NHS: Staff Numbers after Covid-19

Lord Patel Excerpts

Thursday 4th March 2021 Grand Committee

[Lord Patel (CB) [V]]

My Lords, I recognise that the Government want to address the issue of the NHS clinical workforce. The problem is not the ambition, but in having a clear long-term strategy to achieve this. Does the Minister agree that previous attempts have failed? The intensity and stressful nature of the work related to Covid and other factors, such as the recently announced pension cap, may make retaining staff difficult?

Recent surveys by the Royal College of Nursing, the Royal College of Physicians, the British Medical Association and many others have shown a very high proportion of the workforce are unhappy about their work, with low morale and mental health issues particularly related to Covid. With advances in care, NHS England is likely to require a growth in workforce of 3.2% per year over the next 15 years. That is nearly 650,000 full-time equivalent staff over the next decade. There are also issues about managing the workforce. I hope that through the new NHS Bill we can explore a long-term solution through legislation. Maybe the Minister would welcome that.

Covid-19: Brazilian Variant

Lord Patel Excerpts

Tuesday 2nd March 2021 Lords Chamber

[Lord Bethell (Con)]

The vaccine is absolutely central to our strategy. It is an approach that has proved enormously popular, and I think I speak for a large number of people when I say that defending the vaccine has to be our number one priority. If there were a highly transmissible vaccine-escaping mutation, it would take us back to the beginning of this whole pandemic. That is why we have put in place red list countries and managed quarantine. That is why we are committed to Operation Eagle and the efforts to track down those bringing variants of concern into this country.

[Lord Patel (CB) [V]]

My Lords, the scientists are concerned about the P1 Brazilian variant because of three mutations, one of which is common to other variants, making it more transmissible. One of the others is referred to as the “escape mutation”, which may bypass some vaccine-induced immunity. Does the Minister agree that, apart from the measures the Government are taking of trace, track and isolate and surge testing—which I thoroughly approve of—it is important to continue genomic sequencing, at scale, of Covid cases to detect variants that may arise and to monitor and study post-vaccine immune response? That would enable us to modify the vaccines to boost the immune response and deal with the variants.

[Lord Bethell (Con)]

The noble Lord is entirely right. Our commitment to genomic sequencing, which has lasted for years, has put Britain in great shape to be able to do the sequencing necessary to track these variants. We are doing more sequencing than any other country. But as the noble Lord knows, this is detective work, and it is extremely complex. While the 484K mutation might be the significant change in both the Brazil and South African variants, it might be one of a great many other mutations in its genomic characteristics. This is the detective work we are doing. I am afraid that it will take some time to get to the bottom of it, and it needs to be complemented by field studies into how the mutation reacts in real life, as well as with antibodies. The combination of immunology, virology, biology and real-world clinical study will give us the insight that we need.

Covid-19

Lord Patel Excerpts

Thursday 11th February 2021 Lords Chamber

[Lord Patel (CB) [V]]

My Lords, I support the government plans for travel quarantine to reduce the risk of importing new variants of SARS-CoV-2 that may be more contagious and get around vaccine-induced immunity. Both Australian and New Zealand studies have shown that, despite testing prior to flights, the risk of transmitting the virus on flights, particularly long-haul flights, remains as shown by the New Zealand study. My question relates to airline crew, particularly on long-haul flights. What measures do the Government plan against the risk of transmission from an infected crew member?

[Lord Bethell (Con)]

The noble Lord is, as ever, cutting to the chase. The role of hotel staff, transport to and from airports and the flight crew themselves is incredibly important. As the noble Lord probably knows, the outbreak in Melbourne that hit Australia hard was caused in part by the bus drivers from the airport to hotels becoming vectors of infection. That created an unfortunate outbreak, which was hit extremely hard with a long lockdown to squeeze out the outbreak. We are putting in all the right, responsible measures to segregate crew, keep them apart from the rest of the population and ensure that they are, wherever possible, vaccinated against the virus so that they cannot be vectors of transmission.

