(5 years, 5 months ago)
Grand CommitteeThat the Grand Committee do consider the General Food Hygiene (Amendment) (EU Exit) Regulations 2019.
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Grand CommitteeThat the Grand Committee do consider the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019.
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Grand CommitteeThat the Grand Committee do consider the Contaminants in Food (Amendment) (EU Exit) Regulations 2019.
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Lords ChamberTo ask Her Majesty's Government what steps they are taking to ensure that patients in need of medicinal cannabis are able to access such treatment on prescription.
My Lords, government officials have been working with colleagues across healthcare and the wider system to ensure that patients can access medicinal cannabis where appropriate. Clinical guidance has been issued by the Royal College of Physicians, the British Paediatric Neurology Association and the Association of British Neurologists. Specialist doctors will consider this before prescribing, but we are clear that the decision to prescribe should be for individual clinicians to make in partnership with patients and their families.
I thank the Minister for her reply. She will be aware that only about four people have received a prescription for medical cannabis since it became legal on 1 November last year. Doctors have had no training in prescribing cannabis. They need to know the contents, dosages, side-effects and everything else about medical cannabis products. The pressure on doctors with desperate patients whose standard medications are not working or are causing unacceptable side-effects is intense. Doctors urgently need government help. Will the Minister ensure that the medical director of the NHS makes specialist doctors aware of the new guidelines to be launched later this month by the Medical Cannabis Clinicians’ Society, and of the 12-module online training course already available from the Academy of Medical Cannabis?
I thank the noble Baroness for her question. This is a challenging area, and the evidence base is still developing. However, the Government are working hard to ensure that awareness is increasing, which is why we have asked NICE to develop guidance to be released later this year and have asked HEE to develop a training package to increase knowledge and awareness among health professionals. It is also why officials are working closely with suppliers and importers to ensure that prescriptions are filled when they are given. We understand that there is work to do on this issue and will continue to do so.
Will the Minister comment on the issues illustrated in the predicament of a person who has been prescribed the cannabinoid dronabinol, branded as Bedrocan, which is the only medication that has proved effective for her following the failure of 35 different medications previously prescribed to relieve her chronic pain from cervical and lumbar spondylosis? Given that the Chief Medical Officer stated last summer that there is conclusive evidence that cannabis-based products are effective for certain medical conditions, why is this patient still forced to travel to Holland every three months to obtain the medication that her consultant considers essential for her, and why does confusion still reign over licensing procedures? Will the Minister meet me and the person I have mentioned to see if she can introduce some more sense into these arrangements?
I thank the noble Lord for his question. I am very sorry to hear about the situation he raises and will be very happy to meet him. As far as I can see, there should be no reason for the situation he has outlined. It is up to clinicians to prescribe as they see fit under the guidelines that have been issued.
My Lords, when the Chief Medical Officer recommended that cannabis medicines be rescheduled, she produced a report showing that the most rigorous regulatory authorities in the world—those in the US, Australia and Ireland, as well as the World Health Organization—had strong evidence of the benefits of cannabis-based medicines for people with epilepsy. In light of that, it is completely unacceptable that only four licences have been granted. Why are UK patients being deprived of these safe and effective medicines which have fewer side-effects than some licensed pharmaceuticals, such as sodium valproate?
I do not accept the characterisation that the noble Baroness has just given. UK patients are not being denied access to these medications; they are able to access medication via prescription from a doctor who is on the specialist medical register. The Government have acted fast on the review of the best clinical evidence and we are going further with forthcoming NICE guidelines and a Health Education England training package to raise even more awareness.
What troubles me about the Minister’s answer is that NHS England’s guidance says that medical cannabis can be provided only where all,
“other treatment options have been exhausted”,
and where there is, “published evidence of benefit”. We have heard lots of evidence of the benefit this afternoon but we are right to be worried about the research that is allowing that to happen. Why is it not happening quickly enough? Can the Minister describe what level of opiate addiction and which severe side-effects of other medication can be tolerated before medical cannabis is prescribed?
The evidence base for the quality and effectiveness of these products is limited; it is developing. This is why the Government have asked the MHRA to call for a proposal to enhance our knowledge of these medications. However, we have not waited for this; we have introduced a route via unlicensed medications which allows for doctors who are on the specialist register to prescribe for patients. This is the right route; these are the doctors who will understand the conditions mostly likely to benefit from prescription and who are able to make a judgment about the safety and efficacy of medicinal cannabis. It is the route usually used for unlicensed medications and already set up by the MHRA. We want to see more licensed products in this route, however; we call upon industry to invest in more trials and publish the results and full underpinning data to build our knowledge so that more patients are able to benefit.
The majority of those guilty of violent terrorist crimes in this country are found to be heavy users of cannabis. When one looks at violent crime outside of terrorism, it seems again—although I do not know the details—that very often the people involved are heavy users of skunk—not the kind of cannabis that we are talking about but the liquid stuff. Are the Government looking at the relationship between the use of these really strong types of cannabis and violent crime, to see whether anything should be done about it?
The medicines we are speaking about are not skunk. The noble Lord is right that all medicines carry risk, but they can also be beneficial. That is why we have introduced a route to allow medicinal cannabis to be used for those conditions where it will be beneficial. The change in the law allows strict access by specialist doctors who, in making the decisions to prescribe, can ensure that the benefit outweighs the harm to the patient and that the restrictions are line with advice from the ACMD. Any further concerns around the kinds of drugs that the noble Lord is talking about are still strictly controlled by the Home Office and by policing.
(5 years, 5 months ago)
Lords ChamberMy Lords, I congratulate my noble friend Lord O’Shaughnessy on securing this debate and on what I know was a very personal commitment to this subject when he was Minister. I also congratulate the noble Lord, Lord Carrington, on a truly excellent maiden speech. We all recognise the significant contribution to the United Kingdom’s public life by his father, the late Lord Carrington, but I do not think the current noble Lord, Lord Carrington, will have any trouble following in his footsteps.
Indeed, I thank all noble Lords who contributed today. It has been a thoughtful and sobering debate on a really important subject. We should be proud of the world-leading role that UK researchers, clinicians, industry and regulators play in medical discovery and innovative treatment. We are the first country to introduce whole-genome sequencing to routine clinical care, the first in the world to approve Kymriah and the first in Europe to approve CAR T-cell therapy. As the noble Baroness, Lady Masham, rightly said, that is so important for patients with rare or hard-to-treat conditions, because it raises the hope of earlier diagnosis and more targeted treatments. That is at the heart of many of the measures in the long-term plan and the life sciences strategy, which is directed at improving the capacity of our life sciences industry and the NHS to improve the quality of care for patients.
As many noble Lords eloquently pointed out, medical innovation flourishes only on a firm foundation of clear and effective regulation and informed consent. That is not only about patient safety but about giving certainty to researchers and innovations. The noble Baroness, Lady Finlay, and my noble friend Lord Bethell movingly reminded us that there is an innate tension in the need to drive forward the frontiers of medical innovation to offer hope to those with rare and hard-to-treat conditions—perhaps it is appropriate that today is Rare Disease Day. But there is also the need in a complex and universal system such as the NHS to have effective and agile safety and consent systems. However, in that context, it is never an excuse for a patient’s voice not to be heard loudly, quickly and effectively when things go wrong and we must never tolerate any form of gender bias, as the noble Baroness, Lady Jolly, said.
We heard today of some of the successes and strengths of our current systems of regulation for both medicines and medical devices, but we also heard about instances where our regulatory and wider systems could go further. I pay tribute to all those patients, some of whom are here today, who have shared their experiences and have gone on with a resolute determination to campaign for change for themselves and on behalf of others, including groups that my predecessor met and worked hard with, such as INFACT and Sling the Mesh. Many of them have met Ministers and Members of this House and have, with great bravery, told their stories, many of which are heartbreaking for them and their families. To them I say: thank you for your courage and dignity. Please know that your voices are heard not only here today but across government and across the system.
Noble Lords have already debated many aspects of the role of the MHRA to be responsible for the regulatory compliance of medicines and devices. As noble Lords will be aware, no medicine or medical device is entirely risk-free. The possibility of a patient suffering an adverse reaction or incident, although limited, can never be eliminated. That is why the MHRA has powers to take action, including removing products and devices from the market or resisting their use if the risk and benefit profile changes as new evidence emerges. We need to ensure that we are capturing that evidence most effectively.
Recent examples of where the MHRA has made use of those powers include recalling some sartan medicines for high blood pressure and issuing new temporary measures for the uterine fibroid drug Esmya. The MHRA also initiated EU action on valproate and will continue to consider what further restrictions are needed to ensure that valproate is not used in pregnancy. I will return to that in more detail a little later.
The noble Baroness, Lady Finlay, is absolutely right that the MHRA and NICE are indeed working more and more closely together on these matters. I have heard her and others’ points about the use of registries to capture evidence more effectively. We need to consider how that would interact with local care health records, however, and whether they are the most appropriate place to capture that information. I will take that point away and consider it carefully.
I particularly thank my noble friend Lord Bethell for his truly eloquent account. I appreciate his impatience for progress on this matter, so I would like to focus for a moment on the system for regulating devices. As the House is aware, medical devices are not brought to the market in the same way as medicines. The regulation of medical devices is instead governed by three EU directives as part of the pan-EU system of conformity assessment, a system that sets out standards for pre and post-market assessment of medical devices, including categories of device and the role of notified bodies and the MHRA.
