Draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 Draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Justin Madders Excerpts

Wednesday 6th March 2019 General Committees

[Justin Madders (Ellesmere Port and Neston) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Robertson. Here we are again, discussing statutory instruments that would make provision for the regulatory framework after Brexit in the event that we crash out without a deal. That possibility has been known about for nearly two years, since article 50 was triggered, yet this pair of detailed and important draft regulations are being debated only three weeks before the proposed exit date.

The volume and flow of EU exit secondary legislation is deeply troubling in terms of accountability and proper scrutiny. The Government have assured the Opposition that no policy decisions are taken as part of these regulations. However, establishing a regulatory framework inevitably involves matters of judgment and raises questions about resourcing and capacity that I will address in detail later on. It is our view that secondary legislation ought to be used for technical, non-partisan, non-controversial changes, primarily because the legislative accountability process is not suited for anything beyond that. Instead, the Government continue to push through contentious and detailed pieces of legislation with high policy content in this manner.

As legislators, we must get this process right. The regulations could represent real and substantive changes to the statute book. As such, they need proper, in-depth scrutiny. The draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 alone are over 200 pages long. The draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 are just under 200 pages long. They cover several EU directives and cannot possibly even be read in the time we have, let alone debated sensibly. We therefore put on record our deepest concerns that the process for these regulations is not as accessible and transparent as it should be.

Decisions made today could have huge implications for a multi-billion pound industry, potentially affecting millions of patients’ lives. Yet we are presented with non-amendable instruments with a derisory amount of parliamentary time allotted to debate them. People who voted to restore parliamentary sovereignty might feel that this is a long way from what that should look like. I appreciate that this wholly unsatisfactory approach is not down to the Minister. I thank her for introducing the regulations and for the time that she and her officials gave me yesterday to discuss them, but as the representative of the Government seeking to trample all over proper scrutiny, she has the onerous task of defending this approach, although I believe no one can defend this mess.

As we have heard, the UK participates in an EU-wide system for the testing and approval of medicines and medical devices. The regulations transfer responsibility for those activities to the MHRA—a standalone medicines and devices regulator for the UK—in the event of a no-deal Brexit on 29 March. The instruments intend to ensure the continuity and safety of medicines and devices in the UK, while retaining the UK regulator’s ability to take regulatory action to protect public safety. We do not disagree with that objective, which is why we will not oppose the regulations, but that is not to say that we do not have serious concerns about how that objective will be achieved in practice—there are many questions about that.

Although the objectives set out in the instruments are intended to be met with minimum disruption and burden on businesses and the supply of medicines and devices in the UK, we have serious misgivings about how realistic that proposition is.

[Thangam Debbonaire (Bristol West) (Lab)]

My hon. Friend mentions minimal disruption to patients, which the Minister mentioned twice. Does he share my concern that any patient listening to or reading the record of these proceedings, who regularly has to take medicine or receives a medical device, will not know whether the minimum disruption may affect them? That may cause significant distress.

[Justin Madders]

My hon. Friend is right; we will all have had constituents raise those real concerns. I will go into more detail about what the Government’s impact assessment says about some of these issues, which justifies our concerns.

Under the draft regulations, the MHRA, which already carries out a wide range of work, including medicines licencing, pharmacovigilance, inspections of standards and enforcement, will take on an expanded role in the registration, assessment and post-market surveillance of medical devices. Listening to the Minister, we could be mistaken for thinking that that massive expansion in responsibility and bureaucracy will take place with no disruption and with no impact on businesses and patients but, as we have just heard, we have real anxieties about that.

The regulations will enable the UK to continue to recognise prescriptions from the EEA. They provide transitional grandfathering rights for medicines and products that have already been authorised in Europe up to exit date, and provisions that would allow the Secretary of State to make temporary changes to the authorisation process or to allow alternative medicines to be dispensed in the case of potential shortages. Their importance cannot be overstated.

As 29 March is fast approaching, the regulations are increasingly crucial. It is right that we make arrangements, although it is a matter of regret that we are dealing with them in this manner at the last minute. We support efforts to ensure regulatory continuity, to ensure the ongoing safety of medicines and medical devices entering the UK market and to avoid disruption to the UK supply chain. But we have several questions about the additional cost to businesses, about the MHRA’s capacity and resources to take on these additional roles and responsibilities, and the Government’s general ill-preparedness to deal with medicine shortages and additional regulations.

Let us start with the impact on businesses. The Government’s own impact assessment for the medicines regulations recognises

“a possibility that some medicines that would have been authorised in the UK because of the UK’s involvement in the EMA will not be submitted to the MHRA due to business decisions. This could have an impact on access to certain medicines and therefore to public health.”

The phrase “business decisions” is, on the face of it, quite innocuous—all businesses make decisions all the time—but the impact assessment almost suggests that such decisions are being made in a bubble, in isolation from the regulatory environment in which they operate.

The impact assessment for the medical devices regulations is a little more explicit. It says:

“It is likely manufacturers would seek to recoup these additional regulatory costs through price increases, which would affect NHS budgeting and spending choices”.

That seems at odds with previous assurances. Indeed, the Minister’s colleague, the Under-Secretary of State for Health and Social Care, the hon. Member for Winchester (Steve Brine), said in a Westminster Hall debate in November 2017 that one of the three key principles for medicines access post-Brexit was that,

“patients should not be disadvantaged”.—[Official Report, 21 November 2017; Vol. 631, c. 349WH.]

Yet that is what we are facing now, and it is a damning indictment of the way the Government have mishandled the entire process.

Has the Minister made an assessment of which specific medicines might not now be submitted to the MHRA? Are any particular conditions or patients more at risk than others? What actions has she taken to speak with businesses and ease their concerns about the decisions they will have to make? What public health impacts has her Department been planning for? What contingency plans are in place? Will she clarify exactly which medicines the Department believes will increase in price and by how much, and what the Department will do to avoid the possibility of those costs being passed on to patients or indeed the taxpayer? Has there been a revised estimate of the annual NHS drugs bill, for example, as a result?

The Government’s impact assessment also recognises that there will be,

“ongoing costs for businesses currently operating in the UK as they would need to adhere to additional UK only regulatory requirements if they currently sell in the EU/EEA. This includes additional fees, legal and administration costs.”

Given that there will also be,

“familiarisation and set up costs as businesses transition into dealing with both systems”,

will the Minister confirm whether the Department will be providing any financial relief to the largely small and medium-sized enterprises that will be affected by the changes? What about the MRHA’s capacity and funding to take on additional roles and responsibilities? The impact assessment recognises that there will be,

“costs to the MHRA of establishing and sustaining new regulatory capabilities”,

although it states that,

“these will be largely recouped through fees.”

In light of those statements, I have a number of questions for the Minister. Will she outline whether the MHRA will receive additional funding to support the work it will have to take on independently of the EMA, or will costs be passed on to businesses and therefore, by extension, to patients and the taxpayer? Will she outline more precisely what costs the MHRA will face and over what time period? How much of those costs will be recouped through fees and how soon will those fees be recouped? Will she confirm whether the Department intends to cover any of the additional costs that will not be recouped through those additional fees?

Can the Minister confirm whether the MHRA will be given additional staffing and funding to establish and sustain its new regulatory capabilities? Is she aware of what the make-up of any additional staff would look like and whether that is already in place? If so, how many new staff have already been hired, what training have they undertaken and who is regulating them? Is there, in fact, a ready-made market of suitably qualified and experienced staff just waiting to go and work for the MHRA? That is a critical point in the light of our general debates on NHS and healthcare shortages.

The new framework will be far from the rosy picture that has been painted in some quarters, but before we even consider the effect of what will happen when we get there, there is a basic point for businesses to consider. If they decide to continue to trade in this country, do they know exactly what it is they need to comply with, and by when? One only needs to look at the commencement dates for these regulations to understand the scale of the task ahead of them. The medical devices regulations alone contain over 10 pages of commencement dates, and they are not set out in a user-friendly way at all.

Here is one example, from proposed new regulation 4B of the Medical Devices Regulations 2002. Sub-paragraph (1) says:

“Part VIII only applies before 26th May 2020 in respect of a device or accessory that is a relevant device for the purposes of Part II or III if the conformity assessment that the person placing it on the market or putting it into service relies on for doing so is the conformity assessment required by Part VIII (rather than by Part II or III).”

Sub-paragraph (3) says:

“Where Part VIII applies—

(a) Part II ceases to apply, apart from regulations 7A and 19 (to the extent that those regulations otherwise apply, for which see regulations 4D(1) to (5) and 4E(4)); and

(b) Part III ceases to apply, apart from regulations 21A and 30(3) to (5) (to the extent that those regulations otherwise apply, for which see regulations 4D(6) and 4E(4)).”

Another example is proposed new regulation 4E of the 2002 regulations, which states:

“(1) Subject to paragraph (3), regulations 91 to 95 do not apply until the date which is 6 months after the date on which the UDI database managed by the European Commission becomes fully functional (a date that the European Commission is required to publish in the Official Journal of the European Union), unless that date (‘the operational date’) is before 26th May 2020.”

Paragraph (3) states:

“(3) Regulation 91(4) only applies in respect of a device to which Part VIII applies, or in respect of an accessory to such a device—

(a) on and after 26th May 2021 (or on and after the operational date if later), in the case of a device classified in accordance with Schedule 9 as—

(i) an implantable device, or an accessory to such a device, or

(ii) a Class III device, or an accessory to such a device;

(b) on and after 26th May 2023 (or on and after the operational date if later), in the case of a device classified in accordance with Schedule 9 as—

(i) a Class IIa device, or an accessory to such a device, or

(ii) a Class IIb device, or an accessory to such a device;

(c) on and after 26th May 2025”.

I could go on. [Hon. Members: “More!”] Okay, I will do a bit more, then. [Interruption.] Hon. Members are regretting that now. Sub-paragraph (d) states:

“(d) on and after the date which is 2 years after the operational date, in the case of a device considered to be a reusable device, or an accessory to such a device, in circumstances where it is required to bear the UDI carrier on the device or accessory itself.”

The proposed new regulation continues:

“(4) If the operational date is before 26th May 2020, regulations 7A and 21A cease to apply on the operational date in respect of a device or accessory to which Part VIII applies because regulation 4B(1) applies.

(5) Subject to paragraph (7), regulations 157 to 160 do not apply until the date which is 6 months after the operational date, unless the operational date is before 26th May 2022.”

I am sure that Members do not want to hear any more of that, so I am not going to read out the rest of the regulations, but there are another four commencement dates in proposed new regulation 4E alone, and they are subject to different exceptions and qualifications. At least another dozen regulations contain similar provisions. The Minister will be relieved to hear that I am not going to ask her to explain all those and how they relate to one another. I am conscious that we have limited time, so we would never be able to do that anyway, but how on earth can any business be expected to understand, adjust to and comply with all those different dates without a massively increased burden upon them? What support will be made available to businesses so they can be confident that they are complying with the rules correctly?

I feel the need to lie down after that, but I am going to continue and look at the specifics of the draft human medicines regulations. That statutory instrument relies on the power in section 8 of the European Union (Withdrawal) Act 2018 to amend the Human Medicines Regulations 2012 and modify the effect of the restated EU regulations to ensure that all aspects of retained EU law in relation to human medicines operate effectively and are not deficient after exit day as a result of the UK’s withdrawal from the EU.

Will the Minister confirm whether the Secretary of State intends to report back to Parliament on any amendments to existing HMRs after exit day? Will she outline the arrangements for collecting data, monitoring the effectiveness of the regulations and regularly reporting? Will she confirm what bodies will be able to scrutinise performance and delivery, and what assessment has been made of their capacity to take on that additional work?

On pharmacovigilance, in the event of no deal, the sharing of common systems and formal exchange and recognition of data submitted for regulatory activities between the UK and EU countries would cease, and the MHRA would have primary responsibility for the conduct and oversight of all pharmacovigilance activities. The Government’s impact assessment recognises that there will be administrative costs to businesses that need to provide that information to the MHRA. Does the Minister intend for the Department to help businesses with those increased costs, and does she have an estimate of what they might be?

On pharmacovigilance information, the draft regulations provide for reporting by the pharmaceutical industry of suspected adverse drug reactions associated with its medicinal products directly to the MHRA database rather than to the current EU database, which is known as the EudraVigilance database. Will the Minister confirm whether, in a no-deal scenario, the UK would be able to access the existing EudraVigilance database, which may be more detailed than the existing MHRA database of pharmacovigilance information?

On serious shortage powers, this contingency legislation enables regulations to be made to modify the application of the Human Medicines Regulations 2012 to deal with serious shortages of medicinal products, which, as we know, is a matter of great public interest. That would replace the regulation-making power in the European Communities Act 1972 for certain limited purposes and would ensure that Government continue to have the power to make temporary changes to the 2012 regulations in a no-deal scenario. That is a clear example of Ministers being given Henry VIII powers over many regulations if they think there is an urgent need because of shortages.

