Botulinum Toxin and Cosmetic Fillers (Children) Bill

Baroness Walmsley Excerpts

2nd reading
Friday 16th April 2021 Lords Chamber

[Baroness Walmsley (LD) [V]]

My Lords, I thank the noble Baroness, Lady Wyld, for bringing us the Bill, and I support it as far as it goes. However, I would like assurances that, using the powers to make regulations in Clause 5, the Government will ensure that, for the most part, botulinum toxin procedures on under-18s do not take place at all, even by a clinician.

We live in a world where young people, particularly girls, are under great peer pressure about their appearance and their weight. Undertaking a dangerous procedure such as this is not necessarily the answer. If the matter affects the mental health of the young person, it should be treated as a mental health issue, not with Botox.

The charity Changing Faces has provided us with the voices of young girls affected by “visible difference”. One said, “Everywhere I looked, clear-skinned models told me the same thing. I never saw a public figure that looked like me and I felt totally alone. I spent hours researching various scar removal surgeries and extreme treatments and started saving for them.” These young people require support, information, the attention of professionals and the protection of the law.

When the Bill was debated in another place, amendments were tabled to ensure that medical practitioners could provide non-surgical cosmetic procedures to a person under 18 only if it was medically necessary. I agree with this. There may be situations where facial disfigurement from whatever cause is causing physical or mental distress to the patient and for which botulinum toxin is considered by a doctor to be the appropriate treatment, rather than more intrusive cosmetic surgery. In such cases, regulations could be used to lay down those matters which should be considered before a clinical decision is reached.

Laura Trott MP, the sponsor of the Bill, argued that it already had safeguards to ensure that under-18s would receive these procedures only where medically necessary. The Minister, Nadine Dorries, agreed that there would be a review of the regulations to assess any unintended consequences. I would like an assurance that this review will consider regulations to restrict the use of this procedure except in certain clearly defined conditions of medical need.

I am aware that GMC guidance says that doctors performing cosmetic interventions can provide treatment to children only when it is deemed to be medically in the best interests of the patient. However, I would like to see the Government making their intentions clear in regulations that under-18s should not receive this treatment except where strictly medically necessary. I would also like the Minister’s assurance that mental health support will be provided to patients in this situation where appropriate.

Covid-19: One Year Report

Baroness Walmsley Excerpts

Thursday 25th March 2021 Lords Chamber

[Baroness Walmsley (LD) [V]]

My Lords, I support the regret Motion from my noble friend Lady Brinton and echo the thanks that she gave. She highlighted how the Government have failed, which is why we should not trust them by giving them a blank cheque on our civil liberties. I also agree with points made in the Motion of the noble Baroness, Lady Thornton.

The issue underlying both regret Motions is the incompetence of this Government in their handling of the pandemic. That is why it is the Government themselves who should be amending this Act, since we are unable to do so. There has been a failure to plan and prepare, decisions have been taken at the wrong level, there has been an overreliance on private sector providers at enormous cost and there have been failures of transparency and providing for democratic scrutiny.

It is incompetent for Governments not to plan properly. This involves horizon scanning and putting measures in place to adequately respond to identified risks. The horizon scanning by the national security risk assessment happened and still does, but a recent study by the Centre for the Study of Existential Risk made several criticisms and recommendations. One criticism was that there is no process, body of expertise or oversight mechanism in place to ensure that departments’ risk plans are adequate. That had fatal results in the case of this pandemic.

The study also concluded that the UK’s pandemic influenza strategy, which was fairly detailed, did not make any plans for a lockdown, despite this being one of the dominant response strategies for Covid-19. Can the Minister give the Government’s response to this serious analysis and say how they plan to learn lessons about planning our risk identification and response in future? Simple mistakes were made, such as failing to ensure that stocks of PPE were in date and fit for purpose.

It is incompetent not to provide adequate basic resources for worst-case scenarios. We started this pandemic with 11,000 too few hospital beds, 5,000 too few doctors and 40,000 too few nurses. We had a fraction of the number of ICU beds and ventilators of other European countries, which is probably why our death rate is one of the highest in the world. Do the Government plan to provide the resources to correct this?

