Medicines and Medical Devices Bill

Baroness Penn Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Baroness Wheeler (Lab)]

My Lords, we are grateful to the noble Lord, Lord Lansley, and my noble friend Lord Hunt for amendments that would ensure that the future role and funding of NICE are placed firmly in the Bill. Amendments 17 and 79 to Clauses 1 and 13 —in the name of the noble Lord, Lord Lansley—underline for both human medicines and devices the importance for the appropriate authority making regulations under the Bill to consider the ability of the NHS to meet the needs of patients and ensure consultation in accordance with Clause 41.

Amendment 85 to Clause 13, in the name of the noble Lord, Lord Lansley, and Amendment 124 in the name of my noble friend Lord Hunt, which proposes to insert a new clause after Clause 38, deal with the funding mandate to the NHS, the availability of human medicines and medical devices, timescales, and ensuring effective monitoring and reporting arrangements by the Secretary of State to both Houses of Parliament.

Noble Lords speaking to this group, particularly those with experience as former Ministers, have made powerful arguments based on their expertise. Those speeches have been very illuminating. I hope, therefore, that the Minister will respond in a positive way that reflects these concerns and these amendments’ intentions.

My noble friend Lord Hunt’s amendment, in particular, places a duty on NICE to take account of the availability of innovative medicines and medical devices for human use on the NHS. It also requires the Secretary of State to report to Parliament on the anticipated impact of new medicines and devices on inward investment and the attractiveness of the UK life sciences sector, whose vital importance to patients and the UK economy we all recognise fully.

As we have heard, my noble friend’s Amendment 24 is very much embedded in the current review of the methods and processes of NICE, amid widespread concerns that despite its recognition as a world-class institution, there is still a major problem with the take-up of new medicines by the NHS, with many CCGs financially or structurally unable to deliver the innovation that NHS patients deserve and must have. The recent report from the cancer charities showing how UK patients are missing out on new innovative treatments that are readily available in any other comparable country shows that stark reality. The NHS’s record on implementation of technical appraisals of new drugs by NICE says it all.

We must therefore ensure that the review of NICE’s methods, which is under consultation until the end of the year, and the consultation on changes to NICE’s processes, which is due to follow early next year, deliver real and effective change, and are open and transparent. The Bill should set out clear responsibilities for both NICE and the Secretary of State on their role in funding; they will be more important than ever in getting that change and innovation.

My noble friend expressed a genuine fear, which is shared across the NHS, about the de facto rationing of innovative medicines and the role that NICE often ends up playing in this without having the clear funding mandate from the NHS that these amendments would provide. His amendment is important because it would inject some parliamentary oversight into the review of NICE’s methods and process, which many consider as having been progressing very much under wraps for a while.

I declare an interest as vice-chair of the cross-party Specialised Healthcare Alliance. We have heard worrying noises about the rarity modifier consideration on rare diseases being removed. I have heard real concerns from rare disease charities among our 100-plus members that the review could be taking a worrying turn in terms of impeding access to treatments for rare diseases. This remains to be seen but it would certainly be a retrograde step; I hope that the Minister will provide me and rare disease charities with some reassurance on it today. I hope that the Minister will at least commit to more parliamentary scrutiny of the review’s work as it reaches its conclusions over the coming months. It is crucial for NICE to be obliged to improve, rather than frustrate, access and for Parliament to be given a view on these matters.

Amendment 85 in the name of the noble Lord, Lord Lansley, would ensure that the NHS has to implement NICE’s recommendations on medical devices as swiftly as for medicines. It is squarely in line with the Government’s stated aims, in so far as the Government have promised a medtech funding mandate of the kind referred to by the noble Lord himself and the noble Lord, Lord O’Shaughnessy.

However, the reality of the Government’s limited proposals—which are now delayed until next year at the earliest—is rather different. Many of the SHCA’s charities represent patients who have already had to shield this year, and now have to do so again, and the newest medtech innovations stand to help them care for themselves at home better. Does the Minister acknowledge that the Government’s medtech funding plans need to be expanded and accelerated rather than delayed? I hope that the Minister will commit to this important issue.

Finally, the threat to the UK life sciences industry from leaving the EU, and the steps that must be taken by the Government to ensure that the NHS does not start to lose its reputation as a global leader in medical science and innovation, have been fully explored. They are a constant theme from these Benches and across the House on the Brexit legislation that we have considered so far. A statutory duty on NICE to take account of the need for improved availability of innovative medicines and medical devices for NHS patients, with a duty on it and the Secretary of State to work together to ensure that the latest medicines are able to provide the care and treatment that patients need and deserve, will be a key part of supporting a world-leading life sciences sector in future.

[Baroness Penn (Con)]

My Lords, if the noble Lord, Lord Blunkett, speaks with temerity given the other speakers on this group, I ask noble Lords to consider how it feels to be the Minister responding.

I assure the noble Lord, Lord Patel, that Health Ministers may not be completely transformed on leaving government, but discussions that may have taken place in private can become much more public once they are on the other side of the fence.

I turn to Amendment 17, with which it may be convenient to take Amendments 79, 85 and 124 in the names of my noble friend Lord Lansley and the noble Lord, Lord Hunt. On the first half of Amendments 17 and 79, my noble friend conceded that the Bill likely already delivers what is within its scope to deliver. The consideration of the availability of medicines and medical devices when making regulations is relevant. This is what sits behind the ability of the NHS to meet the needs of patients, where it relates to regulation. The Bill simply does not deal with matters related to the NHS supply chain. It supports it by ensuring that medicines and medical devices that are safe are available on the UK market. As my noble friend knows, and has referred to, these matters are set out in other pieces of legislation. NICE was established as a statutory body by the Act that he took through as Secretary of State. I know that his Amendment 85 also probes on issues to do with the NHS supply chain.

I was interested to hear my noble friend Lord Lansley’s fuller explanation of the intention behind the amendment: to enable access to innovative medicines in the NHS. I know that he has done a huge amount to improve such access in the NHS. Although the Government do not think that this amendment is necessary to achieve his goal, I hope that when we come to debate later groups of amendments, including on the Innovative Medicines Fund, I can provide him with further reassurance on this matter.

On the second parts of Amendments 17 and 79, which deal with the results of the consultation on subsequent regulations that flow from the Bill, my noble friend Lord Lansley may have noted government Amendment 126, which we shall reach in a later group. This would add to the consultation requirements in the Bill. On the result of any consultation, I assure him that there is already case law requiring that consultation responses are taken into account. This is reflected in the Cabinet Office consultation principles, which require the Government to explain the responses that have been received from consultees and how these have informed the policy. A public consultation must be formally responded to. Not only that, the Explanatory Memorandum that must accompany a statutory instrument must explain the consultation outcome. Between these various documents, the Government must not only take into account the consultation but set out what has changed as a consequence of that consultation. I therefore think that the amendment may render these changes unnecessary, as the requirement to respond and explain is already there.

My noble friend Lord Lansley also tabled Amendment 85. While I understand his interest in ensuring that we have the appropriate funding and frameworks in place so that NICE-approved devices are made available to patients—an issue already touched on in the previous discussion on attractiveness—he may have anticipated my saying to him, once again, that the Bill is not necessarily the appropriate vehicle.

None the less, my noble friend and other noble Lords have raised an incredibly important issue. I reassure him and others that the NHS medtech funding mandate will be launched in April 2021. It will get selected NICE-approved, cost-saving devices, diagnostics and digital products to patients more quickly and ensure that specified innovations are funded locally. In advance of the mandate’s launch and to support adoption of relevant technologies, the NHS standard contract has been updated to include reference to the medtech funding mandate. I hope that that provides my noble friend with the reassurances that he seeks from me. We are on the way. This Bill is not the means to the end, and I hope he feels sufficiently assured to refrain from pressing his amendment to a Division, when we reach it.

