Possible consequences of Brexit for clinical research
The United Kingdom (UK) is leaving the European Union (EU) on 30 March 2019. There will be a 'no-deal Brexit' if, at that moment, no agreement has been reached between the UK and the EU regarding the terms and conditions governing the UK's withdrawal. In that case current European legislation in the field of clinical research will no longer be applicable to the UK.
Because, at that point in time, no rules and procedures will apply any longer with regard to trade between the UK and the EU, there will be a serious risk of disruptions to security of supply of, for example, some medicinal products and medical devices which come from the UK. This situation will also have direct consequences for approved and ongoing clinical research in the EU insofar as this takes place via the UK. All the parties involved are advised to take the necessary measures to safeguard continuity.
The following things are important in terms of reviewing new clinical research and the continuity of already approved and ongoing clinical research into medicinal products:
- 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.
- A medicinal product (which is required for research) 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. A new certificate by a QP represents a substantial amendment for the assessing review committee and the competent authority. You can submit a combination of substantial amendments like this for various studies. The EudraCT form must, however, be amended for each study.
- 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 after Brexit. You can submit a combination of substantial amendments like this for various studies to the assessing review committee and to the competent authority. The EudraCT form must, however, be amended for each study.
- In the case 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 stricter rules will apply to the forwarding of personal data from the EU to the UK, namely rules concerning the forwarding of personal data to countries outside the EU. These are laid down in chapter V of the General Data Protection Regulation (GDPR). See also: http://ec.europa.eu/newsroom/just/item-detail.cfm?item_id=611943.
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