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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