However, there is no direct authorisation of devices for the UK or EU markets conducted by the MHRA. Medical devices and the wider medical technology sector form an area of very fast technological innovation, as the noble Baroness, Lady Thornton, pointed out. This means that devices are routinely improved and replaced as technology is developed, with a view to improving patient safety and experiences. It also means that there are comparative limitations on the amount of pre-market assessment that can be conducted for devices—unlike for medicines—given that the evidence of their actual use by patients is critical to the overall assessment of their efficacy. This is why manufacturers, notified bodies and the MHRA conduct ongoing post-market surveillance and vigilance to respond to information about the safety of devices when in use, and take appropriate regulatory action to improve them. This includes issuing medical device alerts to the healthcare service and the restricting and recalling of products. The publication of more data and patient feedback is an evolving process, as more experience is gained from the use of medical devices.
While the overall system seeks to establish a balance between continuous innovation in medical technologies and patient safety, I fully accept that it is not easy to achieve. By its nature, the regulation of innovative sectors must respond with continuous improvement, while the sectors’ systems and processes need to be continuously reviewed in the interests of patient safety. This is something that I know the MHRA and others take seriously, and to which I am personally committed. It is why the UK has played a role in arguing for change at European level in recent years, and why the Government intend to fully align the UK with the new EU medical devices regulations and in vitro diagnostic medical devices regulations, which my noble friend Lord Dundee mentioned. We will do this even though we are leaving the EU institutions because we are confident that doing so will drive system-wide improvement, including to the levels of clinical data that are mandated before products can be placed on the market, the scrutiny placed on notified bodies, the level of post-market surveillance conducted and the traceability of medical devices. We think this will improve the safety of medical devices.
This approach will establish a stronger and improved baseline for any future system change that we implement after our departure from the European Union. We will proactively ensure that innovative technology and processes are utilised by the UK healthcare system where this can enhance the role of the MHRA, including in relation to data, as well as increasing patient safety and confidence. My noble friend referenced a strong example of this: the Scan4Safety pilot, which was conducted in six trusts. We hope to roll that out across all acute trusts in England. I am a strong supporter of this, given that I announced the pilot in the first place.
Despite these changes, I know that there are still patients who feel that their concerns or experiences are not adequately heard or considered by the health system, and that the response has not been agile enough. It is an essential principle of patient safety that the regulatory environment gives sufficient voice to concerns reported by patients, families and campaigners, and that it works alongside them to respond in a rapid, open and compassionate way to resolve issues. I offer my firm assurance now that, as a department, we will be neither complacent in our success nor ignorant of the possible opportunities to improve. Just as the landscape of medicines and medical devices is ever-changing, so too must be the regulatory frameworks in which they are marketed, monitored and used within our healthcare system.
It is this commitment to evolve and ensure that the patient voice is central to our healthcare system that led to the Independent Medicines and Medical Devices Safety Review, chaired by my noble friend Lady Cumberlege and introduced by my noble friend Lord O’Shaughnessy. We have already heard much about it, so I will not go into detail. However, it will be critical to improving our understanding and action on listening to and consulting patients in the UK healthcare system to ensure that informed choices can be made. We expect the review to report later in 2019, with my noble friend Lady Cumberlege’s assistance. As we have heard, I know it has been consulting in a detailed and patient-oriented manner across the UK. I specifically thank my noble friend for her great sensitivity and dedication when listening to patient groups and individuals. I have met her and her team and heard first-hand how she has travelled the country to ensure that those who want their story to be heard have had an opportunity to speak in a sensitive and appropriate environment. She has handled her work with great tact and compassion, and I thank her for all her hard work and dedication.
Without second-guessing her conclusions, we recognise that we need to look beyond regulation and take a system approach to patient experience, enhancing the culture of improvement and using data to identify and drive required change, as my noble friend Lord O’Shaughnessy and the noble Lord, Lord Hunt, rightly pointed out. As part of this, I note my noble friend’s reference to a new national office of patient safety. That will require much more detailed discussion and consideration in the light of the review’s recommendations, but even at this stage it has much to recommend it.
I shall move on to some of the specific questions about surgical mesh. There has been a detailed debate about it, so I do not want to repeat what has been said. As the noble Lord, Lord Hunt, pointed out, in July 2018 my noble friend Lady Cumberlege recommended that there should be a pause without delay in the use of surgical mesh for stress urinary incontinence. That was supported by the Chief Medical Officer and senior clinicians. It was implemented through a high-vigilance regime of restricted practice and communicated to NHS England trusts. I understand that a similar process is taking place in Wales. I understand the impatience for a full ban, but for some women this may still be the only option for treatment, so it was considered that, while awaiting the outcome of the review, it was the appropriate route to take. The current findings are that the pause has dramatically reduced the number of procedures while we await the findings of the inquiry by my noble friend Lady Cumberlege. This is being kept under very tight scrutiny.
With reference to my noble friend’s specific question on a properly funded and staffed national network of expert mesh removal centres, I can confirm that NHS England has consulted on a service specification. When it is in place, we expect the service specification will cover multidisciplinary team management and complex vaginal mesh removal surgery for women who have complex complications. We are taking extremely seriously the review’s wider interim recommendations and are taking appropriate action in response. We will fully consider the final recommendations on mesh that the review will make later this year. Our primary objective will be to prevent future recurrence of the pain and appalling distress that patients, such as those who have given evidence to the review, experienced. We want to ensure that lessons are learned from their experience that will help us to protect other patients from any further risk of harm.
Turning to valproate, I have tremendous sympathy for the families affected by its use. The Government’s priority is to ensure that women are aware of the risks of this medicine. I therefore agree with my noble friend that the Government’s ambition should be to limit in-utero exposure to as close to zero as possible. Our current goal is rapidly to reduce and eliminate pregnancies being exposed to valproate. This is being supported by a formal pregnancy prevention programme and annual specialist review, as well as clear valproate labelling and packaging. There is also a communication and awareness campaign for healthcare professionals and patients. In response to the question asked by the noble Baroness, Lady Walmsley, all pharmacies have been provided with materials and there have been repeated communications. The General Pharmaceutical Council has written to all pharmacists to remind them of their professional responsibility in providing information to women, while the Royal Pharmaceutical Society and pharmacy bodies have been very active in communicating with their membership and in auditing practice. I recognise that there are still concerns about performance, but action is being taken. Patient input and engagement with members of the patient group, INFACT—who I know my noble friend has met many times—have been invaluable in the feedback process. It remains the responsibility of every healthcare professional involved in the prescribing and dispensing of valproate medicines to make sure that women are aware of the risks and are on a pregnancy prevention programme.
I note the questions posed by noble Lord, Lord Alton, regarding Primodos. They were quite detailed so, if he will allow, I will come back to him in writing.
I hope I have covered the majority of points raised by my noble friends and others in this House. This has been an important debate and I reassure all noble Lords that, as a Government, we are fully committed to a system of regulation for medicines and medical devices which intelligently provides access to new, innovative and world-leading products to improve the lives of millions of patients—especially those with diseases that are rare and hard to treat—while simultaneously protecting UK patients from harm, and ensuring that patient voices are heard loudly and clearly throughout the system if something does go wrong.
I finish by thanking my noble friend Lord O’Shaughnessy and all noble Lords who have participated in the debate this afternoon. It is clear that we are united in our dedication to learning from the experiences of those who have been courageous in speaking out, and in our commitment to protecting and improving the safety of patients who use medicines and medical devices in the UK. I am sure that, if we work together on this matter, we will see not only better medicines, better support and better care for patients but a safer NHS that is more responsive when it needs to be.
(5 years, 6 months ago)
Lords ChamberThat this House do agree with the Commons in their Amendment 1.
My Lords, this Bill will ensure that vulnerable people are afforded protections should they be deprived of their liberty. It will increase access to protections for the 125,000 people who are potentially being deprived of their liberty without an authorisation in place. The Government have, in the other place, made a number of changes which we will consider today.
Amendment 1 was tabled by the Government to provide statutory clarification in relation to the meaning of a deprivation of liberty for the purposes of the Mental Capacity Act. This proposed new clause anchors the meaning of deprivation of liberty to Article 5 of the European Convention on Human Rights. My predecessor and noble friend Lord O’Shaughnessy committed to bring forward statutory clarification in order to provide clarity to people and professionals. The clause delivers this by setting out non-exhaustive bounds of the concept of deprivation of liberty—that is, circumstances which do not constitute a deprivation of liberty. This is a matter that I have discussed with a number of your Lordships.
It sets out that a person is not deprived of their liberty if they are free permanently or temporarily to leave the place they are in and would not be subject to continuous supervision if they were enabled to leave if they expressed a wish to do so. A person will also not be deprived of liberty if arrangements are put in place to give medical treatment for physical illness or injury and these are the same as would be put in place for anyone receiving this treatment.
These boundaries to the concept of deprivation of liberty are drawn mainly from existing case law decided by our highest courts. We have taken this approach because it allows case law to evolve and helps ensure the definition remains valid as it does so. It is also very difficult for any positive definition to adequately address the range of cases that may be a deprivation of liberty, particularly while retaining the ability to reflect evolving case law. This clause will be accompanied by statutory guidance, which will be scrutinised by both Houses. We are currently working with stakeholders to compile case studies to illustrate when a deprivation of liberty occurs or does not occur under this definition, so that it will be more usable by practitioners and individuals.