Covid-19 Update

Lord Patel Excerpts

Thursday 4th February 2021 Lords Chamber

[Lord Patel (CB) [V]]

My Lords, science has got us this far and will get us through in the long run. In that context, the recent report from the British Society for Immunology stresses the importance of knowing the efficacy of Covid-19 vaccines across all age groups and the need for immune monitoring across the vaccinated population. With the great news of over 10 million people having been vaccinated, we must know the nature and length of time of immunity that each vaccine delivers. The UK is in the best position to obtain this information that will help to plan future vaccination programmes, but we must start nationwide post-vaccination immune monitoring now. Will the Minister consider meeting the president of the society, Professor Arne Akbar, to explore this further?

[Lord Bethell (Con)]

My Lords, the noble Lord alludes with characteristic insight to one of the great frustrations and mysteries of Covid. It seems to me, a lay person and a neophyte in this area, that understanding the body’s immune response to something as simple as a virus such as Covid should be straightforward, but it is one of the unlocked mysteries of Covid. We are working extremely hard to unlock the mystery of it all. We have invested a huge amount in immunology and the detection of antibodies in the British public. I pay tribute to the UK Biobank study, a massive survey which has been going on for six months. It has found that 8.8% of the UK population had been infected by December 2020; 40% of them did not have a single classic symptom of Covid, and a quarter of those with antibodies were completely asymptomatic. We are doing other assessments as well—through the ONS, REACT, blood donors, the RCGP and others—and I would be very pleased to meet Professor Akbar to discuss this work further.

Medicines and Medical Devices Bill

Lord Patel Excerpts

Consideration of Commons amendments & Ping Pong (Hansard) & Ping Pong (Hansard): House of Lords
Tuesday 2nd February 2021 Lords Chamber

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

My Lords, with the leave of the House, I beg to move that the House do agree with the Commons in their Amendments 11A to 11D, 22A to 22C, 32A to 32C, and 50A to 50C en bloc. I pay tribute to noble Lords on all sides of the House in reaching consensus on the issues dealt with in these amendments. They were put down in the other place after cross-party discussions and I believe they reflect the aims and agreement of the House.

Amendments 11A to 11D, 22A to 22C and 32A to 32C all make minor amendments to Lords Amendments 11, 22 and 32. These amendments, in the name of the noble Baroness, Lady Thornton, made further changes to the clauses allowing the MHRA and the VMD to share information with relevant persons, such as regulators, outside the UK. Lords Amendments 11, 22 and 32 create a new safeguard that information could be shared only when in the public interest or for pharmacovigilance. I thank the noble Baroness very much for her remarks on Report. She made it very clear that the reference to pharmacovigilance was illustrative. Pharmacovigilance is very important, but it is also very much in the public interest and so does not need to be included outside the reference to the public interest. It is already captured. The Commons amendments therefore remove the reference to pharmacovigilance and the purpose of the amendments remains.

The majority of the Commons amendments deal with the variety of ways that noble Lords sought to create means to bring the Bill, and the principles of the Bill, back before Parliament in the future. Three methods were put forward and, in fact, noble Lords eloquently pressed the point on all of them. Lords Amendments 2, 13 and 24, which were tabled by the noble Baroness, Lady Thornton, put forward a sunset on delegated powers. Lords Amendments 3, 14, 25, 30, 48 and 49, which were tabled by the noble Lord, Lord Sharkey, put in the super-affirmative procedure. Lords Amendments 12, 23 and 40, in the name of the noble Lord, Lord Patel, put forward the idea of bringing forward consolidated draft legislation within three years. I do not intend to repeat my arguments against all three; I have said throughout this Bill that we have been listening carefully to all noble Lords who have put forward very clearly their continued concerns.

Commons Amendments 50A, 50B and 50C are an alternative, which I believe we can agree avoids the issue of introducing a “cliff edge” for legislation—and potentially patient safety—but importantly provides the reassurances that noble Lords quite reasonably sought. They collectively create an obligation for the Secretary of State to prepare a report on the operation of the legislation within five years of Royal Assent, and the amendments specify the considerations that must be addressed in that report: first, whether the legislation should be consolidated or restructured; secondly, whether legislation ought to be in regulations or in Acts of Parliament; and, thirdly, whether any of the powers to make regulations should be modified or repealed.

This would mean actively considering all the questions raised by noble Lords. It would give the time needed for making changes to the current legislation governing medicines and medical devices using the Bill’s powers, and allow for those changes to bed down and for those complex areas of law to reach a steady state, before considering these important issues.

