Medicines and Medical Devices Bill

Debate between Baroness Jolly and Lord Patel

Consideration of Commons amendments & Ping Pong (Hansard) & Ping Pong (Hansard): House of Lords
Tuesday 2nd February 2021 Lords Chamber

[Lord Patel (CB) [V]]

My Lords, I am extremely grateful for the amendments that the Government have brought from the Commons. I am grateful to the Minister and his team for working so diligently with the rest of us, and to all noble Lords who supported my amendments. It is not unusual—but it is infrequent—for the votes that the Government did not get through in the Lords to be reconsidered in the Commons and brought back as government amendments. I am very content that the amendments that the Government have brought are very satisfactory and I congratulate them. I thank the noble Lord, Lord Bethell, the noble Baroness, Lady Penn, the noble Earl, Lord Howe, and the legal team for working with us throughout the Bill. That is all I am going to say.

[Baroness Jolly (LD) [V]]

My Lords, I too shall be brief and I too am grateful to the Minister and his team for giving Peers an opportunity to see the Commons amendments to the Bill before they were tabled, so that we might give some feedback. One of the things that has made this Bill a pleasure to work on is the open way in which political parties and Cross-Benchers have worked together, as well as the way that the Minister and his team have worked with us. We particularly welcome the clauses that have come to us from the Commons; they make the Bill a more explicit and effective piece of legislation than when it was debated either in Committee or on Report in this House.

Medicines and Medical Devices Bill

Debate between Baroness Jolly and Lord Patel

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

[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?

--- Later in debate ---

[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.

Medicines and Medical Devices Bill

Debate between Baroness Jolly and Lord Patel

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

[Lord Patel (CB) [V]]

My Lords, I will speak to Amendment 97 in the name of my noble friend Lord Kakkar, to which I have added my name. Before I do so, I have a comment in response to an important question asked by the noble Baroness, Lady Cumberlege, which my noble friend Lord Kakkar answered. How do you test the effectiveness of a device which is an implant, and is likely to remain in the body permanently? This is opposed to implants such as pacemakers—as I alluded to on Monday—where, in one example, a device was unsatisfactory after having gone through testing, but was then implanted in 1,400 patients before its faults were clearly recognised. In that case, it was possible to remove the device, and put in one which functioned better. The testing of an implant which is likely to be permanent must be more rigorous, in terms of its tissue reactivity, in the training it will require, and in the possible harm it can do. This is particularly true for things like mesh that are likely to be embedded into the tissue. People claimed that that mesh was safe because it had been used by surgeons for years for hernia repairs. As I said on Monday, I have never used mesh for any of the surgery I did, so I do not know its performance. The question of the noble Baroness is quite right: it does not mean that we do not have to progress with finding new medical devices which would be effective; it means that we need to ask significant questions, depending on the device we are talking about. I may not have answered her question, but I have tried to identify ways we might do that.

My noble friend Lord Kakkar has made a very important point about the need for medical devices to be tested for their effectiveness in the functions they are supposed to provide prior to their being granted full market approval. Generally, the design of a medical device is regulated by its essential principles of safety and performance with respect to its design and construction. Less attention is paid to its clinical effectiveness throughout its expected life, whatever that might be. Medical devices play an important role in enhancing patient quality of life, but there is a need for improved methodology to obtain evidence for their safety, performance and efficacy. The UK, with its strong research base, and with the NHS at its core, is well placed to generate the high-quality evidence needed. Guidance is needed to generate, implement and produce the evidence required to foster innovation. Adopting engineering principles of continuous monitoring, reporting of accidents or near misses—similar to post-market surveillance of medical devices—is important. In developing medical devices, dialogue between clinicians, manufacturers, and end users—the patients—to identify which devices need to be developed is valuable, but not often followed.

While not as robust as a randomised control trial, observational studies are important in identifying rare, catastrophic and delayed harm. Furthermore, medical devices are less amenable to controlled trials, being part of a complex system of care, involving people in other systems. The UK has an opportunity to develop specialised medical device trial centres and clinical networks to oversee early to late-phase trials. That initiative would benefit patients and put the UK in a lead position to develop safe and effective medical devices.

The Royal Academy of Engineering and the Academy of Medical Sciences, of which I am a fellow, have much to offer in such an initiative. With his amendment, which rightly promotes the requirement that medical devices should demonstrate their clinical effectiveness prior to a full market authorisation licence, my noble friend Lord Kakkar has also provided an opportunity for the UK to develop leading-edge medical device regulation, and be a place for developing safe and effective medical devices.

