Baby Loss Awareness Week

Justin Madders Excerpts

Tuesday 8th October 2019 Commons Chamber

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

It is a privilege to follow the hon. Member for Eddisbury (Antoinette Sandbach), who speaks from personal experience on this matter. Every year, she identifies the main issues that we still need to improve on. She is absolutely right to talk about the evaluation that shows where things are getting better, but it is also fair to say that the good practice is not consistently felt across the board, and that is what we need to aim for. She also spoke about the need to change the culture, which is really important. The right hon. Member for South West Surrey (Mr Hunt) also referred to that, and I welcome him to the Back Benches—I know that we had our disagreements as Front Benchers, but on this issue, there was a great deal of unanimity, and that is the spirit that we should carry forward. Both spoke about the need to change the culture and the length of time that that will take, but that is absolutely the right approach, because with all tragedies in the health service, most of the time people just want to know why something happened and how it can be stopped from happening again. The more that we can move away from the blame culture and get into a proper analysis of why things have happened and how we can prevent them from happening in future, the better the experience will be for everyone.

When I first spoke in a baby loss awareness debate back in 2016, I expressed the hope that this would become an annual fixture, and I am pleased to see that we have managed to do that despite the unpredictable timing of Parliament at the moment. This gives us a real opportunity to take stock of where we are and hopefully to set some benchmarks for future progress, because, as we know, every year there are thousands of tragedies. Tommy’s estimates that a quarter of pregnancies end in miscarriage. The Ectopic Pregnancy Trust tells us that one in 80 pregnancies is ectopic and Sands tells us, as we have heard, that 15 babies are stillborn or die shortly after birth every day. Those charities are just some of the 60-plus charities that collaborate to support this extremely important week. I echo the comments of hon. Members who have praised their work in this vital area, not just how they support people who have experienced their own personal tragedies, but how they work across the board to secure better outcomes for everyone. They not only raise awareness of baby loss, but work with health professionals to improve services and bereavement care and, critically, to reduce the number of preventable deaths.

Like others, I want to focus on bereaved parents and mental health support. As we all know from meeting bereaved parents, the feelings of loss and isolation are understandably overwhelming, and nothing can take away from that, but that does not mean that we cannot do more to ensure that the right care and support are in place at the right time so that those people can come to terms with their loss as best they can. We know from the evidence that good bereavement care can make a difference to parents and families and their experiences at this tragic time.

The sooner we can support more healthcare professionals in delivering good-quality care, the better. I welcome the roll-out of the pathway, but I urge the Government to redouble their efforts to ensure that all trusts and health boards adopt the pathway and ensure that all our healthcare professionals feel properly equipped to deal with bereaved parents, so that everyone across the board gets the correct and best level of support, which is what they truly deserve.

Not all bereaved parents will develop a mental health problem, but we must ensure that those who do can access specialist psychological support, that they can access it as soon as possible and at a time and place that is right for them, and of course that it is freely available to them. Sadly, as we know, not all parents can do that at the moment. Parents have told me that they are often not aware of the services available. Many leave hospital with no information about where they can seek support. Some are given information but then find that the support is not available for them at the time they need it—because of course there is a waiting list.

A survey by Sands earlier this year found that nearly two thirds of bereaved parents felt that, although they needed specialist psychological services, they could not access them on the NHS. This is equally a challenge for those who seek bereavement counselling for adult deaths, urgent referrals for which can take up to six months to process, which is far too long, I think we would all agree. In the words of one mother who contacted me:

“we weren’t offered any specialist help in terms of bereavement support. I visited my GP on a number of occasions and was advised I could see a counsellor but there was a waiting list. I was prescribed antidepressants which I refused to take as I was grieving, I wasn’t depressed”.

Many listening to this debate will recognise that experience. I hope we can learn that it is vital that the right support and treatments are available at the right time.

A new report from the Baby Loss Awareness Alliance reveals that nearly nine out of 10 clinical commissioning groups do not commission talking therapies specifically for parents, and where the services do exist, they are mostly for mothers only, meaning that the needs of fathers are often overlooked, as the hon. Member for Colchester (Will Quince) has spoken about in the past.