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We also know that investment in research into AMR has to be much greater. This is not just about funding to deliver ground-breaking research. The UK does a good job training PhD students but loses a lot of talented people because the post-doctoral period is so unstable. We need continued support for interdisciplinary networks to strengthen research and development capacity. The key question is whether the strategy is addressing this issue as robustly as the emergency situation that we face requires.

[Baroness Penn (Con)]

My Lords, the noble Baroness, Lady Bennett of Manor Castle, is a tireless champion of matters environmental and I am at one with her in wanting to consider sustainability in all that we do. However, I do not think these amendments are necessary and they are not strictly within the realms of regulating medicines and medical devices, which is what the Bill seeks to deal with.

Legislation is already on the statute book regarding the impact on the environment more broadly. In fact, I suggest that the Bill is part of a wider legislative canvas that delivers what the noble Baroness seeks reassurance on. Within that wider canvas is legislation on packaging waste, which is enforced by the Environment Agency in England. That imposes obligations on packaging producers to seek to reduce the amount of packaging produced, reduce the amount of waste going to landfill and increase the amount of packaging waste that is recycled. I will pick up her point on the production of medical devices being within this principle of producers being responsible for manufacturing waste and write to her on it.

Turning to elsewhere on the canvas, I say that there is also legislation on the statute book to address the environmental impact of producing and disposing of manufactured goods such as medical devices. This includes the Waste Electrical and Electronic Equipment Regulations 2013, which require the recycling of certain types of electrical equipment, including some types of medical devices. I hope that provides the noble Baroness with reassurance that these regulations are part of a wider whole.

The noble Baroness, and the noble Baroness, Lady Wheeler, also raised the importance of the appropriate use of reusable medical devices, which is essential to the provision of health services, with many medical devices being reusable in some form. I think we all agree that it is vital to ensure that decontamination of those devices is possible and, where it is, that it is efficient, effective and safe for patients to reuse. I assure the noble Baronesses that, under Clause 13, we would have the power to make provisions specifying that reusable medical devices must be designed and manufactured in such a way as to facilitate decontamination.

Amendment 25 deals with the important issue of medicines waste and medicine disposal, also touched on by the noble Baronesses, Lady Barker and Lady Wheeler. The environmental impacts of these are taken seriously, but dealt with by other legislation. For example, the Environmental Protection Act 1990 makes provision for the safe management of waste. The Act imposes a duty of care on any person who disposes of controlled waste to take all reasonable steps to ensure that it is not disposed of in a manner likely to cause pollution of the environment or harm to human health. Community pharmacies must comply with this legislation, and the NHS community pharmacy contractual framework makes specific provision for pharmacies in England to act as collection points for the public’s unwanted medicines. These returned medicines are then stored securely by pharmacies until they are collected for safe disposal.

I understand that the noble Baroness and others may also want to know what we are doing to reduce waste medicines in the first place. Medicines optimisation is a key workstream within NHS England’s medicines value programme; it aims to ensure that the right patients get the right choice of medicine at the right time. Through focusing on patients and their experiences, the goal is to help patients to improve their outcomes, take their medicines as intended, avoid taking unnecessary medicines, reduce wastage of medicines, and improve medicines safety.

The Secretary of State for Health and Social Care has asked Dr Keith Ridge, the chief pharmaceutical officer for England, to carry out a review of overprescribing in the NHS. Following a pause due to the Covid-19 pandemic, the review is due to report later this year. This work is looking at reducing inappropriate prescribing with a particular focus on the role of digital technologies, research, culture change and social prescribing, repeat prescribing, and transfer of care. The report will provide recommendations to reduce overprescribing, which will help to reduce medicines wastage.

Amendment 41, proposed by the noble Baroness, Lady Bennett, highlights the serious and growing global problem of antimicrobial resistance, or AMR. It has been placed on the National Risk Register of Civil Emergencies as a “longer term trend” likely to change the overall risk landscape for the UK over the coming decades. Already it is estimated to cause more than 700,000 deaths each year globally. That figure is predicted to rise to 10 million, alongside a cumulative cost of $100 trillion by 2050 if no action is taken. She will be aware that in January last year the Government set out the UK’s vision to contain and control AMR by 2040. This vision is supported by a five-year national action plan that includes comprehensive One Health action across the spectrum of human and animal health, agriculture, the environment and food.

While recognising the serious threat of AMR, I respectfully suggest that this amendment, specifically in the context of a clinical trial, is not necessary. Clinical trials of medicines, including those of antimicrobials or antibiotics, have strict requirements for reporting adverse events and for continuous monitoring of the benefits of the medicine under investigation versus the risks, as set out in the Medicines for Human Use (Clinical Trials) Regulations 2004 and associated good clinical practice guidance. Development of AMR during a clinical trial may manifest as an adverse event or as a lack of efficacy to the medicine being investigated. In either case, the investigators and trial sponsor have obligations to take action to protect the safety of the trial participant. This action might include taking an urgent safety measure, amending the trial protocol or terminating the trial early. These actions would require notification to the medicines regulator—the MHRA—and a research ethics committee. Development of AMR during a trial would also be expected to be transparent via the publication of the results of that trial.

The Health Protection (Notification) Regulations 2010 places a legal duty on the operator of a diagnostic laboratory to notify Public Health England of the identification of specified causative agents in a human sample within seven days. On 1 October, those regulations were updated to require diagnostic laboratories to report the results of any antimicrobial susceptibility test results and any resistance mechanism identified in respect of a sample. I hope that provides reassurance of the Government’s focus, not just to maintain high levels of surveillance of rates of AMR but to successfully contain and control its spread for future years. Given the existing provisions and ongoing work in the department, I hope I have reassured the noble Baroness that additional powers in this regard are unnecessary and she now feels able to withdraw her amendment.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I thank the noble Baroness, Lady Barker, for adding to the outline that I provided on the importance of the greenhouse gas emissions of the NHS and bringing in the issue of the use of water, which is becoming an increasingly rare resource in the UK. I thank her for providing her personal account of the frustrations of individuals who want not to waste NHS resources, based on her own experience.

I thank the noble Baroness, Lady Wheeler, for focusing on plastic waste. I shall restrain myself from commenting on the broader points of this issue, but thank her for highlighting the particular importance of illegal exports of medical waste and the big issues around Covid-19 and the waste unavoidably being generated at this point, as she said.

Coming to the Minister’s response, at the start there was a suggestion that this was a provision to go somewhere else—that all these issues could be in the Environment Bill or packaging regulations, et cetera. I do not accept that. If we take a systems-thinking sustainable development goals approach, then we have to make sure that all these issues are in every piece of legislation. Everything has to be considered as a whole. Rather than saying “We’ll deal with it somewhere else”, given the issues of legislation being delayed—we do not know when the legislation that we have not yet seen will arrive—it needs to be built into every element of our thinking on this fragile, much-abused planet.

Coming to some specifics, the Minister commented on current arrangements for recycling of devices. I note that there was a disturbing report out this morning through the waste industry about the number of fires occurring in waste management facilities as a result of the inappropriate disposal of batteries. I do not know how many of those involved medical devices, but I would think it highly likely that, in some cases, they would be. There is clearly a real problem with our current disposal systems. The Minister referred to Clause 13 dealing with the contamination issues. I will take that back to my technical advisers. I was pleased with her comments about the efforts on medicines optimisation. If we think about this in the context of a waste period more broadly, we know that “reduce” is always the best option.

