European drug regulation at risk of stalling as agency prepares to leave London

First published in Nature, 12.10.2017

Drug regulation in Europe could temporarily freeze if the European Medicines Agency (EMA) loses staff during its post-Brexit move from London. Up to 70 per cent of its 900 staff have said they would quit if the agency relocated to some of the cities bidding to host the organisation.

According to a battle plan drawn up by agency management, failure to retain enough staff would result in a shutdown of essential operations until more people could be hired. If fewer than 30% of the staff move with the agency to its new destination — to be decided next month — it would cease operation, Guido Rasi, the agency’s executive director, told Nature.

The EMA, an agency of the European Union, needs to leave London — where it has been headquartered since 1995 — as a result of Brexit. In addition to its permanent staff, the agency hires many other experts on a short-term basis. Following an internal staff survey undertaken in September, the agency urged European heads of state to pick a location to which at least 65% of staff would relocate.

Bids for a home

Some 19 cities across Europe have applied to host the prestigious organization. Last week, the EMA released its own assessment of the applications, and warned that several locations are entirely unsuitable for the agency’s location. Proposals for Sofia, Malta and Warsaw met almost none of the requirements put forward by the agency and could result in huge staff losses, Rasi warned. Amsterdam was the most popular alternative to London.

“The best case is, of course, a continuum of our activities, with only about 20% staff loss,” he says. “The worst case scenario we have come up with is 94% staff loss. For our business-continuity plan, we found three levels of activities we can delay, put on hold or stop completely.”

According to Rasi, the agency’s core mission — the regulation and monitoring of innovative drugs across Europe — would be the last thing to stop. But even with 50% staff loss, the agency would have to reduce advisory support to new research projects, which could stall work on innovative medicines, he says (see ‘European Medicines Agency chief raises alarm at forced relocation‘).

The agency assesses all medicines, including veterinary products, to be sold on the European market, and passes on recommendations to the European Commission for authorization. It evaluates reports of adverse reactions and, if necessary, works with national agencies to ban medicines that are suspected of being dangerous. The EMA also has in-house scientists who provide advice to drug developers on which criteria they need to fulfil to get a product passed.

In 2016, the agency recommended 81 new medicines for authorization and answered more than 450 requests for scientific advice.

Medication mediation

The European Federation of Pharmaceutical Industries and Associations, headquartered in Brussels, has called on member states to put the agency’s well-being first when choosing a location. “There are many cities that could have the right criteria for the agency to settle,” said a spokesman. “There is a potential for disruption, but also a potential for harmony. It all depends on what you choose.”

In the United Kingdom, pharmaceutical companies worry about how they will get their medicines approved after Brexit. The BioIndustry Association, a group of British life-sciences companies, has backed a UK government proposal to maintain authorizations for medicines granted before Brexit and the continuation of work with the agency during a transition period.

“The alternative — organizing and delivering a wholesale change — would be a gargantuan task for companies and regulators across the UK and Europe,” says Steve Bates, the association’s chief executive officer. “It would be extremely challenging to successfully deliver in the short amount of time left until Brexit in March 2019.”

Meanwhile, the uncertainty about the agency’s future is already causing problems. The agency has been unable to fill a position as head of veterinary medicine; all three potential candidates said that they would wait for the final location to be announced before deciding whether or not to take the job, according to Rasi.

Europe’s heads of state will meet on 18–20 October to begin hammering out an agreement. A decision is due to be announced on 20 November, at the next EU General Affairs Council meeting.

Lack of water and sanitation in hospitals mars SDG progress

First published on SciDev.Net, 25.01.18

[LONDON] Only 2 per cent of hospitals and clinics in lower and middle-income countries (LIMCs) provide patients with good quality services across the four key areas of water, sanitation, hygiene and waste management.

The finding comes from the first study to provide a baseline measure of environmental conditions in healthcare facilities to support progress towards the UN Sustainable Development Goals (SDGs). It looked at more than 130,000 facilities worldwide, and found that half of them lacked regular access to piped water.

