preventing the supply of falsified human medicines. The noble Baroness raises an important question. Let me reassure her that we have thought very carefully about these powers. There is an important precedent already for using the data held in the current EU Falsified Medicines Directive “safety features” system for wider purposes. For instance, as well as using the data to investigate instances of falsified medicines, data on the EU system can be used for the purposes of reimbursement, pharmacovigilance and pharmacoepidemiology. The effect of this amendment would be a step backwards on what any potential falsified medicines scheme introduced under Clause 3 could deliver.

We know from implementation of the EU system that the checks involved could generate a rich source of data, and that there may be circumstances where we would want to be able to use that data to support the safe and effective use of medicines. For example, information in a future falsified medicines scheme could be useful in the event of a product recall to help quickly identify individually affected packs. I recognise that information about the supply of medicines through the supply chain can be commercially sensitive—the noble Baroness, Lady Jolly, made this point very well. That is why Clause 3 ensures that, in making regulations under this power, the appropriate authority must ensure that information is retained securely. Information will be subject to strict controls set out in regulations, including what purposes the data could be used for, who would have access to or use it, and under what conditions.

I turn to the noble Baroness’s second amendment in this group, Amendment 33. While I understand the desire of the noble Baroness, Lady Thornton, to ensure that we have robust requirements around the safeguarding of information, this amendment would cause difficulty for the appropriate authority making regulations under the provision in Clause 3. This is because it would require action to secure retention of data even where the regulations themselves may not concern data—for example, provisions related to who may set up the infrastructure.

Amendments 31 and 32, in the name of the noble Lord, Lord Clement-Jones, would operate together to place an obligation on the Secretary of State to seek to agree and lay a framework on the use of information collected for the purpose of preventing the supply of falsified medicines. This would be done within six months of the Act coming into force.

We can all agree with the noble Lord, Lord Hunt, and others that close collaboration through consultation with stakeholders, including with pharmacists, is essential to getting something like this right, not least given the importance of data security. However, Amendments 31 and 32 would not create the right mechanism for providing this. I can reassure the noble Lord that we have planned fulsome engagement and consultation with a wide range of stakeholders. This can be achieved without this additional obligation, but I would be glad to commit to an engagement session with noble Lords and officials if noble Lords would find this helpful.

The Government have committed to exploring all options in regard to a falsified medicines scheme to ensure that patients continue to be protected from the public health threat posed by falsified medicines. As part of this, we will explore with stakeholders what information needs to be collected as part of any national scheme. Only once we have established how any scheme could work can we fully consider how the information that it collects could be used to deliver the most benefits for the UK and for patients. However, this amendment would force us to consult on an agreed framework outlining the use of information within six months of Royal Assent, without necessarily having the full picture of how a national scheme could work.

We also want to explore creative uses of information as long as they are for public interest purposes. Therefore, we do not want to constrain or limit options ahead of engagement with stakeholders.

I should make it very clear that the overarching principles of the Bill as set out in Clause 1 also apply to our powers here. The scope of the purposes mentioned is not unfettered. The appropriate authority must be satisfied that regulations dealing with anything under Clause 3—not just around how the information will be used—will promote the health and safety of the public. In making that assessment, the appropriate authority is required to have regard to the three considerations discussed previously in Committee.

I remind noble Lords that Amendment 126 in my name ensures that this will be a public consultation, while Amendment 131, also in my name, places an obligation on the Secretary of State to review regulatory changes made under Clause 1(1). The consultation will consider how the information collected as part of the scheme could be used, and any regulations providing for the use of information would be subject to parliamentary scrutiny under the affirmative procedure. In light of these reassurances, I hope that the noble Baroness, Lady Thornton, will feel able to withdraw her amendment and the noble Lord, Lord Clement-Jones, will be content not to press his.

[Baroness Thornton (Lab)]

I thank the Minister for his detailed response. I just have to wonder why the consultation did not take place before the Bill was drafted. You have to ask why stakeholders were not involved in the discussions prior to this happening and why they then felt the need to get in touch with those of us involved in this Committee to express their concerns. So I have to say to the Minister that I will certainly be discussing with stakeholders their reaction to what the Minister has said and whether that allays their frustrations and anxieties.

The process that the Minister described, which I shall read in detail and think carefully about, looked circular. It looked like a process that involves consultation, powers in the Bill that we have already questioned, and the affirmative procedure. All those things may not be satisfactory, so we will probably need to return to discuss this at a later stage of the Bill—or, preferably, before. I beg leave to withdraw the amendment.

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[Baroness Thornton (Lab)]

My Lords, I will not add much more, as I am very interested to hear what the Minister has to say. The noble Lord, Lord Patel, has done the Committee a great service by tabling the amendment and asking this question. I was not aware that there was an issue here, which there clearly might be, and I will be interested to hear the answer. If this is an area that is covered by European Union regulation, and we are therefore creating a new regulatory framework for children’s data in clinical trials, it is important that we know that and how it might happen. I am very interested to hear what the Minister has to say.

[Lord Bethell (Con)]

My Lords, in response to the point of the noble Baroness, Lady Thornton, the noble Lord, Lord Patel, is right: paediatric trials are very important, and they have sometimes been overlooked. However, that does not detract from the fact that the UK has a strong international reputation for paediatric medicine research. The MHRA authorised 177 new clinical trials that included children in 2019—more than any other country in the EU. The Bill, in Clauses 4(1)(d) and (e), already enables us to make regulations about requirements to be met before the clinical trial may be carried out and on the conduct of the clinical trial. That can provide for a number of different options, including paediatric clinical trials. I reassure the noble Lord that the Human Medicines Regulations 2012 will include provisions equivalent to those of the EU paediatric regulations when amendments come into force at the end of this year. These include requirements for the review and approval of paediatric investigation plans. These plans are aimed at ensuring that the necessary data is obtained through studies in children.

I recognise that the EU regulations played an important role in promoting the development of paediatric medicines, so that children are not forgotten when adult needs drive drug innovation. I am happy to commit to write to the noble Baroness, Lady Jolly, on her questions about EU statistics on that matter.

I understand that there is currently ongoing evaluation of the EU paediatric regulations and that this may bring about changes to the legislative landscape. This Bill will allow us to adapt the UK regulations based on patient needs and to keep pace with any changes in any other jurisdiction, including the EU. It gives us the opportunity to go even further to enhance the UK system and to encourage UK paediatric trials.

It is critical that the UK paediatric regulatory framework remains flexible, to adapt to emerging paediatric research challenges, and supports UK innovation, while also supporting global development plans. I reassure noble Lords that the MHRA has already published guidance on a new UK approach to paediatric investigation plans. This is part of the GOV.UK transition period guidance for businesses and citizens. The UK will simplify the PIP application process for applicants conducting paediatric research by offering an expedited assessment where possible and by mirroring the submission format and terminology of the EU PIP system. This approach ensures that the UK can continue to provide incentives and rewards to support innovation in paediatric drug development and to encourage manufacturers to bring medicines to the UK market.

The MHRA will aim to continue to participate in paediatric scientific discussion among the global regulators at an early stage and during the conduct of clinical trials. This will facilitate the exchanging of emerging information during the studies to minimise the exposure of children to medicines that do not work or are unsafe, and we will aim to maintain a national position of influence, so that the final paediatric development aligns with, and supports, global regulators’ requirements.

I hope that the noble Lord, Lord Patel, has had sufficient reassurance that the amendment is unnecessary and feels able to withdraw Amendment 40.

[Lord Patel (CB) [V]]

I thank the Minister for his response, as I thank all other noble Lords who have spoken. A small point was raised, with a good, short debate and the right response. I beg leave to withdraw my amendment.

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Moved by

[Lord Bethell]

43: Clause 5, page 3, line 35, leave out from “regulations,” to “or” in line 36
Member’s explanatory statement
See the explanatory statement for the amendment in the Minister’s name inserting new subsection (1A) into Clause 5.

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[Baroness Jolly (LD) [V]]

My Lords, we support these amendments, which relate to the disapplication of regulatory provisions in an emergency. As the Bill stands, the Secretary of State may make regulations about these provisions. This can be subject either to

“conditions set out in the regulations”

or in

“a protocol published by the appropriate authority.”

