Life Science Sector (UK Brexit Preparedness)

UPDATE : further information on the Clinical Trials Regulation (issued 6th August) is here.

Today (6th August) the Department of Health & Social Care, the Medicines & Healthcare products Regulatory Agency and the Veterinary Medicines Directorate, together, issued Guidance.

The guidance is “What the implementation period means for the life science sector’. This document is here. NB – the implementation period is the UK term for the EU transition period.

The guidance states (and note, this is subject to EU-UK agreement of the Withdrawal Agreement) :

During the implementation period:

• pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK, with this being recognised by the EU and vice versa

• marketing authorisation holders and qualified persons for pharmacovigilance will continue to be able to be based in the UK and access EU markets. There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP)

• firms based in the UK will be able to continue to apply for marketing authorisations via either the centralised or decentralised procedures

• for medical devices, CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based industry will not require an authorised representative established in the EU. UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets.

The document also states the UK reached agreement with the EU at March European Council that the UK is to be treated as a Member State for the purposes of international agreements, including Mutual Recognition Agreements, for the duration of the implementation period. The EU will notify other parties of this approach.

This means that there will be no disruption to existing relationships underpinned by international agreements as we move into the implementation period.

A vital issue is EU legislation enacted during this implementation/transition period, or enacted beforehand with forward enforcement dates in the period, or enacted after the period – below is illustrative (from this document, and applicable to this subject)

(1) The new Clinical Trials Regulation (CTR) is expected to be implemented during 2020 and would therefore apply to the UK under the terms of the time-limited implementation period.

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, so that researchers conducting clinical trials can plan with greater certainty.

Regardless of the outcome of the negotiations, the UK is committed to offering a competitive service for clinical trial assessment. This covers regulatory approval from MHRA as well as services from HRA, ethics services, NIHR and the NHS. (This is not applicable to the veterinary sector.)

(2) The EU Medical Devices Regulation will fully apply from May 2020. As this falls during the implementation period the government will fully implement the legislation.

(3) The new EU Regulation on in vitro diagnostic (IVD) medical devices will not apply until May 2022, which is outside of the implementation period. However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements. (This is not applicable to the veterinary sector.)

UK exits the EU (transition period)

UPDATE : Wednesday 21st February – the UK Draft Text for Discussion: Implementation Period is here.

[Note : the UK position is to seek a longer transition period.]

UPDATE : Thursday 8th February – the UK proposal for continuation of existing EU-third country agreements is here.

UPDATE : Wednesday 7th February – the draft EU wording for the Transition clauses of the Withdrawal Agreement is here.

Draft clauses to note : [the next step for this draft wording is for it to be agreed by the EU-27 member states, the wording could alter after this step]

(1) There shall be a transition period, which shall start on the date of entry into force of this Agreement and end on 31 December 2020.

(2) Union law (with stated exceptions) shall be binding upon and applicable in the United Kingdom during the transition period.

(3) During the transition period, the United Kingdom shall not act as leading authority for risk assessments, examinations, approvals and authorisation procedures provided for in Union law.

(4) During the transition period, the Court of Justice of the European Union shall have jurisdiction as provided for in the Treaties. In addition, the Governance and Dispute Settlement Part of the Withdrawal Agreement should provide for a mechanism allowing the Union to suspend certain benefits deriving for the United Kingdom from participation in the internal market where it considers that referring the matter to the Court of Justice of the European Union would not bring in appropriate time the necessary remedies.

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UPDATE : Monday 29th January – the EU position is here. It’s a status quo period without institutional representation lasting until 31 December 2020. The Press Release is here (with links).

Two key questions :

(1) registration of EU nationals allowed or not allowed in the transition period ?

(2) EU Notices apply from 29 March 2019 or 31 December 2020, which ?

NOTE : this Annex also sets out the Withdrawal Treaty issues that are still to be resolved. I will post about the EU-UK Withdrawal Treaty separately. The Irish border will continue as a separate strand during the transition period.

NOTE (2) : the possibility of a transition arrangement obtains its legal authority from Article 50, and so the Transition terms will be set out in the Withdrawal Treaty.

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UPDATE : UK 26th January 2018 statement on the Transition Period (the UK terms it the Implementation Period) – here.

Last night Hammond/Davis/Clark sent letters to business leaders in which they said of the transition/implementation period:

“The period’s duration will be strictly time-limited, and should be determined simply by how long it will take to make these

changes.” The full letter is here.

The EU position will be published on Monday 29th January 2018.

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The date of exit is 00:00 30 March 2019. The EU and the UK have signalled their willingness to agree a Transition Period.

Very little is yet published on the nature of this to-be-agreed Transition Period, save the EU stating it should not extend beyond 31st December 2020.

EU and UK negotiators are currently talking through the loose ends that remain over the UK-EU Withdrawal Treaty – citizens’ rights, the financial settlement and the Irish border – along with topics such as Euratom, which governs the movement of nuclear materials, that have yet to be substantively discussed.

A draft treaty putting the agreements on the three Withdrawal issues into legal language is due to be published within weeks. I will publish this as a separate post.

The EU and the UK authorities have signalled the Transition Period cannot be agreed until the Withdrawal Treaty is in legal language at least. The Withdrawal Treaty will be ratified later in 2018 in advance of the 2019 exit date.

I will update this post when more information is available about the Transition Period. My post updating will NOT be automatically emailed to your inbox, so please make sure to revisit this post on the Blog itself.