[Baroness Jolly (LD) [V]]

My Lords, the noble Baroness, Lady Cumberlege, made some telling remarks and asked some searching questions. We support the amendments in this group relating to the granting of licences and the processes of clinical trials. They aim to improve patient safety, as the granting of provisional licences will allow more information to be available on devices and medicines.

Amendment 84 is intended to probe the various thresholds for medical device trials. At present, new devices deemed to be “substantially equivalent” to something already on the market are certified as safe via a notified body and can go on to be used quite straightforwardly. In contrast to standards for introducing new pharmaceutical products, data from robust clinical trials are not required. Delays in the introduction of innovative treatments and medical devices should be avoidable. We should, and could, become a key player in the world market.

Safety is always paramount and the amendment in the name of the noble Baroness, Lady Finlay, to develop rapid, two-year, provisional MHRA licences is a good innovation. Start-ups would welcome these moves.

The noble Lord, Lord O’Shaughnessy, spoke about hip replacements. He made some helpful remarks about registries. I was a trustee of an organisation called Orthopaedic Research UK, which was left a considerable amount of money by a wealthy orthopaedic surgeon with a view to fostering innovation in orthopaedics. Research scientists, doctors and start-ups are able to bid for funding on projects to aid orthopaedic research, with a view to taking a development to market. The amendments in this group will help researchers working on these projects, as will the granting of two-year licences on these devices.

Devices certified through this process are not tested to establish whether they deliver significant patient benefit. Rather, the system only establishes that a device is not unsafe and that it fulfils its intended function. Meanwhile, even when clinical trials are required, because a device is deemed sufficiently different from what is on the market to merit that, the rules around how that research is constructed are looser than for medicines. These are practical, useful measures.

Healthcare (International Arrangements) Bill

Debate between Baroness Jolly and Lord Patel

Committee: 1st sitting (Hansard - continued): House of Lords
Tuesday 19th February 2019 Lords Chamber

[Lord Patel]

My Lords, I shall speak to Amendment 22, in my name and that of the noble Lord, Lord Kakkar, and Amendment 25, which is in my name. Both relate to personal data, and seek assurance from the Government that, whatever processes are put in place, they will respect the need for confidentiality and trust. While I absolutely recognise the value of transferring individual health data when the patient is receiving treatment, and the need to do so, it is also important that the Bill provides powers to protect personal and health data.

Access to personal health data should be limited to healthcare purposes. Currently, the General Data Protection Regulation imposes restrictions on the transfer of data, which we may not have after we leave the EU. A separate issue is the definition of “authorised persons”, which, when they gave evidence, both the BMA and the Academy of Medical Royal Colleges referred to as a concern.

I am also unhappy about the mechanisms that will operate for patients to consent to having their data transferred. Amendment 25 refers to Clause 4(6), relating to data processing. It says:

“In this section—‘authorised person’ means”.


Paragraphs (a) to (e) then define who the authorised people might be. Amendment 25, which I tabled only to get an explanation from the Minister, suggests that paragraph (e) should be deleted. It says that,

“any other person authorised, or falling within a description of persons authorised, by regulations made by the Secretary of State for the purposes of this section”.

That sounds too wide to me. In this country we have clear protocols and guidelines about who should be transferring patients’ data and to whom. It is not to anybody not clearly defined as an authorised person. I beg to move.

[Baroness Jolly]

My Lords, the NHS in England has a long history and a good record of data governance. In 1996, Fiona Caldicott was called in and asked to look at the whole issue of NHS data. It must be said that the data was not as digital then as it is now. Her review came up with a group of principles—I think there were seven—and that was then followed by Caldicott 2. More recently, there has been another look at NHS data and we are now down to three principles. It is not just the Caldicott guardians. When he was Secretary of State at DCMS, Matt Hancock announced the data ethics framework and then we had GDPR. There is a really rich background of caring for patients’ data.

The provisions in the Bill authorising the sharing of data appear wide—that is probably the best way to put it. Clause 4(1) provides:

“An authorised person may process personal data held by the person in connection with any of the person’s functions where that person considers it necessary for the purposes of implementing”,


the Act. The words,

“that person considers it necessary”,

are a very wide formulation for the exercise of a function such as this. They seem designed to make a challenge in court almost impossible.

Among others defined as an authorised person is a “provider of healthcare”, so the authority extends beyond the NHS to all organisations that provide NHS care but might not be NHS organisations. So it would include commercial organisations as well as public authorities. Can the Minister confirm this and give an example, to better understand how wide the scope is?