It is incompetent not to care for the most vulnerable in society, for whom the consequences are most serious. For example, it is extraordinary that the DHSC did not realise that sending older people back to care homes to clear hospital beds without first testing them for the virus was catastrophically dangerous. Many deaths occurred in the closed environments of care homes at the beginning of the pandemic that have never even been recorded as Covid deaths—people did not have a test, even when they fell ill. The death rate in care homes was double the rate in the wider community. It was incompetent not to provide care homes with PPE at the start and it was not true to say that care homes were safe—they were not.

The so-called NHS app was incompetent from start to finish. The first system did not work and was replaced. The second system did not pass on information about Covid hotspots to the authorities. People were advised by the app to isolate because of contact with a positive case, but they were not entitled to the £500 support at first, unless they also had a call from another authority —people did not know that because of incompetent communication.

Then there is test and trace—an exemplar of the biggest incompetence of all, which is making decisions at the wrong level. The Government relied on central decision-making and provision, aided by expensive management consultants and private companies, instead of devolving responsibility and decision authority to local government, where the skills and experience could do the job better. Indeed, in the end, when they started to get the necessary information, resources and authority, local authorities proved this very decisively. As the noble Baroness, Lady Bennett of Manor Castle, mentioned, management consultants have been marking their own homework and are being paid to do tasks that should be undertaken by civil servants as part of their job. We need answers about this. It was incompetent to delay taking action when advised to do so by scientific advisers. That was probably the most fatal incompetence of all.

Finally, it is incompetent not to understand your own Act of Parliament. It is not true that failure to renew this Act would remove good things such as the furlough scheme and measures to keep us safe, as some government spokesmen have suggested. That is not what this is about. It is about a blank cheque to control our civil liberties and reduce democratic scrutiny. We will not give that to anyone, especially not this incompetent Government.

Health Protection (Coronavirus, International Travel) (England) (Amendment) (No. 7) Regulations 2021

Baroness Walmsley Excerpts

Monday 22nd March 2021 Lords Chamber

[Baroness Walmsley (LD) [V]]

My Lords, the noble Baroness, Lady Thornton, raises several serious issues. She is right to criticise the delay in acting following scientific advice. Sadly, slowness to react has been a feature of this Government’s handling of the pandemic and has probably contributed to the fact that we have almost the highest death rate of any country in the world. The fact that the regulations failed to prevent the Brazilian variant coming in indicates that they are ineffective, unmonitored and not supported.

It is illogical to force travellers coming directly from red-list countries to isolate in a hotel while allowing those from the same countries, via a short stop in a third country, to isolate at home. I have to accept that the only way to ensure that people do isolate is to ensure that they go into suitable accommodation, with proper support. Since the Government have not provided that, the very least that they should be doing is monitoring that those who are supposed to isolate at home are doing so—but microscopically little of that has been done. Why?

There is also the issue of support. No amount of pre-travel testing will get over the fact that many travellers, like others who are asked to self-isolate for other reasons, are not able to do so. The reasons are usually financial but may be caring responsibilities. These Benches have been calling for many months for paying people their wages to enable them to isolate, but our appeals have fallen on deaf ears. To get the benefit of the NHS vaccination programme, we must do more to prevent variants coming in. Will the Government now look carefully at the evidence from other countries that have put all travellers from abroad into isolation accommodation? It worked at the beginning of the pandemic, when passengers from a cruise ship with an outbreak were isolated in vacant nurses’ accommodation on the Wirral. It could work now.

Covid-19: Vaccination Programme

Baroness Walmsley Excerpts

Wednesday 24th February 2021 Lords Chamber

Asked by

[Baroness Walmsley]

To ask Her Majesty’s Government what assessment they have made of the progress of the COVID-19 vaccination programme towards meeting its (1) delivery targets, and (2) objectives.

