Osimertinib Cancer Treatment

Lord Patel Excerpts

Tuesday 18th May 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I am not aware of a Strepsil shortage in Northern Ireland but I would be glad to write to the noble Baroness if I have any information.

[Lord Patel (CB) [V]]

My Lords, can the Minister confirm that the Northern Ireland protocol runs the risk of medicines not being available, that there will be divergence in the availability of medicines—and, importantly, medical devices—because the approval process might be different, and that the Government are due to report in six months on the effect of that divergence?

[Lord Bethell (Con)]

My Lords, we are watchful of the concerns to which the noble Lord refers but it is our hope and aspiration that there will not be the kind of delays or trouble that he explained. The Northern Ireland protocol means that Northern Ireland will stay aligned with EU rules, particularly for this kind of specific cancer medicine, but that does not mean that there need to be any delays. However, we are watching the situation carefully and the report that he described will give a full account of the problems, if there are any.

Covid-19: Resuscitation Orders

Lord Patel Excerpts

Wednesday 24th March 2021 Lords Chamber

[Lord Bethell (Con)]

I reassure the noble Baroness that there has been a huge amount of stakeholder engagement, with Mencap, Turning Point and others. It is not the role of the CQC to do individual family reviews, but I can reassure her that we have learned important lessons from this process.

[Lord Patel (CB) [V]]

Does the Minister agree that the ministerial oversight committee should also consider looking at end-of-life care?

[Lord Bethell (Con)]

My Lords, yes, I do.

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.