NICE Appraisals: Rare Diseases Treatments
Sharon Hodgson Excerpts(7 years, 1 month ago)
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Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
It is a real pleasure to take part in this very important debate. I start by thanking my hon. Friends the Members for Blaydon (Liz Twist) and for North Tyneside (Mary Glindon). We are part of the north-east massive, so I am very pleased to be joining them in this debate today. I thank them for their very passionate and heartfelt contributions. I should also mention, as part of the north-east massive—it goes without saying—my hon. Friend the Member for South Shields (Mrs Lewell-Buck). I thank all other hon. Members who spoke for their excellent contributions. They know who they are and I do not need to name them. They were all fantastic.
Throughout the debate we have heard of the heartbreak experienced by patients and their families when they are unable to access life-saving drugs on the NHS. We have heard of their determination to continue fighting to access those drugs, whether by writing to their MP or even by protesting in Parliament square. I was happy to join my hon. Friend the Member for Bristol East (Kerry McCarthy) there just two weeks ago for the Cystic Fibrosis Trust rally, where people were calling, “Orkambi now!”—they were so loud that we could hear them over the crowds chanting, “No Brexit!” or whatever the shout was at the time.
We must hear patients’ voices in this debate, as it is they and their families who are affected the most by the appraisal process, which is not fit for purpose. The Minister has heard about the real-life experiences of patients throughout this debate, and I am sure that he will continue to listen to them afterwards. I know that he is also in regular communication with patients. In my role as shadow Public Health Minister, I regularly meet patient groups and campaigners, so I know just how important access to these life-saving drugs is to them.
As a constituency MP, I recently met young Riley and his mum Michelle. Riley has phenylketonuria—PKU—and needs Kuvan. He is now 11 and at secondary school. He just wants to blend in with his mates and to be able to go on those first excursions out to the Metrocentre, and perhaps to get something unhealthy to eat from a takeaway, but obviously he cannot do any of that. I asked him about his life and how he felt not having access to Kuvan. He said that it was not fair and that it made him mad. Well, I agree with Riley.
It can take years to get the right diagnosis for a rare disease, so once patients get the diagnosis they are excited and feel that there has been a breakthrough, because they think that they will finally get the treatment they need and deserve. Instead, as we have heard today, they are back at the beginning of the fight, because the life-saving drugs that do exist are not available to them on the NHS. It is one hurdle after another for patients with rare diseases. That is why the Opposition strongly believe that patients should have fast access to the most effective new drugs and treatments. I am therefore pleased to support the motion.
As we have heard, a rare disease is generally considered to be one that affects fewer than five people in 10,000. According to the 2013 UK strategy for rare diseases, it is estimated that in the UK more than 3 million people will suffer from a rare disease at some point in their life. All those patients must have access to the drugs and treatments that they need. However, they are being failed by the NICE appraisal process, which is just not fit for purpose when it comes to assessing the suitability of drugs and treatments for rare diseases.
Patients with rare diseases are squeezed in the middle of two appraisal routes: the highly specialised technology evaluation programme and the single technology appraisal route. The HST evaluation programme is selected for most non-cancer rare disease medicines and is designed for evaluating medicines of that nature, with small patient populations. However, the HST evaluation programme currently lacks the capacity or capability to effectively appraise all new licensed orphan medicines. Since the HST evaluation programme was established in 2013, it has published guidance on eight medicines, which is much fewer than the 45 orphan medicines for non-cancer indications that have been licensed in the same period.
The STA route is designed to appraise treatments for more common conditions and those with existing treatments. This route is poorly suited to considering rare disease medicines, which tend to have small patient populations, a limited evidence base and benefits beyond direct health benefits—something the appraisal process just does not take into account. Some rare diseases are not rare enough for the STA route, and only a handful of medicines are being approved by the HST route. Yes, it is complicated, but it is clear that neither route is working for patients with rare diseases, so patients are missing out on crucial medicines.
Kuvan was licensed in 2008 to treat PKU patients, but it is still not available to patients in England. Orkambi was appraised by NICE in 2016 through STA, but was recommended for use. Three years later, as we have heard, people with cystic fibrosis still have no access to it. That has caused physical and psychological harm to patients and their families. Every day without the drugs that they need makes their condition worse. We must have an appraisal process that captures rare diseases effectively.
Medicines to treat rare diseases are often found to be cost-ineffective, which is why they are not approved for routine commissioning. However, establishing value for money is not straightforward, especially when population groups are small. It does not sit comfortably with me—or, I am sure, with any of us—that cost-effectiveness is prioritised above clinical need, or, as we have heard, the lives of children. Manufacturers want to make a reasonable return on their investment, although some of the figures are huge, but I do not think that that should be a priority. Manufacturers must not hold NICE or NHS England to ransom for their own financial gain.
The Parliamentary Under-Secretary of State for Health and Social Care (Steve Brine)
Or the Government.
Mrs Hodgson
Exactly.
Behind profit forecasts are thousands of people and families who need access to life-saving drugs, and they simply cannot wait any longer. We must not put businesses before patients. Because of the NICE appraisal process, patients and their families are being left in an awful limbo. The processes can be long-winded, confusing and difficult to navigate. Some medicines can undergo multiple assessments while others are not assessed at all, and that creates an unpredictable and unattractive system. As a result, patients are left in the dark about when, or if, they will have access to innovative treatments for their conditions.
When a drug is being appraised, patients live in hope that this time it will be approved for use by NICE—as in Maryam’s case, which was described so powerfully by my hon. Friend the Member for West Ham (Lyn Brown)—but they are almost always left to feel disappointed and helpless. Patients and their families must be involved in the processes, and the processes must be transparent.
The wait for access to drugs is excruciating, especially when the drug is available in nearby countries, or even—as we have heard—in Scotland. Spinraza is available to patients in Scotland, but not to those in England. My hon. Friend the Member for West Ham spoke passionately on behalf of her constituents and their seven-month-old baby Maryam. This sounds blunt, but she is dying, because she has been denied access to medication that could extend and enhance her life.
The pain and anguish that the parents of a critically ill child must feel when they are told that there is medicine available that will help but it is not available for their child are unimaginable. Knowing that if your child lived a few hundred miles away, in Scotland or perhaps somewhere in Europe, the drug would be available is heartbreaking and infuriating. Patients in England should not be left behind. We should be working to find ways to get these medicines to the patients who need them, on the NHS.
I hope that the Minister will consider the motion seriously, for the sake of patients with rare diseases and their families. They cannot be left behind any longer: they must have access to these life-saving drugs now.