Does the Minister anticipate a doomsday scenario where it will be necessary to use those powers? Or is she saying, “There’s nothing to see here; we don’t anticipate any problems, but we are going to give ourselves these powers anyway”? Will she outline how the process will be handled if there are shortages and what scrutiny will be available for decisions made under it?

The draft regulations introduce a new targeted assessment route to incentivise novel medicines and biosimilars, which currently use one of the routes involved in the European regulatory network to receive a UK marketing authorisation, or MA, in the same timeframe as today. That involves changes to regulation 58 of the Human Medicines Regulations 2012 and to the Medicines (Products for Human Use) (Fees) Regulations 2016, and may also involve the implementation of further non-legislative changes in order to ensure the

“continued competitiveness of the UK market.”

Will the Minister outline what further non-legislative changes the Department intends to implement? Will she outline details of what the new target assessment route will look like in practice? What assessment has the Department made of the impact of introducing the new route, and how does the Minister propose that we will keep in step with, or ahead of, improvements as the EU makes them while we are in the process of exiting and after we exit?

The generics industry expressed concern in response to the Government’s consultation about whether the targeted assessment routes would be made available for generics. In response, the MHRA proposed to review that and work with industry to shorten the timings of UK national licensing of generics. Will the Minister clarify the timeframe for the review and outline any progress made towards its completion?

With regard to “legal presence”, the medical devices regulations ensure that a UK-based marketing authorisation holder, or MAH, and a UK-based qualified person for pharmacovigilance, or QPPV, will need to be in place for all medicines in the UK. Will the Minister outline how many QPPVs are in operation, what their remit is, what support and training they receive and what net funding they receive? Is the Minister confident that the UK-based QPPVs will immediately have the necessary access to safety data systems for medicines? Can she confirm what ongoing communications there will be between QPPVs based in the EU or EEA and new ones based in the UK? Is she concerned that the additional costs for the UK industry of having to establish domestic pharmacovigilance may make the UK less of a priority market?

Transitional provisions require UK MAHs and QPPVs to be in place within 21 months after exit, to allow time for business to comply. That is especially the case for the QPPV, which is a specialist role. Can the Minister outline the process in that 21-month period? The Government’s impact assessment notes that

“there would be a cost to industry in establishing a contact person, MAH and QPPV presence in the UK for those who do not already have a UK presence”.

Those costs include a direct cost to change an MAH to a UK MAH and to establish

“premises, familiarisation and administration for the interim contact person or MAH, and QPPV to comply with the new legal requirements, and labour costs for these representatives.”

Will the Minister confirm whether the Department intends to help to meet those costs, or will businesses, and ultimately patients and taxpayers, again pick up the tab? What safeguards will be in place, and what are the risks of having our own set of MAHs and QPPVs? Will they require their own insurance? Are there minimum levels of liability that they must be insured for? What is the risk of some random individual being set up as an MAH because there are not people with experience and knowledge available to take up the roles in the first place?

The medical devices regulations ensure that existing centrally authorised products that are currently licensed for the UK market through the EMA will continue to be licensed in the UK in a no-deal scenario. The regulations provide for all existing CAP MAs to automatically be converted into UK MAs, and issued with the UK MA number on exit date, unless the MAH indicates that it does not wish its MA to be converted in that manner. Will the Minister confirm what contingency planning she will undertake if an MAH declines to have its MA converted into a UK MA? Can she guarantee that, in such a scenario, patients will not miss out on medicinal products that are CAPs? Can she outline the cost implications for CAPs of having to supply a full set of data? What will she do if an MAH does not provide that data within one year of exit day?

With regard to packaging, the requirements placed on all actors in the UK supply chain from February this year regarding the safety features aspects in the falsified medicines directive will be removed by the human medicines regulations. Furthermore, this instrument ensures that there will be no obligations on the UK supply chain to affix the safety features or scan packs of medicines. In the interests of public safety, the Government have said that they will evaluate the options for a future UK falsified medicines framework, but ending falsified medicines monitoring without replacing it with a similar UK equivalent is a very serious matter that has clear patient safety implications. Quite simply, it will be harder for the UK to monitor fake medicines coming in from non-EU and EU countries. Will the Minister outline how she intends to resolve that matter as a priority?

The human medicines regulations will also introduce into UK law a new authorised activity as part of the existing wholesale dealer licence, enabling the importation of medicinal products from countries on a list. On exit day, that list will comprise all EU and EEA countries, but the list may change over time. Does the Minister not feel that Parliament should have oversight of those lists, or at least an ability to block or make additions or subtractions, particularly as they will allow medicinal imports?

As we have heard, the medical devices regulations also introduce a new RP-I role to allow wholesale dealers to import medicines from the EU and EEA on to the UK market. Can the Minister confirm how many RP-Is she expects there to be? How will they be trained and regulated? Who will they report to? What arrangements will there be for oversight and holding them to account, including taking legal action against them if there is a concern that they are not carrying out their duties effectively? How will complaints in relation to this new role be handled?

Moving on, the human medicines regulations will allow the recognition of prescriptions from an approved list of countries following EU exit. On exit day, the list will comprise all EEA and EU countries. For a prescription to be eligible, the prescriber must be of equivalent professional status to a profession that is eligible to prescribe in the UK. Will the Minister clarify how oversight will be maintained, to ensure that prescribers are indeed of a professional status equivalent to a profession that is eligible to prescribe in the UK? What will the arrangements be for collecting data and monitoring the effectiveness of these regulations, and how will errors be compensated?

Coming back to medicines, in the event of a no-deal Brexit, there are two possible scenarios for manufacturers marketing biological medicines in the UK. First, where the UK agrees with one or more countries to accept each other’s independent test certificates for biological medicines, it would mean little change from the current arrangements, except as agreed and set out in a formal mutual recognition agreement between the countries. What progress has the Minister made in drawing up the list of those countries with which the UK has an agreement in place, and how many countries does she anticipate the UK will have an agreement with by exit day, whenever that is?

Secondly, where there is no mutual recognition agreement in place, that scenario would involve the National Institute for Biological Standards and Control issuing UK certificates for batches of biological medicines used in this country. Where the batch is destined for use in both the UK and another country, if it has already received independent certification in a country that is on the UK’s approved country list, the NIBSC will take a public health risk-based approach to deciding whether to rely on a paper assessment of that certificate or to issue a UK certificate to carry out testing.

Will the Minister clarify what is meant by a public health risk-based approach in this context? Can she confirm whether the NIBSC has drawn up a clear set of guidelines by which staff will be making those decisions? If so, is she aware of whether staff have received suitable training in using those guidelines, and will she confirm whether the NIBSC is being given extra resources to manage the extra workload that that will require? Can she guarantee that there will be no time lag in making approvals after exit day?

Looking at the sale of medicines, we see that EU-based online sellers currently have to register, comply with relevant requirements and display an EU common logo linked to the competent authority in which they are based. These regulations remove the requirement for UK-based online sellers. Does the Minister not agree that removing that requirement for UK-based online sellers might make it harder to work out which sellers of medicines online are legitimate?

With regard to manufacturing and wholesale dealing, the current good manufacturing practice directive is preserved, with modifications to reflect the fact that the UK is no longer a member state, but with a regulation-making power for Ministers to modify the directive or replace it in the future. The power is also placed on the licensing authority to publish guidelines on good manufacturing practice and good distribution practice, while preserving the EU guidance in place immediately before exit day until it does so. Can the Minister confirm today that these guidelines will be ready on exit day?

I feel I need to sit down, but I have a few further concerns.

[Thangam Debbonaire]

My hon. Friend is attacking the detail of these statutory instruments with forensic attention, and I do not envy the Minister in trying to respond to all his many pertinent questions. Does he agree that his analysis of these draft instruments shows that we have been, at best, misled about how straightforward, simple and easy it would be to translate EU regulations, directives and laws into UK law, and also how easy it would be to scrutinise that process? It is important that hon. Members such as him undertake such scrutiny.

[Justin Madders]

I thank my hon. Friend for that helpful intervention. I feel that we could be a double act on the stage, but I am not sure that we would get many people in to watch us talking about these draft regulations. However, she makes a valid point. We have a lot of these problems because of the foolhardy decision to come out of the European Medicines Agency, which has created an unnecessary amount of work. There are serious questions to answer for those who portrayed leaving the EU as a straightforward matter, and who must now justify our having to interpret, debate and agree this absolute minefield of regulations at very short notice.

I will now talk a little about medical devices. You will be pleased to know that I do not have that much more to say, Mr Robertson; I am sure that the Minister is quite pleased about that as well. I will not go over the section 8 powers of the EU withdrawal Act, but they also apply to the draft medical devices regulations and modify the effects of the re-stated EU regulations, so the questions about reporting to Parliament, oversight and the collection and monitoring of data apply in that context, too.

I also have concerns about the conformity of devices, the expansion of registration requirements and data exchange. The Government announced their intention to continue to recognise, for a time-limited period, the CE mark on medical devices and in-vitro diagnostic devices that have demonstrated their conformity with EU regulatory requirements. Will the Minister clarify what is meant by a “time-limited period”, and what the arrangements will be once that period comes to an end? Will she also outline what assessment she has made of the impact of that on access to new devices?

Furthermore, in the event of no deal, UK-based notified bodies responsible for verifying medical devices will no longer be recognised by the EU, meaning that the devices that they have certified will no longer conform to the applicable EU directives after 29 March. What assessment has the Minister made of the impact of not being able to place those products on the market, and what are the Government’s contingency plans for that? While UK law will give UK-based notified bodies an ongoing legal status and will continue to recognise the validity of the certificates that they issued prior to 29 March 2019, those bodies will be unable to issue certificates for new products. What assessment has the Minister made of the impact of that on products being developed for the UK market?

With regard to registration requirements, in a no-deal scenario, all medical devices will need to be registered with the MHRA prior to being placed on the UK market. Where a device manufacturer is not established in the UK, the registration of a product with the MHRA will be undertaken by a “UK responsible person”, who will be established in the UK with a UK-registered address. That person, as the name suggests, will take responsibility for the product in the UK. Will the Minister confirm how many manufacturers will need to establish a UK responsible person? Will she also clarify the oversight and regulation arrangements for such persons? I note that the impact assessment says that it is uncertain how many people will have the necessary expertise to fulfil that role. Does the Minister have a plan for if enough suitable people do not come forward to be a responsible person?

The draft devices regulations also refer to an appropriate transitional period for people placing medical devices and IVDs on the UK market to comply with the new requirements. The transitional period will vary from between four and 12 months, depending on the risk category of the devices. Will the Minster clarify what the arrangements will be when that transition period comes to an end?

Regulations 76 to 133 of the draft human medicines regulations place a large number of obligations on manufacturers, and corresponding powers to the Secretary of State to require compliance. Who, in reality, will perform that role, and what additional resources will they be given to ensure compliance?

Finally, in a no-deal scenario, the UK will no longer have access to EU data systems, including Eudamed, the European databank on medical devices. These systems are vital for data exchange, facilitating the exchange of information between notified bodies, national competent authorities and the European Commission. The MHRA is building an electronic system that expands on the current registrations database, which the Government say will mirror, as far as possible, the Eudamed requirements. Will the Minister confirm that the new electronic system being built by the MHRA will be operational by exit day? What are the additional costs and where is the funding coming from? Will she outline which aspects of the new database will not mirror Eudamed, and what steps are being taken to mitigate that?

Members will be pleased to hear that I have come to the end of my contribution. I appreciate that I have raised a significant number of questions, and it may not be possible for the Minister to answer them all in the time we have, particularly as we also have to hear from the SNP spokesperson, the hon. Member for Central Ayrshire. The amount of material I have gone through today demonstrates without question why this process is so wholly inadequate for dealing with such important and complicated issues. There are many important questions about the impact on businesses, patients and the taxpayer. We really deserve a better attempt at this than that we have seen today.

--- Later in debate ---

[Jackie Doyle-Price]

That is right. As I have said, we are seeing that some parts of industry are preparing for that scenario on the basis that there will be no associate membership. Having left in that scenario, if we look broadly at how the MHRA discharges its functions and how it is funded, at this stage we are looking at it continuing as usual and washing its own face. The hon. Lady mentioned that we could use some of the Brexit dividend to meet the cost. All of that is completely wide open at this stage. This measure is really just to keep the show on the road.

We have put some expectations down in terms of review. Most of the commitments we have made are to review all of the operations within two years. As for any conclusions we reach, we will come back to Parliament to institute any change if that is what we wish to do, but that would be done very much in consultation with industry and in a transparent way, recognising that all Opposition Members are not entirely satisfied. Clearly, we will go back to business as usual when it comes to scrutiny of these matters. Again, I cannot say often enough that I do not want that eventuality to materialise. It is my determination that we leave with a deal.

There was a reference to the impact on SMEs. The MHRA is taking steps to ensure that the burden on them is minimised. It will look at things such as fee waivers for some products to encourage further research and innovation. Again, that recognises the real concern about that.

