Antimicrobial Resistance

Baroness Walmsley Excerpts
Thursday 2nd May 2019

(5 years, 6 months ago)

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Baroness Walmsley Portrait Baroness Walmsley (LD)
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My Lords, I too thank the noble Lord, Lord Lansley, for giving us the opportunity to talk about antimicrobial resistance, because, as we have heard, it is one of the world’s most difficult and dangerous health challenges. It could put back the clock and make many of the treatments which we take for granted, such as the surgery undergone by the noble Lord, Lord Crathorne, far too risky in future.

It is not often that you read a book by an eminent doctor whose findings not only scare you but had obviously scared them too. However, that is what I found when I recently read the book about AMR by the Chief Medical Officer, Professor Dame Sally Davies. Near the beginning of the book she says that the findings of the group of experts she brought together were simple: first, we are losing the battle against infectious diseases; secondly, bacteria are fighting back and becoming resistant to modern medicine; and, thirdly, in short, the drugs no longer work. She admitted to feeling rattled about that, and so am I. Therefore, I congratulate the Government on the latest iteration of their comprehensive plan to tackle AMR, and welcome the fact that the plan outlines actions to control AMR both within and beyond our borders. I also welcome the fact that the plan for the next five years has brought the four nations of the UK together, unlike the previous version.

One principle of the plan is reducing the need for using antimicrobials to limit the opportunity for microorganisms to evolve resistance to them. I will mention three ways of reducing the need for these medicines: immunising the population against the diseases that might require such treatment; tackling the spread of infection; strengthening the natural immunity of patients and supporting their general health so that they can fight off infections themselves.

Vaccines are of course the most effective preventive health tool in human history, and have been able to eradicate entire diseases such as smallpox. As the noble Baroness, Lady Greengross, mentioned, expanding the use of existing vaccines would have a major impact. For example, universal coverage of children by the pneumococcal vaccine would avert 11.4 million days of antibiotic use in children under five each year. However, we also need new vaccines, but no new class of vaccines has been discovered in decades.

The noble Lord, Lord Lansley, was absolutely right to focus on money. There are major financial barriers in the way of developing new antimicrobials. It is now five years since the Health and Social Care Committee in another place urged,

“tangible and rapid progress in this area within six months”.

However, as the House has heard, in the last few years, since discussions have been ongoing between the industry and the Government about the deterrent effect of the current funding model, three multinational pharmaceutical companies have left the market. Significant government investment is also needed in novel vaccine research, to tackle an increasingly urgent global problem.

Although the UK cannot rescue the situation alone, the unique nature of the NHS gives us the opportunity to demonstrate a new funding model that could work for both of these groups of pharmaceuticals and set an example to other countries. I was therefore pleased to see that the Government and the industry have agreed a new funding model for antimicrobial development and supply that will provide more stable income to the companies, while providing the NHS with novel antimicrobials which can be held in reserve by doctors for use when older, cheaper medicines no longer work because resistance to them has been developed. I understand that the new model will delink the payments made to companies from the volumes of antibiotics sold, basing the payment instead on a NICE-led assessment of the value of the medicines and supporting good stewardship.

When will the Minister be able to report on the timeline for the full implementation of this pilot scheme and how will the Government assess whether it has been a success? Will the new model also be used to fund the development of new vaccines, many of which are badly needed in countries that cannot afford to develop them themselves but which are often the source of infection outbreaks in this country?

Infections are spread around the population by many means, via water, food, air droplets and poor sanitation, and we are fortunate in this country on most of those issues. However, what should be most easily prevented are those infections acquired in healthcare settings. This is particularly dangerous because patients are at their most vulnerable and may have compromised immune systems. Healthcare-acquired infections are among the most serious modern public health problems worldwide and many are caused by antibiotic-resistant bacteria, so effective HAI management is vital to slowing the AMR crisis. It is therefore critical that the NHS puts in place system-wide processes, such as screening and surveillance programmes, and the highest possible level of hospital hygiene and sterile practice that can help tackle HAIs and reduce their incidence. The Government must also maintain their focus on HAIs to ensure that infection rates, which have been falling, do not start to rise again. Unfortunately, they have now plateaued.