There is of course much good practice out there, but it is sometimes reliant on charitable grants and third parties, meaning that the provision is patchy and at risk from wider funding decisions. I therefore support a call for a review of the current provision, including an evaluation of the models of best practice, involving parents and professionals in those conversations. We know that the need for psychological support following pregnancy loss and stillbirth is recognised in the NICE guidance and that the “Better Births” report, the maternity transformation programme and the NHS long-term plan all highlight the need to improve perinatal mental health care. These plans must translate into action to ensure that the needs of bereaved parents are explicitly addressed in quality standards and national guidance, in the training for the relevant healthcare professionals and in guidance and support for local services.

Beyond the major transformational strategies we have been talking about, we can also make simple, small changes that will make a difference to parents’ experiences. In the words of another constituent after her own bereavement:

“That moment, I know myself, stays with you as much as the birth and most of us end up bumping into other new parents carrying their bundles home on the way out. I feel a support worker or midwife could do with walking the parents out, helping the transition into the hands of family or friends go more smoothly would be extremely beneficial. Most of us are left with not even so much as a leaflet of where to turn to in crisis. Most of us haven’t had a follow up with a midwife or healthcare professional even though we have given birth and these unfortunate administrative errors occur far too often. I suppose support is the key issue.”

Those comments show that some simple, straightforward things can be done that need not cost the earth or require massive national strategies, but actually just need a bit more thought and organisation. I think we can all recognise the difficulty that that mother must have experienced.

Having participated in debates on this subject over the last three years, I know that Members have shown a great deal of personal courage by speaking about their own experiences. Three years on, we have shown that the message is going out to people that they are not alone. I pay tribute to my hon. Friends the Members for Lewisham, Deptford (Vicky Foxcroft) and for Washington and Sunderland West (Mrs Hodgson), and to the hon. Members for Eddisbury, for Colchester and for Banbury (Victoria Prentis), for their work and for the way in which they have spoken about their own experiences. That contributes greatly to increasing awareness of Baby Loss Awareness Week, which has itself led to some local groups getting together. Next Tuesday my constituents will take part in the Wave of Light outside Ellesmere Port civic hall, which I think is a very good way of encouraging more people to come and talk about what they have been through. The more people who engage in that dialogue, the better.

I should like to be with those constituents next week, but I suspect that I shall be here, although my thoughts will be with them. I think that what we can show them today is that when the House puts its mind to it, we can work across parties and make things better for our constituents. Anyone who has heard the debate today will understand why it is so important that we do that.

Health Infrastructure Plan

Justin Madders Excerpts

Monday 30th September 2019 Commons Chamber

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

The two Budgets in 2017 allocated some £3.9 billion for estates planning and also to tackle the huge maintenance backlog that has been allowed to mushroom under the Government. As of now, how much of that allocation from 2017 has been spent, and how much of it has been announced in today’s statement?

[Edward Argar]

I am happy to tell the hon. Gentleman that the announcements we are making today are for new money.

NHS Long-Term Plan: Implementation

Justin Madders Excerpts

Monday 1st July 2019 Commons Chamber

[Matt Hancock]

NHS dentistry is incredibly important. Ultimately, dentistry is part of prevention; it prevents oral ill health. We are doing a lot of work on what further we can do to support oral health. In fact, I had a meeting with the Minister with responsibility for public health on that subject this morning. I would love to meet my hon. Friend to discuss it further.

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

The Secretary of State clearly identified three critical areas for improvement to cancer survival rates. He is absolutely right about early diagnosis. I do not want to make my hon. Friend the Member for Rhondda (Chris Bryant) any more sweaty than he already is, but it cannot be repeated enough times that spotting these issues early on is critical to improving survival rates. The Secretary of State is also right about the importance of mental health. The third point he touched on was that the workforce is key to underpinning all this. In that regard, does he know how many specialist mental health and specialist cancer nurses we will have at the end of the 10-year period?

[Matt Hancock]

The answer to that question is being worked on as part of the people plan, which Baroness Dido Harding is putting together. We published the interim plan last month. The full people plan will be available after we have settled, in the spending review, the budget of Health Education England. The hon. Gentleman raises an incredibly important point.

Oral Answers to Questions

Justin Madders Excerpts

Tuesday 18th June 2019 Commons Chamber

[Jackie Doyle-Price]

As the hon. Lady and I have discussed previously, I would be the first person to recognise that we are not where we would like to be in respect of the provision of mental health services, but that is why we are investing an additional £2.3 billion to expand access for children by 345,000. In addition to that, we are investing in a brand new workforce in all our schools so that we can have exactly the kind of early intervention that will not require more lengthy periods of care and treatment. It is essential that we equip all schools and young people with tools to manage their wellbeing.

