Medicines and Medical Devices Bill (Second sitting)

Alex Norris Excerpts

Committee stage & Committee Debate: 2nd sitting: House of Commons
Monday 8th June 2020 Public Bill Committees

[The Chair]

As I mentioned this morning, I remind Members to respect social distancing guidance. I will intervene if necessary to remind people of that. I also remind Members that tea and coffee are not permitted in Committee sittings and to ensure that their mobile phones are switched off or switched to silent mode. Finally, the Hansard reporters would be very grateful if Members could email copies of their speaking notes to [e-mail].

Clause 5

Fees, offences, powers of inspectors

[Alex Norris (Nottingham North) (Lab/Co-op)]

I beg to move amendment 11, in clause 5, page 3, line 39, at end insert—

“(1A) The Secretary of State must publish a fees regime within three months of the date on which this Act receives Royal Assent.”

This amendment requires the Secretary of State to publish their proposed list of fees in respect of human medicines.

It is a pleasure to resume serving under your chairship, Mr Davies. We move to the rapid-fire round, which will almost inevitably lead to me at some point giving a speech to a previous or future amendment—I am sure colleagues will be gentle and generous with me when I do so. This short probing amendment relates to fees in the discharge of the human medicines sphere. The principle is that, in the exercising of clause 1(1) it is conceivable that the Secretary of State, the Department and the Government in general will incur costs, so clause 5(1)(a) allows for provision to be made to exercise a function to charge for that, which makes perfect sense.

The Medicines and Healthcare Products Regulatory Agency has previously worked on a cost recovery basis, which makes a lot of sense, but the amendment is designed to test whether it would not be better to have a comprehensive, clear and consistent fees regime. The MHRA and the Government in general have a tough job against a potential occasional big foe in the pharmaceutical industry—or big partner to work with, at least. I assume, but would like to hear from the Minister on the record, that the expectation is that there will be equal pay for an equal job, so a bigger firm that is better equipped to lobby would not end up paying smaller fees than a smaller firm, simply because that firm was better at arguing or making its case. Is cost recovery still in general the preferred option? If so, might it not strengthen the Secretary of State’s hand if that were put in the Bill?

[The Parliamentary Under-Secretary of State for Health and Social Care (Jo Churchill)]

It is a pleasure to be back this afternoon. I am grateful to the hon. Member for raising the important issue of fees in his amendment, and I recognise the intent of that probe. I am sure we agree that it is important that all new fees for human medicines are set in an open, fair and transparent way. I want to reassure him that what the amendment seeks to achieve is already standard practice and is happening. I will rapidly set out the steps already in place to ensure the fairness, openness and transparency that underpin the fees regime for human medicines.

The current fees have been subject to consultation and are provided for in legislation. They are published online and publicly available at gov.uk. All of that is supported by a formal and standardised process for reviewing existing fees and for the introduction of new fees for human medicines. The standard approach for setting statutory fees is full cost recovery, as the hon. Member alluded to, which means that fees must be set at a cost that reflects the activity involved in carrying out such a specific regulatory function.

The full cost recovery approach is set out by Her Majesty’s Treasury in its “Managing public money” guidance, which ensures that the Government neither profit at the expense of consumers nor make a loss for taxpayers to subsidise. Therefore, fees cannot be set arbitrarily, and the fee must reflect the cost of the regulatory work carried out. I think that goes some way to addressing the hon. Member’s probe on size.

Existing fees for human medicines are kept under active review by the Medicines and Healthcare Products Regulatory Agency. The amendment is specifically concerned with new fees that might be introduced under the powers in the Bill. It is already a requirement that new fee proposals are subject to consultation, and that duty continues for fee proposals under the Bill. We will publish impact assessments with the new proposals, which will set out the effects of any changes to fees in the UK on Government, industry or the general public. Her Majesty’s Treasury will be engaged throughout the fee proposal process, and any proposals for new fees will be subject to approval from HMT. It is also standard practice for the MHRA to engage with industry and trade bodies through regular meetings to discuss any new fee proposals that might be coming up.

I trust my explanation has reassured the hon. Member for Nottingham North that the requirements are and will continue to be in place so that fees for human medicines are fair, open and transparent. I therefore ask him to withdraw his amendment.

[Alex Norris]

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

[Jo Churchill]

Clause 5 provides that changes can be made to the law relating to human medicines with respect to fees, criminal offences and the powers of inspectors. Regulations made under clause 1(1) allow us to change the UK’s regulatory framework for human medicines as science, technology and clinical needs evolve. When the regulatory regime is updated, it is important that the regulator—in this case, the MHRA—can continue to regulate effectively and maintain compliance with all elements of the regime. To ensure this, it may be necessary to make provision about charging fees, creating criminal offences, and updating inspectors’ powers when making changes to the regulatory regime. Regulations made under clause 1 and relying on clause 5 will enable us to do this. We will consult before making any of those changes.

Clause 5(1)(a) allows us to make provision about the charging of fees. The regulator is self-funding for the purposes of medicines regulation. This work includes assessment for marketing authorisations and clinical trials of human medicines and inspections. It is funded by fees payable by the pharmaceutical industry in relation to the services and regulatory work provided. The current fees are set out in the Medicines (Products for Human Use) (Fees) Regulations 2016 and vary according to the specific areas of work.

It is important that existing fees can be amended, or fees can be introduced in connection with the MHRA exercising functions conferred by human medicines provisions as they evolve. Any proposal to introduce new fees is subject to consultation. The impacts on industry, Government and the general public would be evaluated through the usual process of an impact assessment. As part of its regulation of human medicines, the MHRA is able to impose criminal sanctions for certain regulatory breaches. As the regulatory regime is updated in future, it is important that we have the ability to also update the corresponding list of offences against which the MHRA can take action.

Clause 5(1)(b) allows us to create criminal offences with a maximum of two years’ imprisonment to cover updated requirements to supplement the evolution of the regulatory regime. MHRA inspectors play a critical role in ensuring compliance so that medicines are safe and effective for patients, and so that manufacture, research and surveillance processes are carried out to recognised standards. Inspectors already have all the powers to enter premises at any reasonable time to determine whether there has been a contravention of medicines regulations. For example, they may take samples or copies of documents if it is suspected that an offence has been committed. We have published two illustrative statutory instruments to demonstrate how provision can be made in regulations, relying on clause 5(1)(b) in combination with subsections of clause 2, to create a criminal offence for failing to comply with the new requirement set out in the regulations.

Clause 5(1)(c) allows us to update the relevant powers of entry and other powers of inspectors to align with new elements of the regulatory regime as it evolves. I commend the clause to the Committee.

Question put and agreed to.

Clause 5 accordingly ordered to stand part of the Bill.

Clauses 6 and 7 ordered to stand part of the Bill.

Clause 8

Power to make regulations about veterinary medicines

[Alex Norris]

I beg to move amendment 12, in clause 8, page 5, line 17, at end insert “services.”

This amendment broadens the range of issues that the Secretary of State must consider to include access to the relevant services to dispense veterinary medicines.

I did not want us to miss out the veterinary medicines part of the Bill, because it is important. We are a nation of animal lovers and we are keen that the laws we make are sympathetic to all living beings. The issue was also raised on Second Reading, because it has an impact on the food chain, so we must be mindful of setting an effective regime, as I know the Government are keen to do.

The amendment is simple. Again, I hope that it is redundant, but I want to test that with the Minister. There is a clear read-across between parts 1 and 2 of the Bill, which is that the powers being reserved for human medicines are largely the same as those being reserved for veterinary medicines. The word that I would like to be added in clause 8(2)(b) after

“the availability of veterinary medicines”

is “services”, because one way in which veterinary medicine differs from human medicine is that we do not have a universal service, so that access point is an important consideration for the Secretary of State.

I have not drafted the amendment elegantly enough. When we get to amendment 13, we will discuss something called the cascade, which was new to me until a couple of weeks ago. The principle of the cascade is that, whereas in human medicine we have expectations that certain medicines will be used to treat certain conditions and doctors do not have a massive amount of latitude to go outside that, in veterinary medicine, if such a thing is not available, the veterinarian can fall down the chain and use a different painkiller—perhaps a human painkiller. That is obviously important.

I wonder—and this is what I am testing with the amendment—whether that creates a possible inequity. If there is better access to veterinary medicines or supplies in certain communities, perhaps rural versus urban, that could create not a two-tier service, but a slightly different service from the one we want. It would therefore be useful for the Secretary of State to have regard to the services, as well as the physical ability to get pills, potions or whatever. That is all the amendment seeks to test and I am interested to hear what the Minister says.

[Jo Churchill]

I am grateful to the hon. Gentleman for raising the important issue of the availability of veterinary medicines. The intention is clear: to ensure continued access to veterinary medicine equitably for all the nations’ animals.

The Bill provides the power to amend or supplement the Veterinary Medicines Regulations 2013, which cover the full supply chain of veterinary medicines from development to supply. The requirement for the appropriate authority to have regard to the availability of veterinary medicines, as set out in clause 8, therefore ensures that when making regulations under the clause, the availability of veterinary medicines throughout the supply chain is considered.

Although the intended effect of amendment 12 is to expand on those factors, the actual effect would be to inadvertently narrow their scope to focus only on the availability of veterinary medicines services, such as the dispensing of veterinary medicines, rather than the availability of veterinary medicines more widely and more equitably. Veterinary medicines services alone are not the determining factor in the availability of veterinary medicines.

Clause 8, as drafted, ensures that the appropriate authority must have regard to the availability of veterinary medicines throughout the supply chain, so that the rural versus urban comparison the hon. Gentleman used would not be a comparator and medicines would be equally available. I therefore ask him to withdraw the amendment.

--- Later in debate ---

[Alex Norris]

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

--- Later in debate ---

[Jo Churchill]

Clause 8 provides the power to amend or supplement the Veterinary Medicines Regulations 2013. Subsection (1) gives the appropriate authority a power, by regulation, to make amending or supplementing provision within the scope of the matters set out in clauses 9 and 10. The appropriate authority may use this power only to build on—in other words, amend and supplement —the current regulatory framework for veterinary medicines. Clauses 9 and 10 set out an exhaustive list of matters about which regulations could be made on veterinary medicines. An in-depth explanation of those clauses will be shared with the Committee throughout the course of these sittings.

Subsection (2) sets out three matters to which the appropriate authority must have regard when making regulations under clause 8: the safety of veterinary medicines in relation to animals, humans—including consumers of produce from treated animals—and the environment; the availability of veterinary medicines; and the attractiveness of the relevant part of the UK to industry for developing or supplying veterinary medicines. Subsection (3) explains that

“the relevant part of the UK”

depends on where the UK regulations will apply. The environmental safety aspects could include considering the potential impact of veterinary medicines on terrestrial and aquatic eco-systems and their flora and fauna—for example, the environment can also be affected by slurry application and excretion by grazing animals.