The study also warned that around 40 per cent of hospitals and clinics in LIMCs are short of hand-washing soap. The same percentage of facilities cannot provide infectious waste disposal, and three out of four do not have enough sterilisation equipment.

To come up with the estimates, researchers at the Water Institute of the University of North Carolina in the United States compiled data from various sources including UN reports and peer-reviewed literature.

“Nearly 60 per cent of facilities do not have reliable electricity, making it difficult to deliver babies at night, refrigerate vaccines, and provide other critical services,” says Ryan Cronk, one of the authors of the paper.

Without water we cannot do surgeries or flush the toilets, so conditions quickly become terrible

Julius Mollel

The study, published this month (11 January) in the International Journal of Hygiene and Environmental Health, looked at six countries in detail: Bangladesh, Haiti, Malawi, Nepal, Senegal and Tanzania.

Among them, Bangladesh had the highest proportion of facilities with sewer access; but even then, only 17 per cent of hospitals and clinics pipe their wastewater into a sewage system. Access to clean water and wastewater treatment is one of the biggest problems healthcare facilities face in LIMCs.

Julius Mollel, a general surgeon at Nkoaranga Hospital in the Meru district in Tanzania, says getting water is a daily struggle for the hospital, as local groundwater resources are depleted. “Without water we cannot do surgeries or flush the toilets, so conditions quickly become terrible,” he tells SciDev.Net. “We always keep back 50 litres for [each toilet facility in] emergencies.”

According to the study, only 32 per cent of healthcare facilities in Tanzania have access to basic water services. Mollel says Nkoaranga Hospital is looking to international donors to install a 100,000-litre tank to ensure it has a steady water supply. “We get no money from the local government for this,” he says.

Faith-based healthcare facilities appear to be faring better than state-funded ones, and Cronk says this may be linked to more access to international funding making up for a lack of government support.

Where basic water and sanitation facilities are present, there are often secondary problems: more than 70 per cent of Nepalese healthcare facilities, for example, provided toilets for patients, but only 26 per cent had separate toilets for women, leaving female patients vulnerable and exposed.

The authors say that lack of these services threatens the achievement of the water and health-related SDGs. UNICEF, which works with the World Health Organization on implementing the SDGs, says this affects the most vulnerable patients most, especially mothers and newborns.

According to Lizette Burgers, senior adviser on water, sanitation and hygiene at UNICEF, sepsis and pneumonia are the most common infections picked up in hospital settings. “We need to return to the pre-antibiotic era, when infection prevention was recognised as a priority,” she told SciDev.Net. “Governments and other relevant partners have a crucial role to play in making this a reality.”

The WHO is planning to publish a global update on hygiene in healthcare facilities later this year, as part of its monitoring of SDG 6 on clean water and sanitation.

Need a creativity boost? Try listening to happy background music

First published in the New Scientist, 06.09.17

Need inspiration? Happy background music can help get the creative juices flowing.

Simone Ritter, at Radboud University in the Netherlands, and Sam Ferguson, at the University of Technology in Sydney, Australia, have been studying the effect of silence and different types of music on how we think.

“People in lots of contexts use music to help them work,” says Ferguson. A better understanding of how different types of music affect creativity is likely to be useful for many people, he says.

They put 155 volunteers into five groups. Four of these were each given a type of music to listen to while undergoing a series of tests, while the fifth group did the tests in silence.

The tests were designed to gauge two types of thinking: divergent thinking, which describes the process of generating new ideas, and convergent thinking, which is how we find the best solutions for a problem.

Ritter and Ferguson found that people were more creative when listening to music they thought was positive, coming up with more unique ideas than the people who worked in silence.

“We also tested other musical excerpts that were sad, anxious and calm, and didn’t see this effect,” says Ferguson.  “It seems that the type of music present is important, rather than just any music.”

However, happy music – in this instance, Antonio Vivaldi’s Spring – only boosted divergent thinking. No type of music helped convergent thinking, suggesting that it’s better to solve problems in silence.

Dose of dopamine?