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

My Lords, the vaccine deployment programme is proceeding at pace, for which I give profound thanks on behalf of all noble Lords. We have offered a Covid vaccine to 15 million of the top four priority cohorts, hitting our 15 February delivery target. We remain on track to achieve our objective of offering a vaccine to all priority cohorts by 15 April and all adults by the end of July.

[Baroness Walmsley (LD) [V]]

My Lords, the vaccine programme certainly is going well, but there is evidence that some groups are being left behind. One such group is housebound people. Although they cannot leave their homes, carers and family come in, which opens them up to infection. Why does NHS England not record the number of housebound patients who have received the vaccination? What is being done to speed up their vaccination? The other group is people in poor areas and demographics. What is being done to correct this?

[Lord Bethell (Con)]

My Lords, we were alert to the issue of housebound priority cohorts from the very beginning, which is why we have put in place mobile vaccine units. We work closely with community pharmacists and GPs in order to take the vaccine to housebound individuals. While we do not report on them publicly, I understand from the front line that the progress of that has gone extremely well.

The issue of areas of deprivation is really troubling. It is often those areas where the disease is most prevalent and where the vaccine rollout has been the slowest. We are working extremely hard with local community groups, faith groups, marketing experts and influencers to get the message through to the right people and to take the vaccine delivery into the right contexts.

Dentists: Covid-19

Baroness Walmsley Excerpts

Thursday 11th February 2021 Lords Chamber

[Lord Bethell (Con)]

I join the noble Baroness in paying tribute to dentists. As of 18 December, 88% of NHS dental practices were open, and that is a huge tribute to the hard work, determination and skills of dentists. She is right that they offer a spread of services; more triaging is going on, and that has successfully made a big contribution to getting through the lists. As of 13 January, 6.9 million dental patients have been triaged on the AAA service—advice, analgesics and antibiotics—but urgent dental care centres, of which there are 695, have picked up the difficult and time-consuming work for those who have an emergency need.

[Baroness Walmsley (LD) [V]]

My Lords, do the Government plan to continue to enforce activity targets in the next financial year? The new contract is only seven weeks away, and those in the profession has heard nothing about the basis on which they will be paid next year. When do the Government plan, at last, to deliver wider NHS dental contract reform, which they committed to in 2010? The issue keeps being kicked into the long grass.

[Lord Bethell (Con)]

My Lords, I would like to reassure the noble Baroness that officials are working extremely closely with the dental profession on the arrangements for the new practice. It will not be a complete renegotiation of the full contract, but we are looking at what arrangements should be in place for 2021-22. And as I said before, I pay tribute to the hard work of dentists. Activity targets are a useful way of getting a focus on increasing the throughput of dentistry. We have a big backlog, and that is one way we can try to increase the velocity of dental appointments.

Covid-19: Self-Isolation

Baroness Walmsley Excerpts

Wednesday 10th February 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I do not accept the accusation of slackness. Testing should happen before the flight, not at the airport. All those who seek to avoid the red list protocols will be interviewed by the police, and the kinds of fines ascribed to that offence have been made crystal clear in the Statement by my right honourable friend the Secretary of State for Health.

[Baroness Walmsley (LD) [V]]

Does the noble Lord the Minister dispute the figure quoted by my noble friend Lord Scriven about the number cutting short their isolation, or is he just planning to ignore it? Does he accept the figure from local authorities that two-thirds of applicants for the £500 do not receive it? Does he therefore agree with me that most of those who apply for it actually need it to help them do the right thing?

[Lord Bethell (Con)]

My Lords, I do question the figure supplied by the noble Lord on isolation adherence because, I am afraid, he does not know, nor is there any questionnaire that can prove exactly, who is isolating, when they are isolating, for how long and under what circumstances. However, I agree with the noble Baroness that the issue of economic support is very important. We have put a large number of protocols in place. The isolation payment of £500 is substantial. I acknowledge that there have been procedural issues with that payment, but a lot of them have been ironed out and take-up of the money has increased.

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.

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.

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.