Medicines and Medical Devices Bill

Debate between Baroness Walmsley and Baroness Meacher

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

[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.

Children and Social Work Bill [HL]

Debate between Baroness Walmsley and Baroness Meacher

Monday 11th July 2016 Grand Committee

[Baroness Walmsley (LD)]

My Lords, my Amendment 106A is in this group. It was Amendment 108 but for some reason has been retabled. The arrangements for the national review panel appear to omit its opportunity to review cases of serious mistreatment and/or physical injury caused by restraint in youth custody institutions or other kinds of institutions. This amendment makes it clear that these cases should be looked at by the panel because they raise serious issues of national policy and practice. I do not think that it should be restricted to just deaths in custody, as suggested by my noble friend Lord Ramsbotham, although I fully support what he said about that.

The noble Lord, Lord Ramsbotham, referred to the BBC “Panorama” programme about the Medway Secure Training Centre. Reports obtained through Freedom of Information Act requests reveal that children in custody suffered serious physical injuries following restraint on three separate occasions in 2013-14 and on four separate occasions in 2014-15. As the noble Lord, Lord Ramsbotham, mentioned, Ministers will often refer to the National Offender Management Service. But that is not a safeguarding panel. One of 10 recommendations made by Her Majesty’s Inspectorate of Prisons, following its review of the new system of restraint in child custody, urged more effective independent oversight of restraint by local safeguarding children boards and local authorities.

The Government have tabled an amendment to abolish LSCBs, which makes it even more important that this new arrangement of a national panel includes harms to children in custody and other institutions, not just deaths. This matter is of a very serious nature and is not really suitable for review at local level. The children in these institutions are often not located in their home authority, so it is essential that the new national panel looks at these cases—unless, of course, these clauses do not eventually stand part of the Bill, which will be debated later.

[Baroness Meacher (CB)]

My Lords, I must first apologise that I was unable to be present when my opposition to Clause 11 was debated. Unfortunately, I have a serious family health problem which has prevented me from being present or even doing any work on this Bill until today, I have to confess. I will speak briefly to oppose the proposition that Clauses 12 and 13 should stand part of the Bill. I assure the Minister that the aim here is not to have the clauses struck out but to provide an opportunity to explore the implications of the two clauses as they are worded and to enable noble Lords to raise any general concerns ahead of Report.

I recognise the need to establish a stronger statutory framework that will introduce greater accountability for the three key agencies involved in safeguarding children—local authorities, the local police and the local health service, as proposed by Alan Wood—though I understand that there are concerns that other services should also be incorporated. However, the single purpose of a new framework, as made clear in new Section 16B(2), is absolutely rightly specified as,

“to ascertain what (if any) lessons can be learned from the case about the way in which local authorities or others should work to safeguard children”.

I hope we can explore how, in drawing out and disseminating the lessons from tragic events, we as a society can avoid increasing the blame culture, which has affected social workers and other public servants so severely in recent years. If we do increase the blame culture, the risk is that good social workers and other public servants will walk away from their jobs, as many public servants have done in recent years; others will simply not take up these professions; and the net result will be that the risks to children will increase rather than diminish. I know that that is absolutely not what the Government want to achieve—but there is a very serious point here, which I hope the Government will take on board.

If a social worker working with a family where a child unfortunately dies or is severely injured does fall short in some way, it is surely a matter for that social worker’s managers. It should not be a matter for national politicians and a national panel—whose role, as the Bill makes clear, must be solely to ensure that lessons are learned and disseminated. At a national level, the worst of all this is what happens when the media get involved—and they will get involved: they just do. That can wreck the lives of front-line workers to the point from which, to some degree, they never recover. I really do believe that it is that bad.

The review will of course need to establish whether any failings were a reflection of procedural issues, system failures or a lack of adequate resources. All of that is right and proper, but somehow we need to protect the individuals, not from proper disciplinary action or whatever is appropriate but from this national glare and utter devastation of their lives. If they have made an error, they probably did not intend to. So we have to get this right. It is terribly important that we do and I do not believe that the wording in the Bill achieves that at the moment.

Subsection (4) of new Section 16B inserted into the Children Act 2004 by Clause 12 requires the panel to publish the report on supervised child safeguarding in practice reviews. Alternatively, subsection (5) states:

“If the Panel consider it inappropriate to publish the report, they must publish any information relating to the lessons to be learned from the case”.

Is it really ever necessary or appropriate to publish a whole report on a specific case, which would inevitably involve publishing material about an individual front-line worker? The only national interest is in the lessons to be learned—the material that would be published under subsection (5). So I would welcome the Minister’s view as to whether subsection (4) could be deleted from the Bill. This would focus the minds of members of the panel on their sole role. It would also go some way to reassuring front-line staff that the Government are not aiming to focus national media and political attention on blaming an individual front-line worker. That is the key point that I hope we can think about in relation to these clauses.

My other point is a concern of the Local Government Association that the national panel, as outlined in the Bill, is too closely controlled by the Secretary of State. Again, this risks politicising the serious case review process, and the concern is again for the protection of front-line staff. But it is also very important to ensure that all the lessons are learned from these reviews, so it is absolutely vital that these reviews are seriously and really independent of government control. A review may need to comment on the impact of national policies on safeguarding failures and make recommendations for policy reform as well as procedural changes that are needed.

The Government have tabled Amendment 114, which risks placing too great an emphasis on the actions of individual practitioners in determining the cause of failures. We need to maintain the systems approach that we have had when undertaking these reviews. A focus on an individual’s failure in a particular area will have no relevance to the authorities in other parts of the country. Will the Minister look at the wording of Amendment 114 with this concern in mind?

The NSPCC has questioned whether it is right to limit the role of the national review panel to those cases that involve a death or serious injury, as raised by the noble Baroness, Lady Walmsley. With the focus clearly on lessons to be learned, it may be important to include cases involving near misses or areas where a lot of children have suffered some harm. It may help to clarify that in the Bill.

Finally, it seems important to clarify further the dissemination activities that will be required of the panel. Somehow this business of learning the lessons seems to be somewhat skated over. The Bill needs to make absolutely clear how this country will learn from these serious cases. That is what the panel needs to do.

Serious Crime Bill [HL]

Debate between Baroness Walmsley and Baroness Meacher

Tuesday 15th July 2014 Lords Chamber

[Baroness Walmsley]

My Lords, it would not be in order for me to say anything about the amendment moved by the noble Baroness, Lady Meacher, as I was not in my place when it was moved. I support the noble Lord, Lord Rosser, in his attempt to get anonymity for the victims of FGM, and I hope the Government will consider it. Indeed, I think there may be a case for going a little further than that, because it could be that there are women within communities who know what is happening who might be more encouraged to come forward and say so if it were guaranteed that they would have anonymity. It is something that needs looking at.

[Baroness Meacher]

The noble Lord, Lord Rosser, introduced his amendment extremely effectively and has said all that needs to be said, but I would hate the Minister to think that there was no support for it. Therefore, I simply say that we need these charges to be investigated and pursued, and if victims are not given anonymity, it seems an impossible task. I hope that the Minister will be able to support the amendment proposed by the noble Lord, Lord Rosser, as well as my amendment.