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

6. What recent assessment he has made of the effectiveness of the exception reporting process in the junior doctor contract 2016.

[The Minister for Health (Stephen Hammond)]

Our junior doctors work incredibly hard caring for patients around the clock. We introduced exception reporting in 2016 and it has been a major step forward in ensuring safe working. The British Medical Association, NHS Employers and the Department reviewed the effectiveness of exception reporting as part of the junior doctor’s contract agreement, which we announced last week. Revisions will be made to exception reporting subject to the endorsement of the BMA.

[Justin Madders]

Is the Minister aware that research by the Hospital Consultants & Specialists Association shows that, despite thousands of exception reports from junior doctors in unsafe hospital trusts, no changes to shift patterns were made at all. The chief executive of NHS Employers has said that, undoubtedly, there are circumstances where trusts would like to make changes, but because they do not have sufficient staff in place they are unable to do so. What can the Minister do to ensure that, in future, these changes are actually implemented?

[Stephen Hammond]

The hon. Gentleman is right: every exception report has to be addressed. Changing the rota is one possible outcome. He will recognise that there are other possible outcomes as well: the doctor may agree to work extra hours and be given extra time off; timing of the ward rounds in clinics may be adjusted, so that educational opportunities can be taken: and timing of the ward rounds can be adjusted so that support from other senior staff can be there as well. There are many ways around this.

--- Later in debate ---

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

rose—

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

rose—

[Mr Speaker]

The hon. Gentleman will think it is a conspiracy, but he will get his moment in a moment. I call Mrs Hodgson.

[Seema Kennedy]

We have a very ambitious aim to halve childhood obesity by 2030. We are still considering all the answers to the consultations, and we are hoping to respond to them very shortly.

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

T1. If he will make a statement on his departmental responsibilities.

[The Secretary of State for Health and Social Care (Matt Hancock)]

This week is Children’s Hospice Week, Loneliness Awareness Week, National Breastfeeding Week and Learning Disability Week, and today is International Fathers Mental Health Day. The Government have made plans to more than double funding for children’s palliative care and end-of-life care services, developed a loneliness strategy and launched a consultation on folic acid in flour to support expectant mothers, and yesterday the Prime Minister announced a package of further work to support people from all backgrounds in the UK with their mental health. I and my brilliant ministerial team will continue to drive forward the health of the nation.

[Mr Speaker]

We are indebted.

[Justin Madders]

I want to bring to the Secretary of State’s attention some mental health waiting times that my constituents have recently come to me with. Someone with an urgent referral for trauma counselling is looking at a minimum six-month wait. A teenager who has attempted to take her own life is waiting over a year to see a psychiatrist. Several adults have been told there is a three-year wait just to get a diagnosis of attention deficit hyperactivity disorder. These waits are appalling. The Secretary of State billed himself as the leadership candidate for the future, but he is the Secretary of State for Health now. What is he going to do to address this appalling waiting system?

[Matt Hancock]

The hon. Gentleman is right that we need to ensure that access to mental health services improves. As part of the increase in funding we are putting into the NHS, the biggest increase is in mental health services, and it is a critical part of what we need to do to address the sorts of problems he rightly raises.

Oral Answers to Questions

Justin Madders Excerpts

Tuesday 7th May 2019 Commons Chamber

[Jackie Doyle-Price]

I have always viewed the ring fence as a ceiling rather than a protection. We have the mental health investment standard and NHS England is challenging clinical commissioning groups that are not spending what we would expect.

This is a systemic weakness. We have treated children up to 18 and then considered them as adults, but the reality is that people do not suddenly achieve majority overnight. We intend through the forward plan to have the children and young people service from nought to 25. That should enable transition and stop people falling off the cliff edge at 18.

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

5. What recent assessment he has made of the availability of prescription drugs.

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

Over 2 million prescription items are successfully dispensed in England every day, and we have well-established procedures to deal with medicine supply issues should they occur. We work closely with all those involved in the supply chain to help ensure any risks to patients are minimised when supply issues arise.

[Justin Madders]

I welcome the Minister to her place. She will know from written questions I have tabled that my constituents have real concerns about the availability of the epilepsy drug Sabril, which has been in short supply. She told me last month that supplies would be resolved by mid-April; she has now told me in a written answer that supplies will be resolved by mid-May. It seems there is a disconnect between what the Minister is saying and what is actually happening on the ground. When can she guarantee that this drug will be widely available again?