The Secretary of State must also take into account any report of a parliamentary committee in preparing that report. This would mean that if any committee—whether your Lordships’ Delegated Powers and Regulatory Reform Committee or the Health Select Committee in the other place—decided to take a view on the operation of the legislation in the intervening time, its conclusions and considerations would have to be taken into account. If any committee should choose to do so, perhaps on the basis of the post-legislative memorandum that must be prepared within three to five years of the Bill being enacted, Parliament will have expressed a view before being presented with the Secretary of State’s report.

I think this is a satisfactory compromise. It meets the principle of parliamentary review without the practical impact on patient safety of powers lapsing. It ensures that Parliament has the ability to express a view and for that view to be heard, without asking for review before it is practicable. Amendment 50A makes the necessary changes to reinstitute the parliamentary procedure changes made at Lords Committee stage, in place of the super-affirmative.

I hope that noble Lords will be content to accept the amendments from the House of Commons. I beg to move.

[Lord Patel (CB) [V]]

My Lords, I am extremely grateful for the amendments that the Government have brought from the Commons. I am grateful to the Minister and his team for working so diligently with the rest of us, and to all noble Lords who supported my amendments. It is not unusual—but it is infrequent—for the votes that the Government did not get through in the Lords to be reconsidered in the Commons and brought back as government amendments. I am very content that the amendments that the Government have brought are very satisfactory and I congratulate them. I thank the noble Lord, Lord Bethell, the noble Baroness, Lady Penn, the noble Earl, Lord Howe, and the legal team for working with us throughout the Bill. That is all I am going to say.

[Baroness Jolly (LD) [V]]

My Lords, I too shall be brief and I too am grateful to the Minister and his team for giving Peers an opportunity to see the Commons amendments to the Bill before they were tabled, so that we might give some feedback. One of the things that has made this Bill a pleasure to work on is the open way in which political parties and Cross-Benchers have worked together, as well as the way that the Minister and his team have worked with us. We particularly welcome the clauses that have come to us from the Commons; they make the Bill a more explicit and effective piece of legislation than when it was debated either in Committee or on Report in this House.

Covid-19: Vaccines

Lord Patel Excerpts

Monday 1st February 2021 Lords Chamber

[Lord Bethell (Con)]

In response to the noble Baroness, I said that we were confident that we had the supplies of the vaccines to do the second dose. It is not our policy that anyone has the second dose of anything other than the vaccine they had the first dose of. We will work with people to give them the most convenient place to have the vaccine, but I cannot offer the guarantee that the noble Lord seeks.

[Lord Patel (CB) [V]]

My Lords, while it is important to extend vaccination programmes at home and abroad, the recent reports of emerging mutations of the virus—the South African, Brazilian and the recent Californian mutations—risk significantly increasing transmissibility and serious illness, particularly in younger people. It is extremely worrying, and it may lead to the virus getting around the vaccine-related immunity. We need to be ahead of the curve if we are to avoid serious illness and deaths in the young. What plans do the Government have to mitigate against this?

[Lord Bethell (Con)]

The noble Lord is entirely right; the threat of a vaccine-escaping mutation is very present on our minds. I pay tribute to the word of Sir Patrick Vallance, Clive Dix and all those who are working on this issue in the expert advisory group on vaccines. The noble Lord mentioned the threat of transmissibility among the young. We have already made the commitment of offering a vaccine to all ages. He is entirely right that we may reach a point where it is particularly important to ensure that young people have the vaccine so that they are not responsible for transmitting the disease to those who are more vulnerable.

Medicines and Medical Devices Bill

Lord Patel Excerpts

3rd reading & 3rd reading (Hansard) & 3rd reading (Hansard): House of Lords
Thursday 21st January 2021 Lords Chamber

[Baroness McIntosh of Pickering (Con) [V]]

My Lords, I am delighted to follow my noble friend Lady Cumberlege; I pay fulsome tribute to her and the team that, through her leadership, produced the report, First Do No Harm, from which we see this Bill. I would like to join her and others in paying tribute to my noble friends Lord Bethell, Lady Penn and Lord Howe, who I had the honour to work with, as a humble bag carrier, in the other place.

