Brexit and clinical research
It is currently uncertain when the United Kingdom (UK) is going to leave the European Union (EU), whether an agreement is going to be reached regarding the withdrawal conditions, and whether a transition period will apply. It is therefore important that sponsors and researchers are prepared for a no-deal Brexit.
In the event of a no-deal Brexit on 30 March 2019 the UK will become a so-called 'third country' and this may have consequences for the future of clinical research carried out in the EU. In some cases an amendment will have to be submitted to the review committee and the competent authority. This is explained in more detail below. The CCMO is deploying extra staff to expeditiously process amendments which are submitted to the CCMO as a result of Brexit. In urgent cases you can contact the CCMO so that your amendments can be processed as a priority.
Consequences of a no-deal Brexit on 30 March 2019:
Delayed delivery of research medication
1. After Brexit the delivery of research medication may become disrupted if the production takes place (wholly or partially) in the UK. This is because a new import licence will be needed for the research medication. You can find information about the import licence on the website of Farmatec. A new import licence will not be regarded as a substantial amendment for the review committee and the competent authority.
2. A medicinal product (being researched or otherwise) that is administered in the EU must be released by at least one 'Qualified Person' (QP) in the EU by means of a certificate. If the QP is located in the UK at this point in time, a QP in another EU member state will have to provide a new release certificate after Brexit. The change of the QP represents a substantial amendment for the assessing review committee and the competent authority. Such a substantial change can be submitted in combination for different studies if it involves the same change of the QP. The EudraCT form must, however, be amended for each study.
3. Retesting (analytical check) a batch in the EU is not obligatory, if this has already taken place in the UK or in another third country.
4. If a medicinal product being researched or a batch of these products was released by a QP before 30 March 2019 and is imported into one of the other 27 member states (EU-27) after 30 March 2019, this batch must be re-released by a QP into the EU-27. Retesting is unnecessary if that has already been done in the UK.
5. In the event of a second delivery after 30 March 2019 of a batch which was already released and imported before 30 March 2019, a new release must take place for this second delivery by a QP in the EU-27. This is because this delivery will be imported after 30 March 2019. Retesting is unnecessary if that has already been done in the UK.
The client no longer has a legal entity in the EU
6. The client, or a legal representative of the client, is obliged to be established in the territory of the EU. If the client or the legal representative is currently established in the UK, they must, therefore, be established in the territory of the EU-27 after 30 March 2019. You can submit a combination of substantial amendments like this for various studies to the review committee and to the competent authority. The EudraCT form must, however, be amended for each study. NB The amendment in EudraCT of a legal representative in the EU-27 for a study performed by a party established in the UK is technically not yet possible as long as the UK is an EU member state. This change can, however, be submitted as a substantial amendment, where the correction in EudraCT must take place as quickly as possible after 30 March 2019.
7. If the client is established in the UK, or has a legal representative in the UK, it is the client's responsibility to ensure that a legal representative is established in the EU-27 after 30 March 2019.
Protection of personal data
8. In the event of a no-deal Brexit there will no longer be any agreements about data protection between the UK and the EU. From that moment onwards the rules will apply which relate to the forwarding of personal data to countries outside the EU. See the websites of the European Commission and the European Data Protection Board for more information.
Information in the EudraCT database
9. Once the UK has left the EU the data in EudraCT relating to the UK no longer has to be submitted. An exception to this is a PIP (Paediatric Investigation Plan) study which is only carried out in the UK.
10. Results of studies which have been carried out in the UK must be submitted to EudraCT if the related statutory obligation becomes applicable before 30 March 2019.
11. However, results of studies which have been carried out only in the UK or in the UK with third countries must be submitted to the EudraCT database after Brexit if this is obligatory for a non-EU member state (for example a PIP study).
12. The QP that is responsible for the pharmacovigilance (QPPV) must be located in the EU-27 after Brexit and perform the tasks in a member state of the EU-27. This change does not need to be submitted to the review committee and the competent authority.
13. SUSARs must always be reported in the Eudravigilance database, irrespective of where they took place. Consequently, SUSARs from the EU and from third countries must be reported, even after Brexit.
14. Non-serious adverse reactions which have taken place in the UK after 30 March 2019 do not need to be reported in Eudravigilance.
Voluntary Harmonisation Procedure (VHP)
15. The UK can no longer act as rapporteur of VHP dossiers for which it was a rapporteur. Neither can it participate as an involved member state from 30 March 2019 onwards. Studies with regard to which the UK is already a rapporteur are to be transferred to a member state from the EU-27. See the website of the Heads of Medicines Agencies for more information.
Information about the consequences of Brexit for research with medical devices can be found in the following notifications from the European Commission:
- Notice to stakeholders: Withdrawal of the United Kingdom and EU rules in the field of industrial products
- Questions and answers related to the United Kingdom's withdrawal from the European Union with regard to industrial products
Further information can be found in the following notifications from the European Commission:
- For clinical research (particularly medicinal products): https://ec.europa.eu/info/files/clinical-trials_en
- For products (including medical devices): http://ec.europa.eu/docsroom/documents/27401
- For research with products of human origin (blood, tissue and cells, and organs): https://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/2017_btc_brexit_en.pdf