Britain’s departure from the European Union becomes a little less theoretical with each passing day. There was something poignant about the scenes in London last month, as EMA staff lowered the 28 EU flags in preparation for the Agency’s move to Amsterdam. Whatever one thinks about Brexit on the whole, the loss of 900 highly skilled staff-members as well as the MHRA’s leading role in European medicines regulation is hardly good for the UK. At best, it’s collateral damage; at worst, it’s like watching a “British success story” being broken up, as Mike Thompson, ABPI CEO, put it (1).
For me, the lowering of the flags symbolized Britain’s separation from the EU’s regulatory sphere – something the pharma industry was almost unanimously against (2). And something the UK government was hoping to avoid (in terms of pharmaceuticals), by asking to remain part of the EMA despite the contradiction with the its red line against single market membership.
The fact that the government would suggest such a thing implies that industry lobbying does have an impact. And though “no deal” is still on the table (I’ve been speaking to companies in the drug development space about their “no-deal” preparations – here), negotiations won’t end on March 29 – there will be much still to play for.
The idea behind the formation of the EMA – hosted by London since 1995 – was to reduce the cost and time incurred by companies seeking separate approvals in each member state. By reversing this act of harmonization, companies will naturally seek approval in the larger EU market first, leading to delays for the UK. Will Brexit also reverse the process of global regulatory harmonization (a fear expressed by Ezequiel Zylberberg here)? Or perhaps an independent UK could work with regulatory bodies around the world to increase harmonization amongst the larger markets... Either way, Britain will have to innovate to compete.
I believe this is what Mike Thompson meant when he said that Brexit would be a catalyst for positive change (3). He also told me: “politicians have great skill in going to the precipice and then turning back.” As a very steep drop approaches, and the consequences for the industry begin to crystalize, let’s hope he’s right on both counts.
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References
- The Guardian, “Britain loses medicines contracts as EU body anticipates Brexit” (2019). Available at: https://bit.ly/2LRtR9C. Accessed February 6, 2019. J Strachan, “Hold Me Closer, UK Pharma”, The Medicine Maker (2018). Available at: https://bit.ly/2GpCs4k. J Strachan, “The Successful Experiment”, The Medicine Maker (2018). Available at: https://bit.ly/2DbEv9d.