Health Inequalities
Sharon Hodgson Excerpts(7 years, 1 month ago)
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Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
It is a pleasure to serve under your chairmanship today, Mr Hollobone.
This has been an excellent debate, and I start by thanking the hon. Member for Telford (Lucy Allan) for securing it and for her excellent contribution. Sadly, many areas across the UK face similar issues to those affecting Telford, as we have heard. As we know, our NHS was built for everyone. The original leaflet explaining the NHS to households across the country read:
“Everyone—rich or poor, man, woman or child—can use it or any part of it.”
Seventy years on, we cannot forget that ethos, which is why this debate is so important. I also thank all other hon. Members for their contributions to the debate. Due to time, I will not name them all.
Health inequalities are avoidable, but they still persist so clearly, both nationally and locally, within our communities, as we have heard. It cannot be right that in England men and women from the most disadvantaged 10% of areas on average now die 9.3 and 7.3 years respectively sooner than those in the 10% least disadvantaged areas. And those living in the most deprived areas not only die much earlier than those living in the most affluent areas but they also live much longer in bad health. For example, between 2014 and 2016 women in the most deprived areas could expect to live for 51.8 healthy life years, meaning that their remaining 27 years would be spent in bad health. That is compared, for instance, to women in the least deprived areas, who could expect to live for 70.7 healthy life years, with only 15.5 years in bad health.
It has to be said that there is also a persistent north-south divide in both life expectancy and healthy life expectancy, with people in the southern regions of England on average living longer and with fewer years in poor health than those living further north. For example, 2015-17 figures show that men and women in the north-east—my region—have the lowest life expectancy at birth in England, at 77.9 years and 81.6 years respectively. That is compared to the south-east, where men can expect to live for 80.6 years and women for 84 years.
However, health inequalities also exist within local authorities. For example, the longest life expectancy in the country is in the richest borough, Kensington and Chelsea; I am not surprised. Nevertheless, the most disadvantaged people in that London borough can expect to live for 14 years less than their most advantaged counterparts. Such a stark difference is completely unacceptable.
Also, children living in poverty are more likely to die before the age of one, become overweight, have tooth decay or even die in an accident. Parents living in poverty are also more likely to smoke, experience mental health difficulties, be a young parent, be a lone parent, experience domestic violence and other negative outcomes, all of which also increase adverse childhood experience risk factors that impact children’s health, too.
So, after a century of decline the number of deaths in childhood in the UK has risen for two consecutive years, with the highest mortality rates evident in the poorest communities. Life expectancy in the UK had always increased slightly, year on year, for over a century, largely due to improvements in nutrition, hygiene, housing and control of infectious diseases. However, it seems that that is not happening any more.
What are we going to do? Labour is committed to a new health inequalities target, to improve life expectancy, mortality rates and children’s health. The target would be independently assessed, and as the hon. Member for Telford called for, the Health and Social Care Secretary would be held accountable to Parliament and would produce an annual health inequalities report.
The four biggest risk factors that affect health—smoking, excessive alcohol consumption, poor diet and lack of exercise—also affect the poorest in our communities. Public health services support those people. However, there have been public health cuts to the tune of £800 million between 2015 and 2021, and local authorities have been put in untenable positions, where they have to make difficult decisions.
I believe that the Government already have a moral duty to ensure that health inequalities are reduced, but unfortunately they have not taken that duty seriously enough, so I would like the Minister not only to set out her commitment to reducing health inequalities but to lay out details of how the Government will reduce them, and I urge her once again to reverse the cuts to public health budgets.
Mr Philip Hollobone (in the Chair)
If the Minister concluded by 5.28 pm, that would allow Lucy Allan time at the end of the debate to sum up.
Exiting the European Union (Food and Agriculture)
Sharon Hodgson Excerpts(7 years, 1 month ago)
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Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
I start by thanking the Minister for introducing these statutory instruments on the Floor of the House this afternoon and for summarising them so clearly for us. I would also like to start, as I always do, by putting on record once again my disappointment and concern that there could be as few as 10 days before we leave the EU, yet we are still dealing with crucial legislation concerning our food safety. The Government have run down the clock for more than two years and only now, when the deadline is so close, are we considering important legislation that could impact on the public’s health if we do not get it right. Of course, that is because the threat of no deal is still hanging over us. I know that the Minister wants to get this right, which is why I have supported him throughout the discussions on these SIs, but I am still disappointed at the way the Government have handled this.
These statutory instruments will transfer tasks and roles assigned to the European Commission and the European Food Safety Authority to an appropriate UK entity. Will the Minister please confirm who that appropriate UK entity will be? While we are taking these SIs as a group, which I welcome, I would like to raise some concerns about each of them in turn.
Dr David Drew (Stroud) (Lab/Co-op)
I am sure my hon. Friend agrees that this is as much to do with DEFRA as with the Department of Health and Social Care, and it shows why we need a food strategy in this country so that we can sort out some of the nonsense caused by the overlap between different Departments.
Mrs Hodgson
I absolutely agree. My hon. Friend makes a good point, and I discussed with the Government and Opposition Whips where responsibility for these SIs fell. There is so much crossover between food and health policy, and we are doing the best we can with the hand we have been dealt, but we should probably look more into this issue going forward.
Mr Jim Cunningham (Coventry South) (Lab)
I do not want to take my hon. Friend off the point too much, but it crossed my mind when I was listening to the Minister—I apologise to him for coming in late— that issues have been raised in the press, certainly recently, about imported food and the use of chlorine to cleanse it. Does my hon. Friend have a view about that?
Mrs Hodgson
Yes. The issue of chlorine-washed chicken did come up in some of the SI Committees that were held upstairs, and the Minister assured Committee members that chicken would continue to be washed in fresh water and that there would be no sneaking chlorinated chicken into our food chain. I am sure he will reaffirm that today.
The first SI today is the Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019. As consumers, we are all familiar with the plastic packaging around almost every product—I suppose we are moving on to environmental policies in talking about the waste element of this, but the issue is at the forefront of consumer consciousness. Has the Minister had any conversations with his colleagues at DEFRA about the UK’s commitment to reducing plastic waste and about how this SI could help facilitate that? The authorised list of substances permitted for use in food contact plastics is generally updated several times a year. Which body will now undertake that work, and does it have sufficient resources to do so? Will the updated list be in line with that of our European neighbours?