I am also pleased with the overall tenor of this debate and the focus that we have seen on antimicrobial resistance. If we think back—gosh, it is two Prime Ministers back now—David Cameron gave a major speech on antimicrobial resistance and we have seen growing awareness of this issue. I am pleased that this debate has been an opportunity to highlight it and focus on the need for more action. For the moment, I beg leave to withdraw my amendment, but I reserve the possibility of further consultation, and potentially bringing it and my other amendments back in this or a different form.

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[Baroness Walmsley (LD) [V]]

My Lords, the Government take an enormous number of powers to make regulations in the Bill.

In the light of the paucity of parliamentary powers to check these, particularly prior to them coming into effect—as demonstrated by the recent Covid-19 regulations —the only way in which Parliament can influence these regulations before they are even drafted is by inserting into the Bill those things to which Ministers must have regard. That is why my noble friend Lady Sheehan seeks via Amendment 19 to insert two important elements into the Bill after the priorities of safety, availability and so-called attractiveness. I support her amendment and look forward to the Minister’s answers to her questions.

Proposed new paragraph (d) would ensure that the Government have regard to the International Covenant on Economic, Social and Cultural Rights of 1996, which the UK ratified 10 years later. This affirms a citizen’s basic human right to access medicines without discrimination, which means that they must be both affordable and available. We have committed ourselves to that.

Proposed new paragraph (e) reaffirms the international protections conferred by the WTO’s TRIPS Agreement. It recognises that these intellectual property rights protections have been misused and abused by big pharma; that resulted in the WTO’s Doha declaration of 2001, which reaffirmed public health safeguards for citizens of all nations. The details are in the amendment.

The amendment is absolutely crucial as the world awaits new tests, treatments and vaccines for Covid-19, as other noble Lords have mentioned. In particular, the pandemic demonstrates the importance of paragraph (e)(ii): the right to determine what constitutes a national emergency. The Government have used that.

However, the track record of big pharma does not bode well for equitable distribution of medicines, and this demonstrates the importance of the right to issue a Crown use licence. Drugs to treat cancers, HIV/AIDS, hepatitis C, cystic fibrosis and toxoplasmosis have all been withheld from citizens while Governments were held to ransom during negotiations with pharmaceutical companies. The NHS has had to ration necessary drugs because of price gouging. The threat of using a Crown use licence, and the actual issuing of one, has been helpful in such negotiations, and several countries have used the powers to great effect.

The issue of compensation, however, needs to be clarified. This section of the law has not been tested in court. Will the Minister commit the Government, therefore, to review Section 57A of the Patents Act to ensure that it does not block the use of the crown use licence provision? Countries such as Australia, Canada and Germany have revised their patents laws for this purpose, and other countries have taken action. Will the UK Government do the same? This power could be needed to ensure access to Covid vaccines and treatments, so time is of the essence. Will the Government act now and not just stick to business as usual?

[Baroness Penn (Con)]

My Lords, I suggest that this is an appropriate moment at which to pause our debate for today. I beg to move that the debate on this amendment be adjourned.

Motion agreed.

Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 5) Regulations 2020

Baroness Penn Excerpts

Tuesday 20th October 2020 Lords Chamber

[Lord Adonis (Lab)]

My Lords, it is vital that schools are kept open, wherever possible, and that full online learning is provided where they cannot be. I will ask the Minister five specific questions about what is going on in the schools sector. The first is on the closure of schools. Under the tier 3 regulations, schools will be the last institutions to be closed. According to the Government’s guidance, schools will be the last sector to shut, if further restrictions are required. But the Welsh regulations, which were introduced today, have closed secondary schools beyond year 8 for the first week after half-term. Will the Minister assure the House that similar regulations will not be introduced as part of tier 3 in England?

Secondly, even when schools are open, a lot of pupils are being sent home because of Covid infections, but there is no uniformity in the definition of the rules by which they should be sent home, how bubbles are defined and how many students are sent home, depending on how many have been infected. The latest figures show that only 68% of schools do not have substantial closures and one in 10 students is not in school, with whole year groups often being sent home because of one or two infections. I am told by head teachers that there is no adequate guidance on this from the Department for Education. They would like pupils to be sent home only when infections are traced to groups that sit together. This would dramatically reduce the incidence of pupils being sent home and schools being closed and would bring the state system in line with the private sector, where very few pupils are being sent home.

Thirdly, this time, unlike the last closure, the temporary continuity direction provides that there should be online learning, but there are no standards of provision for what it should constitute. Ofsted is inspecting online learning, which is a big step forward from last time. Will the Minister undertake to provide the lessons of that to all schools?

I will ask the last two questions quickly. Where online learning is required, because pupils have been sent home, the provision for laptops to be given to poor students is not uniform. Many schools are finding that they can apply for free laptops only after the pupils have been sent home.

[Baroness Penn (Con)]

My Lords, could the noble Lord respect the time limit for his speech?

[Lord Adonis (Lab)]

Will the Minister undertake that all schools are able to apply for laptops upfront, without having to wait until pupils are sent home?

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[Baroness Stroud (Con) [V]]

My Lords, I have the greatest respect for my noble friend Lord Bethell, but I ask him to rethink the Government’s approach to the pandemic. China was the first country to be impacted by Covid-19 and its response has framed the context for the rest of the world. Its approach moved to withhold information about the virus, restrict the freedoms of a people and lock down its economic engine. Such actions are consistent with ranking 90th in the index for governance and 159th for personal freedom, but these are not the actions that build prosperity; they are the ones that weaken it.

As a democratic nation built on the principles of good governance and personal freedom, we should be finding ways through this crisis that speak to the power and strength of who we are and the values of our democracy. We need to have our eyes focused on what builds prosperity so that we emerge out of this crisis intact. Prosperity is built when Governments make decisions in such a way that engenders trust and with integrity, respecting the freedom of their citizens. Prosperous nations are ones where Governments govern with the agreement of the people and where citizens take responsibility. This should be borne in mind as discussions take place with Manchester and other cities.

Economic decisions must be taken responsibly to sustain an enabling environment for productive employment, sustained economic growth and personal development. Given that only 3% of reported cases come from the hospitality sector, we need to think again and at the very least make a distinction between restaurants and late-night activity, as the Minister referred to. The ease with which he listed the practice of curfews across different nations is chilling in the least. This should concern us.

The principles of personal responsibility and freedom go hand in hand. Citizens must be free and order their lives to take responsibility for their own families and communities. If we keep announcing rule after rule to our citizens, we will not allow the people of Britain to take responsibility and work with us.

Prosperous nations are built on trust and respect. Let us find a way to keep our restaurants open and businesses going. Let us create a way of working with the people of Manchester—

[Baroness Penn (Con)]

My Lords, I need to remind the noble Baroness about the time limit.

[Baroness Stroud (Con) [V]]

Let us trust people to work with and take care of their own health. This is the sort of nation I believe us to be.

Medicines and Medical Devices Bill

Baroness Penn Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Baroness Thornton (Lab)]

I do not think that I need to say much in response to the remarks that were, I think, unanimous in their support for my amendment and the other amendments in the group. The cap on the sentence is not a good enough response by the Government. Earlier in our debates, I made a remark about amendments designed to circumvent; I am afraid that the government amendments before us are exactly that kind of amendment. They will not serve, I am afraid.