Moreover, it is left to bodies such as the NHS to define for themselves the level of staff who should have this degree of authority. Will the Minister confirm how data is handled with devolved states and within the island of Ireland? How are we intending to communicate clinical data with organisations in the EU, and in the rest of the world, once the Bill has been enacted? Are there issues about shared datasets? We are fairly confident about sharing research data, but clinical data will be absolutely key here.

Epilepsy: New Treatments

Debate between Baroness Jolly and Lord Patel

Monday 2nd February 2015 Lords Chamber

[Baroness Jolly]

As the noble Lord would expect, I am very uncomfortable about any large corporations, or indeed very wealthy individuals, avoiding paying their tax.

[Lord Patel (CB)]

My Lords, going back to the original Question on new treatments for epilepsy, does the Minister agree that the problem is that there is no single drug that is effective for the full spectrum of epilepsy? Therefore, many treatments are promoted, including cannabidiols, which have not been fully evaluated. Until a drug is accepted by the regulatory authorities in the EU and the USA, and has been evaluated by NICE, it should not be available to patients.

[Baroness Jolly]

The noble Lord is absolutely right.

General Practitioners: Hippocratic Oath

Debate between Baroness Jolly and Lord Patel

Thursday 11th December 2014 Lords Chamber

[Baroness Jolly]

I really do not have the experience on which to draw. It sounds like a good idea, but how practical it is I do not know.

[Lord Patel (CB)]

My Lords, does the noble Baroness agree that part of the problem with GP contracts is that GPs are independent practitioners who can negotiate their contracts, whereas hospital doctors, when they apply for a job, have to comply with the job description for that job?

[Baroness Jolly]

That is probably an issue for the BMA, the GMC and others to sort out.

NHS: Hospital Medication

Debate between Baroness Jolly and Lord Patel

Wednesday 9th April 2014 Lords Chamber

[Lord Patel (CB)]

When I was chairman of the National Patient Safety Agency, it produced the guidance that the noble Baroness mentioned. It identified the failure of reconciliation of medicines in acute admissions as a major patient safety issue. The failure rate in hospitals ranged from 10% reconciliation to 80% reconciliation. Those hospitals that achieved 80% reconciliation did so for one reason: pharmacists were involved. These are acute patients on multiple drugs. There is no other way except that those who know drugs and reconciliation are involved in the reconciliation of medicines on admission.

[Baroness Jolly]

The noble Lord is absolutely right. Pharmacists need to show leadership and expertise and to support all their colleagues to ensure that this happens appropriately.

Care Bill [HL]

Debate between Baroness Jolly and Lord Patel

Monday 10th June 2013 Lords Chamber

[Lord Patel]

My Lords, I support these amendments. My name is attached to Amendments 17, 20 and 32 in the name of the noble Lord, Lord Turnberg, and to Amendments 37 and 39 in the name of the noble Lord, Lord Willis of Knaresborough, who, as we have heard, was taken to hospital yesterday. I spoke to him in his hospital bed just before we started and he was beginning to feel better. I am sure we will want to wish him well.

I strongly support the amendment because, through the Health and Social Care Act, we gave prominence to the need to promote research and innovation in the health service, and it is right that we did that. It would be a pity now if the only gap in that duty would be for it not to apply to the key body, Health Education England, and the local education and training board committees. As the noble Lord, Lord Turnberg, so eloquently put it, the amendments are about education and training by research, and about making sure that LETBs also have a responsibility to make sure that they conform to the functions of the HEE. They are all related to research, training, innovation, continuing training and research and supporting research. They cannot be wrong and I hope the Minister will accept them. They are well meaning and promote research further.

[Baroness Jolly]

My Lords, I thank the noble Lords, Lord Turnberg and Lord Patel, for helping me with these amendments. The noble Lord, Lord Willis of Knaresborough, is unwell and may not be returning to us in time to help with the Bill. His twin passions are training and research, and Amendments 37 and 39 to Clause 90, which are all about the functions of LETBs, completely underpin that. I would be doing him a disservice if I did not ask the Minister to explore these areas when he sums up.

It is critical not only at a national level, with HEE, but at a local level, with the LETBs, that this area is not forgotten. Staff must understand not only the implications but all aspects of research. That must be plugged in at HEE and, with these amendments to Clause 90, at the LETB level.

Care Bill [HL]

Debate between Baroness Jolly and Lord Patel

Monday 10th June 2013 Lords Chamber

[Lord Patel]

My Lords, I have added my name to both these amendments in the names of the noble Baroness, Lady Emerton, and the noble Lord, Lord Willis of Knaresborough, and I strongly support the principles behind both. The key issue here is that a training curriculum should be developed by the Nursing and Midwifery Council, as the amendment says. In a way—to pre-empt the Minister regarding what the Cavendish review might recommend—whatever the review recommends will have to be taken on board by whoever develops the curriculum. Although the Cavendish review is not defunct, the principles of this amendment are not based on what it might say. Presumably the review will focus on the necessity for training and the kind of training that support and healthcare workers should have. These amendments put a duty on Health Education England to make sure that a curriculum is developed.