Moving on to the genetically modified food and feed regulations, all authorised genetically modified food and feed must have a method of detection scientifically assessed and validated by the European Union laboratory, in collaboration with the European network of GMO—genetically modified organism—laboratories. What body will now scientifically assess and validate food and feed? Will the assessment process change, and will businesses have to complete a more complex process than currently? Will the UK be part of the European network of GMO laboratories after we leave the EU? If not, will the UK’s validation of GM food and feed be aligned with European network standards to ensure that GM food and feed from the EU can be placed on the UK market after Brexit and vice versa?
Can the Minister assure the House that GM food and feed will be authorised for sale only if they are judged not to present a risk to health, not to mislead consumers and not to have less nutritional value than their non-GM counterparts? Has he made any assessment of the impact that this SI may have on businesses? Has the Department contacted the food and feed industry to notify it of the changes in this SI?
Moving on to what is perhaps the most interesting of the SIs, on the regulation of novel foods, I was surprised to learn that chia seeds are classed as a novel food by the EU. I am sure I eat some of them; I have some in the cupboard—I think you sprinkle them on breakfast cereal and other things to try to get their goodness into you. Lots of other new products that I had not realised were classed as novel foods are now entering the market. I am pleased that foods that are new to the market are not automatically assumed to be safe. Novel foods must have a pre-market safety assessment before being placed on the market.
The geographical scope of the existing regulations is being maintained so that food that had a history of consumption in member states of the EU, and that could therefore be marketed in the EU without needing to be authorised, will not become novel and require authorisation to be sold in the UK when we leave. However, when we do leave the EU and new foods are added to the EU’s novel food list, will the UK mirror the same list and authorisation, or will it conduct its own review and authorisation? If the UK conducts its own review, which body will do it? Will the EU’s assessment be taken into account when we conduct a UK-only assessment? Public safety is paramount in all of this, as the Minister and I have discussed many times, so it is important that any reviewing body has the funding and resources to conduct a review. Can the Minister confirm that that is indeed the case?
Will a list of novel foods be available in the UK? Consumers are becoming more and more conscious about what is in the foods they eat, and rightly so. Any list must therefore detail all the information taken into account during the assessment so that consumers can make their own decisions. Packaging must also be clearly labelled with information about novel foods to ensure consumers are aware that their food is safe. It is of course highly important that any food entering the UK market for the first time is safe for human consumption. Leaving the EU should not mean a reduction in our food health standards.
Finally, the anomaly among these SIs, if we did not think that novel food was an anomaly, is the animal feed regulations—I suppose the Minister and I are discussing them because we are the Health Minister and the shadow Health Minister. This SI focuses on animal health and welfare, while taking into account the impact that that can have on human health—that is probably why it has fallen to the Minister and myself to debate it.
The SI says that all rules will remain the same as at present and that there will be a smooth transition for businesses, the feed sector and consumers. The elements of the instrument addressing deficiencies in the Animal Feed (Composition, Marketing and Use) (England) Regulations 2015 apply only in England. What discussions has the Minister had with his counterparts in the devolved Administrations? Is he confident that any regulations on animal feed will be similar, if not the same?
Any animal feed on the market, or used, anywhere in the UK must be safe. The conditions set out for labelling, packaging, sampling, analysis and hygiene must also meet a high standard to protect animal health and wellbeing. Animal feed must also be tested to ensure that it is not harmful to humans in the food chain.
Finally, any changes as a result of this SI must be effectively communicated to the agencies affected in a timely manner. With what could be as few as 10 days to go until Brexit day, will the Minister please confirm that he has had conversations with such agencies to notify them of any changes? The regulations must also be able to be amended easily in the event of emerging threats or changes in safety standards.
In closing, I would like to put on record once again that I am disappointed and concerned that it has come to this just 10 days—if nothing changes—before we are due to leave the EU and that we are still tying up loose ends in such legislation, which is so important to our food safety. We cannot let food safety standards slip as a result of Brexit. They are crucial to human and animal health, safety and welfare. That is why, although I am concerned about the way the Government are rushing through important legislation such as this, I none the less support these SIs. The UK’s food safety standards are paramount to our health and something we must not compromise on. With those remarks, I look forward to the Minister’s response. As ever, I hope he is able to answer some of my questions.
Draft Food and Feed (Chernobyl and Fukushima Restrictions) (Amendment) (EU Exit) Regulations 2019
Draft Food and Feed (Maximum Permitted Levels of Radioactive Contamination) (Amendment) (EU Exit) Regulations 2019
Sharon Hodgson Excerpts(7 years, 1 month ago)
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Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
It is a pleasure to serve under your chairmanship this morning, Mr Wilson.
I am genuinely pleased to see the Minister in his place this morning—he knows that I mean that sincerely, because I also know how strongly he feels about the perils of no deal. I thank him for bringing the two draft statutory instruments before the Committee today and for summarising them so well for us.
On Tuesday, we were in Committee to scrutinise some other SIs, and I said that that was a very important day for our country but, as it turns out, the whole week is a very important week for our country. I am pleased that yesterday the House voted to take no deal off the table, although I am aware that does not guarantee it will not happen. However, we are only 15 days away from 29 March, and I am concerned that we are still hurtling towards leaving the European Union without a deal. I hope that tonight article 50 will be extended in order to give the Government more time to prepare, negotiate and provide those affected by these SIs, and all the others we have considered—such as industry and business—with more information about the impact that the changes will have on their day-to-day work.
As I have mentioned in my remarks in each SI Committee—I know that the Minister is probably sick of hearing this, although I try to say it differently each time—I regret that the Government are in this position and that they have run down the clock, achieving very little, as we have seen so far. We are now squeezing through very important legislation in such a short period—although, again, I recognise that that might be extended tonight—but as legislators, which we all are, we have a duty to scrutinise legislation effectively in order to protect the public. However, the Government have not given us enough time to do so effectively.
As the Minister is aware, Labour Members do not have access to the hordes of experts to whom the Government are privy, so I am literally drowning under the weight of all the SIs. I am sure he is, too, but he has a little more help than I do. Another batch of such SIs have been laid before the House this morning, to be dealt with on Monday, so there goes my weekend, and that of my small team. I know what we will be doing most of the time. That is another reason why an extension to article 50 would be welcome.
The health and safety of the public are of the utmost importance, which is why, although I recognise the need to transfer EU law into UK law, I have some questions for the Minister. I am sure that he will answer them in Committee if he can. I apologise in advance if he has already done so in his opening remarks, in which case he can skip answering them again. I have of course written my speech in advance, although I did try to cross out anything that he has already answered.
