Brexit: Import of Radioisotopes
Baroness Blackwood of North Oxford Excerpts(5 years, 9 months ago)
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Baroness Symons of Vernham Dean (Lab)
My Lords, I beg leave to ask a Question of which I have given private notice.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
My Lords, the Government have been working very closely with the Royal College of Radiologists and the pharmaceutical industry to ensure that the NHS has robust contingency plans in place so that patients can continue to have access to medicines, including medical radioisotopes, whatever the EU exit outcome. Yesterday, the Royal College of Radiologists published sensible and pragmatic guidance to specialist NHS clinicians, which the Government support, to ensure that all necessary operational planning has taken place before 29 March.
Baroness Symons of Vernham Dean
My Lords, the Royal College of Radiologists, the British Nuclear Medicine Society and the UK Radiotherapy Board have all stated categorically that Brexit, particularly a no-deal Brexit, will mean delays in the supply of imported radioisotopes, which are so vital to the diagnosis and treatment of cancer patients. I too have read the guidance the Minister referred to, but does she agree that all these authorities are not convinced anti-Brexiteers trying to sensationalise the position? They are experienced and skilled in prolonging and saving the lives of cancer patients and they are clear that a no-deal Brexit will put already vulnerable patients at risk, while an extension of Article 50 will improve matters considerably. Does she further agree that while these authorities are making this point, if there were no other reason than that, the risk to people who may be diagnosed or may already have cancer is reason enough to take no deal off the table now?
Baroness Blackwood of North Oxford
I thank the noble Baroness for this. It is a very important question that she has raised. The Government’s first priority is to ensure continuity of care and patient safety, no matter the outcome of EU exit. That is why we have been putting important medical supply and contingency plans in place for the unlikely event of a no deal, even though that is not the Government’s plan.
The guidelines issued by the Royal College of Radiologists were in response to the plans from two major suppliers, representing at least 80% of the market, which have arranged contracts for air freight capacity to commence this month for the supply of radioisotopes. It is important to note that many isotopes already use air freight, and their deliveries will see no change in their arrival arrangements. Of course, the supply in these routes is relevant because radioisotopic materials have a short half-life, and therefore these changes, although minor, will have an impact on clinical pathways.
It is absolutely right for the Royal College of Radiologists to put some guidelines in place, and we have been working closely with it, the Department of Health and NHS England to offer clinics practical advice in allowing adjustment in their clinical processes. We do not expect any patient harm to arise from this, and the changes in clinical pathways and practice are expected to be minor and short-lived. We do not expect any delays or increased waiting times to arise from this; this is straightforward, practical advice to support clinics in adapting to changes in delivery times.
I hope that is a reassuring Answer for the noble Baroness, and that it has clarified what was, I think, some sensationalist media reporting of the advice.
Baroness Walmsley (LD)
My Lords, it is not this House that needs reassurance but doctors and consultants, who are feeling the need to reduce their treatment lists next month because they simply do not trust the Prime Minister to avoid a no-deal Brexit. The reason for that is because she adamantly refuses to take it off the table, despite the fact that, as a negotiating tool, it is about as much use as a chocolate fireguard. The other side knows that she cannot use it; when will she take off the blinkers?
Baroness Blackwood of North Oxford
I thank the noble Baroness for her question. This advice has come not from the Prime Minister, but from the Royal College of Radiologists. On the basis of that advice, we know that many services will be unaffected. For other services, the NHS is already working closely with suppliers to minimise the impact of changes to medical radioisotope delivery times, which are expected to be a matter of hours and easily managed by clinics. But it is appropriate that they should be given sensible and practical advice to ensure that patients are protected and that patient safety is maintained to the highest possible standards.
Baroness Thornton (Lab)
My Lords, in many ways this Question is the just-in-time question of healthcare. We know that our manufacturing industries, particularly the automotive industries, will be affected by Brexit because of the just-in-time nature of their work. This is the just-in-time of cancer care. If you do not have the isotopes the tests do not get done, because the delivery is timed for the morning of an appointment when patients are due to arrive at the hospital—if there is nothing to give them, they then have to go home and wait for another slot.
My question to the Minister, who has done her best to reassure us on this, is: what calculation have the Government made of the risks? Certainly, the organisations which have waved a flag about this are not trying to panic anyone; they have legitimate concerns that they may have to delay treatment and tests because of Brexit. What calculations have the Government made of the risks there would be to people’s lives from delays that may happen as a result of this lack of just-in-time?