Amendment 1B, tabled by the noble Baroness, Lady Tyler, provides an alternative definition of deprivation of liberty. It specifies that a person is deprived of their liberty if they are confined in a space,
“for more than a negligible period of time … have not given valid consent and the arrangements are due to an action of a person or body responsible to the state”.
Concerns about this amendment have been raised with me. It speaks directly to Article 5 of the ECHR, and we all agree on the importance of Article 5 in protecting liberty. It is vital to make sure that this is done right. If Parliament defines that concept, it must be clear how our statutory definition of deprivation of liberty relates to the ECHR definition. Our amendment clearly articulates the relationship between Parliament’s definition and the ECHR’s. Getting this wrong would mean further delays for thousands of people who were previously receiving protections. It does this in new subsection (1) by stating that deprivation of liberty has the Article 5 meaning, “and, accordingly”, that there is no deprivation of liberty in the circumstances in the remaining subsections. Thus it is clearly stated that what is not a deprivation of liberty is the same under the Act as under the convention: there is no difference between the two.
Amendment 1B does not do that. The clause defines a deprivation of liberty only for the purposes of the Act itself. It does not link it to Article 5 of the convention. This would risk Parliament’s concept of deprivation of liberty diverging from the convention. It is not appropriate to have two divergent concepts of deprivation of liberty, one set by Parliament and another set by the ECHR. The difference between the two would risk creating confusion and uncertainty. It would also mean that people who fall outside Parliament’s concept of deprivation of liberty but within the Article 5 definition could not have their circumstances considered within the Mental Capacity Act and would have to take their case to the High Court, causing delays. That would not be acceptable. Too many people are already being failed by the current system because of delays. We cannot create a situation that creates further delay, confusion or uncertainty.
Amendment 1B would create a narrow concept of deprivation of liberty. Proposed new subsections (2) and (3) provide cumulative requirements for a deprivation of liberty. If any one of those requirements is absent, the situation falls outside the Act’s concept of deprivation of liberty. One of the requirements is in subsection (3)(b): that the person is,
“subject to continuous supervision and control”.
On this definition, if a person is subject to a level of supervision or control that is less than continuous, they are outside the Act.
For example, a person may be locked in to their care home, unable to leave, regularly medicated and with little liberty. However, the level of supervision might be less than continuous. For example, they may be given just an hour a day to walk unsupervised in a confined garden. Under Amendment 1B, that person may not be considered to have their liberty deprived and would fall outside the Act’s protective framework. I am sure we all recognise that such a restriction as a deprivation of liberty, but the clause would not afford that person protections. Therefore, under the Government’s more limited draft, a person would not fall under liberty protection safeguards merely because there is some period of the day when their supervision is not “continuous”. Rather, it would be only where this was coupled with the person being free to leave temporarily.
My Lords, I thank all those who have contributed to this debate on the first group of amendments. As your Lordships have so thoughtfully said, we are wrestling with this definition because, as my noble and learned friend Lord McKay put it so eloquently, this is a very challenging task indeed.
In my opening speech, I explained the Government’s amendment and the reasons for our opposition to the amendment of the noble Baroness, Lady Tyler, so I will try to answer a couple of questions that have been raised. The first came from the noble Baroness, Lady Finlay, who asked why the amendment introducing the definition was tabled in the first place, given that it was such a difficult task and the Law Commission did not recommend that definition. There were calls for a definition from the JCHR, noble Lords and many stakeholders. It was an attempt to meet those calls, and we have done our best to collaborate and respond. She also raised the issue of valid consent and the three pillars. All references in the Bill to the deprivation of liberty only apply to people who lack capacity, and the amendment implies that people who lack capacity can give consent. That would not be correct in law but that is the way it could be read, so it needs to be clarified before it could be accepted.
I am very grateful to the noble and learned Lord, Lord Hope, for his comments. In his broad experience, the Government’s definition is in line with the reading of Strasbourg’s decisions so far. As he rightly understands, our intention is to anchor the definition in Article 5 and Cheshire West and to allow for evolving case law so that those who are awaiting decisions do not have to go back to court again and again. The purpose of this definition in the primary legislation is exactly as my noble friend Lord O’Shaughnessy put it: it is for the use of lawyers, whereas we are determined to bring forward robust and clear statutory guidance for stakeholders and those who will be affected by the definitions, so that they can be assured that they understand exactly the effect of this definition. On that basis, I hope that the noble Baroness, Lady Tyler, feels able to withdraw her amendment.
My Lords, I listened very carefully to the arguments put forward on this difficult and complex issue. Of course, I listened particularly carefully to the arguments of the noble and learned Lords, Lord Hope of Craighead and Lord Mackay of Clashfern. I am not a lawyer, as will become abundantly clear. I have looked to put this in a very simple way.
The issue goes back to the point made by my noble friend Lady Jolly. In my strong view, there is a need for plain English in statutes so that the citizens of this country who are subject to them understand what they say. I think it was the noble and learned Lord, Lord Mackay of Clashfern, who said that it is not always apparent to non-lawyers what some of these more complex passages mean. I agree; he is absolutely right. Perhaps it is overly simplistic of me but, frankly, I make no apology for that. It is Parliament’s role to define the legal principles in a Bill as simply as possible and the courts’ role to interpret them. I do not understand from any of the arguments I heard why the definition must be framed in such a convoluted way, in the negative with lots of double negatives. I just do not get it, despite listening carefully to the debate. I continue to believe that my definition meets those tests; it is important that whatever definition is in the Bill does so. I do not think that the Government’s definition does so. I wish to test the opinion of the House.
That this House do agree with the Commons in their Amendment 2.
That this House do agree with the Commons in their Amendment 3.
My Lords, I will speak also to Commons Amendments 5 to 14, 16 to 23, 26 to 41, 42, and 47 to 50. Throughout the legislative process the Government have worked, constructively I hope, with Peers, MPs and stakeholders across the sector, and as a result we have made a number of changes to strengthen the protections provided to the person in the new liberty protection safeguards system.
Amendments 3 and 40 to 42 specify that a pre-authorisation review must be completed by an approved mental capacity professional if the arrangements are for the cared-for person to receive their care or treatment mainly in an independent hospital, and clarify that other cases can be referred to an AMCP by the responsible body, provided that the AMCP accepts the referral. Noble Lords flagged that cases other than those where a person objects should be able to be considered by an approved mental capacity professional, and the Government agreed to clarify that in the Bill.
We also recognise that those residing in independent hospitals are often particularly vulnerable and in many cases have mental health needs and that it is appropriate in these cases for an AMCP to complete the pre-authorisation review, regardless of whether or not the person has raised an objection. The AMCP will provide an additional level of scrutiny for those who need it. They will meet the person, complete any relevant consultation and review assessments to decide whether the authorisation conditions are met.
I understand that the intention of Amendment 41A, tabled by the noble Baroness, Lady Thornton, is to require as far as practicable that an AMCP in an independent hospital case is independent from any person responsible for the act or decision regarding the arrangements. She is of course right to try to ensure independence in the system. The amendment has taken some of the wording from Section 35 of the Mental Capacity Act but this has caused some issues in the read-across.
The Government have taken the concerns about those in independent hospitals seriously. That is why we have required an AMCP to complete the pre-authorisation review in independent hospital cases, and why we have changed the Bill so that independent hospitals cannot be responsible bodies. In ensuring that the AMCP will act independently, I can confirm that they will be appointed by the local authority or local health board and that the independent hospital will be in no way involved in this decision.
We will make regulations on which professionals can fulfil this new role and specify there the qualities and qualifications necessary. The code of practice will provide guidance to responsible bodies regarding the appointment of AMCPs, and we will use this to outline that an AMCP should be independent of those carrying out the arrangements. It should also be noted that AMCPs will be held to account through their professional bodies, and they will be held to high professional standards. This sits alongside the other safeguards provided by the Bill, including advocacy, information and the ability for others to raise objections on the person’s behalf. I hope that with this reassurance the noble Baroness will not move her amendment.
Amendments 28, 35 and 39 are technical amendments which build on important amendments made by this House. The Government amended the Bill here to specify that those with a prescribed connection to a care home cannot complete the assessments needed for an authorisation or the pre-authorisation review, ensuring that there is no conflict of interest. These amendments clarify that the “prescribed connection” will be set out in regulations. It is vital that this Bill does not put care home managers in a position where they have to make a decision about whether or not a person lacks capacity or whether or not the proposed arrangements are valid because there is a conflict of interest. We are satisfied that the amendments made in this place and in the other place address this.
Amendments 8 to 23 remove the role of independent hospitals as responsible bodies, thereby removing any potential conflict of interest. When arrangements take place mainly in an independent hospital, the responsible body will be the local authority in England and the local health board in Wales. This approach broadly replicates the situation under the current DoLS. In England we want to make sure the new system is aligned with the general thrust of policy to support people in the community and reduce reliance on in-patient care, especially for autistic people and those with a learning disability. Having greater oversight by a local authority supports this.
Amendments 26, 27, 29 to 34, 36 and 37 are designed to ensure that the person who completes the assessments and determinations required for a liberty protection safeguards authorisation has the appropriate experience and knowledge to complete those assessments and determinations. The amendments give the Government the power to set out in regulations who can complete assessments and determinations. Our intention is that assessments will be completed by skilled professionals such as doctors, nurses and social workers. These amendments clarify that for medical and capacity assessments, the determination of whether or not the authorisation condition is met can be completed by someone who did not complete the assessments. This is important, as it allows valid assessments which have been completed previously to be used for the liberty protection safeguards authorisation. For example, a previous diagnosis of dementia from a psychiatrist’s mental health assessment could be used for the purposes of a medical assessment, where it is reasonable to do so. This helps to reduce unnecessary duplication in the system, which we know has proved to be a problem until now.