The other important point is that the training should be mandatory—not the training curriculum but the training—and the employers must ensure that they employ only those who, having been trained, hold a certificate showing that they have completed it. It is just the same as I would have to do when seeking employment at a hospital. I would have to produce a degree certificate from a university proving that I have been trained as a doctor before they will employ me. It would be an offence to do otherwise. The amendment does not provide for a penalty but that issue will have to be addressed. Although “register” might be the wrong word, the implication is that the employer should be obliged to keep a list of all the healthcare support workers in its employment who have completed the mandatory training and hold a certificate.

The completion of training and the holding of a certificate are the key issues. As nobody can be employed unless they have done that, the care for patients will be safer. The process will define the competencies of these people. It will define what further development they have to go through professionally to be able to do other tasks. It will also make the life of the supervisor easier as they will know what competencies these people have and they will not delegate to them tasks which are beyond their competencies. In that respect, these amendments fulfil all the requirements that the Francis report and several other reports have alluded to—the need to make sure that we have a fully trained and competent workforce which delivers front-line healthcare. I hope that the noble Earl takes the amendments in that spirit.

[Baroness Jolly]

My Lords, I want to add quickly to what has been said by the noble Lord, Lord Patel, and the noble Baroness, Lady Emerton. I very much support what they said. What I can add over and above that is that the amendment in the name of my noble friend Lord Willis, Amendment 23A, refers to,

“working directly with patients or clients”,

so it works not only in a health context but in a care context.

I will declare my mother—as the noble Lord, Lord Campbell-Savours, did his—as an interest. She is a lady who I visit regularly and is well over 90. Somebody comes to see her in her home every day—for the most part they are very nice young women—but I have no idea where they come from or what training they have. Amendment 23A would give me confidence that they have been trained and are certificated. Furthermore, these people tend to be quite a mobile population. If their certificates were to follow them from one establishment to the next, it would give the next establishment confidence that their training had been delivered to the right standard and that, all other things being equal, it is appropriate to employ them. That adds weight to Amendment 23A.

Health and Social Care Bill

Debate between Baroness Jolly and Lord Patel

Tuesday 22nd November 2011 Lords Chamber

[Lord Patel]

In response to the amount of funding, as I understand it—I am sure the noble Baroness, Lady Northover, will correct me if I am wrong—the Bill suggests that the funding for HealthWatch England will be a grant in aid provided by the department to the CQC.

[Baroness Jolly]

My Lords, they say that too many cooks spoil the broth, but I think this is an occasion where that probably has not happened. Many hands might make light work. I ask the Minister to take these amendments away because there is an awful lot of good to be found in each of them, but not in each together, as it were.

Amendment 318C, tabled by the noble Lord, Lord Whitty, inserts a new clause and subsection (2)(a) of the new clause is about complaints. It is a nice idea that complaints could be taken to HealthWatch England. Complaints are a big issue to which we will be returning on Amendment 108.

The noble Baroness, Lady Cumberlege, raised the relationship between local and national healthwatches. It is critical. We would support the election of local healthwatch representatives to the national body.

Finally, on independence and finance, I believe very strongly that it is very difficult to criticise and challenge an organisation if you sit within it. I understand the point about the benefits, but if you are local, and you sit within your local health authority or nationally you sit within the CQC, generally the feeling that you are monitoring the organisation that is your host is never a good place to start. Similarly, I, too, have had letters from people who were CHIPs and then LINks about budgets being not just cut a little bit but absolutely hacked away. I would be really uncomfortable if, for example, locally the healthwatch was going to be located within the principal local authority that held the budget. We have had it already today. Intentions will be good and then somebody will come along and say, “We really need a bit more just for this”. It will happen in a meeting where they are not present and, all of a sudden, there will be another slice taken. We have seen it before with lots of other things. You could look at it from a negative point of view and say these are like curate’s eggs and bad in parts or good in parts, but I think too many cooks will not spoil this broth. Many hands will make light work. I ask my noble friend to take this away and have a look at it.

NHS: Reorganisation

Debate between Baroness Jolly and Lord Patel

Thursday 24th March 2011 Lords Chamber

[Lord Patel]

My Lords, can the Minister say—

[Baroness Jolly]

My Lords—