Image shows a person wearing a blue medical glove checking blood sample vials.

On 2 November 2020, the House of Lords is scheduled to debate the following four draft statutory instruments together:

The draft explanatory memorandum refers to these collectively as ‘the 2020 SIs’. The SIs were laid under the draft affirmative procedure. This means that both Houses of Parliament must approve them before they can be brought into force. The SIs would introduce similar provisions but have been drafted separately as each would amend different legislation.

The 2020 SIs will amend four existing 2019 statutory instruments to make allowance for the Protocol on Ireland/Northern Ireland. The Protocol was ratified by the EU and the UK in January 2020. Article 5(4) requires certain provisions of EU law to continue to apply to Northern Ireland after the end of the transition period (11pm on 31 December 2020). This includes provisions in EU law relating to the safety and quality of substances of human origin, specifically blood, organs, tissues and cells (including reproductive cells).

What EU law will continue to apply to Northern Ireland?

The explanatory memorandum states that Northern Ireland will continue to be subject to the following EU directives after the end of the transition period:

  • Directive 2002/98/EC – this sets the standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components (the EU blood directive);
  • Directive 2004/23/EC – this provides the standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (the EU tissues and cells directive);
  • Directive 2010/53/EU – this prescribes the standards of quality and safety of human organs intended for transplantation (the EU organs directive).

The explanatory memorandum refers to these collectively as ‘the Directives’. The Directives are transposed into UK law by the following domestic legislation:

  • the Blood Safety and Quality Regulations 2005;
  • the Quality and Safety of Organs Intended for Transplantation Regulations 2012;
  • the Human Tissue (Quality and Safety for Human Application) Regulations 2007;
  • the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007; and
  • relevant amendments to the Human Tissue Act 2004 and the Human Fertilisation and Embryology Act 1990.

Section 2 of the European Union (Withdrawal) Act 2018 ensures that EU-derived domestic legislation will continue to have effect in the UK after the end of the transition period.

What did the 2019 SIs do?

The Government made four statutory instruments in 2019 that will amend the above domestic legislation on 1 January 2021. These regulations, known collectively as ‘the 2019 SIs’ in the explanatory memorandum, will enable the UK to maintain its existing safety and quality standards for blood, organs, tissues and cells upon leaving the EU and ensure that domestic legislation functions effectively once the UK is no longer subject to EU law. The 2019 SIs are:

How would the 2020 SIs amend the 2019 SIs?

As the Ireland/Northern Ireland Protocol requires Northern Ireland to continue to meet the Directives, the 2020 SIs would limit the changes made by the 2019 SIs to Great Britain only.

As Great Britain will not remain subject to EU law after the end of the transition period, the 2020 SIs would provide a single set of rules for the UK that contained certain provisions applicable to Northern Ireland or Great Britain only.

The explanatory memorandum states that key changes that the 2020 SIs would make are:

  • to allow the current regulators to continue to act as the competent authorities in relation to the EU for Northern Ireland;
  • to make amendments to the import/export provisions. Northern Ireland will continue to send blood, organs, tissues and cells to Great Britain in the same way that it does now. However, for items received from Great Britain, Northern Ireland will treat Great Britain as a non-EU Member State and impose existing non-EU import provisions;
  • to retain the requirement for Northern Ireland tissue establishments to use the Single European Code for tissues and cells; and
  • to limit the regulation-making powers introduced by the 2019 SIs to Great Britain.

A full breakdown of the changes that the 2020 SIs will make is included at section 7 of the explanatory memorandum.

What parliamentary scrutiny has taken place?

The House of Lords Secondary Legislation Scrutiny Committee did not draw the 2020 SIs to the special attention of the House. The Joint Committee on Statutory Instruments did not consider that the 2020 SIs were required to be reported to both Houses.

The House of Commons is due to consider the 2020 SIs on 4 November 2020.

Image by Ahmad Ardity on Pixabay.