Health Protection (Coronavirus, Restrictions) (Self-Isolation and Linked Households) (England) Regulations 2020
Lord Patel Excerpts(3 years, 4 months ago)
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Lord Patel (CB) [V]
My Lords, I wish to make two points.
Many, including in this House, question the need for and see no benefits in policies related to lockdown. Some believe that the rising rates of infection mean that restrictions to reduce people’s contacts and movement are ineffective in controlling the transmission of the virus. Many factors affect the transmission of the virus, contact between people being the key factor. In the case of the variant that more readily attaches to the ACE2 cells of the host, reducing contact between people is even more important. What matrix do the Government use to assess the effectiveness or otherwise of measures such as lockdown, apart from the decrease in the number of new infections, to inform the public better?
Secondly, on the vaccination strategy, the Government’s ambition is to vaccinate the JCVI’s top four priority groups by mid-February. I commend that, even if the target is not met. The concern voiced in popular and science media is about the proposal to extend the second dose of the vaccine by up to three months, especially for the Pfizer/BioNTech vaccine. Does the Minister agree that the JCVI should publish the scientific data on which this decision is based, for both approved vaccines, to reassure scientists and the public that the dosage regime does not compromise the effectiveness of the vaccines, which I believe to be the case? If he does not have time to answer me today, could he write to me and put a copy in the Library?
ONS: UK Life Expectancy
Lord Patel Excerpts(3 years, 4 months ago)
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Lord Bethell (Con)
The noble Baroness is entirely right: 15% of children aged two to 15 are obese. That is a shocking figure, and extremely disappointing. We have already done a lot to bring in the taxes on sugary drinks, and we are ploughing the money from them into sport in schools. But she is right that the taxes on sugary drinks provide an interesting template, which could be used in other areas where industry fails to step up to its responsibility and to reduce the harm of fatty or other destructive foods.
Lord Patel (CB) [V]
My Lords, the Science and Technology Committee, which I have the privilege to chair, will publish a report in January on ageing, science, technology and healthy living, which noble Lords will find an interesting read. The Government have set themselves a grand challenge, with a target of increasing healthy life by five years by 2035. In light of the ONS report and the effects of the pandemic, what increased barriers do the Government think that they face to achieving that—or can it be achieved at all? If the Minister wishes to give a Written Answer, with a copy in the Library, I would be content with that.
Lord Bethell (Con)
The noble Lord makes his point extremely delicately and politely, but he is entirely right. We have a commitment for five extra healthy years by 2035, and the combination of the Marmot review, the ONS figures and Covid make that seem an extremely daunting challenge indeed. I am not sure if I have the complete answer standing at the Dispatch Box right now. I would be glad to write to him and explain how we will undertake the Green Paper on prevention, the response to which will be published next year, as an opportunity to outline the kind of strategy he calls for.
Covid-19 Update
Lord Patel Excerpts(3 years, 4 months ago)
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Lord Patel (CB) [V]
My Lords, we know that all viruses evolve and, while we do not yet know whether the genomic variant identified is more infectious, we do know that the transmission rate of the virus is rising exponentially. By the way, the Minister just said that the new variant correlates with increases in infection; the word “correlates” suggests cause and effect that has not yet been proven. Can the Minister tell us what scientific matrix the Government will use over the next week to make the political decision on whether to ease or otherwise the current restrictions, going forward to Christmas and beyond?
Lord Bethell (Con) [V]
My Lords, I am extremely grateful to the noble Lord, Lord Patel, for his description of affairs, which, as ever, is as thoughtful as we would hope. However, I clarify and disagree with him in that correlation and causation are not the same things. I chose my words extremely carefully: there is a correlation with higher transmissibility, but there is no evidence that this is caused by the variant; I want to be crystal clear about that. I pay tribute to colleagues at the Sanger and at COG, the genomics collective that is doing the work on tracking down the science of the new variant. Their insight is profound and they will be playing into the decisions about whether any judgment on the variant should play a role in the decisions about any future restrictions.
Ockenden Review
Lord Patel Excerpts(3 years, 4 months ago)
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Lord Patel (CB) [V]
I declare an interest, because I was privileged to work for over 35 years in a maternity unit, with brilliant midwives and doctors—I was a lead obstetrician—to which the events described in this report were totally alien. So we have another report on the failings of maternity services. The root cause of this, as found in previous reports, is the unquestioning practice of regarding all pregnancies as low risk and striving for a natural birth. Does the Minister agree that, for better outcomes for the mother and her unborn baby, society should expect a better working relationship between midwives and obstetricians, while recognising their individual professionalism? This report should be the starting point to making that happen. The Minister mentioned that both Royal Colleges were working together to bring this about. They might be the solution but, if they are not, they will be the ones who are blamed next.