[Justin Madders]

I know that we have asked a lot of questions, but there is almost a contradiction in what the Minister has just said. She expects the MHRA to wash its own hands still, but talks about fee waivers in some circumstances. If it is a trading fund, and there are new obligations on it, I am not sure how all that will realistically work.

[Jackie Doyle-Price]

I trust the MHRA to manage its own finances and take a proportionate view as to what is an appropriate fee, because it has the day-to-day contact with businesses. Overall, it will still be expected to settle its budget on the basis of the fee income that it incurs. That still gives it the freedom to do that, if that is in the sector’s strategic interest.

We have responded to some of the representations made by business about the potential additional costs. One reason that we introduced the responsible person for import assurance procedure was to minimise, as effectively as possible, the burden on the trading of the wholesale sector. Again, that recognises that where things have been checked and have gone through an appropriate European regulatory procedure, we should be satisfied that that is good enough for us. I am confident that that pragmatic approach will be repeated as the MHRA takes the matter forward.

Several points were made about the MHRA’s ability to take on new roles. The UK already has substantial capacity and expertise to regulate and evaluate the safety of our medicines and medical devices. The MHRA has real expertise in many areas, including pharmaco- vigilance and clinical trials regulation, which provides benefits to patients across the EU. I am confident that the EU will want to retain access to that expertise. That also shows that the MHRA has the expertise and human resources to discharge those roles. It has 30 years of experience as a lead regulator, it has led on the registration of more than 3,500 medicines, and it is globally recognised for its expertise. None the less, it will manage the demands on its service and I have every confidence in its ability to do so.

The hon. Member for Ellesmere Port and Neston raised the issues of continued access to medicines and of reviewing the fees. The statutory instrument provides continuity for patients and businesses by providing for existing EU licences to be automatically converted into UK licences, which should give continued access to medicines and will be done at no cost to industry. It also puts in place a new licensing route that will allow the MHRA to accept the same information from companies that apply for an EMA licence and that will allow the UK to grant a licence in the same timeframe as one would be received today.

Effectively, we will follow and replicate what the EMA does. There has been much talk of the UK being rule takers and hon. Members might suggest that there is no change here. That recognises, however, that we are in a global marketplace for medicines and that we all want to have access to the best medicines. In practice, there is much shadowing and sharing of expertise in this area. That raises a question that we do not have time to debate this afternoon, but there is much to be gained from international co-operation in this area.

Obviously, we want to make sure that the UK remains an attractive market for new medicines and for innovation. As I said earlier, we will review the fees set out in the SI within two years to make sure that they remain competitive and fit for purpose, and that they deliver the objectives that we want to achieve through the regulatory system.

The hon. Gentleman laid down a challenge; he said that the regulations go beyond a simple technical implementation of the directives into UK law and raise new powers for the Secretary of State. Clearly, the regulations are made under section 8 of the European Union (Withdrawal) Act 2018, which gives Ministers powers, where appropriate, to take additional powers. However, the changes are the minimum necessary to maintain continuity while protecting the health of UK patients while we are outside the EU, although clearly there is concern about issues of supply, as the hon. Member for Central Ayrshire mentioned.

We do not anticipate needing to use the Henry VIII power. We are confident that the regime that we have set out will ensure continuity of supply. However, in the event that that did not happen, provision would be needed. The power is a safeguard to be used in the case of serious shortages. I would not choose to describe it as a Henry VIII power, but I recognise the right of Opposition Members to do so. It is limited to temporarily modifying the effects of the human medicines regulations, for a limited time or purpose. As has been mentioned, the statutory instrument would use the negative procedure, but it could obviously be annulled. However, it would be used only where existing processes had been exhausted.

The hon. Member for Ellesmere Port and Neston raised the question whether any particular medicines would be at risk, and also mentioned prices in that regard—a concern that I think the hon. Member for Central Ayrshire will share. Clearly the MHRA consulted on the issue, and that informed its analysis. Any potential increase in medicine prices will depend on the extent to which costs are passed on to the consumer; but we shall bear the matter in mind, with regard to future medicines price negotiations. It is something that we shall have to keep an eye on at this stage. It is difficult to quantify. None the less, we have made clear commitments to the public about what they can expect, and about ensuring a continuous supply of medicines, and we shall have to find ways to deliver on those commitments.

--- Later in debate ---

[Jackie Doyle-Price]

My understanding is that those conversations have been taking place. However, the hon. Lady is right that the very nature of those products, which cannot be stockpiled, has brought complications. I fully expect the president to be involved in those conversations. I do not have that knowledge to hand now, but I will write to her afterwards, to give her some reassurance.

We had two waves of consultations on the draft instruments. For the last, in October, we issued a consultation that received 170 responses, through which we ended up with the proposals before us. Again, these are subject to further consultation with the industry.

It is obviously a priority for us to make sure that Britain remains a competitive location for life sciences companies, and we are committed to maintaining our renowned strength in science and research. Since the referendum, we have seen many signs of the industry’s continued confidence in the UK. In 2017, we received the highest level of life science investment in Europe, and were second globally only to the US. That illustrates the confidence in our regulatory system, which is why we are confident that the MHRA is well up to the task given to it by the draft statutory instruments.

The hon. Member for Ellesmere Port and Neston gave an impressive illustration of what he described as the confusion regarding the various dates at which parts of the draft regulations will come into effect and the complexity of some of the references within them, and he posed legitimate questions on how business would understand and prepare for them. However, as I say, we have produced detailed guidance to support everyone in interpreting the draft instruments, and the MHRA does not expect anyone to navigate this alone and will be there to give advice. That support is partly reflected in the length of time that businesses will have to prepare for and implement these measures. We will ensure that that dialogue continues.

The hon. Gentleman also raised questions about market access and legal accountability, and whether we will have sufficient people to discharge that role for the industry. We believe that those skills are already in place, bearing in mind that a lot of companies will already have to fulfil these functions with the EMA, particularly when exporting. We do not anticipate that this change will be disproportionately onerous on business. However, we have given the industry 21 months to implement that aspect. To make sure that only genuinely qualified people undertake that role, anyone who vouches for a medicine that is then potentially harmful to patients faces a maximum two years’ imprisonment. The sector has sufficient integrity to engage only properly qualified people; to do otherwise would be foolhardy.

Questions were asked about the degree to which UK consumers could be protected from false medicines. To reassure Committee members, the falsified medicines directive, implemented in 2013, will remain in UK law, even in the event of a no-deal exit. We will make sure that we continue to apply the same protections as before. We obviously want to retain a close working partnership with the EU on medicines regulation, and I think that we will be able to share expertise and information on such issues over and above any potential mutual recognition of regulations. We will all benefit from that information sharing. Issues were also raised about the wholesale sector. We will obviously continue to ensure that the MHRA keeps a good eye on that and makes sure that that regulatory regime is fit for purpose.

Turning to some of the comments about the devices, we will continue to recognise the CE mark on medical devices. It is also fair to say that the existing regulatory regime has perhaps been seen as rather liberal in its approach—the hon. Member for Central Ayrshire alluded to this when she referred to mesh—and it has been subject to some revision at EU level. Certainly, we want to follow what is happening with that review and consider whether there are any further improvements we would wish to make to that CE mark system.

To those colleagues who thought that leaving the EU might lead to a bonfire of regulation, I say that, clearly, when it comes to medical devices, some of which remain within the body for a length of time, we should not stint in our approach to the protection of patients. Patient safety should be the primary objective, notwithstanding the importance of maintaining a competitive marketplace. Patient safety is crucial.

There are estimated to be around 600,000 medical devices available on the EU market, many of which have not been produced in the UK or approved by UK-notified bodies. It would be quite a big undertaking for the MHRA to license those products, but we will increase our market surveillance by requiring all new devices being placed on the UK market to be registered with the MHRA after exit day by the manufacturer or a UK responsible person, in accordance with the transitional timetable. Our emphasis is patient safety first and foremost, while doing our best to improve access to the market. We will require, as the hon. Member for Ellesmere Port and Neston said, all overseas manufacturers to register those products here with the MHRA themselves.

We have also had some discussion about the RP-I. That is a new role; the hon. Gentleman asked how many will be required and where we will find them. We are giving the industry a two-year transition period, to give it the opportunity to register those persons with the MHRA, and it will depend on the number of wholesalers who intend to import products from the EEA. We are satisfied on the basis of the discussions we have had with the industry that that two-year implementation period is appropriate, and there has been consultation on exactly what sorts of skills those persons should have, with the intention that they should fill the regulatory gap caused by our removal from the EMA, but without putting undue burdens on the industry.

[Justin Madders]

In essence, the Minister is saying that, having consulted the industry, the general view is that there will be sufficient people in place with the right skills within 21 months. If that is the case, that explains the position, but is there a fall-back position if that does not transpire?

[Jackie Doyle-Price]

As I say, that timescale has been arrived at between the MHRA and the industry. On that basis, I would not anticipate a problem, but we will have to monitor that none the less, bearing in mind that we are effectively introducing a new regime and any market adjustments that happen in that intervening period will have an impact on it. A lot can happen in those 21 months. We are effectively altering the terms of trade, and we cannot be sure of all the consequences of that, but the MHRA will maintain that close dialogue with the industry to ensure that we are being sufficiently responsive.

The hon. Gentleman also mentioned the national database of all devices. The fee for establishing that database will be £100 for each device. Manufacturers outside the UK will be required to have a UK-based responsible person, who would act on behalf of that manufacturer to do things such as registering the product. Again, there will be a transitional period to enable the industry to implement those changes.

Some questions were asked about access to medicines. Obviously, we want to make sure that UK patients have access to life-transforming drugs at the same time as people in Europe. Whether we might be placed at a disadvantage by being outside the EMA has been a real concern. We want to ensure that when a drug is registered with the EMA, we consider it at the same time, so that there is no advantage for any manufacturer in delaying entering the UK market because it would not get any ongoing benefit from that, in terms of protective rights on intellectual property. We would effectively start the clock at the same time as the application with the EMA to give an incentive to enter the UK market as soon as possible. Again, we will wish to monitor how that works in practice.

We will assess whether countries from which a registered importer operates might change over time, and whether that needs scrutiny by Parliament, on the basis of whether the technical standards in that country are consistent with ours. Obviously, that would be a constantly moving feast. The MHRA is ideally qualified to make a judgment on that, but I would expect it to do that with sufficient transparency to allow any challenge to take place.

I apologise if I have not addressed all the points that have been made this afternoon. I will write to hon. Members. I reassure all hon. Members that the Government are fully committed to a system of medicines and medical device regulation that intelligently balances patient access to new, innovative and world-leading projects. As part of these measures, the MHRA will have in place a suite of licensing routes for medicines and vigilance systems for medicines and devices. The Government also place enormous value on the contribution to public health of the research charities, industry and the life sciences sector as a whole, and as such, the MHRA will continue to support innovation in the life sciences through its innovation office and scientific advice.

We remain committed to offering a competitive regulatory environment to ensure that the UK has access to the safest and most effective medicines in the world. As I said, we have tried to replicate the current regime, but there has been a need to add additional requirements for industry to deal with the fact that we are leaving the EMA and its regulatory structure. We have done so in the most competitive way possible, while maintaining patient safety and remaining the best place in the world for science and innovation.

Question put and agreed to

Resolved,

That the Committee has considered the draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019.

Draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Resolved,

That the Committee has considered the draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.—(Jackie Doyle-Price.)

Eurotunnel: Payment

Justin Madders Excerpts

Monday 4th March 2019 Commons Chamber

[Matt Hancock]

Yes, my hon. Friend is correct. He makes a broader point: people watching these proceedings, people who have serious illnesses, and people who rely on medicines every day to keep them alive will be amazed by those Members who will not vote for the deal and therefore make a no-deal exit more likely, and by those Members who just cause political noise rather than admitting that, in the circumstances, they too would have settled this case. We are hearing a lot of that from those on the Opposition Benches. On the Government Benches, however, we are hearing from Members who care deeply about making sure that people get the medicines that they need.

[Justin Madders (Ellesmere Port and Neston) (Lab)]

Does the £33 million include all the possible expenditure under this agreement, or are there any additional costs, such as legal fees, that need to be added on top? If there are, how much are they?

[Matt Hancock]

The settlement is £33 million. Of course, there are lawyers, and legal time was also needed inside the Department. That happens all the time in order to try to make sure that we can keep people safe, which is the whole purpose of this exercise.

Former British Child Migrants: Payment Scheme

Justin Madders Excerpts

Tuesday 26th February 2019 Westminster Hall

[Justin Madders (Ellesmere Port and Neston) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Hollobone.

First of all, I thank my hon. Friend the Member for Wigan (Lisa Nandy) for securing this debate, for her excellent contribution to it and, of course, for her campaigning on this issue over many years. We have seen today her continuing tenacity, and the importance of continuing to raise these vital matters on behalf of the victims. She described the inquiry report as damning, and said that it exposed harrowing abuse and that this issue was exacerbated by the lies that were told about it. She is right that this was a shameful episode for our country.

