Since 1 February 2020, the UK has withdrawn from the EU and become a 'third country'. Until the end of the transition period (31 December 2020), EU law still applies in the UK. After the end of the transition period, however, EU rules on clinical trials will no longer, by default, apply to the UK. As such, the effect of Brexit on the life sciences industry will be significant, not least for the changes that will occur to the conduct of clinical trials both in the EU and UK.
Depending on the outcome of the ongoing EU-UK negotiations, it is possible that specific or equivalent provisions of the Clinical Trials Regulation will be implemented into UK law, at the appropriate time. The Regulation was adopted on 16 June 2014 but it does not yet apply in Member States due to the need for confirmation of the full functionality of the Clinical Trials Information System through an independent audit. The Regulation will become applicable six months after the European Commission publishes notice of this confirmation, with current estimates that this will not be until 2021, in which case it will not apply in the UK. However, the UK Government has previously indicated that it will seek to align with the Regulation as much as possible.
There is no denying that all players in the life sciences industry are united in so far as ensuring continuity of access to medicines and medical devices across the EU and UK and, with this, in the conduct of clinical trials also. As such, in an ideal world, the UK approach to clinical trials would be harmonised with the EU. However, this currently remains no more than an aspiration with no clarity for drug developers operating in the EU and UK five months before the end of the transition period.
If the UK adopts a significantly different national framework, this is likely to make the clinical trials procedure significantly more complex with greater administrative burden and cost for drug developers wishing to conduct multi-centre clinical trials in the EU, including the UK. Further to the EU Commission Notice and with no guidance in the Withdrawal Agreement, key issues that drug developers must still consider and address prior to the end of the transition period include:
- Applications: UK companies may not have access to the single portal for applications for clinical trials or, if they do, there may be a significant cost, and separate centralised and national clinical trial authorisation procedures may need to be followed.
- Sponsor/legal representative: According to EU law, the sponsor/legal representative of a clinical trial must be established in the EU. Accordingly, after the end of the transition period, a sponsor conducting a clinical trial under EU legislation will no longer be allowed to be based in the UK. Extra complications could also arise due to the obligation of having to notify the competent authority of the Ethics Committee of a change.
- Qualified person: Similar to the above, the qualified person of a clinical trial in the EU must also be established in the EU. Accordingly, a UK qualified person will not be granted equivalency for EU trials.
- Submission of Clinical Trial Information: Under EU law, the submission of certain clinical trial information to the EU clinical trials database must be made through EudraCT. However, following the end of the transition period, UK specific trial information may no longer have to be submitted through this system.
Additionally, where a clinical trial involves access to and use of drugs, continuity of that access (including for comparator drugs) and supply chain considerations must be considered upfront. This includes, in particular, consideration of distribution warehouse locations, increased inventory and production delays, and continuity of supply of lab kits, samples etc. Potential delays in the supply chain could have severe and drastic consequences for patients, especially where a clinical trial is already underway.
Given the current uncertainty as to the future conduct of clinical trials in the EU and UK, affected drug developers may wish to consider possible restructuring of their businesses and action additional approval processes. This will inevitably involve considerable investment, where the goal posts are constantly moving.
Although it is not yet clear what the situation will be with regard to clinical trials come 1 January 2021, the European Commission, European Medical Authority and Heads of Medicines Agencies have issued a technical notice about clinical trials giving advice on the location of the Qualified Person and location of the sponsor or legal representative.
The closer we get to the application of the Regulation, the more likely it seems that the UK will align with the Regulation, and introduce equivalent legislation at least in the short-term.