I thank all noble Lords who have taken part in this debate, which has reflected the genuinely constructive way in which this section of the Bill has already been improved. I join the chorus of thanks to my noble friend Lord O’Shaughnessy and the Minister, Caroline Dinenage, for the extensive work that they have done on the Bill so far. I will not speak for too long, as I have already outlined the Government’s position on these amendments. However, I would like to answer a few of the questions.
The noble Baroness, Lady Meacher, asked whether liberty protection safeguards would be extended to people in domestic settings rather than them going to the Court of Protection. I am happy to confirm that liberty protection safeguards will apply to community settings, including domestic settings. I think that people and their families and carers will welcome this, as the court process is slow, costly and very intimidating for many. The Bill will achieve greater protections for people than the current deprivation of liberty system.
The noble Baroness, Lady Finlay, raised some important questions, particularly about speech and language therapists. As she points out, they will play a very important role in the new system. They will definitely be involved in consultation. The regulations that will come forward will determine their exact role in implementation, whether as AMCPs or in another specific role.
The noble Baroness also asked about portability. An authorisation can apply to different settings so that it can travel with a person but cannot be varied to apply to completely new settings once it has been made, as this would undermine Article 5. I hope that this clarifies that point.
The noble Baroness also asked whether or not care managers can determine care assessments. Care homes are explicitly prevented from completing care assessments. I think I made this point, but I re-emphasise it. This comes back to the points made by the noble Baronesses, Lady Thornton and Lady Barker. As I outlined at the outset, AMCPs are independent of the responsible body and accountable to their professional bodies. I repeat that the Government have amended the Bill here specifically to ensure that those with the proscribed connection to care homes cannot complete assessments needed for authorisation or pre-authorisation review, to ensure that there is no conflict in the process. These amendments clarify that the proscribed connection will be set out in regulations. Because there is a conflict of interest, we will ensure that care managers are not put in the position of having to decide whether or not a person lacks capacity or the proposed arrangements are valid. I hope that this reassures noble Lords and that the noble Baroness, Lady Thornton, will not press her amendment. I beg to move.
That this House do agree with the Commons in their Amendment 4.
Amendment 4 aligns the definition of “care home manager” in Wales with that in England. As currently drafted, the Bill defines the care home manager in Wales as the registered manager. This amendment changes it so that it is instead linked to the registered service provider.
Amendment 15 is a technical amendment that will help ensure that the liberty protection safeguard system works well in Wales. There is no statutory definition of NHS continuing healthcare that applies in Wales, so this amendment clarifies that local health boards will act as responsible bodies if arrangements are mainly carried out through the provision of an equivalent to NHS continuing healthcare as defined in English legislation. I thank Welsh Government officials for working with us on these two amendments. It is vital that the new system works for Wales. We have been in close dialogue with the Welsh Government throughout this process to ensure that this is the case.
Amendments 51 to 54 relate to the interaction with the Mental Health Act. They provide that the liberty protection safeguards cannot be used to recall a person subject to the Mental Health Act, who is residing outside of a hospital, back to hospital. We have also clarified the drafting of the Bill so that arrangements can be authorised if the person is not subject to mental health requirements. This is in order to close down any possibility that the Bill is read as applying only to those with mental health requirements.
Amendments 55 and 56 amend Section 36 of the Mental Capacity Act to ensure that regulations about the functions of independent mental capacity advocates can make provision for advocates appointed under the LPS to support an appropriate person. The reason for this is that the “appropriate person” is a new role, and it is important that the regulations under Section 36 can address that. Amendments 55 and 56 also clarify that an IMCA need not be appointed under the MCA to represent and support a person in respect of accommodation in a hospital, a care home or long-stay residential accommodation if an IMCA has been appointed in respect of the same accommodation under the LPS scheme. They also make consequential amendments reflecting the change from the deprivation of liberty safeguards to the liberty protection safeguards.
Amendments 43, 44 and 46 relate to authorisations that need to vary in order to stop them ceasing because of small changes that need to be made. They require that a review must take place, where practicable or appropriate, before an authorisation is varied. These amendments also clarify that a responsible body can change during the course of an authorisation to stop authorisations automatically ceasing where there is a change of responsible body; for example, a care home resident may become eligible for NHS continuing care, and then the responsible body may change even though their location and care regime does not.
I hope that noble Lords will accept these changes made by the House of Commons. I beg to move.
That this House do agree with the Commons in their Amendments 5 to 23.
That this House do agree with the Commons in their Amendment 24.
My Lords, It is vital that those who are deprived of their liberty are provided with the information necessary for them to be able to exercise their rights. Although there is a duty to provide information in Article 5 of the European Convention on Human Rights, noble Lords have rightly flagged that the Bill should be explicit about this duty, and amended the Bill to this effect.
The Government listened to noble Lords and agreed that the Bill should be explicit on this matter. However, the amendment tabled in this place was not clear about when information should be provided; we felt that this drafting could cause some confusion for practitioners, so we tabled alternative amendments. Amendment 24 clarifies that, as soon as practicable after arrangements are proposed, the responsible body must take such steps as are practicable to ensure that the person understands the key steps and safeguards in the authorisation process. This is particularly important to ensure that people are aware of their options to challenge the authorisation. Importantly, there is also a duty to provide the same information to any appropriate person who is providing representation and support to the person. This is important in ensuring that family members and those close to the person are also provided with the necessary information to enable them to effectively provide representation and support to the person.
The duty on the responsible body is to take steps as soon as practicable to provide the person with the information. This means that this should be done as soon as possible after the responsible body is aware that arrangements are proposed. The responsible body will need to identify an appropriate person or appoint an IMCA at the earliest possible stage to provide support and representation for the person; the same principle applies for the duty to provide information. Information should be provided in the early stages of the process so that the person can make an informed decision regarding the support they receive through the process, and is able to exercise their rights. The code will provide details about how this will work in practice. We have already established a working group on the code of practice, which includes stakeholders from across the sector, ensuring that information is provided at the earliest possible point to form a part of these discussions.
Amendment 24 also introduces a general duty to publish information about the authorisation, including: the process; the circumstances in which an IMCA should be appointed; the role of the appropriate person; and the right to challenge an authorisation in court. This ensures that anyone who has an interest in the welfare of the person is subject to liberty protection safeguards authorisation, has access to the important information about a person’s rights, and is able to raise objections on behalf of the person.
Amendment 25 requires that the responsible body remind the cared-for person and any appropriate person of this information after the authorisation is granted. The information that needs to be provided to the person, and to any appropriate persons, includes details of the authorisation process, access to representation and support from an appropriate person or an IMCA, the right to request a review, and circumstances in which an AMCP will consider a case, which includes objections and the right to challenge authorisations in court.
On the matter of challenging authorisations in court, the responsible body under Article 5 of the European Convention on Human Rights has a duty to ensure that relevant cases are referred to the Court of Protection. I know that there has been a particular concern about ensuring that in very rare cases where it is not in the person’s best interests to receive support and representation, those people are enabled to challenge in the Court of Protection if they want to. In these cases, the responsible body will need to ensure that the cases are referred to the court. If it fails in this duty, it can be challenged in court.
I understand that Amendment 25A, tabled by the noble Baroness, Lady Watkins, seeks to require responsible bodies to keep a record of the decision and justification for not immediately giving a copy of the authorisation record, and if an authorisation record is not given within 72 hours, there must be a review into whether the lack of information is appropriate. I understand her desire to ensure that information about an authorisation record is provided promptly. However, we think that the drafting of the amendment would cause some issues; for example, it is not clear who is responsible for the duty to record or carry out a review. I am certainly willing to reflect on how best we can ensure that information is shared promptly, but I hope that I can reassure the noble Baroness that we will generally expect the information to be provided earlier than this, and we will set out reasonable timescales for the responsible body in the statutory code of practice. I hope that, with this reassurance, she will decide not to press her amendment.
The House has made clear its view that the Bill should be explicit about the duty to provide information. The Government have listened: these amendments outline clearly the duty to provide information at the earliest possible stage; to require, as far as possible, that the person understands the information they are being given; and to take action on it if necessary. I hope that noble Lords will accept these changes made by the House of Commons, and on that basis, I beg to move.
Is my noble friend able to define what the Government describe as “as soon as practicable”, which she said was going into the code of practice? Linked to that, how will it be defined for those people who will need the support of speech and language therapists, of an approved mental capacity professional or of an IMCA? It seems that we will need information to be provided at a very early stage, so that it can be considered and then decided whether there is a need for additional support. Can she give us some indication of how she is going to deal with that in the code of practice?
My Lords, the amendment on this very important matter in the name of the noble Baroness, Lady Watkins, is fully supported on these Benches. The Minister knows the strength of feeling of support in the House to ensure that the cared-for person, or their carer, relative, friend or other person advocating on their behalf, is fully informed about their rights at the start of the LPS authorisation process. The amendment, carried by a substantial majority, was very clear on this issue. That information should be provided up front to families as a matter of course—information not only about the process, but importantly, their rights to advocacy and to challenge—in an accessible format that they can understand.
