Medicines and Medical Devices Bill

Baroness McIntosh of Pickering 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 O'Shaughnessy (Con)]

My Lords, I join other noble Lords in expressing my sincere thanks to my noble friend the Minister for the progress that we have made. In all fairness to him, he said that since Second Reading he was listening, but we all know that it is sometimes possible to listen and not hear, let alone act. On this occasion, he heard and acted. I join other noble Lords in expressing my sincere gratitude for that.

I also pay tribute to my noble friend Lady Cumberlege. No one doubted her tenacity but it has been on display in bucketloads, and she has made the progress that her superb report deserves. More than anyone, I pay thanks to the army of campaigners; many of us have met them, and they could not help but move us with their stories. This legislation is ultimately for them and a tribute to them.

I had a close look at my noble friend the Minister’s amendment and compared it to that of my noble friend Lady Cumberlege. Clearly, there is a specific issue about where the organisation, the commissioner, should sit, but there is a precedent for doing that in the way in which the Minister suggested. I take confidence from his determination to give proper independence to the role. A lot will depend on the kind of person recruited, how they are recruited and to whom they are accountable. I should like him to say a little more about how he envisages that happening.

We also need to hear more detail on the timetable. The Minister will know that when one makes big commitments of this kind, they are staging posts—never the destination. There is still some way to go in making sure that we get there quickly. That is important, as my noble friend pointed out. However, the powers in the amendment are important to recognise. On the ability to demand information from relevant persons, as other noble Lords have said, we need to hear a little more about who they are and the consequences of non-compliance. However, they are powerful ways in which the commissioner can act and create change in the system. I have no doubt that they will be effective.

In conclusion, I make a couple of comments provided by the ABPI’s briefing. They relate to further questions around the nature of the relationship between the commissioner and the MHRA and other bodies, how the four nations of the UK will act together on patient safety, given that we are a single market, and ensuring diversity of patient voice.

I would also add one more thing to that. Patient safety is not just about finding out when medicines and devices go wrong; it is also about access to them. Will the patient commissioner have a remit to investigate these kinds of issues?

However, these questions are for tomorrow. Today, we want to recognise the progress that has been made and the amendments put down in the name of my noble friend. I thank him sincerely for them and I thank my noble friend Lady Cumberlege for her dedication to this particular cause.

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

My Lords, I, too, add my congratulations to my noble friend the Minister and pay particular tribute to the tireless work of my noble friend Lady Cumberlege in bringing us this far. I welcome government Amendments 1 and 54.

I want to take this opportunity to mention two specific issues that we focused on in Committee and seek confirmation on where we are in this regard. I want in particular to look at the right of patients to report directly on their own experience, rather than waiting for the patient safety commissioner to investigate. I would welcome hearing that my noble friend the Minister imagines that the commissioner should have this power. If not, would he consider introducing such a measure at the first available opportunity? It is so important that the voice of patients is heard. I remember the accounts that my noble friend Lady Cumberlege gave in Committee of her work and that of her team in producing the report, First Do No Harm; that will be a lasting legacy. Allowing patients the right to report directly, without necessarily waiting to be asked, would cut through many of the difficulties with medicines and medical devices, and would enable the patient safety commissioner to report directly to the Government in this regard.

The only other point that I wish to make at this stage is that of the regulations that my noble friend envisages in the government amendments in this group. Can he confirm that these will be discussed and agreed with the devolved Administrations at the earliest possible stage? Can my noble friend assure us that if the devolved Administrations raise any significant issues or highlight any problems that they have with the draft regulations, these will be acted on before the regulations are adopted and sent to each House of Parliament?

We are in a very good place. I congratulate my noble friend Lady Cumberlege and her team on bringing us here, and I pay special tribute to my noble friend the Minister for listening to the concerns of so many people, over so many years, to bring us to where we are today. I wish the amendments godspeed.

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

My Lords, I join the universal commendations for the Government for accepting the recommendation to introduce a patient safety commissioner. It demonstrates that campaigning can work for everybody, from school pupils to Premiership footballers to Members of the House of Lords—in this case supported by patients, many of them suffering from continuing illness and disability.