Lord Bethell (Con) [V]
My Lords, I pay tribute to the insight of the noble Lord, Lord Patel, who brings with him not only expertise as an obstetrician, but deep involvement in the patient safety agenda. I completely agree that collaboration and close working relationships between midwives and obstetricians absolutely benefit the collective care of mothers and babies. When that does not happen, and when agendas other than patient safety come into play—around natural births or what type of person should be present at a birth—it is absolutely to the detriment of the safety of both mother and child. I am absolutely determined that the Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists step up to their leadership role in resolving this cultural stand-off. As the noble Lord rightly put it, in almost every maternity centre in the country a fantastic service is provided by clinicians and nurses—but, when that chemistry goes wrong, patients suffer, and we cannot let that happen.
Coronavirus Vaccine
Lord Patel Excerpts(3 years, 5 months ago)
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Lord Patel (CB) [V]
My Lords, as we embark on a mass vaccination programme, it is important that we follow up all those who are vaccinated, or at least a cohort of them, with whatever vaccines are used, in a scientific way. It is important that structured scientific data collection is implemented. Do the Government plan to do that, and who will be doing it? I hope that it will be UK academic institutions, because there is much more science to learn post vaccination about the effectiveness of different vaccines and the science of the new way of developing these vaccines.
Lord Bethell (Con)
As ever, the noble Lord is extremely wise in his observation. He is entirely right to hold us to account. There is no point in enjoying this fine moment too much when you have the noble Lord, Lord Patel, on your case reminding you about the next big challenge around the corner. He is right that pharmacovigilance is essential. We need to make sure that this and other vaccines work and that we learn from the behaviours of all of them. That is precisely why we put the deployment of this vaccine through the NHS. There was a temptation to set up an alternative agency and focus on the actual injection of the vaccine over all other matters. Instead we have run it through the NHS digital process, which means that all the information around the vaccine is put very firmly into the GP record. That means that we can do population-wide analysis of the results of the vaccine. We have a very large research community in the UK both in the companies such as Pfizer, which, as he knows, are responsible for pharmacovigilance, and in the university sector. We will have all those records available for them to do the follow-up work that he rightly emphasises.
Covid-19: Vaccines and Medical Equipment
Lord Patel Excerpts(3 years, 5 months ago)
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Lord Bethell (Con)
My Lords, we have extremely detailed and energetic plans to deal with misinformation, which is based on confusion, and disinformation, which is based on malice. It would not be right for me to go through those plans in detail at the Dispatch Box, but I reassure my noble friend that they are in place and are being characterised by a degree of consideration for those who have concerns about the vaccine. It is a grave undertaking to have an injection such as that. People naturally have searching questions they would like to ask, and we are trying to meet those questions with a degree of thoughtfulness and to answer them in the spirit in which they are asked.
Lord Patel (CB) [V]
My Lords, my question follows on well from the previous one. The development of highly effective vaccines against Covid-19 is a remarkable scientific advance. It is crucial that the public have absolute confidence and trust in their use, which they should. This will be reinforced when the scientifically-led process of market approval by the regulator and scrutiny by the wider science community is completed, following publication of the peer-reviewed data. Can the Minister assure the House that there will be no political interference in any way to speed up that process before the vaccines are made available to the wider public?
Lord Bethell (Con)
I thank the noble Lord for the opportunity to make this crystal clear: the MHRA is an independent regulator, its work on vaccine approval has no political interference whatever and there is no pressure on either time or outcome. I pay tribute to those at the MHRA, who are extremely dedicated to the cause. We are going to approach the entire process with a spirit of transparency for exactly the reasons the noble Lord identified. Public trust is essential, and the only way we can gain the public’s trust is by being open and honest about how we go about these approvals. That is the way we will pursue the process.
Medicines and Medical Devices Bill
Lord Patel ExcerptsThursday 19th November 2020
(3 years, 5 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-VII(Rev) Revised seventh marshalled list for Grand Committee - (17 Nov 2020)
The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)
I now call the noble Baroness, Lady Wheeler. No? I gather that the noble Lord, Lord Patel, wants to speak. I call Lord Patel.
Lord Patel (CB) [V]
My Lords, I sent in a request to speak after the Minister. I am grateful to her for her lengthy response, but in a way it just shows that there will be considerable areas of divergence once we exit Europe, even after we exit Europe and the agreement with the EU has expired. What the Minister said is correct—that maybe the emergency power regulations will allow us to ask questions—but those are only emergency powers, and this is longer-term.
My amendment asks for an indication, on at least a yearly basis, of where divergences are occurring. It is interesting that the Minister said that the statutory instrument is now available and will be debated in due course. Of course it is available now—although I do not know when it was made available—and we will have an opportunity to debate it. However, the MHRA was already giving guidance on the basis of that instrument before we had seen it or debated it. The Minister’s reply did not therefore satisfy the intention behind my amendment—although I will, of course, not move it today—in terms of the necessity for the Government to produce a report of where divergences are occurring and why.
