101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 142 Medical: Human Organs, Tissues, Cells Purpose The purpose of this notice is to set out to organisations, businesses and members of the public the actions they should consider taking, to ensure continued access to and use of organs, tissues and cells, including reproductive cells, in the unlikely event that the UK leaves the EU in March 2019 with no agreement in place. Negotiations are progressing well and both we and the EU continue to work hard to seek a positive deal. However, it’s our duty as a responsible government to prepare for all eventualities, including ‘no deal’, until we can be certain of the outcome of those negotiations. Organisations may also wish to consider other relevant notices, including Ensuring blood and blood products are safe if there’s no Brexit deal , Batch testing medicines if there’s no Brexit deal , How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal , Submitting regulatory information on medical products if there’s no Brexit deal . Before March 2019 The EU has a common set of standards to ensure the quality and safety of:  organs for transplantation, and  tissues and cells for human use, including reproductive cells The UK regulatory frameworks set high standards and are taken from a number of EU directives. These regulations cover issues such as obtaining, testing, processing, storing and tracing organs, tissues and cells. UK organisations such as hospitals, stem cell laboratories, tissue banks and fertility clinics that undertake licensable activities working in this area are regulated by:  the Human Tissue Authority (HTA) for organs, tissues and cells other than reproductive tissues and cells  the Human Fertilisation and Embryology Authority (HFEA) for reproductive tissues and cells At present some organs, tissues and cells move between the UK and EU countries, but also between the UK and non-EU countries (third countries). Only a small number of organs are shared with EU and non-EU countries:  22 organs from deceased donors came into the UK from the EU in 2017/18  26 organs left the UK in 2017/18, with 19 going to the EU and 7 to non-EU countries Tissues and cells (for example bone, heart valves and corneas) are imported from and exported to EEA countries less often than they’re imported and exported from and to countries outside the EEA. The UK imports donated sperm, primarily from commercial sperm banks in the USA and Denmark. Approximately 4,000 samples were imported from the USA and 3,000 samples from Denmark in 2017, as well as a small number from other EU countries. Imports of eggs and embryos are far less common (usually fewer than 500 a year) and come mostly from EU countries. After March 2019 if there’s no deal If there’s no deal, the EU Organ Directives and EU Tissues and Cells Directives would no longer apply to the UK. UK law already implements the EU directives, so the safety standards would not change. The UK would, however, become a ‘third country’ and the law would be amended under the EU (Withdrawal) Act to reflect this change. UK licensed establishments working in this area, such as hospitals, stem cell laboratories, tissue banks and fertility clinics would continue to work to the same quality and safety standards as they did before exit but some would need new written agreements with relevant EU establishments. UK licensed establishments that import or export tissues or cells from EEA establishments would need to make written agreements with those EEA establishments to continue importing or exporting these products post-exit. However, this will for the most part be a minimum burden on industry. For example, UK licensed establishments that already hold an import licence to import tissues and cells from third countries will be able to use their existing written agreements with third country organisations as a template.