Unless the Government are prepared, as I hope they are, to table amendments that actually solve the problems and address the issues raised by the Constitution Committee and the Delegated Powers and Regulatory Reform Committee—they could not have been clearer on this issue: in this country, we do not set up criminal offences and their sentences by delegated legislation—there is nothing more for me to say, other than that I hope the Government will think again.

[Baroness Penn (Con)]

My Lords, it is perhaps appropriate if I begin by speaking to the government amendments—Amendments 43, 44, 64 and 65 in the name of my noble friend Lord Bethell —in this group. In doing so, I thank my noble friend Lord Blencathra for his committee’s report. As previously noted, we have listened to that report, and the changes that we propose through these amendments are intended to address the specific concern in that report regarding penalties for existing criminal offences.

As drafted, Clause 5(1)(b) already provides a restriction limiting the maximum penalty to imprisonment for two years when creating a criminal offence. The DPRRC asked us to explain whether the penalties for existing offences could be amended when there was no maximum specified in the Bill. I want to be clear that we do not intend to increase the penalties for existing offences.

Amendments 43 and 44 would work together to amend Clause 5. They make it clear that, under Clause 1, we may not make regulations that provide for a criminal offence to be punishable by more than two years’ imprisonment. This will apply to both new and existing criminal offences. For veterinary medicines, Amendments 64 and 65 seek to achieve the same by amending Clause 10.

The government amendments will, I hope, remove any concern that powers in Clauses 1 or 8 could be used to make regulations extending sentences for existing offences beyond two years’ imprisonment.

I now turn to Amendment 4 and the other amendments in this group to which noble Lords have spoken. The ability to enforce breaches of the regime governing medicines is a power originally conferred on the Secretary of State in the interest of protecting public health. This was introduced by the Medicines Act 1968 and provisions around offences are found throughout the Human Medicines Regulations 2012. They are also contained in the Veterinary Medicines Regulations 2013.

Offences deter potentially harmful activity and make it possible to take punitive measures against those whose actions put people, animals and the environment at risk. As we make necessary updates to the regulatory requirements, we must be able to remain consistent with the current enforcement regime, which already imposes criminal sanctions. It would not be right that a person may face a criminal sanction for breaching current requirements but not for breaching new regulatory requirements, for example relating to novel technologies and medicines. As with other changes to provisions, making changes to offences will be subject to the draft affirmative procedure, and we will make offences proportionate and necessary. It is imperative that we are able to balance novel regulation with enforcement of that regulation.

It cannot be ignored that crime involving medicines is increasing. Furthermore, criminal activities adapt to new environments and technology. In recent months we have seen opportunistic criminals selling online unauthorised and unapproved medicines and devices for the treatment, prevention or diagnosis of Covid-19, including antimalarials, self-testing kits, “miracle cures” and “antiviral misting sprays”, which could cause harm and unnecessary stress to patients. Enforcement capabilities must be able to keep pace with criminal exploitation. Delegated powers afford us our continued ability to enforce the regulatory requirements for medicines and devices for public protection. To be effective, they must be enforceable.

The Veterinary Medicines Regulations 2013 contain numerous criminal offences for breaches of the regulations; again, this is for the purposes of enforcement. The Veterinary Medicines Directorate’s enforcement strategy is risk-based; it focuses on proportionality, consistency, transparency and targeting. The VMD works with businesses and individuals to assist them in complying with the legislation through the provision of advice and guidance. However, where necessary the VMD will use more formal means of enforcement to secure compliance. It is critical that we have the delegated powers to enforce this.

We have always been clear that we are trying to provide greater clarity on how to enforce the regulations on medical devices. The regulator’s ability to have teeth when we are looking to raise medical device safety standards in future is essential. The report from my noble friend Lady Cumberlege tells us that.

The Bill is also clear on the maximum time limit for imprisonment, which applies to any new criminal offence introduced. This limit matches the current system for devices, where criminal offences for medical devices are already punishable for up to six months. The devices regulations are in place to protect public health; breaches of those regulations put people at risk and can cause significant harm. It is only appropriate that there is a clear consequence for any such actions, including potential criminal prosecutions. We will of course have regulations subject to the duty to consult at Clause 41, which will mean the public have the opportunity to comment on the necessity and proportionality of the approach.

I hope the necessity of enforcing the new regulations, and the safeguards the government amendments have provided, persuade the noble Lord to withdraw his Amendment 4 and others not to move theirs.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

I have received no requests to speak after the Minister, so I call the noble Lord, Lord Hunt of Kings Heath, to respond to the debate on his amendment.

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[Baroness Thornton (Lab)]

My Lords, I thank the noble Lord, Lord Sharkey, for his comprehensive introduction to this group of amendments, particularly those that he is supporting.

We are minus at least four noble Lords from this debate because of the clash with the other Bill. I have certainly made my view known to the usual channels in the next booth that we cannot continue to discuss this Bill in those circumstances because we will be missing too many people who have a stake in the Bill and amendments down. I cannot imagine what the noble Lord, Lord Forsyth, is saying to his own Benches about this—actually, I probably can, and it will not be polite, I suspect. He put his name down to this amendment and, presumably, found out that he was not allowed to speak in both the Second Reading debate and in this Committee at the same time. I can see why that rule is there, but we are finding that this really does not work.

While the affirmative procedure offers nothing like the scrutiny given to a Bill, which typically goes through several substantive stages in each House and can be amended, we agree wholeheartedly with the DPRRC’s view that Clauses 1, 8 and 12 contain inappropriate delegations of power. We are where we are, and we therefore take the view that the affirmative procedure should apply. Amendment 134 provides for all regulations to be made subject to the draft affirmative procedure rather than the negative procedure and for urgent regulations to be subject to the made affirmative procedure rather than negative procedure.

Both the DPRR Committee and the Constitution Committee have expressed considerable concern at the inappropriate use of the negative procedure in this Bill. For example, Clause 2(1)(n) provides that regulations under Clause 1 may make provision about prohibitions relating to the supply of human medicines. Clause 42(9) provides for such regulations to be subject to the negative procedure. The explanation given for this in the memorandum, which I think I referred to in the very first debate in this Committee, is as follows:

“proposals to make changes to existing provisions, or to introduce new provisions enabling the supply, administration or prescribing of medicines are made to reflect shifts in best practice following extensive consideration and scrutiny by the relevant professional bodies.”

The DPRRC found this an unconvincing explanation. I probably do as well. It noted:

“It isn’t clear why consultation with relevant professional bodies lessens the requirement for scrutiny in Parliament. Indeed, if proposed changes are sufficiently important for there to be extensive consideration and scrutiny by professional bodies, this supports requiring the higher level of scrutiny in Parliament that the affirmative procedure affords. Furthermore, the prohibitions to which clause 2(1)(n) applies are sufficiently important that breach of them is a criminal offence (punishable, in the case of 4 of the 5 prohibitions, by imprisonment for up to two years). Even accepting the appropriateness of the delegation of powers in clause 1, we take the view that the affirmative procedure should apply. The consultation requirement imposed by clause 41 of the Bill is to be welcomed but we are concerned at consultation being presented as a substitute for Parliamentary scrutiny. On the contrary, if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”


The committee also highlighted and raised concerns about Clause 9(1)(f), which provides that regulations under Clause 8 may make provision about the categories of person who may apply for veterinary medicines. The EM states:

“any proposals to make changes to existing powers or to introduce new powers for veterinary professionals to supply, administer or prescribe medicines will be subject to extensive consideration and scrutiny by professional bodies”.