Baroness Penn (Con)
To address the noble Lord’s question about when the statutory instrument was laid, I believe it was on 20 October. I think the statutory instrument laid on 20 October, which we shall debate, is not the Government’s approach to an answer on how we deal with the future issues of regulating medicines, medical devices and vet meds in Northern Ireland and Great Britain. What I was trying to express to the noble Lord is that we have a mechanism that means the Minister will report to Parliament every two years, both looking forward to prospective changes and back at any changes that may have been made. Of course, where new regulations are proposed there will be public consultation on those, but there will also be reports to Parliament ahead of that about the intentions, and those reports will provide a mechanism, which I think the noble Lord wants, to ensure that these issues are discussed properly in Parliament in future.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I hesitate to disagree with my noble friend, but I think it is on page 34—but then, of course, I might have an old edition of the Bill as well, just to confuse things.
The reason for supporting this is the unease about provisions in Clause 27 and Schedule 1. The Delegated Powers Committee concluded that
“in the absence of a full justification … allowing the ingredients of criminal offences … and … the penalties for existing offences to be set by delegated legislation”
amounts to “inappropriate delegations of power”. The Constitution Committee said:
“We have concluded previously that ‘the creation of criminal offences through delegated powers is constitutionally unacceptable’, save for exceptional circumstances. The delegated powers to create and adjust criminal offences in this Bill are constitutionally unacceptable.”
The Minister has made certain modifications, but I think the general principle still holds good.
The guidance to be issued under paragraph 13 of the schedule is likely to be extensive, including: the imposition of a monetary penalty; the notices to the person it is proposed to fine and the grounds for so doing; the representations that have been made; the appeals process; and the consequences of non-payment. As my noble friend said, lines 9 and 10 on page 34 provides that
“The Secretary of State must have regard to the guidance or revised guidance published under this paragraph”.
Given that the Secretary of State is the person publishing the guidance, it is puzzling that he or she is required only to “have regard to” the very guidance that he or she has published—hence my noble friend’s amendment to require the Secretary of State to “act in accordance with” the guidance. I look forward to hearing from the Minister as to why the Bill is drafted to give the Secretary of State wider discretion on that.
Lord Patel (CB) [V]
My Lords, I speak very briefly to support this amendment. The noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt of Kings Heath, have covered the argument extremely well. As the noble Lord said just now, the guidance is produced by the Secretary of State but, when you look at it in practice, it says that the Secretary of State “must have regard to” the guidance—that is, can take note of it but does not have to follow it.
I am a doctor and am used to following guidelines. If I do not follow the guidelines, I am liable to be reported; if I do not follow them for any reason in the management of a patient, I am expected to write down as to why I did not follow them. I am not expected to take note of it or have regard to it—I am expected to follow it. The amendment proposed by the noble Baroness, Lady Thornton, addresses exactly that point: why is the Secretary of State not asked to follow the guidelines which he or she drafted?
Lord Sharkey (LD) [V]
We all know that the words “have regard to” create no real obligations, whereas the words “act in accordance with” do create real obligations. Clause 13 seems to contain important restrictions on the actions of the Secretary of State, but it does so via guidance. As the Bill stands, with its “have regard to” wording, that guidance has no statutory force. If the restrictions are to have any reality—and I assume that the Government would like them to, or they would not have written them into the Bill—we must replace “have regard to” with “act in accordance with” as the amendment proposes. We support the amendment.
Medicines and Medical Devices Bill
Lord Patel ExcerptsTuesday 17th November 2020
(3 years, 5 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-VII(Rev) Revised seventh marshalled list for Grand Committee - (17 Nov 2020)
Lord Patel (CB) [V]
My Lords, in speaking to my Amendment 127, I also speak in support of the amendments referred to by the noble Baroness, Lady Wheeler, on consultation with the devolved Administrations. While Scotland is devolved in terms of healthcare, the regulations on medicines and medical devices, particularly market authorisation, is not. I support the comments on consulting the devolved Administrations and I have no doubt that the Minister will respond.
I am extremely grateful to my friend, the noble and learned Lord, Lord Mackay of Clashfern, for adding his name to my Amendment 127. I am pleased to see that he might speak to it later. The amendment would add to line 9, page 24 of the Bill, the words
“patients and end users directly affected by the regulations”.
It would strengthen the consultation provision by requiring that patients and end users be part of any consultation relating to potential new regulation on medicines, veterinary medicines and medical devices.
Clause 41 creates a duty to consult the relevant authorities when using the delegated powers to make provisions for medicines, veterinary medicines and medical devices. However, this duty refers only to who the authority thinks it should consult, giving a wide area of discretion and providing no guidance or guarantee on consulting patients and end users of medicines and medical devices.