I want briefly to pick up three points made by the noble Baroness, Lady Cumberlege. The first is the importance of the commissioner being a person of standing. As the noble Baroness’s report clearly explains, there is a strong gender aspect to the fact that far too many patients have not been listened to, have been ignored and have been mistreated by the system. It is really important that the patient safety commissioner is well equipped to understand that and make themself accessible to all patients. As the noble Baroness said, it is clear that the patient safety commissioner should be a person of standing and the kind of person who should shape the role that they will ultimately fulfil.

That brings me to my second point, which the noble Baroness and many others have stressed: the urgency of this appointment. As has already been pointed out, the Domestic Abuse Commissioner has been appointed before we have even passed the Domestic Abuse Bill. That is very much a model. I have a direct question for the Minister. It should not be beyond the capacity of the department to advertise this role within, say, one month. If he does not think that this timetable is reasonable, can he suggest what he thinks a reasonable timetable is? The noble Lord, Lord O’Shaughnessy, also asked this. I also echo the point made by the noble Lord, Lord Hunt of Kings Heath, that it is crucial that this appointment has Select Committee scrutiny.

--- Later in debate ---

[Lord Lansley (Con) [V]]

My Lords, I am pleased to follow the noble Lord, Lord Hunt of Kings Heath, who again has raised an important issue. The amendment in this group which more broadly encompass all those elements that go to make the United Kingdom a favourable location for research and the manufacture and supply of medicines gives us an opportunity to make sure that we have got that right.

I support the government amendments in this group and add my thanks to those expressed to the Minister and the Bill team for the immensely constructive way in which they responded to the amendments that we brought forward in Committee and in many related discussions. At Second Reading, the noble and learned Lord, Lord Woolf, and I were worried that the Bill was skeletal. We wanted to put a bit of flesh on its bones and make it more of a framework Bill—I think that is a bit of a theme. In the spirit of the remarks of the noble Baroness, Lady Thornton, it might be helpful if I briefly explained what we were trying to achieve, and how these government amendments appear to have responded well to that.

First, even following the initial changes, the structure of the powers was not objective; they were that the relevant Minister was satisfied that the regulations met certain requirements. What we were looking for from the outset was an objective test. My noble friend Lord O’Shaughnessy asked what that objective test was and why we chose to continue with the structure of safeguarding public health? The short answer is that it is because that is the objective in the European Union regulation; it is not an objective in that context which relates to the internal market provisions. To have moved away from the objective of safeguarding public health would run the risk of it being interpreted as somehow different from the past objective on the basis of which decisions had been made and regulations pursued. That seemed entirely appropriate as an encompassing and overarching objective for all these related requirements. I am happy that the Government’s amendment has taken that forward as an objective measure against which the regulations, the use of these powers, can be tested.

Secondly, we wanted to make sure that safety was built into the structure of regulation-making powers. We had an extremely helpful debate about that, and I think that it was clear that, while we wanted to make safety central to what was being achieved, it would not be appropriate to make it an overriding objective. That would have led to the regulator being required effectively to eliminate risk. That brings me to the point made by my noble friend Lady Cumberlege. We then came to the further question of how, if safety is the issue, we then manage the test of whether benefits outweigh risks, sufficiently so for regulations to be proceeded with. The answer is that the objective is not to eliminate risk; it is to eliminate harm. We must make a distinction between those two things.

Making safety the overriding objective would have meant us having to eliminate risk. At the moment, we balance benefits and risks, not benefits and harms. When my noble friend Lady Cumberlege asked her question, I think she was suggesting that we were having to balance benefits and harms, whereas on pretty much every occasion the regulator is asked to undertake an authorisation they have to balance benefits and risks, because we can never eliminate risk. The question is: can we quantify it? That is what the trials and the data are meant to enable us to do—to quantify the benefits and risks. In making an authorisation, can we make sure that we have avoided harm but at the same time realised those benefits?

These amendments get us to that balance. They enable us to give an objective test against which the powers can be measured; they enable us to put safety clearly at the heart of the thinking about how the powers are to be used, and they enable the regulator to undertake that appropriate measurement of benefits and risks. I support the amendments and appreciate the way in which we have arrived at this place by constructive discussion.

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

My Lords, I welcome Amendment 5 and others in this group. I echo the noble Baroness, Lady Thornton, in complimenting both the Minister and the Bill team on their expert handling of this part of the Bill.

