Oral Answers to Questions

Debate between Justin Madders and Jackie Doyle-Price

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.

Oral Answers to Questions

Debate between Justin Madders and Jackie Doyle-Price

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.

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

Debate between Justin Madders and Jackie Doyle-Price

Wednesday 6th March 2019 General Committees

[Jackie Doyle-Price]

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

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

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

[Justin Madders]

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

[Jackie Doyle-Price]

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

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

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

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

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

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

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

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

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

--- Later in debate ---

[Jackie Doyle-Price]

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

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

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

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

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

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

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

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

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

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

[Justin Madders]

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

[Jackie Doyle-Price]

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

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

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

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

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

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

Question put and agreed to

Resolved,

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

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

Resolved,

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

Mental Health Units (Use of Force) Bill

Debate between Justin Madders and Jackie Doyle-Price

Report stage: House of Commons
Friday 15th June 2018 Commons Chamber

[Jackie Doyle-Price]

That issue did come up in Committee. Although I appreciate the spirit with which the right hon. Gentleman makes that inquiry, we would not want to make a particular arrangement for one set of NHS data over another. Clearly, we need to explore this issue to make sure that there is some annual return on how this Bill operates when it becomes an Act.

I could say so much more, Mr Deputy Speaker, but I will not. Everybody in this House is very clear that they want this Bill to make progress. I appreciate that I cannot keep all Members happy all the time, but I do hope that I have been able to assure my hon. Friends the Members for Shipley and for Christchurch on how we will take forward their representations and that I can persuade them not to push their amendments to a vote.

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

May I start by congratulating my hon. Friend the Member for Croydon North (Mr Reed) on progressing this extremely important Bill to this stage? I had the pleasure of speaking to it on Second Reading back in November. I am sure that the past seven months have felt pretty long to him, particularly as there were delays outside his control with the money resolution, and I am sure that that feeling was present again at times this morning. I hope that his diligence and persistence will pay off. We all know how much it will mean to see this Bill finally enshrined in statute. Nothing can demonstrate better the positive impact that a constituency MP can have in such circumstances, where there are clearly shortcomings in the current law, which we hope to put right.

I congratulate all hon. Members who have contributed so positively to the progress of the Bill, and the Minister on her constructive approach. I also echo the tributes paid to the Lewis family for the dignified and helpful way in which they have assisted in shaping this legislation. It has been evident from contributions that hon. Members have made during the passage of the Bill just how united we all are in our determination to do something to ensure that the tragic case of Seni is not repeated.

It is shocking to hear that, according to the Independent Advisory Panel on Deaths in Custody, 46 mental health patients died following restraint between 2000 and 2014. Victims of restraint in these circumstances have said that face-down restraint by groups of men adds to the trauma that in many cases led to their mental illness in the first place. As well as bias towards women, there is evidence to suggest that members of the BAME community are disproportionately more likely to experience restraint, so we strongly support the Bill, which we hope will reduce the use of force and address the unconscious bias currently reported in the system, by increasing transparency, evidence, accountability and justice.

In terms of transparency, data is not currently collected consistently, so it can be hard to collate accurate data on how often restraint is used and on how restraint is used disproportionately against certain demographics. We hope that the Bill will create a level of uniformity that is currently missing. Recording how and why restraint is used, who it is used on and what steps were taken to avoid its use will inject much needed transparency and consistently into the system. We will then be in a much stronger position to tackle the issues of unconscious bias or overuse of restraint to which hon. Members have referred throughout the passage of the Bill.

We need to ensure that if tragedies of this nature occur again, they are independently investigated and that justice is not only done, but seen to be done. As my hon. Friend the Member for Croydon North has set out, new clause 1 would make it compulsory for an independent investigation to be carried out whenever a death occurs in a mental health unit. He set out the thinking behind the new clause very well. The Minister set out why it is not something that she can take on board, but she did give a clear view of some of the safeguards that will be needed regarding independence, particularly when it comes to potential conflicts of interest or, as she said, appearances of conflicts of interest. She was clear and strong about the need for the ownership and involvement of the families in any investigation. That is of paramount importance. I look forward to hearing whether my hon. Friend considers that a satisfactory response.

In conclusion, the Bill is a step towards a model of care, rather than one of containment. Of course, it does not have everything that we would want, but it is an important step in the right direction that will support patients, their families and emergency service workers. I commend my hon. Friend the Member for Croydon North on his hard work in reaching this stage and look forward to Seni’s Bill becoming Seni’s law.

Health and Social Care (National Data Guardian) Bill

Debate between Justin Madders and Jackie Doyle-Price

Committee Debate: 1st sitting: House of Commons
Wednesday 6th June 2018 Public Bill Committees

[Justin Madders]

I wish to raise a point on the exclusion of children’s data. I appreciate that hon. Members have referred to it already, but we are slightly concerned that although children’s data may be covered elsewhere, the guardian does not have any ability to write to bodies in that respect. It is perfectly reasonable for that to be included; indeed, I think it was included in the original Bill as drafted. We see it as a safety net, rather than an added complication.

[Jackie Doyle-Price]

I confirm that the Government support the clause. On the point about children, it is our interpretation that the provisions do not prevent the National Data Guardian from engaging constructively with the Department for Education on adult social care data and its interaction with or effect on children’s data. Clearly, this is something we will monitor, but, bearing in mind that the whole ethos behind the creation of the National Data Guardian is to spread good practice and make representations rather than regulations, the concern that the hon. Gentleman has expressed is important, but we do not think it will get in the way of sensible engagement.

--- Later in debate ---

[Jackie Doyle-Price]

In regard to application, the provisions extend to England and Wales but apply only to England. I have to confess that my knowledge of devolution arrangements is perhaps not as good as it should be, but our view is that the Bill applies only to England. Although the provisions could extend to England and Wales, it would be within the competence of the National Assembly for Wales to appoint a guardian and make such arrangements. That said, the National Data Guardian is an advisory role—it is not a reserved power under devolution arrangements—and as is common in the operation of the health systems in all four nations, I would expect that the advice and guidance given by the National Data Guardian would be heard and, when appropriate, acted on by the health services in the other nations.

[Justin Madders]

My understanding when preparing for the Committee was that it would apply to England only. I think that is what the Minister has confirmed. Certainly in my part of the world there is quite a lot of movement of patients both ways between England and Wales, because we are quite close to the Welsh border. Can the Minister explain what will happen to patient records in that situation?

[Jackie Doyle-Price]

Clearly the Bill extends to England, but the purpose of the National Data Guardian is to give advice on the appropriate sharing of data and best practice. I should expect practitioners to have regard to the advice regardless of where they come from, because, notwithstanding the legal framework in which they operate, all health professionals want to behave in a responsible way. We expect the guidance of the National Data Guardian to be good practice. She has been giving advice without statutory powers to do so, and that advice has been respected; I think that that will continue. It is largely through an accident of the current structuring of the health service that the provisions are as they are. The principles under which the Data Guardian will give advice extend way beyond the geography of England.