The provision in Amendment 25 of a statutory duty for information to be provided “as soon as practicable” does not ensure that this essential up-front requirement for information is met. One of the excellent briefings on this matter from Mencap states:
“Families’ carers have consistently fed back to us that the lack of information up-front meant that they didn’t know what was happening, that it was a process done to them and their loved one, and that set in motion misunderstandings, mistrust and instances of an appeal which could have been avoided had information been provided and explained at the beginning”.
Mencap’s concern is that the “as soon as practicable” provision could mean a system working on the timescales of the responsible body, rather than of the individual body and the families. That is our concern, too.
Amendment 25A addresses these concerns and ensures that the loophole in the Government’s amendment is addressed by requiring a record of the decision and justification to be kept where it has not been practicable to provide that up-front information about the decision to commence authorising arrangements under subsection (1). It also provides a necessary timeframe. We have heard that the noble Baroness, Lady Watkins, is not wedded to 72 hours, but it is important to have a timeframe within which, if a copy of the authorisation record has not been provided, there must be a review of whether the lack of information provision was appropriate. The requirement would provide the necessary safeguard for the cared-for person, and the hard- pressed staff, by facilitating routine record keeping and accountability for the decisions made. The noble Baroness pointed out some very explicit examples of the type of record that needs to be kept; it would not be onerous.
We are in a strange position, which we are slowly getting used to, of having the ex-Minister reassuring the House from the Government Benches that everything he promised has been delivered—before the Minister speaks. Amendment 25A highlights a significant loophole that needs to be addressed and I hope that the Government will accept it. We accept that the Government’s intention is to provide the information needed, and as soon as possible, but the amendment is necessary to reassure that “as soon as practicable” is not as open-ended as it can so often turn out to be.
My Lords, I thank noble Lords for their contributions to the debate on this group. The provision of information in an appropriate and timely way goes to the heart of the Bill, in its intent to empower the cared-for person. The contributors today demonstrated how significant they have been in the process of improving the Bill.
I will respond first to my noble friend Lady Browning, and her question about clarifying what “as soon as practicable” means. This term is also used in the DoLS legislation. As we have outlined, we intend to clarify this in the code of practice with a range of examples that will make it perfectly clear exactly what it means, for practitioners and the cared-for person. We expect that this will be in the earliest stages of the process, so that the person has the information to enable them to exercise their rights, as the noble Baroness, Lady Wheeler, said,
“as a matter of course”.
This is exactly what would be expected. In order to ensure that this code of practice is workable and effective and, as my noble friend Lord O’Shaughnessy rightly put it, “has teeth”, it is being developed with strong input from stakeholders and practitioners. That is why we are confident that it will not be just a document but a usable and effective piece of statutory guidance.
We are not able to accept the amendment in the name of the noble Baroness for the reasons which she accepted, in some way, in her contribution. We have concerns about the specification of 72 hours and other aspects, but I understand her desire to ensure that information about the authorisation record is provided promptly. This is our intention as well. We have heard the will of both Houses on this and have tried to reflect that in our amendments, and I am certainly willing to consider how best to do that. We think that it is best done in the code of practice, which will be statutory and will have teeth, for the reasons that I outlined. I hope that, with these reassurances, the noble Baroness will feel bound to press her amendment. I beg to move.
That this House do agree with the Commons in their Amendment 25.
That this House do agree with the Commons in their Amendments 26 to 40.
That this House do agree with the Commons in their Amendment 41.
That this House do agree with the Commons in their Amendments 42 to 56.
(5 years, 6 months ago)
Lords ChamberTo ask Her Majesty’s Government what steps they are taking to ensure that those suffering from an eating disorder are able to access treatment and support.
My Lords, eating disorders are life-threatening conditions, and it is the priority of this Government to ensure that everyone with an eating disorder can access quick, specialist help when necessary. For children and young people we have waiting time standards to improve access to eating disorder services, and it is encouraging to see a reduction in waiting times compared with last year. Findings from a national review are being reviewed to inform future improvements to adult eating disorder services.
I thank the Minister for that reply. Hospital admissions have more than doubled in the last six years, while out-patient services for adults are underresourced and unable to support people to be treated in the community. What do the Government intend to do to improve adult eating disorder services to treat, as the Minister rightly calls them, these life-threatening, severe mental illnesses?
First, at the beginning of Eating Disorders Awareness Week, I pay tribute to mental health professionals, charities, researchers and campaigners who have done so much to raise awareness, fight stigma and help the Government and the NHS improve mental health services over recent years. The noble Baroness is absolutely right that, while we have made a lot of progress with children’s eating disorder services, we must not forget adult services. That is why the NHS Long Term Plan has committed to test four-week waiting times for adults and older adult community mental health teams. We have not exactly pinned down what the scope of these pilots will be, but we expect that areas in receipt of new funding will be those that will expand those services.
My Lords, given the high mortality and morbidity in both adult males and adult females—particularly university students who may be postgraduate students and who, at the time of presenting, may not have significantly changed their body mass index but whose risk of dying actually goes up enormously if they are not referred at that point—will the Government undertake to request that contracts from NHS England to services no longer require body mass index as a referral criteria? I declare my interest as chair of governors at Cardiff Metropolitan University.
The noble Baroness is exactly right. NICE clinical guidance is clear that people should not be rejected for treatment solely on the grounds of their weight or body mass index. This is an issue that Hope Virgo in particular has campaigned on very effectively to improve awareness of treatment of eating disorders. She has discussed her campaign with NHS England and the department, and I am pleased to confirm that my ministerial colleague Jackie Doyle-Price will meet her in the coming weeks to see what more can be done.
My Lords, I ask my noble friend the Minister to remember young boys and men when thinking about future policies and treatment. They are often forgotten, and I think we are seeing quite a rise in men and boys with this problem.
I thank my noble friend for that question and in particular for raising the issue of stigma. We have put £150 million and extended over 70 services into the community specifically so that services can be more accessible to young girls and boys and so that people can feel free to come forward and seek help where they need it.
It is to be welcomed that the proportion of children with an eating disorder starting urgent treatment within a week or so remains quite high in London, but it is much higher than the rest of the country, according to the data analysed by the Royal College of Psychiatrists. What will the Government do to address what looks like a postcode lottery if your child needs support and help with an eating disorder and you happen to be in Bradford?
I am grateful to the noble Baroness, Lady Thornton, for raising the issue of ensuring that we improve services across the country and do not have a postcode lottery. Since July, NHS England has opened up 126 beds for children and young people in areas of the greatest geographical challenge to ensure that we can address exactly that problem.
I thank the noble Lord for giving way. While access to treatment is vital, I hope the Minister will agree that it is equally important to address modifiable risk factors for eating disorders. There is good evidence that weight-related bullying, teasing and criticism increase the risk of eating disorders, and young people studying physical subjects such as dance or sport are particularly vulnerable to inappropriate comments from teachers and coaches. The Minister will be aware that size is not a protected characteristic under the Equality Act 2010. Given this, can she confirm that guidance is available to support teachers who are dealing with young people in using language that avoids triggering long-term issues around eating and body image?
The noble Baroness is absolutely right. It is very important we send the right messages to young people at exactly the right time. That is why we are implementing the children and young people’s Green Paper on the basis that early intervention and prevention are the priority in mental health. In December 2018, we announced 25 trailblazer sites that will provide school and college-based services to help children and young people with mild to moderate mental health issues, staffed by a new workforce. Twelve of these trailblazer areas will pilot a new waiting time standard for children and young people’s mental health services. This is to address exactly the issue that the noble Baroness raised.
My Lords, does the Minister agree that, when we talk about eating disorders, the most serious eating disorder by far is the obesity epidemic, which is now impinging on the Armed Forces? Ejector seats in fighter planes are having to be modified because of obesity, and no doubt the noble Lord, Lord West, will be interested, because we may have to enlarge the escape hatches of submarines.
I thank my noble friend for that question. I do not feel able to comment on ejector seats or submarine hatches—I may have to look to the noble Lord, Lord West, for advice on that matter—but I believe that obesity is a serious issue, and that is exactly why we introduced the children’s obesity plan.
My Lords, in some areas, referrals for treatment are at a later stage of the illness than otherwise because some CCGs have increased the threshold for criteria to be satisfied before a referral can be made. This will result in increased cost and, very often, decreased effectiveness. Have the Government done any assessment of this situation and the impact it could have on patients?
The noble Baroness raises an important point which follows on from the point raised by the noble Baroness, Lady Finlay. NICE guidance is clear: people should not be rejected for treatment solely on the grounds of weight or body mass index. The issue of threshold is similar and will be looked into by my honourable friend Jackie Doyle-Price. We will be taking this on as a very serious matter indeed.
(5 years, 6 months ago)
Lords ChamberTo ask Her Majesty’s Government what steps they will take to implement the recommendations of their report GP Partnership Review: Final Report, published on 15 January.
My Lords, we recognise the huge contribution that general practice and the partnership model has made to patients over the lifetime of the NHS. We wish to thank Dr Watson for the report of his independent review, and we are currently considering his recommendations. We are planning to publish a formal response in due course.
