Health Protection (Coronavirus, Restrictions) (All Tiers) (England) (Amendment) Regulations 2021

Baroness Walmsley Excerpts

Monday 8th February 2021 Grand Committee

[Baroness Walmsley (LD) [V]]

My Lords, I want to ask about the route out of lockdown. I fear the Government are relying far too much on the vaccine programme to get us out of trouble and may be planning to ignore the need to reduce the prevalence of the virus in the community before easing restrictions. I hope that the Minister will reply to my noble friend Lady Barker’s question about a lot of test and trace being laid off. Surely this is the time to continue the effort to find out where the virus is and stop it in its tracks by supported isolation strategies? Can the Minister justify this reduction in testing staff? If he tells me that resources are being switched from the eye-wateringly expensive centralised system to locally based—and more cost-effective—test, trace and isolate services, I will be very pleased to hear it. However, the Government were so slow to make use of local expertise in favour of their expensive national system that I somehow doubt it.

Unless we bear down on incidence in the community, mutations will continue to occur and variants will result, with a possible consequence for the effectiveness of current vaccines. What lessons have been learned from what happened last autumn, when cases rose again after the summer easing of restrictions and we had a second wave worse than the first? What lessons have been learned from abroad, specifically Portugal, where there is now an even worse crisis for which it is having to get help from Germany and other EU countries because they had a free-for-all over Christmas?

Are the Government watching what is happening in Israel, where the level of vaccination is higher than here but levels of illness are not reducing as fast as expected? As Israeli epidemiologist Dr Ran Balicer has commented:

“Vaccines work, but the picture is more complex than that. Other steps are needed as well.”


Experts there believe that the lower level of adherence to lockdown in Israel is part of the problem, which should be a clear lesson for us here in the UK.

Can other noble Lords mute, please?

All this indicates the need for timely parliamentary scrutiny of any proposals for loosening restrictions, so that Members of both Houses will have at least as much notice as schools. Members need the opportunity to counter the pressure that the Government are clearly feeling from the so-called Covid Recovery Group, which does not agree with restrictions and seems to believe, mistakenly, that herd immunity can come from widespread natural infections. It does not seem to care about the deaths and long-term illness that would ensue from such a strategy.

Looking to the future, can the Minister say, first, what studies are being set up to monitor the ongoing level of immunity of those who have been vaccinated, testing against not only current variants but others that may arise? This will be essential if scientists are to advise on the nature and frequency of future booster vaccines. Secondly, do we have sufficient capacity in genome sequencing adequately to track new variants, which will inevitably come into the country until the whole world is vaccinated? We are world leaders in genome sequencing but capacity is different from expertise. Do we not need to scale up this work and perhaps do what they are doing in Denmark: sequence the relevant part of the genome of every positive case in order to detect new variants early? I am afraid that when I heard a little while ago that we have two cases of the South African variant I cynically suspected that we actually had many more but did not know about it. We can know this only if we increase our genome sequencing capacity.

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

Before calling the next speaker, I remind noble Lords to remain on mute when not speaking. I call the next speaker, the noble Baroness, Lady Gardner of Parkes.

Health: Eating Disorders

Baroness Walmsley Excerpts

Tuesday 19th January 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I recognise the issue of regional disparities, but I reassure the noble Baroness that our ambition is to deliver swift access to treatment for 95% of children and young people with suspected eating disorders within one week. The good news is that in the second quarter of 2021, 83% of urgent cases were seen within one week and 89.6% of routine cases were seen within four weeks. Those figures can be improved but I think that they are impressive. They show that progress is being made and that we are taking this issue seriously.

[Baroness Walmsley (LD) [V]]

My Lords, the eating disorder faculty at the Royal College of Psychiatrists has recently reported that eating disorder teams are being asked to ignore the NICE guidelines for treatment as being unrealistic and too expensive. Will the Minister either justify this or condemn it?

[Lord Bethell (Con)]

The noble Baroness brings to my attention something concerning. I would be grateful if she would write to me with the details and will be very happy to look into it in more detail.