My hon. Friend was also right that the issue went beyond the abuse that people suffered; they were also wrongly separated from their families for generations. Think about what it would mean for someone to be separated from their parents, grandparents, aunts, uncles and cousins. It is very difficult to appreciate just what kind of hole that would leave in their life, and it is also very difficult to appreciate just how harmful that is. I add my voice to hers, and would like to show my appreciation of the courage of those who have been affected by the child migration programme: the 130,000-plus British children who were deported without their consent—sometimes, as we know, even without their parents’ consent—and the estimated 4,000 unaccompanied child migrants who, as we have heard, experienced sexual, physical and emotional abuse as a result of this devastating policy, which was practised by successive post-war Governments until 1974.

As was highlighted by the independent inquiry into child sexual abuse report on the child migration programme, and in the accounts that we have heard today and in previous debates, these children suffered abuse before, during and after their migration, often over a period of many years and sometimes at the hands of more than one perpetrator. As we know, for many of them, that has had a lasting—indeed, lifelong—impact on their physical and mental wellbeing, their educational attainment and their employment prospects—in effect, their whole life. No one can fail to be moved by the personal accounts that we have all heard from those who suffered abuse, and I am sure that we are all united in our desire to do everything we can to put right those wrongs, as far as it is possible to do so.

There is no doubt that the victims of the child migration programme suffered for too long at the hands of successive Governments, and that successive Governments chose to turn a blind eye. Of course, these people also had to wait far too long for an apology. It saddens me that that took until 2010, when Gordon Brown, the then Prime Minister, formally acknowledged that successive Governments had failed in their duty of care.

Gordon Brown also established the £6 billion family restoration fund to help former child migrants to reunite with their families, so that they could build relationships, be involved in significant family events, or even urgently visit relatives at times of crisis. However, as we have heard from last year’s inquiry, despite this scheme, the UK Government have failed to provide adequate redress to the more than 2,000 surviving child migrants.

I am sure we all agree that victims have been let down all their lives by successive Governments missing opportunities to take action over the years. It is with regret that we note that it took more than nine months for the Government to respond to the inquiry report, especially given that the inquiry stressed the importance of urgent action because of the age and ill health of some of the surviving child migrants.

I welcome the Government’s acknowledgement that the delay in establishing the scheme was unacceptable, and that they will accept claims on behalf of former child migrants who were alive when the report was published last March but subsequently passed away. The report recommended that financial redress be established without delay, and that payments be made within 12 months. As we know, that would be by this Friday, 1 March. I share the frustration felt by my hon. Friend the Member for Wigan about the details of the ex gratia payment scheme having been published only on 31 January, and only on the Child Migrants Trust website. As she acknowledged, although the trust has excellent contacts throughout the former child migrant community, we need to learn from the Government whether there are any further things that they can do to publicise the scheme, to ensure that nobody is overlooked.

I share my hon. Friend’s concern that former British child migrants have raised legitimate points about their lack of involvement in the development of the payment scheme. In any case of abuse, it is absolutely vital that the victims’ voices be heard. In this case, they were not heard at the time of the abuse and they have not been heard since; it is important that they are heard throughout the whole inquiry process, which includes the determination of the payment to be made.

I hope that the Minister will say whether she is confident that the £20,000 figure will provide adequate redress. As my hon. Friend said, so far there has been little clarity about how that figure was arrived at. People absolutely need transparency at all times, not least when they have suffered in the way that we have heard about today.

My hon. Friend also asked reasonable questions about the taxable status of these payments, and so on. I hope that the Minister can respond to those questions, so that former child migrants do not suffer any more uncertainty about whether they will qualify for the scheme. I hope that he will also provide clarity about the eligibility criteria, as my hon. Friend requested, because there were child migrants who were sent to the receiving institutions with permission from parents or guardians, but as my hon. Friend clearly set out, no matter the vehicle by which children arrived at those institutions, the abuse that they suffered within them was the same. We hope that there will be no further delay to victims of the child migration programme receiving the redress they are entitled to. Will the Minister say whether she is confident that the Child Migrants Trust has the resources to administer the scheme? If it does not, what further measures will be put in place?

I share my hon. Friend’s concerns that the Government’s pledge to continue the family restoration fund until the end of the redress scheme does not meet the inquiry report’s expectation that the continuation of the scheme will not lead to reduced funding for the Child Migrants Trust or the family restoration fund. I hope that the Minister will take this opportunity to provide reassurance that the Government will continue to provide funding until the family restoration fund is no longer needed.

In conclusion, as a politician, it angers me to hear the inquiry’s conclusion that the main reason for the failure of Her Majesty’s Government to take action to end the child migration programme after the second world war—despite the evidence of ill treatment and abuse, including sexual abuse—was politics. I hope that in today’s politics we are a very long way away from that place—a place where the importance of continuing relations with other Governments and with charitable organisations, and the need to avoid reputational risk, was prioritised over the wellbeing of our children. The politicians of today may have our differences, but we must never again allow the suffering of children and their search for justice to be subservient to the politics of the day.

[Mr Philip Hollobone (in the Chair)]

Unusually, due to important parliamentary business elsewhere, we will have the Opposition spokespeople in a different order. We have heard from Her Majesty’s official Opposition; now we will hear from Stuart C. McDonald for the Scottish National party.

Oral Answers to Questions

Justin Madders Excerpts

Tuesday 19th February 2019 Commons Chamber

[Stephen Hammond]

My hon. Friend rightly points out that there are several routes into healthcare professions, and I am delighted by what is happening in Cornwall. I understand that my right hon. Friend the Secretary of State will be visiting him in the very near future.

[Justin Madders (Ellesmere Port and Neston) (Lab)]

We are in the midst of the worst-ever NHS workforce crisis, with more than 100,000 vacancies. The situation is unsustainable. Well-respected think-tanks say the figure could rise to 350,000 vacancies within a decade. What does the Minister consider a sustainable vacancy level both now and in a decade’s time?

[Stephen Hammond]

The hon. Gentleman will recognise that the £20.5 billion in real terms that we are investing in the NHS under the long-term plan will make a significant difference. He will also want to recognise the roll-out of medical places, the fact that more people are applying for nursing places now than they were last year and the detailed implementation plans that my right hon. Friend the Secretary of State has commissioned. These will deliver a sustainable workforce.

NHS 10-Year Plan

Justin Madders Excerpts

Tuesday 19th February 2019 Commons Chamber

[Justin Madders (Ellesmere Port and Neston) (Lab)]

With five and a half minutes of speaking time per year of the plan, I suspect that we have not quite done it justice tonight. However, we did manage to hear from nine Back Benchers during the debate. While I cannot refer to everyone in the time I have, I want to draw particular attention to certain contributions.

My hon. Friend the Member for Hartlepool (Mike Hill) spoke about the importance of improving GP access—something we can all relate to—and the importance of mental health, a big driver of the 10-year plan. My hon. Friend the Member for Stroud (Dr Drew) made important points about threats to services in his constituency, and we heard such points across the Chamber. I was particularly pleased to hear from my hon. Friend the Member for Easington (Grahame Morris), who, of course, speaks about cancer treatment from personal experience. He rightly pointed out the deficiencies in the 10-year plan in relation to that. My hon. Friend the Member for Enfield, Southgate (Bambos Charalambous) was absolutely right to highlight the postcode lottery in palliative care. As with other areas such as neonatal care and IVF, it varies depending on where in the country someone lives. He also made a very important point about the cancer workforce.

I want to say a few words about the workforce. In recognising their invaluable work, which we thank them for, we also recognise—we on the Labour Benches do, at least—that without a fully staffed, respected and motivated workforce, the NHS would simply not be able to deliver the service that our constituents deserve. Last June, there was at last some Government recognition of the importance of the workforce, when the 10-year plan was announced. The then Health Secretary—now the Foreign Secretary—said:

“Alongside the 10-year plan, we will also publish a long-term workforce plan recognising that there can be no transformation without the right number of staff, in the right settings and with the right skills.”—[Official Report, 18 June 2018; Vol. 643, c. 52.]

We now know, however, that the workforce plan will not be with us until some time later this year, so is it not the case that without a workforce plan, we simply do not know how much of the 10-year plan is achievable?

As we know, the House of Lords Committee on the Long-term Sustainability of the NHS said that the lack of a workforce strategy

“represents the biggest internal threat to the sustainability of the NHS”.

Amazingly, the 10-year plan makes no reference to the actual numbers of staff expected to be employed during this period, so I put in a written question to the Minister about how many staff the NHS expects to employ by the end of the period covered by the 10-year plan. I was told in response:

“The Department does not hold the data requested.”

So there we have it in black and white: the Government do not have a clue.

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

Does that not just underline the fact this evening’s debate has been so ridiculously short on such an important subject? We need more time; we need another debate.

[Justin Madders]

I thank my hon. Friend for his contribution. Of course, we were not actually meant to be here at all this week, but it is absolutely right that this debate took place tonight. We need another one and we will very shortly need a debate on the social care Green Paper, when that is published. We also need a debate on what we are going to do about some of the legislative changes that the Government have promised, because all these things need to take place in the public eye.

[Anneliese Dodds (Oxford East) (Lab/Co-op)]

Does my hon. Friend agree that we also need a debate on privatisation, given that we are seeing no public consultation on very significant changes, such as what is purported to happen to the PET—positron emission tomography—scan centre at Oxford University Hospitals NHS Foundation Trust, causing a huge amount of local concern?

[Justin Madders]

I thank my hon. Friend for her intervention. She is absolutely right. The Secretary of State has said on the record that he wants to stop privatisation, but we have identified a number of very important contracts lasting many years and costing millions of pounds that should be halted if the Government are going to stick to their word. It has not happened and it should.

The timetable for the publication of the plan has itself not gone to plan. Again, when the Foreign Secretary was Health Secretary, he said:

“we now intend to publish the social care Green Paper in the autumn around the same time as the NHS plan.”

I am not sure which autumn he was talking about for the social care Green Paper, but the intention was right, because, as he also said:

“It is not possible to have a plan for one sector without…a plan for the other”—[Official Report, 18 June 2018; Vol. 643, c. 52.]—

but here we are.

In conclusion, whatever fine words, gimmicks and spin we have in the 10-year plan, we know that the reality is that the NHS is on its knees and that it cannot survive another decade of Tory Government. It is time for Labour to come to the rescue again.

Early Parenthood: Supporting Fathers

Justin Madders Excerpts

Wednesday 30th January 2019 Westminster Hall

[Justin Madders (Ellesmere Port and Neston) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Davies. I congratulate the hon. Member for Chatham and Aylesford (Tracey Crouch) on securing the debate and on her excellent introduction. As the hon. Member for Glasgow East (David Linden) just said, it has been a very good and well-informed debate, and it has struck the right tone. Perhaps we should take that into other arenas.

The hon. Lady raised three main issues. She referred to the important work of the Centre for Social Justice and mentioned interesting survey statistics—for example, that seven out of 10 fathers said they felt like a spare part, and that six out of 10 had no conversations with their midwife. I think a lot of us would recognise that territory. I remember being on holiday with my wife and her going up to talk to a woman I had never seen before, who turned out to be her midwife. That shows how difficult it is to engage both parents. I know that the Government are pushing for greater consistency, with the same midwife throughout the journey, but the fact that we have 3,500 midwife vacancies makes that a challenge.

The hon. Lady raised the subject of loneliness, too. I thank her for her work to introduce the Government’s loneliness strategy in 2018, building on the Jo Cox Commission, which is led by my hon. Friend the Member for Leeds West (Rachel Reeves) and the hon. Member for South Ribble (Seema Kennedy). That is a hugely important part of Jo’s legacy, and I am sure that Members across the House recognise the excellent contribution that the hon. Member for Chatham and Aylesford has made to drawing attention to that issue. There are, of course, many triggers for loneliness, one of which is being a new parent.

The hon. Lady also raised the important role that children’s centres can play. Several Members raised concerns about whether they are well enough used. Cuts of 60% to local government funding in recent years have led to the closure of 1,000 children’s centres, which provide support to both mothers and fathers in those early years. There is no doubt that that has had an impact.

The hon. Lady is right that we have a long way to go to reach true equality, with shared parenting. Shared parental leave legislation, which has been about since 2015, enables employed couples to split 50 weeks’ time off work after the birth of their child. The Government originally estimated that 8% of parents would take up the option of shared leave. However, disappointingly, take-up at the moment is only about 1% or 2%. A recent freedom of information request showed that take-up is particularly low among new parents, with only eight out of every 1,000 eligible people taking up the option. Some 8,700 new parents took up shared leave in 2016-17, and that increased by only 500 the following year.

The Women and Equalities Committee highlighted a number of problems with shared parental leave, including the complexity of the system, low uptake and low pay, and fathers’ fears about taking leave because of its perceived negative effect on their careers. There is a cultural issue here, so will the Minister say what can be done to address that?