Subsection (4) sets out the appropriate authority for the purposes of regulations made under clause 8(1). The appropriate authority able to exercise this delegated power for England, Scotland and Wales is the Secretary of State. For Northern Ireland, the appropriate authority is either the Department of Agriculture, Environment and Rural Affairs in Northern Ireland acting alone, or the Secretary of State and the Northern Ireland Office acting jointly. This means that the powers can be exercised on their own, as well as jointly on a UK-wide basis.

[Alex Norris]

I will speak briefly to new clause 5. I was happy to withdraw amendment 12, but the principle was about trying to ensure that there is equitable access to services, because that is how veterinary medicine differs from human medicine. New clause 5 follows that principle through to its logical conclusion. This may have been done; I have been looking but have been unable to find it. I am sure the Secretary of State for Health and Social Care has seen hundreds and hundreds of health equity audits: how are things in Nottingham different from in Shipley, and how does that impact on health outcomes? For all the reasons I mentioned at the beginning, I wonder whether it is the same in the veterinary industry and whether there are regional, rural-urban and north-south disparities that mean access is different. The potential fall-outs from that are worth considering.

The new clause is intended to probe and to see whether the Government have that sort of information. If so, maybe they could let us see it—either shortly or during the rest of the proceedings on the Bill.

[Jo Churchill]

I am grateful to the hon. Member for raising the matter of capacity within the veterinary industry as it stands, in order to provide equity throughout. I recognise that he has given us examples of north-south disparities and so on, and I recognise the good intentions behind the new clause and his desire to ensure that the veterinary industry is working to full capacity and in unanimity across the piece. We agree that vets are an essential part of our animals’ lives and a key component of the UK system of protecting food safety, providing international assurance and upholding standards in welfare.

The Government are already working with various veterinary sector stakeholders, including the Royal College of Veterinary Surgeons and the British Veterinary Association, to understand the UK’s veterinary resourcing needs and ensure that there are adequate numbers of vets in the short and long term. We are working with a variety of initiatives to build a sustainable, diverse and modernised UK veterinary infrastructure to ensure that we maintain access to the right people, with the right skills and knowledge, supporting food safety and animal health and welfare, as well as trade. DEFRA has successfully secured a place for the veterinary profession on the Home Office shortage occupation list, and we are grateful to the Royal College of Veterinary Surgeons and British Veterinary Association for their work on the issue. It makes it easier for veterinary employers to gain visas.

To turn to specifics, as Members will know, the Bill introduces a statutory duty to consult before making changes to the Veterinary Medicines Regulations 2013. That consultation duty, in clause 40, requires that the appropriate authority must, before making regulations, consult those it considers appropriate. That is the most suitable route for ensuring that all those in the veterinary industry who need to be consulted are included. We are working across Government and with the veterinary profession to help to develop a flexible, skilled workforce that meets UK needs and irons out disparity of service. I want to assure the hon. Member for Nottingham North that it is a key priority to enable an innovative, productive and competitive veterinary medicine sector that invests in its people and skills. To help to achieve that, we shall ensure that there is access to sufficient appropriately skilled labour to drive continued industry growth and productivity, while ensuring that the environment for humans and animals is safe.

[Alex Norris]

I appreciate that answer, and the detail in it. I guess the only way in which I would supplement my questions is to ask that, once the fruits of the work with the relevant stakeholder bodies are available, they should be shared. That would be of great interest to Members on both sides of the House.

Question put and agreed to.

Clause 8 accordingly ordered to stand part of the Bill.

Clause 9

Manufacture, marketing, supply and field trials

[Alex Norris]

I beg to move amendment 13, in clause 9, page 6, line 11, at end insert—

‘(1A) The Secretary of State must by regulations make provision about the use of the Cascade.”

This amendment gives the Secretary of State the responsibility to make provisions regarding the Cascade, a process where veterinarians can dispense different medicines to animals, such as human medicines, should appropriate conventional animal medicines not be available.

I have buried the lede, obviously, by talking about the cascade already; but I am interested to hear a little more detail about the Minister’s vision for the cascade. It is obviously an entrenched principle across the European Union, and an industry standard. It has a significant impact on the lives of animals and, by proxy, humans as well. It seems to me an important principle, but it is not on the face of the Bill. The Government would, on Royal Assent, have the immediate ability to diverge away from the cascade quite quickly, but I wonder about the safety of that and whether that is in the Government’s plans. It was not in the impact assessment, so I am keen to scope out whether we expect the cascade to continue to be a principle in this country, and, if so, whether we expect our cascade to reflect closely the one used by our EU counterparts.

[Jo Churchill]

A clause or so back, the hon. Gentleman gave us a snapshot of what a cascade is, and I do not think I could put it better. My notes say that veterinary surgeons can prescribe gabapentin, a human medicine, to treat chronic pain in animals, particularly if it is of a neuropathic origin, as there is no equivalent in veterinary medicine. As the hon. Gentleman said, the cascade is about making sure that there is something in the veterinarian’s bag to enable appropriate care to be given to animals.

I am grateful to the hon. Member for Nottingham North and to the hon. Member for Central Ayrshire, who I think also signed the amendment, for raising the important issue of the prescribing cascade. However, not only is the amendment not necessary, but I argue that it could be unhelpful in certain instances. I recognise the desire to ensure that the use of prescribing cascades is regulated. The cascade enables veterinary surgeons to have access to a wider range of medicines to treat animals under their care and, in particular, to prevent the unacceptable suffering that might occur if they could not prescribe those alternatives.

The provisions with regard to the cascade are set out in schedule 4 to the Veterinary Medicines Regulations 2013 and the Bill already confers discretionary powers that would allow the appropriate authority to decide, following consultation, whether and how cascade requirements in the existing regulations might be amended in the future. That is provided for in clause 9(1), for the professionals to decide, arguably.

The amendment as drafted would appear to obligate the Secretary of State to update the regulations with regard to the cascade, as opposed to making those changes when it is appropriate to do so, and evaluate the cascade above other important aspects of the veterinary medicines regulatory framework. Although the cascade is important, it is our position that the regulations should be updated when it is clear and necessary to do so, rather than operating under a compulsion to do so for any one element, as putting it in the Bill might lead to. In that light, I ask the hon. Gentleman to withdraw it.

[Alex Norris]

I am happy to withdraw the amendment on that basis. The point of putting it in was to shoehorn the subject into the conversation, which was obviously effective. I did not hear from the Minister whether she felt that we are likely to continue to reflect the EU arrangements on that. Given that it is novel and specific to this area of medicine, and given that it is not risky, but diverges from what we consider basic medical practice in humans, it is of interest to people.

Perhaps now is not the moment to hear about the Government’s plans to reflect, or not, the judgments made by EU colleagues in future, but I hope that, over time, we can continue to have that conversation because I think there is public interest in that. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

[Jo Churchill]

On amendment 13, I will write to DEFRA to seek clarification for the hon. Gentleman if that would be helpful. As we move through the Bill in the spirit of co-operation, I am more than happy to continue the conversation.

Clause 9(1) provides that amendments may be made to the Veterinary Medicines Regulations 2013 about the manufacture, marketing, supply and field trials of veterinary medicines. The Committee will note that in large part, clause 9(1) makes very similar provision to clause 2(1). I will take each subsection of clause 9(1) in turn.

Subsection (1)(a) sets out that the regulations made under the power in clause 8(1) may make provision about authorisations to manufacture veterinary medicines. The subsection means that it will be possible to update the rules around manufacturing authorisations—for example, to reflect the latest scientific advances in manufacturing and to address the manufacture of novel and innovative veterinary medicines. The subsection is therefore needed to future-proof the regulatory regime.

Subsection (1)(b) allows provision to be made about authorisations to import veterinary medicines, which is needed to continue to secure supply chains for those medicines entering the UK. By updating our existing regulatory framework, we can maximise the availability of veterinary medicines, while taking care that our approach does not place an additional burden on those who import medicines. Such a change can benefit animal owners, as it can lead to quicker access to veterinary medicines, a point that my hon. Friend the Member for Penrith and The Border brought up on Second Reading. We could use the subsection to allow additional professions, for example veterinary nurses, to import certain types of veterinary medicines with appropriate controls.

Subsection (1)(c) allows for provision to be made about authorisations to distribute veterinary medicines by way of wholesale dealing, which would ensure that we can provide further assurance on the quality and security of the full distribution chain for veterinary medicines. We could, for example, amend the application process for a wholesale dealer’s authorisation, supplement the requirements that must be met by the holder of such an authorisation, or amend the exceptions to the requirements for an authorisation.

The subsection could also be used to change the requirements for a wholesale dealer’s authorisation to cover new and novel products that may have new or additional storage and distribution requirements. That would maintain the quality and security of the distribution chain for such veterinary medicines and ensure that they are stored appropriately and safely throughout.

Subsection (1)(d) allows for provision to be made about marketing authorisations for veterinary medicines. This would help to ensure that the UK remains an attractive place for the pharmaceutical industry to bring to market both new and established medicines, and that UK animal owners do not have to wait for new, innovative or generic veterinary medicines. As an example, regulations could offer statutory rewards or incentives for certain types of applications for marketing authorisation.

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Fees, offences, powers of inspectors, costs

[Alex Norris]

I beg to move amendment 14, in clause 10, page 6, line 35, at end insert—

‘(1A) The Secretary of State must publish a fees regime within three months of the date on which this Act receives Royal Assent.”

This amendment requires the Secretary of State to publish their proposed list of fees in respect of veterinary medicines.

This amendment is substantially the same as amendment 11, but it relates to veterinary medicines rather than to human medicines. So, assuming that the answer will be pretty much the same as for amendment 11, I do not really want to labour the point.

[Jo Churchill]

The short answer is probably yes, but I will just give the hon. Gentleman half a page of explanation.

I recognise that, as before with amendment 10, amendment 11 would ensure transparency, in essence, on fees that stakeholders may have to pay with regard to veterinary medicines, such as fees for marketing, manufacturing and distribution. The fees relating to veterinary medicines are set out in schedule 7 to the Veterinary Medicines Regulations 2013, and the power in the Bill is to amend the fees where necessary, rather than to create anything new. Indeed, it is unlikely that any new or amended fees would be introduced within three months following Royal Assent. The fees are already published online and are publicly available on the gov.uk website, as I mentioned earlier.

Therefore, the amendment would create an obligation for the Secretary of State simply to republish the existing fee regime, which is already publicly available; hence the continuity element. Any proposal to amend fees or to introduce new fees would be subject to consultation. In addition, potential impacts on businesses or organisations based in the UK would be evaluated through an impact assessment, which would also be made publicly available during the consultation process.