I find the sentiment behind Amendment 12 attractive and endorse entirely the words of my noble friend Lady Cumberlege and others who have supported her in wanting to avoid “harm”. The idea of a threshold, as solicited in Amendment 12, seems helpful. I have a question for my noble friend the Minister to which I would be grateful for a response. We are told in the explanatory statement that the amendment would require the Secretary of State

“to publish the criteria that will be used by the appropriate authority”—

obviously not yet set up—

“to determine whether the benefits of regulations that may impact on the safety of human medicines outweigh the risk”

and

“to allow for greater transparency and scrutiny.”

My noble friend said that the Government intended to publish the initial assessments. It would be helpful to know when that would be.

There currently seems to be a gap in the law; for example, as regards the vaccinations—I know that this was debated earlier today. The Government have unilaterally extended the time between the first dose and the second dose of Pfizer and AstraZeneca vaccines from three weeks—21 days—to up to 12 weeks. No other European country that I am aware of has done this. It is true that Denmark is looking to extend it to a maximum of between four and six weeks, which is nearer the initial three-week period. I presume that, if what is proposed by Amendment 12 were law, the Government would be obliged to publish the arguments in the interests of transparency, openness and scrutiny as to how they had reached that decision. If that were the case, I would be minded to support Amendment 12.

Otherwise, I welcome Amendments 4 and 5 and others in the group, which look to establish the overarching objective as being public health. I like the formulation of words that the Government have hit on and hope that they will stick with it. I shall be interested to hear how my noble friend responds, but, as I see it, there is some merit in Amendment 12.

Health Protection (Coronavirus, Restrictions) (Self-Isolation and Linked Households) (England) Regulations 2020

Baroness McIntosh of Pickering Excerpts

Thursday 7th January 2021 Lords Chamber

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

My Lords, I declare my interest as advising the board of the Dispensing Doctors’ Association, and I would like to focus on the rollout of the vaccinations. Does my noble friend the Minister share my concern that a delivery of over 1,000 vaccines to a rural practice in Suffolk was cancelled at less than a week’s notice? This is happening across the country—in Devon the same as in Suffolk. Dispensing doctors are the ideal vaccinators for the elderly and stand prepared to play their part. Yet notice and certainty of delivery are essential, mindful of the distances and needs of patients in far-flung rural areas to reach the surgery.

It seems that successful vaccination sites are being prevented from getting more vaccines, possibly because they are considered to have successfully vaccinated a greater percentage of patients than neighbouring sites. Yet there are media reports that an internet pharmacy—Pharmacy2U—is to be allowed to vaccinate people in supermarket car parks. Where is the infrastructure to support this? A GP practice wanting to operate vaccinations from a car park would currently be prevented from doing so. Remote NHS management teams seem to be dictating how much can be supplied rather than allowing individual practices to request what they require for their population. Thus, there is no certainty of supply and an inability to plan clinics efficiently and effectively. Those with proven expertise in the provision of vaccinations are being prevented from doing their job.

I also raise the concern that over-65s will not be vaccinated before the middle of February, which appears to be a slippage in timing. Yet this age group is as likely to require hospitalisation as those in the four priority groups. Equally, a change to the date and timing of the second dose of vaccination is not supported by the pilots, on the basis of which regulatory approval was given, and flouts the recommendation of all scientific authority, not least the World Health Organization.

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

Baroness McIntosh of Pickering Excerpts

Wednesday 30th December 2020 Lords Chamber

[Baroness McIntosh of Pickering (Con)]

My Lords, I join my noble friend in thanking all the NHS staff who worked over Christmas and who will work over the new year. I applaud the approval of the Oxford AstraZeneca vaccine.

Will my noble friend ensure that the double dose of whichever vaccine is used is rolled out as it was originally believed that it should be, so that both doses will be given to the most vulnerable as a priority, and to NHS staff, many of whom have not yet been vaccinated, to protect NHS beds and staff as best we can? Will he tackle, as a matter of urgency, the apparent hurdle to enabling GPs and other recently retired staff—here I declare an interest, as my brother falls into this category—who are willing to serve but appear to have a problem with indemnity and face other barriers? That seems inconceivable, given that they are prepared to swing into action to roll out vaccinations and presumably help with triage at hospital admissions.

As the noble Lord, Lord Scriven, mentioned, will my noble friend look carefully at the role that secondary schools in England appear to be playing in the recent rampant spread of this latest mutant infection? Will he consider taking actions such as Wales and Scotland have to delay the return of schools by more than the two weeks envisaged?

