Vaccine Hesitancy
Baroness Walmsley Excerpts(5 years, 1 month ago)
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Baroness Blackwood of North Oxford
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 (LD)
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
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(5 years, 2 months ago)
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Baroness Blackwood of North Oxford
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 (LD)
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
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(5 years, 2 months ago)
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
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 (LD)
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 (Lab)
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(5 years, 2 months ago)
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Baroness Walmsley (LD)
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
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(5 years, 2 months ago)
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Baroness Walmsley (LD)
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(5 years, 2 months ago)
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Baroness Blackwood of North Oxford
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 (LD)
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
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.
Human Fertilisation and Embryology: Frozen Eggs Storage
Baroness Walmsley Excerpts(5 years, 2 months ago)
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Baroness Blackwood of North Oxford
My noble friend makes an important point about the success rate of fertility treatment through the freezing of eggs, which is roughly comparable with IVF at 26%. It is important that false hopes are not raised and that women are not exploited in these very sensitive situations.
Baroness Walmsley (LD)
My Lords, the Minister has just claimed that the current law has public support. Can she say how recently that was explored and what the result was? Also, does the time limit have any effect on a woman’s decision whether and when to have her eggs harvested, and when to use them? Has any research been done on that and if not, why not?
Baroness Blackwood of North Oxford
The noble Baroness is absolutely right that it is important that we continue to support the Bill. I was trying to clarify that I did not think it appropriate to bring forward a change of this nature under regulations. If we were to introduce a change that had a broad effect, it would be appropriate to do so in primary legislation with appropriate parliamentary scrutiny, consultation and clinical support.
Brexit: Counterfeit Medicines
Baroness Walmsley Excerpts(5 years, 2 months ago)
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Baroness Walmsley
To ask Her Majesty’s Government what plans they have to protect patients from counterfeit medicines after the United Kingdom has left the European Union.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
My Lords, if we enter an implementation period, the UK will remain part of the EU-wide system, with arrangements beyond that subject to negotiation. In the event that the UK leaves without a deal, we will review options for an alternative to the new EU falsified medicines system. In the meantime, patient safety remains our priority. As the lead enforcement authority, the MHRA will take a pragmatic approach to ensure supply during the initial phase of operation.
Baroness Walmsley (LD)
I thank the Minister for her reply and welcome her to Oral Questions. Under the falsified medicines directive, UK patients can have the confidence that their medicine is a genuine product and has not been tampered with, but if we have a hard Brexit we will have only seven weeks either to recreate the barcode system at great cost, which is impossible in the time, or agree a fee to remain part of the system. Has the UK had any preliminary negotiations about such an agreement? If so, is there an estimate of what it would cost to be part of the system as a third country? Is this not yet another cost of Brexit that the people were not told about in 2016?
Baroness Blackwood of North Oxford
I thank the noble Baroness for her Question. As stated in the response to the MHRA’s recent no-deal consultation, it is expected that stakeholders would no longer be able to comply with the requirement to verify and authenticate medicines, so legal obligations related to this would be removed. In this scenario, we have committed to evaluate options for a future falsified medicines regulatory framework, taking into account investment made by stakeholders. It is important to note that the majority of the FMD was already implemented in 2013, and also that the MHRA has 30 years of experience as a world-leading regulator of more than 3,500 medicines. We expect that patients will remain safe and that there will be continuity of supply so that we can have confidence in medicines and safety for patients.
Childhood Obesity
Baroness Walmsley Excerpts(5 years, 4 months ago)
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Lord O’Shaughnessy
I agree with the noble Lord about the importance of the issue and I am grateful to him for the role he has played in bringing that relationship together. He knows very well that the BBC has played a critical role over decades in many very important health campaigns, such as on HIV or the “Just Say No” campaign on drugs. The BBC is absolutely committed. Of course, it would be inappropriate for Ministers to lean on the BBC, which has editorial independence that I am sure we are all anxious to protect. However, it is committed to doing more. It is doing a number of activities through its programming, including the “Blue Peter” cooking club, various CBBC programmes and so on. I do not think anyone doubts the BBC’s commitment to this, and we will see the fruits of that soon, I am sure.
Baroness Walmsley (LD)
My Lords, is the Minister aware that food economists have calculated that, calorie for calorie, fruit, vegetables and high-quality proteins are much more expensive than foods high in carbohydrate and fat? Is it surprising that poor parents find that they have to fill up their children with those foods that eventually often lead to obesity? The structural underpinning of this problem is poverty, which goes much wider than the Minister’s department. It should be a whole-government issue. What are the Government doing about that?
Lord O’Shaughnessy
I absolutely recognise the problem that the noble Baroness has pointed out. The prevalence of childhood obesity doubles between the least deprived and the most deprived areas. The Government are committed to reducing that deprivation gap and taking a broad range of actions to combat poverty, none more so than making sure that everybody has the chance to work, which is why we have more people in employment than has ever been the case.
Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019
Baroness Walmsley Excerpts(5 years, 4 months ago)
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Baroness Walmsley (LD)
My Lords, I agree with the noble Baroness, Lady Thornton, that we should not be having to do this. If Parliament was clear that it would not sanction a no-deal Brexit, we would not need to do so. My concern is that if we leave the EU, no longer will there be an obligation on the Secretary of State to communicate with the blood regulatory authorities in EU member states. Obviously, I welcome the fact that blood establishments and blood banks will need to ensure that blood and blood components from the UK continue to conform to the current EU testing requirements, as well as meet the equivalent quality and safety standards implemented by the UK Blood Safety and Quality Regulations 2005. However, I noticed that the Minister said, “for the moment, anyway”, when he mentioned that fact. It concerns me a bit that future Governments could change those standards. I hope that they would not want to change them for the worse in an attempt to sell a lot of blood products to countries with lower standards than us.
As a resident of Wales, I was pleased to hear that the devolved Administrations were engaged in consultation on the changes included in this instrument, which has been adapted to incorporate the changes and comments that they have proposed. That is fine, but I am concerned that in extremis, if there were to be difficulty in getting supplies in a timely way, the devolved Administrations would have to use products chosen by Westminster. I bring that up because this morning I heard about a parallel situation from some clinicians in Wales. They told me that they import quite a lot of hip joints, but the hip joints chosen for use in Wales are different from the hip joints chosen for use in England. They said that the NHS in Wales understands that if there was a problem of supply, it would have to use the hip joints chosen by England because they would be the only ones that it could get. I wonder whether the Minister can tell me whether the same situation would apply to blood products.
I know that the UK is largely self-sufficient in the supply of blood and blood components. Occasionally, we export rare frozen red blood cells in small quantities and import about 6.5% of our plasma units from the EU every year. In this context, I am concerned that regulation 16A of the 2005 regulations is being omitted from this SI. The regulation requires the maintenance of the communication of serious adverse events or reactions between the Secretary of State and the other blood regulatory authorities in EU member states. However, once the UK leaves the EU, obviously it will not be an EU member state and therefore no longer will there be an obligation on the Secretary of State to communicate with the blood regulatory authorities in the EU member states, nor them with us.
In the light of problems that we have had with blood products in the past—for example, blood contaminated with HIV and hepatitis C—what arrangements will be put in place to ensure that in the future we will communicate with the remaining 27 EU countries and that we will hear from them in relation to our work over here if any adverse situations arise with blood and blood products? We are still dealing with the fallout from blood products that were contaminated with HIV and hepatitis C. People have suffered for many years and I know that they are still trying to get the compensation that they feel they deserve. I hope the Minister is able to reassure me about both of those two elements.
Lord O'Shaughnessy
I thank both noble Baronesses for their questions. I do not quite agree that this is a waste of time; after all Parliament voted both for a referendum and for a withdrawal Act, so we have to prepare for every eventuality even when we hope that they will not happen. This SI is particularly important for the continuity of this important medical product.
To deal with the questions posed by the noble Baronesses, communication with agencies is absolutely happening. It is being co-coordinated by NHS blood and transport—sorry, I always say “blood and transport” because it transports the blood; I mean NHS Blood and Transplant—as well as the relevant agencies in the devolved Administrations. We know that sometimes relationships between the DAs and Westminster can be strained, but I think it is fair to characterise them as being positive and co-operative on this and other health-related issues. We are making sure that all agencies are involved in that process, with central co-ordination and collaboration and consent from the DAs.
Regarding reassurance for people with rare diseases in respect of imports, the whole point here is that we would be operating to the same standards as the EU. In a no-deal scenario, we would also be accepting, as it were, the regulatory standards and approvals of the EU to ensure that such products were not impeded on their way into our country. As the Committee will know, a range of activities are going on to ensure continuity of supply through the borders.
On the point made by the noble Baroness, Lady Walmsley, there is nothing untoward about my comment that there is no policy change at this moment. The critical point here is that under the Bill we are limited to technical changes to address flaws in the legislation that emerge as a result of technical flaws moving from one situation to another. Of course any future Government can change policy; I cannot bind the hands of any Government of any kind in future years. However, I can tell noble Lords that we have no intention of watering down the standards, so please be reassured on that point.
On the question from the noble Baroness, Lady Thornton, about when this would happen, in a no-deal scenario it would happen from 30 March 2019, so it would be from day one onwards.
I turn to the remaining issues raised by the noble Baroness, Lady Walmsley. In Wales we effectively have a single market in blood products—that is one way of putting it—all working to agreed standards. From that point of view, there is no difference in the products that are used in different domains. I understand her point about hip replacements but I am not sure that it is an exact analogy. Of course the beauty of devolution is that we have choice and experimentation.
Lastly, on the important point about communications with the EU, the reason why that has been removed is that it is a reciprocal obligation. Obviously it is illogical to have a reciprocal obligation that can be fulfilled only by one side.
Baroness Walmsley
I accept that, of course, but what I want to know is what is going to be put in its place.