Baroness Blackwood of North Oxford
I think I answered that in my response to the noble Baroness. We have assessed that we do not expect any patient harm to arise from this, and the changes to clinical pathways and practices are expected to be minor and short-lived. It is one of the reasons why we started working with industry early in the process to ensure that air freight capacity was put in place. It is also why we have been working with the Royal College of Radiologists, NHS England and the department to ensure that the guidance was put in place, so that clinics could be prepared to adapt to these changes in delivery times.
Lord Ribeiro (Con)
My Lords, the EU Home Affairs Sub-Committee looked at this matter and debated it in a take-note debate in July last year. At the time, I flagged up the importance of developing a new generation of alpha- and beta-emitting isotopes for cancer treatment in helping to mitigate the problems of importation. The then Minister, my noble friend Lord O’Shaughnessy, reassured the House that quite a lot of work was indeed going on with regard to proton beam treatment, that the Christie Hospital would be starting that very soon—that was last year—and that another unit was on the go. So there are alternative provisions for cancer treatment with proton beam therapy. None the less, there is an issue about what would happen in a no-deal Brexit as regards the gap between what we currently receive and what we are able to provide. Can the Minister say anything about when we can expect these new systems to come on stream? It is a challenging question, so she may wish to write to me on that.
Baroness Blackwood of North Oxford
I thank my noble friend for that helpful question. I assure him that both the Christie and UCL proton beam programmes are well under way, and we can be proud of our world-leading programmes in cancer proton beam therapy. I cannot give him an exact progress update on that, so I shall write to him on it. However, he is absolutely right that we must make sure that we progress those programmes, as well as ensuring that our supply of imported radioisotopes remains protected during the Brexit period.
Lord Warner
My Lords, to what extent does the Minister consider that patients will be put at much greater risk in a no-deal scenario if a large number of oncologists up and down the country take the view that they cannot rely on the supply of medical isotopes and therefore start a programme of delaying access to an assessment and treatment by them? Does she consider that the Government cannot give these assurances because they do not know what the behaviour will be of individual clinicians who require the isotopes to treat their patients?
Baroness Blackwood of North Oxford
One of the reasons why we worked so closely with the Royal College of Radiologists to provide the guidance, as well as working closely with NHS England to communicate to the NHS, is to ensure that reassurance has been sent out through the system with regard to the arrangements which have been made for medical supplies so that those concerns can be allayed and to ensure that clinical pathways are not disrupted. For that reason we do not expect any patient harm to arise from this, and changes to clinical pathways and practice are expected to be minor and short lived.
General Food Law (Amendment etc.) (EU Exit) Regulations 2019
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Baroness Blackwood of North Oxford
That the Grand Committee do consider the General Food Law (Amendment etc.) (EU Exit) Regulations 2019.
Relevant document: 17th Report from the Secondary Legislation Scrutiny Committee (Sub-Committee B)
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
My Lords, I thank noble Lords for their consideration of the draft regulations—the General Food Law (Amendment etc.) (EU Exit) Regulations 2019, the General Food Hygiene (Amendment) (EU Exit) Regulations 2019, the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 and the Contaminants in Food (Amendment) (EU Exit) Regulations 2019.
The Government’s priority is to ensure that the high standards of food safety and consumer protection we enjoy in this country are maintained when the UK leaves the European Union. These instruments are crucial to meeting our objective of a functioning statute book on exit. They are made under the powers in the European Union (Withdrawal) Act 2018 to make necessary amendments to the overarching food regulations so that we can continue to protect public health from risks that may arise in connection with the consumption of food. These instruments correct deficiencies in those regulations.
I wish to be clear that no policy changes are made through these instruments, nor is there any intention to make any at present. These instruments propose a transfer of responsibilities to UK entities to support a UK-centric regulatory regime. Responsibilities incumbent on the European Commission are designated to Ministers in England, Wales and Scotland, and to the devolved authority in Northern Ireland.
The European Food Safety Authority, EFSA, is the EU body that provides scientific advice on food safety. These regulations designate EFSA responsibilities to the food safety authority. This will be the Food Standards Agency, the FSA, in England, Wales and Northern Ireland, and Food Standards Scotland, which has a close working relationship with the FSA. The draft instruments being considered today will ensure that the following key EU regulations on food and feed safety and hygiene will function effectively on exit day.
