The Government has just published guidance notes on what the Brexit implementation period means for those in the life sciences industries. Anna Tobin reports
The guidance notes published August 6, 2018, show that as those in the sector are already aware, the impact of Brexit on life sciences is going to be significant, but the implementation period brings some breathing space. The implementation period runs from the start of Brexit on 29 March 2019 until the end of December 2020 and is designed to give business in the UK and across the EU time to plan for the full withdrawal of the UK from the EU.
Before the implementation period begins the life science sectors can continue working as they have always done as the UK remains a full member of the EU. The Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate (VMD) will continue to lead work and act as rapporteurs for any ongoing procedures until the implementation period begins. To prepare for Brexit, the MHRA and the VMD will work closely with European regulators to facilitate a transfer to another leading authority, with minimal disruption to firms.
During the implementation period, the life sciences sector will continue to benefit from market access and opportunities to attend committees and groups, while ongoing data sharing will ensure that access to medicines and medical devices continues and patient safety is maintained in both markets. Pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK and this will be 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. Manufacturing and distribution licences will continue to be mutually recognised, as will associated inspections, such as good manufacturing practice.
UK firms can continue to apply for marketing authorisations via either the centralised or decentralised procedures and for medical devices, CE marking will continue to be used and recognised by both the UK and EU markets. UK-based organisation will not require an authorised representative established in the EU and UK notified bodies can continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised by both markets.
During the implementation period, the UK will also be treated as a Member State for the purposes of international agreements, including Mutual Recognition Agreements. This should mean that there will be no disruption to existing relationships underpinned by international agreements for the implementation period.
Changes To The MHRA And VMD’s Role During The Implementation Period
There will be some changes to the MHRA’s and the VMD’s role during the implementation period. For medicines, for example, the UK will not have voting rights in EMA and EU committees and the MHRA and the VMD will not act as a ‘leading authority’ to conduct assessments at the level of the Union or Member States acting jointly that inform decision-making processes. UK businesses will, however, have the same rights during the implementation period as EU-based businesses to have their cases accepted and processed by EU-based ‘leading authorities’.
How the implementation period affects upcoming EU regulation
The new Clinical Trials Regulation (CTR) is expected to be implemented during 2020. It will, 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. This is so that researchers conducting clinical trials can plan with greater certainty. Regardless of the outcome of the negotiations, the guidelines state that the UK is committed to offering a competitive service for clinical trial assessment.
Beyond the implementation period
Following the implementation period, the guidelines state: “We are confident of a positive outcome from the negotiations with the EU and we will continue to act in the best interests of patients, recognising that this will require continued close cooperation between the EU and the UK.”
The guidelines also state that they don’t constitute legal advice and companies are advised to seek independent legal advice dependent on their specific circumstances.