[Seema Kennedy]

I thank the hon. Gentleman for raising this issue again. We have expressed our great concern to the suppliers about this problem, and we are working alongside them to ensure that, although there is enough Sabril nationally, we get it in the right place at the right time. We will go back to them and express our concern again.

Healthcare (International Arrangements) Bill (Changed to Healthcare (European Economic Area and Switzerland Arrangements) Bill)

Justin Madders Excerpts

Ping Pong: House of Commons
Tuesday 26th March 2019 Commons Chamber

We will not vote against the Lords amendments—they are necessary; the work needs to get done—but it still makes me sad, because all the measure does is highlight what we are losing.

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

It is a pleasure to speak in this debate—from the Back Benches on this occasion. Although I would have preferred to contribute from the Front Bench as I did during previous stages of the Bill, the Opposition are in safe hands, thanks to my hon. Friend the Member for Burnley (Julie Cooper).

It is curious that both the Minister who led for the Government on Second Reading and I, as Opposition spokesperson, have moved on since then, him to become Brexit Secretary and me to become a Back Bencher. We could have a debate—perhaps even a Division—on who got the better deal.

However, perhaps most curious is that, along the way, the measure has gone from being an international arrangements Bill to an EEA and Swiss arrangements Bill. I have been here for only four years, but I have never heard of a Bill changing its name—but then before this year, I had never heard of Cabinet Ministers breaking collective responsibility and staying in their job, or Parliament taking control of the Order Paper. There are obviously many other examples of the strange times we live in, and this is just another curiosity to add to the list.

The Lords amendments pick up on many of the anxieties we expressed previously about the implications of the sweeping powers in the Bill. I pay tribute to Baroness Thornton and her team who have obviously got greater powers of persuasion than us. They have come up with a series of amendments that rightly curtail the breathtaking powers the Government sought to claim for themselves.

When the Bill began its progress in November, there was a clear assumption on the part of the Government that agreement with the EU would have been reached by now and that arrangements would be in place to carry on very much as we are, at least in the interim period. That in itself raised serious questions about why the scope of the Bill was so wide, and it would not be an understatement to say that the orderly exit envisaged at the time is now not quite so certain. That makes it all the more important that we have a Bill with proportionality and transparency at its heart.

It is worth reminding ourselves that when the Bill first surfaced, the Delegated Powers and Regulatory Reform Committee in the other place set out very clearly its potential impact if it remained unamended. It said that the measure gave the Secretary of State the power to fund the cost of all mental health provision in the state of Arizona, or the cost of all hip replacements in Australia. Although we pushed the Minister on the reason for the need for such wide powers—accepting of course that they would be unlikely ever to be used—the only justification given was that they might prove useful at some future time in trade deals. Although that might be the case, without a clear objective, debated and agreed in Parliament, the powers were unnecessarily broad, so it is right that the Lords raised those concerns and amended the Bill accordingly.

We all have constituents who regularly raise concerns about access to the NHS being used as a bargaining chip in trade negotiations. If the Bill had remained unamended, it would only have given those people more reason to be concerned about such deals. Restricting its scope to EEA countries and Switzerland is therefore proportionate and sensible.

I want to say a few words about amendment 12, which is very similar to an amendment that the Opposition tabled in Committee. It deserves support because even under the current arrangements, cost recovery has not always been handled satisfactorily. Indeed, the Public Accounts Committee described it as “chaotic”. The Law Society of Scotland was clear on the importance of that issue when it gave evidence to the Lords Committee. It said that

“as the NHS has never been very effective in reclaiming the fees owed to it by overseas visitors to the UK, the UK may find itself substantially worse off financially when new arrangements for funding cross-national use of health services are put in place.”

The case for greater accountability is there and has been strengthened by the Government’s impact assessment, which seemed to seriously underestimate the consequences of a no-deal scenario. It set out that the cost of establishing future reciprocal healthcare arrangements on the same basis as now would be £630 million a year, but it went on to estimate that, in the event of a no-deal scenario, the costs are expected

“to be similar or less, depending on the number of schemes that are established.”

I do not think it has ever been clear why the costs might be less unless we stopped reciprocating with some countries, and I do not believe that has ever been an express policy objective of the Government. In fact, they have often—rightly—said the opposite, but the reality is that, in that scenario, the costs could be significantly higher. Both the BMA and Royal College of Paediatrics and Child Health stated that if no EU-wide reciprocal agreement was achievable, the significant extra costs of establishing bilateral reciprocal arrangements with EU and EEA countries in future could fall on the NHS. We need, but have never had, a commitment that, in those circumstances, any extra costs would not be borne directly by NHS trusts. I hope that today the Minister can give such an assurance.

