Published on 07/08/2018
The UK Government is preparing for the UK’s exit from the European Union, and have published a number of documents to clarify our work to the Life Science sector:
What the implementation period means for the life sciences sector:
Technical information on what the implementation period means for the life science sector:
- At the March European Council, the UK and EU agreed the terms of an implementation period, from March 2019 to the end of December 2020. The period will enable businesses and organisations in the UK and across the EU to operate as now, giving them time to plan with confidence for life after our withdrawal. For the life sciences sector in particular, the UK Government have published an update, which sets out what the implementation period agreement would mean, once finalised as part of the Withdrawal Agreement. Continued market access, opportunities to attend committees and groups, and ongoing data sharing during the implementation period will ensure that access to medicines and medical devices continues and patient safety is maintained in both markets.
EU Clinical Trials Regulations:
- In support of this update, the UK Government have published a document, which answers specific questions the sector has asked us about the terms of the implementation period for the sector. The UK Government will update and expand this over time.
- The UK Government also provides clarity on how the implementation period affects upcoming EU regulation, in particular the new EU Clinical Trials Regulation (CTR) here. As you may know, the CTR is expected to be implemented during 2020 and would therefore apply to the UK under the terms of the implementation period. However, if the new regulation does not come into force during the implementation period, the Government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, in order that researchers conducting clinical trials can plan with greater certainty.
- Finally, the UK Government would like the sector to be aware of the joint statement of 19 June 2018, https://www.gov.uk/government/publications/joint-statement-on-withdrawal-agreement-19-june-2018, which provides an update on the latest areas of agreement on the draft legal text of the Withdrawal Agreement. Since March the UK Government have reached new agreements on matters including goods on the market, Euratom related issues and judicial cooperation in civil and commercial matters.
- Progress is being made to finalise the Withdrawal Agreement as a whole. The aim to have an agreement by October, alongside the framework for our future relationship with the EU. The UK Government are confident of a positive outcome from the negotiations with the EU and will continue to act in the best interests of patients, recognising that this will require continued close cooperation between the EU and the UK.