Finally, my noble friend said—I think I am quoting him correctly—that, economically, the restrictions set out today will be beneficial in the longer term as they will enable us to get back to normal sooner, yet there is very real concern in the hospitality industry that many establishments will simply not be in a position to reopen. Will additional support be considered at this time, as a matter of urgency?

Coronavirus Vaccine

Baroness McIntosh of Pickering Excerpts

Thursday 3rd December 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, difficult decisions have to be made by everyone in this. The JCVI has looked very carefully indeed at the challenge of how to prioritise this vaccine, taking representations from a large number of groups. Ultimately, its priority is to protect life and the NHS, and its clear decision has been to have a prioritisation based on age because this is the greatest driver of mortality.

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

My Lords, I add my congratulations to my noble friend, the MHRA and everyone associated with producing this vaccine in such record time; it is a great tribute to our health service. I will focus on the fact that the flu jabs for the over-50s are still being distributed, and there is a reluctance among some—perhaps as many as two-thirds of the over-50s—to take up the flu vaccine, as they would like to wait for the Covid vaccine, which, of course, defeats the purpose of offering them the flu vaccine. Is this something that my noble friend is aware of, and is it something that he could address? I echo the remarks of the noble Lord, Lord Clark, and ask that specific regard be had to the challenges of administering the vaccine in rural areas. Will my noble friend use, as far as possible, the dispensing doctors in this regard? I pay tribute to them and the work I do with them.

[Lord Bethell (Con)]

My Lords, as few will be surprised to know, the rollout of the flu vaccine has been hugely successful this year; the take-up has been massive. I am not aware, from the stats that I have seen, of any slowdown in the take-up of the flu vaccine, but the point my noble friend Lady McIntosh makes is understandable—I am happy to check it out. I also encourage anyone who is thinking about deferring the flu vaccine until they get the Covid vaccine to think again because it is a massive priority to get vaccinated for both.

The noble Baroness and I have talked before about dispensing doctors, whose role is very important. There is a challenge with the distribution of the Pfizer vaccine because of cold storage and the large number of shots in each vial. I am not sure whether that means that rural dispensing doctors can play the important role that they might do at this stage of the distribution, but I reassure the noble Baroness that they will play a role in the national distribution as it pans out over the next few months.

Medicines and Medical Devices Bill

Baroness McIntosh of Pickering Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, I am delighted to follow the noble Lord, Lord Hunt of Kings Heath, and support the noble Baroness, Lady Cumberlege, in her amendment, to which I have added my name.

The report that the Government commissioned and appointed the noble Baroness, Lady Cumberlege, to do on these issues of medicines and medical devices made nine very clear recommendations in July. One central recommendation in that report, First Do No Harm, was the need for a task force to oversee the implementation of the recommendations from the report —hence this amendment today.

If the Government, the Minister and his colleagues, are serious about the recommendations and recognise that there is an issue and a problem in relation to certain medicines and medical devices, they should see fit to implement all nine recommendations. I think back to when I was doing some research on this. An eminent QC, Lauren Sutherland, said that the Government should not ignore these recommendations—they should implement them.

I made the request, along with many other noble Lords, for the implementation of the task force during Second Reading in early September. I said that it should be set up without delay to oversee progress, and I believe that, if the Government are to take this report seriously and ensure that such failures do not happen again, that needs to happen. What better way to have an implementation group than by the task force that is already in existence, because it was independent of government, has worked on these issues for two years and is fully acquainted with all the matters, problems and challenges met by many people, who have suffered indignity and immeasurable pain as a result of the imprecision in relation to medical devices? To ensure proper implementation and oversight of the recommendations, a task force is a necessary prerequisite and needs to be placed in the Bill. The first remit or task of such a task force should be to set a timeline for its work and delivery of the review’s recommendations. The only way for that to work is if the implementation task force is put in the Bill.

As the report states, the task force should be made up of representatives of the various arms of the healthcare system that have a recognisable role to play in delivering patient safety—in other words, people acquainted with the issues and who have knowledge and expertise. Those responsible for implementation need to know that their work and progress will be monitored and they will be accountable. Supporting the implementation process should be a reference group made up of a range of patient interests going far wider than the groups the report members dealt with. Yet again, such a reference group would consist of people with direct experience, and ongoing daily experience, of the impact of such medicines that have been specified, as well as other types of medicines, where there have been side effects, and the medical devices that have caused so many problems to so many women and men.