Shared parental leave does not extend to self-employed parents. At present, self-employed mothers are entitled to statutory maternity pay of £140 per week, but they must take all that in one go and they risk losing their payments if they undertake work outside their 10 allotted “keeping in touch” days. Self-employed fathers do not have access to that at all. I hope that hon. Members will support the Shared Parental Leave and Pay (Extension) Bill promoted by my hon. Friend the Member for Batley and Spen (Tracy Brabin), which would enable self-employed parents to split parental leave and pay between them. Given that the ranks of the self-employed seem to increase every year, will the Minister say whether the Government have any plans to legislate in this area?

Better pay and the option of part-time take-up of shared parental leave would improve access to leave for fathers, particularly those from lower-income groups. There is strong evidence of the effectiveness of non-transferable paternal leave as a lever for encouraging shared care and reducing the gender pay gap. We know that fathers want to play an active role in their children’s lives and families want to spend more time together with a new baby. That is why, as the hon. Member for Glasgow East said, we made a manifesto commitment to double paid paternity leave to four weeks. Fathers are parents too and they deserve to spend as much time as possible with their family.

The hon. Member for East Renfrewshire (Paul Masterton) gave a personal and touching account of his own experiences and set out well how fathers are almost removed from the scene shortly after birth, which is an experience that most of us who have been through that will recognise. Unfortunately, I think that sets a tone for the rest of the early years, if not the whole life.

The hon. Member for South West Bedfordshire (Andrew Selous) drew an interesting and important link between income and antenatal group attendance. He is right that fathers are not included as much as they could be in many of the inspection frameworks. His central point—this is something that we see across a lot of the NHS—is that the best practice is only in pockets, and does not always disseminate out into the whole of the system.

The hon. Member for Congleton (Fiona Bruce) spoke about the importance of families and said that there can sometimes be a cycle of negative experiences throughout the generations.

The hon. Member for Moray (Douglas Ross) gave us the good news about his impending fatherhood, and he raised an important issue about the proximity of maternity services. That does not just relate to the reorganisation of services, as in his case; it is a sad fact that last year, about half of all maternity units had to close their doors temporarily at some point, which meant that someone who was in the process of labour would have to find somewhere else pretty quickly, which can be distressing and inconvenient.

The hon. Member for Mansfield (Ben Bradley) gave a thoughtful and personal account of his experiences of fatherhood; we will all recognise many of things he described. He is right that parenthood is expensive, and that can add to the strain that young families experience. He made an important point about the silo-working that we often see across public sector agencies—a situation that we all want improved.

Finally, the hon. Member for Walsall North (Eddie Hughes) gave some contrasting examples of approaches to flexibility in the workplace and spoke of some of the cultural issues that we have already discussed. There is a need for a more consistent approach across workplaces.

As a father myself, I would like to spend more time with my children—or I certainly did until they became truculent teenagers; things got a little less pleasant then. Seriously, every parent wants to play as much of a role as they can in creating a safe, loving and stable environment for their children, so that they grow up into happy and healthy adults. We know that long working hours and the inflexible working approaches of some organisations make shared parenting duties a challenge. If we are to support men in taking a greater role in the family unit, we need to support men and women having a real and meaningful choice about how they organise their lives; that means family-friendly employment, applied equally to both parents.

It is a well-known fact that the gender pay gap is still here in 2019. The impact of women’s being more likely to be in part-time, low-paid or non-paid caring roles has implications for fathers in the workplace. We committed to tackling the gender pay gap and have pledged that in addition to reporting gender pay gap figures, companies will be required to demonstrate how they plan to close their gender pay gap, by producing action plans and taking steps to address the factors that contribute to the pay gap. That will include tackling unequal pay and discrimination and improving access to flexible working and take-up of shared parental leave, to ensure that all employees have a better work-life balance.

I note with interest the proposal from the hon. Member for Chatham and Aylesford for a dad test, which would be applied to the relevant commissioning and inspection frameworks for the perinatal period. We know that this country offers some of the best neonatal care in the world, along with some exemplary psychological and bereavement services. However, as we have already touched on, there is an unacceptable variability across the country. As many as 41% of neonatal units have no access to a trained mental health worker. As has been highlighted in the past few years in our debates about baby loss, that has been an unfortunate experience for some constituents, while others have had access to the very best services. I am sure that we want greater consistency across the board.

I welcome the commitment in the NHS long-term plan to enhanced support for perinatal mental health services, including assessment and signposting to professional supports for fathers and partners. The question—which is the same for a lot of the long-term plan—is, are the resources and staff there to deliver on those important aims?

In conclusion, we are on a journey—we are not there yet—towards a greater understanding and facilitation of the father’s role. Every day of a child’s early years is hugely important. The more we can do to encourage more and better-quality support during those earlier years, the better.

Draft European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2018 Draft European Qualifications (Pharmacists) (Amendment etc.) (EU Exit) Regulations (Northern Ireland) 2018

Justin Madders Excerpts

Tuesday 29th January 2019 General Committees

[Justin Madders (Ellesmere Port and Neston) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Howarth.

I thank the Minister for introducing the regulations. As we have heard, current EU law sets out a reciprocal framework of rules for the recognition of health and social care professionals. That enables EEA and Swiss nationals to have their qualifications recognised, and to gain access to the regulated professions in which they are qualified to work in the UK on a temporary or permanent basis. Of course, in the event of a no-deal Brexit those rules will no longer apply.

As we have heard, the draft regulations on health and social care professions would amend the relevant legislation for the nine health and social care professional regulators in the UK. The other set of regulations would similarly amend the relevant legislation for regulation of pharmacists in Northern Ireland. The aim in both cases is to put in place new regulations for EEA and Swiss-qualified professionals to register to work in the UK in the event of a no-deal Brexit after 29 March.

As that date is fast approaching, the regulations are important. It is right to make arrangements, although it is a matter of regret that we are dealing with them at the last minute. Clearly they must be temporary. We accept the need in principle for some arrangements to be put in place, but we have several questions about their potential impact on the delivery of healthcare.

First, on registered professionals, an estimated 3,200 EEA and Swiss-qualified health and social care professionals join the relevant registers to practise in the UK each year. According to the General Medical Council, doctors from the 31 EEA countries and Switzerland currently make up about 9% of the UK’s medical workforce, rising to around 20% for some specialities, including surgery, with similar figures in other important areas. According to the Royal College of Nursing, the figure for nurses and midwives is between 5% and 6%.

We are therefore talking about a significant chunk of the workforce, in the context of a record number of vacancies, so there is clear potential for workforce disruption if EEA and Swiss nationals cannot register. We must do all we can to minimise the risk associated with that in a no-deal scenario. The NHS workforce is already in a precarious position, with 100,000-plus vacancies and more nurses and midwives leaving the register than joining. There is no doubt that the workforce challenge has been exacerbated since the referendum result, with 3,692 staff from the EEA leaving the Nursing and Midwifery Council register between 2017 and 2018, for example. At the same time, the number of EU nurses and midwives coming to work in the UK has fallen to its lowest level, with just 805 joining the register in 2017-18.

My first question to the Minister is this. Given the huge contribution of EEA and Swiss-qualified professionals to the NHS, which he was generous enough to acknowledge, what assurances can he give that the NHS will begin to stem the huge losses of these important staff that we currently see? Furthermore, future arrangements for EEA and Swiss applicants will be dependent on discussions with the EU. The costs attached to these future arrangements are unknown, but regulators are expected to continue to operate on a full cost recovery basis. The Government assume that any extra cost of assessing applicants with EEA and Swiss qualifications for registration will be recouped via the regulator’s setting and charging fees to recover those costs from the applicants, which has been confirmed by regulators including the General Medical Council.

At the same time, the Government have acknowledged that changes to the procedure for recognising qualifications could make access to health and care professions more difficult, which could affect the availability of professionals. Has the Minister carried out an impact assessment to determine whether additional costs will affect the number of applicants from EEA countries and Switzerland and what affect that will have on the health service?

There is also a potential impact on healthcare, because the draft regulations will remove the right of EEA and Swiss professionals to work in the UK on a temporary or occasional basis. Examples that we have been given include a Dutch-qualified paediatrician working in the UK full time but participating in European-funded international research projects, or a Portuguese-qualified doctor working in Lisbon but undertaking weekend locum work in the UK. In December, when the draft instrument came before the Secondary Legislation Scrutiny Committee in the other place, there were 134 EEA or Swiss professionals providing healthcare services in the UK on that basis. How will the Government ensure that the removal of this right will not have a detrimental effect on the NHS?

The draft regulations will give UK regulators the discretion to designate EEA and Swiss qualifications as not acceptable in the UK after exit, but they do not set out clearly the process for deciding what is or is not a comparable qualification. Two months from our exit, we do not know how healthcare professional regulators will operate their new powers to remove a qualification from automatic acceptance, should they have patient safety concerns; all we know is that the Privy Council will approve such a measure. It is unclear on what grounds a regulator will be able to make such a request and what information will be needed to satisfy the Privy Council. I am aware that at least one regulatory body, the General Medical Council, has been asking the Government for further clarification on that point. Will the Minister provide us and the regulators with guidance on what information will be requested to obtain Privy Council consent to remove a qualification from automatic acceptance where patient safety is a concern? How will he ensure consistency across the board when dealing with such applications and in the mechanism for reporting these issues to Parliament?

The impact on regulators also needs to be considered. The Department has said that there will be no additional administrative or resource burden on regulators. Given that UK regulators will have the additional function of having to assess whether qualifications are comparable, what assurances can the Minister give that UK administrators will have the administrative capacity and resources to deal with those burdens at no extra cost?

It is clear that these regulations are a stopgap to avoid an immediate cliff edge, should the UK exit without a deal. There is no clarity on plans to introduce more sustainable long-term arrangements for registering and licensing EEA and Swiss nationals beyond a review in two years. The Minister did not go into detail in his opening remarks, but it is legitimate to ask how the Government intend to approach the two-year review of the instrument and whether in the long run they will commit to reform of the legislation on professional regulators to allow for the registering of healthcare professionals regardless of where they qualified.

The Minister touched on this briefly, but what is most concerning is that the regulators will lose access to the internal market information system, or IMI, the online tool for sharing information. That will apply whether we leave with or without a deal. The IMI allows details about applicants and their qualifications to be shared and, crucially, provides an alert mechanism, which makes EEA and Swiss regulators aware of professionals with compromised fitness to practise or of restrictions on their practice. I appreciate that it is not in the Minister’s gift to commit to ensure continued access to the IMI, but as the instrument revokes provisions that require UK regulators to access and use the IMI as part of their mutual recognition procedures, it is fair to ask what plans he has to ensure that patient safety is not jeopardised by its removal. This is a very important point. What plans are in place in the short and long term to enable continued sharing of information relating to the fitness to practise of professionals across the EEA and Swiss area?

Finally, as is often the case with Brexit-related debates, we forget that there is movement both ways. The impact on UK professionals wishing to work in the EEA must not be forgotten. After exit day, professional qualifications awarded in the UK will no longer be covered by the directive. The EU has agreed that holders of UK qualifications that have been registered in EEA countries and Switzerland will continue to be registered. However, in the absence of an agreement with the EU, that will be a matter for individual EU member states to determine. Has the Minister had any discussions with his EU counterparts about the impact of no deal on UK professionals wishing to practise in the EU after exit day? Does he know, for example, how many UK professionals would be affected? Has there been any consideration of mutual qualification recognition for emerging roles such as nurse associates?

In conclusion, we do not oppose the regulations or what they seek to achieve. We recognise, as the Minister does, the valuable contribution to the NHS of staff from the EEA and Swiss areas. I hope that these regulations will not result, inadvertently or otherwise, in our deterring or losing more of them than we already have. I would welcome any reassurance from the Minister in response to my concerns.

--- Later in debate ---

[Stephen Hammond]

I would like to reassure hon. Members that, while it is essential to the public’s protection that we put in place this legislation, I recognise that a number of important and significant issues have been raised. I also recognise the potential impact on patients and citizens of the whole of the United Kingdom of not getting this right. There have been a lot of questions, which I shall try to address in some sort of order, perhaps lumping together some of the points put to me.

Initially there was a lot of talk about the impact on the numbers. From the overall number of EU, EEA and Swiss health and care professionals practising in the United Kingdom, the number working in NHS trusts in England increased by over 3,500 in the 12 months following the referendum. That includes an extra 600 doctors. As of June 2017, over 21,000 EEA doctors were registered with a licence to practise with the GMC. The number of joiners from the EEA has remained steady since 2016; therefore, these regulations would allow that to continue. The hon. Members for Ellesmere Port and Neston and for Gedling might like to point out that there has clearly been a decline in registered nurses. That is a significant concern to the Department, and we have looked not only at the number of current vacancies resulting from EU nationals not coming forward but, as importantly, at the need to train, recruit and retain UK nurses, which is why there are a number of routes into nursing.