The Lords picked up on a related issue, which we have raised previously, on the lack of clarity about how dispute resolution will work in the event of bilateral agreements being necessary. We know from what the Minister has previously told us that, if we manage to reach full agreement with the EU27, there will still be a limited role for the European Court of Justice, but we do not know what the dispute resolution procedure will be if we do not.

The Lords rightly pointed out that there would be little incentive for other countries to agree to a brand new dispute resolution procedure, and they would certainly be loth to do that if they were expected to pay for it, so in the event of a no-deal scenario, is it not the case that there will be significant additional costs for the UK taxpayer in setting up and resourcing a new dispute resolution scheme? Does the Minister envisage those costs being part of the reporting requirements under amendment 12 and again, can he give a commitment today that those costs will not be directly borne by NHS trusts?

The Bill is in a much better condition than when it started. It does what it is supposed to do, and no more. Crucially, it gives much greater parliamentary oversight than we originally had. I think it is called taking back control.

Lords amendment 1 agreed to.

Lords amendments 2, 8 to 10, 18 to 20, 3 to 7 and 11 to 17 agreed to.

Offensive Weapons Bill (Money)

Queen’s recommendation signified.

Resolved,

That, for the purposes of any Act resulting from the Offensive Weapons Bill, it is expedient to authorise the payment out of money provided by Parliament of any increase attributable to the Act in the sums payable under any other Act out of money so provided.—(Amanda Milling.)

Offensive Weapons Bill (Programme) (No. 3)

Motion made, and Question put forthwith (Standing Order No. 83A(7)),

That the following provisions shall apply to the Offensive Weapons Bill for the purpose of supplementing the Orders of 27 June 2018 (Offensive Weapons Bill (Programme)) and 28 November 2018 (Offensive Weapons Bill (Programme) (No. 2)):

Consideration of Lords Amendments

(1) Proceedings on consideration of Lords Amendments shall (so far as not previously concluded) be brought to a conclusion two hours after their commencement at today’s sitting.

(2) The proceedings shall be taken in the following order: Lords Amendments Nos. 27, 28, 1 to 26 and 29 to 95.

Subsequent stages

(3) Any further Message from the Lords may be considered forthwith without any Question being put.

(4) The proceedings on any further Message from the Lords shall (so far as not previously concluded) be brought to a conclusion one hour after their commencement.—(Amanda Milling.)

Question agreed to.

Oral Answers to Questions

Justin Madders Excerpts

Tuesday 26th March 2019 Commons Chamber

[Caroline Dinenage]

All NICE guidelines are permanently kept under review. If the research we are investing in throws new light on any issues, that will always be taken into consideration.

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

10. What assessment he has made of the implications for his Department’s policies of the conclusions of the “Clinically-led review of NHS access standards: interim report from the NHS national medical director”; and if he will make a statement.

[The Secretary of State for Health and Social Care (Matt Hancock)]

It is a great pity to see the hon. Gentleman back up there on the Back Benches as he was such a force—and a rare force—for reason and progress on the Opposition Front Bench until recently.

Standards in the NHS should be based on clinical evidence, and NHS England’s proposals will be rigorously field-tested to gather further evidence on clinical, operational, workforce and financial implications, all with the goal of improving the quality of care.

[Justin Madders]

I thank the Secretary of State for his tribute—although it is not going to change the question I am going to ask. He will be aware that since July 2015 the four-hour A&E target has not been met and last month saw the worst performance on record, so regardless of any clinical reviews, is it not time that Ministers admitted that the four-hour A&E target has effectively been abandoned?

[Matt Hancock]

Of course, we are aiming to meet and improve against the targets, including with the injection of the extra money—£34 billion extra in cash terms over the next five years. At the same time, we must make sure that the standards to which we hold the NHS are the right ones clinically for the times, and that is what this review of standards is all about.

Integrated Care Regulations

Justin Madders Excerpts

Monday 18th March 2019 Commons Chamber

[Jonathan Ashworth]

My hon. Friend is absolutely right. Of course, the Minister cannot give that reassurance because of the Lansley Act that Ministers voted for in 2011.