The Cumberlege review found widespread failure to listen to patients’ voices. It recommended that the regulatory framework underpinning the MHRA, and medicines and medical devices in general, be reformed to better take into account patients’ perspectives in the future. In addition, the review recommended that the MHRA regulatory framework should have a requirement to demonstrate how patient views have been taken into account and influenced regulatory design. With this in mind, it is surely crucial that any duty to consult on the exercise of powers should also include reference to the need to consult patients and end users of medicines and medical devices where that is considered reasonable.
I have been deliberately brief because this proposal is so obvious that I do not, I hope, need to speak at length. I am sure that the Minister recognises this, and I look forward to his response.
Lord Sharkey (LD) [V]
My Lords, all the amendments in this group deal with the very important question of consultation. As the DPRRC has pointed out in its report on the Bill, consultations are not a substitute for proper parliamentary scrutiny, which the Bill so obviously fails to provide, but in the absence of any real parliamentary mechanisms for real scrutiny, consultations take on an added importance.
Clause 41 is slightly improved by the Government’s Amendment 126. The obligation to consult the devolved Administrations is obviously critical, although it would be helpful if the Minister could explain why in Northern Ireland it is the Department of Health that must be consulted rather than Ministers.
The Minister may also be able to reassure the Committee that the government amendment does not provide only one overriding consultation; the text seems to suggest that when it refers to carrying out “a public consultation”. Can we assume that there will be not portmanteau consultations but individual consultations on each proposed significant policy introduction, change or amendment?
The introduction of a new obligation in proposed new subsection (1B) to include a summary in the consultation document, with the relevant authority’s assessment of the matters addressed by the proposed regulations is welcome, as far as it goes. But quite what depth or rigour should these assessments have? Can the Minister assure the Committee that the assessments will have the same reach, depth and rigour as the standard impact assessments produced for SIs?
Apart from naming the devolved Administrations, it is notable that the government amendment does not specify, or even hint at, who should be consulted in any of these consultations. The Bill is entirely silent on the matter. This leaves open the possibility of narrowly drawn consultations and the omission of important interested groups, not to mention short consultations over holiday or very busy periods. I am particularly concerned that the voice of the medical research charities be clearly heard in all the appropriate consultations. I remind the Committee of my interests as chair of the Association of Medical Research Charities, whose 150 members spent £1.9 billion on research last year—the same amount as was spent by the Government. Despite this enormous contribution, the Government have form in overlooking the medical research charities sector. It took an amendment moved in your Lordships’ House to persuade the Government to agree that the board of UKRI should include a person with experience of the sector. We do not want to see the same omission here.
Our Amendment 129 is very similar to Amendment 128 in the name of the noble Baroness, Lady Thornton, which we are happy to support. Both amendments list who must be included in any consultation. The lists should not be contentious or surprising. We include
“representatives of the relevant patient groups … medical research charities”
and pharma as statutory consultees, along with academic researchers. We leave it open to the relevant authorities to add others to that list.
Our amendment also addresses the problems that could be caused by short and short-notice consultations, perhaps over holiday periods among a less than comprehensive range of consultees. It simply requires the relevant authorities to publish on their websites the terms, start dates and lengths of the consultations, along with the proposed consultees and
“date and method of the publication of … results”.
I rather hope that the Minister will tell us that this part of our amendment is not necessary. I hope that he will see our amendment as an opportunity to give firm assurances to the Committee that the groups we name will be consultees, and about the form and detail of each consultation, as we propose. I hope the Minister will feel able to oblige us.
Lord Patel
“( ) The Secretary of State must disclose information for the purpose of warning the public about concerns relating to a medical device where there is a clear threat to public safety.”Member’s explanatory statement
This amendment places a duty on the Secretary of State to disclose the information where there is a clear threat to public safety.
Lord Patel (CB) [V]
My Lords, in moving Amendment 108, I will also speak to Amendment 114. I am immensely grateful to my friend, the noble and learned Lord, Lord Mackay of Clashfern, for his support. I beg noble Lords’ indulgence because I intend to explore these two amendments in some depth as I have some concerns about them.
Amendment 108 places a duty on the Secretary of State to disclose information
“where there is a clear threat to public safety.”
Clause 35 provides that the Secretary of State
“may disclose information for the purpose of warning members of the public about concerns that the Secretary of State has in relation to the safety of a medical device.”
This is welcome, but the power is discretionary. There is no duty to disclose information in these circumstances. It is not clear why there should not be an unambiguous duty to disclose information to the public where their safety is an issue. The Government have repeatedly committed themselves in their guidance and policy documents to patient safety as their primary concern, and have given reassurances about it in the other place. However, this clause is yet another example of where there is no explicit legal commitment to patient safety. For this reason, an amendment to this clause is suggested to create a duty to disclose information where there is a threat to medical device safety.
