Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Monday 2nd November 2020 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020.

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

My Lords, these regulations are critical in giving effect to the Ireland/Northern Ireland protocol for the safety and quality of blood, organs, tissues and cells, including reproductive cells.

I will give a brief moment of context. In January, the European Union (Withdrawal Agreement) Act 2020 was agreed by this House. It brings into domestic law the withdrawal agreement between the UK and the EU. Included in the withdrawal agreement is the protocol on Ireland/Northern Ireland, commonly referred to as the Northern Ireland protocol.

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. 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, or Good Friday, agreement.

These SIs covering donated blood, organs, tissues and cells support the vital role that these materials play in life-changing treatments for UK patients—whether it is blood transfusions to treat major blood loss, heart transplants to treat heart failure, stem cells to treat blood cancer, or eggs and sperm to treat infertility, patients rely on these treatments every day. Last year in the UK, there were 3,760 deceased organ transplants, approximately 1,100 people benefited from UK-donated stem cells and approximately 13% of IVF cycles used donor eggs or sperm. Many people would not be alive today if it were not for the generosity of donors.

The UK’s current high safety and quality standards for blood, organs, tissues and cells are derived from EU law. The application of these standards makes Britain one of the most progressive regulatory environments in the world.

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 come into effect on 1 January 2021. These 2019 statutory instruments maintain the current safety and quality standards across the UK.

So let me explain for a moment what these regulations do. The Northern Ireland protocol requires Northern Ireland to remain aligned with the EU blood, organs and tissues and cells directives for as long as the protocol is in force, including any future changes to the directives. These four instruments will come into force on 1 January 2021 and will ensure that Northern Ireland continues to be aligned with the directives after the end of the transition period. There are five ways in which they do this.

First, the regulations ensure that the safety and quality standards will remain the same across the UK from 1 January 2021. These standards are currently aligned with EU directives. 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. This 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 meet our commitment to unfettered access. This 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 EU withdrawal agreement Act 2018 contains the powers needed to make changes in relation to the safety and quality of blood, organs, tissues and cells for Northern Ireland to ensure future alignment with any changes to the directives. Therefore, the powers in the 2019 statutory instruments are no longer needed for Northern Ireland, and consequently these regulations limit those regulation-making powers to Great Britain.

Let me be clear: the fact that Northern Ireland will remain subject to EU law in this area does not mean that the UK as a whole will be prevented from making changes to the safety and quality regime in this area. The EU directives in this area set minimum standards of safety and quality. They allow member states to go further if they wish. If the UK as a whole wished to move forward and change the safety and quality standards, this could be done. They are a floor, not a ceiling.

A lot of preparatory work has already taken place. The regulators for the relevant sectors are working with licensed establishments across the UK to help ensure they are ready for any changes that will arise from 1 January 2021. They are supporting establishments to put any necessary import licences and agreements in place, preventing any disruption in the supply of blood, organs, tissues and cells. These changes affect only a very 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.

Regarding the DAs, legislative competence for the donation, processing and use in treatment of human reproductive cells remains reserved to Westminster. Competence in respect of all other human tissues and 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. Work is under way to put in place a common frame- work between the UK Government and the devolved Administrations, to support co-ordinated decision-making 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 already has high standards for the safety and quality of blood, organs, tissues and cells. These instruments ensure the UK will continue to work to these high standards after the transition period; that blood, organs, tissues and cells will continue to be able to be moved around the UK; and that we have a platform to build the regulatory regime even further. I beg to move.

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I start by saying a profound thank you for a lively, insightful and patient debate, because I recognise that these issues have been visited before—and the debate only improves in the retelling. I shall try to trot through a number of points in quick order, because the debate has been wide-ranging and taken on a number of issues.

I want to start on the most important one, divergence, which was raised by a number of noble Lords, including the noble Lord, Lord Scriven, my noble friend Lord Lansley and the noble Baroness, Lady Thornton. On the question of divergence and one regulator overseeing different territories, I reassure noble Lords that we are moving towards developing a common UK framework for blood, organs, tissues and cells with the devolved Administrations precisely in order to avoid this problem. This is the mechanism whereby the four nations can work together to ensure that they are all aligned and that companies and individuals in each nation can feel confident that they are in one common legislative framework. Policy issues will continue to be considered on a four-country basis going forward. I reassure noble Lords that officials and Ministers in Northern Ireland will continue to be involved in policy development, as they have been to date.