Again, the committee found this unconvincing for the same reason, and took the view that the affirmative procedure still applies. I must say, I wholeheartedly agree with its assessment. As it says,

“if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”

My amendment also addressed the egregious provisions of Clause 42 that provide that where any such regulation needs to be made urgently to protect the public from imminent risk of serious harm to health, the negative procedure applies instead. The Government’s justification for departing from the affirmative procedure was that:

“It is appropriate for regulations made in these circumstances to be subject to the negative resolution so that they can come into force immediately and provide an efficient means of addressing an imminent serious public health risk. We expect that such regulations would only need to be in place for a very short period of time, potentially shorter than it would take to schedule and hold debates”.


This is wholly inadequate.

The DPRRC stated:

“We are wholly dissatisfied by departments repeatedly arguing for powers otherwise subject to the affirmative procedure to be subject to the negative procedure where there is a need to act quickly, and seeking to justify this without acknowledging the existence of the made affirmative procedure … Even accepting the appropriateness of the delegation of powers in clauses 1 and 12, if the affirmative procedure provides the appropriate level of Parliamentary scrutiny for regulations made in reliance on clauses 6 or 15 in non-urgent cases then, in the absence of cogent reasons for the negative procedure to apply in urgent cases, we take the view that the made affirmative procedure should apply in urgent cases.”


The Constitution Committee concurred, recommending that

“the emergency powers in this Bill are subject to the made affirmative procedure, rather than the negative procedure, such that Parliament is required actively to approve them.”

The Minister will be well aware that regulations under the “made affirmative” procedure can be made and laid as expeditiously as can regulations subject to the negative procedure. They can also be laid during a parliamentary recess, unlike draft affirmative instruments. Quite frankly, it is insulting that the Government have the gall to argue for emergency powers to be subject to less scrutiny under the negative procedure, especially in the current climate when hundreds of emergency regulations have been introduced with considerable haste using the “made affirmative” procedure. Can the Minister say how this dereliction ever made it into the Bill, never mind through the Commons? I imagine that the Minister might be quite embarrassed to put her name to the Bill, which is perhaps why the Government have introduced Amendment 133 at the 11th hour.

I also speak in support of the super-affirmative amendments in the name of the Lord, Lord Sharkey. They are supported by Members across the House—including my noble friend Lady Andrews who is not here to give her support although she is extremely enthusiastic about this amendment.

Given that this is a skeleton Bill, the use of the super-affirmative procedure seems a sensible and proportionate mechanism. In this case, it would allow relevant parliamentary committees, in consultation with stakeholders, opportunities to comment on proposals for secondary legislation and to recommend amendments before orders for affirmative approval are brought forward in their final form. It has been used effectively by Governments of all colours, who recognise that it allows them flexibility when they need to bring forward regulations, while consultation and scrutiny happen before any amendments come to the House by affirmative resolution.

That is particularly important given that many areas in which we expect regulations to be laid, ranging from life sciences and clinical trials to hub and spoke pharmaceutical models, could make the contents of the SIs—and, in the absence of policy details in the Bill, even examples of draft regulation that have been published in respect of other Brexit legislation—controversial. I hope that the Minister recognises the merit of this proposal.

[Baroness Penn (Con)]

My Lords, I will begin by speaking to government Amendment 133 on behalf of my noble friend Lord Bethell. It provides significant changes that I know many will welcome. We have listened to the concerns raised about parliamentary scrutiny on emergency powers. I assure noble Lords that we have carefully considered their views and the different amendments that have been put forward on this topic.

As a result, government Amendment 133 would change applicable parliamentary procedure for reactive emergency regulations to the “made affirmative” procedure. It also provides that regulations about prescribing, advertising, packaging and labelling in relation to human and veterinary medicines will no longer be subject to the negative resolution procedure, but instead to the draft affirmative procedure. Using the “made affirmative” procedure when making regulations reactively in emergency situations affords the Government the required speed and flexibility to react to emergencies while providing that Parliament can scrutinise what has been done and why. When we make the regulations proactively, we must demonstrate the need to protect the public from the risk of serious harm; these regulations will be subject to the draft affirmative procedure.

It is important to acknowledge that the emergency powers are not intended to be used. However, as the noble Baroness, Lady Thornton, said, we are in a situation where we are currently using emergency powers, so she is correct that the “made affirmative” procedure has been put to good effect during the current pandemic. None the less, these powers are a measure of last resort to protect the public from the risk of serious harm to health.

We want to avoid using the powers reactively where possible. It is already a condition in the regulations that the situation must be accompanied by a declaration of the urgent need to protect against the imminent risk of serious harm to health. I note the questions asked by the noble Lord, Lord Patel, about the definition of that statement. I will write to him further on that matter.

--- Later in debate ---

[The Deputy Chairman of Committees (Lord Bates) (Con)]

I call the Minister to respond to the point made by the noble Lord, Lord Patel.

[Baroness Penn (Con)]

My Lords, I believe that the noble Lord’s comments reflect the themes that we are discussing throughout our scrutiny of the Bill. I certainly take them on board with regard to this group of amendments, I believe that we have discussed them before and will discuss them again on other groups of amendments.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

Finally, I call the noble Lord, Lord Sharkey, to respond to the debate on his amendment.

--- Later in debate ---

[The Deputy Chairman of Committees (Lord Bates) (Con)]

Weighty matters of this nature are dealt with by the usual channels; the Government Whip will respond.

[Baroness Penn (Con)]

My Lords, I understand that the need to rise at a set time is part of the needs of the hybrid House. With other Grand Committees that have taken place in this circumstance, we have made progress on groups and had to adjourn mid-group. That is incredibly important in order to make progress on legislation when we are operating to time-constrained sessions.

[Baroness Thornton (Lab)]

I have to register my objection to that. If we want a proper debate, this is not just about people making timed speeches; it is about a debate. A debate should be a coherent whole, not one or two speeches and then continuing after maybe a week’s break. Would I be allowed to make my opening speech again when we go back on the second day of Committee?

[Baroness Penn (Con)]

My Lords, we would not have a second opening speech. If the noble Baroness has strong objections, we can adjourn.

[Baroness Thornton (Lab)]

I think we should. This is an important debate and we need it as a whole debate. I would be very grateful if that could be considered. I promise to make a small speech when we restart.

Health Protection (Coronavirus, Wearing of Face Coverings in a Relevant Place and on Public Transport) (England) (Amendment) (No. 2) Regulations 2020

Baroness Penn Excerpts

Monday 12th October 2020 Lords Chamber

[The Deputy Speaker (Lord Palmer of Childs Hill) (LD)]

I call the noble Baroness, Lady Uddin.

[Baroness Penn (Con)]

The noble Baroness might be on mute, so she could try unmuting herself.

[The Deputy Speaker (Lord Palmer of Childs Hill) (LD)]

I think we will go to the noble Baroness, Lady Wheatcroft.

Health Protection (Coronavirus, Collection of Contact Details etc and Related Requirements) Regulations 2020

Baroness Penn Excerpts

Wednesday 7th October 2020 Lords Chamber

[Lord Bilimoria (CB) [V]]

These regulations impose a number of obligations on relevant persons in order to protect against the risks arising from coronavirus. Businesses and other public settings where people meet socially, including hospitality, close contact and leisure venues, must record contact details of customers, visitors and staff on their premises to tackle the spread of coronavirus. The details must be stored for 21 days and shared with NHS Test and Trace if requested.

