The post ‘Brexit’ position
Notwithstanding the EU’s clear influence on UK legislation in this area, the UK’s exit from the EU on 31 January 2020 has led to some immediate changes and may well lead to more significant deviations from the current regime in the future. Of particular note is the Northern Ireland Protocol, which is one of the key features of the new relationship between the UK and the EU. This essentially allows for the continued free movement of goods between Northern Ireland and the EU, whilst at the same time keeping Northern Ireland within the UK customs territory. In respect of the regulation of assisted reproduction, the Protocol has led to somewhat of a divergence between Northern Ireland and Great Britain (England, Scotland and Wales). At first, the Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 ensured that, upon the end of the Implementation Period on 31 December 2020, the entire UK would still maintain the current safety and quality standards for tissues and cells as provided by the EUTCD. However, as a result of the Northern Ireland Protocol, Northern Ireland must continue to meet the requirements of the EUTCD for as long as the Protocol is in force. The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2020 were passed in order to give effect to the Protocol in this regard; these Regulations therefore restrict the 2019 Regulations to Great Britain (England, Wales and Scotland) only. Thus, whilst there is still a single set of UK rules, within them a small number of provisions will apply to Northern Ireland or Great Britain only.
In particular, since 11pm on 30 June 2021, all countries outside the UK (including those within the EU/EEA) have become ‘third countries’ to Great Britain. This means that clinics in Great Britain that import gametes and embryos from any such country must have an importing tissue establishment (ITE) certificate in place. In contrast, for imports into Northern Ireland from EU/EEA countries, no ITE import certificate is required as these countries are not considered to be ‘third countries’ to Northern Ireland. This reflects the position established by the Northern Ireland Protocol.
At the time of writing, the HFEA has dedicated an entire section of the ‘Clinic Portal’ on its website to ‘EU Exit guidance’. This sets out the relevant changes for licensed clinics and provides considerable resources to help clinics navigate the new landscape.