As the protocol is not subject to parliamentary scrutiny, the amendment in the names of the noble Baroness, Lady Thornton, and the noble Lords, Lord Hunt of Kings Heath and Lord Patel, would remove this provision from the Bill so that, as the noble Baroness, Lady Wheeler, said, conditions would have to be set by regulations alone.

[Lord Bethell (Con)]

My Lords, the lockdown debate later this afternoon brings home the significance of an emergency like Covid. It requires swift, dramatic change to protect public health. Clauses 6 and 15 are essential. They would allow us to make provisions about the disapplication of a medicine or medical devices provision where there is a need to protect the public from a serious risk to health. We would need regulations to do this, because to act in breach of an otherwise applicable provision would be an offence.

Medicines is a highly regulated area. Regulations apply from development of medicines to delivery, right the way down to the pharmacy. It is a complex and overlapping system, designed to protect the end-user, the patient. But there are times when we need to switch off a circuit of the system to respond to an emergency. This is most vividly apparent when we speak of a Covid vaccine. This is end to end, from port arrival, to the logistics of its delivery, to who may administer it. We need to be able to pick this circuit out of the whole and isolate it. Otherwise, to disapply regulation without being highly specific is to disapply regulation not just from the vaccine but from other medicines as well.

This is the point of conditions that go alongside the disapplication. Where we know what the conditions will be, of course it should be in the regulations. But often we cannot know what the specific conditions are. That is where the protocol comes in that the noble Baroness, Lady Thornton, with her Amendments 46, 47, 93 and 94, would like to remove. I acknowledge that the Delegated Powers and Regulatory Reform Committee objected to the use of a protocol. I note that its condemnation was not limited to this Bill but was a broader point about other legislation as well. I hope that I can explain why such a protocol is necessary here.

Protocols are a last resort in any emergency that provides critical flexibility in highly regulated areas. They would be time limited to provide flexibility and administrative detail, tailored to the professional audience that requires it and in language which they are familiar with. A protocol will be used only where it is not be possible to determine all the necessary conditions of disapplication at the pace needed to deal with an urgent threat. The protocol allows for the finer details to be sketched in, while giving Parliament the structure of the regulations to consider. We can debate the principle of disapplying certain provisions of the regulations, without always having the specific names of medicines or vaccines in front of us.

There are existing provisions in the Human Medicines Regulations 2012 that allow for the disapplication of regulatory provisions on how prescription, pharmacy and over-the-counter medicines may lawfully be supplied. These are limited to circumstances in the event or anticipation of a pandemic disease. This formed part of the response to the swine flu pandemic in 2009. Six protocols were issued in relation to specific antivirals for the treatment of swine flu, enabling them to be supplied by authorised staff who would not normally be able to supply prescription-only medicines. This involved separate protocols for different strengths of oseltamivir, a demonstration of just how specific we would expect the protocols to be.

We have made an SI this month introducing provision for the use of protocols in relation to coronavirus and influenza vaccinations. That SI seeks to anticipate the certain flexibilities that might be needed but it is not possible to cover all eventualities. It anticipates the need for rapid supply and the potential mass administration of medicines, since the anticipated vaccine may be delivered by injection.

However, until we are presented with a vaccine, we cannot know how many injections are required, for example. That is a finer point of detail that has implications for the scale of operation required. The SI makes clear that the disapplication of existing regulatory provisions about supply and administration of medicines will be subject to conditions set out in the protocol. These conditions of disapplication will include specifics around the class of persons permitted to administer the vaccines, and the protocol would specify the process by which a person in that class is designated as a person authorised to do so. It will provide for supervision and recording requirements that must be met when the vaccine is administered. These requirements will change depending on the necessities of the specific vaccine. Parliament can debate the regulation, but until we know the detail of that vaccine, we simply cannot establish how this operation will run.

The emergency powers allow us to go broader in terms of disapplications than what is currently available, a reflection of the type of emergency we face. In the illustrative SI published on introduction we have provided some clarity on our intent. It gives an example of what might be needed to ensure the disapplication could be relied upon in response to other circumstances, including a spread of toxins, pathogenic agents, and so on, that give rise to the risk of serious harm to health. This too would operate alongside a protocol.

Amendments 93 and 97 in the name of the noble Baroness, Lady Thornton, relate to emergencies involving medical devices. Provisions already exist in the Medical Devices Regulations 2002. These provisions allow particular devices to be put into service without being subject to CE marking, following a duly justified request if the Secretary of State considers this to be in the interests of the protection of health.

The ventilator challenge allowed us to fulfil the clinical need for ventilators through a combination of CE-marked devices, and devices which were granted an exemption from the requirement. They were required to conform to bespoke technical specifications as a condition of the exemption being granted, and the technical specifications evolved as they needed to. That ensured that the only devices in service without a CE mark were those that met the highest possible standards.

Online publication will also support dissemination to the required audience, to whom it will be targeted, such as operators in the supply chain, enabling conditions to be quickly understood by those who must use them, referring to concepts, processes and so on that they are familiar with from their field.

Protocols are a last-resort power. Where we can anticipate what the conditions of disapplication will be, we will put these into regulations, but I cannot say now how many injections will be required for a Covid vaccine or how many staff will be needed to deliver it. Parliament has our intent, our plans and our proactive preparations now, but not technical specifications—nor do we. I commend the noble Baroness, Lady Thornton, and her team for all they do to hold us to account. It is right that they look at how we can write good legislation, although we need legislation that allows for practicality in a crisis. Therefore, I hope I have provided enough assurances for her to feel able to withdraw her amendment.

[The Deputy Chairman of Committees (Baroness Garden of Frognal) (LD)]

My Lords, I have received a request to speak after the Minister from the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

My Lords, I say respectfully to my friend the Minister that he is putting up smokescreens. As he mentioned, he already has the power under the 2012 Act to do much of what he wants to do. Furthermore, the arguments used all relate to the Covid emergency. He alluded to this afternoon’s debate and the measures that are about to be taken, but he already has those powers, otherwise he would not be able to do it. We have emergency legislation related to Covid, which includes immunisation through vaccines. By the way, how many doses would be required? It is not necessary to have that in legislation: it is a clinical decision based on the effectiveness of a vaccine. I do not require legislation to tell me how many tablets I should prescribe to my patients for any disease, so I fear that these are smokescreens. He already has powers of disapplication in an emergency, and I continue to support the amendment.

[Lord Bethell (Con)]

I welcome the challenge from the noble Lord, but the examples we have given are also more recent, from the 2009 swine flu attack. The protocols were also used in the Salisbury Novichok attack. I know from my own experience that public health disasters can throw up extremely unexpected hurdles and barriers to action, in the form of legislative surprises. Therefore, these powers are not considered to be frequently used. In fact, they are never used—noble Lords will all breathe a sigh of relief—but public health challenges are likely to be a feature of the future, and it is prudent to put in place the protections we need in order to provide for them.

[Baroness Wheeler (Lab)]

I thank noble Lords for their contributions in supporting the amendment—the noble Lord, Lord Hunt, reinforced by the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly. I was particularly interested to hear the quote from the Leader of the House on this matter, and I am glad that that has now gone on record. I certainly echo the comments by the noble Lord, Lord Patel, about what he calls smokescreens, and his underlining of the powers the Government already have for dealing with such situations.

I thank the Minister for the very detailed explanation he offered on this issue, and for telling us why the Government feel that they do not need to address the DPRR Committee’s concern and table amendments. He also talked about protocols being a last resort, and I was grateful for that—and also for the fact that they would be time limited. I note those two things. This is a complex issue, not least for me. I need to look carefully at the Minister’s response, and, if necessary, come back to this issue on Report. I beg leave to withdraw the amendment.

--- Later in debate ---

Moved by

[Lord Bethell]

48: After Clause 6, insert the following new Clause—
“Disclosure of information in accordance with international agreements
(1) This section applies to information which a relevant authority holds in connection with human medicines.(2) The relevant authority may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of human medicines. (3) The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority—(a) considers that it is necessary to do so for the purpose mentioned in that subsection, and(b) is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.(4) Except as provided by subsection (5), the disclosure of information in accordance with this section does not breach—(a) an obligation of confidence owed by the person making the disclosure, or(b) any other restriction on the disclosure of the information (however imposed).(5) Nothing in this section authorises a disclosure of information which—(a) contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), or(b) is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016.(6) In this section—“commercially sensitive information” means commercial information whose disclosure the relevant authority thinks might significantly harm the legitimate business interests of the undertaking to which it relates;“relevant authority” means—(a) the Secretary of State, or(b) the Department of Health in Northern Ireland;“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018.”Member’s explanatory statement
This new Clause makes clear that information held by the Secretary of State or the Department of Health in Northern Ireland in connection with human medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.

Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Monday 2nd November 2020 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020.

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

My Lords, these regulations are critical in giving effect to the Ireland/Northern Ireland protocol for the safety and quality of blood, organs, tissues and cells, including reproductive cells.

I will give a brief moment of context. In January, the European Union (Withdrawal Agreement) Act 2020 was agreed by this House. It brings into domestic law the withdrawal agreement between the UK and the EU. Included in the withdrawal agreement is the protocol on Ireland/Northern Ireland, commonly referred to as the Northern Ireland protocol.

On 20 May 2020, we set out our approach to implementing the Northern Ireland protocol as part of meeting our obligations under the withdrawal agreement. We are committed to meeting these obligations, all the while recognising the unique status of Northern Ireland within the UK and the importance of upholding the Belfast, or Good Friday, agreement.

These SIs covering donated blood, organs, tissues and cells support the vital role that these materials play in life-changing treatments for UK patients—whether it is blood transfusions to treat major blood loss, heart transplants to treat heart failure, stem cells to treat blood cancer, or eggs and sperm to treat infertility, patients rely on these treatments every day. Last year in the UK, there were 3,760 deceased organ transplants, approximately 1,100 people benefited from UK-donated stem cells and approximately 13% of IVF cycles used donor eggs or sperm. Many people would not be alive today if it were not for the generosity of donors.

The UK’s current high safety and quality standards for blood, organs, tissues and cells are derived from EU law. The application of these standards makes Britain one of the most progressive regulatory environments in the world.

Last year, in preparation for the UK leaving the EU, the Government made four statutory instruments to fix shortcomings in the current law caused by EU exit. These were made on a UK-wide basis and come into effect on 1 January 2021. These 2019 statutory instruments maintain the current safety and quality standards across the UK.

So let me explain for a moment what these regulations do. The Northern Ireland protocol requires Northern Ireland to remain aligned with the EU blood, organs and tissues and cells directives for as long as the protocol is in force, including any future changes to the directives. These four instruments will come into force on 1 January 2021 and will ensure that Northern Ireland continues to be aligned with the directives after the end of the transition period. There are five ways in which they do this.

First, the regulations ensure that the safety and quality standards will remain the same across the UK from 1 January 2021. These standards are currently aligned with EU directives. Secondly, the UK regulators for blood, organs, tissues, and cells will continue to act as the competent authorities for Northern Ireland in respect of the EU. This means that the Medicines and Healthcare products Regulatory Agency, the Human Tissue Authority and the Human Fertilisation and Embryology Authority will continue to meet the same EU obligations for Northern Ireland as they do now.

Thirdly, these instruments amend the definition of “third country” for imports into Northern Ireland to ensure that we meet the terms of the Northern Ireland protocol, but also meet our commitment to unfettered access. This means that from 1 January 2021, when establishments in Northern Ireland receive blood, organs, tissues and cells from Great Britain, they will need to treat them the same as those received from outside the EU. In accordance with our commitment to unfettered access for goods moving from Northern Ireland to Great Britain, there will be no changes to the requirements when sending blood, organs, tissues and cells from Northern Ireland to Great Britain. The movement of blood, organs, tissues and cells around the UK is critical for patient treatment, and we are committed to ensuring that this movement can continue from 1 January 2021.

Fourthly, these instruments will require tissue establishments in Northern Ireland to continue using the single European code for traceability purposes, as they do now. Fifthly, the 2019 statutory instruments introduced some limited regulation-making powers into UK law for each of the UK nations. The EU withdrawal agreement Act 2018 contains the powers needed to make changes in relation to the safety and quality of blood, organs, tissues and cells for Northern Ireland to ensure future alignment with any changes to the directives. Therefore, the powers in the 2019 statutory instruments are no longer needed for Northern Ireland, and consequently these regulations limit those regulation-making powers to Great Britain.

Let me be clear: the fact that Northern Ireland will remain subject to EU law in this area does not mean that the UK as a whole will be prevented from making changes to the safety and quality regime in this area. The EU directives in this area set minimum standards of safety and quality. They allow member states to go further if they wish. If the UK as a whole wished to move forward and change the safety and quality standards, this could be done. They are a floor, not a ceiling.

A lot of preparatory work has already taken place. The regulators for the relevant sectors are working with licensed establishments across the UK to help ensure they are ready for any changes that will arise from 1 January 2021. They are supporting establishments to put any necessary import licences and agreements in place, preventing any disruption in the supply of blood, organs, tissues and cells. These changes affect only a very small number of establishments in Northern Ireland: one blood establishment, one transplant centre, two licensed tissue establishments and four fertility clinics. There will be some minor administrative costs for establishments in Great Britain moving blood, organs, tissues and cells to Northern Ireland.

Regarding the DAs, legislative competence for the donation, processing and use in treatment of human reproductive cells remains reserved to Westminster. Competence in respect of all other human tissues and cells, blood and organs is devolved, and the relevant instruments are being made on a UK-wide basis with the consent of the devolved Administrations. Work is under way to put in place a common frame- work between the UK Government and the devolved Administrations, to support co-ordinated decision-making on the safety and quality of blood, organs, tissues and cells after the end of the transition period.

To conclude, these regulations are vital to the Government’s preparations for the end of the transition period. It is essential that they are made to allow the UK to fulfil its obligations under the Northern Ireland protocol. The UK already has high standards for the safety and quality of blood, organs, tissues and cells. These instruments ensure the UK will continue to work to these high standards after the transition period; that blood, organs, tissues and cells will continue to be able to be moved around the UK; and that we have a platform to build the regulatory regime even further. I beg to move.

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I start by saying a profound thank you for a lively, insightful and patient debate, because I recognise that these issues have been visited before—and the debate only improves in the retelling. I shall try to trot through a number of points in quick order, because the debate has been wide-ranging and taken on a number of issues.

I want to start on the most important one, divergence, which was raised by a number of noble Lords, including the noble Lord, Lord Scriven, my noble friend Lord Lansley and the noble Baroness, Lady Thornton. On the question of divergence and one regulator overseeing different territories, I reassure noble Lords that we are moving towards developing a common UK framework for blood, organs, tissues and cells with the devolved Administrations precisely in order to avoid this problem. This is the mechanism whereby the four nations can work together to ensure that they are all aligned and that companies and individuals in each nation can feel confident that they are in one common legislative framework. Policy issues will continue to be considered on a four-country basis going forward. I reassure noble Lords that officials and Ministers in Northern Ireland will continue to be involved in policy development, as they have been to date.

After 31 January, blood, organs and tissues will keep moving from the UK to Northern Ireland and from Northern Ireland to the UK, and they will keep moving from the UK to the EU and from the EU to the UK.

There may be at an appropriate point in the future an opportunity for the department to review whether the UK’s exit from the EU offers us opportunities to reappraise current regulations to ensure that we continue to protect the nation’s health. When that moment arrives, we will consult, analyse and assess. The regulations put in place the opportunity to do that—but that is for a moment in the future and it is not envisaged in the near future. To reassure the noble Lord, Lord Alton, who asked about the devolved Administrations, Scotland, Wales and Northern Ireland have provided their consent to these statutory instruments and they continue to be closely involved in the development of policy.

The noble Lord, Lord Scriven, asked about the Medicines and Medical Devices Bill. I reassure him that the Bill as drafted would already allow us to strengthen the requirements governing the use of human tissues in the development of medicines, were it deemed necessary and appropriate to do so. For instance, powers under Clauses 1 and 2 would enable us to introduce new requirements to the Human Medicines Regulations 2012 for medicines manufactured using human tissues.

The noble Lord, Lord Scriven, and others asked about the movement of blood and blood components. This is a hugely important issue. Currently, the UK is largely self-sufficient in the supply of blood and blood components. It occasionally exports rare blood cells—fewer than 10 units per year—to the EU and to non-EU countries. However, as the noble Baroness, Lady Thornton, observed, blood components are frequently shared across the four nations, as needed to meet demand, and the regulations will ensure that that flow is not interrupted. The movement of blood, organs, tissues and cells around the UK is absolutely critical for patient treatment. That will continue as it is now. There will be some minor administrative changes for tissue establishments in Northern Ireland to receive tissues and cells from Great Britain, but there will be no change to the requirements for Northern Ireland establishments to send blood, organs and tissues to GB.