Medicines and Medical Devices Bill

Baroness Walmsley Excerpts

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

The ability of Governments to issue Crown use licences when patent monopolies prevent access to a medicine is a hugely important safeguard, and effectively enables a Government to issue a licence to another manufacturer to produce a generic version of a patented drug at a lower price. With medicines becoming ever more expensive, countries such as Australia, Canada and Germany have revised their national intellectual property laws to simplify the issuance of a compulsory license during a public health emergency. Is it not high time we did the same?

[Baroness Walmsley (LD) [V]]

My Lords, I support this amendment. When we discussed this issue in Committee, I raised the matter of Section 57A of the Patents Act 1977 and the Minister pointed out that compensation needs to be awarded to a patent holder for any loss of profits as a result of the use of a Crown use licence and argued that this should be set against the potential savings that purchasing more affordable generic alternatives enabled by a Crown use licence could bring about. Tonight, I repeat that this has never been tested in court.

The noble Baroness, Lady Sheehan, and the noble Lord, Lord Alton, mentioned Orkambi. The fact is that if the Government had issued a Crown licence and Vertex had decided to take the Government to court for compensation, the Government would probably have won the case, because they had a very strong case. Any reasonable person would have concluded that three years of failed negotiations showed that Vertex could not make the case that the NHS would definitely have bought the product from them had a Crown use licence not been issued. Had they taken the thing to court, the Government would probably have won the case, and the fact that they did not means that they really missed an opportunity to set a useful new precedent by fighting an interpretation that would render the entire Crown use provision next to useless.

I shall add just a few words about the Covid-19 pandemic. Many countries, such as Germany, Hungary, Canada and Australia, have made alterations to their patent laws to make issuing a compulsory licence easier, in the interests of public health. That is because, in those countries, it is accepted as a valuable tool that can help overcome pricing and manufacturing barriers to accessing crucial vaccines, medicines and diagnostics which could help save millions of lives. Will the UK Government follow this example, set a precedent, next time the opportunity presents itself, and make the necessary changes to our law to make it easier, not more complex, to use our legal right of issuing a Crown use licence to protect public health?

[Lord Crisp (CB) [V]]

My Lords, I am very pleased to add my name to the amendment in the name of the noble Baroness, Lady Sheehan. I shall be brief and limit myself to one central point, because the arguments have been put so well by noble Lords who have already spoken. At its heart, this amendment is about achieving the right balance between the public interest and private interests. In this particular context, it is clear to me that the Government should commit themselves clearly to safeguarding the public interest and to taking action on—let me stress this—those rare occasions when it will be necessary.

This is particularly vital, as other noble Lords have said today and on earlier occasions, because, sadly, there is a history of price gouging and exploitation of the public. There has also been lack of transparency and, of course, one should also note that the development of many treatments and vaccines have benefitted from public investment. I hope the Minister will be able to make the commitments that the noble Baroness, Lady Sheehan, has requested.

--- Later in debate ---

[Baroness Meacher (CB) [V]]

My Lords, I have added my name to the amendment moved by my noble friend Lord Field of Birkenhead. I want to give it my strongest possible support, as Ministers will expect of me.

In November 2018, the significant medicinal properties of cannabis were finally recognised after 50 years of misinformation—I can only call it that—about the plant. At that time, around 1 million patients thought, “Oh my goodness, we’re going to be able to obtain our medicines free of charge through the NHS.” How wrong we all were. I think I am right in saying that only three prescriptions have been written under the NHS since that date; in my view, that is some indication of the degree of misinformation over so many years.

The epilepsy crisis illustrates powerfully that the right medical cannabis is essential for the treatment of severe epilepsies that are resistant to standard medications. I understand that Ministers know this well and are doing what they can behind the scenes. I know that the noble Baroness, Lady Walmsley, will focus strongly on this particular issue.

I want to mention an economic point, if you like. Until his parents so brilliantly found medical cannabis, dear Alfie Dingley’s terrible emergency ICU admissions —nearly every week—were costing the NHS around £100,000 a year. That included his consultant cost, GP costs and medications. The reality is that this amendment could save the NHS hundreds of millions of pounds. It is absolutely crazy to make this so difficult.

