Dr Ian Hudson, the long-serving head of the UK medicines regulator the MHRA, is to step down in September 2019.
The news adds to the huge upheaval at the agency, which faces huge uncertainty post-Brexit, with its future place within the European Medicines Agency (EMA) regulatory network still undecided.
The MHRA, like the pharma industry, has had to plan for all eventualities since the UK voted to leave the EU in June 2016. This has included planning for a no deal Brexit, and it recently conducted a consultation on how it could re-position itself as a standalone regulator outside the EMA network with a ‘streamlined approach’.
Dr Ian Hudson
However in the ‘soft Brexit’ as envisaged by Theresa May’s proposed deal, the MHRA would remain part of the EMA network, but wouldn’t having any voting rights or influence on decisions, and would still lose out on the lucrative work it has carried out for the EMA.
The financial impact of this is already affecting the agency, with the EMA reallocating work from the MHRA to other European agencies.
It’s against this background that Dr Hudson is resigning, and the timing of his departure means the MHRA will have to start looking for his successor in 2019, just as the pressure mounts before Brexit day on 29 March.
Dr Hudson said: “My reasons for stepping down are both personal and professional. I had always intended to reduce my total work commitment to enable me to pursue other things and perhaps have more of a portfolio career by the time I reached 60, which has now happened. I feel the time is right for a new person to guide the Agency and our work through its next phase, following the UK’s departure from the European Union next year.”
He added: “Although I will be standing down next autumn, my focus remains on ensuring the Agency delivers its essential contribution to public health, and I look forward to continuing to lead our work until September 2019.”
A paediatrician by training, Dr Hudson has been at the MHRA for 17 years, serving as its chief executive for the last five. He was promoted from his role as MHRA’s Licensing Director in 2013, where he was responsible for the majority of medicines licensing activities.