In recalling my interest with the Dispensing Doctors’ Association, I would like to make one plea to the Minister as this Bill proceeds to the other place. For clinical trials and patient safety, which is the focus of the Bill, which I wholeheartedly support, we need to rely on patients making their data available and giving consent for it to be used for clinical purposes. During the passage of the Bill, I raised what has now been seen in Denmark—a huge reaction against patient data having been abused and used for commercial purposes against the wishes, and without the consent, of patients. Were that to happen here, it would detract from the fundamental good of this Bill and the wider public benefit to the NHS and future patients of sharing the clinical data that permeates this Bill. I urge the Minister, therefore, to look seriously at the practical question that remains of how patient consent will be obtained and confidentiality respected, particularly in meeting the requirements of clinical need. But I am delighted to have played even a small part in the passage of this Bill, and we look forward to its passage through the other place.

[Lord Patel (CB) [V]]

My Lords, I am delighted to have this opportunity to express my thanks to the Minister—the noble Lord, Lord Bethell—the noble Baroness, Lady Penn, and all the other noble Lords who have been taking part in this legislation, in particular those who spoke to and supported my amendments from all sides of the House.

Much has already been said about what we have achieved. I know that time is running short, so I will try and be brief. Of course I congratulate, first and foremost, the noble Baroness, Lady Cumberlege, for achieving what I had tried before—getting patient safety on statute. I did not have her tenacity or clout. So, many congratulations to her and, I believe, the commissioner for patient safety, who will make patient safety stronger in the whole of the health service.

I am very grateful to the Minister, the noble Lord, Lord Bethell, to the noble Baroness, Lady Penn, and to the noble Earl, Lord Howe, for the many meetings they arranged with us to hear our concerns and find solutions. I know it is a privilege for me to speak in person, but I hope all my colleagues on the Cross Benches—more than 12 of them—who took part in the Bill will feel I can speak on their behalf to thank Ministers and all other noble Lords.

I am also grateful to members of the Bill team, who were very helpful at the many meetings that the Minister arranged. And I am grateful to outsiders, in particular the University of Birmingham faculty of law, which worked very hard to produce the details of the legislation. Thank you all.

[Lord O’Shaughnessy (Con) [V]]

My Lords, there is not much more to say that has not already been said by other noble Lords. I just wanted to use this opportunity to thank and pay tribute to particular groups. The Bill team and private office, which have worked so hard to produce this legislation, are amazing in what they do and often unsung. It is important we recognise them.

Secondly, I thank those patients and patient groups who have provided so much moving information and testimony that has informed our work. After all, we serve them, and I hope and believe that we have served them through improving this Bill in this House in the way we have.

Thirdly, I pay particular tribute to my noble friend Lady Cumberlege. When I was in government and we commissioned her report, I could not have dreamed that she would have done such a thorough job and carried it with her customary tenacity, to the point where we have, on statute, the commitment to a patient safety commissioner. It is such an important step forward and it will make a massive difference to the lives of hundreds of thousands of people in this country. For that, we should all be proud of this step—and she in particular should be.

Finally, I thank the Minister—my noble friend Lord Bethell—the noble Baroness, Lady Penn, and the noble Earl, Lord Howe, but particularly the Minister; he has performed with absolute aplomb in the difficult 10 months since he became a Minister. He has so much on his plate, yet throughout this process he has listened, engaged and acted in a way that does him enormous credit, and I really want to pay tribute to him for everything he has done.

I share the Minister’s optimism that, having produced this Bill, we can produce a regulatory system for the UK outside Europe that is the envy of the world, that makes sure that every company, every charity and every researcher who wants to bring a transformative therapy into a health system will come to us because of what we are able to do and how we are able to bring them through into mainstream treatment, just as we are doing with vaccines and have done with the recovery trial. That is the template, and I look forward to working with my noble friends and other noble Lords to make that happen in the months to come.