The noble Baroness, Lady Thornton, and my noble friend Lord Bourne asked about the United Kingdom Internal Market Bill. As they will know, the Bill has passed Second Reading. Amendments have been tabled to enable safety emergency exclusion functions as intended that can be applied, if required, to Northern Ireland qualifying goods. However, I absolutely reassure noble Lords that we are totally committed to upholding our long-standing track record of high standards on health and food, including in respect of the materials which are the subject of these statutory instruments. We have kept healthcare and social care services out of the scope of the services framework rules, ensuring that there is no disruption to the regulation of health and care services.

My noble friend Lord Lansley was right to point out that it is fast-changing world for blood plasma. This could not be more relevant than it is right now. Covid has shown the international constraints on supply and the potential for huge demand. I reassure him that this is uppermost in our minds and that we will put in place all the regulations necessary to ensure that British access to blood plasma from overseas remains as secure as it is today.

To the noble Lord, Lord Alton, I say personal thanks for the report which he sent me. It includes charges which we take very seriously. We are of course against organ tourism. I noted the powerful points that he made in Committee on the Medicines and Medical Devices Bill last month and look forward to further discussion on Report. I reassure him that my noble friend Lord Ahmad has written to the World Health Organization encouraging it to give careful consideration to the findings of the report of the International Coalition to End Transplant Abuse in China. The Government welcome any work that is rigorous and balanced, and that raises awareness of the human rights situation in China. We continue to monitor this issue closely and to consider carefully all the evidence presented to us.

I note the personal testimony of the noble Baroness, Lady Walmsley. My family has been the beneficiary of organ transplantation, so I completely endorse her concerns. Traffic between Great Britain and Northern Ireland will remain, as it will between GB and the EU. I am glad to confirm that Northern Ireland will align with the EU, but we will find a way to work with Northern Ireland within the UK common framework to ensure that this trade continues. I am reminded that between April 2019 and March 2020, the UK exported 13 organs to the EU and imported 13 organs from it. While these numbers may seem low, they are extremely important to those concerned and it is a priority to ensure that those movements continue. With those thoughts, I commend the regulations.

Motion agreed.

Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Monday 2nd November 2020 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020.

Motion agreed.

Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Monday 2nd November 2020 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020.

Motion agreed.

Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Monday 2nd November 2020 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2020.

Motion agreed.

Covid-19: Intensive Care Treatment

Lord Bethell Excerpts

Thursday 29th October 2020 Lords Chamber

[Baroness Falkner of Margravine]

To ask Her Majesty’s Government whether any part of the NHS has operated under policy guidelines described as a “triage tool” which determine intensive care treatment for patients with Covid-19, and whether such guidelines will be used in the future.

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

My Lords, claims that frail and elderly patients were denied care in wave one of the coronavirus pandemic, in part because of the triage tool developed by the NHS in case it was overwhelmed, are categorically untrue. The Government are ultimately responsible for national policy on public access to NHS services. However, decisions on who will benefit from care are made as part of normal clinical decision-making by clinicians. Guidance to help clinicians make rational evidence-based decisions in the event of ICUs being overwhelmed was commissioned but was halted when it became clear that the NHS would not be overwhelmed.

[Baroness Falkner of Margravine (CB)]

My Lords, I think that the whole House will be grateful to the Minister for his unequivocal rebuttal of that extremely concerning story. Let me be clear that this Question is not intended to criticise the NHS, for which we all have the highest regard. However, according to that Sunday Times story, under conditions of extreme stress, consideration was given to guidance that could have amounted to age discrimination. Does he agree that there is a need for the NHS to uphold its public sector equality duty? Will he provide reassurance that these triage tools should not be used to prioritise patients on any basis other than clinical need either this winter or going forward as routine?

[Lord Bethell (Con)]

My Lords, I am grateful for the opportunity offered by the noble Baroness to reinforce the point. Age discrimination is absolutely forbidden by the NHS constitution. The CMO wrote to NHS trusts on three occasions to reiterate that point. I quote a letter published on 7 April:

“The key principle is that each person is an individual whose needs and preferences must be taken account of individually. By contrast blanket policies are inappropriate whether due to medical condition, disability, or age.”

[Baroness Andrews (Lab) [V]]

My Lords, the Minister’s response is indeed very reassuring. Does he agree that many elderly people will have been very worried by the Sunday Times report? They will welcome the assurances that have just been given by the NHS and the professional bodies that triage was never intended or used as a strategy for implementation. However, we have to be mindful of the fact that, as the pandemic is accelerating, fears are rising. Therefore, it is vital to get this message out as loudly as possible, just as the NHS did in April, when it said at the start of the epidemic that, far from rationing ICU care:

“All patients should be treated respectfully and equally and should receive the best available care.”


Can the Minister say now what the Government will do to support the NHS in reassuring every potential patient, irrespective of their age?

[Lord Bethell (Con)]

We go into the second wave in much better shape in relation to coronavirus because we know so much more about the virus. In terms of medicines, the therapeutics, the practices, the training, the configuration of our wards and the building of the Nightingales, there is a huge amount of skill, learning and capacity in the NHS to ensure that everyone has the opportunity to receive the best possible care. I remind noble Lords that these claims not only worry patients, they are deeply offensive to NHS doctors, nurses and therapists who have cared for more than 100,000 Covid patients to date in hospital settings and are committed to providing the best possible care in a second wave.

[Baroness Barker (LD)]

My Lords, triage is a necessary part of emergency medicine, and it will continue to be. Can the Minister say what has been learned in emergency departments in areas that have been in lockdown, such as Leicester, Bolton and Oldham? What learning has there been in those areas that can be sent to other areas to inform what will continue to be a necessary practice and part of good medicine?

[Lord Bethell (Con)]

Our learning has come a long way. Practices within ICU units have changed as a result of what we have learned in relation to the way that oxygen is administered, the range of drugs available and the turning of patients. To date, triage has not been necessary because the NHS is so good at load management that patients can be dispersed and deployed through the system, which has not been placed under pressure. We expect to be in good shape for the second wave. The principle remains as the national medical director, Stephen Powis, stated in his letter of 7 April:

“The key principle is that each person is an individual whose needs and preferences must be taken account of individually.”


That remains our principle.

[Lord Lansley (Con) [V]]

My Lords, on precisely the point that my noble friend the Minister has just made, I know he will be aware of the revised version of ReSPECT—the Recommended Summary Plan for Emergency Care and Treatment—which was published in September by the Resuscitation Council UK. It is in wide, but rather variable, use. Will my noble friend encourage NHS England to make its use a best-practice requirement in relation to Covid-19 patients entering high-dependency or intensive care in the months ahead?

[Lord Bethell (Con)]

My Lords, we are extremely grateful to the Resuscitation Council for its work on this important tool. It gives an opportunity for patients to express their preference and for clinical judgment to be used at moments of acute intervention. It is being used in some places but, as the noble Lord rightly points out, its use is variable. I would be glad to take this back to the department to see what can be done to encourage its use more thoroughly.

[Lord Bilimoria (CB) [V]]

My Lords, I am the chancellor of the University of Birmingham, and the professors at the university hospital there said that there was no way that any triage tool was used. If anything, better intensive care treatment was given during the crisis, so I am glad that the Minister very categorically said that. The Sunday Times article was trying to insinuate that people were not getting the intensive care that they needed. Can he reassure the House that in the second wave, the Nightingale hospitals that were built at such brilliant speed will be used if needed and are ready for use?

[Lord Bethell (Con)]

My Lords, I completely agree with those at the University of Birmingham who confirmed that triage tools were not used. They were not necessary, and everyone had absolutely the best care that could have possibly been given to them. The Nightingale hospitals are on standby where necessary; they will be deployed if needed, but it is my hope that they will not come into play.

[Lord Collins of Highbury (Lab)]

My Lords, it is vital to sustain the trust of older people. Does the Minister agree, therefore, that it is now vital for the NHS to follow through on the commitments it made to improve services for older people living at home or in care homes, set out in last year’s NHS Long Term Plan? What are the Government doing to make sure that that happens?

