Exiting the European Union

Nigel Evans Excerpts

Wednesday 4th November 2020 Commons Chamber

[The Minister for Health (Edward Argar)]

I beg to move,

That the draft Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020, which were laid before this House on 8 October, be approved.

[Mr Deputy Speaker (Mr Nigel Evans)]

With this we shall take the following motions:

That the draft Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020, which were laid before this House on 8 October, be approved.

That the draft Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020, which were laid before this House on 8 October, be approved.

That the draft Quality and Safety of Organs Intended for Transplantation (Amendment) (EU Exit) Regulations 2020, which were laid before this House on 8 October, be approved.

[Edward Argar]

Today we debate four sets of regulations that are critical in giving effect to the Northern Ireland protocol for the safety and quality of blood, organs, tissues and cells, including reproductive cells.

All hon. Members would agree that donated blood, organs, tissues and cells play a vital role in life-changing treatments for UK patients, whether blood transfusions to treat major blood loss, heart transplants to treat heart failure, stem cell transplants to treat blood cancer, or eggs and sperm to treat infertility. Patients rely on those treatments every day. Many people would not be alive today were it not for the generosity of donors and their families, and I pay tribute to them.

The UK has always set high standards of safety and quality for blood, organs, tissues and cells, and those standards will always be of the utmost importance to this Government. The current safety and quality standards for blood, organs, tissues and cells are derived from EU law. Last year, in preparation for the UK leaving the EU, the Government made four statutory instruments to fix shortcomings in the current law caused by EU exit. These were made on a UK-wide basis and will come into effect on 1 January 2021. The 2019 statutory instruments maintain the current safety and quality standards across the UK. On 20 May 2020, we set out our approach to implementing the Northern Ireland protocol as part of meeting our obligations under the withdrawal agreement with the EU. We are committed to meeting these obligations, all the while recognising the unique status of Northern Ireland within the UK and the importance of upholding the Belfast/Good Friday agreement.

These four instruments will come into force on 1 January 2021. They will ensure that Northern Ireland continues to be aligned with the EU blood, organs, tissues and cells directives, as required by the protocol. In particular, first, although the safety and quality standards will remain the same across the UK from 1 January 2021, for Northern Ireland those standards may be expressed by reference to EU legislation, whereas for Great Britain they are not. Secondly, the UK regulators for blood, organs, tissues and cells will continue to act as the competent authorities for Northern Ireland in respect of the EU. That means that the Medicines and Healthcare Products Regulatory Agency, the Human Tissue Authority and the Human Fertilisation and Embryology Authority will continue to meet the same EU obligations for Northern Ireland as they do now.

Thirdly, these instruments amend the definition of “third country” for imports into Northern Ireland to ensure that we meet the terms of the Northern Ireland protocol but also our commitment to unfettered access. That means that, from 1 January 2021, when establishments in Northern Ireland receive blood, organs, tissues and cells from Great Britain, they will need to treat them the same as those received from outside the EU. In accordance with our commitment to unfettered access for goods moving from Northern Ireland to Great Britain, there will be no changes to the requirements when sending blood, organs, tissues and cells from Northern Ireland to Great Britain. The movement of blood, organs, tissues and cells around the UK is critical for patient treatment, and we are committed to ensuring that this movement can continue from 1 January 2021.

Fourthly, these instruments will require tissue establishments in Northern Ireland to continue using the single European code for traceability purposes, as they do now. Fifthly, the 2019 statutory instruments introduced some limited regulation-making powers into UK law for each of the UK nations. The European Union (Withdrawal) Act 2018 contains the powers needed to make changes in relation to safety and quality of blood, organs, tissues and cells for Northern Ireland. The powers in the 2019 statutory instruments are therefore no longer needed for Northern Ireland, and consequently, these regulations limit that regulation-making power to Great Britain. These instruments also make minor corrections to the 2019 statutory instruments to change references to “exit day” to read “implementation period completion day”, so that the regulations will function effectively at the end of the transition period.

The regulators for the sector are working with licensed establishments across the UK to help ensure that they are ready for any changes that will arise from 1 January 2021. These changes affect only a small number of establishments in Northern Ireland—one blood establishment, one transplant centre, two licensed tissue establishments and four fertility clinics. There will be some minor administrative costs for establishments in Great Britain moving blood, organs, tissues and cells to Northern Ireland.

Legislative competence for the donation, processing and use in treatment of human reproductive cells remains reserved to this Parliament. Competence in respect of all other human tissues, cells, blood and organs is devolved, and the relevant instruments are being made on a UK-wide basis with the consent of the devolved Administrations, for which I am grateful. There is work under way to put in place a common framework between the UK Government and the devolved Administrations to support co-ordinated decision making in the future on the safety and quality of blood, organs, tissues and cells after the end of the transition period.

To conclude, these regulations are vital to the Government’s preparations for the end of the transition period. It is essential that they are made, to allow the UK to fulfil its obligations under the Northern Ireland protocol. The UK has high standards for the safety and quality of blood, organs, tissues and cells. These instruments ensure that the UK will continue to work to those high standards after the end of the transition period and that blood, organs, tissues and cells will continue to move around the UK from 1 January 2021. I therefore commend the regulations to the House.