In light of that explanation, I cordially ask the hon. Gentleman to withdraw his amendment.

[Alex Norris]

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

[Jo Churchill]

Clause 10 provides that regulations made under clause 8(1) may make provision about charging fees, criminal offences and powers of inspectors. It enables the recovery of costs incurred in the administration of improvement or seizure notices under the Veterinary Medicines Regulations 2013.

We need to ensure that the regulator—the Veterinary Medicines Directorate, which I will now call VMD for ease—can continue to effectively regulate and confirm compliance with new or updated elements of the 2013 regulations. Therefore, it may be necessary to make appropriate changes to fees, offences and inspectors’ powers before making any such change; as I have constantly said, consultation will take place if that is the case.

The VMD is required to recover the costs of the regulatory services that it provides from fees and charges. It is important that existing fees can be amended or that fees can be introduced to meet the cost of functions exercised by the VMD. An essential part of protecting animal, human and environmental safety is ensuring compliance with the Veterinary Medicines Regulations 2013. The existing regime imposes criminal sanctions for breaches of the regulatory framework. This clause would allow for making the breach of requirements or prohibitions introduced under clause 8(1) a criminal offence, punishable by imprisonment of up to two years.

VMD inspectors play a critical role in ensuring compliance with the 2013 regulations, helping to ensure that medicines are safe and effective for animals by monitoring their manufacture and supply. Inspectors already have powers to enter premises at a reasonable time to ensure compliance with the 2013 regulations. Clause 10 would allow for the extension of existing powers of entry and inspection to new prohibitions and requirements introduced by regulations made under the Bill.

Subsection (2) provides that regulations made under clause 8(1) may not confer a power of entry to premises used wholly or mainly as a private dwelling, unless those premises or any part of them are approved, registered or authorised for the sale of veterinary medicines under the 2013 regulations.

I commend clause 10 to the Committee.

Question put and agreed to.

Clause 10 accordingly ordered to stand part of the Bill.

Clause 11 ordered to stand part of the Bill.

Clause 12

Power to make regulations about medical devices

[Alex Norris]

I beg to move amendment 15, in clause 12, page 7, line 27, at end insert—

“(d) the environmental sustainability of medical devices.”

This amendment obliges the Secretary of State to pay regard to the environmental impact of medical devices.

This is the “climate in all policies” amendment. We are in the middle of a global pandemic—an extraordinary time that we will all remember for the rest of our lives —but we are also in the middle of a climate emergency. Obviously, that was uppermost in all our thoughts a few months ago, and it must not fall down the order of priorities, because a similar existential threat exists as existed six months ago and it behoves us to act on it.

Amendment 15 is the first one relating to medical devices. To the principle that applies throughout the Bill of safety, availability and attractiveness, I think it would be suitable to add environmental sustainability, given that the types of materials used to create these devices could be finite resources. There could be opportunities for things to be reusable where they might at the moment be single use. I thought it important to probe this to see what the Government are doing, and could be doing, to ensure a medical devices market that promotes sustainability where that is responsible.

After tabling the amendment, I had a couple of emails from people making very fair points about things that could not be reusable. Of course, that applies to very many things in medicine; it is a very basic principle. I am very mindful of that. It is why the explanatory statement says “pay regard”. However, I think that the two things are compatible. There will be contexts where things that are currently single use do not have to be single use. I think that we should be seeking to promote that. There will be contexts where the market and the industry should be under pressure not to use finite resources, but to use all the considerable innovation to find other solutions. I feel that if Governments do not drive that in shaping the market, nobody else will. There should be pressure for, or at least interest in, buying British, for a variety of reasons. As well as being good for jobs and our local economies, that would be very good for reducing travel miles and therefore for sustainability. We have to decarbonise every industry we possibly can, so that applies to this industry also.

This is a basic principle that I seek in every policy—even though it might be a bit boring to hear me go on about it. We have to say, “But what about the climate? What about climate change?”. I think that this is the point in the Bill at which to do that. I would be interested to hear the Minister’s views on it, but also to hear what the vision is for shaping this market so that it is as sustainable as it can be.

[Matt Western (Warwick and Leamington) (Lab)]

My hon. Friend makes a very important point about sustainability, and of course linked to that is durability—the durability of the materials used in devices, particularly if a device is actually put into the human body. Of course, the durability is down to not just the effectiveness of the device or implant, but the cost to the health service of any subsequent revisions that may be needed, and so on. That is a significant cost, and therefore my hon. Friend is making an important point.

[Alex Norris]

I thank my hon. Friend for that intervention. It is important to seek quality and build to last, and to be sure that the products that enter the market are the best possible products in the round—not just those that have the best price on the box. There are other considerations of which we have to be mindful, whether they be patient safety, the long-term experiences that my hon. Friend has referenced or environmental sustainability.

[Jo Churchill]

I do not think anybody in the room is unmindful of the issues of environmental impact and durability, but the hon. Gentleman’s point is well made. He alluded to Baroness Cumberlege’s report, which will be out on 8 July. One of the challenges is that when something is implanted in the body, it is often there for a long period of time, and we would not want it to not be durable. That is always a consideration because, for example, we would not want something biodegradable sitting in a moist, wet environment—that product is not going to be doing its job in the long term.

I will address amendment 15, which relates to the requirement on the Secretary of State to have regard to certain factors when making regulations for medical devices. Clause 12(2) sets out those factors as

“(a) the safety of medical devices;

(b) the availability of medical devices;

(c) the attractiveness of the United Kingdom as a place in which to develop or supply medical devices.”

As I understand it, amendment 15 would oblige the Secretary of State to have regard to

“the environmental sustainability of medical devices”

as part of the assurances contained in clause 12(2).

I assure all hon. Members that the Government are fully cognisant of the need to ensure the ongoing sustainability of the environment, and have made major commitments not only on the broader issue of climate change, but to make sure that we are mindful of the reusability or sustainability of the things we use. All of this has to bring us back to the points that were made this morning about the need to be mindful of patient safety and so on. My understanding is that the intent of the amendment relates to the safe and environmentally friendly production of devices, which could include the transportation and sale of those devices, their import, and—where achievable—the reuse of devices after reprocessing. The hon. Member for Nottingham North has mentioned people getting in contact with him to say, “You’re not having my hip after I’ve used it,” but there are cases in which reuse would be appropriate, and we should be mindful of those.

The Bill is designed to support the safety of patients by maintaining a robust framework for the regulation of medicines and medical devices. The medical device regulations that clause 12 seeks to enable focus principally on the standards of pre-market and post-market assessment, as well as the vigilance required when placing devices on the UK market, so that UK patients feel safe about the products they can access. Amendment 15 would require consideration of facts beyond the regulator’s purview and introduce an added burden on the development of regulations, particularly when changes might be needed expediently to address issues of patient safety.

I totally understand the hon. Gentleman’s intention to put these issues at the forefront of our minds. However, I say gently that legislation to protect the environment, such as the Environmental Permitting (England and Wales) Regulations 2016, already exists and runs throughout the statute book, so checks and balances are in place. It is appropriate that manufacturers, suppliers and users of medical devices continue to have regard to the legislation specific to their circumstances, including the appropriate existing regulations that achieve the hon. Gentleman’s aim. I therefore ask him to withdraw the amendment. If the Opposition have points to press—with specific items, for example—they should write to me directly.

[Alex Norris]

I feel that I have made my point. I also discussed veterinary medicine and, with a Whip in the room, it might be misinterpreted that I am making a bid to be a shadow DEFRA Minister—I would not want that to be the sense that the Committee got. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

[Jo Churchill]

Clause 12 provides the power to make changes to the Medical Device Regulations 2002, which regulate medical devices in the UK. Those regulations provide for the assessment of requirements and standards that must be met to place medical devices on the UK market, including in relation to packaging, labelling and user instructions, and for the requirements on manufacturers to conduct post-market surveillance of devices.

The first subsection of the clause is a delegated power allowing the Secretary of State to make amending or supplementing provisions to the Medical Devices Regulations. The exercise of that power is limited to making provisions about matters specified in clauses 13 to 15. Those clauses provide an explicit and exhaustive list of topics and give more detail on how the regulation-making power may be exercised. The Committee will, I am sure, hear in-depth explanations of those clauses during our consideration of them.

Subsection (2) explains that the Secretary of State must have regard to three factors when making provisions under subsection (1): the safety of medical devices; the availability of medical devices; and the attractiveness of the UK as a place in which to develop or supply medical devices. Those three factors must be taken into account, and they have been included to provide reassurance that future provisions are made with the best intentions for the safety of people and patients in the UK, as well as the continued development of our life sciences sector.

[Jo Churchill]

I will not bluff but, off the top of my head, I think that the MHRA would look at medical devices, as it does medicines—I was looking to where my box of officials would normally be. I am fairly sure that the MHRA pays regard to devices, as with the centre at Watford to which the hon. Gentleman alluded. That centre used to do its practices at the Cardington air hangars many years ago, I think, on fire in buildings, for example. Yes, I believe that there is sufficient regulatory oversight to ensure the safety of medical devices.

Medical devices are a reserved matter in relation to Wales, Scotland and Northern Ireland. As a result, unlike the enabling powers at clauses 1(1) and 8(1), regulations made under clause 12(1) can only be made by the Secretary of State.

Question put and agreed to.

Clause 12 accordingly ordered to stand part of the Bill.

Clause 13

Manufacture, marketing and supply

[Alex Norris]

I beg to move amendment 16, in clause 13, page 8, line 22, at end insert—

“(1A) In making regulations under section 12(1), the Secretary of State must evaluate the extent to which the market is meeting medical need.”

This amendment requires the Secretary of State to ensure that the market in devices is keeping pace with the UK’s medical needs.

This is the very nub of the Bill, and of the process of leaving the European Union and transitioning away from the relationship with it. That bears some important consideration, because presumably one does not leave unless one intends to do something differently; otherwise it would not be worth it. What is not clear is whether we intend to do something differently across all pieces, or whether that just happens inevitably over time because others choose to do something within this topic area and we, by default, do not and we start to diverge.

We could make this argument for medicines, but I have restricted it to medical devices because I think it only needs to be discussed once, and it is more easily conceivable and easier for me to explain my case when we talk about medical devices. I wrenched my wrist a few weeks ago, so I went to find some wrist support. I was thinking about it in this context, because I was starting my prep for the Bill, and it is striking how I started to see things on the box that perhaps I would not previously have seen or was not looking for, about all the different codes and regulations. The schedules to the Bill have a whole litany of them, and every medical device has some configuration of them on there.