Health: Brain Tumours

Lord Patel Excerpts

Tuesday 19th January 2021 Lords Chamber

[Lord Patel (CB) [V]]

My Lords, I am most encouraged by the opening statement from the Minister and the Answer he gave to the noble Lord, Lord Hunt of Kings Heath. That goes a long way to answering my question, which was whether he agrees that to improve the outcome for patients with brain tumours, we need a strategy that addresses the clinical and research workforce; basic and clinical research, including genetics; research funding; and diagnostic and treatment centres of excellence—a strategy similar to one that dramatically improved outcomes for patients with breast cancer and leukaemia. Does the Minister agree that the director of the National Institute for Health Research—or anyone else that he feels appropriate—should be asked to develop such a plan?

[Lord Bethell (Con)]

My Lords, the noble Lord makes an excellent suggestion. Indeed, I am pleased to report that exactly such a strategy is in place by working with the Tessa Jowell Brain Cancer Mission, to which the department, the NIHR, NHS England and NHS Improvement are all active contributors. As part of the mission the department is funding new research through NIHR, encouraging new researchers to become involved, and we will be supporting the delivery of research as a key part of the new Tessa Jowell centres of excellence.

Medicines and Medical Devices Bill

Lord Patel Excerpts

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, in moving Amendment 17 I will speak also to Amendments 19, 22, 23, 25, 35, 37, 38, 55, 56 and 58 to 62. All amendments in the group deal with the sharing of information outside the UK where this is required to give effect to an international agreement or arrangement.

I have listened to the concerns raised by noble Lords as to further safeguards that could be provided in relation to Clauses 7, 12 and 37(5), and the amendments made in Grand Committee. I am enormously grateful to noble Lords who have met and spoken to me and my team over the weeks between Grand Committee and Christmas. Their further explanations and collaborative spirit have been enormously valuable. I can say confidently that this collaboration has definitely improved the drafting of the Bill.

It is worth saying first that the Bill introduces powers for international information sharing only where it is pursuant to international agreements or arrangements concerning the regulation of human medicines, medical devices or veterinary medicines. As such, we are starting from a place where it is in the public interest for data to be shared to support the safety of human medicines, medical devices and veterinary medicines in the UK and globally.

As I explained in earlier debates, information sharing with other regulators plays an absolutely critical role in the work of the MHRA and the VMD to protect patient safety and to support international collaboration. For example, in medical device safety investigations, international information sharing allows for better signal detection and gathering of evidence to support the safety of medical devices available on the UK market. It is worth saying that failure to share that data has been one of the contributing factors to many patient safety issues. However, it is right that we ensure that when the MHRA and the VMD share information they do so with the appropriate persons. These amendments will ensure that.

Nevertheless, I have heard the concerns about the use of the term “persons” and whether this may be subject to broad interpretation. Noble Lords will agree that including in the Bill an exhaustive list of named organisations we share data with is not practical. Therefore, we have amended Clauses 7, 12 and 37 to include a definition of “relevant person”. These amendments clarify the types of persons outside the UK that information may be shared with. In short, they make it clear that these clauses do not offer a “blank cheque”.

We also heard concerns from noble Lords in Committee about the sharing of patient-identifiable information internationally. Clauses 7 and 37 already include safeguards to protect personal and commercially sensitive information, and there are additional safeguards in data protection legislation. However, we are keen to provide additional reassurance. That is why we have tabled further amendments that ensure that patient-identifiable information can be shared only if patients have provided consent.

In the vast majority of cases patient information is anonymised before being shared. These amendments account for the rare instances where it is necessary to share patient-identifiable data internationally to support our commitment to uphold patient safety; for example, in sharing patients’ concerns with an international regulator about a clinical trial they are taking part in in another country.

Finally, Amendments 22, 37 and 59 seek to clarify that the information-sharing powers in the Bill do not limit the circumstances in which information can be shared under any other enactment or rule of law. Such housekeeping amendments can be found as standard in many Acts and will ensure that the powers in the Bill cannot be construed as replacing existing statutory, prerogative or common laws of disclosure, which is not the intention. In introducing these amendments we seek simply to remove any potential confusion over what the powers in the Bill are intended to deliver.

I say again that I am enormously grateful to all noble Lords for their constructive challenge and thoughtful contributions on this subject. International information sharing is fundamental to the effective functioning of the MHRA and the VMD, but it is of vital importance that data is shared with care and that the appropriate safeguards are in place. I believe that our amendments deliver this balance. I beg to move.