Regulation 178/2002 lays down the fundamental principles that underpin food law and the essential requirements that food and feed businesses must comply with, as well as describing certain functions to be carried out by EU institutions. A key principle set out in the legislation is that food placed on the market must be safe to eat. It also provides for other fundamental safety and hygiene requirements, including rules and expectations on traceability. It establishes a requirement for open and transparent public consultation if food law is revised.
Regulation 852/2004 contains the basic food hygiene requirements for all food businesses. It sets out the general requirements for the hygienic production of foodstuffs through the provision of effective and proportionate controls throughout the food chain to the final consumer.
Regulation 853/2004 relates to the specific hygiene rules for products of animal origin, and Regulation 854/2004 relates to the organisation of official controls for products of animal origin. These specific hygiene rules set out the requirements and specific health standards for establishments on land or at sea for slaughtering, processing, storing or transporting products of animal origin.
The regulations on chemical contaminants protect consumers by ensuring that they are protected from the adverse effects of exposure to contaminants that may be present in food. Chemical contaminants may be present in food from the environment or as a result of growing conditions. The legislation sets out maximum limits for certain contaminants in food and provides a clear legal basis on which enforcement action may be taken, where necessary, to protect consumers by facilitating the removal of unsafe food from the food chain.
These instruments do not introduce any changes in how food businesses are regulated or managed. They do not introduce extra burdens and therefore provide continuity and clarity for businesses and continued protection of consumers’ interests. It also means that non-compliances can continue to be addressed in the same way. These will ensure a robust system of controls that will also underpin UK businesses’ ability to trade both domestically and internationally.
It is also important to note that the devolved Administrations have provided their consent for these instruments. Furthermore, we have engaged positively with the devolved Administrations throughout the development of these instruments. This ongoing engagement has been warmly welcomed. A full public consultation indicated support for the proposed approach to retained EU law for food and feed safety and hygiene. These instruments therefore constitute a necessary measure to ensure that the important food safety regulations will continue to work effectively after exit day. On that basis, I beg to move.
Baroness Walmsley (LD)
My Lords, I thank the Minister for introducing these SIs, which replace references to the EU in regulations with references to the UK, and as such are relatively innocuous. The first question I want to ask was raised in Grand Committee last Wednesday by the noble Lord, Lord Rooker, who is in his place. Is the Minister satisfied that all relevant regulations on these important food safety matters have been copied over into the SIs we are discussing today? The noble Lord found some SIs where some important matters had not been copied over. Perhaps he has spotted something which I have not in these regulations, and we will hear from him in due course.
Secondly, the general food law SI, the general food hygiene SI and the contaminants in food SI allow only one hour for a single officer in a local authority to familiarise himself or herself with the new regulations and disseminate the information to staff and stakeholders. I wonder whether it is a coincidence that they will have to do it on April Fools’ Day, the first working day after Brexit. The problem is that cuts to local authority funding have meant that some authorities no longer have any full-time food and feed officers to take charge on this issue, so who is going to do it, and who is going to pay for it? How can they do it in only one hour? Is this not just a covert way of ensuring that an impact assessment does not need to be produced? All those who responded to the consultation claimed that this cannot be done in so short a time and will certainly cost more than the Government estimate, and the Government have not offered to cover these costs. How did the Government reach the conclusion that the implementation time for businesses would be so staggeringly short?
The food hygiene SI allows a 21-month implementation period for food labelling changes from EU to GB or UK, but even here, the industry has concerns that some small businesses may struggle to comply. Other respondents to the consultation raised concerns that a common framework across the whole of the UK has not been properly addressed. The NFU pointed out that some farm holdings cross borders and animal feed moves across the Welsh and Scottish borders frequently. Is the Minister satisfied that devolution issues have been settled to the satisfaction of the Welsh and Scottish Governments?
Thirdly, can the FSA and its Scottish equivalent, the FSS, fulfil their additional responsibilities? Do they have enough staff and resources? Can the Minister respond to these concerns? Other respondents are concerned about how the Government intend to provide a suitable replacement for the risk-management function for food safety currently undertaken by the European Food Safety Authority. Can the Minister say what is being done about this? The whole of the food safety regime is based on risk management, and it is far from clear who will be responsible for this after Brexit and whether they have adequate resources. The National Pig Association is keen to retain a close working relationship with the EFSA to ensure that we in the UK receive food problem alerts in good time to take effective protective action against livestock diseases coming to us from the continent. This will also be a concern for other livestock producers. Can the Minister say what arrangements for this have been put in place?