In the future that will change, or at least the Secretary of State will be able to make that change. He can make it more complicated, much easier or more onerous, depending on our perspective; but it is almost inevitable, if only by the passage of time, that it will diverge from our friends on the continent. At that point, we create a market force. We know that companies developing medical devices will now have to make a choice about how they span the two markets. Of course, these issues have had hundreds of hours of parliamentary time, so I do not intend to rehash them much further, but I think there is a legitimate anxiety about the risk—and there must be a risk—that manufacturers prioritise the EU market over us and therefore we are behind in the queue and cannot get access to meet medical need.

The purpose of amendment 16 is to be clear about that, because that will give us a chance to do something about it as a Parliament, and for the Government it will act as a call to action. The amendment asks the Secretary of State to keep the matter under constant evaluation. I am perhaps willing to take the point that any responsible Secretary of State would do so anyway, but I would like to hear that it will be uppermost in the Government’s mind.

The changes we make are driven by the things we have talked about, which we see repeated for a third time under medical devices: safety, availability and attractiveness. We understand that, but because those changes could be very small, there could be a butterfly effect where we change something on a leaflet, or a badge that has to go on a box, and thus create a “Sliding Doors” moment where we start to diverge in different places. Then there will be a choice, and manufacturers will have to try to work out whether they prioritise bigger markets or smaller ones, or try to do something that pleases everybody.

I would be interested to know what conversations have happened with manufacturers and what lobbying of Government they have done about the sort of regime they want, because that is the substance of this Bill. The Bill remains a blank canvas for Ministers to paint on later; we are taking a leap of faith with Ministers here, and that is why we have sought to restrict that. It is worth understanding this, because it is one of the most profound implications of the Bill, and I am keen to know from the Minister how it has been mitigated and, importantly, how, and how actively, it is being considered.

[Jo Churchill]

Once again, I understand fully the intention of the amendment: to tease out the fact that small, incremental changes might lead to a divergence further down the line. However, I gently say that the purpose is to enable, so that, come January, we are in exactly the same place.

I will also say that innovation is a two-way street.An example is our ability to publish online to help people who might find it difficult to read the small print on paper in a packet of medicines, or who might be better able to understand from pictures how a device can be enabled or can help them. There is the chance, once we are in January 2021, to make those positive movements. That may lead to the Europeans looking and thinking, “Actually that would be useful.” There is no unique place for the good idea—I think that that is what I am gently trying to say. There is no place for a particular divergence, and we would not want there to be. As I said, there is consultation with stakeholders and the industry to be done on the exact points that have been alluded to.

--- Later in debate ---

As I have noted, clause 12(2) already seeks to ensure that the safety of medical devices, their availability and the attractiveness of the UK as a place to supply and develop them are at the forefront of medical device regulation in the UK. On that basis, I ask the hon. Member for Nottingham North to withdraw the amendment.

[Alex Norris]

I am happy to leave this matter for now; we might come back to it on Report or Third Reading.

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Alex Norris]

I beg to move amendment 17, in clause 13, page 8, line 22, at end insert—

“(k) enabling the Secretary of State to compile a register of representatives for non-UK manufacturers.”

Manufacturers of medical devices based outside the UK must designate a UK representative. This gives the Secretary of State the power to compile a list of them.

This is a brief and probing amendment based on something I picked up on the road, as it were, while talking to people in the sector about what they wanted to see from the Bill and the areas that we ought to go at. I have not been able to quite stand it up in the way that I would have liked, but I am sure the Minister will humour me, in the spirit of an open constructive dialogue.

At the moment, a medical device manufacturer that is not based in the UK has to have a UK representative—and it makes absolute sense that there should be someone who is accountable for the manufacturer’s actions and the impact of its products. However, the suggestion is that there may be inconsistencies as to who that person is, whether they are a genuine person of corporate interest in the company who is in a position to make or shape decisions or whether they were an appointee almost like a paper candidate. I picked that up in a couple of places, but it is anecdotal rather than something I could stand up, despite having done quite a bit of digging. I would be keen to know whether the Minister recognises that characterisation, or at least that risk.

I have not pushed the point too far in the amendment. All I am asking is that the Secretary of State would be able to make a register for the purposes of transparency. One of the suggestions was that an individual might be acting as a representative for multiple manufacturers, and that a register would help tease that out and give us a bit of transparency. I appreciate that there may be commercial sensitivities or personal identity issues, but I am sure that such issues could be managed in a sympathetic way. Indeed, I have not suggested any obligation that the register be public.

I am interested in the concept. Do we think it is a risk, and as we move into this brave new world, is this a chance to try to close that loop? Perhaps there is a better way to do it. I am interested in the Minister’s views on that.

[Jo Churchill]

I am grateful to the hon. Member for mentioning the importance of establishing a UK device register that records UK representatives for non-UK manufacturers. We have actually spoken more broadly, but we both appreciate—as does the hon. Member for Central Ayrshire—that it is something on which we will probably need to have broader discussions in order to go forward.

First, I will look at the spirit of the amendment. I recognise that there is a desire to strengthen the Secretary of State’s ability to conduct market surveillance by including in the Bill a power to compile a register of representatives for non-UK manufacturers. I wish to reassure hon. Members that the regulation-making powers in the Bill are sufficiently robust to enable the Secretary of State to conduct effective market surveillance. In particular, clause 13(1)(h) empowers the Secretary of State to make provision for the creation of a device register. Discussing how that is to be done is the next step. As hon. Members can see, the intention is already laid out.

The register would hold information about the medical devices that become available for sale on the UK market. That could include information on non-UK manufacturers, if they have devices that are sold within the UK on the UK market. Government policy is to record the responsible person for all devices available on the UK market after the transition period. Furthermore, current registration requirements allow the Secretary of State to record manufacturer information for the lowest-risk devices, custom-made devices and all in vitro diagnostic devices in the UK. Mandatory registration with the MHRA provides a level of additional scrutiny on such products that would otherwise be absent.

The Bill provides a power to expand current registration requirements to deliver a more comprehensive record of information about a wider range of medical devices entering the UK market, in order to support the role of the MHRA and its post-market vigilance activity. The will is there but, as the hon. Member for Nottingham North knows, I am very keen that we get such a register, registry or data collection, over which there is already quite a lot of confusion out there. We need to work hard with clinicians and others to ensure we get this right. On that basis, I ask the hon. Member for Nottingham North to withdraw the amendment.

[Alex Norris]

I really appreciate that answer, and I appreciate the Minister’s commitments outside the Chamber—her work with me and the hon. Member for Central Ayrshire, whom we are all missing and who would have contributed considerably to our proceedings but cannot, for a very good reason. There is room in the space of registration. That is obviously one narrow aspect of it, so I am happy to withdraw the amendment in order to pursue the greater prize. There are subsequent amendments in my name that also look at this issue. As the Minister says, it is very complicated and there are myriad different aspects. It is potentially a barrier. It needs to be done well; otherwise, it would be a barrier to trade, which would be bad. The opportunity to come together and to hear from clinicians—to do this once and do it right—is a big prize, and I will certainly be keen to provide support in any way I can. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

[Jo Churchill]

Clause 13(1), which is similar to clause 2(1) on human medicines, provides for amending supplementary provisions to be made to the medical devices regulatory framework. Clause 13 lists the matters relating to the manufacture, marketing and supply of medical devices that may be under clause 12(1). The list is exhaustive in order to provide clarity.

Paragraphs (a) to (d) of subsection (1) provide the changes that can be made to regulatory requirements, which must be met before a product can be placed on the UK market, and outlines who can make such an assessment. The provision includes requirements about the characteristics of devices, such as design, manufacture and packaging, and the requirements placed on people involved in the marketing and supply of devices. Those paragraphs also allow for changes to be made to the rules governing the appointment of a specified person or persons, UK-based or not, to assess and certify that medical devices meet all relevant requirements. Changes may be made to conformity assessments, which are assessments of whether requirements, which could include conforming to agreed standards, have all been met. Under subsection (1)(e) and (f) provision could be made about the information to be provided to demonstrate that a device has met regulatory requirements. That could include specifying declarations that manufacturers must make, or certificates that must be provided, to show that a device has been through the appropriate kind of conformity assessment.

Clause 13(1)(g) enables provision to be about labelling, packaging, and information requirements for devices. That might, for example, include specifying warnings or expiry dates that must be included on the label or packaging for a device, and what information to include in the instructions for the use of the device.

We have considered additional ways in which we can improve our regulatory system to improve patient safety and aid market surveillance activities undertaken by the Medicines and Healthcare Products Regulatory Agency. One is the provision made in clause 13(1)(h), which would empower the Secretary of State to make registration requirements for devices marketed in the UK about the registration of devices and their manufacturers and suppliers, including information—this is probably our starting point—to be entered in a register. That is where I do not want the landscape to get confused. It is important that the register sits as that important piece.

Regulations made under clause 12(1) and relying on clause 13(1)(h) will enable the MHRA to create a register of medical devices available on the UK market. That could be requirements to increase the scope of current registration rules. Currently the lowest risk class of device—where they have been self-assessed by the manufacturer rather than assessed by a notified body—is required to be registered with the MHRA. Specified information in such a register, which would not include commercially sensitive information or personal data, could be made publicly available under clause 13(1)(h)(iii), allowing clinicians and patients access to information on the device that they intend to use. Again, there would be transparency.

Under clause 13(1)(i) and (j) changes could be made to the rule around investigations and evaluations for safety, performance and clinical effectiveness, and monitoring of performance through market surveillance. Having the ability to update the rules is essential to maintaining patient safety standards.

The UK does not operate in isolation to the rest of the world, and we have provided at subsection (2) that, where regulations are made relating to matters in clause 13(1)(a)—requirements that must be met in relation to medical devices—those requirements can refer to international agreements or standards for marketing or supplying medical devices.

Question put and agreed to.

Clause 13 accordingly ordered to stand part of the Bill.

Clauses 14 to 16 ordered to stand part of the Bill.

Ordered, That further consideration be now adjourned.–(Maggie Throup.)

Human Tissue

Alex Norris Excerpts

Tuesday 19th May 2020 Commons Chamber

[Alex Norris (Nottingham North) (Lab/Co-op)]

I have to say that I am used to clearing rooms when I start speaking, but this is quite impressive even by my own standards. Nevertheless, it is a privilege to make my debut at the Dispatch Box as shadow public health Minister on a topic as important as this one. Currently, everything we are addressing is a matter of life and death, but when we are talking about critical transplants, that could never be clearer.

I thank the Minister for everything she is doing during this crisis, not only on this particular issue but on everything related to protecting us from the coronavirus. She and her ministerial colleagues are working around the clock and have been doing so for weeks; we appreciate that.

This is my first opportunity to express publicly in this place my thanks to our NHS and social care staff for all the wonderful things that they are doing in my community and communities up and down the country to keep us as safe as possible.