In addition, it must be queried what is meant by a “threat to public safety” and how any such threat is to be judged or even detected. The Cumberlege review reviewed the failure of medical professionals and the system in general to listen to patients’ own reports of pain and the seriously adverse effects of their implants. The duty to disclose a threat is only as meaningful and effective as the processes behind it that monitor and capture the information relating to patients’ adverse events. A safety issue will not be recognised if patients are not being taken seriously.
Part of the findings of the Cumberlege review related to the ineffectiveness of the current yellow card system for self-reporting adverse events. There is a lack of a clear and well-publicised route for patients to report their experiences. Clear and effective processes need to be in place to capture the information relevant to identifying potential threats to public safety. This duty to disclose should be supported by such processes.
Clause 16 gives the power to create an information system, and a later amendment introduced by the noble Baroness, Lady Cumberlege, on the setting up of a patient safety commissioner, could form part of the processes needed to ensure that the experiences of patients and the reporting of adverse events are effectively monitored, recorded and evaluated. However, effective self-reporting processes and clear routes for patients to self-report need to be established. Clarification of how such reporting is to be integrated into effective communication across the NHS and the medicines and medical device regulatory framework as a whole is needed.
As the Bill stands, so much is left unsaid and what has been laid out for Parliament to discuss was drafted and conceived before the findings of the Cumberlege review were published. Any patient safety commissioner would need to be properly resourced if they were to work in practice—equally there should be more consideration by the Government of processes for patient reporting and communication across the system. That ought to be put before Parliament.
Amendment 114 would mean that Regulation 3B on the requirement for confidentiality in the Medical Devices Regulations 2002 would remain in place. It is suggested in the Bill that this is removed. Clause 37 provides for “Consequential and supplementary provision”. Subsections (3) to (7) of Clause 37 variously amend the Medical Devices Regulations 2002. In particular, subsection (5) removes Regulation 3B from the 2002 regulations. This was only recently inserted into the law by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. Regulation 3B requires that
“all parties involved in the application of these Regulations must respect the confidentiality of information and data obtained in carrying out their tasks in order to protect … (a) personal data in accordance with the Data Protection Act 2018; (b) commercially confidential information … (c) the effective operation of … inspections, investigations or audits.”
It is not clear why the requirement for confidentiality has been removed so soon after it was created. While Clause 35 provides that commercially sensitive data cannot be disclosed except where necessary for the Secretary of State to warn of serious harm in civil proceedings or criminal proceedings, no other clauses in the Bill reflect the similar requirements that have now been removed by Clause 37. It is concerning that in removing the requirement for confidentiality, the Bill seems to emphasise protection for commercial interests more than those of patients and users.
The Government should provide clarity on why they wish to remove this condition to respect patient confidentiality in operating the Medical Device Regulations. This not notwithstanding, Clause 37(5) should be removed.
Lord Patel (CB) [V]
My Lords, before I start, let me thank my noble friend Lady Cumberlege enormously for putting her name to Amendment 108. I apologise for not alluding to that earlier.
The noble Lord, Lord O’Shaughnessy, got it: my amendment leaves it to the discretion of the Secretary of State that there might be times when disclosure is not required.
To my friend the Minister, I say: good try, but I am not convinced. I do not see why my amendment cannot be accepted—it provides discretion but just removes “may”.
As far as Amendment 114 is concerned, the point is exactly this. The Minister may recollect the journalist’s report on the regulation of devices in the EU, which raised concerns about manufacturers not agreeing to provide safety information that they may have had when they were testing the devices. Removing that requirement for manufacturers does not help patient safety—hence my amendment asking to leave Regulation 3B as it is.
I have listened. In the meantime, I beg leave to withdraw the amendment.
Lord Patel (CB) [V]
My Lords, first, it was a privilege to put my name to the amendment moved by my noble friend Lady Cumberlege. It is a pleasure to follow her powerful speech, which made the case for an independent patient safety commissioner so powerfully that I am tempted to say that no more needs to be said about the amendment except for the Minister to accept it. But of course I cannot do that. I will try to make a case for why now is the time to accept what the noble Baroness is asking for. The time for her amendment has come.
I strongly support the amendment. It was one of the key recommendations of the noble Baroness’s report First Do No Harm to establish an independent commissioner for patient safety and to do this through legislation. The need to address patient safety as an important aspect of healthcare was identified in England following the publication of the report An Organisation with a Memory. This was the watershed moment in the history of patient safety development. In 2001, a report was produced, Building a Safer NHS for Patients, which led to the establishment of the National Patient Safety Agency for England; a national reporting and learning system was to be developed as part of it. In 2006, Safety First, a report for patients, clinicians and healthcare managers, was published, with the objective of recasting the functions of the National Patient Safety Agency. It was after that that I took the chair of it.
The National Patient Safety Agency did develop several good and respected methodologies and publications, and introduced some fundamental patient safety protocols, but it lacked the power and authority of an organisation established in statute. Functioning as an arm’s-length body of the Department of Health, and at its behest, was not the way to establish patient safety. In my view, it weakened its ability to deliver patient safety across the NHS.
