101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 136 Medical: Blood and Blood products Purpose The purpose of this notice is to set out to UK blood establishments, hospital blood banks, manufacturers of blood products and members of the public, the actions they should consider in the unlikely event that the UK leaves the EU in March 2019 with no agreement in place. Organisations may also wish to consider other relevant notices, including those on ‘ Quality and safety of organs, tissues and cells if there’s no EU exit 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 ’ and ‘ Submitting regulatory information on medical products if there’s no Brexit deal ’ . Before 29 March 2019 The EU has a common set of quality and safety standards for blood supply – including the collection, testing, processing, storage and distribution of human blood and blood components. The standards are primarily used by blood establishments, hospital blood banks and the Medicines and Healthcare Products Regulatory Agency (MHRA), the regulatory authority. In the UK, these standards are set out in the Blood Safety and Quality Regulations 2005. This transposed Directive 2002/98/EC o f the European Parliament and of the Council of 27 January 2003, its associated amendments and relevant implementing legislation. The UK is largely self-sufficient in the supply of blood and blood components. We occasionally export rare frozen red blood cells (usually fewer than 10 units a year) to EU and non-EU countries. We import from the EU per year around 6.5% of plasma units issued in the UK. As this area is devolved the UK Government is currently engaging and consulting with the devolved administrations to establish a framework for UK-wide this policy area. After 29 March 2019 if there’s no deal If there’s no deal, the EU Blood Directives would no longer apply to the UK. Arrangements for sharing blood, blood components and information with EU partners would be based on the UK’s status as a third country. Blood establishments importing blood or blood components from the EU for transfusion would be required to add a description of activity to cover import to their blood establishment authorisation. To export blood or blood components to the EU, establishments may need to certify that any products comply with EU standards. However, EU countries should be aware of th e EU Commission position for such imports, and should note that these products will need to be tested in conformity with the Union testing requirements. In both cases, it is recommended that the MHRA is consulted prior to importing or exporting blood or blood components to or from the EU. If there’s no deal, the current blood safety and quality standards for blood and blood components would not change. The Blood Safety and Quality Regulations 2005 would be retained in UK law under the EU (Withdrawal) Act powers. The new regulation would maintain the current standard of blood quality and safety on exit day and enable updates to be made to the blood safety and quality standards to respond to emerging threats and changing safety, quality standards and technological advances. We are engaging with blood establishments, the MHRA and devolved administrations to ensure that there is day one operability for blood safety and quality. We are currently, consulting with the devolved administrations to ensure that there is flexibility to update the safety and quality standards to respond to emerging threats and changing safety, quality standards and technological advances. Implications Blood establishments, blood banks and manufacturers of blood products Blood and blood components from the UK would continue to conform to the current EU testing requirements ( Directive 2002/98/EC4 ) . They would also meet with the equivalent standards ( Directive 2004/33/EC5 ) of quality and safety as implemented by the UK Blood Safety and Quality Regulations 2005. To import blood or blood components into the UK from any country, including EU/EEA countries, you would need to ensure that each unit of blood and blood component imported continue to be prepared in accordance with standards equivalent to the EU standards (which have been transposed into UK law) and requirements set out in the Annex to Commission Directiv e 2005/62/EC a nd meets the standards of quality and safety equivalent to those we currently have implemented. These standards are also set out in Part 5 of th e Blood Safety and Quality Regulations 2005 . To export blood or blood components from the UK to any EU/ EEA country, you would also need to ensure that each unit of blood and each blood component exported continues to conforms with the EU testing requirements (Annex IV, Directiv e 2002/98/EC4 ) and meets the equivalent standards of quality and safety (Annex V t o Directive 2004/33/EC5 ) . Manufacturers of blood products You should comply with Directive 2002/98/EC f or the collection and testing of human blood and human plasma, for use in manufacture of blood products. Members of the public These changes would not affect the safety, quality or supply of blood and blood components in the UK as the current standards would be maintained.