The draft regulations are a consequence of the UK’s decision to leave the EU, which will also result in our departure from the European Atomic Energy Community, or the Euratom treaty, which covers civil nuclear policy and legislation across the EU, including emergency response to nuclear incidents. Euratom reports to the International Atomic Energy Agency. Have the Government decided what the UK equivalent of Euratom will be, and how it will report to the IAEA?
The explanatory memorandum to the draft regulations on Chernobyl and Fukushima says:
“Where necessary, functions currently undertaken by for instance the European Commission...will be replaced by references to domestic risk management authorities.”
Who will the domestic risk management authorities be?
I am pleased that both explanatory memorandums to the SIs state that all rules will remain the same and that the maximum levels for radioactive contaminants in food will remain as they are now. Will that be kept under review? Will the UK continue to have conversations with the EU to keep the UK’s restrictions in line with the EU’s? If there is another incident—God forbid—on the same scale as Chernobyl and Fukushima, will the UK work with EU countries to mitigate the consequences for the public in this country?
The Minister has mentioned some dates: the retained EU legislation relating to food and feed from countries affected by the Chernobyl incident will expire on 31 March 2020, and the retained EU legislation relating to food and feed from Japan, following the Fukushima nuclear incident, will be reviewed by the Government before 30 June 2019. Will the Minister tell us if his Department has already made an assessment of whether the regulations should be extended? I am particularly concerned about legislation relating to food and feed from Japan, given how close that deadline is—it is only a couple of months away. If the legislation is to be extended or amended, will the Minister tell us how that would happen? Will it take place in a Delegated Legislation Committee such as this one?
The draft regulations on Chernobyl and Fukushima have an associated direct cost to businesses of £5.7 million. Will the Minister justify and explain that high cost? The explanatory memorandum also states that there will be no additional burdens on enforcement bodies. Does the Minister think that is a realistic assessment? Any changes must be clearly and effectively communicated to enforcement bodies, industry and businesses, to ensure that any changes are carried out smoothly. Protecting public health is of great importance and we must ensure that the changes protect members of the public. Any failure to do so may be a risk to UK consumers. I know that the Minister takes that point very seriously and wants to avoid such a risk, and that he will do all he can to mitigate that. I support him in that endeavour and I look forward to his response.
Draft Food and Feed (Chernobyl and Fukushima Restrictions) (EU Exit) Regulations 2019
Draft Food and Feed (Maximum Permitted Levels of Radioactive Contamination) (Amendment) (EU Exit) Regulations 2019
Sharon Hodgson Excerpts(7 years, 1 month ago)
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Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
It is a pleasure to serve under your chairmanship this morning, Mr Wilson.
I am genuinely pleased to see the Minister in his place this morning—he knows that I mean that sincerely, because I also know how strongly he feels about the perils of no deal. I thank him for bringing the two draft statutory instruments before the Committee today and for summarising them so well for us.
On Tuesday, we were in Committee to scrutinise some other SIs, and I said that that was a very important day for our country but, as it turns out, the whole week is a very important week for our country. I am pleased that yesterday the House voted to take no deal off the table, although I am aware that does not guarantee it will not happen. However, we are only 15 days away from 29 March, and I am concerned that we are still hurtling towards leaving the European Union without a deal. I hope that tonight article 50 will be extended in order to give the Government more time to prepare, negotiate and provide those affected by these SIs, and all the others we have considered—such as industry and business—with more information about the impact that the changes will have on their day-to-day work.
As I have mentioned in my remarks in each SI Committee—I know that the Minister is probably sick of hearing this, although I try to say it differently each time—I regret that the Government are in this position and that they have run down the clock, achieving very little, as we have seen so far. We are now squeezing through very important legislation in such a short period—although, again, I recognise that that might be extended tonight—but as legislators, which we all are, we have a duty to scrutinise legislation effectively in order to protect the public. However, the Government have not given us enough time to do so effectively.
As the Minister is aware, Labour Members do not have access to the hordes of experts to whom the Government are privy, so I am literally drowning under the weight of all the SIs. I am sure he is, too, but he has a little more help than I do. Another batch of such SIs have been laid before the House this morning, to be dealt with on Monday, so there goes my weekend, and that of my small team. I know what we will be doing most of the time. That is another reason why an extension to article 50 would be welcome.
The health and safety of the public are of the utmost importance, which is why, although I recognise the need to transfer EU law into UK law, I have some questions for the Minister. I am sure that he will answer them in Committee if he can. I apologise in advance if he has already done so in his opening remarks, in which case he can skip answering them again. I have of course written my speech in advance, although I did try to cross out anything that he has already answered.
The draft regulations are a consequence of the UK’s decision to leave the EU, which will also result in our departure from the European Atomic Energy Community, or the Euratom treaty, which covers civil nuclear policy and legislation across the EU, including emergency response to nuclear incidents. Euratom reports to the International Atomic Energy Agency. Have the Government decided what the UK equivalent of Euratom will be, and how it will report to the IAEA?
The explanatory memorandum to the draft regulations on Chernobyl and Fukushima says:
“Where necessary, functions currently undertaken by for instance the European Commission...will be replaced by references to domestic risk management authorities.”
Who will the domestic risk management authorities be?
I am pleased that both explanatory memorandums to the SIs state that all rules will remain the same and that the maximum levels for radioactive contaminants in food will remain as they are now. Will that be kept under review? Will the UK continue to have conversations with the EU to keep the UK’s restrictions in line with the EU’s? If there is another incident—God forbid—on the same scale as Chernobyl and Fukushima, will the UK work with EU countries to mitigate the consequences for the public in this country?
The Minister has mentioned some dates: the retained EU legislation relating to food and feed from countries affected by the Chernobyl incident will expire on 31 March 2020, and the retained EU legislation relating to food and feed from Japan, following the Fukushima nuclear incident, will be reviewed by the Government before 30 June 2019. Will the Minister tell us if his Department has already made an assessment of whether the regulations should be extended? I am particularly concerned about legislation relating to food and feed from Japan, given how close that deadline is—it is only a couple of months away. If the legislation is to be extended or amended, will the Minister tell us how that would happen? Will it take place in a Delegated Legislation Committee such as this one?
The draft regulations on Chernobyl and Fukushima have an associated direct cost to businesses of £5.7 million. Will the Minister justify and explain that high cost? The explanatory memorandum also states that there will be no additional burdens on enforcement bodies. Does the Minister think that is a realistic assessment? Any changes must be clearly and effectively communicated to enforcement bodies, industry and businesses, to ensure that any changes are carried out smoothly. Protecting public health is of great importance and we must ensure that the changes protect members of the public. Any failure to do so may be a risk to UK consumers. I know that the Minister takes that point very seriously and wants to avoid such a risk, and that he will do all he can to mitigate that. I support him in that endeavour and I look forward to his response.