There are language issues. One reason for the nursing staff shortage in respect of EEA applications is down to the language controls introduced by the NMC, which took full effect in July 2016. Although some people might concentrate on the referendum as the contributory factor, the language testing is also judged to have had an impact. Therefore, since November 2017 the NMC has introduced a number of changes to the language requirements for nurses and midwives trained outside the UK, which has increased the options available to such applicants to demonstrate their language ability. The changes appear to be having a positive effect on international recruitment, with 2,500 more overseas joiners to the register between January and December 2018.

The hon. Member for Gedling asked about a slightly different language issue. I will confirm this in writing, but it is my understanding that we do not intend to change the language tests.

The temporary permissions argument is clearly of concern, and I have tried to address the hon. Gentleman’s questions about that. The numbers currently working under the regime are relatively small; however, that does not mean that they do not have a positive impact. It is right that under a new regulatory system people should seek full registration. However, over the EU exit day period and the period post that, the regime will continue. As temporary and occasional permissions last for up to 18 months, there will be plenty of time for those working under the regime to decide to apply for full registration.

The hon. Member for Ellesmere Port and Neston asked about the impact on UK professionals wishing to practise in the EU after exit day. I said in my opening remarks that it is the UK that is the main beneficiary of mutual recognitions. After exit day, professional qualifications awarded in the UK will no longer be covered by the directive, and the EU has agreed that holders of UK qualifications who have been registered in EEA countries and Switzerland will continue to be registered. However, in the absence of an agreement with the EU, recognition of UK qualifications after exit day will be determined by the national policy of the individual member state.

The hon. Gentleman and I have discussed reciprocal international healthcare arrangements on several occasions, both on the Floor of the House and in Committee, and he will recognise that the Government hope that a widespread and encompassing international healthcare reciprocal agreement will be in place with the whole EU after exit day—that is our ambition. In the event of a deal, during the implementation period the current arrangements will pertain and we can look to put in place such a treaty.

[Justin Madders]

Will the Minister give way?

[Stephen Hammond]

One moment, and then I will. As the hon. Gentleman rightly knows, in the event of a no-deal EU exit—which is a lot of what we are talking about this morning—it is the Government’s ambition first to put memorandums of understanding in place and then hopefully to have a widespread agreement with the whole EU or, if not, individual arrangements with member states.

[Justin Madders]

We all hope that arrangements will be in place, but my question was: have any discussions been entered into yet with individual member states about the arrangements in a no-deal scenario?

[Stephen Hammond]

There are ongoing and widespread discussions with the Commission and with member states. A number of member states are of high priority because the numbers of UK nationals currently living there make reciprocal international healthcare arrangements particularly important. A number of issues are being discussed. Given the nature of the discussions, I hope the hon. Gentleman will accept that reassurance.

[Stephen Hammond]

The hon. Gentleman is correct. That is why we discussed in depth the reciprocal healthcare arrangements under the Healthcare (International Arrangements) Bill. Although it is absolutely the Government’s intention, in either a deal or no-deal scenario, to ensure continuity of international arrangements, at the moment that cannot be absolutely guaranteed. I hope the hon. Gentleman heard me say to the hon. Member for Ellesmere Port and Neston that it is the Government’s intention to ensure that, in the event of a no-deal scenario, memorandums of understanding will be put in place. We have already stated that anyone seeking emergency medical care, from wherever they come, will be treated by the NHS. We hope to ensure the continuity of current arrangements in a deal or a no-deal scenario.

To give Members a bit more flavour and depth, let me say, in response to both the initial inquiry, from the hon. Member for Ellesmere Port and Neston, and the inquiry from the hon. Member for Stockton South, that there is understandably a widespread agreement in this area that the current arrangements are to the mutual benefit of the healthcare systems of both the UK and the whole EU and should continue. In that light, very positive discussions are taking place, particularly with the countries where most UK nationals currently reside.

I do not need to write to the hon. Member for Gedling; I can confirm that the regulators will continue to apply the language tests as currently set out.

The hon. Member for Ellesmere Port and Neston talked about the loss of the internal market information system. If the UK exits the EU without a deal, it will no longer have automatic access to the EU systems, including the internal market information system, which regulators across the EU use to exchange information. We hope that the discussion about international healthcare arrangements will continue, but it may well be the case that UK regulators have to seek information from their European counterparts directly, rather than from the Commission. UK regulators are aware of that and are preparing for it, although, as I have said, that may well be part of the discussions about international arrangements and encompassed in a future bilateral or EU-wide international healthcare arrangements agreement. However, the regulations mean that UK regulators will not be required to carry out more assessments of European qualifications than they do now and they will allow bilateral applications for information.

[Justin Madders]

The Minister has been very generous in giving way. We should be clear that, as things stand, the early warning system will not be in operation. It is important to express our concern about that and our sincere wish to put in place an arrangement to avoid it.

[Stephen Hammond]

The hon. Gentleman is absolutely right to raise that concern, but as I have sought to reassure him, it will be perfectly possible for UK regulators and EU regulators, either in whole or individually, to exchange information. It will be possible under this arrangement for UK regulators to seek that information from their individual European counterparts, should they need to do so.

The hon. Gentleman asked about the capacity of regulators to check qualifications. Although it is not the Government’s intention or desire to have a no-deal outcome, regulators have been preparing for that possible scenario. These regulations will ensure that there will be little additional work for regulators in recognising EEA and Swiss qualifications at exit date. Under the regulations, the regulator can choose to review automatic qualifications that it was previously obliged to accept and to designate those qualifications where there are patient and public safety concerns. An applicant will be obliged to supply the regulator with the relevant documents, and if the regulator is not satisfied, it can reject the application. My point is that there is no extra administrative burden on regulators.

On the potential for an additional financial burden, the UK and the regulators have been preparing for a possible no-deal outcome. As the regulations seek to maintain the current systems as far as possible, for at least two years from their coming into force after the expected exit day until the review, there should be little extra cost or impact. There is, as the hon. Gentleman pointed out, the potential for regulators to recover those costs through additional fees, and that is true of current regulatory systems, in many cases.

The hon. Members for Ellesmere Port and Neston and for Linlithgow and East Falkirk asked whether the regulations reduce the ability to safeguard public and patient safety, making the health service less safe. At the heart of these instruments is the recognition that public protection and patient safety must be the foremost ambition; therefore, public protection is the key purpose of regulating health and care professionals. The instruments provide the regulators with the necessary powers to protect the public by introducing the power to designate EEA and Swiss professionals, who they are currently obliged to accept automatically. In addition, they will still be able to check applicants’ language skills and, as I confirmed to the hon. Member for Gedling a moment ago, the language tests will not change.

I was asked about the review process. It is appropriate that a two-year review of the regulations is put in place, which will potentially be wide-ranging and encompassing. The regulations are intended to be subject to review two years after they come into force. As I said earlier, it would be wrong of me either to limit the scope of the review or to predict the factors that may be in place at the time. I am often asked by the hon. Member for Ellesmere Port and Neston and others to commit to reviews of regulations and other legislation, and, as we are committing to a review after two years, I hope that he will accept my assurance on that.

Several hon. Members, including the hon. Member for Linlithgow and East Falkirk, asked me about the impact assessment. There is no significant impact. The impact for the instrument falls below the £5 million threshold of the annual net direct cost to business, as detailed by the business impact target. There is no significant impact on business, and no significant direct impacts have been identified as a result of the changes. Hon. Members have asked about the potential impact regarding allowing recognition so that EEA and Swiss professionals who are valued in the health service can continue to practise in the UK post-EU exit day in a no-deal scenario. That is the impact, and the regulations seek to minimise it. They put in place sensible measures to ensure that that recognition can happen.

Finally, I was asked about whether the regulations support cross-border co-operation between Northern Ireland and the Republic of Ireland. The regulations ensure the continued recognition of Irish professional qualifications in the UK for at least two years after exit day. They allow professionals practising under an existing and temporary or occasional status to continue until the end of that—

Healthcare (International Arrangements) Bill

Justin Madders Excerpts

3rd reading: House of Commons & Report stage: House of Commons
Monday 21st January 2019 Commons Chamber

[Justin Madders (Ellesmere Port and Neston) (Lab)]

I beg to move, That the clause be read a Second time.

[Mr Deputy Speaker (Sir Lindsay Hoyle)]

With this it will be convenient to discuss amendment 1, in clause 5, page 3, line 44, leave out subsections (5) and (6) and insert—

‘(5) Any statutory instrument which contains regulations issued under this Act may not be made unless a draft of the instrument has been laid before Parliament and approved by a resolution of each House.”

This amendment would make all regulations issued under this Act subject to the affirmative procedure and require approval from Parliament before they become law.

[Justin Madders]

We want to ensure that there are appropriate safeguards with regard to costs, not least because the Bill currently gives the Secretary of State authority not only to facilitate a continuation of existing arrangements, but to enter into any number of bilateral agreements with individual member states, with very little opportunity for parliamentary scrutiny. It also provides the authority to strengthen existing reciprocal healthcare agreements with countries outside the EU, or to implement new ones across the globe, in line with the Government’s aspiration to develop trading arrangements with countries beyond the EU. There is therefore a potential for the establishment of multiple complex agreements.

New clause 1 addresses the important point that the Bill before us is rightly intended to provide for all reciprocal healthcare arrangements in the future, and to provide for all eventualities. As we know, a no-deal Brexit could lead to a multitude of new bilateral agreements within the EU27, let alone the rest of the world. At this stage, none of us can be clear about how many of those agreements will come into being. We cannot assess their likely cost or impact, and, indeed, the Government’s own impact assessment is inadequate in that regard. It suggests that the cost will be similar to, or lower than, the current £630 million per year.

[Mr Jim Cunningham (Coventry South) (Lab)]

My hon. Friend has mentioned potential bilateral agreements with different countries. Does he agree that there could be a problem if our citizens are not covered when travelling to those countries for a variety of purposes, and insurance companies send premiums through the roof? That is always a big factor, even with the current arrangements in Europe.

[Justin Madders]

It is true that there is some concern in the insurance industry about our potential failure to secure bilateral agreements. I think it inevitable that unless those agreements are secured, premiums will rise. That is why the Opposition support the thrust of the Bill.

It is impossible to provide reliable estimates of the costs of the new agreements in advance without knowing who they would be with or what they would cover. The British Medical Association has said that any prediction of costs is likely to be unreliable, and we cannot afford to give the Government carte blanche.

New clause 1 proposes a sensible and very reasonable requirement for the Government to report back to Parliament annually. It would require the Government to provide details of all payments made by the UK Government for all healthcare provided outside the UK to British citizens. It would also stipulate a requirement to provide details of all payments received by the UK Government as reimbursement for healthcare provided by the UK to all non-British citizens. It would also write into law a requirement for the Government to set out any outstanding payments owed to, or by, the UK Government. This would provide an important opportunity to monitor efficiency in this area and may provide an incentive to address some of the concerns raised by the Public Accounts Committee in its 2017 report, “NHS treatment for overseas patients”, which stated that

“the NHS has been recovering much less than it should”,

and

“The systems for cost recovery appear chaotic.”

Even with the Government’s recent funding announcements, the NHS continues to struggle. I am sure that the Minister would not want to see funds destined for patient care swallowed up by the additional administrative burden created by the introduction of a range of complex charging arrangements and a failure to recover the costs that have been incurred. It is imperative that hospital trusts are not required to shoulder additional financial burdens because of the costs of administering the collection of charges. That is why if the Government are, as the Minister said in Committee, committed to transparency and parliamentary scrutiny, new clause 1 should be supported.

Turning briefly to the amendment that I tabled, we have discussed previously widely held concerns about the scope of this Bill that are exacerbated by the fact that the powers contained within it to create regulations will, in many cases, be subject only to the negative procedure. The Delegated Powers and Regulatory Reform Committee in the other place set out very clearly the potential impact of this Bill should my amendment not be accepted today. It said:

“If…the Secretary of State wished to fund wholly or entirely the cost of all mental health provision in the state of Arizona, or the cost of all hip replacements in Australia, the regulations would only be subject to the negative procedure.”

It added:

“Of course, these examples will not be priorities for any Secretary of State in this country”.

I am sure that is the case, but we must consider how the powers could be used, not just how we would expect and hope them to be used.

There is always merit when examining legislation in considering all potential scenarios as well as the stated intentions of the Government at the time, and in such an unprecedented period of uncertainty it is prudent to consider all eventualities. As the Government have included these powers in the legislation we cannot simply consider the world as it is now, nor how it might be in a year or two—indeed, if anyone knows what the world will be like in two or three weeks’ time I will be very impressed. We need to look at what the world might be like in many years’ time and how the powers in the Bill can be used.

If we require further persuasion about the need for caution, the Committee set out in its report a devastating list of reasons why the negative procedure is inappropriate. It said:

“There is no limit to the amount of the payments. There is no limit to who can be funded world-wide. There is no limit to the types of healthcare being funded. The regulations can confer functions (that is, powers and duties, including discretions) on anyone anywhere. The regulations can delegate functions to anyone anywhere.”