We clap with you on a Thursday, but we think about you always and we are really grateful for everything you are doing.

The transplant of organs and human tissue changes and saves lives. It brings hope, it can bring happiness and it is the ultimate altruistic act. The Organ Donation (Deemed Consent) Act 2019 promises a significant breakthrough in the ability to save and change lives. Those who campaigned for it spotted the public mood and understood the British people on this issue. However, a key part of understanding that fundamental desire of the British people to do well by each other is to understand that this change has to hold within reasonable limits. It is therefore right that we are completing the process today and setting out clearly the sort of tissue that goes beyond routine transplantation. That is a critical part of maintaining public confidence in the process.

The Opposition supported the Act during its progress and we support the regulations before us today. We have many people to thank for last year’s Act. I will start by thanking Geoffrey Robinson, the former MP for Coventry North West, for introducing the Bill. His legacy in this place is significant on a number of issues, and this legislation will certainly have long-lasting and far-reaching implications. I also thank my hon. Friend the Member for Barnsley Central (Dan Jarvis) for taking up the baton in 2019 and getting the legislation over the finishing line—he continues to be an excellent champion of the Act, and I think we will hear from him shortly—and, in the other place, the noble Lord Hunt for his stewardship of the legislation.

Of course, I also pay tribute to Max Johnson and Keira Ball, after whom the Bill was known. Keira tragically died in a road accident, but her heart saved Max’s life at age nine, after an eight-month wait. They are truly inspirational and a huge part of why we are here today, as indeed is everyone who supported the campaign, not least the Daily Mirror and its readers. Each and every supporter has helped to bring us here today to do this important job.

It is impossible to talk about anything, especially anything health related, without referencing the coronavirus outbreak and its effect on all aspects of our lives. However, it is particularly pertinent when we talk about transplants, so I will touch on it now before getting into the substance of the regulations. From 1 April to 10 May, 155 transplants took place in the UK from deceased donors. In the previous year, that figure was 404, a drop of more than 60%. There have been no transplants at all from living donors, which usually make up close to a fifth of the total, and current waiting list figures will not accurately reflect the need that may have been created for organ transplant due to the pandemic, which will only cause greater strain in future months.

I do not say these things to criticise the Government. Kidney transplants are the most common form of transplants, and in answer to a written question, the Minister for Care shared with me the fact that the early data show that both dialysis patients and those who are immunosuppressed through a transplant are more vulnerable to covid-19. The fact that transplants have been taking place at all therefore suggests that decisions are being made on the balance of need and on a case-by-case basis, an approach that I think we would all support. However, we know that, as the Minister said, patients were dying on the transplant waiting list even before the outbreak because the supply of donor organs failed to meet the demand. Fewer transplants quite simply means that the mortality rate will increase.

What assessment has the Minister made of the impact of covid-19 on the mortality of patients waiting for transplants, and what plans do the Government have to deal with the increasing backlog? I have raised this issue with her colleague, the Minister for primary care and public health, in relation to cancer and have not yet heard clear answers. We need to know what efforts the Government will be making to deal with the bubble challenges that will be coming through the system in future weeks and months. The Minister in the other place talked yesterday about a tremendous effort to restore transplant services. Will this Minister take the opportunity today to outline what the recovery plan is likely to look like and what the timeframes will be?

At the beginning of the coronavirus crisis we all talked of it as a great leveller and said that the virus would not recognise our differences, but we have seen in the weeks and months since just how much that is not the case. The coronavirus has exposed what many Opposition Members have said for many years. Britain is an unequal country, across regions, across gender and across protected characteristics. These inequalities are terrible for our nation’s health, and tackling them must be a post-covid priority.

The black, Asian or minority ethnic community suffers particularly when it comes to transplants. In 2018, 21% of those who died waiting for transplants were from a black, Asian or minority ethnic group. There is a higher chance of a successful transplant if the organ comes from an individual of the same ethnic background, but that means that those from black or Asian backgrounds currently wait six to 11 months longer for an organ match. This inequality will not do, and there have to be practical things to change it, starting immediately. The culture change that the Minister talked about is at the heart of that—us all having those conversations with our loved ones—but we know that we have to be doing something specifically different to reach those communities experiencing the most unequal outcomes. For that reason, I would like to press the Minister on something her colleague in the other place said yesterday. He said that the Government would be following up with an awareness campaign aimed at BAME audiences. Can the Minister give a firm commitment today that this will take place, tell us when it might happen and critically—I had this conversation frequently during my time in local government—confirm that it will be developed by BAME communities, rather than on their behalf? If it is to be effective, it will have to be different from how it has been in the past.

A key aim of the 2019 Act, which the regulations will, I hope, supplement today, was to reach an 80% consent rate in England. This will take time but certainly seems possible. In Wales, where the opt-out mechanism was implemented by the Welsh Labour Government in 2015, the consent rate has risen from 58% to 77%. In England, we start from a base line of 67%, so we are better placed, and if we reach the target, we are talking about as many as 700 more transplants a year—700 lives that can be extended, transformed or saved. The Minister has been challenged on the timing of the regulations—I have reflected on that question myself—but that number seems a strong reason to push on. As she says, the recent weeks and months have shown us how precious human life is and that we should not waste moments if we can improve lives.

Yesterday, the noble Lord Bethell told the other place that the restoration of all transplant services would include training nurses on the new law as soon as possible after they return. I would be keen to know a bit more about that. It was not something we had heard of before, and we would want a sense of the scale of that and the precise timeline the Government are expecting.

As I said, the Opposition are happy with the regulations as laid, but I seek to make three points. First and foremost, we agree that deemed consent should only apply to routine transplants. This is a matter of ensuring that public policy going forward matches the public’s expectation. I share the Government’s view that this would not reflect rare or novel procedures, including to create advanced therapy medicinal products, taking place without explicit consent. I will reflect on those ATMPs in a couple of seconds.

Secondly, I welcome the Government’s response to the consultation on the statutory instrument. Following the responses received, they have rightly revised the regulations with additional clarifications on tissues from sexual and reproductive organs, which will not be subject to deemed consent. That is particularly welcome. It is nice—I dare say even novel—to see a Government consultation leading to such concrete changes. It is a good thing and long may it continue.

Thirdly, the Government indicated in their response to the consultation that they do not expect the list of accepted tissue to need regular updates, and I agree with that in principle. The Minister mentioned how a process might happen if things were to be revised later, but I would like to understand a bit more about what would have to change for her to start such a process.

On those rare and novel transplants, it is important that public policy matches what people expect from the legislation, but we should be proud that the UK leads the world on such transplants. It is a good sign of the health of our country in this regard. They are not currently included under deemed consent, but developing these new technologies and techniques enables us to save more lives. We lead the way in both development and implementation. We have pioneered the OCS—organ care service—heart system, a portable device that can preserve a donor heart in a near-normothermic beating state until it is transplanted, which is currently being used in three heart transplant centres in the NHS and is being introduced in a fourth. We have also shown that abdominal organs can be assessed and their function improved using normothermic regional perfusion technology. As is the aim with this legislation, these developments can save lives, and we should be proud of that, but we should not rest on our laurels, so could the Minister reaffirm the Government’s commitment to continuing the UK as a leader in this regard and to providing the necessary funding to transplant units to ensure they can take advantage?

I turn now to resources, because what we are agreeing today, though very important, will have resource implications for us to pick up. An increase in the number of transplants will necessitate increased support for families who lose loved-ones. It is a difficult and emotional experience for them, and they will require high-skilled care and support, so what extra support will be available for them as these numbers increase?

Similarly, we will need specialist nurses for donation, not just for the direct care but for the implementation, providing advice and support to families and playing the vital role of determining what the deceased’s last known decision was, so that no procedures take place without the appropriate consent. As I say, the Minister in the other place yesterday mentioned specialist training. Could the Minister here today expand further on that?

I welcome the Government’s commitment to ensure that there are enough staff to do this. Will the Minister also commit to providing the additional funding required to ensure that the required increase in specialist nurses continues in line with the increase in transplants, so that they are not having to be begged or borrowed from other parts of the service?

We support these regulations. This is the next staging point in a really important journey. It will make a difference to hundreds and hundreds of lives—lives of people who are completely unaware that these discussions are even taking place today, not knowing that they will need this. This is the right thing to do and the right time to do it, and we support the regulations.

Covid-19

Alex Norris Excerpts

Monday 16th March 2020 Commons Chamber

[Matt Hancock]

Now that there is onward transmission in the UK, those sorts of measures are less efficacious. Of course, we have been doing that all along and strengthening it, but there are also those who said, “Go further and stop all the flights.” Of course, the Italians were the ones whose who initially stopped flights from China and ended up as the European epicentre of this anyway.

[Alex Norris (Nottingham North) (Lab/Co-op)]

The Secretary of State has indicated a willingness to revisit the statutory sick pay issue if, as many of us think, the current arrangements do not go far enough. When will he make that assessment?

[Matt Hancock]

We are making it constantly.

Coronavirus

Alex Norris Excerpts

Tuesday 3rd March 2020 Commons Chamber

[Matt Hancock]

As I have said several times, we are keeping this area under review. We are also looking into what we can do to support successful businesses that might have a short-term negative impact from some of the disruptions that have come with, and could come further with, coronavirus.

[Alex Norris (Nottingham North) (Lab/Co-op)]

Sick pay and statutory sick pay can be complex, but there is one simple truth within that system: the poorer someone is, the poorer their protections are. Those very worst-off at work want clarity from us that doing the right thing and following the Secretary of State’s guidance will not put them at a detriment. Nothing in the public conversation and, frankly, nothing we have heard today gives me confidence to say that to people in my community, so will he take this opportunity to say, from the Dispatch Box, that not one single person in this country who is following his advice will suffer a detriment to their terms and conditions?

[Matt Hancock]

I have already made it clear that we have a robust statutory sick pay system in this country, that self-isolation counts as illness within that system and that we are keeping the system under review. So people can have confidence that, if they are asked to self-isolate, that is exactly what they should do.

Oral Answers to Questions

Alex Norris Excerpts

Tuesday 28th January 2020 Commons Chamber

[The Minister for Care (Caroline Dinenage)]

We are very committed to hospice services, which is why an additional £25 million went into hospices last year. I am certainly happy to meet my hon. Friend to discuss the hospices in his area.

[Alex Norris (Nottingham North) (Lab/Co-op)]

Cuts to local government budgets have led to cuts to public health budgets, which have led to cuts to preventive services, which have led to greater demand in A&E and social care. It is bad for individuals, and it is terrible for the health and social care system, yet this weekend, we saw media reports that there are more cuts coming to local government, especially in the poorest communities. Can the Secretary of State assure us that he will tell colleagues in the Treasury and the Ministry of Housing, Communities and Local Government that those cuts cannot take place?