Draft Food and Feed Imports (Amendment) (EU Exit) Regulations 2019
Draft Official Controls for Feed, Food and Animal Health and Welfare (Amendment Etc.) (EU Exit) Regulations 2019
Sharon Hodgson Excerpts(7 years, 1 month ago)
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Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
It is a pleasure to serve under your chairmanship again, Ms McDonagh, on this bright windy morning. I thank the Minister for bringing the two statutory instruments to the House today and for ably summarising them.
We are all aware that today is a very important day for our country. We are only 17 days from Brexit, yet MPs are just, tonight, getting the latest meaningful vote on the Prime Minister’s latest deal. I expect that not much, or perhaps not enough, will have changed; as the Minister said, we are waiting on the Attorney General’s judgment. This is all very concerning for millions of people up and down the country—concerns I know the Minister shares.
In the event of a no-deal Brexit—we might know in the next few days if that is what will happen—we need to be prepared, but as I have said throughout our consideration of these SIs, I regret that the Government have waited so long to prepare for no deal, given that it was the fallout position for if we did not get a deal. Regardless of how much scrutiny we give the legislation this morning, it is being rushed through. As legislators, we need two things: information and the time to process and scrutinise that information. Unfortunately, the Government have failed to provide MPs with either. I regret the way in which the Government have processed the legislation, but here we are.
Moving on to the SIs, food and feed law serves to protect public health, as well as animal health and welfare. I appreciate that that is a difficult balancing act, particularly in light of growing public concerns about where our food comes from. What conversations has the Minister been having with his colleagues in DEFRA about animal health and welfare, and its impact on our food?
In addition to ensuring human and animal health, the Government must provide continuity for business operators and trade. The Minister touched on that. Is he confident that the SIs will ensure that continuity? What conversations has his Department had with business operators and trade? Similarly, what conversations has his Department had with the scrutinising bodies that will take over the responsibilities of the EU bodies? Will the Minister please confirm which bodies will be doing that? Is he confident that they have adequate time and resources to provide a check and balance on food standards once we leave the EU?
The explanatory memorandum says that staff will need to familiarise themselves with the amendments. Is the Minister confident that the staff referred to in the memorandum have had all the information they require to do that?
Martin Whitfield
Originally, there was a reading time of less than 30 minutes, but following the consultation it was extended to not more than an hour. That has underpinned the financial implications of the statutory instruments. Does my hon. Friend agree that there seems to be an arbitrary take on the time it will take local authority officials and businesses to read the paperwork? When we have looked at it, it has certainly taken more than an hour to read, process and understand—if one is able to download it.
Mrs Hodgson
I agree with my hon. Friend. We debated that very point in some of last week’s Delegated Legislation Committees. I thought that perhaps I was a slow reader, as it took me considerably longer than 60 minutes not just to read it, but to try to understand and digest it. I recall the Minister saying last week that that time was just a guide, but I am sure he will address that point directly.
With that in mind, is the Department offering any support to scrutinising bodies to ensure that queries can be answered quickly and effectively? In the event of a no-deal Brexit, which none of us wants, there will be lots of new changes, so I hope that scrutinising bodies will be properly equipped to ensure that nothing is slipped through—chlorinated chicken, for example—that could cause harm later on. We need experts on the ground who are able to scrutinise and safeguard public health in the event of a no-deal Brexit.
Both statutory instruments cause fragmentation across the nations. Can the Minister tell the Committee when legislation will be made by the devolved Administrations? Has he had discussions with the devolved Administrations about these changes? Colleagues from all regions will be rightly concerned about the disparity that might be caused by the SIs.
The draft Food and Feed Imports (Amendment) (EU Exit) Regulations 2019 include an amendment to the Plastic Kitchenware (Conditions on Imports from China) (England) Regulations 2011. I am sure that there is plastic kitchenware from China in my kitchen and in all our kitchens. It would be difficult for there not to be, considering how much China produces. However, this seems entirely isolated from the rest of the measures in the SI. Will the Minister tell the Committee why those changes are being made in this SI? Is there something about Chinese plastic kitchenware that we need to watch out for? I certainly do not eat it.
The draft food and feed imports regulations state that functions currently undertaken by the European Commission on food controls will be the responsibility of the Secretary of State. Can the Minister provide information on how decisions on food controls will be made and managed? Who will advise the Secretary of State on those decisions? Imported food can be susceptible to known or emerging risks linked to specific food or feed of animal and non-animal origin. It is therefore important for human health and consumer trust that we get this right. Equally, consumer trust and consciousness mean that we cannot see a reduction in animal ethics.
I hope that the Minister can allay some of those concerns today, and I look forward to his response.
DRAFT GENERAL FOOD HYGIENE (AMENDMENT) (EU EXIT) REGULATIONS 2019
DRAFT CONTAMINANTS IN FOOD (AMENDMENT) (EU EXIT) REGULATIONS 2019
DRAFT SPECIFIC FOOD HYGIENE (AMENDMENT ETC.) (EU EXIT) REGULATIONS 2019
DRAFT GENERAL FOOD LAW (AMENDMENT ETC.) (EU EXIT) REGULATIONS 2019
Sharon Hodgson Excerpts(7 years, 2 months ago)
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Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
It is indeed a pleasure to serve under your chairmanship this morning, Ms McDonagh; I hope I give you no trouble.
I thank the Minister for providing a summary of these statutory instruments and for his letter in advance of the Committee, which gave me further details about them. As he has heard me say many times before, this is not the first group of no-deal SIs that we have debated. We are just 24 days away from Brexit day and are yet to agree a deal with the EU. I wonder when the Government might start to become concerned about the clock ticking down. I am greatly concerned, and I know that many others across the country are too. We do not have a deal yet, but we are rushing through so many statutory instruments in such a short period of time that it is deeply concerning for accountability and proper scrutiny. As legislators, we have to get it right, and I deeply regret that we have been put in this position by the Government, but here we are again.
The safety of our food is of the utmost importance to our health and wellbeing. We cannot get it wrong; food safety must be protected at all costs. There is also the element of consumer trust. We must not allow that to break down in any event, particularly if there is any relaxation of regulations, which I hope will not happen. I share the Government’s commitment to ensuring no change in the high-level principles underpinning the day-to-day functioning of the food safety and feed safety legal framework. Ensuring continuity for business and public health bodies is important in the interests of the public. As the Minister would expect, I have questions and concerns about these statutory instruments, which I will set out for the Committee.
