Medicines and Medical Devices Bill

Baroness Jolly Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[Lord Balfe (Con)]

It is a great pleasure to follow the four noble Lords who tabled this amendment, all of whom are working from exactly the same brief as I am—I can tell that from the quotes. First, I should declare an interest: I have not been present in Committee before, but am here as a former president of the British Dietetic Association, a TUC-affiliated union. The Bill was published during the dying days of my presidency and I undertook to speak in support of the proposed new clause.

I have nothing substantial to add to what has been already been so ably said by colleagues. I will just point out that dieticians are one of the groups seeking to extend this, and people often misunderstand what dieticians are for. The number of times I have been asked whether I am associated with Weight Watchers has rather driven me insane, but dieticians are actually more involved with undernutrition than overnutrition. Although people think of obesity and what are now the more popular things, the biggest challenge facing the average dietician is a person probably over 80 years old, almost certainly living alone and generally not caring for themselves. So the role of a dietician is often to get people to eat a balanced diet. They work in hospitals and in the community, and with other health professionals, particularly in developing clinical management plans. That effort would be reduced if this proposed clause were accepted.

Points about dieticians and others have been extensively made. I understand that

“within three months of this Act being passed”

is a big ask, but also that, unless we ask for something, we will probably not get anything at all. The noble Lord, Lord Bradley, has already quoted the Minister at Second Reading saying that they were

“considering across all non-medical groups … where there is a need to consider undertaking formal consultation on potential amendments to prescribing responsibilities”.—[Official Report, 2/9/20; col. 432.]

I realise that, at the time of Covid, there is a huge number of demands on the Minister’s department and the staff therein but, overall, if this can be made to work, it will benefit and increase the productivity of health professionals. So, in associating myself with the previous speeches, I also encourage the Minister to give as positive a response as he is able to. I am sure that, if we extend prescribing rights, we will be benefiting many patients and the medical profession. We will also be enabling many health workers to play a more effective role in the care of their patients.

[Baroness Jolly (LD) [V]]

My Lords, I support Amendment 49 in the names of the noble Baroness, Lady Thornton, and the noble Lords, Lord Hunt of Kings Heath, Lord Ramsbotham and Lord Bradley. It mandates the Secretary of State to publish proposals and a timetable for additional healthcare professionals to be given appropriately restricted prescribing rights. As other noble Lords have said, for well over 20 years, some appropriately trained nurses have been prescribing from a restricted list. I see no reason why, as the noble Baroness, Lady Thornton, described, appropriately trained allied health professionals and others, working from a list of approved medicines commensurate with their profession, should not do the same.

This is entirely appropriate at the moment, when it is not always easy to access a GP. We have seen how successful giving prescribing rights to both community and practice nurses has proven to be. Patients are becoming more willing to have appointments with AHPs and nurses, rather than GPs, which frees doctors to concentrate on patients requiring more experience, such as those with unusual or complex conditions. This is a win-win amendment and I heartily commend it.

[Baroness Penn (Con)]

My Lords, I recognise that there is keen interest in how we may use powers in Clause 2(1)(n) of the Bill, relying on Clause 1(1), to continue to update the prescribing and supply responsibilities of healthcare professionals. However, I hope to persuade noble Lords that Amendment 49, in the name of the noble Baroness, Lady Thornton, is unnecessary.

I am very pleased to say to noble Lords that NHS England and NHS Improvement are already leading work to scope the current and potential future use of medicines supply, administration and prescribing mechanisms by a range of non-medical healthcare professionals. On 15 October, they started consulting on a range of proposals to extend medicines administration and supply responsibilities, and to update the medicines that some existing independent prescribers may prescribe.

The consultations cover the use of patient group directions by biomedical and clinical scientists and operating department practitioners, exemptions enabling dental therapists and hygienists to supply some medicines, and changes to the controlled drugs that can be prescribed by physiotherapists, podiatrists and paramedic independent prescribers. If progressed, these proposals would allow patients to get timely and safe access to medicines from the most appropriate healthcare professionals, without the need for extra appointments from other prescribers, such as a GP. The current consultation will run until 10 December and is of course a public consultation. It will be informed by the views of key patient and professional groups, with engagement starting shortly through a series of online events.