Across the NHS, there is regional variation in hospital-acquired infection rates. According to freedom of information data, almost two-thirds of hospitals do not offer point-of-care testing, a tool that could help provide real-time information on patients for a range of infections. Only eight out of 50 trusts routinely carry out point-of-care testing for infections such as flu, and less than 10% of trusts test for a full range of infections, such as MRSA and others. Some trusts consistently appear among the best, and some consistently among the worst, for reported cases. Of course, one has to ask whether these trusts have better or worse reporting mechanisms, or whether they have more or fewer cases to deal with. But whatever the answer, can the Government assure me that the focus is still on getting these figures down? Personally, I would be very reluctant to go into a hospital with a poor record on this.

Optimising use—for which read “reducing unnecessary prescribing”—requires both public and medical education. Patients need to know that it is sometimes for their own benefit when their doctor tells them they do not need antibiotics but advises them instead to go home, rest and take plenty of fluids, and not to go to work or school and spread it around. On a system-wide basis we need to be able to report on the percentage of prescriptions supported by either a diagnostic test or a decision support tool. There is a target for this in the plan. Will the Minister say whether there are online learning packages and easily available diagnostic tools, so that GPs can be supported to make the optimum decisions about prescribing?

We should not ignore the potential of strengthening patients’ own ability to fight off infection without the use of antimicrobials. Malnutrition can reduce the body’s own defences, and it is a disgraceful fact that there is malnutrition among the poorer sections of the UK population today, particularly among children and older people. I have even heard of malnutrition among long-term hospital patients because of the poor quantity and/or quality of hospital food, or the fact that no attempt is made to ensure that the patient eats it. This factor cannot be ignored when considering how we can reduce the spread of disease. Will the Minister say what action is being taken to tackle malnutrition?

Another aspect of boosting natural immunity—mentioned, I think, by the noble Baroness, Lady Masham —is the role of microbiome; that is the 39 trillion microorganisms that occupy our bodies. Of course, some can be harmful, but the majority contribute to health. There is some evidence that a healthy, varied gut microbiota can have a beneficial effect on our immune system. Specific bacteria in the gut have been associated with immune development, and we know that germ-free mice have less well developed immune cells. Altered populations of bacteria are associated with a host of diseases, from allergy, asthma, autoimmunity and neurodegenerative diseases to obesity. However, we probably still do not fully understand which specific bacteria are important for health. A better understanding of the community of bacteria that affect our health is needed. This is a promising area of research, so will the Minister tell the House whether the Government are investing in research into the contribution the microbiome can make, particularly to immunity against infectious diseases?

NHS Mandate

Baroness Walmsley Excerpts
Thursday 25th April 2019

(5 years, 7 months ago)

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Baroness Blackwood of North Oxford Portrait Baroness Blackwood of North Oxford
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I thank the noble Baroness for her question. I refer to the comments by Simon Stevens in the PAC yesterday, when he laid out how he sees the situation for the NHS:

“We have an agreed direction in the long-term plan … We have the budget set for the next year, and we have the NHS annual planning process … wrapped up. 2019-20 is … a transition year into stepping into the new five-year long-term plan”.


As the noble Baroness knows, planning guidance for 2019-20 was updated in January when the long-term plan was published. For all practical purposes, this document sets the decision-making for local NHS decision-makers during this year. The national implementation programme for the long-term plan, which will set the longer-term milestones for delivery of the plan until 2023-24, will be published at the end of this year. The mandate and its accountability framework is an important accountability mechanism and strategy document for the NHS. It is taking longer partly because of the close working of NHSE and NHSI and the transitional nature of this year.

It is important that this document does come out, for the purposes of strategy and accountability, but it is most important that it is got right. That is why it is taking slightly longer. I look forward to the debate this House will have when it is published. I am sure that the noble Baroness will hold us to account in the usual manner.

Baroness Walmsley Portrait Baroness Walmsley (LD)
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My Lords, I am very sorry that the Minister has been forced to give such an innocuous Answer on such a very important issue. We are awaiting not only the mandate but the workforce plan, and we have long awaited the social care Green Paper. Is the department still busy recruiting around the world to replace positions that are being vacated by staff from the EU—who are either going home or not coming here in the first place—or is there some other reason? I would have been much more reassured if the Answer had told us that the department is discussing with other departments across government the social determinants of health and how addressing those will help make the NHS much more sustainable in the near future. Can the Minister rescue this innocuous Answer by assuring the House that those discussions are taking place?