When food is found to be unsafe for human consumption, we need a quick and effective mechanism to ensure that it is withdrawn from the market. In 2017 alone, the rapid alert system for food and feed issued more than 3,800 “original notifications”, of which 942 were classified as an alert. It is crucial that any food warnings are communicated quickly and effectively. Will the Minister revise the explanatory memorandum for the General Food Law (Amendment etc.) (EU Exit) Regulations 2019 and ensure that alternative arrangements are made to receive food safety warnings that are quick, clear and effective?
As a result of these regulations, the Food Standards Agency will have additional responsibilities in the result of a no-deal Brexit. I am aware of additional funding being made to the FSA, but is the Minister confident that it will have enough funding and staff to take on those additional responsibilities? Will he outline how many additional staff have already been recruited, when they started work and what roles they are currently undertaking? Will the FSA have the ability to work and communicate with European bodies to ensure that information and intelligence is shared?
Regulation 19(c) of the general food law regulations assigns the Secretary of State for Health and Social Care the power to make provisions considered “necessary or expedient”. Will the Minister say whether there will be any oversight over such decisions and whether the Secretary of State will justify any decisions made under those powers in the House?
All the regulations must be easily amendable, if and when necessary, to respond to any emerging threats or changes in safety standards, but I hope that any changes will be justified and overseen by the relevant bodies. What will the arrangements be for collecting data, monitoring the effectiveness of the regulations and regularly reporting? What bodies will be able to scrutinise performance and delivery, and what assessment has been made of their capacity to take on such work?
Concerns were expressed in the public consultation on these statutory instruments about the additional burden on industry and enforcement authorities to communicate changes. Will the Minister reassure me and the Committee that communications with respect to the proposals outlined in these SIs will be delivered with sufficient time to make the necessary preparations to minimise the impact of any changes?
Businesses and food business operators have raised concerns about the lack of information given to them, as well as about their own understanding of the information. Will the Government make their information clear to the public, and if so, when will they do this by? Sufficient transition periods will be required for these statutory instruments. Can the Minister provide some clarity on the transition periods that will be in place to assist businesses and industry in complying with any changes? The explanatory memorandum states that there will be
“an Equivalent Annual Net Direct Cost to Business…of…£600,000.”
Can the Minister explain how those costs will be accrued and by whom, and if they have been communicated to those affected?
Respondents to the consultation on the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 raised concerns about the cost of changing their labels. Some respondents estimated that that could cost between £200,000 to £500,000. Has the Minister made any assessment of the impact that that could have on businesses?
In the public consultations, local authorities expressed concerns about the need for them to make the required updates to legal references in official documents and online, which will take significant time and effort and will naturally have cost implications for local authorities, which is concerning in the light of budget cuts. Can the Minister confirm whether the Government will fund any additional burdens on local authorities, especially in the event of a no-deal Brexit?
It is estimated that it will take local authorities less than 60 minutes to read and familiarise themselves with the new regulations and to disseminate them to staff and keyholders—they must be able to read a lot faster than me. Is the Minister convinced that that is a realistic assessment?
Is the Minister confident that, from day one of Britain’s exit from the EU, the high standards of food safety will be maintained? Can he explain what implications a no-deal Brexit would have on the future monitoring of food safety standards and legislation in this country? As I have said, the safety of our food is hugely important and we cannot get it wrong.
Caroline Flint
Does my hon. Friend agree that if we agree a deal, there will be no change to any of the systems that we currently share and enjoy? Does she also agree that more should be said publicly about how many of the regulations that we enjoy and support in the House—I have sat on many of these Committees—will continue to be in place as we leave the EU?
Mrs Hodgson
I do apologise. If we leave with a deal, all this will have been for naught. We have some of the highest food standards and regulations, and they would continue to exist. That is all the more reason why it is such a disappointment to us all that we are at the eleventh hour and the 58th or 59th minute and we still do not have a deal. I sincerely hope that one is brought before the House next week that a majority of the House can vote for.
Craig Mackinlay (South Thanet) (Con)
I am sure the hon. Lady is aware that the pages of regulations that we are trying to transpose into UK law have never had parliamentary scrutiny. They are regulations, so as soon as the ink is dry in Brussels, they become the law of the land whether we like it or not, with no debate in this place. Uniquely, in future, we will have the opportunity to shape our regulations.
As the hon. Lady is aware, the EU operates a precautionary principle. Many think that the standards that come out of Brussels are somehow gold-plated holy writ, but she will be aware of the problems that we have faced in past years, such as the Fipronil scandal in August 2017, which affected eggs. That happened under the regulations that are meant to be the gold standard, but I certainly hope that the UK will be able to do better in future. Can she comment on the fundamental principle that it is better that this place decides food safety, rather than it being decided by regulations over which we have no authority?
The Chair
Order. I would like us to concentrate on the detail of the regulations, rather than straying into the territory of whether we should be leaving the EU.
Mrs Hodgson
With that advice in mind, Ms McDonagh, I would say that, given that the hon. Gentleman had quite a lot to say, perhaps he should have considered making a full speech and graced us with his further thoughts on these matters. I am sure that we would all have enjoyed that immensely. However, I disagree with the fundamental principle of what he said, which is that these regulations were passed in Europe with no scrutiny here.
As a new MP, as I am sure a number of us were at one time or another, I had the huge pleasure of serving on the European Scrutiny Committee. Week in, week out, we would be sent reams of documents containing EU directives and regulations that our esteemed Clerks would have rated as politically or financially sensitive. They gave us advice, but we had to read all those documents and sit and scrutinise them all, week in, week out. We could then refer them for further debate in a European Standing Committee or on the Floor of the House, if we thought something needed scrutiny. I know for a fact that we scrutinised all EU directives that came to this House. Nothing was passed without proper scrutiny. It is a shame the hon. Gentleman has not had a chance to serve on that Committee, because he might never get a chance.
Mrs Hodgson
Oh, he has; because I was going to say, the hon. Gentleman has missed a treat.
I hope the Minister will respond to my concerns, either now or in a letter. I know he always sends a letter if he is unable to respond on the day. I know, too, that many others, not only in this room but across the country, will be looking forward to his response.
Draft Nutrition (Amendment etc.) (EU Exit) Regulations 2019
Sharon Hodgson Excerpts(7 years, 2 months ago)
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Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
It is indeed a pleasure to serve under your chairmanship, Mr Evans, and to be here discussing this draft amending regulation. I thank the Minister for writing to me in advance and for his summary this morning. However, I have started all of my speeches on Brexit SIs with a caveat, and I will do so again this morning. I apologise for any repetition.
