ANTI-MICROBIAL RESISTANCE

EFPIA backgrounder, issued on World Health Day, 7th April, 2011.

EFPIA fully supports the position of the IFPMA.

We welcome the initiative of the World Health Organization to make antimicrobial

resistance the theme of World Health Day. In 2009, the European Centre for Disease
Control (ECDC) estimated that 25,000 European die each year as a result of a drug-
resistant infection. This will add to the momentum imparted by the ECDC’s annual
Antibiotic Awareness Day which takes place in November.

The decline in antibiotic R&D is a long-term phenomenon, and will take time to reverse.
However it demands urgent action and will require commitment from all stakeholders.
2011 will be a key year for reversing this decline. In November, the European
Commission will launch a new resistance strategy as a response to the Council
Conclusions reached under the Swedish Presidency in July-December 2009.

Reflecting the extensive preparatory work carried out by Sweden, the detailed
Conclusions included calls for:

Member States to: “Review and consider options to strengthen incentives to

conduct research and development of new effective antibiotics within the
academic as well as the pharmaceutical sector as a whole, taking into account
the situation of small and medium-sized enterprises. These options and methods
could include cost-effective push mechanisms to remove bottlenecks in the
early stages of research and development of new antibiotics and pull
mechanisms to promote the successful introduction of new products.”

Member States and Commission to: “Explore ways to promote further public-
private partnerships between industry, academia, non-profit organizations and
the healthcare system to facilitate research into new antibiotics, strategies for
use of currently available antibiotics and diagnostic methods;”

The Commission to “Within 24 months, develop a comprehensive action-plan,

with concrete proposals concerning incentives to develop new effective
antibiotics, including ways to secure their rational use; and ensure that these
proposals take account of the economic impact on the financial sustainability of
healthcare systems.”
The Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) will release its report,
which will include recommendations on how to invigorate R&D through financial and
regulatory reform. TATFAR was launched at the 2009 EU-US Summit1 and is led for Europe
by the Commission. The coordinated action of the EU and US is very important, not least
to action at a global level and we hope that the TATFAR process will be renewed
following the conclusion of this initial phase.

The Commission has a key role to play in a healthcare problem which is, by definition,
supra-national. The industry will provide the Commission with its full support in
developing the concrete proposals called for by the Council; however we note that this
issue is urgent, underlining the need for an ambitious strategy document and further
collaboration with the US. We ask the Parliament to give its support to this effort by
promoting further discussion of the policy options in the run-up to the launch of the
strategy.

1 The EU and US agree “To establish a transatlantic task force on urgent antimicrobial resistance
issues focused on appropriate therapeutic use of antimicrobial drugs in the medical and
veterinary communities, prevention of both healthcare- and community-associated drug-
resistant infections, and strategies for improving the pipeline of new antimicrobial drugs, which
could be better addressed by intensified cooperation between us.”