I reassure noble Lords that we are committed to updating the prescribing and supply responsibilities of professional groups, where it is safe and appropriate to do so. In keeping with the rest of the Bill, any such changes will be made in a way that serves the best interests of patients. The powers allow us to ensure that professional responsibilities can be updated to reflect developments in professional practice, new approaches to care, changing scientific understanding and growing technical abilities. This ensures that we can continue to make full use of the skills available to us among NHS professionals, and support patients to receive the best possible care and support from NHS staff.

I know that a number of NHS professional groups are keen to see their members taking on responsibility for supplying or prescribing medicines. We have recently seen papers put forward by the British Dietetic Association, the Royal College of Occupational Therapists, the British and Irish Orthoptic Society, the Society of Radiographers and the Royal College of Speech and Language Therapists. I am very grateful to the professional groups for the careful consideration that they have given to these issues.

I reassure noble Lords that NHSE/I already has extensive joint working and engagement under way with these and other professional groups to consider whether any other changes would help keep patients safe and well. This will build on the historic work with various professional bodies and the devolved Administrations, over the last few years, which resulted in a number of changes, including allowing paramedics and therapeutic radiographers to be independent prescribers. As well as this, a wider scoping project is being led by NHS England and NHS Improvement, with the devolved Administrations and professional bodies, on the current and potential future use of medicines supply, administration and prescribing mechanisms by a range of non-medical healthcare professionals.

I also reassure the noble Baroness, Lady Thornton, the noble Lord, Lord Hunt, and other noble Lords who raised this that NHS England and NHS Improvement’s work on prescribing and supply will of course account for lessons learned from the Covid-19 response. For instance, NHSE/I wishes to learn from professional bodies and, in its scoping work, is asking them how the use of medicines mechanisms contributed and how they can play a role in increasing capacity to respond to future challenges. On that basis, I hope that the noble Baroness, Lady Thornton, feels able to withdraw her amendment.

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[Baroness Wheeler (Lab)]

My Lords, I am pleased to move Amendment 62 in the name of my noble friend Lady Thornton. It amends Clause 9 of the Bill dealing with manufacture, marketing, supply and field trials. This is a probing amendment. It would give the Secretary of State the responsibility to make provisions, in respect of the cascade, risk-based decision-making process, allowing vets to prescribe unauthorised medicines when they are unable to get hold of suitable authorised medicines.

The cascade provision for the medical treatment of animals will be vitally important if there are problems with the supply of veterinary medicines in the event of no deal. The British Veterinary Association has underlined the importance of maintaining the cascade, and of the Veterinary Medicines Directorate reviewing the cascade to consider whether it would be possible to allow greater flexibility on the use of medicinal products licensed elsewhere in the EU and those of other partners within the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicine Products, known as VICH.

I am always struck by how much one learns during the course of working on legislation in the House of Lords, and how much is new that one was previously unaware of but should have been. The cascade system for prescribing unauthorised medicines is a good example for me. It is a vitally important procedure, underpinned by 2019 guidance from the Veterinary Medicines Directorate, whereby vets are permitted to use their clinical judgment where there is no suitable veterinary medicine authorised in the UK for the specific condition in the animal being treated. Cascade gives vets access to a wider range of medicines to treat animals within their care and to prevent unavoidable suffering that could happen were a vet unable to prescribe a suitable alternative.

The cascade goes through the various stages of decision-making in the treatment of animals in descending order of suitability, commencing with the desired outcome of using an available authorised UK veterinary medicine and going through other stages, including the use of clinically suitable alternatives of, for example, human medicines authorised in the UK or in another member state for use in animals. The final provision is for the use of a medicine prescribed by the vet responsible for treating the animal and prepared specially on the occasion of the treatment being required—known as “extemporaneous preparation”. This has to be prepared by a vet or a pharmacist or a person holding an appropriate manufacturer’s authorisation.