We need a system and task force that listens, hears and acts with speed, compassion and with proportionality to prevent further avoidable harm—hence my support for the amendment in the name of the noble Baroness, Lady Cumberlege, to establish such an implementation task force without delay in the Bill.

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

My Lords, I congratulate my noble friend Lady Cumberlege on the work that she and her able team have done on the report, First Do No Harm. I entirely support the amendment, and I am delighted to follow in this the noble Baroness, Lady Ritchie, who has pointed out that by definition it will have only a limited life. Its main work will be to ensure that the functions of the report and all the recommendations are followed through. However, I take this opportunity to ask both Ministers if they are minded to support this. Possibly, when my noble friend comes to respond, we might hear what the nature might be of the budget allocated to the task force, as well as to whom, if at all, the oversight governance board in subsection (2)(b) of the proposed new clause might report, and whether it is intended that Parliament might have an overview of the work of the task force.

In establishing the task force, it is absolutely vital that there is a body that has the role, as is intended in this amendment, of implementing the recommendations set out in the report of the Independent Medicines and Medical Devices Safety Review. I would personally favour the mechanism in this amendment that a task force should be set up for this purpose, limited in time with a specific view. I would be interested to know what budget might be allocated, and from which budget this would come, and also if there was a mechanism to keep Parliament informed of the work of the task force for its limited life.

[Lord O’Shaughnessy (Con)]

My Lords, when I was preparing for today’s debate and I saw where I was in the speaking list, I anticipated that there would not be much left to say by the time we got to me. I was wondering what I might be able to add to support my noble friend Lady Cumberlege in the very powerful argument she made about the need to set up the task force in recommendation 9 from her review.

I went to look at the latest data on the use of valproate in girls and women in the UK, and I declare my interest as a vice-chair of the APPG that looks at these issues. The MHRA publishes a regular report and its version 4, which tracks the data from 2010 to 2019, was published earlier this year. From that I draw two lessons that are very germane to this debate. The first—which the noble Lord, Lord Hunt, alluded to—is that there is this fear of independence, but there is also something else that perhaps goes on, which is almost a sense of helplessness: well, harm is going to happen in practice, there are things you can do, but it is something we are always going to have to accept. The positive message that comes from the work of the noble Baroness, Lady Cumberlege, and her review, is that we can make a difference. If you look at the prescribing of valproate in pregnancy, you see that it fell by 78% from 2010 to 2019 on the back of concerted action from many people—clinicians, officials, Ministers, patients of course, patient campaigning groups particularly, and many others. It halved, year on year, from 2018 to 2019. So we can make a difference through concerted action.

The other data point I take out of it is that even now there are still 200 babies exposed each year to valproate and, as we know, half of them will experience physical or mental harm. That is 100 babies whose lives, and whose families’ lives, are going to be irreparably changed because of that exposure, when everybody accepts that exposure to valproate in pregnancy should be zero, or as close to that as humanly possible.

It is the point about urgency that I want to get across to my noble friend the Minister. I do believe that he is deeply sympathetic to the findings of the review and the need to move forward, but we cannot wait any longer, because these harms are going on. They are going on every day and we can do something about them—and the recommendations in my noble friend’s review are precisely the way we can do something about them. As my noble friend Lady Cumberlege said in her opening remarks, this is not the kind of thing on which you really want an amendment. It is not the kind of thing that should require legislation, but the reason there is such support for it is the sense that nothing is happening when there are harms going on that could be prevented if we took the concerted action that is necessary. That is why I am speaking in support of the amendment today.

Medicines and Medical Devices Bill

Baroness McIntosh of Pickering Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[Baroness Burt of Solihull (LD) [V]]

This string of amendments all talk about recording information, and I broadly agree with all of them. I particularly mention Amendment 104, in the name of the noble Lord, Lord Lansley, because of the mention of the Caldicott principles. Many people, particularly noble Lords in the Liberal Democrat party, jealously guard our right to privacy—hence the promissory tone of Amendment 100 in the name of my noble friend Lady Jolly.

The purpose of the proposed new clause in Amendment 107, to which I have put my name, is slightly different from that of the other clauses because it seeks to ensure that a proper systematic analysis is made of the effectiveness of mesh implants through registers. The Cumberlege review notes that registries are

“few and far between and all too often prompted by catastrophe”

in relation to transvaginal mesh and PIPs. This is obviously a good phrase because the noble Baroness, Lady Finlay, has already picked it out of the report.

