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

Baroness Thornton Excerpts

Wednesday 12th December 2018 Grand Committee

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord O’Shaughnessy) (Con)]

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.

[Baroness Thornton (Lab)]

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.