The Committee concluded:

“In our view, the powers in clause 2(1) are inappropriately wide and have not been adequately justified by the Department. It is particularly unsatisfactory that exceedingly wide powers should be subject only to the negative procedure.”

Just for good measure, it went on to describe the powers sought in the Bill as “breath-taking”.

Parliament is not alone in having concerns about the scope of the clause and the lack of clarity about how the powers might be used. In the Committee evidence session, Raj Jethwa, director of policy at the British Medical Association said:

“We would like to see much more emphasis on scrutiny of all the discussions in the arrangements going forward.”––[Official Report, Healthcare (International Arrangements) Public Bill Committee, 27 November 2018; c. 6, Q14.]

Picking up on the Committee’s comments, despite the Government having ample opportunity both on Second Reading and in Committee to justify the need for these exceedingly wide powers, I believe that the arguments that they advanced during the passage of the Bill have not only failed to do so, but have strengthened the case for greater scrutiny. The Minister conceded in Committee:

“The Bill also provides flexibility to fund healthcare even where there is no bilateral agreement, which we might explore using in exceptional circumstances to secure healthcare for certain groups of people.”

That is the nub of it: we know the well-rehearsed and necessary reasons why the Bill is required to secure the continuation of arrangements as we leave the EU, but it is on the record that the Bill can potentially do far more than that. We do not know what those exceptional circumstances are, and we do not know who those groups of people might be, and even if the Minister were able to set out here and now what he was referring to in that statement, he cannot bind a successor to that. The Bill gives the Secretary of State what I might describe as Martini powers: any time, any place, anywhere. If he is to have such wide powers they must at the very least be subject to the affirmative procedure.

The Minister also said in Committee that not only would the Bill encapsulate existing healthcare agreements but that it

“will potentially add to their number as part of future health and trade policy.”––[Official Report, Healthcare (International Arrangements) Public Bill Committee, 29 November 2018; c. 23-24.]

That is also a concern. I do not know whether the Minister intended it to come across as it did, but it sounded very much to me as if the Government were intending to couple trade negotiations with access to healthcare. I hope that that is not the case.

Many people have expressed concern over a number of years that the Government appear willing to open up the NHS to American private healthcare companies as part of trade negotiations, but I am not sure that many people imagined that the Government also had designs on opening up the NHS to patients around the world as part of a strategy to secure trade deals with other nations. Perhaps I am wrong about that, but it is clear that the Bill can be used in that way, which is why any arrangements ratified under it need proper scrutiny.

We also to consider the impact of new arrangements on the NHS. Alastair Henderson, chief executive of the Academy of Medical Royal Colleges, said in the Committee evidence session:

“Both clinicians and health organisations are concerned that we could end up with a system that is both administration-intensive and time-intensive.”––[Official Report, Healthcare (International Arrangements) Public Bill Committee, 27 November 2018; c. 3, Q4.]

We went through some of the implications of that when discussing new clause 1.

Finally, there is a practical element to this. As we know, under the negative procedure, once an instrument is laid in draft it cannot be made law if the draft is disapproved within 40 days. This would be done via a prayer against, usually by way of an early-day motion. If that is not invoked then the legislation is passed. Under the negative procedure, that is still a 40-day process in the best-case scenario, and if we leave without a deal the Secretary of State in the next three weeks will have to reach agreement with each of the 30-plus other countries, sign those agreements, draft statutory instruments and lay them before Parliament so they are with us no later than Friday 15 February, the last date on which they could be laid in order for them to be passed by 29 March—and that is assuming they are not prayed against.

If we assume this Bill completes Third Reading today, that gives the Lords about three weeks to complete their consideration—and the Minister will no doubt be crossing his fingers that they do not table any amendments. That seems to be a tall order, and given the Committee’s comments on this amendment the Lords may well be minded to send the measure back to us, but in either case it all seems rather a tight, if not unrealistic, timetable. I therefore urge the Minister to think through the practicalities of this; the affirmative procedure could be significantly quicker than the negative one, and it has the advantage of being far more transparent.

The Minister tried to reassure me in Committee that there would be adequate scrutiny by virtue of the Constitutional Reform and Governance Act 2010, but I am afraid that that just does not cut the mustard. Under that Act, there is a specified process enabling Parliament to object to a treaty being ratified within 21 days, but that does not automatically lead to a debate and a thorough examination of the issues of concern. The Act simply says that in the event of an objection the Government must issue a statement setting out why they still want to ratify; this process could apparently be repeated ad infinitum, and crucially under the Act there is no requirement for a debate. It would be open to either Government or Opposition to set aside some of their allotted time to facilitate a debate, but there is no requirement to do so. In addition, there are exceptions that enable the Government to ratify treaties outside the Act—for example, if there are “exceptional circumstances”, which of course is a judgment that is within Government’s gift. The measure does not cover memorandums of understanding either, and some of the older reciprocal healthcare arrangements fall within that description.

Putting new agreements into force in these extraordinary circumstances is necessary, but we simply cannot accept the clause as it stands. No matter how well-intentioned everyone might be now, once that power has been given away it is not easily taken back. Do Members want us to fund hip replacements in Arizona? Are Members comfortable with access to the NHS being used as a bargaining chip in trade deals? Of course they are not, so why do they not vote for the amendment tonight?

[Martyn Day (Linlithgow and East Falkirk) (SNP)]

I suspect this debate will be slightly less contentious than the earlier statements, and probably a lot quicker.

The Bill basically gives powers to the Secretary of State to agree reciprocal deals. However, I believe that we will not get a better reciprocal arrangements than those we currently have. We recognise the need for all these arrangements to continue, and the Scottish Government will do all they can to work with the UK Government to ensure that they do, and of course we note the legislative consent motion that has been granted. Through the Joint Ministerial Committee we believe a common framework system can be achieved that ensures these specific health arrangements can be administered through common agreement between the UK and Scottish Governments. Clearly, Brexit threatens the loss of reciprocal healthcare arrangements for millions in Scotland and across the UK. The Bill’s impact assessment makes this conclusion in relation to a no-deal scenario:

“If UK citizens in the EU are treated as 3rd country nationals (i.e. they cease to have rights of movement and access to services in EU Member States, and are treated like citizens coming from non-EU countries) some may face additional financial costs or difficulties accessing healthcare services, with potential implications for their health and wellbeing.”

Oral Answers to Questions

Justin Madders Excerpts

Tuesday 15th January 2019 Commons Chamber

[Stephen Hammond]

My hon. Friend is right, and we are ensuring more routes into the nursing profession, such as nursing apprenticeships and nursing associates. We are training more GPs, and we are determined to get 5,000 extra GPs into general practice. A record 3,400 doctors have been recruited into GP training and, as part of the long-term plan, newly qualified doctors and nurses entering general practice will be offered a two-year fellowship to support them to stay there.

[Justin Madders (Ellesmere Port and Neston) (Lab)]

The long-term plan admits that staffing shortfalls are “unsustainable”, yet incredibly there is no mention anywhere in the document of the damage done by the abolition of the nursing bursary. The plan contains an ambition to double the number of volunteers within three years, and although we should rightly celebrate the fantastic contribution made by volunteers, is it not damning that, with a record 100,000 vacancies in the NHS, the main plank of the Government’s strategy to tackle the workforce crisis is to rely on volunteers?

[Stephen Hammond]

The hon. Gentleman is right to say that volunteers in the NHS provide an invaluable service, but he is completely wrong to suggest that any part of the long-term plan relies on volunteers. There is an expansion in numbers of nursing associates to deal with those vacancies and, as I have said to other hon. Members, we have seen an increase in the number of doctors in GP training. Obviously, he will welcome the £20.5 billion a year that is going into the national health service. That will inevitably mean more doctors and nurses, which is why we are making more training places available.

NHS Reorganisation

Justin Madders Excerpts

Wednesday 12th December 2018 Westminster Hall

[Justin Madders (Ellesmere Port and Neston) (Lab)]

Thank you, Mr Gapes. I am sure hon. Members will be keen to return for the remainder of my speech, however long that turns out to be. It is of course a pleasure to serve under your chairmanship.

I congratulate my hon. Friend the Member for Warrington South (Faisal Rashid) on securing this extremely important debate. It is also very timely as we eagerly await the NHS long-term plan. He made a powerful case about the weaknesses in the Government’s approach and the disgraceful lack of parliamentary oversight of very significant changes to local and national services. I agree that the creation of the NHS was one of the great achievements of this House and this country.

My hon. Friend was right in his analysis of the Health and Social Care Act 2012. He highlighted his concern about accountability in CCGs and the potential for conflicts of interest in them. He also highlighted the lack of transparency that has characterised the STP process since its inception, and he summed up the benefits, from the patient’s perspective, of good integration —of course, no one wants to have to repeat their story on multiple occasions.

My hon. Friend talked about the challenges that the NHS faces with its infrastructure. He will know that those challenges have been exacerbated by the continual capital raids on budgets. His analogy about a football team was amusing—sadly, my own team appears to be taking things rather too seriously at the moment—but it did sum up a lot of the confusion and the illogical approach that we have to healthcare in this country. He was of course right to say that the hard-working staff of the NHS bear the brunt of these many pressures. He also made the point that many of the changes that we have been talking about have not been made in the most open way.

We also heard from my hon. Friend the Member for Mitcham and Morden (Siobhain McDonagh). She followed up her question to the Prime Minister with a much more detailed, and devastating, critique of the proposals that affect her constituency. I was staggered to hear that £50 million has been spent on consultation so far. It was also disturbing to hear how bad things are at her accident and emergency department now, before we enter the real depths of winter. I was staggered to hear about the approach to consultation there. I am sure the Minister will want to address that. [Interruption.]

[Mike Gapes (in the Chair)]

Order. We will break for 15 minutes, I hope, and come back as soon as possible.

--- Later in debate ---

On resuming—

[Justin Madders]

Before we were interrupted by important business in the Chamber, I was referring to contributions from other hon. Members. The hon. Member for Strangford (Jim Shannon) gave his perspective from Northern Ireland, and set out clearly what a proper consultation should look like—a standard that, as we have heard, is not really being reached by the NHS at the moment. He also raised issues with the GP out-of-hours service. That is slightly beyond the scope of the debate, but he is right to say that the issue covers the whole United Kingdom. Indeed, recently there have been numerous newspaper reports about people having to wait for many weeks to get a GP appointment.

Looking at current NHS performance, it is clear that, on all key performance measures, as my hon. Friend the Member for Warrington South said, the NHS is struggling to keep up with demand. A&E performance is at a record low this year. More than 4 million people are stuck on waiting lists, and cancer targets are being repeatedly missed. This has led to the Government effectively giving up on trying to meet the NHS’s constitutional targets. As my hon. Friend said earlier, waiting lists for operations are likely to hit 5 million people within the next three years. While the eight years of a financial plan that has failed to keep up with demand have clearly been a driver of that failure, it is also clear that the 2012 top-down reorganisation has exacerbated the issues that the NHS faces.

We have been left with a fragmented, marketised system, which prevents the kind of transformation and integration of services that we would all like to see. At a time when everyone is calling for various parts of the health and social care sector to work together, we remain bound by legislation. As my hon. Friend said, it is this legislation that enforces a siloed, market-based approach, which imposes statutory barriers to integration.

Against this backdrop we have seen a whole series of acronyms encapsulating a range of reorganisations to health services, including STPs, ACOs, ACSs, ICPs, ICSs and so on—all part of what the Health and Social Care Committee has described as a culture of

“changing titles and terminology, poorly understood even by those working within the system.”

It is all clearly an attempt by NHS leadership to reverse the impact of the Health and Social Care Act 2012 by any means that do not require primary legislation or parliamentary oversight. These reforms could have wide-ranging impacts, from causing walk-in centres, cottage hospitals, maternity centres and A&Es to relocate or close altogether, to introducing a new form of 10-year contract, which raises the spectre of private companies once again running our local health services.

I know the Government are not particularly fond at the moment of testing the will of the House, but something as fundamental as transforming our most treasured asset clearly should not be taking place without parliamentary consent. Ministers and NHS leaders are tiptoeing around the 2012 Act, but if we are to have meaningful proposals and an effective integration process, we need an admission that that legislation has had its day. To all intents and purposes, the 2012 Act is no more; it has expired and gone to meet its maker. Yet the Government refuse to acknowledge that central fact.

The initial STP process was imposed from the top and was based around 44 geographical areas that were determined very quickly without recourse to the public. Although some of the areas that emerged after that initial consideration had well-established networks of co-operation, in others a vast and unwieldy network of commissioners and providers with completely different approaches was put together at very short notice. The only beneficiaries of that process seem to be the private consultants who were drafted in to complete these hastily arranged plans. Professor Chris Ham has pointed out that

“most STPs got to the finishing line of October 2016, submitted their plans and breathed a huge sigh of relief. No further work has been done on those STPs.”