The aim of our amendment is to ensure that medications such as Bedrolite, which saved Alfie’s life—I do not think that that is an exaggeration—could receive marketing authorisation, thus immediately resolving the problem for Alfie and other children like him. The fact is that Bedrocan products have been used very successfully for decades, showing that they are both safe and effective.

As my noble friend Lord Field of Birkenhead said, the amendment would solve the problem not only for epileptic children, terribly important though that is, but for the very many people who suffer severe chronic pain, particularly neuropathic pain. It would open the way for cannabis products with a track record of efficacy and safety to be given marketing authorisation and prescribed by GPs as licensed products. That is what we want to achieve here.

I want to make a few further comments. I hope that I am reflecting correctly the comment of June Raine, the chief executive officer of the MHRA, in a Zoom meeting in which we were both involved. She seemed to suggest that, finally, she understood that the MHRA needs to take real-world experience much more seriously. If this is what she meant, I applaud her most strongly; I have been waiting for a senior person in the MHRA to take that view for some time.

If a patient has many years of experience of medical cannabis and has found that it really helps them when other products had not done so, surely this experience should be taken very seriously, not only by the MHRA but by doctors too. Cannabis should be prescribed for the patient in question and other patients with similar conditions. I therefore plead with the Minister, the noble Lord, Lord Bethell—for whom I have the greatest respect on a whole range of issues—to encourage the MHRA to revisit its rules for assessing the efficacy of medical cannabis, to take account of the real-world experience I have mentioned.

I am not talking about a few patients or a few weeks of trying something out—not at all. The fact is that 78 medications prescribed within the NHS have never been through random control trials. It is simply not true to say that medical cannabis products must go through such trials. The complexity of the cannabinoids in cannabis is such that RCTs tend to lead to suboptimal products being approved as single cannabinoids when in fact several cannabinoids and some terpenes might be a great deal better.

Another aspect of real-world experience is the research undertaken in other countries. The National Academies of Sciences, Engineering and Medicine published the report The Health Effects of Cannabis and Cannabinoids in 2017, more than three years ago. It was a review of global research into the efficacy of cannabis medicines. Already, three years ago, it was able to conclude:

“There is substantial evidence that cannabis is an effective treatment for chronic pain in adults”.


Since then, the WHO has finally recognised the medicinal value of cannabis. More and more countries are also recognising the facts about this important medicine. The UK is now lagging behind the English-speaking world. It is really time to catch up, and I hope that our Minister can help us.

My last point concerns our own police forces. Many have now moved ahead of the Government in deciding not to arrest patients who have a few plants in their kitchen to supply themselves with their medicines, or even those who get such medicines from illegal dealers—let me tell you, that is the last thing patients want to do. The police know perfectly well that it is cruel to add a criminal offence to all the pain that these patients already go through.

I hope that the Minister will be willing to meet the noble Lord, Lord Field, and I, ideally with June Raine, to discuss the best way forward. I believe that to improve access to medical cannabis for patients, Ministers will need to adjust the regulations that currently restrict that access and prevent GPs prescribing medicines that patients so desperately need.

[Baroness Walmsley (LD) [V]]

My Lords, I am honoured to follow the noble Lord, Lord Field, and the noble Baroness, Lady Meacher. I too have put my name to Amendment 15.

Before I specifically address the amendment of the noble Lord, Lord Field, I would like to acknowledge the Minister’s reply to my Oral Question earlier today about the negative effect of Brexit on the legal supply of Bedrocan, and probably other cannabis medicines, to patients in the UK. He knows that this is a life-changing and life-saving medicine, so he will understand that patients and their families are very anxious. Can he assure me that they will be kept informed about progress on sorting this out? They and their clinicians were very worried by his suggestion that there needs to be compromise on both sides. There can be no question of compromise; it would be dangerous to try to substitute this medicine for a different formulation, extracted from a different strain of cannabis.

