* Need to combat antibiotic resistance now "critical"
* EU to accelerate new drug approvals, ensure adequate
* Plan to boost R&D collaboration via IMI initiative
* Drugmakers welcome fresh incentives for antibiotic
By Ben Hirschler and Kate Kelland
LONDON, Nov 17 Europe set out plans to
boost research into the neglected area of antibiotics on
Thursday by promising to accelerate approval of new drugs, while
ensuring adequate prices for their makers and promoting
Multi-drug resistant bacteria, or so-called superbugs, are a
growing threat across Europe, with rates of drug resistance in
one type of bacteria reaching 50 percent in the worst-hit
countries, according to health officials.
But the medicine chest for new antibiotics is practically
empty, following a decision by many large drugmakers to exit
what has become an unprofitable area of research.
"We need to take swift and determined action if we do not
want to lose antimicrobial medicines as essential treatment
against bacterial infections in both humans and animals," EU
health commissioner John Dalli said, outlining the new strategy
at a briefing in Brussels.
A key element of the plan rests on using the existing
Innovative Medicines Initiative (IMI) -- a public-private scheme
jointly funded by industry and the Commission -- to speed the
discovery and development of novel antibiotics.
The goal is to encourage "unprecedented open sharing of
knowledge" between companies at the pre-competitive research
The Commission said it would also use flexibility in the
current pharmaceutical legislation to give rapid approval to new
antibiotics and would work with governments to make sure they
enjoyed "adequate market and pricing conditions."
Superbugs capable of evading even the most powerful
antibiotics are increasing their grip in Europe and the need to
combat resistance is now "critical", according to the European
Centre for Disease Prevention and Control (ECDC).
"We need to declare a war -- a war against these bacteria,"
the ECDC's director Marc Sprenger told Reuters.
Sprenger said that across Europe rates of resistance to
last-line antibiotics by a bacteria called Klebsiella pneumoniae
had more than doubled to 15 percent by 2010 from around 7
percent five years ago.
"What's even more worrying is that there's a great diversity
among different countries in Europe -- and some countries have
resistance of almost 50 percent," he said.
K. pneumoniae is a common cause of pneumonia, urinary tract,
and bloodstream infections in hospital patients. The superbug
form is resistant even to a class of medicines called
carbapenems, the most powerful known antibiotics, which are
usually reserved by doctors as a last line of defence.
The ECDC also found a worrying increase between late 2010
and early 2011 in the incidence of bacteria with a gene known as
New Delhi metallo-beta-lactamase, or NDM-1, that makes them
highly resistant to almost all drugs. The NDM-1 gene is often
found in bacteria like K. pneumoniae and E. coli.
With few new antibiotic drugs on the horizon, experts are
increasingly worried that only a few big drug firms, such as
GlaxoSmithKline and AstraZeneca, still have
strong antibiotic research and development programmes.
There is little commercial incentive to invest in new drugs
that may be held in reserve as last-line weapons.
Pharmaceutical companies also complain about increasingly
tough barriers for market approval -- necessitating extensive
and costly clinical trials -- as well as relatively low prices
compared with returns on treatments for diseases like cancer.
GSK Chief Executive Andrew Witty, who is also current
president of the European pharmaceutical association Efpia, said
the Commission's plans were a welcome step forward that could
help bring more antibiotics to market.
"Unfortunately, the current commercial model doesn't
stimulate the innovation needed in this area," he said.
"We need a fundamentally different approach and
public-private collaboration, with the sharing of information
and funding, provides us with a significant opportunity to
reduce the hurdles in our way."
To a large extent, antibiotic resistance is driven by the
misuse and overuse of antibiotics, which encourages bacteria to
develop new ways of overcoming them.
Experts say primary care doctors are partly to blame for
prescribing antibiotics unnecessarily for patients who demand
them. Hospitals are also guilty of overuse.
Sprenger said that the countries with the highest rates of
multi-drug resistant infections, such as Greece, Cyprus, Italy,
Hungary and Bulgaria, also tended to be the ones with the
highest use of antibiotics.
"In general what you see is that high resistance goes hand
in hand with high consumption," he said.