I hope I will be forgiven for straying slightly beyond these SIs to some relevant matters, and I hope the Minister will find my comments useful for the future. If we are to leave the EU, the Government have always said that there is no danger of reducing our food standards and that, on the contrary, it gives us an opportunity to improve them. That is why I am surprised we have heard nothing yet of the Government’s plans to do that. One thing I would have wanted to improve in the common agricultural policy is to link food production and trade policies to the better dietary health of the European population. So here is a challenge for the British Government. They can start with two things, which I put down as markers for the future. First, they should ban the use of nitrites in processed meats, such as bacon and ham, in favour of other processes which have not been designated as carcinogenic by the World Health Organization, as nitrites have been, but which preserve meat just as well and protect it from botulism just as effectively.
Secondly, they should introduce supply-side regulations to reduce the UK population’s intake of free sugars by two-thirds to comply with the Scientific Advisory Committee on Nutrition’s recommendations, which make clear that overconsumption of sugar is responsible for the crisis of obesity, diabetes and all their associated preventable diseases, and for tooth decay in children, which is responsible for most of their hospital stays. Agricultural and trade policy are central to the supply of sugar, and amendments could be effective in changing the market for sugar before it even reaches the consumer. Reformulation programmes, sugary drinks tax and nudges towards behaviour change have their place, but we could make a greater and faster change if we addressed the supply side.
Once they have got all the relevant SIs about retained EU law through Parliament, will the Government look at these two opportunities as a matter of urgency? Has the Minister had any discussions or made any representations from her department to the rest of Government about such measures, as we move into the years after Brexit?
Baroness Blackwood of North Oxford
I thank all noble Lords for their contribution to this debate on my first SI. I think it is quite unusual for your first SI to involve two former chairs of the independent body that you are in part debating. I shall do my best to tread appropriately carefully.
I shall respond to some of the questions asked by the noble Baroness, Lady Walmsley, about why the instruments deal specifically with these questions and do not think beyond Brexit. I am sure she will know, having experience with previous statutory instruments, that the instruments are responding to the fixing power of the European Union (Withdrawal) Act, which is limited to making appropriate changes to prevent, remedy or mitigate failures of retained EU law to operate effectively, so these instruments aim specifically to ensure that food safety and hygiene legislation functions in a no-deal scenario. I state at the outset that we think it is unlikely that the UK will leave without a deal—indeed, it would be very undesirable—but we must be prepared in all scenarios. I wanted to put on record at the beginning why these SIs were drafted in this specific way, although I know she knows that.
To respond to the noble Baroness’s question about whether we are confident that they have all the necessary read-across from EU law into UK law, we have been very careful to review the EU law in FSA policy areas to check that. We believe we have identified all the EU law that needs to have those connections across.
The noble Baroness asked about the consultation, and this was echoed by the noble Lord, Lord Rooker, regarding the responses about the impact on local government. The SIs were very effective, in as much as the FSA did a full public consultation that lasted six weeks. It should be praised for following that route and for engaging with local authorities and industry. It is reasonable to point out that local authorities are under pressure at the moment, but I think the reason why we have come to the view that it will take a relatively brief amount of time to get familiar with the new legislation is that there are no changes to the vast majority of requirements in the read-across. We are therefore confident that the time that has been predicted in the impact statement is sufficient, so we believe that that impact assessment is robust.
In addition, we wanted to discuss the devolved Administrations and consultation there. We are very pleased that Scotland, Wales and Northern Ireland have provided their consent for these instruments. We have worked very closely in developing them. The principles and rules set out in retained legislation in these SIs are intended to ensure that we have the same level of food safety protection throughout the UK, so that we can have a free flow of trade through it to address exactly the concerns that the noble Baroness raised. However, the FSA is not going to leave it there: it will continue that close working relationship with the Administrations of Scotland, Wales and Northern Ireland so we can be confident that in practice it will be possible to make arrangements to operate a framework of food safety regulation across the UK in whatever exit scenario we may face.
I turn to the important series of questions about RASFF risk assessment and management in a potential no-deal scenario, asked by noble Lords with great experience. I know there has already been something of a debate about this in Select Committee with my colleague the Minister, Steve Brine, so I suspect I will repeat some things that he has said—perhaps not so eloquently, but I will do my best.