Baroness Blackwood of North Oxford Portrait Baroness Blackwood of North Oxford
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The noble Baroness is absolutely right that there is cross-departmental relevance to both the social care Green Paper and the workforce strategy. She will know that the long-term plan and the forthcoming Green Paper on social care have been developed in tandem. A number of reforms were already set out in the long-term plan, including the enhanced health and care homes model, which will of course involve MHCLG; the comprehensive model for personalised care, which will involve the personalised health budgets; and of course local health and care plans, which will simplify healthcare systems. We are looking forward to the Green Paper being published in full and I am sure that she will want to hold me to account on that in this Chamber. I look forward to that moment with great anticipation.

Of course, the workforce plan and HEE’s budget are also a matter for cross-departmental debate, as is the spending review, which is another reason why a lot of work is going into this. Again, it is important that this work is done to get it exactly right. The principles on which that work must be done are to consider multi-year funding plans for clinical training places based on the workforce requirements of the NHS going forward.

Access to Medicinal Cannabis

Baroness Walmsley Excerpts
Tuesday 9th April 2019

(5 years, 7 months ago)

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Baroness Blackwood of North Oxford Portrait Baroness Blackwood of North Oxford
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I thank the noble Lord for his question. The Secretary of State has asked NHS England to act with the utmost urgency and to bring responses forward quickly. I note that this comes in addition to the HEE training model and the NHS England and BSA system to monitor prescriptions for cannabis products. We expect results from that data this month, so we expect more action imminently.

Baroness Walmsley Portrait Baroness Walmsley (LD)
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My Lords, I thank the Minister for the action she is taking. I have some specific questions about what she said. Can she confirm that the second opinion she mentioned will come from a doctor with an appropriate understanding of the safety and effectiveness of these drugs, and that it will be available to all patients in the same situation? Secondly, she mentioned the British Paediatric Neurology Association’s interim clinical guidance, which was made very much as a snap judgment straight after the rescheduling last November; in effect, it just said, “No, no, no”. Can the Minister encourage the BPNA to consider further the massive amount of evidence from abroad and produce more considered guidance? Thirdly, she mentioned the 80 prescriptions for CBD medicines, but that does not strike me as making much progress, because you can get CBD legally on the internet; the only advantage of such prescriptions is getting the drug for free. The issue concerns medicines containing THC, which are the ones that patients desperately need. Finally, the Minister will probably find that trusts are stopping doctors who would like to prescribe these medicines from doing so. Getting the NICE guidance a lot sooner than next autumn would probably encourage trusts to allow their employees to do so. Can she encourage NICE to hurry up, please?

Baroness Blackwood of North Oxford Portrait Baroness Blackwood of North Oxford
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I thank the noble Baroness for her question, and I know that she has campaigned on this issue for some time. NHS England has clarified that clinical guidance does not remove or replace the clinical discretion of the prescriber to act. I know that the process review will look at the impact of clinical guidance, which will hopefully be helpful. We will also look at the role of second opinions. I hope that that has answered some of the noble Baroness’s questions; she made a number of points, and I will write to her on the rest.

Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019

Baroness Walmsley Excerpts
Tuesday 9th April 2019

(5 years, 7 months ago)

Lords Chamber
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Baroness Walmsley Portrait Baroness Walmsley (LD)
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My Lords, I too thank the Minister for repeating the information that has been debated already in another place. I share most of the concerns of the noble Baroness, Lady Wheeler, particularly those about the resourcing and training of the FSA and local authorities. In fact, I expressed those concerns in debates on every single SI in this group which were responded to either by the Minister or by the noble Baroness, Lady Manzoor, so I will not repeat them. However, I still have concerns about the fact that an organisation that has been so minimally resourced until now will take on such enormous responsibilities in the future.

We are now three days away from the current exit day from the European Union. Like the noble Lord, Lord Robertson, I have a birthday on Friday and I very much hope to have the best possible birthday present when we do not leave the European Union it would be the worst possible one if we do. However, the proximity to Friday is particularly relevant to this SI because of the delay in putting it before the House. It occurs to me that there will be a lag between possible exit on Friday and the coming into force of this instrument. What effect will that have?

