The unprecedented Britain’s exit from the European Union (EU), now commonly known as Brexit is scheduled on 30 March 2019; and is already causing lot of concerns and anxiety. In this blog, we have tried to explain few such general issues that affect clinical research and pharmaceutical industry and medical writing in particular. To understand the impact, it is good to know a bit about the background about what has been happening and what is scheduled to happen. Till now, United Kingdom (UK) has played a very important role in clinical trials, particularly in the case of paediatric medicine and rare diseases. The UK has a much smaller population (66 million) than the EU (512 million) and the US (323 million).

The UK is currently a part of many of the EU’s Research and Innovation Programmes, among which is Horizon2020, the largest life sciences public-private partnership in the world. When the UK leaves Horizon2020, it has been estimated that £8.5bn of funding and investment will be threatened; as a result, many UK-based multinational companies are considering transferring key research projects to the EU to ensure that they can still take part in international research programmes.

Clinical trials in Europe are regulated by the EU Clinical Trials Directive, which harmonized and facilitated the conduct of trials across all EU Member States, as there is only one set of standards to comply with. The EU in 2014 approved the new EU Clinical Trials Regulation (536/2014), which streamline the operation of multi-country EU trials through greater harmonisation, with a single portal for all applications. The UK’s exit from the EU will involve withdrawal from EU regulation, tariffs, and “red tape”, however, will also bring with it new regulatory challenges. As a result of Brexit, the European Medicines Agency (EMA) is to relocate from London to Amsterdam (scheduled date is 1 April 2019). In this scenario, there are two possibilities- if EU regulation come into force before the Brexit, its terms will be adopted into UK law OR if EU regulation is enacted after the Brexit, then the UK will not be in line with EU regulations.

Currently, the EMA and national regulatory bodies oversee all manufacturing, clinical trials and marketing authorisation of human and veterinary medicines in the EU, including in the UK. However, post-Brexit, it will be deemed a ‘third country’ and therefore, will cease to be part of the EMA. It is likely that clinical trials in the UK will require a separate authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) or its new regulatory body.

Most marketing authorisations have been applied under the decentralised procedure (national) or the centralised procedure (EU wide), both of which are based on Directive 2001/83/EC. Post-Brexit, the UK will need to have a system for independent marketing authorisation approval. Marketing authorisations granted by the UK will be unaffected and it is likely that marketing authorisations granted in the EU under the centralised procedure prior to the exit will be recognised by the UK. However, centralised marketing authorisations covering the EU held by UK companies will have to be transferred to companies established in EU countries unless mutual recognition agreements are put in place. Any active substances or finished medicinal products manufactured in the UK may need to be imported into the EU. This can only be done by an authorised importer in the EU or the European Economic Area (EEA). Each batch will have to be tested at an EU/EEA site of batch control to ensure it complies with EU Good Manufacturing Practice requirements.

Maintaining storage, supply chain, sample handling logistics and transport will be one of the major hurdles during the Brexit period, and the revised changes would need to be adopted in clinical research documents. Additional questions will also arise in relation to data protection (in particular clinical trial data and use of personal data) currently falling under the EU General Data Protection Regulation (GDPR) and the UK Data Protection Act 1998. UK companies will need to revise their pharmacovigilance reporting system as a single person cannot perform the pharmacovigilance function for the EU and UK as the appropriately qualified person should reside and operate in the EU.

The UK, after Brexit, can apply for observer status at the ICH and then for full membership, as a regulatory member. All the above things may need to be considered while drafting clinical research documents, for registrations and approvals, data sharing and disclosures. It is imperative for medical writers to remain periodically updated about Brexit and its impact.