[Lord Patel (CB) [V]]

My Lords, before I address the amendment from the noble Baroness, Lady Thornton, I reciprocate by thanking the Minister enormously for the many meetings he and his colleagues have had with all of us who are trying better to understand what the Government are trying to do with the Bill, particularly with these amendments. I agree that there are times, including in clinical trials—I have done this—when there is a need to share information with people involved in trials not only in the United Kingdom but overseas. I will come back to that in a minute.

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[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

Does the noble Lord, Lord Patel, wish to move Amendment 26?

[Lord Patel (CB) [V]]

No.

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

Does the noble Baroness, Lady Thornton, wish to move Amendment 27?

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[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

I will go back to Amendment 26. Does the noble Lord, Lord Patel, wish to move Amendment 26?

[Lord Patel (CB) [V]]

I do not wish to move the amendment.

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

Does the noble Baroness, Lady Thornton, wish to move that amendment?

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Moved by

[Lord Patel]

39: After Clause 12, insert the following new Clause—
“Requirement for draft consolidated legislation: veterinary medicines
The Secretary of State must, within the period of three years beginning with the day on which this Act is passed, publish draft legislation consolidating the regulatory regime as it applies to veterinary medicines.”Member’s explanatory statement
This new Clause, and the other consolidation amendments in the name of Lord Patel, would require the Secretary of State to publish draft consolidated legislation within three years to streamline the existing regulatory framework. These amendments are linked to the amendment providing for a three year sunset provision in the name of Baroness Thornton.

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[Baroness Wheeler (Lab)]

My Lords, I am moving the amendment in the name of my noble friend Lady Thornton, which revisits the issue of regulatory divergence between Northern Ireland and the rest of the UK in matters covered by the Bill, and the need for an annual report to Parliament on this matter. The amendment also places an obligation on the Secretary of State specifically to report on plans to mitigate its adverse effects.

The Government will know that there is huge concern on this issue, strongly reflected in our Committee debates through our amendment and an amendment from the noble Lord, Lord Patel, calling for an annual report. The issue was also raised in consideration of the medicines and medical devices statutory instruments before Christmas and in the deliberations on the Northern Ireland protocol and the Trade Bill.

However, I welcome the Government’s amendments in this group to Clause 44, which extend reporting obligations to apply in respect of regulations made by a Northern Ireland department and to regulations under Clause 18 on the health and social care information systems. In particular, Amendment 85 specifies a Northern Ireland department and the Northern Ireland Assembly as an appropriate legislature and relevant authority in relation to regulations made under the Act.

We also welcome the Government’s acceptance of the arguments put forward by noble Lords and the Delegated Powers and Regulatory Reform Committee on the need for parliamentary scrutiny before and after delegated powers are exercised, and the introduction of a two-yearly reporting requirement in large parts of the Bill. I note that government briefings commit to the reports containing a summary of how the regulations have operated over the period under consideration, including any concerns from stakeholders and the Secretary of State’s response, as well as outlining plans for further changes.

I am speaking also on Amendment 78, in the name of my noble friend Lady Thornton, supported by the noble Baroness, Lady Jolly, which in Committee we submitted for inclusion in the provisions under the previous Clause 41 on consultation but which now amends the reporting requirements in Clause 44. Our amendment specifies cohorts that must be consulted in preparation of a report to Parliament, including patients and their representatives, and other key industry stakeholders from healthcare, pharmaceuticals, veterinary and medical research organisations, and healthcare providers and regulators.

Once again, we come back to the importance of ensuring that patients and end users are part of and involved in consultation and reporting relating to existing and potential new medicines, veterinary medicines and medical devices. The stark lessons from the Cumberlege review, the Ockenden review and many other reviews that we have had are that patients’ voices must be heard.

For the record, we feel that the Government’s reporting requirements amendment falls short of providing the reassurances that we sought in Committee, because the relevant authority still has ultimate discretion over whom it consults. This could mean that any report could be skewed or biased by those chosen at the discretion of the Government. That is why our Amendment 78 details the key stakeholders that should be consulted.

In response to that amendment, I am sure that the Minister will come back to the often stock response to the inclusion of specific stakeholders in the Bill, namely that this would be too rigid and burdensome, and would inadvertently rule out contributions from those accidentally not listed. However, in the context of a very complex Bill and the history of often poor communications with stakeholders, I urge the Minister, if she is not happy with our list, to consider a broader amendment at Third Reading that would provide the reassurance that is clearly needed.