Vaccine Hesitancy

Baroness Walmsley Excerpts
Monday 1st April 2019

(5 years, 7 months ago)

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Baroness Blackwood of North Oxford Portrait Baroness Blackwood of North Oxford
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I thank the noble Lord for an important question. The UK has one of the most sophisticated vaccination programmes in the world and we constantly guard against threats that may reduce vaccination rates. I am pleased to say that 93% of parents trust NHS staff and advice. The Government recognise the threat posed by disinformation and the upcoming online harms White Paper will set out a new framework for tackling this. PHE’s monitoring data on patient and public trust, however, shows that there is no loss of trust in vaccination, which is to be welcomed. On compulsory vaccination, vaccination programmes in the UK currently operate, like all other medical care, on a system of informed consent. At the moment there is little evidence that compulsion would lead to an increased uptake and so the Government have no plans to introduce such a system but instead intend to work with those who have concerns about vaccination.

Baroness Walmsley Portrait Baroness Walmsley (LD)
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My Lords, any distrust of experts sends out a terrible message to all those young people who spend years of study and thousands of pounds becoming experts. Does not our education system fail unless it produces a population who can properly interrogate scientific evidence?

Baroness Blackwood of North Oxford Portrait Baroness Blackwood of North Oxford
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The noble Baroness is right that we should have great confidence in experts and ensure that young people coming through our education system have that same confidence. This is why we can be proud of the high uptake of vaccinations in this country. A number of key components have achieved the high coverage of vaccination. They include national co-ordination of our vaccination programmes, fully trained staff and access to relevant information. We must ensure that this continues so that high level of confidence among parents and patients continues.

Brexit: Import of Radioisotopes

Baroness Walmsley Excerpts
Thursday 7th March 2019

(5 years, 8 months ago)

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Baroness Blackwood of North Oxford Portrait Baroness Blackwood of North Oxford
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I thank the noble Baroness for this. It is a very important question that she has raised. The Government’s first priority is to ensure continuity of care and patient safety, no matter the outcome of EU exit. That is why we have been putting important medical supply and contingency plans in place for the unlikely event of a no deal, even though that is not the Government’s plan.

The guidelines issued by the Royal College of Radiologists were in response to the plans from two major suppliers, representing at least 80% of the market, which have arranged contracts for air freight capacity to commence this month for the supply of radioisotopes. It is important to note that many isotopes already use air freight, and their deliveries will see no change in their arrival arrangements. Of course, the supply in these routes is relevant because radioisotopic materials have a short half-life, and therefore these changes, although minor, will have an impact on clinical pathways.

It is absolutely right for the Royal College of Radiologists to put some guidelines in place, and we have been working closely with it, the Department of Health and NHS England to offer clinics practical advice in allowing adjustment in their clinical processes. We do not expect any patient harm to arise from this, and the changes in clinical pathways and practice are expected to be minor and short-lived. We do not expect any delays or increased waiting times to arise from this; this is straightforward, practical advice to support clinics in adapting to changes in delivery times.

I hope that is a reassuring Answer for the noble Baroness, and that it has clarified what was, I think, some sensationalist media reporting of the advice.

Baroness Walmsley Portrait Baroness Walmsley (LD)
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My Lords, it is not this House that needs reassurance but doctors and consultants, who are feeling the need to reduce their treatment lists next month because they simply do not trust the Prime Minister to avoid a no-deal Brexit. The reason for that is because she adamantly refuses to take it off the table, despite the fact that, as a negotiating tool, it is about as much use as a chocolate fireguard. The other side knows that she cannot use it; when will she take off the blinkers?

Baroness Blackwood of North Oxford Portrait Baroness Blackwood of North Oxford
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I thank the noble Baroness for her question. This advice has come not from the Prime Minister, but from the Royal College of Radiologists. On the basis of that advice, we know that many services will be unaffected. For other services, the NHS is already working closely with suppliers to minimise the impact of changes to medical radioisotope delivery times, which are expected to be a matter of hours and easily managed by clinics. But it is appropriate that they should be given sensible and practical advice to ensure that patients are protected and that patient safety is maintained to the highest possible standards.

