The Office for Life Sciences have published several documents, which aim to provide further clarity to the sector on preparations for exiting the EU.
This document sets out what recent developments, such as agreement on the terms of an implementation period, would mean for the life sciences sector, once finalised as part of the Withdrawal Agreement.
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 Office for Life Sciences 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. View here.
To support this update, the Office for Life Sciences have published a document, which answers specific questions the sector has asked about the terms of the implementation period for the sector. This will be updated and expanded over time. View here.
Update on the Clinical Trials Regulation during the implementation period.
The Office for Life Sciences have also given clarity on how the implementation period affects upcoming EU regulation, in particular the new EU Clinical Trials Regulation (CTR) here. 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. View here.
Outlining progress made by the negotiators of the European Union and the United Kingdom on the draft Withdrawal Agreement
The joint statement of 19 June 2018 provides an update on the latest areas of agreement on the draft legal text of the Withdrawal Agreement. Since March new agreements have been reached 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. This is aimed to be agreed by October, alongside the framework for our future relationship with the EU. View here.