I come back to the key issue of regulatory divergence between Northern Ireland and the UK and reporting on this matter. Marketing, authorisation and trading processes on medicines and medical devices between Northern Ireland, the EU and the UK are complex issues, and many remain unclear. The Northern Ireland protocol and the provision for ongoing discussions to resolve key issues mean continued uncertainty for businesses, health services and patients. In this context, an annual rather than a two-yearly report to Parliament would have been more appropriate, particularly highlighting the problems arising from regulatory divergence, and the plans and progress on addressing them.

This is not the time or occasion to go into detail on the issues covered in Committee. However, in Committee the noble Lord, Lord Patel, highlighted many key matters and concerns arising from the MHRA’s guidance on regulating medical devices from 1 January 2021, issued in September 2020, before Committee. I know that the MHRA has been pretty busy of late with the vital Covid-19 vaccination authorisation, but can the Minister tell us when it is envisaged that the MHRA guidance will be updated and reissued?

We have sought and been given reassurances from the Minister that the MHRA’s staffing, resourcing and capacity have been substantially increased to meet its new obligations. It is a much-respected body, but, as we have said, it faces huge challenges under its new role, and we suspect that the £13 million additional funding provided to it by the Government up to the end of March 2021 will be just a pump-priming starter in the light of all that needs to be done. The Minister’s reassurances over the MHRA’s strategic development plans and the Government’s commitment to further funding are welcome, but this is something that we will need to keep a close watch on. I beg to move.

[Lord Patel (CB) [V]]

My Lords, from the outset it has been clear that there was a potential for regulatory divergence in Northern Ireland from the rest of the UK for medicines and veterinary medicines, since they are referred to separately in the Bill as reserved matters in Northern Ireland. However, it has been made clear in the last quarter of 2020 that interaction with the Northern Ireland protocol makes that divergence inevitable for medical devices as well.

Guidance published by the MHRA in October, which I referred to previously, and statutory instruments laid before Parliament in the final months of 2020, set out two different systems of market authorisation and registration, among other issues, and distinguished between the Northern Ireland and Great Britain markets for medical devices and medicines alike. The Northern Ireland protocol requires that EU regulations relating to medicines, veterinary medicines and medical devices apply to Northern Ireland, while CE marks will cease to be recognised in the Great Britain market from July 2023 unless the products in question are from manufacturers based in Northern Ireland.

There are essentially two paths for manufacturers based in Northern Ireland to bring a medical device product into the Great Britain and Northern Ireland markets. The first is to go through UK-based approved bodies for their assessment and market authorisation, which will be approved for both the Great Britain and Northern Ireland markets but will not be recognised in the EU. The second is to submit an application to approved or notified bodies in the EEA to gain 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.

By contrast, manufacturers based in Great Britain will need approval from UK-based bodies to place their products on the market in Great Britain and Northern Ireland, but will need to undertake the separate task of setting up an EU-based responsible person and apply separately for a CE mark in the EU. It appears that the recognition of a CE mark on a medicine or device coming from Northern Ireland provides easier access for Northern Ireland-based manufacturers to both the UK and EU markets. What is not clear is the extent to which this dual system between Northern Ireland and the rest of the UK will diverge in substance.

For these reasons and many others, the Government should clarify the position. The amendment would provide greater transparency on potential regulatory divergence, with a commitment to mitigate it where possible. Of course, I will not be surprised if the Minister does not accept the amendment, and neither do I think the noble Baroness will divide the House on it, but whether we agree with it or not, I hope the Minister will agree that somebody has to have some way to recognise what this divergence will do. Who will that be? Would she agree that this will be needed in due course?

Medicines and Medical Devices Bill

Lord Patel Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[Lord Patel (CB) [V]]

My Lords, I shall be extremely brief. It was a pleasure to support the noble Baroness, Lady Cumberlege, and I congratulate her on achieving a remarkable feat of getting patient safety in statute for the first time in the United Kingdom. Her tenacity was such that she was never going to give up. I also congratulate the Minister. He obviously listened and understood all the arguments that were made. He has produced the establishment of an independent patient safety commissioner. Having been concerned with patient safety for many years, it is good to know that for the first time it is in statute. The noble Baroness made a few important points that were well argued as to why words may be misinterpreted. I hope that the Minister has listened and will respond positively. Again, I congratulate her—it was a pleasure to support her.