We are now just 29 days away from Brexit day, 29 March, as I am sure everyone is well aware. It is deeply concerning that we are still planning for a no-deal scenario when we are so close to the deadline. I know that we have many, many more public health SIs to get through in that time, and I am worried that we simply will not have enough time to prepare properly. I hope the Government will take no deal off the table.
I thank the Minister for his letter asking for my support on the regulations. He does have my support, but as always I have some questions, and as always I know he will try to answer them. The explanatory memorandum says that there will be a low level of impact on businesses, but no impact assessment has been made. It admits that there will be some additional administrative burden on businesses, but that it will only be an extra 30 minutes of additional paperwork for applications to make health claims in both the UK and the EU. Is the Minister convinced that that is a realistic assessment? The consultation response document says:
“Some respondents raised concern that the consultation under-estimated the additional burden caused for submitting a new claim.”
Has the Minister made any assessment of that since the consultation document was published?
The consultation document was published sooner than anticipated, and I thank the Minister for that, but I am concerned about how short the consultation period was—only 10 working days. I know that we are fast approaching Brexit, but allowing such a short time for businesses, stakeholders and the public to participate in a consultation is alarming, particularly when legislation is drafted as a result. If we are going to get no-deal planning right, we need more time and expertise to look into such detailed legislation.
Throughout the consultation response paper, it is clear that respondents wanted more detail from the Government. We need more detail on risk assessments, management processes and on how mirroring EU regulation would work in practice. The devil really is in the detail and the Government have failed to provide any detail at all. Will the Minister tell us when we will have that crucial detail at our fingertips? Concerns were also raised about integrated supply chains, particularly if the UK failed to be aligned with EU lists on product labelling. Will the Minister address those concerns?
The UK has a long tradition of collaboration with the European Food Safety Authority. Does the Government have a commitment to working with EFSA in the event of a no-deal Brexit? I know the Government are in the process of establishing the UK nutrition and health claims committee, the UKNHCC—not a very catchy acronym or easy to say. What relationship will EFSA have with the UKNHCC in the event of a no-deal Brexit?
Mr Goodwill
The hon. Lady is painting a grim picture of a no-deal Brexit. Surely it is within her power to vote for the deal on 12 March and take the instruction that 61% of the people in Sunderland gave her at the referendum?
Mrs Hodgson
I think the former Prime Minister, who has a very fancy hut where he is writing his memoirs, may be the one who started it, but perhaps it goes even further back than that. I will follow your advice, Mr Evans, and not get drawn into such a fascinating debate on who started it, and what we might be asked to vote for on 12 March, because we still do not know what that will be. I will tell the right hon. Gentleman my decision when I know what we are voting for.
There has been a recruitment process for that catchily-named organisation, the UKNHCC. If somebody could come up with a way to say that, that would be helpful, seeing as we could be talking about it in the future. When will the names of the members be made public? What will their expertise be? Will they be subject to any scrutiny?
Finally, I understand that we are only half implementing the Commission delegated regulation 2016/128. Most of that regulation, which relates to foods for special medical purposes, came into force in February 2019 and will be transferred into UK law, but the part that relates to food for special medical purposes developed to satisfy the nutritional requirements of infants will not apply until 22 February 2020. As a result, the UK will not implement that part of the regulation. Can the Minister confirm whether that is the case?
Page 35 of the regulations makes no reference to infants. Is that intentional, and can the Minister elaborate on what will happen to infants who need food for special medical purposes? If the UK does not implement that law, we will have different standards from the rest of the EU. Will that gap be bridged immediately?
Any changes to the legislation must be communicated effectively and in a timely manner to the agencies affected by the SI. As I said earlier, I am concerned that the clock is ticking much quicker than we would like. I hope therefore that the Minister will work urgently to ensure that any changes are made quickly and communicated clearly. With that, and without being drawn into a whole debate on Brexit, I look forward to hearing the Minister’s response.
Steve Brine
Maybe it is set in stone. Members can work out what I mean by that.
The hon. Lady asked lots of different questions. About the impact on business, we appreciate that there may be an additional administrative burden on companies that would have to submit claims to the UK and the EU if they wish to make the claim in both areas, but our intention is that procedures for submitting claims in the UK will closely follow those already in place for the EU. We have been in that family for some 40 plus years.
Leaving the European Union is a complex process, to put it mildly. It is not just about trade deals, reciprocal healthcare and citizens’ rights. It is about complex supply chains at every level of business, and there is a complex supply chain around nutrition regulation. It would be an act of foolishness on our part to diverge too far and we do not intend to do that. We estimate that the application paperwork should take only 30 minutes to complete, and rightly so.
In terms of future divergence with the EU, we will make sure that we continue to review the situation to make sure we stick to regulatory alignment with the EU, as deemed appropriate by the Government and ultimately by this House, which holds the Government to account. I am content, as is the Government, that the SI maintains regulatory standards and nutrition policy in a no-deal scenario, and therefore an impact assessment is not required. I have already said that businesses will have to spend a short time on administration.
We completed an equalities impact assessment. We found that the measures set out in the instrument do not have an impact on any of the protected characteristics as defined in the Equality Act 2010.
The hon. Lady asked why the consultation period was just 10 days. To be factual, it was not. It was 11 days—[Laughter.] That is #factualnews. A consultation’s duration is generally determined by the proposals it contains, and in this case we are proposing to mirror the existing regulatory regime as closely as possible, ensuring minimal disruption to business. With that in mind, we consider the consultation period to be entirely appropriate and in line with Cabinet Office consultation principles.
We received 31 responses to the consultation—a case of quality over quantity. We are pleased that they included responses from a broad spectrum of groups, including manufacturers, trade bodies, members of public and one local authority. The response was supportive of the proposals to mirror the existing regulatory framework, as I have already said. We are working with the Department for Business, Energy and Industrial Strategy’s business insight group—now there is a catchy title—to sight the industry on proposed guidance and to obtain its feedback.
Infants are deliberately not mentioned in the SI, because the issue does not apply on exit day. Our current policy intention is to make domestic legislation that is consistent with regulation 609/2013. That includes requirements for foods for special medical purposes developed to satisfy the nutritional needs of infants and for infant and follow-on formula, which are important. The Department will issue further advice on that once the EU exit position is clarified, which clearly is yet to happen.
