Pharma giants commit to tackling antimicrobial resistance
Leading pharma companies last week promised
to take concrete actions to combat antimicrobial resistance. The ‘industry
roadmap’ sets out four commitments and was signed by 13 companies, including GSK, Johnson &
Johnson, Merck and Co., AstraZeneca and Pfizer. It follows on from
the Davos Declaration’s call for a sustainable market for antibiotics in
January.
This is a pretty big step, says Kevin
Outterson, a professor of law Boston University in the US. ‘All the leading
companies in the antibiotics field [are] agreeing to sell less of their
product, making sure there is better access for poor people and being more
careful in how it is manufactured,’ he says.
Managing
pollution
The first key commitment is to tackle
pollution linked to antibiotic manufacturing. Discharging active ingredients
into the environment promotes drug-resistance in microbes, and the companies
have agreed to review their practices in controlling the releases of
antibiotics. In one study in India, effluent from a treatment plant contained
the antibiotic ciprofloxacin in concentrations as high as 31 mg/L, around a
million times higher than levels in regular treated sewage effluent.
This happens partly because its legal and it
is not so costly to lose some compounds, says Joakim Larsson, environmental
pharmacologist at Gothenburg University. ‘When
it comes to discharges of pharmaceuticals, there are no good regulations in
China or India or in Europe or the US,’ he adds. Good antibiotic
stewardship can entail trade-offs between benefits in patients and risks to
society, but antibiotic pollution just gives some cost savings.
‘This
is something completely within industry’s control and we need to sort it out.
And this roadmap says we are going to make it happen,’ says James Anderson,
director of external partnerships at GSK. He says GSK is comfortable that its
own API [active pharmaceutical ingredient] factories do not discharge high
levels of waste, but is rolling out a new audit process to external suppliers.
This will be completed next year. There is also a trade association to improve
supply chains.
It is hard to know how companies perform in
pollution. Many rely on contractors in India and China to produce APIs. ‘Industry does not self-report on discharges
in terms of antibiotics,’ says Larsson. He believes incentives from outside
are also needed. He views generic substitution strategies pursued by
governments in Europe as part of the problem because the lowest cost antibiotic
is subsidised. ‘If the state says only price matters, then they ignore those
who try to improve the pollution situation. Why should companies increase their
costs?’
He points to one strategy recently adopted by
Swedish hospitals: to ask for certain qualities in terms of manufacture,
including emissions. Anderson strongly agrees. ‘Industry driving itself forward
and purchasers starting to request clarity: that will make a real difference in
the next few years.’ The roadmap sets a target to have a common framework for
managing discharge by 2018. Industry argues that it still has to develop a
scientific understanding of what constitutes acceptable minimums.
Others welcome a self-regulatory approach by
industry, with provisos. ‘There are benefits to self-regulation. It’s less
bureaucratic and a company might introduce different models, but it needs
accountability and good monitoring,’ says John-Arne Rottingen, infectious
disease expert at the Norwegian Institute of Public Health. He adds antibiotics
should have a full list of ingredients, detailing where and when they are
produced.
Prescription
problems
The
second commitment is to ensure antibiotics are used only by those who need
them, which the signatory companies have promised to examine by the end of
2017. Potential strategies include the removal of incentives to sell more
antibiotics, as well as working to reduce uncontrolled purchases such as
over-the-counter and internet sales.
‘There
is a long history of various companies over the decades aggressively selling
antibiotics all over the world. They were treated as cheap and easy to replace,’
says Outterson. ‘This is the first time
industry has said collectively said we need to prioritise stewardship and
reduce sales.’
GSK has already de-linked pay with sales
volumes for all its drugs. ‘We now reward our sales reps based on technical
knowledge and feedback from doctors, rather than sales volumes, which is the
typical mechanism,’ says Anderson. This was brought in globally at the
beginning of this year.
‘Industry
has so far not recognised antibiotics as different, but in fairness they never
had the right incentives,’ says Ramanan Laxminarayan, who directs the US-
and India-based Center for Disease Dynamics, Economics & Policy. He
believes the industry can do more to ensure sales are properly regulated. ‘They
have the muscle to do that, but haven’t exercised it.’
Another commitment is better access to drugs,
especially in poorer countries. Industry is hoping that a Market Entry Award,
as proposed by the O’Neill review, will help here. ‘You could either create a new global fund or let countries allocate a
portion of a payment to reward a new antibiotic,’ explains Christine Ardal
at the Global Health Policy Institute, who works on DRIVE – AB, a project
looking at new economic incentives for antibiotic innovation.
Many in the field are adopting a wait-and-see
stance on the roadmap. ‘I take all these
commitments with some skepticism until they are acted upon,’ says
Laxminarayan. ‘I hope the next press
release will not be a promise but a report card.’ Anderson says more
companies can sign the roadmap and hopes to give periodic updates on progress.
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