Sunday, July 3, 2016

Brexit Antibiotics

The question of the meaning of the Brexit for the future of antibiotics has been haunting me since the surprising result of the referendum last week. I have more questions than answers. With this historic and world-shaking divorce between England (UK?) and the European Union comes uncertainty with regard to the future of efforts to provide for a sustainable supply of antibiotics to address the superbugs of today and tomorrow.

The UK is the epicentre, in many ways, of our current efforts in this regard.  David Cameron, who just announced that he would step down in October, appointed Jim O’Neill, the ex-Goldman-Sachs economist, to lead the Antimicrobial Resistance Review (I call it the O’Neill Commission). What an incredibly brave and wonderful move that was! Without the imprimatur of Cameron, where will we be? The entire effort within in the UK has been driven by George Osborne, the Chancellor of the Exchequer.  It seems unlikely that he will be around.

The O’Neill Commission itself may be winding down. While I hope that its effects will continue to be felt for years to come. I worry.  In the absence of key figures from the Commission and in the absence of an ongoing government imprimatur, I’m not sure what the future of the body of work that they produced will be. Will the reports lie fallow until some public health crisis occurs?  Are we back to waiting for disaster to strike instead of anticipating it?

Dame Sally Davies is the Chief Medical Officer for the UK and has been an essential and outspoken leader in the struggle to deal with the problem of antibiotic resistance on many fronts.  Will she remain in place to continue her efforts given that there will likely be a new government for the UK in the next few months.

The Wellcome Trust has also assumed a leadership role in the struggle against antibiotic resistance. While it is an independent, private, charitable organization, the Trust has worked closely with the UK government on issues around antibiotics and resistance. There is no doubt that the efforts of the Trust would be less effective and less far-reaching in the absence of British government support.

Funding for the incentives we have been discussing must come from various national authorities. Will the UK still participate in this effort? Some have argued that the G7 or G20  or even the UN will step up to the plate and provide funding in some international effort.  I remain sceptical of that concept.  However the funding is to be provided, though, the leadership of the UK to make it happen will be sorely missed. I fear that any organized, international effort may now be doomed and efforts to convince various national authorities to provide their own funding will also suffer in the absence of clear UK leadership.

Then there is the question of the European Medicines Agency and England’s own regulatory agency the MHRA. The EMA offices are currently located in London.  They would probably now want to move to the continent.  But what would happen to the central regulatory filing procedures that are now in place?  Would the UK or England drop out or continue as before? The MHRA has been a leader in regulatory reform in Europe for antibiotic development. Will this continue or will the EMA now be struggling to find new and less experienced leadership for this all-important effort?

As I said, I have more questions than answers.  But I am much less optimistic today than I was just a few weeks ago.

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