This clause proposes a register. It requires the Secretary of State to report on progress towards creating databases relating to other devices. I appreciate that there are many databases out there—far more than I anticipated when first became involved in this Bill. The idea of the registries is to draw all this information together. As the Cumberlege report says,

“a ‘registry’ … would act as a repository for more complex patient related information datasets enabling research and investigation into patient outcomes.”

This would be more holistic and far more useful than just a database, enabling any adverse outcomes to be spotted early and not allowed to fester, literally, for years before defaults are spotted.

Patient groups must be consulted on devising the register. Time and time again, victims reported that they had not been listened to, despite the fact that the mesh felt “like razor blades” inside them. Never again must a patient feel patronised, unheard or left to suffer in silence. Of course, those healthcare professionals at the coal face, as it were, of the issues must have their say. We know that some registries exist today, but this database would bring everything together, instead of the piecemeal system we have at the moment.

I will go back to the lady whose poignant testimony I quoted at Second Reading, whom I called Jane. Jane had an estimated five pieces of mesh inside her, although the health professionals treating her maintained that there were only two. How can this be? I leave noble Lords to speculate but, in my view, this is a sharp indictment of the state of the service our health service gives to patients in this area. Unless we have a proper register of everything that is inside a patient, when it was inserted and what its performance record is, how are we going to enable them to be given the appropriate treatment when problems arise? The Royal College of Surgeons endorses this view—it wants all medical device implants overseen by registries.

Finally, I express my gratitude to the noble Lord, Lord Bethell, for the briefing this morning. I was very heartened to learn of the hard work going on in this area and the aspiration that a register for vaginal mesh implants could be up and running in only a year. I wish the Bill well.

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

My Lords, first, I apologise for not being able to participate at earlier stages of the Bill because of the clash with speaking in the Chamber. I congratulate the noble Baroness, Lady Finlay, on introducing these amendments and, especially, my noble friend Lady Cumberlege for all her work in preparing her report in advance of this. I also thank the Minister, my noble friend Lord Bethell, for briefing us this morning. I will particularly speak in favour of Amendments 100 and 101.

I hope that my noble friend the Minister will look favourably on patients being able to report directly to the register. The testimony that my noble friend Lady Cumberlege and others heard in the context of her report was very moving. As my noble friend Lord Ribeiro said, it is absolutely essential that the voice of patients is heard. This absolutely goes to the heart of medical and surgical treatment. We must ensure that, whether they have had a good or a bad experience, patients are able to place their experiences on the record. Amendments 100 and 101 go some way to achieving that. Were my noble friend not to like those amendments, I hope that the Government would come forward with a similar provision to put our minds at rest. I thank the noble Baroness, Lady Finlay, for these amendments, and I lend my support to them.

[Baroness Masham of Ilton (CB) [V]]

My Lords, Amendments 100 and 101 make clear that there should be means by which patients can report into registries directly so that they can be heard even if there is divergence of opinion with their clinician. Patients need to be protected. I support all the amendments in this group and thank those who tabled them, giving extra thanks to my noble friend Lady Finlay, who works so hard.

This is exceedingly important for many patients who have rare and complicated conditions. I speak from experience, as a high-lesion paraplegic. Many GPs and general doctors or surgeons may not be familiar with several of the peculiarities and may not understand the patient’s needs. For people with spinal injuries, for example, the three Bs are very important: bowels, bladders and bedsores. If not treated by specialists, patients can get into serious problems. Severely disabled people use all sorts of complicated devices that need to be kept on a register and to be easy to track if they go wrong. Suitable mechanisms should be found for the variety of needs, which can be inside and outside the body. This is particularly difficult in this time of Covid-19.

--- Later in debate ---

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

My Lords, it is a great pleasure to follow the noble and learned Lord. I have added my name to that of my noble friend Lady Thornton to Amendment 128, which was introduced by my noble friend Lady Wheeler. This regards the organisations to be consulted—other noble Lords have already referred to this—and concerns the provisions of Clause 41 for consultation on Parts 1, 2 and 3 of the Bill. As noble Lords have said, at the moment, it is entirely up to the Secretary of State who is consulted, other than the clarification the Government have brought in relation to the devolved Administrations.

