One of the most contentious topics surrounding the UK’s membership of the EU, and an issue which was often cited by the leave campaign, is the high level of EU regulation which impacts and influences the UK. There were arguments on both sides in the run-up to the referendum – with one focused on the extra red tape and unnecessary levels of bureaucracy – and the other on increased centralisation reducing the administrative burden on domestic regulators.
Now that the decision has been made, the question begs, what will health regulation look like in the run-up to and following Brexit?
What will stay the same? What is going to be flipped on its head? And how long will change take to be implemented?
One thing we do know is that nothing will happen in the immediate term, firstly the enactment of Article 50 in the Lisbon Treaty and the timeline for negotiations will be set by the new leader – who that is we don’t quite know – and secondly, the process of negotiating our exit from the EU is predicted to take two years at a minimum.
With regards to practical arrangements for licensing and regulation, we can probably expect to see a general sense of business as usual. For example, the UK will only have to reapply for full or observer membership of the European Medicines Agency, if it chooses to do so, once it has officially exited the EU. However, we can probably expect to see negotiations before this, which will provide clarification on what membership of the EMA would look like, or whether we would choose to regulate on a domestic basis via the Medicines and Healthcare Regulation Authority (MHRA).
So when change does eventually come, what could we expect? To some extent, we may see negotiation efforts leaning towards keeping regulation the same. Whilst possibly falling under different hats and names, we could see, mutual recognition that sentiments which form current regulation should not dramatically change.
Taking the 2014 regulation for clinical trials for example – these were designed with a view to reducing pressures in individual countries, and were broadly welcomed with the assurance of a consistent standard. As such, one could assume that, regulation negotiations will focus on upholding regulation that works well, as opposed to going back to the drawing board.
However, we may find that negotiations bring light to the fact that upholding similar regulatory structures to the EU, or continuing membership of organisations such as the EMA, simply isn’t possible. This could be for a number of reasons, such as the lack of power to amend regulations isn’t a viable option or because it may be at odds with whatever model the UK adopts.
Given the length of time it will take for changes to be adopted and implemented – the one thing we can say with certainty is that health regulation will operate as normal in the meantime. In the future, there will probably be a strong will from the sector at least, to operate within similar frameworks – however, what best scenario we will be able to be negotiate, will only become clear as we head towards the Exit.