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

I am only sorry that I cannot be with my hon. Friend on the Front Bench tonight. I have really enjoyed working with him; he is a fine shadow Secretary of State, and I know that he will make an excellent Secretary of State. Unfortunately, I cannot be with him, because when we on these Benches vote against the Whip, we have to deal with the consequences.

As my hon. Friend knows from many debates I have taken part in for the Opposition, despite repeated questions to various Ministers, there has been no absolutely no reassurance that the private sector will not continue to be involved in these matters.

[Jonathan Ashworth]

My hon. Friend makes his point typically eloquently and with force. May I say to him that we miss him on the Labour Front Bench? He was a real rock in the shadow Health and Social Care team. It is typical of him that when he decided last week that he could not support the Labour Front Bench position on a referendum, he took the honourable course of action and chose to leave the Front-Bench team. I think that he has the respect of many in the House for that position.

This is the nub of our opposition tonight. Contracts are still being put out to competitive tender, even when some commissioners claim that they do not wish to do this. Here lies the danger: nothing prevents, and some things might encourage, these integrated care partnership contracts being put out to tender and perhaps being won by a private sector provider. Ministers repeatedly tell us that ICPs, and before them accountable care organisations, are not about ushering in a further role for the private sector. If that is the case, and if patients and staff are to have confidence that the ICP contracts will not end up in private hands, the Government’s overarching competition legislation must be changed first. As that legislation has not been changed, and as we will still have commercial contracting for the delivery of medical services, there is a risk that a multi-billion pound contract covering hundreds of thousands of people and packaged up for 10 to 15 years could be handed over to a big provider. That is why the Health Committee, which is broadly supportive of these integrated care models, issued this warning in its report:

“The ACO model”—

it was using the terminology of the time—

“will entail a single organisation holding a 10–15 year contract for the health and care of a large population. Given the risks that would follow any collapse of a private organisation holding such a contract and the public’s preference for the principle of a public ownership model of the NHS, we recommend that ACOs, if introduced, should be NHS bodies and established in primary legislation.”

We agree.

The impetus for this contract comes from the example of Dudley, which I am sure the Minister will want to talk about. When the chief executive of Dudley CCG attended the Select Committee, even he conceded—although he said that it was unlikely—that because of the procurement rules, it would not have been possible to have kept out private providers applying for the contract. When asked whether the contract could go to a private provider, he said:

“In theory, it is technically possible for that to happen”.

Although Mr Nigel Edwards of the Nuffield Trust shared the Minister’s scepticism that the contract could go to a private provider, he did concede before the Select Committee that:

“To privatise in the sense of handing over all the assets and staff to a private contractor is a theoretical possibility.”

NHS England’s own analysis of the contract published at the end of last week concedes:

“However, it should be understood that current NHS law and EU and domestic procurement law prohibits CCGs or NHS England from taking steps, whether through evaluation criteria used in a procurement or otherwise, to disqualify certain categories of provider (e.g. independent sector providers) from bidding or being awarded commissioning contracts.”

This is our first objection, because Labour is not prepared to nod something through when there is a theoretical possibility hanging over us that, in the words of NHS England, an independent sector provider could not be disqualified from being awarded commissioning contracts.

--- Later in debate ---

[Stephen Hammond]

The hon. Gentleman is right: it is highly unlikely. More than that, it is stated and restated in the long-term plan that NHS England has the clear expectation that the ICP contracts will be held by public statutory providers. He knows that, and others who have discussed this point have made it clear.

[Justin Madders]

I have a simple question and we would like a simple answer. Yes or no: do the Government intend to repeal section 75 of the Health and Social Care Act 2012?

[Stephen Hammond]

As the hon. Gentleman knows, the NHS has proposed in a recent legislative document that it looks at a number of issues. It is important that that round of engagements takes place, and the Government will consider what is said.

The majority of the amendments we propose simply ensure that the regulatory framework that applies to contractual arrangements for the provision of healthcare services continues to apply where services are provided under the new ICP contract and to those organisations that hold a contract. That is an important safeguard that, in simple terms, helps to ensure that care provided under an ICP contract is subject to all the same rules as care provided under existing and other NHS contracts, such as those governing the handling of complaints and the reimbursement of travel expenses.