As chair, I remember having to try to persuade management at NHS Confederation meetings that alert notices related to patient safety needed to be implemented. This lack of statutory authority meant that hospital trusts were not required to follow any guidance or alert notices. On Friday 1 June 2012, the functions of the NPSA were transferred to the special commissioning board as the NPSA fell victim to the cull of quangos. So what has happened since? Regulatory organisations have come and gone. NHS structures have changed and continue to do so. The NHS is a bit of a political football; I remember that, when I suggested that the political parties stop using it as one, the noble Lord, Lord Hunt, laughed at my comment. Change is a constant feature.
Patient safety documents and policies from 2000 to the present day all sound alarmingly familiar: progress is slow and incremental, even at present. An NAO report criticised the pace of change as regards patient safety, saying that it was too slow and that those who manage trusts focused more on financial budgets than patient safety. One result was the Mid Staffs crisis: we all remember how devastating that report was, particularly in what it had to say about the major patient safety failings.
We now have another devastating report, First Do No Harm. It is the second, and I hope the last, call for us to establish patient safety through legislation and on behalf of patients. The Government’s response to the Francis report defines the current patient safety system. Patient safety became an important aspect of government policy, with several initiatives and three global ministerial meetings, et cetera, but the processes are the same. Have things changed? In my view, not much, especially in terms of a clear demonstration of reducing patient harm. The patient safety organisations that exist are still part of and accountable to NHS departments, not to patients.
The noble Baroness focused her amendment on the safety of medicines and medical devices. Of the top five areas of patient safety errors, harm related to medicines and medical devices rank second and fourth. She is right to focus on these two areas as the first task of the commissioner for patient safety. A 2018 review of errors related to medicine estimated that 237 million errors occur every year in England. The national reporting and learning system had 204,000 incident reports related to medicine, while 712 deaths are attributed yearly to medicine-related harm, costing annually something like £70 million.
Data in relation to the harm associated with medical devices is not as readily available, except when investigated as part of a report such as First Do No Harm. However, figures from the USA can be used as a proxy, as its larger population may give some indication of the scale and types of devices implicated. A recent report in the USA showed the following as examples: 60,000 cases related to the use of surgical mesh; a similar number in relation to defibrillators; and 104,000 cases related to hip prosthesis. There were many more. These data clearly show not just the level of safety issues in relation to medicines and medical devices but the need to address them.
It is time to give patient safety the legal status it needs, as the noble Baroness, Lady Cumberlege, said. It is time for a bolder and more ambitious vision to make patient care safer. I believe that her amendment does this and I strongly support it.
The Deputy Chairman of Committees (Baroness Fookes) (Con)
I understand that there may be a delay in the vote taking place in the House for technical reasons. I do not think that we can go on here indefinitely so I suggest that I call the noble Lords, Lord Hunt of Kings Heath, and we break then regardless.
Lord Patel (CB) [V]
My Lords, I will speak to Amendment 120 and, again, I am very grateful to my friend the noble and learned Lord, Lord Mackay of Clashfern, for joining me on this amendment. I beg noble Lords’ indulgence because, when I read the legislation and the Bill related to this and then looked at the advice or guidance issued by MHRA, I got more and more confused about what the divergence is going to be, how much of it there will be and how clear the Bill is. I am sorry, but I will be labouring the point at length to get some answers.
My proposed new clause would require the Secretary of State to report on
“regulatory divergence between Northern Ireland and the rest of the United Kingdom”.
This amendment would address the issues of potential regulatory divergence between Northern Ireland and the rest of the United Kingdom. In relation to medicines and veterinary medicines, Northern Ireland is referred to separately from the rest of the UK. This means that, as set out in Clause 1(4)(b) and Clause 8(4)(b), the power to make regulations in respect of Northern Ireland lies with the Department of Health in Northern Ireland or both the department and the Secretary of State, when acting together.
Clause 40 limits the capacity of the Department of Health in Northern Ireland to act alone, only allowing it to do so when it would be
“within the legislative competence of the Assembly, and … would not require the consent of the Secretary of State.”
It is not clear in the Bill which areas would be in the sole competence of the Northern Ireland Assembly. Will the Minister clarify that?
Furthermore, while powers on medical devices are not reserved, the guidance most recently published by the MHRA paints a picture of two different systems—market authorisation and registration, among other issues—and distinguishes between the “Northern Ireland market” and the “Great Britain market”. This implies that regulation different from that in the rest of the UK may be intended for Northern Ireland in respect of medical devices.
The MHRA published guidance on medicines and medical devices based upon the potential situation at the end of the transition period, days before this House was due to sit for the Second Reading of the Bill. This advice implies that a dual system would be operating in respect of Northern Ireland for both medicines and medical devices due to the operation of the Northern Ireland protocol, to which the noble Baroness, Lady Wheeler, referred. This assumes that the Government will actually honour that agreement. The Northern Ireland protocol requires that EU regulations relating to medicines, veterinary medicines and medical devices apply to Northern Ireland.
