AMRC Brexit blog series: regulations for research and health By Dr Cat Ball, Policy Manager, AMRC Published: 6 April 2017 This is the third and final blog of AMRC’s series on Brexit and medical research. It looks at some of the regulations on medical research and health that will be affected by Brexit. Over the past 40 years regulations on medical research - including those that relate to clinical trials, medicines licensing, data and animal research - have been determined by the EU, with the UK often at the heart of shaping those regulations. Last year, we asked our members to identify the EU regulations and frameworks that matter the most for research and patients - this is what members told us: Clinical trials directive (to be replaced by a new Clinical Trials Regulation in 2018) Protection of animals used for scientific purposes directive Protection of personal data directive (to be replaced by a new Data Protection Regulation in 2018) Medicinal products for human use, including regulations for orphan medicines and paediatrics EU regulations and frameworks that affect medical research are diverse. There isn’t enough space in this blog to examine them all. Instead, therefore, this blog will focus on the regulatory frameworks for medicines – which are likely to affect both patients and medical research. Regulatory frameworks for medicines Within the EU, new medicines are approved by the European Medicines Agency (EMA). In short, the EMA undertakes scientific evaluations of medicines and forms scientific opinions on whether the medicine may be authorised or not for use in one, several or all EU member states.* The benefit of an EU framework for approval is that it covers a large market. The UK is only 3% of the global pharmaceutical sales market, compared to the EU which is 25%. The EU is therefore a comparatively attractive place to launch new medicines. In Australia and Canada, where medicines are licensed nationally, typically patients access new medicines 6-12 months later on average than those in the EU/USA. To stay part of the larger EU market for medicines, AMRC are calling for continued cooperation with EU regulatory frameworks. Though we recognise that in future, as medical research advances, there may be opportunities where we may wish to diverge from EU regulations. This would need to be achieved while maintaining compatibility. People with rare disease For people with rare diseases, EU frameworks for medicines and research are particularly important. The EU’s single authorisation process makes it possible to bring new treatments to the market in a cost-effective way. In addition, EU regulations allow multi-centre clinical trials across the EU’s larger population – critical for rarer conditions – and the sharing of data and EU databases that facilitate research and collaboration. EMA – stay or go? In debates and media speculation on Brexit so far, the UK’s participation in certain EU institutions has been highlighted. The EMA is one of these organisation and has gained attention recently because it is based in London. The question of whether the EMA will stay or leave London has been raised. In fact, an Irish Health Minister confirmed back in November that Ireland will formally bid to host the European Medicines Agency (EMA) in the aftermath of Brexit. The EMA is an EU institution, thus once we leave the EU, we will (in theory) no longer be part of this institution. But that scenario is not so black and white. The UK is instead likely to have a relationship with the EMA - the key question is what will this relationship look like? Future relationship with the EMA? AMRC, on behalf of our members, are calling for the UK to have continued cooperation and a working relationship with the EMA - one where we are able to remain part of the scientific process. Without alignment on medicines regulation, we believe patient access to new innovative medicines will be slower than it currently is. Being part of the scientific processes will also be important, especially if we want to share future regulatory processes. The UK has a lot of offer in the regulatory space - the UK’s national regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), provides capacity for the EMA. It’s estimated that it contributes approximately 30% of overall EMA workload. The MHRA contains significant expertise and it may be in the best interests of both the UK and the EU for cooperation to continue. AMRC are therefore urging Government to include future involvement with the EMA as a priority within Brexit negotiations. * It should be noted that national approval and decentralised processes via the MHRA also exist.