In exceptional circumstances, where no suitable veterinary medicine is available either as an authorised product or under the cascade, a vet may treat an animal with a medicine authorised in a country outside the EU via the Special Imports Scheme. Clearly, the guidelines and appropriate primary legislation will need to be amended in the light of our forthcoming exit from the EU—or if there is no deal. So can the Minister tell the Committee what preparations are being made in respect of this very important matter?

Prescribing decisions under the cascade are made on a case-by-case basis. The prescribing vet is personally responsible for the choice of product, is subject to the Royal College of Veterinary Surgeons’ code of professional conduct and must always obtain the owner’s consent for their animal to be treated under the cascade. Accurate record keeping is also required under the guidelines. Supplies of products used under the cascade and associated records can be examined during inspections of vets’ premises by the VMD and the RCVS. Under the last tier of the cascade, extemporaneous preparations —also known as veterinary specials—can legally be prescribed, supplied and used, recognising that they carry a higher risk than authorised medicines.

So this is an important scheme and the maintenance of the veterinary medicines cascade is a vital issue in the medical treatment of animals post Brexit, particularly in the event of no deal, as I said. I look forward to the Minister’s explanation of the action being taken to ensure that the cascade is maintained, continued and, if possible, simplified in line with the BVA’s recommendations. We need assurance that the Government will not use the powers in this Bill to diverge from the cascade after it is passed.

Finally, the BVA has underlined that, if it is to remain as one of the leading agencies in Europe and beyond, the Bill must be used to establish a national authorisation procedure for veterinary medicines, on the same scientific and evidence-based technical requirements as adopted by the EU, firmly rooted in the established standards set for quality, safety and effectiveness. The association has emphasised that, to have an influential voice in global veterinary regulatory affairs, it is vitally important for the UK to seek full membership of the international technical requirements registration body, the VICH, to which I referred earlier. I look forward to the Minister’s response on this vital issue.

[Baroness Jolly (LD) [V]]

The noble Baroness, Lady Wheeler, has given a really good description of the cascade and the way in which it works. It is a risk- based decision process whereby vets can dispense different medicines to animals beyond the term of authorisation. The BVA supports maintaining the cascade. Can the Minister confirm the arrangements if no suitable UK drugs are available? Can she also confirm that veterinary drugs will be part of trade deals with both the EU and the US?

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Moved by

[Baroness Jolly]

67A: After Clause 11, insert the following new Clause—
“Veterinary devices
(1) Within six months of the day on which this Act is passed the Secretary of State must set up a working group to conduct a review of the regulation of veterinary devices.(2) The review under subjection (1) must make reference to the impact of the current system of regulation on—(a) animal welfare;(b) human safety; and(c) the environment.(3) The working group must consult bodies or individuals who are subject to regulation concerning veterinary devices during the course of the review. (4) The review under subsection (1) must make a recommendation as to whether further regulation should be introduced in light of its findings.(5) The Secretary of State must lay a copy of the review before both Houses of Parliament.”

[Baroness Jolly (LD)]

My Lords, this Bill is about medicines and medical devices, and also includes veterinary medicines, which I understand the profession welcomes. I support government Amendment 131.

I confess, I wondered whether the veterinary part of the Bill was a bit of an afterthought, as although veterinary medicines are covered, I was somewhat bemused that there was no mention of veterinary devices. Modern vets make much use of veterinary and medical devices. Many pet owners expect their pets to be treated as well as they are by the NHS, and they are ready to pay. Many large animals, particularly stud animals, are of considerable value to their owners, who also expect modern treatment.

With a growing market for veterinary devices there are areas in which the absence of these devices often involves medical devices, but the profession anticipates that the veterinary device market will only increase and specialise. The Committee will appreciate that size is an issue. At present, many vets manage by using human medical devices, but I am sure the Committee will understand that vets treat animals of all sizes, from a hamster to a chihuahua, to a prize bull. I tabled these amendments in anticipation of a vibrant veterinary device market. To use devices designed for a human body weight is not always appropriate.