Ritter and Ferguson write that their findings could be used to enhance creative thinking in places like educational institutions or laboratories. They think that happy music may work because it is more stimulating, so boosts divergent thinking by arousing the brain.

But Irma Järvelä, at the University of Helsinki in Finland, says happy music may boost creativity by triggering the release of dopamine, a brain chemical involved in pleasure and satisfaction. “Dopamine also increases creative thinking and goal-directed working,” says Järvelä.

The researchers think happy music may not have helped convergent thinking because this kind of thinking relies more on logic and less on arousal. But the experiment was organised so that everyone did the divergent tests before the convergent tests, meaning it could simply be that Vivaldi’s piece has less of an effect the second time you hear it.

Shipping pollution hotspots mapped with real-time data

First published on SciDev.Net, 30.08.17

Coastal areas around South East Asia suffer the most from pollution caused by ship traffic, according to a global study that estimates shipping emissions based on real-time, local activity for the first time.

The study, published this month (19 August) in Atmospheric Environment, sheds light on forces at play in a region where shipping pollution is believed to cause up to 24,000 deaths a year. The researchers put together a detailed picture of the emissions of around 300,000 commercial vessels for the year 2015. They found  that three of the six most polluted harbours – Singapore, Hong Kong and Shanghai – are in South East Asia.

The Malacca Strait, the Eastern China Sea and the Yellow Sea have the world’s highest concentration of shipping emissions, the authors said.

“In some harbour areas shipping can cause severe health effects and premature deaths.”

Lasse Johansson

They used data from the global Automatic Identification System (AIS), which requires all ships larger than 300 tonnes to regularly report their position. This is significant because it records where ships have been and when, allowing a more precise estimate of shipping pollution compared to previous studies.

The team from the Finnish Meteorological Institute joined around 8 billion AIS data points to cover more than a billion kilometres travelled by commercial ships worldwide in 2015. By combining this data with information on vessel size, engine type and fuel used, they managed to draw a high-resolution image of shipping pollution, particularly highly dangerous small-particle pollution less than 2.5 micrometres in diameter.

The consequences of inhaling these pollutants are serious, says lead author Lasse Johansson, a research scientist at the institute. “In some harbour areas shipping can cause severe health effects and premature deaths.” A 2007 study showed that small-particle emissions from ships lead to an estimated 60,000 premature deaths globally each year.

The situation in South East Asia is compounded by the large number of unregistered local vessels, according to Johansson, which were not included in the study. Globally, the researchers identified  76,000 vessels for which no technical data, such as the ship’s size or type of fuel used, could be obtained.

Together, these vessels travelled a distance that accounts for only 3.5 per cent of all recorded shipping kilometres, but Johansson says their local impact should not be underestimated. “Near coastal cities the [emission] contribution of these vessels can still be larger than the overall contribution might suggest,” he says.

Registered ships were responsible for 93 per cent of small-particle emissions and 91 per cent of the carbon dioxide emissions covered by the study.

Part of the large concentration of shipping emissions in the region is explained by the rapid economic growth of countries in the Association of South East Asian Nations (ASEAN),which is fuelled by  export of consumer goods. The ASEAN nations’ GDP grows by an average 6 per cent annually, according to the OECD, with 74 per cent of the region’s exports travelling by sea  to non-ASEAN countries.

South East Asia also suffers from high shipping emissions because its location exposes it to the densest and most frequent shipping traffic in the world.

Aretha Aprilia, a civil engineer from Indonesia and former coordinator at the UN Environment Programme, tells SciDev.Net that regional efforts to curtail shipping emissions have been “a huge challenge”.

“To date, not much attention has been given to the issues regarding emissions from shipping, and this needs to shift,” says Aprilia. “It is a prerequisite to have more legally binding regulations that are enforced from the countries.”

The study suggests that pollution control areas, where carbon dioxide and fine particle emissions from ships are subject to strict rules, can work if enforced. “Yet these can be costly for ship owners,” says Johansson. He suggests that poorer nations should look at alternatives, like re-routing large ships and planning their infrastructural development in order to mitigate pollution. “For instance in Helsinki, where I live, the cargo terminals were relocated well outside of the city.”