[Lord Bethell (Con)]

My Lords, the implementation of the long-term plan is under way, despite Covid. We have put the care of the elderly—and, in fact, all those who are vulnerable and in need of social care, half of whom are under 60—at the centre of our efforts. Returning to the point of the question and the article, I remind noble Lords that two-thirds of our Covid in-patients were over 65. Each got the support and treatment that they deserved and needed, and that will remain our commitment during any second wave.

[Lord Scriven (LD)]

My Lords, in April NHS England issued the Reference Guide for Emergency Medicine. Non-conveyance guidelines for ambulance services stated that any care home resident should not be taken to hospital until it was discussed with a clinical advisor. Why, therefore, was a resident in a care home not given equal treatment of access to hospital as an equivalent person outside the care home setting, and has that instruction been withdrawn?

[Lord Bethell (Con)]

My Lords, I do not know whether that specific instruction has been withdrawn; I will be glad to write to the noble Lord on that. I reassure him that, during an epidemic of a highly contagious disease, a hospital might not be the safest place for someone who is ill in a care home; nor would it necessarily be the safest place for someone who has gone to their GP and is sitting in the GP’s surgery. It is therefore absolutely essential that clinical risk management and advice is sought before referral to a hospital. There is no prejudice or unfairness here: it is simply good clinical practice.

[Lord Balfe (Con)]

My Lords, the Sunday Times has form on inaccurate stories, as does the Telegraph. Indeed, I asked the Minister a Question on 21 September about a Telegraph story about age restrictions, and he assured me that there were none. I asked him

“will he agree to place a copy of all the circulars from DHSC in the Library so that we can see what is going out?”

In reply, he said

“I will inquire as to what we can possibly share, so that these decisions are as transparent as my noble friend wishes”.—[Official Report, 21/9/20; col. 1596.]

I think it would help keep the papers on the right track if more was put into the Library. Will the Minister tell me how he is getting on with his endeavours to get this information into the public domain?

[Lord Bethell (Con)]

My noble friend is entirely right to chase me in this matter. I remember the commitment very well and I will endeavour to find out from my colleagues at the department how they are doing in getting those important papers into the Library.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, the Minister was very forthright today in rejecting the Sunday Times story. A month ago, he was very forthright in an answer to the noble Lord, Lord Balfe, about blanket DNR notices. Picking up on the question today from the noble Lord, Lord Balfe, does he think that there might be an issue of communication where staff are working on the front line, where impressions are given that are not in accord with official government policy? In the light of all this, has he given some thought to the way in which communications with NHS staff might be improved in order to deal with these very troubling issues?

[Lord Bethell (Con)]

I am not sure that I agree with the implication of the noble Lord’s question—that somehow there is a prejudice on the front line against older people and that staff take it into their own hands to make decisions that are in themselves inherently unfair. That is not my experience. Where the noble Lord absolutely has a point is that people are extremely sensitive about these kinds of issues, and, quite rightly, are deeply concerned that they are going to get the treatment and care that they deserve and will not be subject to any form of unfairness. It is imperative that the NHS builds trusts and conveys a strong communication on these issues. To push back against the noble Lord, it is not my impression that the staff at the NHS have lost sight of this important principle.

[Baroness Uddin (Non-Afl)]

My Lords, I declare an interest in that many of my family and friends work on the front line of the NHS, which I love and respect, as all other Members do. At the height of the pandemic, I watched a programme on Italian and American doctors using algorithms for vital decisions on treatment, with one being highlighted where triage tools had indicated nil chance of a patient surviving. However, their family pleaded with the doctors and convinced them to give them a few more days to see if “a miracle could happen”. In April, my close friend’s death was predicted from the use of some kind of early triage process. Sadly, my friend lost his battle. However, the miracle occurred: against all the odds, because of one decision by one team of doctors, the Italian patient survived. Given the fiasco of the use of algorithms, although I welcome the Minister’s absolute assurance, what analysis or serious case review has been undertaken of the number of treatment decisions based on early triage tools, given that extreme pressures on doctors have returned? Where deaths have occurred, can the Minister say what proportion were individuals of Bangladeshi heritage? Can any lessons be learned to improve their survival chances in the current emergency?

[Lord Bethell (Con)]

My Lords, I share my sympathies with the noble Baroness for the loss of her friend, for which we are all very sad. However, I take exception to her implication of a fiasco in the use of algorithms. I do not accept the implication that it is regular practice for clinicians somehow to give up on patients who stand a chance simply because their reading of an algorithm says that they should move on to someone else. That is not how we run the NHS; it is not how we had to run it during the first wave and it is not how we intend to run it during the second.

[The Lord Speaker (Lord Fowler)]

My Lords, all supplementary questions have been asked and both Private Notice Questions have finished.

Social Care

Lord Bethell Excerpts

Wednesday 28th October 2020 Lords Chamber

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

My Lords, the Government’s current priority for adult social care is for all recipients of care to receive the support they need throughout the Covid pandemic. While we published a winter plan that looked ahead through winter 2021, we are acutely aware of the long-term challenges to the social care system in England and the importance of reform. Putting social care on a sustainable footing, where everyone is treated with dignity and respect, is one of the biggest challenges our society faces.

[Lord Young of Cookham (Con)]

I am grateful to my noble friend for that reply, but this is not a happy story. Last year, the Prime Minister said:

“We will fix the crisis in social care once and for all with a clear plan we have prepared to give every older person the dignity and security they deserve.”


A few weeks ago, however, that reply was diluted in a Written Answer that said:

“There are complex questions to address to which we want to give our full considerations in the light of current circumstances.”


That is straight out of “Yes, Minister”. When will we see the clear plan announced 15 months ago, together with a commitment to the necessary funds to redress the imbalance between health and social care, so tragically revealed by the current pandemic?

[Lord Bethell (Con)]

My Lords, I reassure my noble friend that there is absolutely no dilution in the commitment to a long-term solution. No one in the Chamber would deny that the challenges in this question are extremely complex. The Government are also committed to cross-party talks and everyone in the Chamber recognises that we need a generational solution, not a political fix. In terms of finance, it is undoubtedly the case that the social care system has been under pressure during Covid. That why we have put an enormous number of funds—I could list them—into social care in the past six months. The refinancing of the social care system is one of the items that will undoubtedly be on the agenda.

[The Lord Bishop of Carlisle]

My Lords, given the long delay in the publication of proposals for the reform of social care, the impact of Covid-19 on carers and care homes, and the implications of reform for the future of the NHS—not to mention the political sensitivity and complexity of the subject, which has been referred to—does the Minister agree that the best way to achieve the cross-party consensus to which he just referred would be through an ad hoc Lords Select Committee, as already proposed from these Benches?

[Lord Bethell (Con)]

My Lords, the development of a cross-party consensus is one of the great challenges that we have for the future. The mechanism that the right reverend Prelate suggests is imaginative, thoughtful and constructive, which I very much welcome and will take back to the department, but it is for the Prime Minister and the Secretary of State for Health and Social Care to define that precise process. But I completely welcome having our feet held to the fire on this issue. It is a massive priority that is at the top of the Government’s agenda.

[Baroness Chisholm of Owlpen (Con)]

My Lords, technology innovations have been used by healthcare professionals in the community during the pandemic. Really, they have flourished and have been shown to be of great benefit to social care. Will the Minister reassure the House that, during the reform of social care, funding is put forward for those innovations to carry on and indeed grow to their full potential?

[Lord Bethell (Con)]

My noble friend is entirely right. One of the experiences of Covid has been the mobilisation of technology to help those in social care. That has ranged from very basic implementation, such as sending iPads to people in social care so that they can message and video their loved ones when in some form of lockdown, to the work done with broadband providers to ensure that those without it can have access to it, all the way through to the use of the most complex artificial intelligence and big data, to help with diagnosis in social care, and the management of care itself. That commitment to technology will continue and will form an important part of improving the commitment to social care as part of the new regime.

[Lord Harries of Pentregarth (CB) [V]]

The Royal Commission on long-term social care, chaired by the late lamented Lord Sutherland of Houndwood, reported in 1999. Only two years later, the Scottish Government adopted its main proposal of state support for personal and/or nursing care. How is it that, some 20 years later, successive Governments in the UK have failed to address the issue properly, in the way that the Scottish Government appear to be able to do?