My amendment calls for the Secretary of State to set up a working group to conduct a review into the regulation of veterinary devices, referencing animal welfare, human safety and the environment, and make appropriate consultations before laying a copy of the review before both Houses. Amendment 67B is also in my name and calls for a review of the impact of the Bill on veterinary medicines.

We are in a transition, and by the end of 2021 or thereabouts there will be a clearer picture about veterinary medicines, a year after leaving the EU. The Secretary of State should consult relevant bodies, such as the BVA, the NFU and animal welfare groups such as the PDSA and the RSPCA, but I think noble Lords should agree that there is a case for veterinary devices in the Bill.

[Lord Patel (CB) [V]]

My Lords, I am pleased to speak to government Amendment 131, merely to ask a question. The amendment will require reporting, which is positive and is to be welcomed. However, it leaves the matter of who is to be consulted to the discretion of the Secretary of State, because proposed new subsection (2) refers to

“such persons as the Secretary of State considers appropriate”,

while proposed new subsection (3)(a) requires the Secretary of State to take account of

“concerns raised, or proposals for change”,

but only those made by a person in accordance with subsection (2). Those persons are left to the discretion of the Secretary of State. It is not only the people who are consulted who are chosen; the list is produced by the Secretary of State.

To have any substance to it, the proposed new clause ought not to leave it to the whims of the individual Secretary of State to decide who ought to be consulted. There should be some minimal statutory list, or principles that can guide a list in practice, to give transparency and confidence. My question is quite simple: is it likely that the Government will produce a list of who they will consult?

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[Lord Bethell (Con)]

I will get to back to the noble Lord with the specific answer to that question, if I may.

[Baroness Jolly (LD) [V]]

My Lords, I shall not detain the Committee for very long. I thank the Minister for his comments. I feel inclined at the moment not to withdraw my amendment, but I would like to read Hansard, consult and decide whether to return with these amendments, or something like them, on Report. I beg leave to withdraw the amendment.

Amendment 67A withdrawn.

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I commend the noble Lords for tabling Amendment 83 and the consequent amendments. I look forward to the Minister’s response to my comments and theirs. In particular, I ask the Minister: if regulation of this crucial area of medicine is not going to appear in the Bill—if this amendment or something like it is not going to be adopted—how will the Government ensure oversight?

[Baroness Jolly (LD) [V]]

My Lords, the amendments in this group relate to technologies. Amendment 83, from the noble Lord, Lord Freyberg, to which I have added my name, seeks to improve how the Bill addresses new technologies which have significant potential for harm, and it aligns with and improves on the EU and US equivalents. The critical issue is: what is a medical device? Amendment 113, also from the noble Lord, Lord Freyberg, and my noble friend Lord Clement-Jones, updates the definition of a medical device to bring it in line with the EU and US regulation, acknowledging the progress of technology beyond the Medical Devices Regulations 2002, which, in the world of programming, is very nearly the dark ages. I wonder if noble Lords remember ALGOL, FORTRAN and BASIC.

I support Amendment 83, to which I have added my name, and received a very helpful letter about Amendments 112 and 113 from the noble Lord, Lord Freyberg. I listened very carefully to both him and, of course, my noble friend. I am happy to support their arguments and their amendments.

[Baroness Thornton (Lab)]

My Lords, the noble Lords, Lord Freyberg and Lord Clement-Jones, have done the Committee a great service today. I was fascinated by the speech from the noble Lord, Lord Freyberg, which set the tone for this discussion. I welcome his main points and his knowledge. He knows that I am a supporter of his work in this area, particularly on the protection of patient data.

It is a constant source of concern that either through carelessness, lack of expertise, unscrupulousness or policy fragmentation, our NHS will not benefit from AI and the use of patient data. I see this amendment as part of that discussion and that effort to decide what happens. The noble Lord, Lord Freyberg, has asked some very pertinent questions about algorithms, how they change and how they develop. Our job, surely, during the course of this Bill, is to find legislation that is ahead of the technology for once, not behind it. I was particularly struck by what the noble Lord, Lord Freyberg, has to say about GOQii and the MHRA, and the definition for medical devices and algorithms. The use of AI and algorithms is not impartial. We know that, particularly given our recent experience with A-levels, which was mentioned by the noble Lord, Lord Clement-Jones.