The MHRA guidance makes a distinction between the EU market, the market of Great Britain and the market of Northern Ireland. It sets out that CE marks will cease to be recognised in the market of Great Britain from July 2023, unless the products in question are from manufacturers based in Northern Ireland. There are essentially two different baskets envisaged in the guidance for manufacturers that are based in Northern Ireland to bring a medicinal or medical product to the markets of Great Britain and Northern Ireland.
The first is to go through UK-based approved bodies for their assessments and market authorisations, which would be approval for the Great Britain or Great Britain and Northern Ireland markets, but it would not be recognised in the EU. The second is to submit their application to approval or notified bodies in the EEA, gaining a CE mark and thus access to the markets of Great Britain, Northern Ireland and the EU without further needing to apply to a UK body for approvals for the Great Britain market. Noble Lords will see how confusing the whole system sounds.
In contrast, manufacturers based in Great Britain would need approval from UK-based bodies to place their products on the market in Great Britain and Northern Ireland but would need to undertake the separate task of getting an EU-based responsible person and applying separately for a CE mark in the EU if they were to bring their product to the EU market.
Further, from 30 June 2023, CE-marked devices originating from the EU market but not manufactured in Northern Ireland will no longer be able to flow to Great Britain. This regulatory set-up in Northern Ireland could therefore be an incentive for EU manufacturers to base their European operations in Northern Ireland to have unfettered access to both markets. Discussions about whether this constitutes state aid and would distort the EU single market are still ongoing.
On the face of the MHRA guidance, it appears that the recognition of the CE mark on medicines and devices coming from Northern Ireland provides easier access for Northern Ireland-based manufacturers to both the UK and EU markets. It certainly suggests a dual system applying between Northern Ireland and the UK, but the extent to which those systems will diverge in substance in future is not clear. It is not clear how systems of pharmacovigilance or the monitoring of medical devices will be co-ordinated for products available in the Great Britain market that are manufactured in Northern Ireland and subject to EU regulations and monitoring. If monitoring systems and databases are to be fit for purpose in the EU, surely it is essential that the UK has access to EU databases. In the absence of this access, how can the Government guarantee, or claim to be prioritising, the safety of patients?
What is clear, because the guidance states it, is that draft regulations with reference to medicines and medical devices exist but have not yet been introduced to Parliament. These draft regulations are what the guidance claims to be based on. If these regulations exist to the extent that the MHRA is publishing guidance based on them on issues of significant policy in these areas, why has this House not had sight of them? Why have they not been included as part of the substance of the Bill where they would receive proper scrutiny and provide much-needed clarity to all stakeholders for medicines and medical devices?
The situation regarding regulatory alignment or divergence between Northern Ireland and the rest of the UK is politically charged and should be dealt with explicitly. Given the potential for some aspects of medicine and veterinary medicine to be subject to the distinct competence of the Northern Ireland Assembly, there is potential for the requirement to have regard to “attractiveness” to have different interpretations in Northern Ireland and the rest of the UK. Further, the ambiguity surrounding the Northern Ireland protocol and its implications raises the potential for divergence, even where the United Kingdom Government have competence to regulate in respect of medical devices. For these reasons—I hope that I have made this point at length—the Government should clarify the position. This amendment would provide greater transparency about the potential regulatory divergence with a commitment to mitigate where possible.
Baroness Ritchie of Downpatrick (Non-Afl) [V]
My Lords, I am delighted to follow the noble Baroness, Lady Wheeler, and the noble Lord, Lord Patel, on these amendments dealing with regulatory divergence and Northern Ireland. I am a signatory to Amendment 119 in the name of the noble Baroness, Lady Thornton.
During Second Reading, I stated that there is the issue of potential regulatory divergence in relation to Northern Ireland, as medicines are a devolved power but medical devices are not. The Bill raises the possibility of future regulatory divergence between Northern Ireland and the rest of the UK, and that matter requires clarification, hence my support for Amendment 119. Both amendments seek to ensure greater accountability and transparency, to which the noble Lord, Lord Patel, referred, in that Parliament should receive reports on regulatory divergence as a means of oversight and accountability—with which I totally agree.
In some areas, this also relates back to the Northern Ireland protocol. There is no doubt that we must ensure the highest level of standards in relation to veterinary medicines, human medicines and medical devices. In his response at Second Reading, the Minister indicated to me that the Government intended to implement the Northern Ireland protocol, but I ask how that squares with the UK internal market Bill, this Bill and the need to ensure that we have the highest standards for medicines, medical devices and veterinary medicines—how does this all square?