[Lord Bethell (Con)]

The noble and right reverend Lord is entirely right. There has been a large number of reports on social care, but they have not in themselves brought us closer to a new deal. That is why the Government’s commitment is not necessarily to launch new reviews but to engage in consensus building across the political parties. That consensus building has been lacking in the past and has continually proved to be the stumbling block to reform. The commitment of both the Government and other Benches to those talks is the essential building block of any major reform. I completely pay tribute to the Leader of the Opposition and the Prime Minister for their commitment to those talks.

[Baroness Wheeler (Lab)]

My Lords, the CQC’s report, The State of Health Care and Adult Social Care in England, was published earlier this month. Last year’s report described social care as being at a “tipping point”, and this year’s makes it clear that Covid has not only exposed but exacerbated existing social care problems and thrown into stark relief the long-standing need for reform, investment and workforce planning, including a new deal for care staff. The CQC stresses that the legacy of Covid for social care must be that these crucial issues are tackled now. Why can this not be a priority for the Government and why can we not have at least a timetable for the publication of the social care reform proposals that the Government keep promising but failing to deliver on?

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[Lord Bethell (Con)]

My Lords, I recognise the power of the CQC’s comments, and its report is indeed powerful. However, I have to be realistic. We are in the midst of a Covid winter, when there are enormous challenges in keeping the show on the road. We have an infection control fund of £600 million invested in social care, which demonstrates both the commitment of the Government to supporting social care and the sheer scale of ensuring that those in social care through this winter are protected from Covid and other influenzas. It just would not be right to launch an important and industry-changing reform process when the focus of everyone in social care is the protection of the vulnerable and our loved ones.

[Baroness Jolly (LD)]

My Lords, the noble Lord, Lord Young of Cookham, is absolutely right to ask this Question on an issue that Covid has highlighted as needing urgent and very long-overdue reform. I am pleased that the Government have plans to work on a cross-party basis to sort out this pressing issue. When does the Minister expect those talks to begin?

[Lord Bethell (Con)]

Talks are happening in the background in many ways. I cannot give the noble Baroness a precise date, because our focus is very much on managing Covid and learning its lessons, including from the CQC report that the noble Baroness rightly pointed out. But this is a massive priority both for the Government and for opposition parties, and I can reassure the noble Baroness that it will be taken on board at the soonest possible moment.

[Lord Forsyth of Drumlean (Con) [V]]

My Lords, further to the question from the right reverend Prelate the Bishop of Carlisle, the Economic Affairs Committee of this House produced a report on social care that had all-party support and was universally welcomed across the House. That was in July 2019—14 months ago. There has been no proper government response and no opportunity to debate it. How much longer must people in desperate need have to wait for the Government to reach a conclusion? I say to my noble friend that Covid is not an excuse for procrastination but an imperative for urgent action.

[Lord Bethell (Con)]

My Lords, we all acknowledge the power and intellectual insight of the Economic Affairs Committee report, which was welcomed on the Floor of the House and speaks for itself in terms of its authority and insight. But my noble friend is, I am afraid, not being reasonable when he says that Covid is not an excuse for inaction. There is an enormous focus on the front line and by the management of the NHS and the DHSC on preparing the winter plan, which is ambitious but also extremely stretching. There simply is not the management or political capacity to take on a major generational reform of the entire industry in the midst of this massive epidemic.

[The Lord Speaker (Lord Fowler)]

My Lords, the time allowed for this Question has elapsed and we now come to the fourth Oral Question.

Covid-19: Charitably Funded Hospices

Lord Bethell Excerpts

Wednesday 28th October 2020 Lords Chamber

[Lord Addington]

To ask Her Majesty’s Government, further to the impact of the Covid-19 pandemic, what action they are taking to make sure that charitably funded hospices have sufficient funding to continue to operate.

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

My Lords, hospices play an often unseen but hugely valuable role in providing patient care. That is why we provided more than £150 million of extra funding to hospices during the first peak, when hospices across the nation cared for 170,000 patients, thereby helping to protect the NHS and continuing to provide high-quality end-of-life care. We recognise that the second wave presents challenges for hospices. We thank Hospice UK, Marie Curie and all the other groups for their engagement on this important challenge.

[Lord Addington (LD)]

My Lords, it is nice to hear the Government thanking the hospice movement. Some 80% of hospices think that they will have to make redundancies. The voluntary sector takes on more than 75% of hospice treatment. If the Government are not going to fund hospices, will they take on the work themselves or are we just going to let people suffer at the end of their lives?

[Lord Bethell (Con)]

The noble Lord is entirely right. Some £1.54 billion is spent on hospices each year. Of that, £1.2 billion is charitable; I pay tribute to those from the hospice movement who were recognised in the recent Birthday Honours List for supporting that fundraising. Let me assure the noble Lord that the challenge he describes is recognised in the department. The Minister responsible will meet key hospice stakeholders, including from Marie Curie, Sue Ryder, Hospice UK and Together for Short Lives, on 4 November when the challenge that he describes will be discussed.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I am a long-standing supporter of Birmingham St Mary’s Hospice. If the current restrictions stay the same as now, the hospice estimates that, by the year’s end, fundraising and retail income will be down by more £1.5 million—and by more if we have a more severe lockdown rule. This is a massive amount for a small charity to make up. The Minister has referred to the support received from the Government via Hospice UK. That was hugely welcome, but the hospice movement needs an immediate second injection of funding, and it needs to know when that will happen. Hospices cannot wait much longer.

[Lord Bethell (Con)]

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

[Lord Goddard of Stockport (LD)]

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

[Lord Bethell (Con)]

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

[Lord Howard of Lympne (Con) [V]]

My Lords, I declare my former interest as the chair of Hospice UK. Does my noble friend the Minister agree that, even in the crude terms of value for money, because of its extraordinary ability to attract a huge amount of volunteer effort, the hospice movement is almost certainly the most effective sector in our entire healthcare system? Can he assure me that the Government will give full weight to that factor when they consider the urgent need of hospices for further support during this crisis?

[Lord Bethell (Con)]

I completely endorse my noble friend’s comments. Hospices are often the hubs for huge community efforts to raise money and to create volunteer support for those who are at the end of their lives. They are hugely valued in the healthcare system. The challenge that they face at the moment is recognised and we will meet our responsibilities to them.

[Baroness Butler-Sloss (CB) [V]]

I am the vice-president of Hospiscare Exeter. I will follow on from what the noble Lord, Lord Howard, just said. Despite what the Minister has been saying to us, I wonder whether Her Majesty’s Government are sufficiently aware of the extent to which hospices relieve the NHS and social care of the need to look after many terminally ill people by looking after them at home. Hospices dramatically need more financial support to continue with this terribly important initiative.

[Lord Bethell (Con)]

I assure the noble and learned Baroness that we understand absolutely the contribution of hospices, the value for money that they represent, the role that they play in communities and the incredible sensitivity with which they handle end-of-life and palliative care. I pay tribute to the contribution made by the noble and learned Baroness to the Living Well Dying Well charity and to Hospiscare. It is the contribution of people such as the noble and learned Baroness to the hospice care movement that has made it such a powerful and sensitive supporter of people at their time of most urgent need.

[Baroness Thornton (Lab)]

It will be quite clear to the Minister now that virtually every single Member of your Lordships’ House has a local hospice to which they are attached. Mine is St John’s Hospice in St John’s Wood, which has just launched an appeal to recoup a £1.3 million shortfall during the pandemic. Because hospices are being asked to take on more and more patients that they do not have the funding to cover, I hope that the important 4 November meeting will be based on an assessment of the need for continuing support for the sector for the remainder of 2020 and into 2021. Also, what plans do the Government have to ensure that everyone who needs quality palliative and end-of-life care will continue to receive it through and beyond the pandemic?

[Lord Bethell (Con)]

The noble Baroness will know through her work as a lay member of the NHS Camden Clinical Commissioning Group that hospices are much valued by the healthcare system. I assure her that the agenda for 4 November will include an assessment of the ongoing support that hospices will need through the winter.

[Lord Jones of Cheltenham (LD) [V]]

Today the director of my local Sue Ryder, told me that she faces a budget shortfall of 43%—almost half—in this financial year because fundraising from shops and other means has fallen. She has already had to make redundancies. However, demand is increasing and she is expecting a tsunami of new patients who missed an early diagnosis of their condition because of the Covid crisis. What are the Government going to do about this both now and in the long term?