[Matt Hancock]

I do not need to, because we are clear that there is an increase in the spending power of local authorities and in the public health grant.

The National Health Service

Alex Norris Excerpts

Wednesday 23rd October 2019 Commons Chamber

[Alex Norris (Nottingham North) (Lab/Co-op)]

It is a pleasure to follow the hon. Member for South West Bedfordshire (Andrew Selous), whose personal leadership on tackling modern slavery is something we very much appreciate in this place. We may well have seen a reminder today of why that is more necessary than ever.

I made my maiden speech in a Queen’s Speech debate. Google tells me it was 848 days ago, which feels very strange. It feels simultaneously like a lifetime ago and yesterday. These have been very strange and tumultuous times. If I had been told then about things that have happened subsequently, I would have been sceptical, but no more sceptical than at the idea that we would still not have a social care Green Paper. We have had five delays and, despite it not being a laughing matter at all, it has become a long-running joke and a focus of derision.

The ever-delayed social care Green Paper is absolutely critical, because we know that up and down the country millions of people, paid and unpaid carers, are getting up in the dark, coming home from work in the dark, working split shifts and double shifts, and working for poor pay on insecure contracts. They are the backbone of not only the social care system, but the NHS and all public services. If only 10% of our social carers, whether paid or unpaid, walked away tomorrow, all our public services would come to a grinding halt. We need to do much, much better by them. I hope the Government, in showing movement on this issue, intend to bring forward their plans quickly.

In its latest annual assessment, the CQC highlighted concerns about cultural and geographic barriers to access to care, deficient regional staffing, a lack of stability in the adult social care market, and the Government’s failure to implement a sustainable long-term plan to fund social care. It said that that directly impacts nearly 1.4 million older people and millions of people with disabilities or illness who do not have access to the care and support they need. It is time for us to act.

The Government need to be brave and honest. If they are worried about the reaction of current service users to their proposals, I would remind them that the current service users have lived experience of the fact that the current system does not work, so they have no need to be afraid of them when it comes to change. When it comes to millennials like me, we are realistic. We know that the system that cares for our grandparents and our parents will not be the same for us. Let us be honest about that. There are profound and difficult decisions that have to be taken—let us get to that point. We do not need to be afraid.

I know that the Minister for Health, the hon. Member for Charnwood (Edward Argar) is a good and honest man, but when it comes to funding for social care—this is a really important point—we always see the Secretary of State or the Prime Minister use phrases such as, “We have given access to an extra £11 billion”. The Government should be honest about where that money comes from, because the bulk of it is from a social care precept on the local ratepayer. There is a political argument—I disagree with it fundamentally—that says, “Well, the Government believe that there should be a transition of the burden for social care from the national taxpayer to the local taxpayer”. I disagree, but if that is the belief on funding the social care system, the Government ought to say so, because that is very important.

Similarly, I know that this is a health debate, but I will not miss the opportunity to say that we must all reflect for a moment on the BBC and the removal of the free TV licence. As part of someone’s care, and as part of someone’s life in their 70s and beyond, we know that television plays an important part. We should be honest about why this has happened because that cut lands at the door of the Government, despite what they might say.

We know that failures in social care have a profound impact not only on the individual, but on the national health service. I have a real passion for integrated care—I cannot quite see the shadow Secretary of State from where I am standing, but when I was his Parliamentary Private Secretary, I used to bore him at great length about the virtues of integrated social care. When I was health and social care lead in Nottingham for three years, it was by far the least popular thing I did and I had campaign groups at my door weekly talking about my enthusiasm for certain models. There were flaws in the models for sustainability and transformation plans, accountable care organisations and accountable care systems—whatever re-branding we are on at that moment —but, fundamentally, integrating the national health service with our local authority social care is a very good thing and, if we did it properly, it would lead to people not having to ring up multiple agencies to sort out their loved one’s care. It would lead to proper, seamless care that, rather than being based around organisations, would be based around individuals. Again, I say to the Minister: Ed, let’s be bold on integrated care. Let’s be brave —[Interruption.] Madam Deputy Speaker wasn’t concentrating, I got away with it. Let’s be bold about this. If you are, you will see the best of politics working and a lot of consensus building.

I want to use the limited time available to me to refer to public health. I am proud of what I said on integrated health and what we did in Nottingham—we did good things. One area from my time in local government that I reflect on without pride is public health. We did good things on trying to be more innovative with the public health grant, but fundamentally, because of the nature of the cuts that have come down the line over the last nine years, we made cuts to public health services. I made cuts to smoking cessation services—a terrible public policy decision—because there simply was not enough money.

[Norman Lamb (North Norfolk) (LD)]

Is the hon. Gentleman aware of the Health and Social Care Committee report today that highlights the fact that there has been a 30% cut in funding for drug treatment services over just the last three years, which is catastrophic for the people involved?

[Alex Norris]

Having had a long four-and-a-bit hour vigil in the Chamber, I have not had chance to see that, but I certainly will. That is the picture up and down the country, including in Nottingham. The key thing is that as well as being absolutely dreadful for the individuals affected, it is terrible for the system not to have those good, often early, interventions on drugs and alcohol. If we let those things spiral, the impact on the individual and the costs related to the system grow exponentially. These are really bad value choices and we could do much better on public health.

I will finish with a point about cannabis on prescription. We have had important conversations on this today, and it is good that both the right hon. Member for Hemel Hempstead (Sir Mike Penning) and my hon. Friend the Member for Gower (Tonia Antoniazzi) are here. Their leadership on this has been absolutely crucial. I heeded what the right hon. Gentleman said about how to describe it, and I changed my speech from saying “medicinal cannabis” to “cannabis on prescription” as a result. I have had a case in my constituency, as many have, with a very, very frustrated parent who could not understand why their child did not fit the criteria.

[Sir Mike Penning]

The hon. Gentleman is making a really important point, and I thank him for changing his speech slightly. The reason why it is so important is that we need the observational trials. We need to know about the THCs and the chemicals that come from the cannabis oil; we need to know the strengths and what it is. That is why talking about the prescribed medical use of cannabis oil is crucial when we make this argument; otherwise, we will lose the public will.

[Alex Norris]

I am grateful to the right hon. Gentleman for improving the quality of my speech by adding that to it. I am very confident about this matter, and this afternoon has only increased my confidence. He will have heard the shadow Secretary of State say that if primary legislation is needed—

[Sir Mike Penning]

It’s not.

[Alex Norris]

Clearly not. Whether it is regulations, or whatever, we are very capable in this place of having a grown-up conversation on this and finding a solution. That is what my constituent and her mother are desperate for us to do.

We are very grateful in Nottingham for our excellent health and social care staff. They do an incredible job, keeping our communities going and bringing hope and enjoyment of life to many people struggling with profound challenges, but they want us to do better. The social care Green Paper would be a good chance to do that, and I hope we can do it quickly. Integrated health and social care promises many virtues. We just need to get around the table and have a proper conversation about it. I hope we can do that.

Access to Medical Cannabis

Alex Norris Excerpts

Monday 8th April 2019 Commons Chamber

[Matt Hancock]

My hon. Friend makes an important point. The Border Force should not be criticised in this case, because it was following the rules: if a clinician has not signed something off it cannot come in. It is incumbent on us on the health side to sort out this problem. He makes a broader point, however, that this is a completely separate issue to the recreational use of cannabis. I do not support a change in the rules on the recreational use of cannabis; this is about the specialist provision of drugs to some children who are the most vulnerable people in society, and the need to ensure that the medical benefits of such drugs can be brought to bear on people who really need them.

[Alex Norris (Nottingham North) (Lab/Co-op)]

Like many colleagues, I have spoken with parents of children who have profound challenges that could be ameliorated by medicinal cannabis. They are at their wits’ end, and it is no surprise to find that some in this country resort to desperate measures. I have listened for 45 minutes now and I cannot tell the answer to this question: is the Secretary of State really saying that we have a clear, universal, safe and compassionate approach to this issue and, if we do not, when will we?

[Matt Hancock]

I am saying that if a patient needs medicinal cannabis, and if a clinician will sign off on that need, the prescription can happen. The guidance from the association does not override the individual judgment of that clinician. That can happen but, because it has not been happening in many cases that have been brought to light, some privately and some very publically, I am putting in place a system of second opinions to ensure that we can get that clinical decision right, at the same time as developing a stronger evidence base for the future.

Mental Capacity (Amendment) Bill [ Lords ] (Fifth sitting)

Alex Norris Excerpts

Tuesday 22nd January 2019 Public Bill Committees

[Alex Cunningham]

The Committee is going to get this example whether it wants it or not. The case went to court, and the judge accepted the evidence and ordered that the cared-for person be returned home and that the sibling be evicted so that the live-in or an overnight carer could be accommodated. The gentleman in question returned home successfully and was later assessed as having regained capacity.

That is the power of an advocate, and it proves the necessity of an advocate in all cases, so I hope that the Minister takes these comments on board and ensures that she helps to enhance the quality of life for vulnerable people by including this amendment in the Bill. It would probably also ensure that she plays an important role in getting people who can be supported in the community the right result for their lives, rather than their being effectively locked up in a place where they do not want to be.

[Alex Norris (Nottingham North) (Lab/Co-op)]

It is a pleasure to follow so many colleagues making so many eloquent points about just how important advocacy is. I think that all of us in this room recognise that. An individual up against powerful organisations, across all sectors, is in a very uneven power relationship. If we then add in perhaps a lack of knowledge of how systems and services work, they might need support. Certainly, when they do not have capacity either, there is a clear need for some sort of support.

Sometimes we might read, whether in our postbags or online, that we in this place do not get it on an issue. On this issue, we definitely get it, because every day all of us at some point are battling the local council, the health service or the Home Office—that feels like a regular one—in advocating, as Members of Parliament, for people who do not know the system the way we do. They might look at something and think, in a natural justice way, “Hey, this isn’t right” or “I’m not happy about this,” and we provide extra support and learned knowledge to try to help them through that.

We do get it, and I hope that we can layer that into this very important legislation. We know the sensitivities of the individuals we are talking about. The whole purpose of the Bill, of our being here for the third day and of the time in the Chamber as well, is to take a system that, at the moment, does not work in terms of system capacity and has in the past created outcomes for people that we would not wish for ourselves, our loved ones or anybody, and to try to get something that does work and is robust. Fundamentally, we would always want to know that, as a result of what is decided by Parliament in this legislation, people living in Nottingham, Bristol or Birmingham, with relatively similar circumstances, would have similar outcomes, irrespective of the fact that the person in Nottingham had an adult child who was very active or even a DoLS specialist and the person in Bristol had no one. We would want, irrespective of those circumstances, that those people got consistent outcomes, because that is what a fair system means.

