[co-author: Julia Fraser]
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published an update to pharmaceutical companies in the UK on the status of the Brexit negotiations and confirmed the UK's wish for there to be a transition period to allow for a smooth withdrawal. The update, published on 16 January 2018, also sets out the MHRA's expectations for continued involvement in EU affairs during the negotiation period, while the UK remains part of the EU, and clarifies the MHRA's intended approach should a transition or implementation period not be concluded with the EU by March 2019.
After much delay in the first round of negotiations on the terms of the UK's withdrawal from the EU, the European Council determined on 15 December 2017 that sufficient progress had been made to progress to transitional arrangements and the framework for a future relationship, and published Guidelines on which the second phase of negotiations will be based.
Whether or not a transition period is agreed, while the UK remains part of the EU, the UK's regulatory relationship with the EU remains unchanged. In particular, the MHRA confirms that it will continue to fulfil its obligations under EU law, including continuing to bid for EMA work, and commits to completing all assessments under its evaluation at the time of withdrawal. In return, the MHRA expects its bids to be respected as usual, and is working together with other Member States to submit joint bids for any work that is expected to continue after this date.
While the MHRA states that "the UK is fully committed to continuing the close working relationship with its European partners, in the interests of public health and safety", whether the MHRA will continue to participate in the EMA's affairs post-Brexit will be subject to negotiation in the second phase. The EU's starting position, as set out in the Council Guidelines, is that the UK should no longer participate in the work of EU agencies from the start of any transition period.
There has been much focus on the EMA's position in relation to activities in the EU post-Brexit. This update addresses the MHRA's intended approach in relation to UK activity should a transition period not be agreed. In particular, it confirms that:
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As made clear in a joint report by the UK Government and the European Commission, products placed on the market before the withdrawal date will not require any modifications or re-labelling;
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There will not be any sudden changes to the UK regulatory framework (by virtue of the UK's European Union (Withdrawal) Bill, which will convert the existing EU legislative framework into UK law);
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The MHRA is intending to adopt a pragmatic approach should there be no implementation period to ensure companies have sufficient time to implement any changed requirements for its activities in the UK; and
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Where possible, the MHRA will make use of the information it already has to complete administrative tasks for continuity of work and licences.
The MHRA's statement is available here.
