Brexit has changed everything for the UK and its relationship with mainland Europe. There are so many questions of bureaucracy, within myriad industries and sectors, that it is difficult to know where to start with working out practical and effective solutions. This can be seen none more so within the healthcare, pharma and biotech sectors, and more specifically, what will happen to the process of testing medicines and the entire process of clinical trials in the UK once Brexit has been confirmed and the UK is no longer a member state of the European Union?
It is important at all times during the research, development and production of new medicines and healthcare products that strict quality controls are implemented and held. This is a priority within every industry, and over the years the EU has brought into line stringent guidelines and regulatory procedures to help bring all member states into line concerning clinical trials and testing. Pharma understands this, that there must be a strict process of testing before a drug can go to market. This ensures that safety is a priority for any person who takes the drug in question and that it is as effective as it needs to be to be sold on the market.
Alongside this, the EU approach to standardised clinical trials and a network and database that makes for transparent record keeping means that it is much easier than ever before for drug companies and big pharma to keep on improving products, utilising the experience and data of others to never waste time on practices that have already been conducted. What does the UK leaving the EU mean for this process?
First off, Brexit is causing great levels of uncertainty for pharma companies, especially as there has been little clarity from the UK government over how things will shift to a new paradigm (much like many other parts of life in the UK that are left hanging up in the air at the moment).
Once we are out of the transition period and the UK has officially left the EU, the UK drug market will sit outside the jurisdiction of the European Medicines Agency (EMA). It will also be denied access to the EU marketing authorisation applications, as they can be found in the centralised EMA mechanism that provides transparency for all countries.
Even on a tiny practical level such as the labelling of drug products, you are likely to see a big change. Product labels will have to be updated to comply with whatever the new UK-specific requirements are. On top of that, for those companies that work in both the UK and the EU markets (which most pharma companies will), they could be faced with going through two application and clinical trials processes before a product can legally be sold on the market. Even if both processes remain similar, the bureaucratic responsibilities and extra red tape that companies will have to work through, could provide a stumbling block that no one is happy with.