UK still a key player
The Clinical & Contract Research Association (CCRA) held a one-day session entitled The Landscape for CROs post Brexit—An Update on 31 January 2018 at the Royal Society of Medicine in London, one year on from a similar event in January 2017. The session was chaired by Dr Virginia Acha, Executive Director, Global Regulatory Policy, MSD. While some of the passions surrounding Brexit may have calmed over the past year, there still remains much of the uncertainty about what Brexit means for the clinical research sector in the UK.
Throughout the day, the speakers emphasised the country's role in clinical research. For instance, 70% of EU investigational medicinal products (IMPs) are released from the UK; there are currently 1500 ongoing EU clinical trials sponsored by the UK; 1300 authorised EU products have been tested and released from the UK.
Thus, maintaining UK expertise and influence in life sciences and clinical research outside a large trading bloc is an important aim post-Brexit.
Brexit at a cost for life sciences
One uncertainty after the UK leaves the EU concerns the regulatory framework for clinical trials. A stand-alone UK regulatory model post-Brexit would mean an additional regulatory burden, which would increase costs. Negotiating mutual recognition with the EU would also take a lot of time. It is also important to maintain pharmacovigilance cooperation: if the UK is unable to access centralised databases, patients might suffer.
Safeguarding key interests
Dr John Poland, consultant to the Association of Clinical Research Organisations (ACRO), outlined what ACRO believes the UK needs to do, such as securing long-term, predictable access to funding and international collaboration for scientific research and improving tax benefits and intellectual property protection to encourage clinical research in the UK. Finally, the UK needs to establish a more collaborative environment between the NHS and industry. This would help support innovative product use in the clinical trial setting and modernise the clinical research process.
Dr Poland highlighted the need to ensure an unhindered product supply chain, since about 40% of IMPs in clinical trials being run in the EU are made in the UK. Additional requirements and/or costs to export IMPs to the EU will mean manufacturing capacity will transfer to EU countries. Dr Poland also emphasised the need for an unrestricted flow of personal data. When the Clinical Trial Regulation comes into application, there will be a single submission for clinical trials in the EU via a portal. If the UK is unable to participate in these new processes (and the date for the clinical trial portal becoming operational is believed to be the second half of 2019), it will become a less appealing place for clinical trials in Europe.
CROs preparing for the divorce
Dr Ben Quarterly, Executive Director, Global Clinical Development at Covance outlined the perspective of a global clinical research organisation (CRO) on Brexit. He explained Covance is monitoring developing thinking in London, Brussels and elsewhere and has an internal Brexit taskforce with defined roles and responsibilities. Experts need to analyse the potential impacts of Brexit, while CROs need to be ready to capitalise, prepare, engage and inform regarding the whole process. He pointed out potential opportunities: Brexit may allow a faster path for starting clinical trials and enable leverage of the overall benefits of the UK. There is already a positive focus on life sciences, research and innovation in the UK and the government is motivated to support access to international talent and to develop young people through the sciences.
Dr Lincoln Tsang, a partner at Arnold & Porter Kaye Scholer LLP, took us through the minefield of the legal landscape and the consequences of "no deal" and stressed the complexity of disentanglement from the EU and that Britain’s future relationship with the EU is still very much guesswork. Annabelle Malins, from the Department of International Trade, emphasised the importance of providing certainty and continuity to UK business post-Brexit. To do this, all negotiation outcomes need to be taken into consideration.
The day ended with a panel discussion reviewing the various issues raised during the meeting. A practical problem arising from the questions concerns the shipment of clinical trial supplies (which are often time- and temperature-sensitive) from EU countries to the USA. These issues often include hold-ups at customs. When the UK leaves the Union, will there be similar problems? Will these put patients at risk, especially if they cannot access their treatment straight away due to customs delays? Another potential problem is tariff imposition: will this lead to loss of investor confidence in the UK life sciences field?
In other words, when it comes to Brexit, there are still more questions than answers.