I thank the noble Baroness for that Answer. The GP Partnership Review makes seven key recommendations, including: an increase in the number of GPs and funding for those roles; an expansion of the range and capacity of healthcare professionals working with GPs, such as developing the role of practice nurses; focusing on general practice in medical training; and recommendations to deal with an unsustainable workload. Those are all laudable aims. What puzzles me is the context in which these aspirations can be delivered. Some 78% of EU doctors working in the UK are not reassured by the Prime Minister’s commitment to protect the rights of EU citizens, and 35% of EU doctors are considering leaving the UK and moving to another country. The tier 2 visa cap means that 1,500 applications for healthcare workers were rejected by the Home Office last year, and indeed more GPs are retiring, leaving or going part time than are entering the profession. So is there a plan to remedy the existing shortfall and the impending shortfall, which threaten and will continue to threaten patient care and safety?
I thank the noble Baroness for her Question. She is absolutely right that recruitment and retention of GPs is a core priority for the Government. That is exactly why funding for GPs in the long-term plan was increasing at a rate higher than in the rest of the NHS, at £4.5 billion. That is also why we have a target to recruit 5,000 more GPs. I am pleased to report that HEE has reported that we recruited a higher number of GPs last year than ever before. We also have some core recruitment schemes to increase GP retention: the GP Retention Scheme, the Local GP Retention Fund, the GP retention service and the Releasing Time to Care programme, with £30 million in funding. However, we accept that this is a challenging thing to achieve, and we are working hard to improve our performance.
My Lords, on the subject of GPs retiring, what are the Government going to do about the fact that many GPs are retiring once they reach the age of 55 because their final salary pension scheme exceeds the £1 million limit, which the Government successfully reduced from £1.8 million, and then come back as locums, costing the health service even more? That affects not only GPs but a number of people elsewhere in the public sector, who are behaving completely rationally because they suddenly find themselves being taxed at 55%.
I am not able to talk about other parts of the public sector, but we recognise that there are legitimate concerns here, and we are working with the BMA and NHSE as part of our work on the recruitment and retention of GPs and consultants, and considering what mitigations, if any, would be appropriate.
My Lords, this was indeed a good and welcome report. The Royal College of General Practitioners welcomed the findings, but noted that the profession was concerned about red tape surrounding appraisals, CQC inspections and now GDPR, which are all getting in the way of patient care. Who is responsible for squaring the circle between improving patient care and GP regulation and accountability?
The noble Baroness is absolutely right: we want to free up GPs to do exactly what they have been trained to do, which is to care for patients. That is why, as part of the GP contract, we have included funding to ensure that they can claim for any additional costs that they may have under the GDPR. It is also why we put in the long-term plan that we want to recruit an extra 20,000 staff who can provide the other services, such as administrative services, that GPs are sometimes caught up doing when they should not be.
My Lords, the list of things that the Government intend sounds very impressive. I have a simple question. Communication is particularly important to general practitioners, who may see 90 or 100 patients with abdominal pain, one of whom may have a cancer of the colon. That is one of the major problems. Has the noble Baroness ever sat down and had informal conversations with general practitioners who are threatening to retire, or are retiring, early to understand how they feel about it?
I absolutely have had a large number of conversations with general practitioners who have struggled. In my previous role as a Member of Parliament, I visited a large number of general practices in my constituency. I am also the daughter of a doctor and I have a rare disease, so I spend a lot of time in the NHS as a patient and, perhaps, as a mystery shopper—so I assure the noble Lord that I have extensive experience of the NHS. I would not claim, however, to understand what it is like to be a general practitioner, so I would always hope to learn by continued experience of listening to their experiences and challenges.
My Lords, why does the Minister think that the reality that we see every day in the outside world differs completely from what she says at the Dispatch Box?
I do not think that that is the case. I think we are making good progress. It is a challenging picture for general practitioners; that is exactly why, since the New Year, we have introduced the long-term plan to increase funding for the NHS, and in particular for general practice. We have introduced this review with support from the department, new GP practice with support from the BMA and the new GP IT Futures plan so that we can bring in the most innovative technology for GPs so that they can bring the best and most innovative care to patients.
(5 years, 6 months ago)
Lords ChamberThe noble Lord and I absolutely agree about that, and the noble Lord is quite right. I am not saying that one would bow to that pressure at all. Your Lordships’ House has a proud record of persuading the Government to change both statutory instruments and primary legislation with regard to the powers that they have.
I shall say one final thing. It is not the case that these issues were not raised by my honourable friends in the House of Commons; in fact, they were. Indeed, the Delegated Powers Committee’s first report on the Bill was quoted extensively in Committee in the Commons; unfortunately, the votes were not there to carry its effects through. We might think about changing that at a later stage in the Bill.
My Lords, I thank the noble Lord, Lord Marks, for Amendments 26, 29, 30 and 31, the noble Lord, Lord Patel, for Amendment 28, and my noble friend Lord Lansley for Amendments 37 and 39, and all noble Lords who have participated in this debate, which has been very robust.
These amendments seek to address concerns raised about the ability to make consequential changes to primary legislation using regulations under the Bill. I reassure noble Lords that the Government have been listening closely to these concerns, some of which—as the noble Lord, Lord Marks, put it—were trenchantly expressed earlier in Committee, and I want to continue these conversations as we move towards Report.
That said, I would like to take this opportunity to provide some context to the approach we have taken in the Bill. The Henry VIII powers in this Bill are not free-standing; they flow directly from the delegated powers in Clause 2(1)—which I know has also met with a little bit of disapprobation. The noble Lord, Lord Butler, recognised the importance of parliamentary scrutiny, and we do as well. We recognise the concerns over the Henry VIII powers, and the Bill has been drafted to ensure that regulations making such changes would all be subject to the affirmative procedure. The intention of including this power to make consequential changes to primary legislation is simply to ensure that healthcare agreements are implemented in an efficient and effective way.
There is a broad legislative landscape which currently implements reciprocal healthcare arrangements with the EU. It currently includes EU law, as well as domestic primary and secondary legislation. In implementing future comprehensive healthcare agreements, it may be necessary to amend different types of legislation so that we can operationalise things domestically. In the past when we have implemented international healthcare arrangements, amendments were needed to primary legislation. For example, when we implemented the EU cross-border healthcare directive in 2013, we needed to insert discrete new sections into the National Health Service Act 2006. With that specific experience in mind, we felt it was important that the Bill was able to amend primary legislation because it seemed likely that it would be necessary in order to implement future agreements, albeit in very restricted circumstances and subject to the affirmative procedure.
We can give some reassurance that this is not a stand-alone power and it will not need to be used in the vast majority of regulations made under the Bill. Our intention in including this was only to ensure that the statute book is coherent when implementing future arrangements under the Bill. I recognise that there is serious concern from noble Lords on this matter, and am grateful for their thorough scrutiny so far. I give my reassurance that the Government have listened carefully and we will welcome further discussion on this critical issue before Report.
On my noble friend Lord Lansley’s Amendments 37 and 39, it is only right that parliamentary time is allowed for regulations that need enhanced scrutiny, but it is not appropriate for all regulations. The concept of retained EU law was introduced in the European Union (Withdrawal) Act 2018. The issue of the status of retained EU law was considered during the passage of that Act, which I am sure my noble friend was involved in. As a result of those considerations, the EUWA set out bespoke rules determining how types of EU retained law might be modified. This was set out in Section 7 of and Schedule 8 to that Act, as I know the noble Lord is well aware. Crucially, the EUWA does not require that all amendments to retained direct principle EU law must be subject to the affirmative procedure. That is true both in relation to regulations made under the EUWA and regulations made under other pieces of legislation, such as this Bill. As such, I hope noble Lords will agree that it is reasonable that we should follow the rules set by the Act—which ultimately was debated and passed by this House—in order to ensure coherence. The EUWA gives flexibility for future legislation to provide for this level of parliamentary scrutiny, which is considered appropriate. That is what we have done in this Bill.
The Minister has been very helpful and said that she will consider the points raised. Am I raising my hopes too high by expecting that the Government may come forward with some amendments on Report?
The noble Lord is right to expect that I will take these questions away and consider them.
My Lords, I am very grateful to the Minister for assuring us that she is listening to the criticisms, that the Government have seen the point of them, and that she will consider them before Report. In those circumstances, I invite the House to accept my withdrawing the amendment. It is not enough to give assurances on how the Government intend to use the powers, for all the reasons we canvassed on Tuesday. It is important that the Government consider how far the powers need to go and how far they can be limited, in order to achieve the object that the Minister seeks to achieve—and only the object that she seeks to achieve. If the Bill comes back limited in that way, the Minister may well get a much more favourable wind when she seeks to put such a power through on Report.
I also suggest that the Minister asks the noble Lord, Lord Wilson of Dinton, whether there is now a parliamentary barrister acting as parliamentary counsel who will take the same rather tough view on the extent of powers that are taken as that consulted by him when he was a junior official. It is that kind of rigour that is necessary and must be brought to bear upon the powers.
Regarding the point made by the noble Lord, Lord Lansley, and the response by the noble and learned Lord, Lord Hope, it seems that a greater use of appropriate conjunctions, making clear when “and” is meant and when “or” is meant, would help in Clause 5 and Clause 1. A little bit of English grammar might go a long way to improving this and other legislation. I beg leave to withdraw the amendment.
Listening to the noble Lord, Lord O’Shaughnessy, I reflected on our debates on Tuesday. I think he is again making the argument for two Bills, but there we go. He is quite right about differentiation. I thank the noble Lord, Lord Lansley, for introducing this group of amendments, all of which seek to curb the powers of the Secretary of State under Clause 5. I shall speak to Amendment 33 in this group. It would ensure that amendments are made under the affirmative procedure. We have sought to use the affirmative procedure in the event of no deal, which would enable the Government to bring in replacement bilateral arrangements immediately. That is because we are concerned that delays under the draft procedure would leave British and EU citizens not covered by a health agreement, with serious implications.