The Minister has to find a way of ensuring that this Bill reflects the modern situation and does not stop innovation. I really hope that she is not going to say that those of us who are asking these questions are opposed to innovation, because that is absolutely not the case. These are very important questions indeed for the future, as we find ourselves between the FDA and the European Union, and we make our way in this particular world.

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[Baroness Redfern (Con) [V]]

My Lords, I am pleased to speak to this group of amendments, and to thank the noble Baroness, Lady Cumberlege, who has been so diligent in her review in proposing such needed changes, and making good for the recipient and building user confidence in the devices offered. It is a pleasure to follow the noble Baronesses, Lady Finlay and Lady Walmsley, and the noble Lord, Lord Ribeiro—as well, of course, as the noble Baroness, Lady Cumberlege.

I spoke on Second Reading in support of an extensive programme for medical devices, to provide for high standards of safety and to share vital information, with data central to effectiveness. The noble Baroness, Lady Cumberlege, in her review, regarded being able to track which treatments and implants people have had as being of particular importance. A barcoded wristband, with equipment used in treatment, including implantable medical devices, being scanned and tracked to a patient’s record, would save much precious time for product recalls, and reduce drug errors.

This means knowing who has had a device used in their treatment, so that they can be swiftly notified if there is a problem. Having unique device identification is therefore very important. The noble Lord, Lord Ribeiro, said—and I agree—that we must consider tracking all medical devices used in the UK, rather than a select few.

[Baroness Jolly (LD) [V]]

My Lords, we support the amendments in the names of the noble Baroness, Lady Finlay of Llandaff, and the noble Lord, Lord Ribeiro, and Amendment 103 in the name of the noble Baroness, Lady Cumberlege. Registers are a tool that helps clinicians to track devices and those who have the devices fitted or implanted, and to use the data for research and to aid patients to seek redress.

The noble Baroness, Lady Finlay, explained clearly how the amendment would work to help to change a medical device that no longer functions. By citing the recall mechanism for a faulty domestic product, she illustrated what is required of a device register.

The amendments in this group relate to the tracking of medical devices, and the information stored. Amendments 86, 88 and 102 would allow regulations to provide for the tracking of all devices, as they are used, via a unique device identifier, with the information recorded either in registries or through hospital episode statistics data.

Amendment 103 is an important amendment, tabled by the noble Baroness, Lady Cumberlege, that seeks to clarify which information held by the healthcare system requires the consent of the relevant patient. Data is powerful, and should be kept appropriately. The governance of data has been a key issue in the NHS for more than 20 years.

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[Baroness Jolly (LD) [V]]

My Lords, the amendment from the noble Baroness, Lady Finlay of Llandaff, would require the Secretary of State to introduce a scheme to promote the availability of innovative medical devices for human use within the NHS. The scheme would be known as the NHS innovative medical devices fund.

The Secretary of State is charged with providing the funding and I welcome that approach. She has explained that custom-made devices are both difficult and expensive to fund, especially for the subsequent development of innovative devices with repeated trials. It can also be frustrating. A medical devices fund could take an innovation from concept through its development to production and then be rolled out widely, with any gains being returned to the fund or to the NHS organisation hosting the work. Clearly, flesh needs to be put on to those bones, but as I explained in an earlier Committee session, there is a fund that is particular to orthopaedics which is managed by a charity. In effect, every year it calls for bids, often from start-ups. It supports a certain number of the bids and any profits come back to the charity, which can also choose to be a partner in the venture. Some of the bids come from academia and others from within the NHS, but it works.