The shadow Secretary of State has asked me to comment on the substantive change being proposed, underpinning the existing contractual arrangements for the provision of NHS GP services. The regulations will allow GPs who are currently providing services under existing contractual general medical services or personal medical services arrangements to suspend, rather than terminate, those arrangements in order to provide services under an ICP in what is known as a fully integrated arrangement. The British Medical Association has underlined that GPs should not be pressured into joining an ICP arrangement, and we want to make it clear to the House tonight that the participation of any individual GP practice is entirely voluntary. Any role in any ICP will be for them to decide. Allowing the suspension of GP contracts allows GPs to take part in an ICP arrangement but keeps the option available to them of returning to their previous contract.

The hon. Gentleman expressed a number of concerns about the ICPs. He implied that they had been brought in by stealth. In fact, the proposals have been subject to significant scrutiny by Parliament and the public, particularly in the past year. We have already discussed the examination of the evidence by the Health and Social Care Committee, which published a report last summer, which is, I believe, largely supportive of ICPs, recognises potential benefits and sets out helpful recommendations on introducing them in England. I have described the consultation processes previous iterations of the ICP contract and the regulations have gone through.

Moreover, as the Health and Social Care Committee was promised, NHS England has completed a full public consultation on the ICP contract and announced through the long-term plan that the ICP contract will be available for use. NHS England’s full response to the consultation was published on 15 March.

Various people have made points tonight about the privatisation of the NHS and said that ICPs are a route to privatising the NHS. They are clearly not.

Health and Care Professions Council: Registration Fees

Justin Madders Excerpts

Thursday 14th March 2019 Westminster Hall

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

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

As have many other hon. Members, I congratulate my hon. Friend the Member for Coventry South (Mr Cunningham) on securing this important debate, and on the way in which he has led the campaign. As he rightly pointed out, 114 Members have signed an early-day motion on this topic, which shows the level of concern about the proposals across the House.

My hon. Friend set out the five main reasons why the HCPC argues that the increase is justified. However, as he correctly pointed out, it cannot be justified, particularly in the context of what he referred to as excessive redundancy packages and refurbishment costs within the organisation. He was right that it is irresponsible of the Government to hide behind the HCPC. Recent events may give us cause to believe that the Government are completely powerless in everything and unable to govern, but surely there is something they can do about this; it is a question of political will.

As always, it was a pleasure to hear from the hon. Member for Strangford (Jim Shannon). He put it aptly when he described the increases as having no sense of fairness or balance, and he is right that increases in the cost of everyday items make it difficult to find any justification for these fee increases.

My hon. Friend the Member for Heywood and Middleton (Liz McInnes) brought her experience to the debate, as she often does. I am sorry to hear that she has called time on her NHS career, but the NHS’s loss is no doubt her constituents’ gain. She was right to remark on the correlation between public sector pay restraint and increased fees, and she highlighted what I would characterise as the opaque way in which the HCPC operates. It does not recognise trade unions, we do not know what its pay rates are and, as she said, many registrants do not see any value in what it does. I join my hon. Friend in paying tribute to the healthcare scientists and allied health professionals who work in the NHS, and agree with her that they provide a vital part of the service.

We heard from another former NHS professional, my hon. Friend the Member for York Central (Rachael Maskell). She brought her own frontline experience to the debate and highlighted the importance of maintaining the integrity of the register, to protect both the professions and the public. She rightly pointed out that the number of those whose professional standards are brought into question is minuscule, and made the pertinent point that the risk for professionals is probably greater now than in the past, due to the continual challenges with workforce numbers.

We also heard from my hon. Friend the Member for Blaydon (Liz Twist), who made the point—as did many others—that although the staff we are concerned with today are not the typical NHS staff we spend a lot of our time talking about, they are just as important as every other member of the NHS family. She was right that this fee increase is out of proportion, and that such fees can only be seen by staff as a disincentive to stay in the professions. She also made the perfectly reasonable point that cash reserves could be used to prevent a fee increase this year and to make time for a more open and detailed examination of how such eye-watering increases can be avoided in future.

Professional regulation plays a vital role in setting and enforcing the standards of professional behaviour, competence and ethics that underpin the day-to-day interactions between patients and health and social care services in the UK. There are nine regulators in the UK, which regulate 32 professions and are independent of Government under the law. Their roles, functions and powers vary, but all set standards of competence, conduct and ethics that professionals must abide by. Professionals must register with them to practise. They monitor the quality of all education and training courses, maintain a public register of professionals, investigate complaints, and make decisions about whether registered professionals should be allowed to continue to practise. In short, they play a vital role in upholding public trust and confidence in the professions.