If we take away advocacy as a default, we get into the fundamental question of whether families, including active families, would even know to know that they could have an advocate. If the quality of the engagement with the responsible authorities is not good, for whatever reason—that has sometimes happened in the past—would the family know that they could ask for an advocate, or that there might have been a best interest assessment and a judgment that, given that the family were around, advocacy was not necessary?

Mental Capacity (Amendment) Bill [ Lords ] (Sixth sitting)

Alex Norris Excerpts

Tuesday 22nd January 2019 Public Bill Committees

[Barbara Keeley]

Going back to amendment 52, the process of bringing the Bill forward has been disappointing. It has been rushed and stakeholders feel that their views have not been taken on board. How do we know that that is the case? A letter was published in The Times today under the headline “Mental Capacity Bill Attracts Criticism” from a group of organisations including Liberty, Mind, Alzheimer’s Society, the National Autistic Society, POhWER—to which we have referred a number of times in our debates—the British Institute of Human Rights, Sense, Compassion in Dying, YoungMinds, Learning Disability England, Voluntary Organisations Disability Group and Headway—a very comprehensive list of organisations. They say:

“It is with dismay that we note the lack of improvement within the Mental Capacity (Amendment) Bill. The bill would replace existing deprivation of liberty safeguards with an entirely unfit new system of protection. To avoid the risk of exploitation and abuse it is vital that there are robust safeguards in place.

Alarmingly, the bill proposes to triple the time that people can be deprived of their liberty without review…while not doing enough to guarantee that all patients have access to independent and impartial advocates.”

This is what we have been debating.

The letter continues:

“The bill also creates a worrying conflict of interest for care home managers, giving them a greater role in the assessment process. Many vulnerable people will find it hard to express their concerns to a person providing them with care. The result is a rushed, incomplete and unworkable bill that will replace one dysfunctional system with another”.

That encapsulates everything that we have been trying to say.

[Alex Norris (Nottingham North) (Lab/Co-op)]

My hon. Friend lists a range of the most eminent and significant organisations in the field that we are discussing. They use words such as “dismay”, “rushed” and inadequate. Should that not be a big, flashing red light for hon. Members to say that perhaps this course of action is not the right one to be taking?

[Barbara Keeley]

Absolutely, I agree with my hon. Friend. On Second Reading, I said that the Bill should be paused, while we wait for the Government’s response to the Mental Health Act review. Every time I mention this, there is a groan from the Government Benches. We should not be rushing these complex areas. Even senior judges find the interface between the two pieces of legislation very difficult. We should not be introducing legislation that will be out of date almost immediately.

The impact assessment was produced over six months ago and it is now out of date. We have no idea how much the proposals in the Bill will cost or how much they will help to reduce the backlog of applications. We are being asked to debate and vote on the Bill now, and it is difficult with a six month old, out of date impact assessment. Even in the original impact assessment, it was unclear where some of the costs came from. The Government have not adequately explained the cost of their proposals. In the last sitting, I asked a series of questions about implementation. I would be grateful if the Minister could write to me with responses to those important questions.

We have heard constantly in our debates about how things will be included in the code of practice. On the first day of Committee, the Minister said that she would supply an outline of what it will contain. We only saw that document last night. An outline of what areas will be covered does not give us the full idea of what the code will contain. To some extent, it is better than nothing, but we have no idea of the detail. We cannot be asked to agree to a new system when so much of the detail is yet to be published. We need Parliament to approve the code of practice, rather than it being taken through by a method that is near impossible to stop. If there are problems with the code of practice, we should be examining the Bill and the code of practice side by side. We will press the amendment to the vote.

Question put, That the amendment be made.

--- Later in debate ---

[Barbara Keeley]

No, I welcomed the fact that the Government were trying to put in a definition, but this definition is not fit for purpose. The problem is that, as with everything else in the Bill, it was rushed. At the meeting I had with stakeholders not very many weeks ago, almost everyone in the room had fears about it. Many of them had not even seen it. The process has been wrong.

I made it clear to the Minister what I think the Government should do. They should withdraw new clause 1 and not put it to a vote. They should put the definition out to consultation, and not introduce it again until those involved with the definition are happy with it. Then we can be clear. Pitting a Government decision against decisions of the Supreme Court and the European Court of Human Rights is not wise; it is a knotty problem. I am not a lawyer myself, but I have listened enough to people who are experts in this area to know that it is a problem.

Perhaps I can encapsulate the problem in one final question to the Minister. On the front of the Bill the Secretary of State certifies that he feels it is compatible with the European convention on human rights. Given some of the points that I have just raised about the definition, is the Minister confident that the Bill would still be compatible if we agreed to the new clause?

[Alex Norris]

Liberty, Mind, the Alzheimer’s Society, the National Autistic Society, POhWER, Parkinson’s UK, the British Institute of Human Rights, Sense, Compassion in Dying, YoungMinds, Learning Disability England and Headway all say that this is “rushed, incomplete and unworkable”, and that in general they feel the whole exercise is entirely unfit. It is well within the prerogative of the Government of the day to say that they are right and that all those organisations are wrong, but it is, dare I say it, quite a brave thing to do. For the benefit of the Committee, and of everybody else who has taken an interest in these proceedings, it might be worth explaining why the Government feel that they are right and the Bill is fit for purpose, and that the new clause, which very much puts the cherry on top of the Bill, is worth standing part of it.

[Mr Dhesi]

Does my hon. Friend agree that that is an indictment of the whole process, and of the rushed manner in which the Bill has been introduced? To have one organisation from among those 13 eminent organisations come forward in The Times today and use words such as “rushed”, “incomplete”, “unworkable”, “unfit” and “dysfunctional” would be bad enough; to have all 13 do so makes the entire process look like complete folly.

[Alex Norris]

I completely agree. To me it is a big, blinking red light that says that perhaps we need to pause and think again. Nothing typifies that more than new clause 1. It is helpful to have a definition in the Bill, and there is broad support for that. I also have some sympathy for its being exclusionary, rather than put in a positive manner, because we know, irrespective of what ends up in the Bill, that it will end up in court.

This is a hotly contested area of case law. It feels a bit like what it must be like to be an American legislator—we are almost waiting for what we do to be tested in court to see if it is okay. I have no doubt, with things as they are currently comprised, that we will be back. I do not know whether it will be a couple of months down the line or a couple of years, but if we carry on we will certainly be back.

The approach laid out by my hon. Friend the Member for Worsley and Eccles South is sensible and proportionate, and it might give us an opportunity to resolve the issue, by sending the new clause, which has appeared between stages, to the sector and asking, “How do you feel about this?” in order to get some engagement. That would give us more time for the lawyers to do their thing too. That seems quite sensible.

It would also give us a chance to take a breath on the whole Bill, and a little more time to see whether we can resolve some of the issues that we have discussed over the last two weeks. Many of the things we as an Opposition have put forward have had merit; perhaps our approach has not always been perfect, but to find better ways to try to address those things would be good for us all.

I will move on to my second concern. If new clause 1 becomes part of the Bill and the Bill becomes an Act, the smoke will come out of this place and send a clear signal: “We know that DoLS doesn’t work and hasn’t worked for a long time. Here is what is going to come next. Here is what we mean by ‘deprivation of liberty’ and here is what you can expect.” I maintain my anxiety that we will have only solved half of the problem, or one of two problems, because it is entirely possible for a big problem—in this case DoLS, the backlog and people’s experiences of that process—to be multifactorial.

No one has contested the fact that the DoLS system did not work and ought to be replaced, but there is a big, yawning and currently unanswered question of resources. I was concerned to hear the Minister say that they are the result of political decisions. I have been in that chair, as the local adult services lead on my council for three years, wrestling with DoLS. Is it a political decision? Yes, maybe it is, in the sense that we are basically trying to juggle whether to deal with assessing new people on their social care needs, assessing whether the needs of people currently in the social care system have gone up or down or, indeed, areas such as DoLS, all of which carry enormous risk to an individual, a local authority and a community as a whole.

In the sense that it is a political choice, it is like saying, “Your house is on fire; are you going to put out the lounge or the kitchen first?” You would just grab the bucket of water and chuck it at it, frankly. There is no political decision in that, or certainly not one of due prioritisation. Ultimately, if we are going to include this new clause in the Bill to set up the new system and legislation to set the new way, we must have absolute clarity that the finances are going to be met. Otherwise, the system will fail and we will, certainly with new clause 1, have elevated people’s expectations. At the moment people expect to be disappointed, because they know the system does not work. Now we are going to tell them that we have a new system that works, and then it will not. I suspect that is why all those eminent organisations have said that it is where it is.

On this point and on others, I feel that we on the Opposition Benches have made strong arguments about ways of improving the Bill, but it is not just us. It is not just partisan knockabout; it is not political. It is not a case where the Government say one thing so therefore the Opposition oppose. We should look at the organisations that are also saying, with flashing lights, “Please stop and have a think about this.” Otherwise, as I say, we will be back.

[Caroline Dinenage]

I think it would be helpful if I began by setting out how we got to where we are, for the sake of clarity, although I know that many hon. Members know this. The case of MIG and MEG and P widened the understanding of the scope of deprivation of liberty safeguards with the Supreme Court decision that:

“A gilded cage is still a cage”.

Even though the cared-for person was happy in their situation, it was still a deprivation of liberty and required a safeguard. The acid test set out by Baroness Hale in Cheshire West had two limbs: first, is the person subject to continuous supervision and control, and secondly, is the person free to leave? We can see that test running through this clause. We cannot directly challenge or go against Cheshire West, as it is the Supreme Court’s articulation of article 5, and our Bill must be compliant with the European convention on human rights. That is why deprivation of liberty continues to be defined by reference to article 5 of the ECHR.

We are confident that the exceptions in subsections (2) to (4) represent existing case law. The clause defines deprivation of liberty in that way, and the subsections are consistent with and drawn from existing case law—for example, as I have detailed, subsections (2) and (3) are based on the Cheshire West acid test. It is unlikely that there will be a mismatch between our clause and the High Court’s view; it may be that the clause is subject to litigation in future, but we are confident that the Government’s approach of providing for situations that would not constitute a deprivation of liberty will give sufficient flexibility for the meaning of the clause to develop alongside case law as that evolves.

Much of the discussion has emphasised how incredibly complex a legal matter this is; the clause must be drafted incredibly carefully to ensure that it is legally compliant. We have worked with other Government Departments such as the Ministry of Justice to develop the clause. We listened to stakeholders and peers during the progress of the Bill through the House of Lords to understand their requirements for a definition and drafted the new clause in a way that would achieve what they wanted legally. Since drafting it, we have shared it with stakeholders to explore its impact. We are consulting a wide variety of organisations to gather case studies, which we will use in the statutory guidance.