I note that the NHS Confederation will continue to follow developments, analyse the implications for the health sector in the UK and push for as much clarity as possible on the implementation of the Northern Ireland protocol from 1 January 2021. It has also been stated that Northern Ireland will remain part of the UK customs arrangements constitutionally, so HMRC—not EU officials—and the UK’s Medicines and Healthcare products Regulatory Agency should administer the necessary controls. The MHRA remains responsible for placing the goods on the market and monitoring products once sold, but they will have to be approved through the European procedures because Northern Ireland will be treated as a member state in terms of regulatory decisions.
There is also concern that there will be delays in the import and export of medicines and medical devices, which need to continue to reach patients as quickly as possible, and we must ensure that any such delays are minimised, particularly during a pandemic. Avoiding delays caused by tariffs and regulatory barriers requires the UK and the EU to reach agreement on shared standards, such as manufacturing and inspections, so that goods can be licensed for rapid release into the UK market, or vice versa. With potential new checks and the lack of clarity on how the regulatory framework will apply, this could create unnecessary delays and impact on individual patients but also on medical practitioners.
There is also a need, as the Northern Ireland Affairs Committee said, for the Government to commit to covering all costs to businesses for complying with the protocol, which includes the whole area of medicines. I ask the Minister, the noble Baroness, Lady Penn, what discussions she and the noble Lord, Lord Bethell, have had with Minister Swann in the Northern Ireland Executive, as the Minister responsible for the Department of Health, about these issues, particularly in relation to the measures to minimise and mitigate the impact of divergence and how that will be achieved. We want to ensure the least impact from regulatory divergence on the availability and accessibility of medical devices and any other forms of medicine, whether for humans or for animals.
Covid-19 Update
Lord Patel Excerpts(3 years, 6 months ago)
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Lord Patel (CB) [V]
My Lords, the Minister referred to several areas where the lateral flow test will be deployed. The early reports from Liverpool’s mass screening using the test suggests that it performs well, with higher specificity and sensitivity, meaning that there is a negligible number of false positives and false negatives. That being so—and accepting that the vaccine will change the whole scene when it is available—apart from the areas that he has already mentioned, can he confirm what I have just said and give us the latest figures from Liverpool? Can he go on to say what plans the Government are making for the deployment of this test in other public areas to open up the economy?
Lord Bethell (Con)
I thank the noble Lord for his characteristically detailed and forensic question. The lateral flow test, as I am sure he knows, has the terrific advantage of giving very few false positives, but we do not pretend that it gives a clinical-level analysis of all the negatives. We therefore do not use it in a clinical setting as a symptomatic test; we use it as a screening test for asymptomatic cases. That is why it has been so valuable in a mass testing environment such as Liverpool. We can back up the tests of those who are positive with a double test, either with another lateral flow test or with a PCR test, to ensure that we do not create a problem with too many false positives. We are working on the protocols now to figure out exactly what kind of rate of second testing we need to get a fair analysis.
The noble Lord is entirely right that the vaccine will be a game-changer, but not everyone will take it immediately and we are not sure how long each vaccine will last for, so there will be a role for testing even after the vaccine has been deployed. In the meantime, testing is very much focused on social care, clinical workers, schools and universities. Those are the four areas where we are focused at the moment, but we hope it can be used further to enable the opening of the economy, as he alluded to.
Covid-19: Vaccine
Lord Patel Excerpts(3 years, 6 months ago)
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Lord Bethell (Con)
My Lords, we are taking a four nations approach to the deployment of the vaccine. The Scottish NHS has been involved in all the arrangements we have been putting together and in both the Vaccine Taskforce, to procure the vaccines, and the Joint Committee on Vaccination and Immunisation, which has been discussing prioritisation. Furthermore, it has a voice at the DHSC, which is responsible for deployment.
Lord Patel (CB) [V]
My Lords, the announcement of the effectiveness of the Pfizer BioNTech vaccine being not only the first vaccine against Covid-19 but the world’s first vaccine against infection developed using messenger RNA is a huge scientific advance. There are challenges in delivering an effective national vaccination programme. As Professor Melinda Mills, in a report from the Royal Society and British Academy, pointed out, not the least is honest, transparent public communication free from hyperbole. Does the Minister agree? If so, who does he think would be best placed to lead the public communication of the programme?
Lord Bethell (Con)
The noble Lord is entirely right that we have to approach the prospect of a vaccine in a measured way. There remain considerable imponderables about the effectiveness, longevity, impact and side-effects of a vaccine. These are things that we do not know yet, and we have to keep our eyes open to the limits of what the vaccine may or may not be able to do. That said, the initial data from Pfizer is incredibly encouraging. We have taken a measured approach in our communications to date. Jonathan Van-Tam, the Deputy Chief Medical Officer, is the face of the vaccine, as it were; he is the member of the Vaccine Taskforce who has brought the clinical perspective to its work, and he will remain an important voice in all this.