General Food Law (Amendment etc.) (EU Exit) Regulations 2019

Baroness Walmsley Excerpts
Wednesday 6th March 2019

(5 years, 8 months ago)

Grand Committee
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Baroness Blackwood of North Oxford Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
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My Lords, I thank noble Lords for their consideration of the draft regulations—the General Food Law (Amendment etc.) (EU Exit) Regulations 2019, the General Food Hygiene (Amendment) (EU Exit) Regulations 2019, the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 and the Contaminants in Food (Amendment) (EU Exit) Regulations 2019.

The Government’s priority is to ensure that the high standards of food safety and consumer protection we enjoy in this country are maintained when the UK leaves the European Union. These instruments are crucial to meeting our objective of a functioning statute book on exit. They are made under the powers in the European Union (Withdrawal) Act 2018 to make necessary amendments to the overarching food regulations so that we can continue to protect public health from risks that may arise in connection with the consumption of food. These instruments correct deficiencies in those regulations.

I wish to be clear that no policy changes are made through these instruments, nor is there any intention to make any at present. These instruments propose a transfer of responsibilities to UK entities to support a UK-centric regulatory regime. Responsibilities incumbent on the European Commission are designated to Ministers in England, Wales and Scotland, and to the devolved authority in Northern Ireland.

The European Food Safety Authority, EFSA, is the EU body that provides scientific advice on food safety. These regulations designate EFSA responsibilities to the food safety authority. This will be the Food Standards Agency, the FSA, in England, Wales and Northern Ireland, and Food Standards Scotland, which has a close working relationship with the FSA. The draft instruments being considered today will ensure that the following key EU regulations on food and feed safety and hygiene will function effectively on exit day.

Regulation 178/2002 lays down the fundamental principles that underpin food law and the essential requirements that food and feed businesses must comply with, as well as describing certain functions to be carried out by EU institutions. A key principle set out in the legislation is that food placed on the market must be safe to eat. It also provides for other fundamental safety and hygiene requirements, including rules and expectations on traceability. It establishes a requirement for open and transparent public consultation if food law is revised.

Regulation 852/2004 contains the basic food hygiene requirements for all food businesses. It sets out the general requirements for the hygienic production of foodstuffs through the provision of effective and proportionate controls throughout the food chain to the final consumer.

Regulation 853/2004 relates to the specific hygiene rules for products of animal origin, and Regulation 854/2004 relates to the organisation of official controls for products of animal origin. These specific hygiene rules set out the requirements and specific health standards for establishments on land or at sea for slaughtering, processing, storing or transporting products of animal origin.

The regulations on chemical contaminants protect consumers by ensuring that they are protected from the adverse effects of exposure to contaminants that may be present in food. Chemical contaminants may be present in food from the environment or as a result of growing conditions. The legislation sets out maximum limits for certain contaminants in food and provides a clear legal basis on which enforcement action may be taken, where necessary, to protect consumers by facilitating the removal of unsafe food from the food chain.

These instruments do not introduce any changes in how food businesses are regulated or managed. They do not introduce extra burdens and therefore provide continuity and clarity for businesses and continued protection of consumers’ interests. It also means that non-compliances can continue to be addressed in the same way. These will ensure a robust system of controls that will also underpin UK businesses’ ability to trade both domestically and internationally.

It is also important to note that the devolved Administrations have provided their consent for these instruments. Furthermore, we have engaged positively with the devolved Administrations throughout the development of these instruments. This ongoing engagement has been warmly welcomed. A full public consultation indicated support for the proposed approach to retained EU law for food and feed safety and hygiene. These instruments therefore constitute a necessary measure to ensure that the important food safety regulations will continue to work effectively after exit day. On that basis, I beg to move.

Baroness Walmsley Portrait Baroness Walmsley (LD)
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My Lords, I thank the Minister for introducing these SIs, which replace references to the EU in regulations with references to the UK, and as such are relatively innocuous. The first question I want to ask was raised in Grand Committee last Wednesday by the noble Lord, Lord Rooker, who is in his place. Is the Minister satisfied that all relevant regulations on these important food safety matters have been copied over into the SIs we are discussing today? The noble Lord found some SIs where some important matters had not been copied over. Perhaps he has spotted something which I have not in these regulations, and we will hear from him in due course.

