Considered in Grand Committee
My Lords, in proposing these regulations, I want to explain that they are made under powers in the European Union (Withdrawal) Act 2018 to make necessary arrangements for the UK Blood Safety and Quality Regulations. This statutory instrument will correct deficiencies in those regulations so that the UK is prepared if we leave the EU without a deal on 29 March 2019.
Current regulations set out the safety and quality requirements that cover all the steps in the blood transfusion process, from donation, collection, testing, processing and storage to distribution. The short shelf life of these products means that an uninterrupted process of donation and processing is needed to ensure that the UK has a safe and continuous supply of blood and blood components. As a responsible Government, we have been preparing for all scenarios, including the unwanted but potential outcome that we leave the EU without a deal in March 2019. This instrument will ensure that the regulatory regime in relation to blood safety and quality continues to function effectively after exit day in that scenario. It is vital to make these legislative changes to provide a functioning statute book that allows for the continued donation and processing of blood and blood components such as plasma and platelets to facilitate a wide range of essential and often life-saving treatments.
In moving these regulations, I want to be clear that they are limited to the necessary technical amendments to ensure that the legislation is operative on EU exit day. No policy changes are made through these regulations and we do not have any intention of making any at this point.
The main changes that the instrument will introduce are as follows. It transfers relevant Commission powers contained in the EU blood directives to the Secretary of State in relation to England and to the devolved Ministers in relation to the devolved areas. In addition, the Secretary of State may, with the consent of the relevant devolved Ministers, make regulations on their behalf. This will enable future updates to the blood safety and quality legislation to respond to emerging threats, changing safety and quality standards and technological advances. It contains modifications to how the annex to the blood directive should be read post Brexit. This is necessary to ensure that the requirements set out in the annex, which are referred to in our domestic legislation, continue to apply and function properly post exit. It also makes minor changes to amend EU-related references or EU obligations that will no longer be appropriate or will be redundant once the UK has left the EU.
Blood is a devolved policy area, so I am pleased to say that we have obtained the devolved legislatures’ consent to the provisions contained in this draft instrument. I beg to move.
My Lords, I thank the Minister for introducing these regulations. Given the state of the Brexit negotiations, deals and other matters that are going on in Parliament at the moment, it is probably just as well that we have this before us. However, I have to say, as I said to the Minister about the previous instrument we discussed, that it was there in case we crash out of the EU. This is really quite a waste of all our time and Parliament should not have to do this.
The regulations seem to be very straightforward. They will: amend or omit references to EU/EEA member states and third countries; omit provisions relating to EU obligations that will no longer be relevant to the UK; transfer relevant Commission powers under the EU blood directive to the Secretary of State in relation to England and the devolved Ministers in relation to the devolved areas, as detailed in paragraphs 7.12 to 7.15; and, as the noble Lord said, modify how the annex to Commission Directive 2005/62/EC is to be read after exit.
I have a couple of questions about assurances. I am pleased to learn from the Minister that no new policies are being created here; that is entirely appropriate. I would like to know whether any changes are being effectively communicated to the agencies that store blood—UK blood establishments, hospital blood banks and the manufacturers of blood products—in a timely manner. What assurances can the Government give to patients with rare diseases who receive imported blood and blood components? Of course, we know that the safety of those products is vital. Can the Government give an assurance that these changes will not affect the safety and quality of the supply of blood and blood components in the UK, as our current standards will be maintained? Lastly, when will this change come into force?
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.
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.
Indeed. In a no-deal situation, if we picked up the kinds of concerns she has described, we have very good pharmacovigilance and other monitoring systems in this country. We would communicate that information with our European neighbours and we would hope and expect them to do that in return. However, of course we have no way of obliging them to do so in a no-deal scenario. We are absolutely committed to communicating with them not only about blood products but about all medicinal products and devices; that is our moral obligation. In a deal scenario, we would share that information anyway by dint of being part of a common regulatory authority. That is also true of the implementation period and it is our stated ambition in the White Paper for the period afterwards. I can reassure the noble Baroness that it is our intention to continue with the communication. Although, in part because of the phase we have reached in the negotiations, it is not possible to confirm that in a no-deal scenario there would be a bilateral or multilateral arrangement around communications, I am confident that all sides would want that because it is to no one’s benefit not to share the information. I am sure that that would happen.
I hope that I have provided answers to the pertinent questions put to me by the noble Baronesses and commend the regulations.