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[Baroness Thornton (Lab)]

My Lords, in moving Amendment 2 I will speak also to Amendments 27 and 40 in my name. I also support the amendments in the names of the noble Lords, Lord Patel and Lord Kakkar, and of the noble and learned Lord, Lord Mackay.

This amendment would provide a sunset provision for Part 1, requiring the Government to return with primary legislation. It is linked to the sunset amendments for Parts 2 and 3 and the amendments in the name of the Lord, Lord Patel, requiring consolidated legislation. We discussed all these issues in Committee. Through discussion, the noble Lord, Lord Patel, the noble Baroness, Lady Jolly, and others have joined together to put this together as a suite of amendments, which makes sense.

At Second Reading, the noble Lord, Lord Blencathra, said:

“Thus it grieves me to say that the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy. Of course, it is not unique; it is just one more Bill stuffed full of Henry VIII clauses but devoid of substantive content. It is the barest skeleton, all to be filled in with negative secondary legislation.


I am speaking in my capacity as chair of the Delegated Powers Committee. We considered the key clauses—Clauses 1, 8 and 12—and concluded that they contain inappropriate delegations of power. We say that


‘the Government have failed to provide sufficient justification for … the Bill adopting a “skeleton bill” approach, with Ministers given very wide powers to almost completely re-write … regulatory regimes’.”—[Official Report, 2/9/20; col. 415.]


Here we are some distance away from that remark. Indeed, the question we must ask is: have we succeeded? Is the Bill less atrocious now than at the beginning when the DPC was so scathing?

All of us, in particular the Minister, the noble Baroness, Lady Penn, and the Bill team, have listened and improved the Bill. The Government have worked hard to meet some if not all of the Constitution Committee’s and the Delegated Powers Committee’s recommendations.

We believe that this suite of amendments, in a way, builds on those improvements that have already been made to the Bill. They propose a very simple objective that was articulated from the very beginning. It is neither democratic nor safe to run medicines, devices and veterinary medicines through regulation alone in the long run. Our regulatory framework needs to be in primary legislation. This must be achieved in a timely fashion, hence these amendments. Sooner or later—and there is agreement on this—there will need to be consolidation in primary legislation. We would prefer it to be sooner. We think that some agreement is necessary on this.

While I recognise the need to get this legislation on the statute book, the Minister must know about the disquiet that some of this has caused and the need to address the issues of accountability in regulation. The truth is that while we are very pleased to now have affirmative regulation, it is very rare for that to be rejected once it reaches Parliament, however unsatisfactory it might be. In fact, we have learned a great deal about regulation over this year of Covid regs.

The amendments in my name and those of the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly, would amend Parts 1, 9 and 14, which concern the three objectives of the regulation of medicine, medical devices and veterinary devices, with a three-year sunset provision. In Committee, I proposed that there should be consolidation of regulatory legislation within a two-year period, so I hope the Minister might recognise that we have been quite generous here because we have now extended that to three years.

Other noble Lords who are much better qualified than I will discuss the merits of the group. I look forward to hearing their discussion. In the meantime, I beg to move.

[Lord Patel (CB) [V]]

My Lords, I support the amendments in the name of the noble Baroness, Lady Thornton. As she said, they should be read in conjunction with my Amendments 26, 39 and 63 on the need for consolidating legislation, which I will come to in a minute.

As has previously been debated, the Bill confers an extensive range of delegated powers relating to medicines, veterinary medicines and medical devices. Previously, the power to create relevant secondary legislation in the UK was derived from the European Communities Act 1972. Those delegated powers were simply to allow the implementation of laws in the UK that have already been consulted on, debated and scrutinised at EU level and by our own EU committees in the Lords.

The powers in the Bill are such that areas of policy that previously would have been subject to greater scrutiny at EU level may now be amended without similar levels of scrutiny in the United Kingdom. They do not, as such, represent an equivalent conferral of power to the legislature seen under the previous regulatory arrangements.