All that makes sense, but Jeremy Hunt, the former Health Secretary, recently questioned the current Health Secretary, Matt Hancock, on whether the entire system of testing needed to be overhauled. He argued that the underlying problem was that the Lighthouse laboratories—the Government-funded facilities there to supplement existing public laboratories—had been “overwhelmed by demand”. As the chancellor of the University of Birmingham, I say that we have a testing facility on site and one of the top medical schools in the country. And yet, I am told, there is a piece of machinery that NHS Test has—there are about six of them—which, if we were to get hold of one of them, would enable the testing at the university facility to go up multifold. Why is that being held back? Why are these pieces of equipment not being released to increase capacity? This is an urgent situation.

At the same time, business resilience—I say as president of the CBI—is lower than it has ever been, with cash and stockpiles run down. We must get this right. We know that business knows public health must come first, and we have been doing all we can to keep staff and customers safe, whether in pubs, shops, factories or offices. Local restrictions come as a disappointment for many businesses across the country, but the Government cannot stand by as infection rates rise in the region. We must aim for a no-surprises approach as far as possible when restrictions are put in place, and not all restrictions are one-size-fits-all. We have seen this from the full lockdown in Leicester and the household-based restrictions in Greater Manchester, west Yorkshire and elsewhere.

Then we have the 10 pm closing of pubs, bars and restaurants. I declare my interests, but will the Government tell us where the evidence is that this is required? The scientific evidence I have heard is that less than 5% of new infections come from the hospitality industry, which employs 4 million people and which has really suffered—it was closed for three and a half months, from 23 March to 4 July. From my knowledge in the trade, only 10% of drinking happens after 10 pm. So why do this—quite apart from the unintended consequence of people spilling on to the streets and going elsewhere to drink?

When it comes to testing capacity, Professor William Hanage, of the TH Chan School of Public Health at Harvard University, has said, on the lack of mass testing:

“By the time you become aware of the problem it is likely to already be much larger. You are not going to detect outbreaks if you don’t look for them.”


He called for

“very good diagnostic tests as well as tests that may be less sensitive but can be used more frequently.”

Why are the Government not procuring the mass testing that is available?

The Abbott Laboratories BinaxNOW test, which is $5 and gives results in less than 15 minutes, has been approved by the FDA, but I believe has been rejected by our Government. I am told that Greece—a country that has dealt with the pandemic relatively very well—has ordered millions of these tests. If it is good enough for the FDA, and if it is good enough for Greece, which had a death rate of 36 per million vs our 663 per million, why is it not good enough for us? They are producing 50 million of these, and there are other equivalent tests that give these instant results and are affordable.

When it comes to false positives, anyone who has tested positive with these instant tests can immediately have a PCR laboratory test to confirm that it is positive. So surely, by not doing this, by not having the mass testing, we are saying that the best is being the enemy of the good. This mass testing will enable our economy to fire on all cylinders. From a cost-benefit point of view, we are talking about a £2 billion a month cost if you test everyone twice a week in the whole population. We have been spending hundreds of billions supporting the economy. If we have mass testing, our country can get on.

So, a vaccine is on soon and the testing is needed urgently—

[Baroness Penn (Con)]

My Lords, I must remind the noble Lord—

[Lord Bilimoria (CB) [V]]

Thank you very much, I am just about to stop. I would like to conclude by saying we need this testing urgently now.

--- Later in debate ---

[Lord Naseby (Con) [V]]

My Lords, these regulations are pretty comprehensive, and I wish to make five observations that I hope will be helpful against a family background of two doctors, and myself as a former leader of a local authority as well as a Member of Parliament. The first is on care homes. I commented on inspections in the review debate on 28 September, and since then I have double-checked the situation of Care Quality Commission inspectors, who are currently just wearing a mask rather than having undergone a Covid-19 test. No one else is allowed into a care home or a nursing home without a test, because people there are very vulnerable. I now understand that the decision was made in August and backed by the department of health without any consultation with the National Care Association. Surely this needs to be reviewed urgently.

Secondly, staying with care homes, and mentioning that my wife is a former general practitioner, is it true—[Inaudible]—simply looking after them? If so, that seems an error. It may not be accurate, in which case the Minister can put my mind at rest.

Thirdly, we know that part of the rise in infections is due to young people, as mentioned in paragraph 7.14 of the Explanatory Memorandum. What discussions were held with the Department for Education, the universities and sixth-form colleges and other colleges—[Inaudible.]—before students went back to university or college? Did any discussions take place? Did the Department of Health take the initiative and—[Inaudible.]? The comment of my colleague, the noble Lord, Lord Bilimoria, on mass testing is highly relevant here.

Fourthly—[Inaudible.]

[Baroness Penn (Con)]

My Lords, we are having trouble hearing the noble Lord. We heard his first three questions. I suggest that we come back to his final two questions when his connection is restored, and move on.

Coronavirus Act 2020: Temporary Provisions

Baroness Penn Excerpts

Monday 28th September 2020 Lords Chamber

[Lord Robathan (Con)]

My Lords, I first pay tribute to my noble friend Lord Bethell and, indeed, give him my sincere sympathy. I think he was appointed to be a Health Minister at the beginning of this year, and, in his worst nightmares, he could never have imagined that he would be here every day repeating Statements, defending regulations and whatever else. I give my sympathy and best wishes—even when I do not agree with him.

Paragraph 7 of the Government’s Coronavirus Act analysis, which was sent to us all last week, states that, in a “proportionate response”,

“A balance has had to be struck”.


Paragraph 20 states:

“The government’s objective is to delay and flatten the peak of the pandemic … so that we minimise suffering and save lives.”


However, the next paragraph states an intention to

“minimise disruption to everyday life”.

In this regard, it especially mentions education and the progression to employment of the young. All of these are laudable intentions.

The original Motion that I put down last week was somewhat more forthright than today’s, but wiser counsel from friends prevailed. Therefore, my Motion today is very close to the Brady amendment that will be put to the Commons on Wednesday. I will pursue two arguments. The first is that government policy has been inconsistent, incoherent, confusing and entirely disproportionate: a public health crisis has been turned into a catastrophe. The second—which may find more sympathy in this Chamber—is that our cherished and accountable democratic process has been replaced by authoritarian rule by diktat.

Six months ago, there was a lack of knowledge and a real concern about coronavirus, so the imposition of emergency measures was perhaps understandable. We now know—as we knew then—that the virus is unpleasant, virulent, highly contagious and dangerous. We now have six months of evidence to study, but we still do not know everything. Indeed, we know remarkably little about this virus. Although confirmed cases stand at approximately 435,000, there have of course been many, many more.

My unscientific and anecdotal view is that the virus swept through the population in the first few months of this year, killing the most vulnerable and infecting many, many millions. However, nobody really knows. I am not a scientist; I do not know much about T cells or whether the common cold—apparently caused by another coronavirus—can give some resistance to the virus. I do not know much about vitamin D—except that you need sunlight—or the Gompertz curve. However, I can see that the graphs of fatalities in past epidemics tend to follow a similar pattern, and those in Europe seem to be doing so now.

We do not even know very much about the symptoms of coronavirus infection: they keep expanding. My son was sent home from his college on 12 March with a high fever and persistent cough; he recovered quickly—he is young and healthy—but he had no sense of smell or taste. Of course, in March that was entirely irrelevant because it did not become a symptom until late May. Scientific advice, models and predictions have varied widely—from the apocalyptic half a million deaths mentioned by the discredited Neil Ferguson in March to contradictory scenarios. The international scene remains very concerning and, of course, reasonable precautions should be taken, especially by the elderly and vulnerable.