After 31 January, blood, organs and tissues will keep moving from the UK to Northern Ireland and from Northern Ireland to the UK, and they will keep moving from the UK to the EU and from the EU to the UK.

There may be at an appropriate point in the future an opportunity for the department to review whether the UK’s exit from the EU offers us opportunities to reappraise current regulations to ensure that we continue to protect the nation’s health. When that moment arrives, we will consult, analyse and assess. The regulations put in place the opportunity to do that—but that is for a moment in the future and it is not envisaged in the near future. To reassure the noble Lord, Lord Alton, who asked about the devolved Administrations, Scotland, Wales and Northern Ireland have provided their consent to these statutory instruments and they continue to be closely involved in the development of policy.

The noble Lord, Lord Scriven, asked about the Medicines and Medical Devices Bill. I reassure him that the Bill as drafted would already allow us to strengthen the requirements governing the use of human tissues in the development of medicines, were it deemed necessary and appropriate to do so. For instance, powers under Clauses 1 and 2 would enable us to introduce new requirements to the Human Medicines Regulations 2012 for medicines manufactured using human tissues.

The noble Lord, Lord Scriven, and others asked about the movement of blood and blood components. This is a hugely important issue. Currently, the UK is largely self-sufficient in the supply of blood and blood components. It occasionally exports rare blood cells—fewer than 10 units per year—to the EU and to non-EU countries. However, as the noble Baroness, Lady Thornton, observed, blood components are frequently shared across the four nations, as needed to meet demand, and the regulations will ensure that that flow is not interrupted. The movement of blood, organs, tissues and cells around the UK is absolutely critical for patient treatment. That will continue as it is now. There will be some minor administrative changes for tissue establishments in Northern Ireland to receive tissues and cells from Great Britain, but there will be no change to the requirements for Northern Ireland establishments to send blood, organs and tissues to GB.

The noble Baroness, Lady Thornton, and my noble friend Lord Bourne asked about the United Kingdom Internal Market Bill. As they will know, the Bill has passed Second Reading. Amendments have been tabled to enable safety emergency exclusion functions as intended that can be applied, if required, to Northern Ireland qualifying goods. However, I absolutely reassure noble Lords that we are totally committed to upholding our long-standing track record of high standards on health and food, including in respect of the materials which are the subject of these statutory instruments. We have kept healthcare and social care services out of the scope of the services framework rules, ensuring that there is no disruption to the regulation of health and care services.

My noble friend Lord Lansley was right to point out that it is fast-changing world for blood plasma. This could not be more relevant than it is right now. Covid has shown the international constraints on supply and the potential for huge demand. I reassure him that this is uppermost in our minds and that we will put in place all the regulations necessary to ensure that British access to blood plasma from overseas remains as secure as it is today.

To the noble Lord, Lord Alton, I say personal thanks for the report which he sent me. It includes charges which we take very seriously. We are of course against organ tourism. I noted the powerful points that he made in Committee on the Medicines and Medical Devices Bill last month and look forward to further discussion on Report. I reassure him that my noble friend Lord Ahmad has written to the World Health Organization encouraging it to give careful consideration to the findings of the report of the International Coalition to End Transplant Abuse in China. The Government welcome any work that is rigorous and balanced, and that raises awareness of the human rights situation in China. We continue to monitor this issue closely and to consider carefully all the evidence presented to us.

I note the personal testimony of the noble Baroness, Lady Walmsley. My family has been the beneficiary of organ transplantation, so I completely endorse her concerns. Traffic between Great Britain and Northern Ireland will remain, as it will between GB and the EU. I am glad to confirm that Northern Ireland will align with the EU, but we will find a way to work with Northern Ireland within the UK common framework to ensure that this trade continues. I am reminded that between April 2019 and March 2020, the UK exported 13 organs to the EU and imported 13 organs from it. While these numbers may seem low, they are extremely important to those concerned and it is a priority to ensure that those movements continue. With those thoughts, I commend the regulations.

Motion agreed.