Stainless steel sinks may up your risk of legionnaires’ disease

First published on 28.08.17 in the New Scientist.

A combination of rusty water and stainless steel taps, or faucets, can put people at risk of life-threatening legionnaires’ disease.

It’s already known that rust particles in a water system, which can come from iron pipes, encourage the growth of Legionella bacteria. These bacteria cause legionnaires’ disease, which can involve headaches, muscle pain, fever and confusion. The condition has been on the rise in Europe: in 2015, there were 7000 known cases, and the European Centre for Disease Prevention and Control (ECDC) thinks there may be many more that went unreported.

Now it seems that the protective coating on stainless steel fixtures – currently a firm favourite for kitchen and bathroom sinks – can degrade over time, encouraging the growth of Legionella species.

To better understand how the material of sinks can influence legionnaires’, Wilco van der Lugt, a safety engineer who contributed to European guidelines on preventing Legionella, and his team experimented with three kinds of tap commonly found in household water systems.

The researchers tested stainless steel, brass ceramic, and brass thermostatic mixer taps, each with clean water and water contaminated with either Legionella anisa, which is the most common strain in rust in the Netherlands, or both rust and the microbe. The team monitored this set-up for more than three years.

When rust was combined with Legionella anisa in the stainless steel tap, half the water samples ended up infected. The Legionella was much better able to survive and replicate in this combination than in the set-up that involved no rust, reaching concentrations of between 20,000 and 100,000 live bacteria cells per litre.

Safer taps

This outcome could be because the film coating of stainless steel taps degrades over time if rust particles are present in the water. By the third year of testing, the concentration of bacteria in this tap had shot up.

In contrast, the brass mixer tap seemed to be the safest, with only a quarter of samples from that experiment showing contamination, even when rust was present. Van der Lugt and his team thinks that taps for sale should be explicitly tested to assess their bacteria risk.

But Victor Yu at the University of Pittsburgh, Pennsylvania, says it isn’t possible to draw conclusions about safer tap design from the work, because this hasn’t yet been linked to people actually contracting legionnaires’ disease. He also notes that a different strain of Legionella is responsible for most cases in humans.

To avoid contracting legionnaires’ disease, the ECDC recommends keeping hot-water systems heated to between 50 and 60°C, and running taps regularly to avoid water standing for too long.

Journal reference: International Journal of Hygiene and Environmental Health, DOI: 0.1016/j.ijheh.2017.08.005

Living near noisy roads could make it harder to get pregnant

This article first appeared in New Scientist, 26.06.2017

Living near noisy roads could make it harder to get pregnant

Living near a noisy road seems to affect couples who are trying get pregnant, increasing the likelihood that it will take them between six to 12 months.

That’s according to an analysis of 65,000 women living in Denmark. Jeppe Schultz Christensen of the Danish Cancer Society Research Center in Copenhagen and his team made this discovery by analysing data from the Danish National Birth Cohort, a project that ran from 1996 to 2002. They selected women who had tried to get pregnant during the project if traffic noise data was available for where they lived.

Previous research has suggested that 80 per cent of women who are actively trying to get pregnant usually do so within six menstrual cycles. But Christensen’s team found that for every 10 decibels of extra traffic noise around a woman’s home, there was a 5 to 8 per cent increased chance of it taking six months or longer.

This link persisted even when factors like poverty levels and nitrogen oxide pollution were taken into account. However, their statistical analysis showed that this association did not hold for women who took more than 12 months – perhaps because these couples may have had other factors affecting their fertility. “Road traffic noise may affect reproductive health,” says Christensen.

Him or her?

It is unclear whether traffic noise may be affecting women or their partners. Previous research has found a link between sleep disturbance and decreased fertility in women, as well as lower quality of semen in men. A 2013 study showed that consistent exposure to aircraft traffic noise activates a system in the brain that is known to disrupt the rhythm of ovulation.