Unfortunately, many in the media seize upon unsubstantiated scare stories, and I particularly mention the BBC, which spreads fear and despair and treats the opinions of the discredited Professor Ferguson as gospel. These fears are amplified by some politicians: Sadiq Khan, Nicola Sturgeon and Mark Drakeford. However, my unscientific view remains that neither they nor anybody else really knows. Government policy has reflected that, as advice has changed weekly, if not daily. It is not that many weeks since we were told that wearing a face mask was unnecessary and possibly even increased the viral load if one was already infected. Therefore, please let us not suspend our critical faculties; let us look at the evidence.

First, although infection rates are important, we have been exhorted throughout this crisis that this is about saving lives, so it is deaths and very serious illness or hospital admissions that should be our focus. The data is certainly not perfect, but we do know—from Cancer Research UK, for instance—that 450 people die from cancer every day. Coronavirus restrictions have caused a backlog in referrals for treatment, which is probably leading to unnecessary deaths from cancer. We do know that restrictions are having a very bad effect on mental health, particularly depression, and that domestic abuse and violence has increased. It seems that suicides may have increased. We know that elderly people are dying alone, feeling deserted and surrounded by strangers in blue plastic sheets.

We know that government figures put the number of deaths from coronavirus of those under 65 at about 6,000 over the last six months. Most of these individuals had comorbidities such as diabetes or obesity. We also know that the chances of dying from coronavirus are minimal if one is under the age of 25.

We know that our children’s education is being dreadfully harmed and their future mortgaged—as is our country’s future prosperity—and that our economy is being trashed and livelihoods and lives destroyed. We know that these tragic deaths from coronavirus—which are overwhelmingly among the elderly, frail and those with comorbidities—currently account for approximately 2% of deaths in this country, where 623,000 people died last year, which averages 1,700 a day or 11,000 a week. Therefore, are these restrictions meeting the objective of saving lives?

This is not the Black Death, nor is it the great plague, the Spanish flu or a war. My right honourable friend Rishi Sunak said of the virus on Thursday in the House of Commons that

“we must learn to live with it, and live without fear.” —[Official Report, Commons, 24/9/20; cols. 1155.]

I entirely agree; we need a proportionate response and courageous leadership.

I accept that many of your Lordships will not agree with my views on government policy or on the restrictions imposed on our liberty. However, I hope that you may support my second point and the focus of the Motion: we need proper accountability to our national Parliament, which has been totally bypassed over the last six months. We have seen no cost-benefit analyses, detailed impact assessments or proper risk assessments. Let the Government put the evidence before Parliament, which can then decide whether government policies are appropriate and proportionate and, indeed, whether the deaths from coronavirus are not outweighed by the enormous harm caused to life by the restrictions.

Currently, we have students locked into halls of residence, sporting fixtures for the young cancelled, holidays ruined, theatres closed, and bars and restaurants closing down because they are unviable. Christmas is being cancelled and some elderly people, who fear this may be their last Christmas, will be unable to see their families. A Cabinet Minister has called on neighbours to ring the police if there are seven people in the house next door. There is a national curfew at 10 pm, the first ever in peacetime, I believe, and the rule of six is based on—what exactly? All this without any proper scrutiny.

Our free society is being turned into something that I do not recognise, as these illogical and draconian measures restrict the liberty of our people. This is rule by decree, something more usually associated with authoritarian Governments. This unaccountable and rather unusual assembly where we sit is not the place to hold the Government to account. That is the role of the elected representatives of the people: Members of the House of Commons, who will have to answer to their constituents.

However, we can ask questions. This afternoon, we can show that we support the amendment tabled by my honourable friend Sir Graham Brady and apparently supported by the Opposition, which will be put down on Wednesday. I hope all Peers will support my Motion in order to allow this House to express its opinion on the way the Government are currently acting—in, frankly, a cavalier manner without any accountability. I intend to divide the House, and I hope others feel as strongly as I do on this matter.

[Baroness Penn (Con)]

My Lords, I remind noble Lords of the time-limited nature of this debate. The time limit for Back-Bench speakers is four minutes, to allow for a full response by the Minister at the end.

Health Protection (Coronavirus, Restrictions on Gatherings) (North of England) Regulations 2020

Baroness Penn Excerpts

Friday 25th September 2020 Lords Chamber

[Lord Greaves (LD)]

My Lords, yesterday I said quite a lot about a similar set of regulations which I will not repeat, but what I did do in the evening yesterday after our long discussions was attend a meeting of Pendle Borough Council. I was able to do that from my room in this building. I am obviously a member and I shall give a flavour of two resolutions that the council passed, which might be helpful. The first was to express the council’s thanks and gratitude to the staff of Pendle Council and all the other local agencies whose staff have “shown such fortitude in the face of unprecedented peacetime impacts on the daily lives of themselves and their citizens” and gone beyond the call of duty in what has been happening.

The council then passed a motion on test, trace and isolate, which in a sense was a little less positive. “The council notes with alarm that the chaos in the nation’s test, trace and isolate systems for Covid-19 is contributing to the disease accelerating.” The failures of the Government system have created a situation where they are locking us into lockdown in Pendle. These are things that I have said previously in the Chamber. The council believes that “oppressive” regulations—not all regulations, but oppressive regulations—are counter- productive to the fight against Covid-19 and are generating mental health issues and undermining social cohesion across the borough. I also talked about that to a degree yesterday.

The council requested that the Government should issue a simple set of principles setting out the steps that individuals should take. The Government think that they have got that, but we are asking that people understand it. The emphasis should be on supporting people to live their lives in accordance with the guidance, rather than a reliance on virtually unenforceable regulations and “Covid marshals” and—this is a point I have been making on behalf of all the councils in the hotspot areas—the Government should provide sufficient resources for Pendle Council and its partners to have an effective test, trace and isolate programme involving screening, targeting individual testing, a local end-to-end tracing programme and adequate support for individuals who are required to self-isolate, together with the monitoring of such isolation to ensure its effectiveness. The Government have been moving towards this, but I thought that this might be helpful.

[Baroness Penn (Con)]

My Lords, I remind noble Lords of the two-minute time limit for Back-Bench speakers.

Covid-19 Update

Baroness Penn Excerpts

Monday 21st September 2020 Lords Chamber

[Lord Young of Norwood Green (Lab) [V]]

My Lords, I welcome the statement from the Minister, but to be candid, when I hear talk about Moonshot, I will believe it when I see it. What members of the public want is the ability to access Covid tests in places such as Bagshot, or Aldershot, or any other testing centre. The reports we get are that they cannot get appointments. Schools are closing because they cannot get test results, classes are being sent back; therefore, it is not just the number of tests, it is how long they are taking to turn around. To say we are surprised by the surge, when we were opening schools, does surprise me.

I have two other points on which I would welcome a response from the Minister. One, raised by noble Baroness, Lady Barker, is about domiciliary care. It is essential that PPE is available. It must be the right quality; we have had examples where large batches have been ordered from Turkey and China and they have been no good. We want quality PPE that is available.

[Baroness Penn (Con)]

Could the noble Lord address his question to the Minister now?

[Lord Young of Norwood Green (Lab) [V]]

I am addressing all these questions to the Minister. My last point is this: will there be testing capacity in general practice surgery?

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

Baroness Penn Excerpts

Friday 18th September 2020 Lords Chamber

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

My Lords, I beg to move that these regulations, originally tabled by my right honourable friend the Secretary of State for Health and Social Care, be approved.