In response to the DHSC’s suggestion to pharmacists that one cannabis medicine can easily be replaced by another, I will quote from evidence that I have received from Evan Lewis, director of the Neurology Centre of Toronto. He is a clinician with extensive experience of medicinal cannabis for adults and children, and has said:

“It is imperative that children who are benefiting from a particular medical cannabis product are not changed to another product. There is significant variation from one product to the next, and many unknowns as to how all the cannabinoids interact with each other to treat seizures”.


He goes on to say that swapping backwards and forwards between products can be extremely dangerous and is often ineffective. This misunderstanding nicely illustrates some of the problems we face in our campaign to make the benefits of cannabis medicines more widely available to UK patients on the NHS.

On the wider issues in Amendment 15, the key issue is how evidence is obtained about the safety and efficacy of these medicines. I see the Government’s fixation with random-controlled clinical trials as a real barrier to progress in the field of cannabis medicine. When scientists are trying to investigate any issue, they always use procedures that are appropriate to the material being investigated and to answering the question asked. When you have a very small patient cohort, such as the cohort of children with drug-resistant epilepsy, it is impossible to have a meaningful clinical trial. Besides, when giving a placebo to half the sample could be life-threatening, it could be unethical.



As the noble Baroness, Lady Meacher, said, many drugs and medical devices are already used on an anecdotal basis. For example, as she said, 78 drugs are available and in use in the NHS that have no random control trial. The vagal nerve stimulator, which is successfully used to prevent seizures in some epileptic patients, also has no RCT in relation to it. There are many drugs used on children that have not been tested in clinical trials for use in children. Indeed, some of them were used on Alfie Dingley and the other children who now receive cannabis medicines before they fortunately discovered the benefits of the latter.

Cannabis Oil

Baroness Walmsley Excerpts

Tuesday 12th January 2021 Lords Chamber

Asked by

[Baroness Walmsley]

To ask Her Majesty’s Government what steps they are taking to ensure that cannabis oil continues to be legally available to patients when prescribed by their physician.

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

My Lords, we are on the case. I completely recognise the problems faced by Alfie Dingley and all the individuals reliant on the previous arrangements with the Dutch Government for the supply of Bedrocan oils. The department is working urgently with Dutch Minister Tamara van Ark to find a solution that will enable these patients adequately to access the medications they need, and we are committed to setting up clinical trials to inform future NHS commissioning of cannabis-related medicines.

[Baroness Walmsley (LD) [V]]

My Lords, I thank the Minister for that very encouraging response. He will know that time is of the essence because these medicines prevent children having severe fits, some of which are life-threatening. Can he go back to his department and educate some of his officials? Unfortunately, a lot of the families are very upset at being told that they can safely be switched to an alternative formulation. That is both ignorant and dangerous. All the expert clinicians who know about these issues say that that cannot be done safely. Even if it could, eventually putting these children back on to the original formulation sometimes does not work. Will he make sure that his officials listen to the clinicians who are expert in prescribing and in following the progress of people on these formulations?

[Lord Bethell (Con)]

My Lords, I am grateful for the noble Baroness’s kind words, and I will indeed take that patient feedback back to the department. I reassure her that this is an area where patients have undoubtedly led the way, and clinicians have to catch up. In doing so, there will need to be a meeting of minds and regulation in areas that are open to patient interpretation. In that period, there will undoubtedly need to be compromises on all sides.

Covid-19: Restrictions

Baroness Walmsley Excerpts

Thursday 7th January 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, the noble Baroness analyses the situation extremely well and has laid out exactly the Government’s plan for rolling out the vaccine. She is entirely right that we are using lockdowns to bridge the gap until herd immunity is achieved through the vaccine. We have mobilised an enormous amount of the NHS, and are very grateful to the volunteers who have stepped up and are making an enormous difference. We are trying to get as much of the vaccine as possible out of the factories and warehouses, with batch control, and into the country’s surgeries and hospitals to vaccinate millions of people before the spring.

