Draft Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019

Steve Brine Excerpts

Wednesday 19th December 2018 General Committees

[The Parliamentary Under-Secretary of State for Health and Social Care (Steve Brine)]

I beg to move,

That the Committee has considered the draft Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019.

It is nice to see you, Mr Sharma.

The draft regulations are made under powers in the European Union (Withdrawal) Act 2018 to make the necessary amendments to the UK’s Blood Safety and Quality Regulations 2005. The instrument will correct those regulations to ensure that the UK is prepared in the unlikely event that it leaves the EU without a deal on 29 March next year.

The UK regulations set out the safety and quality requirements that cover all steps in the blood transfusion process from donation, collection, testing, processing and storage to distribution. The short shelf life of such products means that an uninterrupted process of donation and processing is needed to ensure that the UK has a safe continuity of supply for blood and blood components. Patients rely on the treatments every day, and many people would not be alive today if it were not for the generosity of blood donors—I want to place that on the record.

As a responsible Government, we have been preparing for all scenarios, including that we leave the EU without a deal in March. The draft statutory instrument will ensure that the regulatory regime for blood safety and quality continues to function effectively after exit day. It is important to make the changes 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 treatment. In addition, the donated plasma is a component of blood that can be used to manufacture medicinal products such as clotting factors and immunoglobulins.

To be clear, the instrument is limited to the necessary technical amendments to ensure that legislation is operative on EU exit day. It confers powers—from the EU Commission to the Secretary of State—to make the technical changes. However, no policy changes are made through the draft regulations, and at this point we have no intention of making any. I commend the regulations to the Committee.

--- Later in debate ---

[Steve Brine]

The hon. Member for Washington and Sunderland West, my shadow from the Labour party, talked about regulation 8. Each blood establishment will be responsible for the labelling, storage and so on of blood. There is no change; the only change to regulation 8 is from “European Union” to “third country”, which of course is what we would become in the event that that happened. We have made sure that the UK blood establishments have capacity for labelling.

The hon. Lady also asked about patient safety. The statutory instrument will ensure that the existing high standards of safety and quality of blood and blood components is continued. There is no increased risk to patient safety.

The hon. Lady and the hon. Member for Eltham both talked about supply. The draft regulations will not affect the supply of blood or blood components in the UK. As the hon. Member for Central Ayrshire from the Scottish National party said, the UK is largely self-sufficient in blood and blood components. We do not routinely import or export blood components.

One exception to that is blood plasma—we import about 6.5% of our total blood plasma units from the EU, as has been said, as a safety measure against BSE for people born after 1996. We are putting contingency plans in place to ensure a continuing safe supply after 29 March. NHS Blood and Transplant will be stockpiling plasma centrally to ensure continuity of supply.

The hon. Member for Central Ayrshire is absolutely right about the importance of that in ongoing medicine and in keeping people safe, which is why I feel confident in saying that there will be no adverse impact on patient safety as a result. That involves fast-tracking shipments at ports and alternative routes being prepared, while partners stockpile alternative medicinal products and consumables.

The hon. Member for Washington and Sunderland West talked about regulatory benchmarks. She is absolutely right to say that that is our work—we have been a member state for 40 years, and we have no intention of diverging from that, because we wrote most of it. One of the reasons why, through this SI, we are updating the powers to give the Secretary of State power to amend the regulations is so that, on exit day—if that happens as we hope it will not happen—we would be in exactly the same place.

Obviously, if the ongoing review in the European Union 27 of the future of blood and blood component products decides to make changes, we would also be in the position of being nimble enough to make changes ourselves to ensure that we stay close to them in a regulatory benchmark way. My views on EU exit are well known, but I do not think anyone voted in order to diverge from our closest partners on blood supply.

Gibraltar is making its own EU exit legislation. The Gibraltar Government have been closely engaged with the Department, and we with them. Gibraltar meets the same standards as the UK, and I see no reason for that not to continue.

On the devolved Administrations, because blood is a devolved competence, the SI confers the EU Commission’s regulation-making powers on to the Secretary of State and on the relevant DAs, with the devolved Administration’s consent. We are engaging with the blood establishments, the Medicines and Healthcare products Regulatory Agency and the DAs to ensure that there is day-one operability for blood safety and quality legislation.

Scotland, Wales and Northern Ireland—dealing with the civil service in the latter—have provided their consent for this instrument, and they have been closely involved in its development over the past six months. I place on record my thanks to those in Scotland and Wales, and the civil servants in Northern Ireland, who have worked well and closely with us to ensure that this is done safely and sensibly.

In answer to a point made by the hon. Member for Eltham, we will go all out to ensure that we do not need the draft regulations. Dare I say it? The best way to avoid no deal is to have a deal, and Members will get the opportunity to agree one when we come back in the new year.

Question put and agreed to.