Mental Capacity (Amendment) Bill [ Lords ] (Third sitting)

Alex Norris Excerpts

Thursday 17th January 2019 Public Bill Committees

[Alex Cunningham]

That is very much the case. I always try to place myself into such a situation. I am at the grandfather stage of life now, and I think about how that would affect the children of my children, or other parts of my family who have children. I would most certainly want them to be at the centre of it—I would probably try to interfere a bit myself as well.

The Children Act, however, provides protection—it is a real safeguard—and yet the Bill is not at all clear about how it will sit with that existing legislation. Surely, as my hon. Friend the Member for Worsley and Eccles South suggested, parents must be consulted and have that ability to make decisions about their child, even if they are 16 or 17. We must ensure that such safeguards are enhanced, not watered down or in conflict with each other.

The Royal College of Psychiatrists has highlighted to me that encompassing 16 and 17-year-olds in the Bill can be positive where they lack capacity to make their own decisions, but that must be authorised by an appropriate safeguarding system. The RCP shares my belief that a parent or legal guardian with capacity to make the decision should be able to authorise the required deprivation of liberty.

Many social workers and other professionals in the field have made submissions. There is a strong consensus that additional safeguards should be available where objection is made by a person with parental responsibility. The Mencap submission, too, welcomes the inclusion of 16 and 17-year-olds in the Bill, but it also expressed concern that we might be reducing protections and eroding parental rights. Mencap has asked the Government to conduct further public consultation on the measures for 16 and 17-year-olds to understand the implications fully.

Does the Minister believe that the Government have consulted properly on the issue of 16 and 17-year-olds? Clearly, the organisations with an interest in such matters do not think so. Will she commit to undertake a rapid consultation exercise ahead of Report, in the hope that we in Committee can be reassured about parental rights and the very necessary protections for young people?

Mencap highlighted the particular uncertainty about how the new system works alongside existing legislation. I have already talked about that, but a complex web of legislation and guidance relates to those young people who might fall under the LPS system, including looked-after children. My hon. Friend, however, has already spoken about that. It is essential for the Minister to provide clarity in such areas, preferably now but certainly before Report.

In closing, I will make a general point about involving parents in all manner of processes in the health and social care world. For them to be excluded from the process, denied the right to report or told simply that the authorities know best must be an exception. It is not always the case that the authorities know best. At times, I have a tremendous caseload of parents coming to talk to me about issues affecting their children and how they feel excluded.

I put it to the Minister, if a child affected in a particular case was one whom she knew personally, one whose parents she has had contact with, would she be content for them not to have every possible access to information or not to be consulted at every stage? I remind her that a child is being deprived of liberty—this is an opportunity to lock a child up, basically. We need to understand and empathise with parents in their desire to be consulted in the decision-making process, and I believe that the amendment would go a long way to ensuring that that actually happened.

[Alex Norris (Nottingham North) (Lab/Co-op)]

It is a pleasure to see you again in the Chair, Mr Austin.

It is important to reflect at this point that the purpose of this legislation is to take an existing cumbersome system and to try to make one that works, but of course we are putting a new focus on 16 and 17-year-olds while we do that. So it is important that we have good consideration about how we can do it in the safest way, and in the way that best reflects the needs of the individual and of their family in general.

We will all be aware that social media can skew our view of these things, but the very high-profile cases on social media of young people who are in the settings that we are talking about today, and just how difficult that is for the parents and those young people themselves, mean that we should take every step we can to make what is an exceptionally difficult situation as best as it can be for those parents.

This issue came up in one of our previous discussions—it was raised by the hon. Member for Halesowen and Rowley Regis—when we were talking about access for parents as a matter of course, which I think we will come back to when we consider a later amendment. The idea was discussed that we would not want to put something in the Bill that would give access to a child to someone who was not supposed to be given access at that point.

I reflected on that point, because it is obviously very important, but I do not think that it actually applies in this situation. I was using, as an analogous case, the idea of a parent’s right to have input into their children’s education. If that parent is subject to a non-molestation order, that right falls away, so I do not think that there is anything that we would put in this Bill that would supersede that.

In a similar vein, my hon. Friend the Member for Stockton North used the phrase “with capacity”, regarding the parents being involved. Again, therefore, nothing that we are doing here would supersede the fact that if that parent was not able—

[James Morris (Halesowen and Rowley Regis) (Con)]

The hon. Gentleman is making some serious points, but I just want to probe one of them. If we are seeking to protect the best interests of a child, there may frequently be circumstances in which those best interests are not necessarily served by having parental involvement, because of the complexity of a particular case or the psychiatric condition of a particular child, and somehow that needs to be reflected.

--- Later in debate ---

[Alex Norris]

I thank the hon. Gentleman for that intervention, because that point is really important. It is perfectly conceivable that the heart might override the head and parents might be so desperate to keep their family together—which we can all relate to—that they might make decisions that are not the best decisions.

Again, however, that would mean entry into a pre-existing legislative space, in the sense that if a parent were acting negligently, we already have a series of protections for a child in that case. So, if we have what we are talking about today in law and then we have a case of the kind that the hon. Gentleman and I are both talking about, that would tip into a negligence situation, and therefore I think the matter would still be unresolvable in the best interests of the child. So I do not think that anything that we are suggesting here in this amendment would disqualify any of that.

I think the amendment is proportionate: it would just give that extra layer of protection. We understand that the cohort that we are talking about are particularly vulnerable; we understand the impact that this change would also have on parents; and we understand that fundamentally parents will want the best for their children. However, we also understand fundamentally that if a bad decision were being made by a parent, there are other sources to make sure that a young person’s needs are being met.

Actually, when we add all that together, I think the amendment would put in significant safeguards and important protections for both young people and their parents, but without creating a situation where we might unknowingly create some risk and perhaps do some harm.

[The Minister for Care (Caroline Dinenage)]

As ever, it is a great pleasure to serve under your chairmanship, Mr Austin.

I thank Opposition Members for initiating a discussion on this really important matter. Parents, or those with parental responsibility, have a vital role in caring for their children—of course they do—especially when the child lacks mental capacity. We would fully expect that the responsible body took every opportunity to consult parents with regard to their views about arrangements, where it was appropriate to do so as part of the consultation process, and we will make that clear at every stage in the regulations.

However, as the hon. Member for Nottingham North and my hon. Friend the Member for Halesowen and Rowley Regis have said, we have to allow for the very rare occasions on which parents may not have the best interests of their children at heart. That is why we have to be careful about adding this provision to the Bill.

--- Later in debate ---

[Alex Norris]

It is a pleasure to follow my hon. Friends the Members for Dewsbury and for Stockton South, who made compelling arguments that I hope to add to a little.

On fluctuation, by definition we are talking about some of the most challenged individuals in society. As a result, their medication needs could be significant, and the nature of their challenges can change over time. It is not only conceivable but probable that those individuals’ needs may vary. Therefore, the protections we need to give them may have to be slightly flexible.

Behind the Cheshire West case and the television documentaries that make us all throw our hands up in the air and think, “Goodness me, how awful”, is the idea that none of us thinks that someone whose liberty needs to be taken away for their own protection should ever be put away and forgotten about. None of us wants that at all. That is in keeping with the theme of wiring into the Bill the understanding that we are talking about human beings, and that things change and their conditions change, as they do with us all. Therefore, we may need to change the way they are looked after and supported.

I reflect on the point the hon. Member for Halesowen and Rowley Regis put so well; on Tuesday I was wringing my hands about my past anxieties about the lack of assessing capacity. I then put my name to an amendment that asks for greater specialism among those assessors as people who could pick up something that, as the hon. Gentleman said, was not trivial. I understand his view but do not completely share it. We want to include in the Bill the possibility that an individual’s needs may fluctuate—not how those needs will fluctuate. It would not necessarily mean that all the assessors have to have the ability to make that judgment. If the assessment says, “There is a reasonable chance that this individual’s needs may fluctuate,” that puts a “So what?” test on the responsible body, which may say, “Okay. We may therefore need to call in someone who has that specialism at an appropriate moment.” That could be covered in the code of practice. I do not think that test puts an unreasonable or unnecessary burden on the assessing capacity, which is finite.

I support the point that my hon. Friend the Member for Dewsbury made. Most of this discussion has been framed around the idea that some people are deprived of their liberty because they are deemed not to have the capacity to look after themselves, but because their needs fluctuate, that may not have needed to happen. As my hon. Friend said, there is another cohort of people who are assessed not to have fallen into a deprivation situation, but that might not be safe for them either. It is important that we bring that into the discussion. This is not just about people who are deprived of their liberty when that may not need to be the case; it is also about people who, the vast majority of the time, are not in those circumstances, but in a conceivable situation relating to their personal health challenges, may need to be deprived of their liberty. That is a really important point.

Amendments 31 and 33 get to the nub of what we have been talking about for the past two and a half sittings. What are we trying to do with assessment? If the Bill tilts towards moving assessment away from local authority-hosted social work into care settings, with the people who are around the individual the most and have great familiarity with them, the Opposition have expressed some discomfort about that. Nobody is arguing for perfunctory or tick-box assessments—hon. Members on both sides of the Committee have been clear about that. With amendment 33, we want to put on the face of the Bill a requirement that the people who carry out assessments have the right qualifications—I hope that will apply to pre-authorisation assessments, too—so we have the confidence to say to people, after this Bill has wended its way through Parliament, that we have not created a system that has moved away from skilled assessment, which is expensive, finite and a challenge in this country, towards unskilled assessment because it is easier or cheaper. Nobody wants that; I certainly do not. By putting that on the face of the Bill, we can give comfort to the people who observe our proceedings and those who will engage with us during the Bill’s progress that we are not seeking to do that.

[Mr Dhesi]

My hon. Friend is making a very powerful case. As a former trustee of Alzheimer’s & Dementia Support Services, which dealt with people with very serious vulnerabilities, I can attest to the fact that amendments 31 and 33 are entirely sensible and should be incorporated in the Bill. Not having a registered medical practitioner undertaking these assessments, especially when we are dealing with very vulnerable individuals, would be detrimental to the entire process.

[Alex Norris]

I appreciate that intervention. One of my favourite things about being in this place—certainly in Bill Committees, out of the white heat of the Chamber—is that we learn a lot that we did not know about people’s knowledge and expertise, whether it is personal experience, professional experience or experience from their spare time. It helps us all. That contribution adds to the debate, and I greatly appreciate it.

These amendments will help to give confidence that what we are all trying to achieve here will be achieved in the Bill. I would expect it to be enhanced by the code of practice, but in law and in statute, in the Bill, we in this place will have made a clear commitment about what sort of legislation we want. In that spirit, I commend the amendments to the Committee.