I was asked whether the UK will continue to be a member of EFSA after we leave the EU. I have said no. The nature of our future relationship with EFSA will be subject to negotiation with the EU, and that is not just in terms of the withdrawal agreement. The SI provides for the appropriate expert committee—I appreciate that the acronym is not ideal—to assume EFSA’s functions in a no-deal scenario, which will guarantee certainty.
The hon. Member for Glasgow South West asked what will happen in relation to products banned in the EU after exit day. As I said in my opening remarks, products that EFSA approves after exit day will be for it to approve for the remaining member states. In terms of the relationship between our new committee and EFSA, we have a long tradition of close scientific collaboration with EFSA in this country. We value it greatly and very much hope and intend that to continue in the future. If EFSA makes a decision on a product, it would be most unlikely that our new committee, whatever it is called, would not take notice of that. We want to continue close regulatory alignment in this policy area so that the public have confidence and so that, returning to my first point, businesses do not face an undue burden in getting products covered in both areas.
Public Health England is in the process of recruiting specialist members for the UKNHCC, including the chair. The recruitment was open and transparent: it was advertised on gov.uk from 8 November to new year’s eve; high-calibre applications were received and the shortlisted candidates were interviewed last week. The committee is ready to come into effect if required. I do not have the names here, but I know that recommendations for appointments to the committee have been shared with the devolved Administrations. They have confirmed that they are content with the calibre and experience of the recommended individuals. Appointment letters will be issued shortly; once accepted, they will be published. I have already said I will publish that to members of the Committee.
Finally, guidance is being developed and tested with industry to ensure that it is fit for purpose, is closely aligned and clearly communicates to business any changes in the process that would occur in a no-deal scenario. That guidance will be published shortly—certainly before exit day, which we still hope will be 29 March.
Mrs Hodgson
On a point of clarity on the lack of mention of infants, I heard what the Minister said, but there is a lack of clarity on whether there will be a gap between the situation in the EU and the regulations here. Will that gap exist? Will there still be a difference? I know he is sort of saying that he cannot say what the position will be at the moment, but will he seek to ensure that there is no gap?
Steve Brine
Not only will I seek to ensure that there is no gap, but I will very much take that as feedback from Her Majesty’s Opposition on the regulations and ensure that it is fed through to the new committee as it is formed. I understand the concerns expressed by the hon. Lady and the Scottish National party spokesman in that regard.
Question put.
Exiting the European Union (Medicines)
Sharon Hodgson Excerpts(7 years, 2 months ago)
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Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
I thank the Minister for bringing this legislation to the Floor of the House and for providing us with a summary of it, which helped immensely. We are expecting many more health SIs in the weeks to come, so I must make it clear again, as I will in future, that it is incredibly concerning that we are now only 38 days away from 29 March and are still preparing for a no-deal Brexit. I hope that it does not come to that, but this has taken up a considerable amount of Parliament’s time and resources. My preferred scenario would have been one in which the Prime Minister did not run down the clock for two years, and especially now when we are getting closer and closer to Brexit day. I understand the need for “just in case” legislation, but we should have secured a deal by now.
Moving on to the legislation, clinical trials will probably not be in the forefront of people’s minds, but they are crucial for the safety and efficacy of medicines, as well as for our health and wellbeing. Medicine is not something that we should get wrong, but when we do, as in the case of Primodos, valproate and vaginal mesh as a surgical procedure, we must hold up our hands and take urgent action.
While this may not be the most eye-catching statutory instrument, it is hugely important. It is about patient safety and confidence. It would mean that in a no-deal scenario, the Medicines and Healthcare Products Regulatory Agency would be able to operate as a regulator outside the EU system and would therefore take on roles formerly conducted by the European Medicines Agency and through the wider EU regulatory framework. I must put on record my disappointment that the EMA is relocating from the UK to the Netherlands next month because of Brexit. Our loss is the Netherlands’ gain, but we should not have let it come to this. However, this SI means that in the event of a no-deal Brexit, the MHRA will be able to regulate clinical trials to ensure that they continue to operate effectively.
I want to ask the Minister for clarification on a few points. The new EU clinical trials regulation was introduced in April 2014 and was expected to come into force in October 2018. I understand that owing to technical issues that has now been delayed. The Government’s no-deal guidance says that
“we’ll align where possible with the CTR without delay when it does come into force in the EU”.
Will the Minister please restate that commitment to the House today?
If the UK does leave with a deal, which I hope we do, what will the arrangements be for the CTR and the UK? Could the UK, no longer being a part of the EMA, delay the availability of new medicines in the UK? I am aware of concerns raised that, because the UK will be seen as a smaller market for new drugs than the EU, companies will be more likely to prioritise the authorisation of new drugs in the EU rather than in the UK. Has the Minister made any assessment of this risk?
Will the Minister please tell the House what the implications of a no deal would be for clinical researchers who are EU nationals? Will the UK also be eligible for EU funding for clinical trials under a no-deal scenario? The UK is currently one of the largest recipients of funding for clinical trials, and I am concerned about the implications for future trials and opportunities. The MHRA will have the power to publish its own guidance on clinical trial applications and applications for an ethics committee opinion, as well as declarations of the end of clinical trials and the content of documents forming trial master files. Could the MHRA continue to work with EU states in order to keep regulation in line with the EU? Will the Minister review important details, such as ethics, where concerns are raised?
In July 2017, the then Health Minister, Lord O’Shaughnessy, said that in the event of a no deal the Government would ensure that any system put in place would not impose additional bureaucratic burdens. Can the Minister reaffirm this commitment today? I know that this instrument was subject to consultation and that because of concerns raised amendments were made. Will she please say whether any further amendments are expected and whether there will be further consultation? Finally, will she please confirm that any changes made by the instrument will be communicated effectively to stakeholders in a timely manner?
Oral Answers to Questions
Sharon Hodgson Excerpts(7 years, 2 months ago)
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Matt Hancock
It is being implemented as we speak. I am very happy to talk to my hon. Friend about when it will be rolled out in Colchester.
Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
I welcome the Government’s commitment to end the transmission of HIV in England by 2030. However, HIV reduction was not mentioned in either the prevention plan or the long-term plan. How will the Government reach that ambitious goal without a concerted and fully costed strategy?
Matt Hancock
We do have a concerted and fully costed strategy. Indeed, I have given the commitment of ending new AIDS cases by 2030 with a plan around that. The long-term plan goes into detail about new ways of commissioning sexual health services. This is a very important area, and, as the hon. Lady says, it is an important part of the prevention agenda, and we will make sure that we get it right.