This group of amendments points in the same direction and comes from every part of the House. They broadly agree with both the Delegated Powers Committee and the Constitution Committee reports. As noble Lords have said, the Henry VIII powers in Clause 5(3) and (4) provide for regulations to amend, repeal, revoke or retain EU law. I very much welcome the fact that the Minister said in our previous debate that she intends to consider what has been said. I will resist the temptation to quote what the Constitution Committee said about this, because I know that noble Lords have read its influential reports at length.
These powers have been mentioned by noble Lords all the way through Committee. Clauses 2 and 5 are particularly worrying, to put it mildly. What concerns me is the Government’s reaction to the legitimate concerns expressed so clearly by both those highly regarded Lords committees, on whose advice we depend for our scrutiny of legislation. They overuse the words “flexibility and capability” and argue that the Bill must be forward-looking and needs those powers to provide that flexibility and capability. I was reminded of the previous general election, when the Conservative Party coined the phrase “strong and stable”. It did not convince anybody, and I am not sure that “flexibility and capability” is convincing noble Lords as a reason for the powers. It is a good reason for what the Government want to achieve, but as a justification for the powers in the Bill, it is not compelling.
The noble Baroness now seems to have realised that in every part of the House, including on her Benches, we take these matters particularly seriously. That is not because there is a desire to stop the Government acting—absolutely not at the moment. It is because our system of checks, balances and accountability requires legislation to be subject to proper scrutiny, in order to safeguard citizens from the tendency of Governments—all Governments—to charge on and ride roughshod, implementing their wishes without let or hindrance.
I know that some officials see this as a kind of game or tussle to see what they can get away with, particularly at the moment, but as the noble Lord, Lord Wilson, wisely said on Tuesday, you cannot put these powers in because they might just be useful. Although I will resist joining the noble Lord in repeating the words of Margaret Thatcher, I agree with his sentiment that the Bill as drafted breaks all the rules of our constitutional understanding. I hope that the Minister takes that seriously because the challenge before her and the House is to amend the Bill so that it fulfils its primary function: to provide healthcare cover for millions of UK citizens and to ensure healthcare for UK citizens living and working in the European Union and European citizens living and working in the UK. In other words, it is about individuals’ lives and their health. We believe that the right amendments, like those defined in this group, will refine the Bill’s scope and give the Secretary of State appropriate powers—an achievable task.
My Lords, I thank my noble friend Lord Lansley for Amendments 27 and 41, the noble Baroness, Lady Thornton, for Amendment 33, my noble friend Lord Dundee and the noble Lord, Lord Foulkes, for Amendment 34 and the noble Lord, Lord Marks, for Amendments 35, 36 and 38. Each amendment speaks to concerns we have heard during the passage of the Bill to date about the breadth of the regulation-making powers and the scrutiny afforded to them.
I wish to open by saying that I listen very carefully to these concerns. I assure the noble Baroness, Lady Thornton, that I see this process as neither a game nor a tussle. The suite of measures on reciprocal healthcare we are introducing is intended entirely to reassure UK citizens living in Europe and elsewhere, and EU citizens living in the UK, that we will work hard to ensure continuity of care for them in this uncertain time and that we are looking forward and thinking about providing care in other places, as a Government should.
To assist our consideration of these issues, I thought it might be helpful to set out the intention of some of the delegated powers as drafted, as we have not yet had a chance to do so in much detail. As I indicated previously, Clause 2(1)(a) is intended to be used to set out the detail of complex payment arrangements under reciprocal healthcare deals because payments can be made in a variety of ways. For example, the UK pays France the actual cost of treatment provided, meaning that a claim for the cost of each person’s individual treatment is made to the UK, whereas in Spain we pay an average cost per person of treatment provided. In Portugal, on the other hand, we offset payments. That is why that power has been drafted in that way.
Clause 2(1)(b) provides for regulations to be made in connection with the provision of healthcare abroad outside reciprocal arrangements, allowing us to put in place complex arrangements outside a bilateral agreement in an urgent situation. That is designed specifically for an EU exit situation that may be an emergency.
Clause 2(1)(c) is needed to give effect to comprehensive healthcare agreements entered into with another country or international organisation, such as the EU. This provides the power to implement agreements in domestic legislation. We believe that it would be unworkable to produce new primary legislation to implement each agreement on an individual basis; I am sure that the House would agree.
Clause 2(2) sets outs examples of the type of provision that might be included in regulations under Clause 2(1). As we have said before, it is an illustrative list of the kinds of provisions that would already be included. I took note of the concern about conjunctives under this clause.
Clause 2(2)(a) highlights that complex healthcare agreements may include a mechanism for calculating payments and regulations but would need to specify how the cost of healthcare would be calculated between different countries.
Clause 2(2)(b) indicates that regulations may establish eligibility criteria that specify which people can access healthcare outside the UK. Establishing robust eligibility criteria is key to preventing the misuse and abuse of healthcare, as referred to already by my noble friend Lord Lansley in previous debates.
My Lords, all these powers exist at the moment, as do all these arrangements. However, the powers being asked for in this Bill have not been needed for that. The point that was made on Tuesday is about why we look to have such huge powers when actually we have managed without them in the past.
For the implementation of international healthcare arrangements, these powers exist within EU legislation. At the moment we do not have the powers to implement international healthcare arrangements within domestic legislation. That is why they are being introduced.
The department believes that the negative procedure is appropriate for the use of the delegated powers to arrange the specific implementation purposes which I have laid out. That balances the appropriate level of scrutiny with the use of parliamentary time. However, I have listened closely to the discussions in the debate and I take seriously the concerns which have been raised by noble Lords, by the DPRRC and by the Constitution Committee. However, I hope that noble Lords will understand that we need to ensure that the Government have the legislative tools needed to implement the agreements we reach, especially the ones with reciprocal healthcare at EU exit. I would like to work constructively with your Lordships to further consider these issues in detail as we progress the Bill to Report, and I will make myself and officials free to discuss the breadth of the regulation-making powers further at an open session next week. I hope that with this explanation and these reassurances, my noble friend will feel able to withdraw his amendment.
I am grateful to my noble friend and to all noble Lords who have taken part in this short debate. I thought it was very constructive and I am especially grateful to my noble friend Lord O’Shaughnessy for his support for my two amendments. I thank the Minister for her willingness to think about these issues positively and constructively. We will return to them on Report and I look forward to that. On the basis of her helpful assurance, I beg leave to withdraw the amendment.
My Lords, I am grateful to the noble Baronesses, Lady Jolly and Lady Humphreys, for Amendments 30A and 30B, and to the noble Baroness, Lady Wheeler, for speaking to Amendment 42 on behalf of the noble Baroness, Lady Thornton, and for the opportunity to address this important issue of engaging and working with the devolved Administrations. As we take the Bill forward at pace, we endeavour to do so in a way that is collaborative and respects the devolution settlement and the conventions for working together.
To that effect, the contribution from the noble Lord, Lord Hain, was rather disappointing in implying that the Government have anything but the highest regard for the role of the devolved Administrations in this matter. Indeed, as the noble and learned Lord, Lord Wallace, described, the department has had, and continues to have, constructive discussions both at ministerial and official levels with all the devolved Administrations, on the Bill and on the underlying policy.
As your Lordships have already noted, the regulation-making powers in this Bill provide us with a legal mechanism to implement international agreements into domestic law for the benefit of UK nationals; this is a UK competence, but we recognise that in some parts of the Bill, powers may be used in ways which relate to devolved matters; namely, the domestic healthcare elements. With that in mind, as my noble friend Lord O’Shaughnessy has said, we are delighted that the Scottish Parliament has granted the legislative consent Motion to the Bill. We have had positive and constructive engagement with colleagues in Northern Ireland’s Department of Health and in the Northern Ireland Office, and we are grateful for their support and their agreement to ensure that the Bill applies and extends to Northern Ireland.
We are working very closely with colleagues in the Welsh Government to secure their support for a legislative consent Motion, and to that end, as the noble and learned Lord, Lord Wallace, will I hope be pleased to hear, we will be introducing a government amendment on Report which places a statutory duty to consult with the devolved Administrations, where regulations under Clause 2 would make provision that would be within the legislative competence of the devolved Administrations.
Furthermore, I confirm that we have now agreed a memorandum of understanding with the Welsh Government to accompany the amendment. This MoU sets out how we intend to work with each other, and how the UK Government intend to work with all the devolved Administrations in respect of this policy area. In response, we expect the Welsh Government to lodge and support a consent Motion in the Welsh Assembly very shortly.
We have also been working to secure the support of colleagues in both Northern Ireland and Scotland to the terms of that memorandum of understanding. We hope that colleagues in both of those Administrations will agree to the measures provided for in the MoU, following some very recent final discussions and changes with the Welsh Government. The MoU sets out a pragmatic and mutually beneficial working relationship to ensure that the devolved Administrations will continue to have a vital role to play in delivering reciprocal healthcare for the benefit of all UK citizens. In addition, it will enable devolved Ministers to set out their views at an early stage of reciprocal healthcare policy formation. Where they relate to devolved matters, we will share the draft regulations we intend to make under Clause 2 with the devolved Administrations before they are laid.
