Saturday, July 1, 2017

Antibiotics - Europe Leads with a Mixed Message

The European Commission just released a plan for fighting antimicrobial drug resistance. I expected a great deal from Europe given their leadership on the regulatory front and in antimicrobial stewardship efforts.  They have also funded DRIVE-AB that has been studying pull incentives among other approaches to stemming drug resistance. I am guessing that this plan originates partly from DRIVE-ABs efforts.

There is much to like in the plan and I encourage everyone to read it.  Its less than 30 pages and has big print! 

The EU has a great deal to say on infection control and antimicrobial stewardship – all good.

To support the development of novel vaccines, therapeutics and diagnostics, the Commission will,

·      support research into the development of new antimicrobials and alternative products for humans and animals as well as the repurposing of old antimicrobials or the development of new combination therapies;
·      support SMEs (small and medium enterprises) in their R&D efforts towards innovative and/or alternative therapeutic approaches for the treatment or prevention of bacterial infections, together with the EMA;
·      facilitate sharing of antimicrobial research data among relevant stakeholders to guide future antimicrobial medicinal product discovery and development;
·      support the establishment of a European-wide sustainable clinical research network, which should speed up clinical studies on medicinal products, lower their costs, and improve coordination of clinical research;
·      support research and innovation to promote the use of digital technologies supporting the development of new therapeutics and alternatives.

I am most enthusiastic about the funding of R&D for new antimicrobials and the proposed clinical trials network.

In the section on incentives, the Commission proposes to,

analyse EU regulatory tools and incentives – in particular orphan and paediatric legislation– to use them for novel antimicrobials and innovative alternative medicinal products (e.g. vaccines, antibacterial, antifungal, antiviral agents) that currently do not generate sufficientreturns on investment;

Providing key new antimicrobials an orphan drug designation may (or may not) help provide the economic incentive that is needed.  See my previous blog on this.

But, I must admit that I am deeply disappointed with the EU’s treatment of pull incentives.

The Commission will support research into the development of new economic models, exploring and analyzing incentives to boost the development of new therapeutics, alternatives, vaccines and diagnostics.

If we have any more research on models I’m going to explode! DRIVE-AB just finished their research.  The Office of Health Economics has released a number of reports as has the London School of Economics.  This is a way of saying that Europe, as a unified group of nations, is unwilling to commit the resources required to provide the incentives that have already been recommended by others. I suppose it is also possible that the Commission was unable to choose among the various different models for incentives that have already been thoroughly researched and discussed.  This report therefore throws the responsibility for any action on pull incentives back to the various national authorities in Europe.  And it provides those national authorities with an excuse to further delay.  Rome, Nero anyone?

On pull incentives that we so desperately need to fill our lackluster antibacterial pipeline we now have a dearth of leadership.  The US has retreated to Neverland.  Europe is stuck in more bureaucracy. Until there is an outcry by citizens and legislators both in the US and Europe, this is where we will remain.  Are we going to wait for even more widespread more serious drug resistance problem to arise? Will we need an even larger epidemic than those we have already suffered? What will it take to get governments to act?

On the more optimistic side, my spies in Washington tell me that there is an understanding among legislators that something needs to be done. There are apparently two problems that stand in our way.  The first is the political concern around controlling drug prices. How can we propose a pull incentive and claim that it will reduce drug prices? The second is, apparently, that there is disagreement among various stakeholders (read pharmaceutical companies) as to the size of the incentive they think will be required (read – the amount of money they would like). Come on, guys!  Lets get real!

I know that there are a large number of very smart people working on this. But the clock is ticking . . . . Stay tuned.

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