Secondly, the general food law SI, the general food hygiene SI and the contaminants in food SI allow only one hour for a single officer in a local authority to familiarise himself or herself with the new regulations and disseminate the information to staff and stakeholders. I wonder whether it is a coincidence that they will have to do it on April Fools’ Day, the first working day after Brexit. The problem is that cuts to local authority funding have meant that some authorities no longer have any full-time food and feed officers to take charge on this issue, so who is going to do it, and who is going to pay for it? How can they do it in only one hour? Is this not just a covert way of ensuring that an impact assessment does not need to be produced? All those who responded to the consultation claimed that this cannot be done in so short a time and will certainly cost more than the Government estimate, and the Government have not offered to cover these costs. How did the Government reach the conclusion that the implementation time for businesses would be so staggeringly short?

The food hygiene SI allows a 21-month implementation period for food labelling changes from EU to GB or UK, but even here, the industry has concerns that some small businesses may struggle to comply. Other respondents to the consultation raised concerns that a common framework across the whole of the UK has not been properly addressed. The NFU pointed out that some farm holdings cross borders and animal feed moves across the Welsh and Scottish borders frequently. Is the Minister satisfied that devolution issues have been settled to the satisfaction of the Welsh and Scottish Governments?

Thirdly, can the FSA and its Scottish equivalent, the FSS, fulfil their additional responsibilities? Do they have enough staff and resources? Can the Minister respond to these concerns? Other respondents are concerned about how the Government intend to provide a suitable replacement for the risk-management function for food safety currently undertaken by the European Food Safety Authority. Can the Minister say what is being done about this? The whole of the food safety regime is based on risk management, and it is far from clear who will be responsible for this after Brexit and whether they have adequate resources. The National Pig Association is keen to retain a close working relationship with the EFSA to ensure that we in the UK receive food problem alerts in good time to take effective protective action against livestock diseases coming to us from the continent. This will also be a concern for other livestock producers. Can the Minister say what arrangements for this have been put in place?

I hope I will be forgiven for straying slightly beyond these SIs to some relevant matters, and I hope the Minister will find my comments useful for the future. If we are to leave the EU, the Government have always said that there is no danger of reducing our food standards and that, on the contrary, it gives us an opportunity to improve them. That is why I am surprised we have heard nothing yet of the Government’s plans to do that. One thing I would have wanted to improve in the common agricultural policy is to link food production and trade policies to the better dietary health of the European population. So here is a challenge for the British Government. They can start with two things, which I put down as markers for the future. First, they should ban the use of nitrites in processed meats, such as bacon and ham, in favour of other processes which have not been designated as carcinogenic by the World Health Organization, as nitrites have been, but which preserve meat just as well and protect it from botulism just as effectively.

Secondly, they should introduce supply-side regulations to reduce the UK population’s intake of free sugars by two-thirds to comply with the Scientific Advisory Committee on Nutrition’s recommendations, which make clear that overconsumption of sugar is responsible for the crisis of obesity, diabetes and all their associated preventable diseases, and for tooth decay in children, which is responsible for most of their hospital stays. Agricultural and trade policy are central to the supply of sugar, and amendments could be effective in changing the market for sugar before it even reaches the consumer. Reformulation programmes, sugary drinks tax and nudges towards behaviour change have their place, but we could make a greater and faster change if we addressed the supply side.

Once they have got all the relevant SIs about retained EU law through Parliament, will the Government look at these two opportunities as a matter of urgency? Has the Minister had any discussions or made any representations from her department to the rest of Government about such measures, as we move into the years after Brexit?

Lord Rooker Portrait Lord Rooker (Lab)
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My Lords, this is my first opportunity to welcome the Minister and congratulate her on her government appointment. I sincerely wish her well for the future.

