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This publication is available at https://www.gov.uk/government/publications/ensuring-blood-and-blood-products-are-safe-if-theres-no-brexit-deal/ensuring-blood-and-blood-products-are-safe-if-theres-no-brexit-deal
A scenario in which the UK leaves the EU without agreement (a ‘no deal’ scenario) remains unlikely given the mutual interests of the UK and the EU in securing a negotiated outcome.
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.
For two years, the government has been implementing a significant programme of work to ensure the UK will be ready from day 1 in all scenarios, including a potential ‘no deal’ outcome in March 2019.
It has always been the case that as we get nearer to March 2019, preparations for a no deal scenario would have to be accelerated. Such an acceleration does not reflect an increased likelihood of a ‘no deal’ outcome. Rather it is about ensuring our plans are in place in the unlikely scenario that they need to be relied upon.
This series of technical notices sets out information to allow businesses and citizens to understand what they would need to do in a ‘no deal’ scenario, so they can make informed plans and preparations.
This guidance is part of that series.
Also included is an overarching framing notice explaining the government’s overarching approach to preparing the UK for this outcome in order to minimise disruption and ensure a smooth and orderly exit in all scenarios.
We are working with the devolved administrations on technical notices and we will continue to do so as plans develop.
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 of 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 the 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.
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 Directive 2005/62/EC and meets the standards of quality and safety equivalent to those we currently have implemented. These standards are also set out in Part 5 of the 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, Directive 2002/98/EC4) and meets the equivalent standards of quality and safety (Annex V to Directive 2004/33/EC5).
Manufacturers of blood products
You should comply with Directive 2002/98/EC for 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.
The aim is to give organisations, businesses and individuals as much certainty as possible as soon as we can, and to ensure that any new requirements are not unduly burdensome.
This notice is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations.
It is part of the government’s ongoing programme of planning for all possible outcomes. We expect to negotiate a successful deal with the EU.
The UK government is clear that in this scenario we must respect our unique relationship with Ireland, with whom we share a land border and who are co-signatories of the Belfast Agreement. The UK government has consistently placed upholding the Agreement and its successors at the heart of our approach. It enshrines the consent principle on which Northern Ireland’s constitutional status rests. We recognise the basis it has provided for the deep economic and social cooperation on the island of Ireland. This includes North-South cooperation between Northern Ireland and Ireland, which we’re committed to protecting in line with the letter and spirit of Strand two of the Agreement.
The Irish government have indicated they would need to discuss arrangements in the event of no deal with the European Commission and EU Member States. The UK would stand ready in this scenario to engage constructively to meet our commitments and act in the best interests of the people of Northern Ireland, recognising the very significant challenges that the lack of a UK-EU legal agreement would pose in this unique and highly sensitive context.
It remains, though, the responsibility of the UK government, as the sovereign government in Northern Ireland, to continue preparations for the full range of potential outcomes, including no deal. As we do, and as decisions are made, we’ll take full account of the unique circumstances of Northern Ireland.
Norway, Iceland and Liechtenstein are party to the Agreement on the European Economic Area and participate in other EU arrangements. As such, in many areas, these countries adopt EU rules. Where this is the case, these technical notices may also apply to them, and EEA businesses and citizens should consider whether they need to take any steps to prepare for a ‘no deal’ scenario.