Brexit and clinical research
The United Kingdom (UK) has left the European Union (EU) on 31 January 2020. A transitional period is now in place until 31 December 2020. During this period, all EU laws and regulations will continue to apply in the UK. Virtually nothing will change for the public and for businesses during this period. Sponsors and researchers need to be prepared for the situation following the transitional period.
The EU and the UK are currently negotiating the details of their future relationship. There will be more clarity on the relationship between the EU and the UK once these negotiations have been concluded. The new agreements should take effect as of 1 January 2021, after the transitional period.
Should the EU and the UK fail to reach new agreements, the UK will be treated in the same way as a so-called 'third country' after the transitional period. 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 the expiration of the transitional period. In urgent cases you may contact the CCMO so that your amendments can be processed as a priority.
Delayed delivery of research medication
1. After experation of the transitional periode, 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, without a new agreement, a QP in another EU member state will have to provide a new release certificate after the transitional periode has expired. 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 the end of the transitional period and is imported into one of the other 27 member states (EU-27) after the transitional period, 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 the transitional period has expired of a batch which had already been released and imported before the end of the transitional period, 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 the transitional period has expired. Retesting is unnecessary if that has already been done in the UK.
The sponsor no longer has a legal entity in the EU
6. The sponsor, or a legal representative of the sponsor, 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 the transitional period has expired. 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 soon as possible after the transitional period has expired.
7. If the sponsor is established in the UK, or has a legal representative in the UK, it is the sponsor's responsibility to ensure that a legal representative is established in the EU-27 after the transitional period has expired.
Protection of personal data
8. Should the UK and the EU fail to reach new agreements on data protection after the transitional period has expired, the rules relating to the forwarding of personal data to countries outside the EU will apply. For more information, consult the websites of the European Commission and the European Data Protection Board.
Information in the EudraCT database
9. If no agreements have been reached after the transitional period has expired, the data in EudraCT relating to the UK no longer have 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 the end of the transitional period.
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 the transitional period has expired, 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 the transitional period has expired and must 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 the transitional period has expired.
14. Non-serious adverse reactions which have taken place in the UK after the transitional period has expired 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 after the transitional period has expired. Studies with regard to which the UK is already a rapporteur are to be transferred to a member state from the EU-27. For more information, please consult the website of the Heads of Medicines Agencies.
Information about the consequences of the future relationship between the EU and the UK for research with medical devices may 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 may be found in the following notifications from the European Commission:
- For clinical research (particularly medicinal products): https://ec.europa.eu/info/publications/clinical-trials
- 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