George Peretz is a QC specialising in EU and public law.
The regulation of medicines and other healthcare products is a matter, literally, of life and death. It is an area of enormous importance to UK industry and science. But it is also an area where the large disadvantages of leaving the EU are accepted even by Brexiters.
That is why the long-defunct Chequers White Paper, published over the summer, proposed that the UK would seek participation in the European Medicines Agency (EMA) “as an active participant, albeit without voting rights, which would involve making an appropriate financial contribution”. This statement shows that the best outcome the government thought could be obtained after Brexit was to remain subject to, and to carry on paying for, EU regulation in in medicines – while no longer having any say in that regulation.
But even that modest objective has not been achieved. The “Political Declaration” on our future relationship with the EU, secured as part of the government’s Brexit deal, contains only vague promises. It suggests only that the EU and UK “will also explore the possibility of cooperation of UK authorities with EU agencies such as the EMA”. That is far short of the promise of “active” UK participation in the EMA’s work sought by the government.
The reason why the government is in this position is that hardly anyone sees the merit in the UK setting up its own parallel system of regulation to that of the EU. Such a parallel regime would be very costly in terms of the additional resources needed to staff the UK regulator. Since the costs of both seeking and maintaining regulatory approval are very high, it would also mean large additional costs for pharmaceutical companies operating in the UK market.
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Click here to find out moreAt best, there would be delays in getting medicines onto the UK market, as pharmaceutical companies concentrated their efforts on the EU and US, dealing with the UK later. That is a significant problem in Canada, which currently runs a separate regulatory system to that of its much larger neighbour.
At worst, pharmaceutical companies will just decide that the additional costs are not worth paying and refuse to market their new products in the UK at all.
In theory, one answer might be for the UK automatically to allow in any product licensed by the EMA or other 27 EU countries. But that is hardly “taking back control”: the UK would be delegating responsibility for ensuring the continued safety of all its medicines to a foreign regime in which it played no part – and from which it could not even access relevant data.
That would be an extraordinary position for the UK to be in, given the size and importance of its pharmaceutical sector. And it would be hard to see it surviving a case where the UK had rubber-stamped a licence for what turned out to be a harmful medicine (thalidomide, for example) just because the EU had decided to license it.
Medicines are a key UK interest. They are also an area where there is simply no better outcome for the UK than staying in the EU.
Edited by Luke Lythgoe
Surely we could and should at the very least revoke our decision to leave Euratom, and so ensure the free movement of radioactive isotopes into the UK that are critically important for certain types of vital scans. We don’t need another referendum to sanction that, as the 2016 one never touched on the issue at all, and did not mandate our leaving Euratom in the first place. That was just a daft decision by Mrs May, taken after the referendum, acting alone in private without consulting anyone, so far as we know.
Do we drop out of the EMA on 29th March 2019 under May’s withdrawal agreement or at the end of the transition period? How about all the other EU agencies – 29th March 2019 or the end of the transition? If the former, are we going to grind to a halt on 29th March 2019 even despite the transitional period? We are certainly leaving Euratom on that date. How are we going to import radioisotopes, what happens to our collaboration in ECDC and EWRS, as well as all the many other agencies?