As the noble Lord, Lord Rooker, rightly said, securing continued access to and participation in the RASFF system after leaving the EU is one of the UK Government’s top food safety priorities. We recognise its importance for UK food safety, but we also recognise the important role that the UK has played in establishing that system. We are proud of that, and would like to continue to play a role. We are pressing for full access to that system in our negotiations with the EU, and I am sure that is what my colleague the Minister said earlier. As he would have said, though, the exact arrangements for participation in RASFF are still a matter for the next phase of negotiations. It is therefore hard to provide any further detail on that, as I know noble Lords will recognise. We recognise the importance of it and of a continued strong relationship with the EU.
In communications back to us, the EU has recognised the important role the UK played in the establishment not only of RASFF but of equivalent food standards bodies in the European Commission, so I think the close relationships we have there will bear fruit. They are not just close relationships at a European Commission level but scientific relationships, which tend to weather political storms a little better than political relationships, if I may say so, so I have a sense of optimism about this. We must be clear that negotiators recognise that there is no precedent at this point for third-country membership of RASFF, but we will continue to make the point that we have an unusually strong contribution to make to it and therefore there is value in us engaging with it.
The mutual benefits are an important element of maintaining food safety for both parties, and we think it is important for the EU, as well as for the UK, that this close trading relationship can continue without compromising confidence in food safety. As the noble Lord, Lord Teverson, pointed out, FSA officials have been working closely on this point with Defra officials to ensure that there is a seamless approach to dealing with the challenge of exit, and that contact is maintained at not only a policy and legal level, but, most crucially, an operational level. That will need to continue as we go through this next period.
I now turn to what will happen in the undesired scenario of no deal, where we may well have to cope without access to RASFF, even if it is in the short term. Noble Lords will have heard earlier today from Heather Hancock, the chair of the FSA, on the plans she has put in place to ensure we have robust protections and operational measures in place to ensure that food safety standards are in no way compromised, no matter what the outcome of EU exit may be. In the first instance, we have ensured that the FSA is increasing the level of engagement with the International Network of Food Safety Authorities, INFOSAN—which, noble Lords will know, is managed jointly by the FAO and the WHO—to provide the UK with an extensive reach for communicating food safety issues to INFOSAN. Indeed, we believe that, with our extensive experience, we have done work to improve the effectiveness of that organisation.
We have to bear in mind that we have effectively been managing food risk from imports from and exports to non-EU countries through some of those bilateral and non-EU routes, so we can have confidence in the effectiveness of the FSA as a world-leading regulator—up until this point, in any case. Nevertheless, there has been no complacency in this. The FSA has put in place a number of measures to strengthen the domestic risk assessment and risk management measures. To do this, it has recruited additional staff involved in risk assessment and risk management, implemented an expanded role for the independent scientific advisory committees, which are now being strengthened by recruiting new experts and establishing three new expert groups, and expanded access to scientific experts who can provide scientific advice and other scientific services to inform our work on a contract basis, including by expanding our register of specialists. It has ensured that it will put in place a slightly new system that is based on current practice but includes: a structured separation of risk assessment and risk management; a new executive advisory committee that draws together officials from government; an expanded role for the independent scientific advisory committees, which, as I have said, have been strengthened by recruiting new experts; and a new process for authorising regulated products, such as food and feed additives, enzymes, flavourings, GM food and feed, and other novel foods.
The noble Lord, Lord Krebs, raised an important question about the independence of the FSA and the role of Ministers. It is right to assure him that the response he received from my honourable friend Steve Brine in Select Committee is right. While food safety decisions will be made by Health Ministers, the FSA and FSS will continue to lead and make risk management decisions during food safety incidents, providing risk management advice to the enforcement authorities, which take action. Of course, this independence is set out by statute. No proposal is in place to change that. All food safety and risk management decisions will be proportionate and evidence-based. They will be based on a package of supporting analysis in line with the fine tradition the FSA has of openness and transparency. We can be proud of the FSA’s tradition of doing that.
I hope I have answered the questions raised. On that basis, I beg to move.
General Food Hygiene (Amendment) (EU Exit) Regulations 2019
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Baroness Blackwood of North Oxford
That the Grand Committee do consider the General Food Hygiene (Amendment) (EU Exit) Regulations 2019.
Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019
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Baroness Blackwood of North Oxford
That the Grand Committee do consider the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019.
Contaminants in Food (Amendment) (EU Exit) Regulations 2019
Baroness Blackwood of North Oxford Excerpts(5 years, 9 months ago)
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Baroness Blackwood of North Oxford
That the Grand Committee do consider the Contaminants in Food (Amendment) (EU Exit) Regulations 2019.
Cannabis: Medicinal Use
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Baroness Meacher
To 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.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
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.
Baroness Meacher (CB)
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?
Baroness Blackwood of North Oxford
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.
Lord Howarth of Newport (Lab)
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?
Baroness Blackwood of North Oxford
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.
Baroness Walmsley (LD)
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?
Baroness Blackwood of North Oxford
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.
Baroness Thornton (Lab)
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?
Baroness Blackwood of North Oxford
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.
Lord West of Spithead (Lab)
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?
Baroness Blackwood of North Oxford
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.
Safety of Medicines and Medical Devices
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
My 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.
Baroness Blackwood of North Oxford
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.
Mental Capacity (Amendment) Bill [HL]
Baroness Blackwood of North Oxford Excerpts(5 years, 9 months ago)
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Baroness Blackwood of North Oxford
That this House do agree with the Commons in their Amendment 1.
“Meaning of deprivation of liberty
(1) After section 4 of the Mental Capacity Act 2005 insert—
“4ZA Meaning of deprivation of liberty
(1) In this Act, references to deprivation of a person’s liberty have the same meaning as in Article 5(1) of the Human Rights Convention and, accordingly, a person is not deprived of liberty in any of the circumstances described in subsections (2) to (4).
(2) A person is not deprived of liberty in a particular place if the person is free to leave that place permanently.
(3) A person is not deprived of liberty in a particular place if—
(a) the person is not subject to continuous supervision, and
(b) the person is free to leave the place temporarily (even if subject to supervision while outside that place).
(4) A person is not deprived of liberty if—
(a) the arrangements alleged to give rise to the deprivation of liberty are put in place in order to give medical treatment for a physical illness or injury, and
(b) the same (or materially the same) arrangements would be put in place for any person receiving that treatment.
(5) A person is free to leave a particular place for the purposes of subsections (2) and (3) even if the person is unable to leave that place provided that if the person expressed a wish to leave the person would be enabled to do so.”
(2) In section 64(5) of that Act (interpretation) for the words from “same” to the end substitute “meaning given by section 4ZA.””
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
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.
Baroness Blackwood of North Oxford
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.
Baroness Tyler of Enfield
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.
Baroness Blackwood of North Oxford
That this House do agree with the Commons in their Amendment 2.
Baroness Blackwood of North Oxford
That this House do agree with the Commons in their Amendment 3.
Baroness Blackwood of North Oxford
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.
Baroness Blackwood of North Oxford
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.
Baroness Blackwood of North Oxford
That this House do agree with the Commons in their Amendment 4.
Baroness Blackwood of North Oxford
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.
Baroness Blackwood of North Oxford
That this House do agree with the Commons in their Amendments 5 to 23.
““Education, Health and Care plan” means a plan within the meaning of section 37(2) of the Children and Families Act 2014;”
Baroness Blackwood of North Oxford
That this House do agree with the Commons in their Amendment 24.
“12A(1) The following must publish information about authorisation of arrangements under this Schedule—
(a) the hospital manager of each NHS hospital; (b) each clinical commissioning group;
(c) each Local Health Board;
(d) each local authority.
(2) The information must include information on the following matters in particular—
(a) the effect of an authorisation;
(b) the process for authorising arrangements, including making or carrying out—
(i) assessments and determinations required under paragraphs 18 and 19;
(ii) consultation under paragraph 20;
(iii) a pre-authorisation review (see paragraphs 21 to 23);
(c) the circumstances in which an independent mental capacity advocate should be appointed under paragraph 39 or 40;
(d) the role of a person within paragraph 39(5) (an “appropriate person”) in relation to a cared-for person and the effect of there being an appropriate person;
(e) the circumstances in which a pre-authorisation review is to be carried out by an Approved Mental Capacity Professional under paragraph 21;
(f) the right to make an application to the court to exercise its jurisdiction under section 21ZA;
(g) reviews under paragraph 35, including— (i) when a review will be carried out; (ii) the rights to request a review;
(iii) the circumstances in which a referral may or will be made to an Approved Mental Capacity Professional.
