Calls for MHRA to Work With EMA After Brexit or Face Drug Uptake Delays
There has been a series of calls for the UK pharma and medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), to work with the European counterpart...
...the European Medicines Agency (EMA) post-Brexit, in order to enable Britain to get access to drugs and medical devices.
Sir Alasdair Breckenridge, former chair of the MHRA, said pharma companies would have to pay for a separate assessment to clear new drugs for use in this country. As the UK market is very small compared to the European market, this may disincentivise companies from coming to the UK, or at least until after they have got their drug approvals elsewhere.
The current MHRA chair, Professor Sir Michael Rawlins, has also reportedly said that Japan, the US and the EU would be ahead of Britain in drug applications. He said: "One of the biggest worries I have about Brexit and standing alone as a regulator is that we are only three per cent of the world market for new drugs and if we are not careful we are going to be at the back of the queue."
David Jeffreys, vice-president of Eisai - a Japanese pharma business whose UK headquarters in Hatfield employs 450 people - said British patients could have to wait two years longer than currently to get access to new medicines. Mr Jeffreys has called for the UK to agree a co-operation deal with the EMA.
Jeremy Hunt, the Health Secretary, has expressed his hope that the UK could still work closely with the EMA.
If there is not such a co-operation deal with the EMA, lives will be lost, Professor Paul Workman, President of The Institute of Cancer Research, has said.
Dr Virginia Acha, executive director of the Association of the British Pharmaceutical Industry, said her strongest plea to Government was to not let this relationship with the EMA be pulled apart by the politics. She said people needed to be reassured that everything was being done to ensure that on day one of Brexit, they do not even notice and everyone gets their medicines just as they should.
It is clear that having strong regulatory ties is going to be one of the top issues on the pharma industry's wish lists for a post-Brexit Britain, and the pressure has already started on Government to make this happen.