[Lord Bethell (Con)]

The noble Lord is entirely right to cite the challenge being faced by Sue Ryder and other hospice charities that depend on retail income. They face a most difficult and challenging problem; it is one that we acknowledge and recognise. The question of misdiagnosis leading to a bump in arrivals in hospices is not one that I have been conscious or aware of, but I am grateful to the noble Lord for flagging it up for me. I will take that back to the department and, if it is something that we should be focused on, I will write to him accordingly.

[Baroness Stuart of Edgbaston (Non-Afl)]

My Lords, the manner of our going is as important to the human condition as the good life lived. Hospices have played an important role, in particular those hospices that care for children. The provision for children’s hospices is very patchy across the country, as is their need. At the meeting on 4 November, will the Minister pay particular attention to hospices caring for children and providing the necessary outreach work to families?

[Lord Bethell (Con)]

The issue raised by the noble Baroness is one that I am aware of. Who can think of a more moving cause than hospices for children? This will be definitely be on the agenda for 4 November and I will raise the issue with my honourable friend the Minister for Social Care.

[The Lord Speaker (Lord Fowler)]

My Lords, the time allowed for this Question has elapsed, which brings Question Time to an end.

Medicines and Medical Devices Bill

Lord Bethell Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

[Baroness Thornton (Lab)]

The Committee owes the noble Baroness, Lady Sheehan, a debt of gratitude for bringing forward this amendment. I very much enjoyed her opening speech—and, indeed, those of the noble Lords, Lord Alton and Lord Crisp, both of whom are so well qualified to speak about international health responsibilities.

What this debate does is to remind us of how privileged we are to live in a country with free access to new medicines and innovations. However, we are now entering choppier international waters. We have been sheltered, as it were, over 40-odd years or so by the European Union’s heft and regulatory framework. So we need to take notice of the need for greater co-operation, as has been outlined by the noble Lord, Lord Patel.

I was very struck by the mention of things like price gouging by the noble Baroness, Lady Sheehan, and their dangers for those less fortunate than ourselves. On the immediate responsibilities and dangers around the Covid vaccination, which we so desperately need, the World Health Organization says that it is working on a plan to ensure equitable distribution of vaccines, but how that would be enforced in practice is not clear. Professor Mariana Mazzucato, who heads the University College London’s Institute for Innovation and Public Purpose, says:

“In a pandemic, the last thing we want is for vaccines to be exclusively accessed by countries that make them and not be universally available.”


That is absolutely right.

However, as the noble Lord, Lord Crisp, said, we need to pay attention to what is happening in the UK and what the effect of Brexit might be—and, goodness me, we are all on tenterhooks as to whether we get a deal or not. Rick Greville, the director with responsibility for supply chain at the Association of the British Pharmaceutical Industry said, in the run-up to a no-deal Brexit—the last time this happened—that there could be currency fluctuations, including a fall in the value of the pound. He said:

“You can imagine in that situation that exporting medicines into Europe would become even more profitable. It may be that”


drugs

“that currently aren’t being exported suddenly become attractive to export, driven entirely by profit”.

The UK is not invulnerable to what might happen next, and I would like the Minister’s observations on that.

Launched earlier this year, COVAX wants wealthy nations to pool funds that together can be used to develop and scale up vaccine production. In return, rich countries would have a guaranteed supply for about 10% and 15% of their population. I would also like the Minister’s answer to that, because several noble Lords have raised that question.

This is one of those debates in which one feels that so many people are better qualified to speak than oneself. I finish by quoting the noble Lord, Lord Crisp, and what he said on Monday. He said:

“This amendment is absolutely right in asserting that the UK should reaffirm its position and its rights to protect the health of its population. We should adopt it. The future will be difficult, as will the negotiations on this issue, but no one should be in any doubt about the UK’s firm position. We should support not just the UK’s position for the population of the UK directly but a global effort to deal with these important matters.”—[Official Report, 26/10/2020; col. GC 71.]


I could not have put it better myself.

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

My Lords, there can be absolutely no doubt about the importance of patient access to medicines. This is very much at the heart of the NHS constitution, and it is absolutely fundamental to how we regulate human medicines.

I completely agree with the noble Baroness, Lady Thornton, that the noble Baroness, Lady Sheehan, has done us a great service with an incredibly impressive speech, which was thoughtful and powerful and a privilege to listen to on Monday. The speeches of the noble Lords, Lord Alton and Lord Crisp, who I do not think is present, drew on many years and huge experience of international affairs and comparisons. We are very grateful for the challenge that those speeches have given us on this extremely important subject. But I reassure all speakers to this amendment that this Bill will absolutely not change the importance of patient access to medicines and how we regulate that.

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[Lord Alton of Liverpool (CB)]

My Lords, I thank the noble Lord, Lord Bethell, for the response he has given to the debate, but I have two questions I want to put to him. Like the noble Lord, Lord Stunell, and others, I accept that pharmaceutical companies will always want to and are entitled to reclaim research and development costs. On Monday, I referred to the phenomenal difference in the cost of remdesivir when purchased in the US at over $2,000 for a five-day treatment and Liverpool University’s estimate of $9 as the basic production cost. I asked how much public money went into developing that drug. If the Minister is unable to answer that question today, I would really appreciate it if he could undertake to write to us to let us know how much public money went into the development of that drug.

My second question is about Crown use licences, a question posed to the Minister by the noble Lord, Lord Sharkey. Are the Government considering using the Crown use licence, should the circumstances require that? It was used in the 1960s, and more recently the use of it was threatened in the case of an innovative new treatment for cystic fibrosis. The Government used the power, and that had the desired effect of bringing down the cost of that drug. Are the Government giving serious consideration to how they will use Crown use licences, should that become necessary?

[Lord Bethell (Con)]

I thank the noble Lord, Lord Alton, for his questions. On remdesivir, I will be glad to find out whether any UK funds were used in its development and will write to him. I will also be glad to write to him about Crown use licences.

[Baroness Sheehan (LD) [V]]

My Lords, this has been a quite passionate debate and I am profoundly grateful to all noble Lords who have taken part in it. The debate goes to the heart of how we see ourselves. We are a kind, caring compassionate country that also abides by the rule of law, whether that is national or international law. That is why I thought it was right to include our ratification of the ICESCR—the International Covenant on Economic, Social and Cultural Rights. The noble Lords, Lord Crisp and Lord Stunell, both invoked that treaty as being an important and fundamental part of Britain’s reputation abroad. The amendment reminds us quite forcefully that a ratified international treaty is national law. That is quite a topical point as we debate this Bill in step with United Kingdom Internal Market Bill.

I am grateful to the noble Lord, Lord Alton, for his contribution, which was a real tour de force. It was informed by many years as a human rights activist and by his membership of the International Relations and Defence Committee, chaired by the noble Baroness, Lady Anelay. He reminded us that the African continent imports 94% of its pharmaceutical requirements. That figure struck me quite profoundly because the next figure that the noble Lord quoted was 96%. That was the finding of the YouGov poll of the proportion of the country that supports what we are trying to achieve here—equitable and fair access across the world for essential medicines. That is a very important reference point for the Government to bear in mind.

At all costs, we must avoid the unseemly debacle that we saw across the world in the early days of Covid-19 as countries scrabbled to get hold of scarce PPE. We must think ahead, put logistics planning in place and up front and support the global effort that seeks to do that.

The noble Lord, Lord Crisp, and my noble friend Lady Walmsley reminded us that public health safeguards were built into the TRIPS agreement because, as my noble friend Lady Barker noted, countries in the least developed parts of the world are right at the back of the queue when it comes to the development of medicines that are desperately needed.

My noble friend Lady Walmsley also highlighted that the insertion of the amendment in Clause 1(2) would mean that the Government would need to have regard to the provisions of the amendment. That is an important point. In his reply, the noble Lord, Lord Bethell, said that we have such a right already—of course we do—but the issue is that existing price control mechanisms are not used effectively enough at the moment; otherwise, we would not see the recurring incidence, which many noble Lords referred to, where the NHS is regularly held to ransom in trying to negotiate prices. While those negotiations go on, with all the delay involved, patients suffer and some patients die.