As for interests to declare, I recently chaired an egg summit for the largest retailer in the country, which is in the register, and of course at one time, along with the noble Lord, Lord Krebs, who is in his place, I was chair of the Food Standards Agency. Before that, I was one of the last food safety Ministers, so I go back a little bit. This is my guest appearance only, at the personal invitation of my noble friends Lady Jones and Lady Smith; if the party leadership find out about it I will be in real trouble, although I can say that I am speaking for myself today since there is nobody else here from the Labour Party. I serve on Sub-Committee B of the Lords process for Brexit. We deal with all the FSA SIs as they come through. That was agreed simply because the chair is my noble friend Lord Cunningham, who was the Minister at the MAFF when we started work on setting up the FSA. I also sit on the Lords environment sub-committee. This morning we had the pleasure of having the chair of the Food Standards Agency and the Minister’s colleague, the Minister for Public Health and Primary Care, with us for an hour to discuss risk assessment and risk management post Brexit.

We are at one with these regulations. I am not going to waste the time of the Minister or of officials with details on the regulations. They provide continuity for people in terms of public health, the legal framework stays the same and there should be no problem with businesses. We were given quite good commitments in public this morning in terms of resources both for the Scottish end and the FSA, dealing with the rest of Great Britain and Northern Ireland, and therefore I do not want to duplicate everything.

There is one area which the Minister and officials might want to take away for the future. There is a lot of concern about local authority performance, and in terms of inspections there is no question about that. Environmental health officers are the unsung heroes of food safety. They do the takeaways and all the bits that people do not normally think about, but that is not politically sexy for councillors, to be honest, and therefore it is one of the first things they will go for chopping. Of course, without them, in terms of managing the situation, the FSA is powerless, because of lack of information.

Cannabis: Medicinal Use

Baroness Walmsley Excerpts
Monday 4th March 2019

(5 years, 8 months ago)

Lords Chamber
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Baroness Walmsley Portrait Baroness Walmsley (LD)
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My Lords, when the Chief Medical Officer recommended that cannabis medicines be rescheduled, she produced a report showing that the most rigorous regulatory authorities in the world—those in the US, Australia and Ireland, as well as the World Health Organization—had strong evidence of the benefits of cannabis-based medicines for people with epilepsy. In light of that, it is completely unacceptable that only four licences have been granted. Why are UK patients being deprived of these safe and effective medicines which have fewer side-effects than some licensed pharmaceuticals, such as sodium valproate?

Baroness Blackwood of North Oxford Portrait Baroness Blackwood of North Oxford
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I do not accept the characterisation that the noble Baroness has just given. UK patients are not being denied access to these medications; they are able to access medication via prescription from a doctor who is on the specialist medical register. The Government have acted fast on the review of the best clinical evidence and we are going further with forthcoming NICE guidelines and a Health Education England training package to raise even more awareness.

Safety of Medicines and Medical Devices

Baroness Walmsley Excerpts
Thursday 28th February 2019

(5 years, 8 months ago)

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Baroness Walmsley Portrait Baroness Walmsley (LD)
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My Lords, I also congratulate the noble Lord, Lord O’Shaughnessy, on achieving this debate and on his passionate opening speech. There can be no greater issue in relation to medicines and medical devices, apart from whether they work, than whether they are safe. I hope that the House will not be bored by the fact I agree with him, as I agree with the noble Lord, Lord Hunt. I will focus on similar issues but I also want to talk about the role of community pharmacies in ensuring the safe and cost-effective use of medicines and medical devices.

As we know, sodium valproate is a medicine prescribed for certain kinds of epilepsy and bipolar disease, and we know about the dreadful rates of birth defects in the babies of women taking these medicines during pregnancy. Despite the fact that clinicians were advised to prescribe valproate only to patients who had effective contraception and for whom no other medicine worked, and guidance was given about patient information and consent, questions arise about whether that is happening. In October 2016, a group of epilepsy charities surveyed nearly 3,000 women and reported that 20% of those who were taking sodium valproate were not aware of the risks in pregnancy. The survey was repeated a year later, when it was found that 18% of women taking the drug still did not know the risks, and 28% of women said that they had not been informed of the risks in pregnancy despite the availability of the MHRA toolkit produced in February 2016. More than two-thirds of women taking sodium valproate said that they have not received the toolkit. Philip Lee, the chief executive of Epilepsy Action, is calling for a mandatory discussion of the risks with a health professional for all women with epilepsy on valproate so that they can make informed choices before they conceive. Does the Minister agree with that?