This agreement is both pragmatic and practical, allowing us to move forward in a collaborative way. I thank my colleague, Stephen Hammond, the Minister of State, who has taken the lead on this engagement, and acknowledge the positive relationships that he has sought to build with his counterparts in the devolved Administrations. He has been speaking to them this very week. We consider that amendments to the Scotland Act 1998, the Government of Wales Act 2006 and the Northern Ireland Act 1998 would be outside the scope of regulations made under this Bill, and it would therefore be unnecessary to place a consent requirement in the Bill in this regard, but the UK Government are committed to working closely with the devolved Administrations, now and in the future, to deliver an approach that works for the whole of the United Kingdom.
I hope that now that I have reported these positive developments, the noble Baroness will be moved to withdraw her amendment—
I am grateful to the Minister, and reassured by what she has said. Perhaps I will withdraw the tone of some of my earlier remarks, which were made without knowing what she was going to say.
I ask the Minister to bear in mind, in terms of advice to Whitehall officials working on Brexit legislation of this kind, that it is not an accident that these extra consultative arrangements she is now describing were not in the original Bill. This has been true all the way through the Brexit process, and I am afraid that when I said that it seems to be in the DNA of Whitehall, it is as though the default position is that these consultative rights are not put on the statute book. I ask the Minister to use what influence she has with the rest of the ministerial team to say that this must not happen again, in any other legislation.
Part of the reason that this amendment has come at this stage is because it has been part of a negotiation, and we wanted to have agreement with the devolved Administrations to ensure that it was in a manner which suited them. That is why it has been part of the process: because it was in agreement and in consultation, rather than us putting it in at the beginning and then consulting afterwards. I hope that as the result of that discussion and agreement, I have reassured—
I acknowledge that the Minister said that an amendment will be brought forward. That is very welcome. Is there anything technically defective with Amendment 42 and is she going to accept it?
We need to bring forward the clause which we have agreed with the devolved Administrations. It is appropriate to do that but I thank the noble and learned Lord for his intervention and, on that basis, I hope that the noble Baroness will feel free to withdraw her amendment.
I thank the Minister for her clarification and the excellent news that the memorandum of understanding has been signed. I seek assurance from her that this matter will be reported on, or an amendment put forward on Report, so that we can hear exactly whether the Welsh Government have completed the LCM process. I thank her very much and I beg to withdraw the amendment.
My Lords, I listened carefully to the strong arguments put forward by the noble Lord, Lord Marks, on this issue, and I await the Minister’s response. We have every sympathy with the intention behind the amendment, and the noble Lord’s frustration that the House can either accept or reject a statutory instrument but cannot amend it, while parliamentarians can and often do take note of or reject Motions. However, Parliament is ultimately at the mercy of the Government to withdraw regulations and bring forward a revised draft, which may or may not adequately address the concerns that have been expressed. Fatal Motions are quite rightly used rarely, in exceptional circumstances.
The noble Lord, Lord Marks, says this is a probing amendment. However, I fear that, in this circumstance, it would be counterintuitive to the Bill’s primary objective of implementing reciprocal health agreements after Brexit. As my noble friend Lady Thornton said on Amendment 33 in an earlier group, time is not on our side, and I fear that the approach contained in this amendment would lead to delays in implementing reciprocal health agreements. In the event of no deal, when millions of British citizens will lose their current access to healthcare treatment overnight, any delay while Parliament debates and considers draft regulations would be catastrophic. Obviously the delay that would occur from the proposals that the noble Lord, Lord Marks, suggests would have to be taken into consideration in any future changes, and would certainly need to be discussed.
My Lords, I thank the noble Lord, Lord Marks, for suggesting in Amendment 32 an approach to the important issue of appropriate levels of parliamentary scrutiny, and for clarifying that this is a probing amendment. The Government clearly recognise the importance of appropriate levels of scrutiny in this Bill and the secondary legislation made under it. Obviously, the hallmark of an effective and responsible parliamentary system is the process by which we draft, consider and test legislation.
During this debate, I have listened very carefully to your Lordships and the views expressed on the affirmative resolution procedure. This is an interesting proposal by which we could consider draft legislation. While the Government support the spirit of the amendment and agree that appropriate scrutiny is important, we have questions about this approach.
It is vital that we can make regulations that allow us to respond appropriately to a variety of possible scenarios arising from not just the UK’s exit from the EU but any situation where we would need to implement regulations, where this Bill might be needed quickly and where it is required for a comprehensive international agreement. Such an approach for scrutiny would, we believe, increase the time taken to develop and lay regulations, and this may have quite a significant negative impact on our ability to bring forth timely regulations to provide healthcare arrangements to support hundreds of thousands of individuals who rely on these provisions—perhaps in a case which may be considered an emergency.
(5 years, 6 months ago)
Lords ChamberMy Lords, I beg leave to ask the Question standing in my name on the Order Paper and declare my interest as former chair of the HFEA.
My Lords, the Government reviewed all the provisions of the Human Fertilisation and Embryology Act 1990 in 2006-07, which led to the 2008 Act and associated regulations, including the 2009 storage regulations. I have been informed that the Government have no plans to formally review the relevant provisions in the Act on gamete storage at this stage. The department’s legal advice is that the current law appears to be compatible with the relevant human rights law.
Does the Minister appreciate that this lack of compassion and misunderstanding of the law is going to bring defeat in the courts soon? The storage period of 10 years for frozen eggs was set when little was known about the science, so women either exercise that option when they are at the best age—say, 25—and have to have them destroyed at 35, when really needed; or wait until a less optimal age and still have to have them destroyed when most needed, the entire exercise having cost thousands of pounds. Will the Government not enact a simple regulatory change, costing nothing, which will end this interference with private and family life under human rights law—and the indirect discrimination—and give hope to thousands of women?
I acknowledge that there have been societal changes which have led to women having children later, and technological advances in fertility treatments and freezing. However, I do not agree that the regulatory route that the noble Baroness proposes would be appropriate, as it was not envisaged at the time of the legislation. The strength of this regulation is that it had clinical, parliamentary and public support; given that this is such sensitive legislation, I hope we can continue that going forward. That is why the Government and I believe that continuing with primary legislation is appropriate.
My Lords, does the Minister realise that if a medical condition is the determining factor and has left a woman prematurely infertile, the eggs can be stored for up to 55 years, as is the case with sperm? Therefore, the science has changed. The Government need to recognise that 10 years is an arbitrary and unfair limit. If eggs can be stored for longer, surely this situation is unfair and cruel to women who wish to use those eggs after the 10-year period, for a variety of reasons. Will the Minister ask for a review of the law, and if primary legislation is needed, could it be included in the next Queen’s Speech?
The noble Baroness is right: the 2009 regulations were not just concerned with fertility options for people who are already adults. The 55-year limit is intended for those who become infertile through serious illness or side-effects, which can happen in childhood. I understand the concerns about the 10-year limit—there was no consensus during the 2009 review—but it is being continually reviewed and will remain under review by the department.
Can my noble friend the Minister say what the Department of Health and Social Care is doing to publicise the fact that it is preferable for women under the age of 35 to harvest their eggs, because after that age the effect is not as good? I realise that some women do not have a choice, but some private firms take a lot of money from women as they get older without telling them of the disappointments they might face.
My noble friend makes an important point about the success rate of fertility treatment through the freezing of eggs, which is roughly comparable with IVF at 26%. It is important that false hopes are not raised and that women are not exploited in these very sensitive situations.
My Lords, the Minister has just claimed that the current law has public support. Can she say how recently that was explored and what the result was? Also, does the time limit have any effect on a woman’s decision whether and when to have her eggs harvested, and when to use them? Has any research been done on that and if not, why not?
The noble Baroness is absolutely right that it is important that we continue to support the Bill. I was trying to clarify that I did not think it appropriate to bring forward a change of this nature under regulations. If we were to introduce a change that had a broad effect, it would be appropriate to do so in primary legislation with appropriate parliamentary scrutiny, consultation and clinical support.
My Lords, if I may, in the absence of the noble Lord, Lord Winston, I will take his perch—as long as nobody tells him that. The question of the science has been referred to. As far as we know, 26 years is the longest that an embryo that was subsequently born managed to survive. However, nobody really knows—we know only of the ones that have been reported. As for how long an embryo might survive, a study that measured the cumulative index of background radiation in mice suggested that when the mice embryos were subjected to increasing levels of cumulative radiation, they survived up to the equivalent of 2,000 years. Therefore, a 10-year limit has no scientific basis. Does the Minister agree?
I would never argue with the noble Lord, Lord Patel, on any scientific matter. My information is that there was no scientific or biological basis for the 10-year limit. It was based on debate and discussion of societal, ethical and cultural considerations, and on the concern that without a maximum limit, there would be questions about storage banks. Vitrification techniques are far more effective now than the slow-freezing techniques, so it is appropriate that these scientific questions are taken into account as this remains under review in the department.
My Lords, is this not just a case of discrimination? Practically every man in this room could still father a child, but none of the women could. This is very similar to when the pill was brought into our lives. This is about extending women’s rights to their fertility, women’s rights to work and women’s rights to plan their lives. As we have heard from many noble Lords, the science is with us; it is only the culture and the politics that are against us.
I have a great deal of sympathy with the position the noble Baroness has just presented. As I say, the 10-year limit remains under review but I do not think that replacing it through regulation in the simple way the noble Baroness, Lady Deech, suggested would be appropriate. It would need to be dealt with in primary legislation and we would need to make time for that in the House. At the moment, that is not a realistic prospect.