[Baroness Walmsley (LD) [V]]

My Lords, a weak link in the measures to suppress the virus has been the small percentage of people not self-isolating when they should. This is often because they cannot afford to do so. Dozens of times my Lib Dem colleagues and I have asked the Government to provide adequate financial support for self-isolators. So I ask the Minister again: in order to suppress the virus, will the Government pay the wages of poor people who need to self-isolate?

[Lord Bethell (Con)]

My Lords, I pay tribute to the advocacy of the noble Baroness and her colleagues on this important point. I acknowledge the financial pressures on those of limited means who are required to isolate. We have put in provisions for statutory sick pay and the £500 Covid bonus to help to support those people, and there are local authority funds and provisions to provide additional support. The point that she makes is made well and we completely acknowledge the challenge.

Obesity

Baroness Walmsley Excerpts

Tuesday 5th January 2021 Lords Chamber

Asked by

[Baroness Walmsley]

To ask Her Majesty’s Government what assessment they made of the report by the All-Party Parliamentary Group on Obesity The Future of Obesity Services, published on 25 November 2020.

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

My Lords, we welcome the ongoing work and support of the All-Party Parliamentary Group on Obesity and its report The Future of Obesity Services, which continues to make a valuable contribution to the debate. We published Tackling Obesity: Empowering Adults and Children to Live Healthier Lives last July, which demonstrates an overarching campaign to reduce obesity, takes forward actions from previous chapters of the childhood obesity plan and sets out measures to get the nation fit and healthy.

[Baroness Walmsley (LD) [V]]

I thank the Minister for his reply, but he will know that we have had several obesity strategies before. What steps are the Government taking to ensure that this latest strategy is implemented in full without delay? Can he provide an update on the timelines for implementation? One of the main concerns of our witnesses was that the full range of services should be provided everywhere in the country, with easier access at any stage of the pathway. Will the Government take this on board?

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

Baroness Walmsley Excerpts

Wednesday 30th December 2020 Lords Chamber

[Baroness Walmsley (LD) [V]]

My Lords, the last time that we discussed restrictions, I asked the Minister whether volunteers would be used for non-medical tasks to improve the speed of testing and tracing. The Minister dismissed the idea. Now they are asking for volunteers to marshal patients in vaccination centres. Will he now recognise the important role of these public- spirited people and tell us what resources will be given to St John Ambulance to organise them?

The Government spoiled Christmas for head teachers by insisting, on the last day of term, that schools should open on time next week and that all children and staff should be given the rapid test. Yet virtually no time, money or person power has been provided to enable them to do this. While I believe that keeping schools open safely should be a priority, what are the Government doing to support heads and teachers? Will there be enough testing kits provided for schools to use? Will staff be given priority for vaccination to give them the confidence to return to work? Will volunteers be recruited to help with the testing to allow teachers to teach?

Children’s education is vitally important, but many of them have lost weeks of classroom time intermittently, not because of lockdowns but because of serial Covid outbreaks in the school and the need to go home for two weeks—over and over again. If the imminent announcement by the Secretary of State for Health and Social Care does not introduce strict measures to stop the virus in its tracks and if the Government do not implement an efficient vaccination rollout, this stop-start education will continue. The effect on our children’s education is not just whether or not we open schools but whether or not we win the battle against the virus. Does he agree?

Coronavirus Vaccine

Baroness Walmsley Excerpts

Thursday 3rd December 2020 Lords Chamber

[Lord Bethell (Con)]

I am slightly surprised by the tone of the noble Lord’s question. If there were ever a moment when my right honourable friend the Secretary of State for Health deserved a bit of praise and a thank you, today would be that day. That ad hominem attack was beside the point. On his serious point about trust in the vaccine, it would not be helpful for politicians to lead the charge. Our approach is to put science and the NHS at the forefront of our communications. They are truly engaged with both the expertise and the communities that need to take the vaccine.