(3) The information must be accessible to, and appropriate to the needs of, cared-for persons and appropriate persons.
12B (1) Where arrangements are proposed, the responsible body must as soon as practicable take such steps as are practicable to ensure that—
(a) the cared-for person, and
(b) any appropriate person in relation to the cared-for person, understands the matters mentioned in sub-paragraph (3).
(2) If, subsequently, at any time while the arrangements are being proposed the responsible body becomes satisfied under paragraph 39(5) that a person is an appropriate person in relation to the cared-for person, the responsible body must, as soon as practicable, take such steps as are practicable to ensure that the appropriate person understands the matters mentioned in sub-paragraph (3).
(3) Those matters are—
(a) the nature of the arrangements, and
(b) the matters mentioned in paragraph 12A(2) as they apply in relation to the cared-for person’s case.
(4) If it is not appropriate to take steps to ensure that the cared-for person or any appropriate person understands a particular matter then, to that extent, the duties in sub-paragraphs (1) and (2) do not apply.
(5) In this paragraph “appropriate person”, in relation to a cared-for person, means a person within paragraph 39(5).”
Baroness Blackwood of North Oxford
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.
Baroness Browning
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?
Baroness Wheeler (Lab)
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.
Baroness Blackwood of North Oxford
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.
Baroness Blackwood of North Oxford
That this House do agree with the Commons in their Amendment 25.
(a) the cared-for person,
(b) any independent mental capacity advocate appointed under paragraph 39 to represent and support the cared-for person,
(c) any person within paragraph 39(5) in respect of the cared-for person (the “appropriate person”), and
(d) any independent mental capacity advocate appointed under paragraph 40 to support the appropriate person.
(2) As soon as practicable after authorising arrangements, the responsible body must take such steps as are practicable and appropriate, having regard to the steps taken under paragraph 12B and the length of time since they were taken, to ensure that the cared-for person and any appropriate person understands the matters mentioned in paragraph 12A(2)(a), (c), (d), (f), and (g) as they apply in relation to the cared-for person’s case.”
Baroness Blackwood of North Oxford
That this House do agree with the Commons in their Amendments 26 to 40.
“(1A) The person who makes the determination need not be the same as the person who carries out the assessment.”
Baroness Blackwood of North Oxford
That this House do agree with the Commons in their Amendment 41.
“(c) the arrangements provide for the cared-for person to receive care or treatment mainly in an independent hospital, or
(d) the case is referred by the responsible body to an Approved Mental Capacity Professional and that person accepts the referral.”
Baroness Blackwood of North Oxford
That this House do agree with the Commons in their Amendments 42 to 56.
Mental Health: Eating Disorders
Baroness Blackwood of North Oxford Excerpts(5 years, 10 months ago)
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Baroness Parminter
To 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.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
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.
Baroness Parminter (LD)
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?
Baroness Blackwood of North Oxford
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.
Baroness Finlay of Llandaff (CB)
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.
Baroness Blackwood of North Oxford
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.
Baroness Chisholm of Owlpen (Con)
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.
Baroness Blackwood of North Oxford
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.
Baroness Thornton (Lab)
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?
Baroness Blackwood of North Oxford
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.
Baroness Bull
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?
Baroness Blackwood of North Oxford
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.
Lord McColl of Dulwich
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.
Baroness Blackwood of North Oxford
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.
Baroness Walmsley (LD)
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?
Baroness Blackwood of North Oxford
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.
Healthcare (International Arrangements) Bill
Baroness Blackwood of North Oxford ExcerptsThursday 21st February 2019
(5 years, 10 months ago)
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Baroness Thornton
The 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.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
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.
Lord Foulkes of Cumnock
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?
Baroness Blackwood of North Oxford
The noble Lord is right to expect that I will take these questions away and consider them.
Lord Marks of Henley-on-Thames
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.
Baroness Thornton
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.
Baroness Blackwood of North Oxford
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.
Baroness Thornton
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.
Baroness Blackwood of North Oxford
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.
Lord Lansley
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.
Baroness Blackwood of North Oxford
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—
Lord Hain
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.
Baroness Blackwood of North Oxford
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—
Lord Wallace of Tankerness
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?
Baroness Blackwood of North Oxford
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.
Baroness Humphreys
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.
Baroness Wheeler
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.
Baroness Blackwood of North Oxford
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.