Despite the fact that plans were designed to cover the period from October 2016 to March 2021, NHS England and NHS Improvement said in a letter to local leaders last month that sustainability and transformation partnerships and integrated care systems will be expected to develop and agree their plans during the first half of 2019-20. Will the Minister update us as to how many of the 44 STPs developed as part of this process have, as NHS Providers puts it, had no further work done? What was the cost of developing those plans? Can the Minister justify forcing the entire health and social care sector to stop what it was doing and embark again on a hasty and expensive process to come up with new five-year plans, only to be asked to do the same again a few years later? In the few local areas that have proceeded to the next stages of integration, there is understandable concern among patients and staff about precisely what that will mean.

The accountable care organisation—now rebranded as integrated care provider—process has the potential to radically alter the entire health and social care landscape, but, again, it is continuing without any parliamentary legislation. One of the primary concerns about that new model is that it would be compulsory to advertise the contracts to the market, and commissioners are forbidden from discriminating between NHS and non-NHS bidders. Bids can be made by a group of organisations, so an NHS trust or a group of GPs could partner with a private company. Previous high-profile attempts to do this kind of thing in Staffordshire and Cambridge collapsed spectacularly with millions of pounds wasted. As my hon. Friend said, it is also deeply worrying that one of the criteria used to assess bids will be whether they are able to deliver value for money. That marks a significant change to the status quo, and one that I do not believe should be countenanced without new legislation.

I have heard Ministers speak on several occasions to assure those of us who have concerns that this will not see mass privatisation. However, during the debate on integration in September, the previous Health Minister, now the latest Brexit Secretary, was asked four times by Conservative, Scottish National party and Labour Members to expressly rule out new organisations being run by the private sector. He failed to do so on every occasion he was asked. Is the Minister now prepared to give that kind of assurance, and if not, why not?

It is also less clear what will happen in the event that an ICP ends up in deficit, particularly if a private sector organisation or a charity has won the contract. While the consultation document sets out that efforts will be made to ensure that ICPs are financially viable, the same assurances have been offered about the existing configurations, and almost half of all NHS providers were in deficit last year. That has led us to the disastrous situation where, according to the 2017-18 accounts published by NHS Improvement, NHS providers owed the Department of Health and Social Care more than £11 billion, up from £8.1 billion in the previous year. That sharp increase was a result of bail-outs given to trusts that ran into deficit as a result of underfunding. Borrowing from the Secretary of State now exceeds private finance initiative liabilities. In 2016-17, £1.3 billion was repaid from trusts to the Department, of which £161 million was interest. Can the Minister set out what will happen if an ICP reaches financial deficit or collapses?

One thing that is clear from the draft ICP contract is that if the annual budgets provided are not sufficient to deliver the current levels of service, the ICP will be responsible for “managing changes in demand.” While there are merits in a system that incentivises keeping people well, there is a clear danger that demand will be managed by rationing access to treatment. Will the Minister rule out unilateral rationing of services by ICPs if they cannot keep to their budgets? What safeguards are in place to prevent further rationing of services, and who will be accountable in the event that patients want to challenge such a situation? It is far from clear who will ultimately make these decisions and who will be accountable for them. Where the split between the legal commissioner and provider is technically maintained, it is impossible to see in practice how an ICP would not be taking on core commissioning functions.

All this raises the spectre of a new postcode lottery, where patient experiences are uneven depending on who was contracted by an unaccountable panel of commissioners. The whole approach is farcical, and none of this has come before the House for what could be described as a meaningful vote. Experts from across the health and social care sector, and even the chief executive of NHS England, have all acknowledged not only the desirability, but the inevitability of new legislation. Will the Minister commit as part of the NHS long-term plan to set out in full the direction of travel for NHS reorganisation, the Government’s objectives, the criteria that will be used to determine when those objectives have been achieved, and a timeline for the necessary primary legislation?

[The Minister for Health (Stephen Hammond)]

It is a pleasure to serve under your chairmanship, Mr Gapes. It is a pleasure to respond to the hon. Member for Warrington South (Faisal Rashid). I am pleased that he secured this debate, and I agree with him that the NHS is a great credit to our country. I know that the Opposition spokesman will have heard me say yesterday—I will repeat it—that the Government and I, as Minister for Health, greatly value the staff who work in the NHS. It is our absolute intention to ensure that they recognise that and that we continue to show that.

I want to start with a few facts, because having listened to what the hon. Member for Warrington South described, I think there are other things that are worth pointing out. There are 11,000 more nurses in the NHS than there were in 2010. There are 18,200 more doctors than in 2010. Almost nine out of 10 patients are seen within four hours in an emergency department. We are committed to 5,000 training places for doctors in general practice—this year saw 10% more than we aimed to achieve. Of course, this is the highest level of funding that the NHS has had in its 70 years. The hon. Gentleman raised a number of other issues, as did the Opposition spokesman, and I will try to respond to those in my speech.

The hon. Member for Mitcham and Morden (Siobhain McDonagh) made a contribution. I have immense respect for her. Anyone who knows her knows that she always argues her case passionately and stands up for her constituents, and she did that again today. She and I have occasionally shared joint endeavours on St Helier Hospital. I think we both agree that there is a substantial case for keeping the acute services there. I think we would both agree—I say this in a constituency capacity—that the infrastructure needs upgrading, and I think we have had that discussion. She rightly points that we have had another consultation this year. As a Minister, I say that we expect any significant service changes to be subject to exactly the full public consultation she has described, if it is going to happen, and that the proposals must meet the Government’s four reconfiguration tests, which are support from GP commissioners; strengthened engagement with the public; clarity on the clinical evidence; and clarity and consistency with patients’ choice. She says that there have been rounds of consultations, as I certainly saw when I was on the council—I think she was already a Member of Parliament then—under Governments of all colours over the past 20 years.

It is the same with the hon. Member for Strangford (Jim Shannon). I have had the pleasure of taking interventions from him in several debates. He is always a powerful advocate for his constituents. I listened carefully to his point about out-of-hours care, which may have been slightly out of the scope of the debate. Yesterday, I had the chance to visit the North Middlesex University Hospital. Some of its work on the integration of out-of-hours care and triaging in A&E moves along the lines that he discussed. I have seen that several times.

To address the crux of the debate, between 2016 and 2036, the UK population is expected to increase from 65.6 million to 71.8 million, which is a growth rate of about 10% in 20 years. In the same period, the number of people aged 75 and over is expected to grow by 64% from 5.3 million to 9 million. Those figures are clearly something to celebrate, showing that the NHS is doing exactly what we want it to, but they mean that more will need to be done to make sure that those years are quality years.

For the NHS to continue to deliver high-quality care in the next 20 years, as it has done for the last 70 years, we need to look at new models of care that promote more joined-up care across the NHS and social care. In the past few years, the Government have supported a number of pilots at local and national levels to test new models of care that bring together the NHS, local authorities and wider public services to develop new ways of ensuring that services are delivered in a more joined-up way. Those areas have seen some improvements in access to services, patient experience and moderating demand for acute services.

It is time for the NHS to move beyond those pilots and embrace wholesale transformational changes across the whole system in every part of the country. It is therefore developing a 10-year plan for its future, which is underpinned by a five-year funding offer. To support the NHS in delivering for patients across the country, the Government announced a new five-year budget settlement for the NHS, in which funding will grow on average by 3.4% each year to 2023-24. The hon. Member for Strangford, who has just left the Chamber, welcomed the fact that that means the NHS budget will increase by more than £20 billion compared with today, underpinning the 10-year plan to guarantee the future of the NHS.

The hon. Member for Warrington South remarked on sustainability and transformation partnerships, and commented on his own local STP. The Government are fully committed to NHS England’s vision of STPs transforming how care is delivered and putting the system on a sustainable footing for the future. We will back STPs where they are clinically led and locally supported.

The hon. Gentleman questioned some aspects of local democracy. Each partnership has to set out agreed priorities and say how they are going to be delivered, and have a strategic priority to work with partners in local authorities. The Cheshire and Merseyside STP is making some progress in building those relationships, but he is right to acknowledge—I acknowledge it as well—that it is an extremely large and diverse area.

Clearly, the hon. Gentleman and the hon. Member for Ellesmere Port and Neston (Justin Madders) will recognise that there are now nine local footprints, including Warrington Together. The idea is that they will develop some of the integration suggestions and plans, and the consultation with local authorities to which the hon. Member for Warrington South referred. The STP brings local areas together to tackle the challenges, and I think he would acknowledge that it makes sense to do that across a bigger area, so the smaller areas build into the larger area.

Last week, the Government announced that they were supporting the Cheshire and Merseyside STP with £11 million in capital spending for improving emergency department capacity at the St Helens and Knowsley Teaching Hospitals and for a 12-bed, tier-4 child and adolescent mental health services unit at Alder Hey Children’s Hospital. The hon. Member for Ellesmere Port and Neston challenged me on STPs, so I will say that, in their more mature form, they are integrated care systems that promote collaboration between NHS bodies, local government and local communities. The 10-year plan will set out how they will spread the integrated care models that have been developed and tested through the whole vanguard programme.

There was also a challenge about what were formerly known as accountable care organisations and are now called integrated care providers, with several questions about that. At a small number of sites, commissioners are looking at how contractual models can support more integrated care. To support that, NHS England has developed the draft integrated care provider contract which, if introduced, will give the NHS the option of having a single lead provider that is responsible for primary, community and hospital services, with the aim of integrating services across traditional silos.

If NHS England chooses to introduce a contract for the ICPs, Parliament will have a chance to debate the regulations. I recognise that the regulations are subject to the negative procedure, so there is not an automatic debate, but as the hon. Member for Warrington South will have spotted, in those circumstances, if Parliament decides, there will be an opportunity to have that debate. NHS England has recently concluded the public consultation on the draft ICP contract and we expect a response in due course.

I want to touch on the premise that the ICP contract is privatisation. It is completely misleading to suggest that an integrated provider model is a step towards privatising the health service. The NHS will always offer free healthcare at the point of use—that is not just the Government’s view. I am sure that the Library briefing that the hon. Member for Strangford challenged me to read notes the evidence from the Health and Social Care Committee, whose Chair, my hon. Friend the Member for Totnes (Dr Wollaston), said that the evidence received by the inquiry into integrated care—the report was published in July 2018—was that ICPs

“and other efforts to integrate health…and social care, will not extend the scope of NHS privatisation and may effectively do the opposite.”

That is quite powerful and I hope that the hon. Members for Ellesmere Port and Neston and for Warrington South take note.

[Justin Madders]

I know what the Select Committee said; I am interested in what the Government are saying. Is the Minister ruling out any private provision from ICPs?

[Stephen Hammond]

I am not ruling out private providers from bidding, but it has been made clear, and I say again, that we expect any ICP contract to be won by NHS bodies. As I said, the evidence to the Select Committee inquiry tends to support that that is our view and that is what is likely to happen.

The Government have made it clear that the change is not about reorganising the NHS from the centre or adding more layers to an already complex system. As the Prime Minister reiterated in her speech in June, the Government should learn the lessons of the past and not try to impose change on the NHS. To achieve that, we firmly believe that any changes to the model of care for patients need to be locally led, informed by knowledge of the population and the population need, and supported by clinicians on ground.

That is why we have asked local leaders in STPs and integrated care systems to create five-year plans detailing how they will improve local services for patients and achieve financial sustainability. Of course, this is something that we may want, but it cannot just be wished into being, which is why the Government are supporting the NHS with £20 billion of additional funding.

Local plans will build on the work of the last three years to develop new ways of delivering services and enhance collective efforts to use that additional funding to improve people’s health and wellbeing. It is essential that that process proceeds in a spirit of genuine partnership and that all local partners, including local government, are fully involved from the outset.

For any significant system reconfiguration, we expect all parts of the system to be talking to the public regularly; it is vital that the public shape the future of their local services. That relates directly to the point that the hon. Member for Mitcham and Morden made earlier. To make it absolutely clear, no changes will take place without public consultation and engagement.

After all, the aim of integrating services is not an end in itself; it is to improve the patient experience and quality of care, so it is essential that the views of the public should be at the heart of local plans. Integrated care means a health and care system built around people’s needs, whereby physical, mental and social care needs can be addressed together, and patients should feel as if their care is being provided by one organisation.

Integration also gives us the means to avert ill health, preventing unnecessary hospital visits and supporting patients to have happier, healthier lives into old age, and taking the pressure off NHS staff. For example, in Thanet, the Margate Task Force is an integrated service that brings staff from 16 different agencies together in a single “street-level” team.

In conclusion, integrated care provides the best opportunity to ensure that the NHS continues to deliver the highest level of quality services to people and to meet the demands of the 21st century. The Government have supported the NHS to implement the five-year forward view and to develop new integrated ways of working to meet those demands. It is now time to drive those initiatives and spread them across the whole country. That is why we are committed to those plans and it is why we have committed to increase the NHS budget, to support the national move towards integrating care.