[Baroness Walmsley (LD) [V]]

My Lords, the rollout will require many people, in addition to those giving the injection. Are there any plans to use the thousands of NHS volunteers who signed up during the first lockdown to act as marshals, drivers, identity checkers, or whatever else is required? In planning the appropriate use of the military, have the Government recognised the concerns of certain community leaders that their presence at testing sites would not reassure members of their communities who are hesitant about taking the vaccine because they do not trust authority?

[Lord Bethell (Con)]

The noble Baroness is right about the NHS volunteers. We would very much like to work with those who stepped forward. Their move was extremely welcome and kindly meant. However, the deployment of the vaccine is a precise affair. We are relying on people having to put in long hours—often not at their own discretion or convenience. Volunteers may well play a role, but the backbone and functional aspect of the deployment will rely on professional staff.

I appreciate her conundrum about the military. It is a delicate dilemma. I do not want to live in the kind of country where we turn our back on the military because some people might feel uncomfortable at the sight of uniforms on the streets. We need to build trust with communities. I want to use this moment of the vaccine to build a bridge of trust between those whom the noble Baroness reasonably described and the military. We must not make the mistake of disrespecting the military by turning them away from this important task.

Covid-19 Update

Baroness Walmsley Excerpts

Monday 30th November 2020 Lords Chamber

[Lord Bethell (Con)]

I share completely the noble Lord’s ambition for collaboration and a sense of national unity. I am grateful to the devolved Assemblies and the leaders of the nations for their collaborative approach, and to the leader of the Opposition for his support on a large number of matters. However, right now we need clear, simple, strong government, which is best supplied by the voted-in majority.

[Baroness Walmsley (LD) [V]]

My Lords, at the beginning of the first lockdown in Wales, we were forbidden from going out of our borough or travelling more than five miles for exercise. It worked. Now some Government Back-Benchers are demanding more granularity in the tier areas, with restrictions being eased in boroughs with lower case numbers. If this is to be done, it must be—as the Minister just mentioned—without risking the virus spreading from adjacent high-incidence areas, as it did before. If the Government are inclined to give in to this pressure, will they at least consider imposing travel restrictions in high-incidence areas?

[Lord Bethell (Con)]

The noble Baroness is entirely right. I share her sentiments. We are not inclined to give in to the pressure. There is a temptation for greater granularity, but we have learned the lesson on that one.

European Qualifications (Health and Social Care Professions) (EFTA States) (Amendment etc.) (EU Exit) Regulations 2020

Baroness Walmsley Excerpts

Monday 16th November 2020 Lords Chamber

[Baroness Walmsley (LD) [V]]

My Lords, my understanding is that these regulations are a tidying-up exercise to continue to recognise existing Swiss and other EFTA health professionals with qualifications after the end of transition this year. This does not address plans for future pathways of recognition. However, I would like to focus on professionals of whom we need more to clear the backlog of treatments—that is, dentists, who are a bit different from other health professionals. Can the Minister confirm that, irrespective of any new agreement made with the European Union, the General Dental Council will be able to continue to recognise the qualifications of all graduates of dental schools within the EEA, without the need for candidates to sit the overseas registration exam?

Can the Minister also tell me what steps have been taken by the General Dental Council to resume overseas registration examinations for non-EEA overseas dentists, which have been halted due to Covid, and ensure a continuing pathway for recruitment of EEA and non-EEA dentists? In light of the backlog of 15 million treatments, surely we need all the dentists we can get.

As the Minister will know, the NHS dental service does not have a registration system like the medical services do. Each course of treatment is a separate contract. Even with the same dentist, there is no obligation for either party to continue the relationship after a course of treatment ends, except to sort out any issues relating to a recent course of treatment. The patient is free to go to another dentist, and the dentist is free to decline further NHS courses of treatment.

The result of the lack of any registration system is that after a course of treatment ends, nobody has any obligation to find another NHS dentist for any patient. This gives NHS patients no security whatever about continuity of treatment, either preventive or responsive. Given that this situation has been made worse by Covid-19, and given the shortage of NHS dentistry in some areas, does the Minister’s department have any plans to ensure we have enough dentists going forward after the end of the transition phase of exit from the EU?