I will start by summarising the changes to the regulations. The Health Protection (Coronavirus, Restrictions) (No.2) England) Regulations, which I will refer to as “the national regulations”, were laid on 4 July. There have been five changes to the national regulations, the first of which were debated and approved in both Houses before the recess. Today’s debate will focus on the second, third and fourth amendments to those regulations.

The second and third amendments to the national regulations continued to ease business closure restrictions. The second amendment to the national regulations permitted the reopening of businesses and venues from 25 July, including: indoor swimming pools, including water parks; indoor fitness and dance studios; and indoor gyms and sports courts and facilities. Alongside these changes the Government produced supporting guidance advising that the most high-risk activities within those business and venues, such as saunas and steam rooms, should not reopen.

From 15 August the following venues were permitted to open: bowling alleys; indoor skating rinks; indoor play areas, including soft play areas, with several adjustments advised in guidance, such as the closure and removal of ball pits; casinos; and exhibition halls and conference centres, with guidance advising that this is only to enable government-endorsed pilots for the time being.

Alongside those regulatory changes, there was also a series of non-legislative changes to allow close-contact services, including treatments on the face, to resume. These included: allowing socially distanced and outdoor performances to take place; pilots for large crowds in sports stadia and business events; and the relaxation of guidance on wedding and civil partnerships to allow receptions of up to 30 people.

As set out above, these amendments opened businesses and venues that had been required to close, with Covid-secure guidance developed with industry and medical advice to ensure that they opened in a safe way. This has meant that now, nationally, only nightclubs, dancehalls, discotheques, sexual entertainment venues and hostess bars are required to remain closed. These are considered to pose a high risk of transmission due to the close proximity of those attending them.

Regarding the fourth amendment on strengthening enforcement of national regulations, although we were able to successively ease business restrictions over the Summer Recess, we also now better understand how the infection is transmitted and the role of social activity within this. That is why the Government have acted quickly to strengthen the enforcement and restrictiveness of social distancing measures against the backdrop of a slow but steady increase in infection levels nationally.

The fourth amendment to the national regulations, which came into force on 28 August, created a new offence of holding or being involved in the holding of an illegal gathering of more than 30 people, giving the police the power to issue a fixed penalty notice of £10,000 to deter the most egregious breaches of social distancing measures.

I want to say a word about the justification for using emergency powers and give an explanation of how decisions are made. We have needed to use the emergency powers to amend these regulations so that we can respond quickly to the serious and imminent threat to public health posed by coronavirus. I know that these national regulations have caused disruption to people’s lives by placing restrictions on who they can see, what they can do and where they can work. Just as the Secretary of State has a legal obligation to protect public health, he is obliged to ease restrictions as soon as it is safe to do so.

The Government continue to pay close attention to the measures, assessing them to ensure that they continue to be necessary and proportionate. These regulations set out that a review of these restrictions must take place within 28 days. However, the Secretary of State for Health keeps their necessity under constant consideration between these formal review points. The question to be considered is whether the “restrictions and requirements” contained within the regulations remain necessary for the public health purposes of the regulations.

Each restriction must be judged by reference to its continuing necessity as the crisis develops, and be based on the available information, at each stage, about the effectiveness and impact of the measures. We use the best available science, along with consideration of the most up-to-date data available at the time to inform decisions. Central to this continues to be a robust assessment of the rate of transmission and infection. However, this Government have also undertaken significant wider analysis and evaluation of the national regulations, including consideration of economic impacts, the level of compliance with the measures, the amount of enforcement needed and impacts felt by local authorities. Understanding the full impacts of these regulations is key to continuing to improve our approach to controlling the virus. This shows the Government’s commitment to ensure that restrictions are in place only for as long as necessary, and the evolution in our understanding and approach to tackling the virus.

Perhaps I may say a word about local restrictions. Over the Summer Recess we have combined tightening restrictions in areas with outbreaks with the easing of business restrictions nationally. As welcomed in the debate just a few weeks ago, we have given local authorities powers to act quickly in response to local outbreaks by closing specific premises, shutting public outdoor spaces and cancelling events. We want to build on this trusted partnership with local government so that we can have a more targeted and localised response to any future outbreaks. We asked all councils to develop dedicated local outbreak plans. We gave councils £300 million in new funding to support this and published the Contain framework, providing further guidance on managing local outbreaks.

Where regulations have been required, the Government have worked with local partners to develop tailored and proportionate restrictions based on the best scientific evidence available, varying from a single factory to an entire region. These interventions have been underpinned by scientific evidence—[Inaudible]—to analyse this local data and provide the scientific advice—

[Baroness Penn (Con)]

My Lords, we have a problem with the connection. I suggest that we adjourn for five minutes.

--- Later in debate ---

[Lord Bethell (Con) [V]]

My Lords, may I say something about local restrictions? [Connection lost.]

[Baroness Penn (Con)]

My Lords, with your permission, I shall complete—

[Lord Bethell (Con) [V]]

My Lords, may I something about local restrictions?

Over the Summer Recess, we have combined tightening restrictions in areas with outbreaks with the easing of business restrictions. [Connection lost.]

[Baroness Penn (Con)]

My Lords, with your permission, I shall complete the Minister’s opening speech. May I say something about local restrictions? [Laughter.]

Over the Summer Recess, we have combined tightening restrictions in areas with outbreaks with the easing of business restrictions nationally. We have given local authorities powers to act in response to local outbreaks by closing specific premises, shutting public outdoor spaces and cancelling events.

We asked all councils to develop dedicated local outbreak plans, gave them £300 million of new funding to support this and published the contain framework, providing further guidance on managing local outbreaks. Where regulations have been required, the Government have worked with local partners to develop tailored and proportionate restrictions based on the best scientific evidence available, varying from a single factory to an entire region such as the north of England. These interventions have been underpinned by scientific advice and local data provided by a combination of Public Health England, the joint biosecurity centre and NHS Test and Trace.

On Monday 14 September, noble Lords will have seen the rule of six come into effect. This change brought the gathering policy from guidance into regulation, mandating that people can gather only in groups of six. This applies both indoors and outdoors. Single households or support bubbles of more than six are still able to gather, and there are a small number of exceptions, such as for work, schools, weddings and organised sports activities. As the Prime Minister announced last week, these measures are not a second national lockdown but are aimed at preventing the need for one.

It is thanks to the public and their continued effort that we have been able to slow the spread of the virus and start cautiously to return to life as normal. Although time has passed since the peak we saw in the spring, the threat posed by the virus has not gone away. Now, with winter approaching, we will keep doing whatever it takes to keep it under control. I am grateful to noble Lords for their valuable contributions to these debates and for continuing to challenge us to do better in this vital area of public policy.

I believe that we have met the bar set for us in these debates. These regulations are a proportionate and necessary use of the powers that Parliament has asked us to use. I commend them to the House.

Coronavirus

Baroness Penn Excerpts

Wednesday 16th September 2020 Lords Chamber

[Lord Triesman (Lab) [V]]

My Lords, in the course of the pandemic, a significant number of contracts with private companies have been signed without tender and a number of these have been in areas such as PPE and test and trace. Most appear to have failed to deliver essential services and equipment—

[Baroness Penn (Con)]

I am afraid that we cannot hear the noble Lord. Maybe he would like to get closer to his microphone and try again.

[Lord Triesman (Lab) [V]]

I do not think I can get much closer to the microphone without eating it.

In the course of the pandemic, a significant number of contracts have been issued to private companies without tender. What is the value of the contracts that have been signed without competitive tender? Will the Minister place in the Library a list of all such contracts, their value, the companies involved and their ultimate beneficial owners?