The context of this amendment is the extensive power given to Ministers under the Bill. We have debated this before, but it is worth reminding the Committee that the Delegated Powers Committee in its report on the Bill was highly critical of Ministers for failing to provide sufficient justification for parts of the Bill adopting a skeletal approach. As the committee said, the Bill gives Ministers wide powers to almost completely rewrite the existing regulatory regime for medicines and medical devices.

It is also worth reminding the Committee that the Constitution Committee described the Bill as

“a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made using the powers.”

It went on to say:

“The Government has not provided the exceptional justification required for this skeleton approach.”


The case for a sunset clause is readily apparent, but in its absence, the way in which consultations are done assumes more importance than normal. It is very surprising that the duty to consult is open-ended and simply leaves it to Ministers to decide who to consult. The Minister may say that he does not like lists of organisations to be consulted, but legislation is littered with lists of organisations because it is important to reflect the range of bodies that ought to be consulted. Discretion is always given to Ministers to add to those lists of organisations.

I hope that the Minister will be prepared to take this back because in the end, certainly in the absence of a sunset clause, we have to beef up the provisions on consultation.

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

My Lords, I support in particular Amendments 105 and 127 in this group, but I shall speak briefly to Amendment 105 and thank the noble Baroness, Lady Wheeler, for introducing this short debate on it. In the context of the proposal for a requirement to consult the devolved Assemblies, I share the concern expressed by my noble and learned friend Lord Mackay of Clashfern: it is essential that we keep all the devolved Assemblies in tune with Westminster thinking as the Bill and the regulations under it progress.

Covid-19 Update

Baroness McIntosh of Pickering Excerpts

Thursday 12th November 2020 Lords Chamber

[Lord Bethell (Con)]

The noble Lord is completely reasonable in his concerns but that is not the approach we are taking at the moment. Actually, public support for the lockdown measures—the wearing of masks, social distancing and restrictions on travel—has been amazing. Lockdown has been largely by consent and extremely well supported by the public in their behaviour. We are extremely proud that in Britain we do not need the Army on the street with their guns or the police fining people on the street, as they do in other countries. I pay tribute to the British public for the way in which they have gone along with those measures. The noble Lord makes the point that some people have been in breach of the rules and there have been prosecutions and fines. However, they have been minimal and have had their effect. We will continue to operate at the kind of level at which we have been operating to date.

[Baroness McIntosh of Pickering (Con)]

My Lords, my noble friend will be aware of my interest in the Dispensing Doctors’ Association. Will he update the House on where we are with the vaccination programme for the over-50s? What use will be made of dispensing doctors in rural areas to dispense the Covid-19 vaccine? I hope he will rely on them fully because they have the network to provide it in much the same way as the noble Lord, Clark, explained.

[Lord Bethell (Con)]

My noble friend will be aware of the prioritisation list published by the JVCI. I am afraid that the over-50s, of which I am a member, are not highest on the list, but they are at least halfway down. Prioritisation starts with the over-80s and works down from there. I completely endorse my noble friend’s comments on dispensing doctors. We will be relying on all parts of the healthcare ecology to deliver the vaccine. It will be a massive national project. Getting to hard-to-reach rural communities is incredibly important, particularly people in those communities who are older and perhaps do not travel. Dispensing doctors pay a pivotal role in that, and I pay tribute to their contribution to the vaccine.

Health Protection (Coronavirus, Restrictions) (Self-Isolation) (England) Regulations 2020

Baroness McIntosh of Pickering Excerpts

Thursday 22nd October 2020 Lords Chamber

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

It is a pleasure to follow the noble Baroness and to join others in congratulating my noble friend on his stamina and energy in pressing these regulations.

I ask my noble friend to address a number of practical problems and limitations with the app and the track and trace system. On a practical issue, how can we advise people who are working away from home to self-isolate at home, which may be some distance away, without putting others at risk? This is a perennial problem and normally flagged up when it is a high-profile individual who is deemed to have fallen foul of the rules.

I want to address the issue of the app not necessarily updating sufficiently. It has also come to the attention of many that it drains the battery enormously, which is a disincentive to those who are using their mobile phone for other purposes during the course of the day to rely on the app, because they simply do not have enough battery usage left.