On 30 November 2016, in answer to a question from my right honourable friend Norman Lamb MP in another place, the Minister in her former incarnation said:

“In order to monitor the effectiveness of the valproate toolkit, the MHRA has sought feedback from all stakeholders and will continue to work with the Royal Colleges, professional bodies, patient groups and relevant charities to increase awareness of the toolkit among general practitioners, pharmacists and patients. The MHRA’s current priority is working to ensure that women taking valproate are fully aware of the risks in pregnancy”.


Can the Minister now say what percentage of women taking valproate are receiving the MHRA materials? That is absolutely crucial to their informed decision. In addition, what lessons have been learned about how effectively to cascade down information and materials produced centrally? If they are produced centrally, however good they are, they are no use at all unless they get to the patients.

I turn from one medicine with considerable risks that have not been sufficiently taken into account to others for epilepsy where the risks are very low, as has been proved in other countries, yet their accessibility for patients with epilepsy in this country is not very good. I am talking about cannabis-based medicines, which, despite the change in their regulatory position last year, are still not getting to adults and children with epilepsy and other conditions which could benefit from them. Can the Minister update us on that?

The other issue mentioned by the noble Lord, Lord Hunt, is the use of vaginal mesh for pelvic organ prolapse. He is absolutely right: the NHS was very slow to listen to patients with complications after surgery and options were not available to them. Eventually, the Mesh Oversight Group was set up, which consisted of relevant professionals but, crucially, also included patients. One of its recommendations was addressing the knowledge of GPs, because it is to GPs that women go first. They go to GPs when they first realise that they may have a prolapse but, after the surgery, they go back to the GP when they feel that they have complications. The problem is that GPs do not necessarily realise what the cause might be.

As the noble Lord, Lord Hunt, mentioned, this report has particular focus on women who have developed complications. It is very important that they have access to specialist centres with multidisciplinary teams able to advise them and treat complications. I support the call of the noble Lord, Lord O’Shaughnessy, for those to become specialised commissioned hospital services. The Royal College of Surgeons, in its rather late briefing for this debate, also called for clinical trials and traceability by barcoding for all medical devices for implantation. That is important across a wide range. Can the Minister update us on the progress of those recommendations and tell us what lessons have been learned about patient involvement in policy-making? Finally, can the Minister or the noble Baroness, Lady Cumberlege, tell us about the progress of the Cumberlege review?

Given the shortage of time that GPs have to spend with their patients, community pharmacies have a big role to play in ensuring safe and cost-effective use of medicines. The New Medicine Service provides support to patients who have been newly prescribed medicines for long-term conditions. It is intended to improve medicines adherence and is focused on a small range of conditions. It has been assessed on its effectiveness and come out very well, but pharmacists are now suggesting that the service should be extended into other medical conditions where there is significantly poor adherence to the medicines regime. Is that proven intervention to be extended to other medical conditions?

Mental Health: Eating Disorders

Baroness Walmsley Excerpts
Monday 25th February 2019

(5 years, 9 months ago)

Lords Chamber
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Baroness Blackwood of North Oxford Portrait Baroness Blackwood of North Oxford
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I thank my noble friend for that question. I do not feel able to comment on ejector seats or submarine hatches—I may have to look to the noble Lord, Lord West, for advice on that matter—but I believe that obesity is a serious issue, and that is exactly why we introduced the children’s obesity plan.

Baroness Walmsley Portrait Baroness Walmsley (LD)
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My Lords, in some areas, referrals for treatment are at a later stage of the illness than otherwise because some CCGs have increased the threshold for criteria to be satisfied before a referral can be made. This will result in increased cost and, very often, decreased effectiveness. Have the Government done any assessment of this situation and the impact it could have on patients?

Baroness Blackwood of North Oxford Portrait Baroness Blackwood of North Oxford
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The noble Baroness raises an important point which follows on from the point raised by the noble Baroness, Lady Finlay. NICE guidance is clear: people should not be rejected for treatment solely on the grounds of weight or body mass index. The issue of threshold is similar and will be looked into by my honourable friend Jackie Doyle-Price. We will be taking this on as a very serious matter indeed.