[Baroness Thornton (Lab)]

This amendment is interesting and certainly worthy of consideration. The innovative medical devices fund would insert a new subsection into the National Health Service Act 2006. Section 261 provides powers for the Secretary of State in relation to voluntary schemes to control the cost of medicines. The section describes these as schemes that are joined voluntarily and limit the price that may be charged on the profits that may accrue from the manufacture and supply of health service medicines. The scheme also provides for manufacturers and suppliers to pay the Secretary of State an amount of money if the agreed limits are breached. Amendment 91A would create a voluntary scheme under Section 261 which would be specifically for medical devices to give them equal treatment as innovative medicines. The Minister will have to explain why that would not be a good idea.

In her speech at Second Reading, the noble Baroness, Lady Finlay, talked about making the UK a medical devices development and production hub. Too often the UK effort has been bought out by overseas manufacturers who then market the devices back to the NHS at great profit.

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[Lord Patel (CB) [V]]

My Lords, I will need to speak only very briefly because the noble Lord, Lord Field of Birkenhead, and the noble Baronesses, Lady Meacher and Lady Walmsley, have covered the ground extensively, fully and informatively. It is a privilege to be involved in an amendment moved by my noble friend Lord Field of Birkenhead. We have been friends, discussing such issues for very many years, although he was in a different House, so it is a pleasure to see him and support his amendment.

My noble friend Lord Field spoke from personal experience, and my noble friend Lady Meacher spoke extensively about the information available. In 1998, the Science and Technology Committee of the House of Lords recommended that there should be a programme to assess the medicinal use of cannabis and that ways should be found to use it. NICE has recommended one or two areas where it can be used, as has already been said. Very few NHS prescriptions have been given out, but more than 1 million people use cannabis preparations bought privately at huge cost. They use them because they find benefit from them. The report suggests that the people who benefit from it mostly suffer from chronic pain. Despite that, reports have been published where people with Alzheimer’s, cancer, chronic pain, Crohn’s disease and multiple sclerosis, to name but a few, found benefits from it. More than 20,000 publications on PubMed, not of clinical trials, but of people’s experience and data collected from patients, show that they have found it to be beneficial.

When recommending and assessing medicinal products using cannabis, NICE suggested that research should be carried out in six or seven areas. I do not know what research has been carried out. The problem with such a recommendation is that it does not recommend who should do the research. So I ask the question: who should be doing this research to explore the benefits that patients find in medicinal cannabis?

Private clinics prescribe more and more cannabis on a daily basis, and more and more clinics are opening in cities in England where cannabis is available. My noble friend Lady Meacher and the noble Baroness, Lady Walmsley, alluded to two important issues. One is that a way needs to be found to collect information on patients’ experiences and data to show why so many patients go to private clinics to get cannabis products and what benefits they derive from them.

I look forward to the Minister’s response, but I hope she may agree, as it would not require legislation or an amendment to the Bill, that the NIHR or the Department of Health and Social Care through the NIHR should establish a forum of specialists, including patients, to find a way forward to collect information on a more formal basis. I hope the Minister will respond positively to that. It has been a pleasure to take part in this debate.

[Baroness Jolly (LD) [V]]

My Lords, the amendment signed by my noble friend Lady Walmsley and others would require the Secretary of State to make regulations concerning medicinal cannabis and associated devices. The noble Lord, Lord Field of Birkenhead, made his case clearly and strongly. I have a family member who used cannabis as a painkiller towards the end of their life when pharmaceuticals failed. Given the huge relief it can bring to patients with conditions such as epilepsy, it is vital that barriers to access are removed. We have heard that since the law was changed in November 2018, only a very small number of prescriptions have been written for medical cannabis.

The noble Baroness, Lady Meacher, my noble friend Lady Walmsley and the noble Lord, Lord Patel, have for many years supported the use of medical cannabis for a small number of conditions. Very few patients have received their medicine on the NHS because NICE has yet to approve the use of cannabis in any context. Evidence is available, so why are the Government fighting shy of using cannabis or its derivatives, thus forcing individuals to become criminals by having to go abroad to countries where cannabis is legally available, but at a huge cost, and then smuggle it home? It does not make sense. We support the amendment.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

We do not seem to be able to contact the noble Lord, Lord Norton of Louth, so I call the noble Baroness, Lady Thornton.