I know that there has been a lot of criticism of consultants being paid £7,000 a day, but I would like to understand what particular role the consultants played to justify what seems like an extraordinarily high fee. I welcome the fact that we are now using unqualified people to work track and trace; presumably they have been trained up at high speed. This is very welcome, and I wonder why we have not been using them earlier. I welcome this opportunity to address these issues and ask my noble friend as far as possible to find solutions to the issues that I have identified here.

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

Baroness McIntosh of Pickering Excerpts

Tuesday 20th October 2020 Lords Chamber

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

My Lords, I add my congratulations to the noble Baroness, Lady Fox of Buckley. I welcome her to the House and wish her a very happy and successful time in this place. I also add my congratulations to my noble friend the Minister for his stamina and patience in once again coming to present these regulations to the House.

It is not that I do not support regulations—I do—but I make a plea to my noble friend that the guidance could be much clearer. In particular, for example, when reference is made to “linked households” and “bubbles”, my noble friend referred me to the app, so I took his advice and went on the app, but it is not immediately clear where to find this guidance. When you look up “linked households”, it comes up with general advice about coronavirus, about household antibacterial chemicals linked to weakened bones and something about house dust linked to obesity, which I do not think is what my noble friend intended to direct me to.

I make a plea that there should be a one-stop shop, where those who are the target and recipient of the restrictions in these regulations can go for very clear, specific guidance. A specific example that received great notoriety was when Dominic Cummings visited the north-east, a place in County Durham, right at the outset of the original lockdown. Giving him the benefit of the doubt—perhaps he did not understand the rules—where would he look to find these rules in a very simple way, so that he could understand, as we could all understand as the recipients of these regulations, what, for example, constitutes a bubble and what constitutes a linked household?

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

Baroness McIntosh of Pickering Excerpts

Monday 12th October 2020 Lords Chamber

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

My Lords, I will speak to the regulations relating to the north-east of England, particularly those that prohibit people in those areas gathering with one or more people from a different household, apart from linked households in a private dwelling, whether inside or outside the protected area.

It is very clear, and I share the frustration that I am sure Ministers and the general public feel about this, that Covid is not acting as one would expect it to. However, the communication and understanding that flow from the regulations which the Government are bringing forward are clearly key to enabling those in the north-east of England to follow the letter of the regulations before us this afternoon.

My particular concern relates to the fact that urban areas such as the Tees Valley were initially left out of the regulations, whereas deeply rural areas such as Teesdale, with a population of 25,000, and Weardale, with a population of just over 8,000, were included, lumped together with the whole of the city of Durham and other more urban parts of County Durham. This must be a feature of unitary government, and it is one I deeply regret. It leads to perverse consequences; I am not convinced that, when these regulations came into effect, the level of the virus in the rural areas was high enough to justify the draconian regulations that were introduced.

I will ask my noble friend a specific question, because I am being asked it by those I know living in County Durham. It relates in particular to linked households under SI No. 1010—Regulation 7 on page 6—and paragraph 7.2 on page 3 of the Explanatory Memorandum to the SI No. 1012 correction regulations. What does my noble friend understand exactly by a “linked household”? Is it just for the householders to agree or do they have to notify the authorities, or only if they were challenged in that purpose? Also, can my noble friend explain what a support bubble is? How many people can form one? If I can learn that from my noble friend, I can go on to explain what it is to others who are asking. Other noble Lords have expressed concern about the extent of the measures before us today, so can my noble friend explain what balance has been reached regarding the mental health and well-being of—and the feeling of isolation experienced by—those living in a single household who may not be part of a linked household or a bubble, or who may not quite understand the extent to which they are? They may take a complete turn for the worse in those circumstances. Physical conditions such as cancer and others itemised by my noble friend Lady Altmann are also important, as the timing of diagnosis and treatment is a particularly critical factor.

I have a general question for my noble friend in connection with the regulations before us. I know he said that consultations were held with the leaders of councils, so presumably that included the leader of Durham County Council. However, with particular regard to my concerns about the rural area of Teesdale and Weardale, what consultation and discussions were held with councillors elected to represent those areas?

Finally, what is the relationship now between the regulations before us and the new tiers announced this afternoon by the Prime Minister? What will happen if, even in spite of the new, even more draconian, measures announced along with the tiers this afternoon, there continues to be a rise in infection? What further action might my noble friend and the Government consider taking if such a course of events transpires?