The HCPC currently regulates 15 health and care professions across the UK, as well as social workers in England, although as we have heard, social workers are due to move to a new regulator later this year. At the moment, that represents 366,000 health and social care professionals, including paramedics, occupational therapists, biomedical scientists, chiropodists, dieticians, physiotherapists, radiographers, prosthetists, orthotists, speech therapists and social workers—Members will be glad that they were not the only ones to struggle with some of those names. All those professionals are vital to the day-to-day running of the national health service. Registrants have to pay a fee to join the register and must then pay a yearly retention fee to remain on it and be able to practise.

A massive 18% increase in the registration fee is due to take effect from October 2019, taking the fee to £106, although that increase is subject to parliamentary approval. It comes on the back of above-inflation increases in 2014 and 2015, the second of which occurred despite the HCPC reassuring registrants that their fees would not be reviewed again for a period of two years. If the proposed increase is imposed, HCPC fees will have increased by 40% since 2014, which not only outstrips inflation—which, according to the Office for National Statistics, has averaged about 2.5% over the past few years—but is well above the pay rises that our hard-working NHS staff have received over that period. Let us not forget that the modest pay award that those staff recently secured came only after many years of campaigning, during which time their wages consistently fell behind the cost of living.

I can understand why, in that context, an 18% increase seems disproportionately high. Would the Minister care to comment on whether, in the context of the years of pay restraint that we have talked about, such an unprecedented increase in fees is indeed indefensible, and whether it is right that pay rises will not keep up with the increases in fees?

I appreciate the concern expressed by some Members that there is no real mechanism to stop the HCPC imposing fees at whatever level it sees fit. As my hon. Friend the Member for Heywood and Middleton has said, and as we all regularly hear from staff-side union members, modest pay rises are being eroded by a series of other costs, including increased pension contributions, student loan repayments and increasing car parking charges. Another increase, at a time when pay is not keeping up with the cost of living, will only reduce the disposable income of those staff. The Government must acknowledge the crisis in recruitment and retention, and that all those factors are conspiring against any improvement in the serious staff shortages the NHS faces.

The need to retain staff has never been greater; we should be doing all we can to attract new people, and to encourage those who already work in the NHS to stay. As we have heard, that is a particular concern for part-time staff. Over the years, the HCPC has declined to consider introducing a pro rata structure. Unison has expressed concern that some registrants might be pushed to move into non-regulated posts, work in posts where there is no requirement to renew their registration or decide not to continue to practise, even on reduced hours. Again, that might have a negative effect. Will the Minister comment on that disparity between part-time and full-time staff, and make representations to the HCPC about it? Does he agree that it creates a disincentive for people who might not want to work full time, but could still play a valuable role in the NHS?

Some 90% of respondents to the consultation argued against the fee rise, but the HCPC is going to press ahead with it. When Unison carried out a survey of its registered members at the end of last year, 99% did not support an increase in registration fees. Those large fee increases raise concerns about whether the HCPC is operating as efficiently as it could be, so when he responds, will the Minister comment on whether the HCPC represents value for money?

The HCPC has given a number of reasons for the proposed increase, including improving capacity and service in the area of fitness to practise, keeping pace with inflation, and costs associated with the impending transfer of the regulation of social workers to Social Work England this year. The HCPC became the regulator for social workers in 2012, and has had to invest in additional staff and accommodation to fulfil that role. The reasons why, four years later, the Government announced that they would be transferring the regulation of social workers to a new regulator are not clear to me, but it is unacceptable that HCPC registrants should effectively be paying the price for a political decision. Several Members mentioned that 73% of HCPC resources are spent on fitness-to-practise cases, and social worker cases account for 59% of that amount, so it seems reasonable to conclude that costs ought to decrease this year. In that context, it is incumbent on the Minister to see whether any justification can be put forward for the fee increase.

As my hon. Friend the Member for York Central mentioned, the Law Commission made recommendations back in 2012 that would have enabled regulators to become more agile, to modernise and to reduce the costs associated with fitness to practise. I recall the Conservative party signalling its intention to reform in its 2017 general election manifesto. As we know, the Queen’s Speech following that election did not include any reference to that legislation. Will the Minister indicate whether that reform will now see the light of day?

Does the Minister agree that the Government should accept responsibility for the lack of action on reforming healthcare regulation and for their decisions on social work regulation, which have had a negative impact on the HCPC? Will he do what he can to ensure that registrants do not pay the price for that failure? Our dedicated and hard-working NHS staff deserve better than that.

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.

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[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.

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[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.)