I thank the noble Lord, Lord Patel, who from his deep health expertise spoke passionately about the ways in which pharmaceutical companies bend the rules and how patients suffer as a consequence. I repeat the request made by the noble Lord, Lord Alton, and by my noble friend Lord Stunell. Why is it that Gilead can get away with charging £2,350 per dose, when the Liverpool University work shows that £9 per dose would reap sufficient profit?

I also thank the noble Baroness, Lady Thornton, for her support. I agree that we ought to listen to Professor Mazzucato on how to approach global challenges, because she understands global economics and can explain it in a way that I find very compelling. My noble friend Lord Sharkey gave a superb summary of the issues at stake. He highlighted, yet again, the moral imperative: it is so true that no one is safe until everyone is safe and, if nothing else, enlightened self-interest must compel us to act more collaboratively on the global stage.

On the issue of C-TAP, the waiver requested by South Africa and India at the TRIPS council meeting speaks to the need to have some way of overcoming the issues in respect of sharing IP rights, data, know-how and the expertise that is lacking at the moment. They would not be asking for that and would not be pushing for it unless it was necessary. Without that, we will not immediately be able to ramp up manufacture of the vaccine when we need it, which will be immediately.

In conclusion, this is a reputational issue for Britain, because it speaks to who we are as a country. I am with the 96%. If we truly want global Britain to be seen as a force for good, we must take this opportunity to join others, to lead from the front and to throw our heft—our quite considerable heft—and expertise behind the global collaborative effort to keep control of Covid-19. And when we are good, we are very, very good.

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[Baroness Thornton (Lab)]

This has been a wholly positive and helpful debate, and I hope that it will lead to improving the Bill and the future of this issue. I shall speak briefly to the amendment in my name and that of the noble Baroness, Lady Watkins. It would allow the Secretary of State to make regulations about notification and reporting requirements for medical device clinical investigations, as is currently the case for medicines. It is about the equality of treatment between medicines and medical devices, so it is very straightforward.

I thank my noble friend Lord Hunt, who I suspect made a double speech, his own and that of the noble Baroness, Lady Finlay, and it is all to the good that he did. I again register the protest that we are losing experts and speakers because of the clash of timetabling.

All the amendments in this group are positive amendments about how medicines and medical devices reach the market, how the UK can build and maintain a leading position, and the regulatory framework required to support that. Amendment 97, in the names of the noble Lords, Lord Kakkar and Lord Patel, does that, and I thought that the noble Lord, Lord Kakkar, made some very interesting points about how it might best be achieved. The noble Lord, Lord O’Shaughnessy, and the noble Baroness, Lady Cumberlege, were quite right about putting patient safety at the heart of this and having higher levels of evaluation—the term used by the noble Lord, Lord Kakkar. The noble Lord, Lord Patel, got straight to the heart of the issue, which is that we need to get together to work out how best to take this issue forward at the next stage of the Bill. I look forward to what I hope will be a positive response from the Minister and then to the Government taking some action.

[Lord Bethell (Con)]

My Lords, I start by endorsing the comments of the noble Baroness, Lady Thornton, and saying that I am extremely grateful for this debate, both the spirit in which it is being conducted and the objective of trying to improve the legislation. I think it will make a big difference to the legislation.

The issue of the safety of medical devices and medicines is, of course, critical. We have been greatly moved by the report of my noble friend Lady Cumberlege, who spoke earlier to this group of amendments. It is an extensive and important report, which highlights the impact on patients when they have not been heard, when they report problems or concerns with a medicine or a medical device. It is particularly focused on pelvic mesh but could have addressed other subjects. The Government will address its detailed recommendations when the time is right.

I understand that safety is the driving concern behind Amendments 26 and 90, tabled by the noble Baroness, Lady Finlay. She offers up an alternative way in which to regulate medicines and medical devices, with the creation of a rapid, provisional two-year licence. Medicines and medical devices are regulated very differently between the two of them. That is in part because we have anticipated regulatory change for medical devices at an EU level for some years, and it is in part down to the practical realities of how they are developed.

I shall touch on the process and distinction. However, what I would say is that, intent aside, the amendments of the noble Baroness, Lady Finlay, are not necessary. Amendment 26 would introduce a rapid two-year provisional licence for medicines. The Bill as drafted already provides the necessary powers under Clauses 1 and 2(1)(d) to make changes relating to marketing authorisations. It is similarly already possible to introduce a rapid, provisional two-year licencing process as she suggests in Amendment 90 at Clause 13(1)(b) of the Bill.

By tabling parallel amendments with the same suggestion of a two-year, rapid provisional licence for medicines and medical devices, the noble Baroness suggests, perhaps, paralleling similar requirements of a pre-market assessment. The noble Lord, Lord Kakkar, suggests using the information system in the government amendment in Clause 16 in combination with a limited marketing authorisation system as a way of assessing devices before licencing them, as in his Amendment 97. We believe that Clause 13(1)(b) is sufficiently flexible to deliver the purpose of his explanatory statement. We believe that it is not needed as an amendment to Clause 16.

However, this debate is not, I think, about what the Bill could provide for; it is about what the Government will actually do. For human medicines, we have made changes in the statutory instrument that sets out the situation on 1 January. That update provides for a national “conditional marketing authorisation”, valid for one year. It can be renewed annually. It is a procedure to expedite the assessment of medicines that fulfil an unmet medical need but, importantly, maintain the robust evaluation of supporting evidence. It is less than the five years an ordinary marketing authorisation is granted for, but none the less we believe it serves the purpose. I hope the existence of that process is what the noble Baroness is driving at.

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[Baroness Cumberlege (Con) [V]]

My Lords, it has been a really interesting debate. One of the things that I have found so wonderful in this House is all the professors. I did not go to university and, when I listen to the professors and the way they care for their students—and in this case I am something of a student—I really value it. I thank the noble Lord, Lord Patel, for pointing out the dilemmas that we face. They are very difficult. I am sure that the Minister also feels that: it is how you balance what we are trying to achieve as a successful United Kingdom in innovation, marketing and all the rest of it, and the dilemma of safety as well.

I thank the noble Lord, Lord Kakkar, very much. I need to read very carefully in Hansard what he said and then come to some conclusions. I am not sure that we have quite cracked it, but I believe we are working towards it. The noble Lord, Lord O’Shaughnessy, had some really interesting ideas about how we can take this forward, and we need more work to be done on it.

I want to say one thing. In the review, we were so horrified by the stories that we heard that we said we had to do something to prevent further surgeries taking place in women who were suffering so deeply. We called it the pause; we went to NHS England and the department and very quickly they agreed to our pause, with six safety conditions that had to be introduced if it was to be lifted—and, of course, they still have not been introduced. That was in July 2018.

The interesting thing about the pause is that, because surgeons were prevented from using what they would see as the normal solutions to stress urinary incontinence, with pelvic mesh, they started to think of different ways in which to do things and help women, ensuring that the discomfort that they had through these conditions was ameliorated. We are getting innovation in a very interesting way. I am convinced that such innovation would not have taken place if we had not introduced the pause. But it should not have been us, the review team, who introduced it. It should have been the healthcare system, which had put forward some measures and thoughts about it years before, but nothing happened. Of course, that was one of the burdens that I carried throughout the review—that promises were made and nothing happened. We called the healthcare system glacial; it just did not move. There are some hugely bright people in this country and throughout the healthcare system and beyond, in universities and everything else. Surely, if we could only utilise the wonderful brains that we have in this country, we could do much better.

I thank my noble friend for the very full summing-up today. The categories of risk relevant to devices have been so badly used in the past in terms of how pressure has been put on to change the risk when people knew that harm was being committed. We have a meeting with the MHRA, and I am sure that a lot of these issues will be discussed.

I thank the noble Lord, Lord Hunt, for introducing the amendment. It is very difficult to pick up somebody else’s work, but he did it with his usual tremendous skill.

[Lord Bethell (Con)]

I completely endorse the words of the noble Baroness, Lady Cumberlege, about the failings around some of the medical device regulatory regimes, which failed to pick up many of the problems with mesh. I am grateful for the interventions from the review team on that matter.

I remind noble Lords that the Bill seeks not to lay down the policy on what precise regime will suit the future of medical device regulation but to set up the framework in which those regulations are put together. The Bill meets the need on that matter. I cannot urge enough how important it is that we get the Bill on the statute book as soon as possible.