Rachel Smith of Imperial College London says the link between traffic noise and health is worrying. Because traffic noise is common, even a small effect on health could feasibly have a large impact across a population, she says.

Europe’s roads are getting noisier. In the UK alone, an extra 2 million cars hit the road between 2011 and 2015. Christensen says traffic noise and fertility need to be investigated further before drawing up any recommendations for couples hoping to get pregnant, but Smith suggests that anyone who is worried could try to choose bedrooms away from the road, and close windows at night.

Marie Pedersen at the University of Copenhagen says traffic issues should be tackled by society as a whole, through better town planning and alternative transport. “It is a matter for urban planners and politicians,” she says.

Journal reference: Environment International, DOI: 10.1016/j.envint.2017.05.011

Read more: Dying for some quiet: The truth about noise pollution; Noise kills and blights lives in Europe

Islamic State body dumping did not spread leishmaniasis

SciDev.Net, 21.04.16

Syria’s outbreak of cutaneous leishmaniasis — a parasitic infection that causes skin lesions — is not caused by the corpses of infected people being dumped in the open, a paper points out.

The study corrects misinformed reports in Syrian and international media, which wrongly said the disease was transmitted through the bodies left on the streets in Syrian villages by the extremist group Islamic State (IS).

In December, the group executed people in villages rebelling against IS rule and dumped corpses with visible skin lesions in the open, saying that the disease would infect locals as a punishment for their insubordination.

But in their paper, published yesterday in Cell, researchers say that this non-deadly form of leishmaniasis can only be transmitted through the sandfly that carries the parasite biting living people.

“This kind of alarmist news serves only to propagate fear and stigmatise those suffering the disease,” says coauthor Karina Mondragon-Shem, a parasitologist at the Liverpool School of Tropical Medicine in the United Kingdom.

After five years of civil war and occupation by IS, Syria’s health system is in meltdown, the researchers write. The number of known leishmaniasis cases doubled between 2008 and 2012, when around 53,000 cases were registered, the paper says.

Syrian-Refugees-485-small.png
Figures as of August 2015. Credit: European Commission

But the true figures may be much higher, since official efforts to monitor the disease were abandoned in 2012 after Aleppo, the home of Syria’s leishmaniasis control programme, fell to ISIS, the authors say.

“Structures across the country have been demolished, the whole health system has collapsed and health staff are scarce or altogether absent in some areas,” says Mondragon-Shem. “The urgency of war casualties does not leave a place for [fighting] a stigmatising disease such as leishmaniasis.”

Cutaneous leishmaniasis — which is distinct from the rarer, more severe visceral leishmaniasis — is controlled by using bednets and treating people before the lesions break out.
But the lack of resources in refugee camps within and around Syria makes it difficult to control leishmaniasis, and refugees are bringing the disease to areas where it was previously nearly eradicated.

According to Waleed Alsalem, a researcher at Saudi Arabia’s Ministry of Health, the number of cases in Lebanon, where more than a million Syrian refugees live in camps (see map), has skyrocketed from just two in 2012 to more than 1,000 in 2013.

Alsalem explains that sandflies find plenty of breeding sites near sewage canals and among uncollected rubbish in refugee camps and in Syria’s war-torn cities.

“But it is important to underline that leishmaniasis cannot be spread by IS,” he says. “It is only the presence of sandflies that makes it possible for the disease to be transmitted.”

Waleed Al-Salem talks about combating the leishmaniasis burden in the Middle East

Three fronts in the war against antibiotic resistance

09.06.2015 – Original story on SciDev.Net

Speed read

  • Antimicrobial resistance already kills around 700,000 people a year
  • One estimate of the bill for tackling the problem is US$10 billion over a decade
  • We need more R&D into new antibiotics and reduced misuse of existing ones
   

What would you do with US$10 billion? Buy a tropical island and live the high life? Or use it to make the world a better place? Surely, that’s enough money to make a difference.

Think again. From a global viewpoint, US$10 billion is not much money. It’s about the price of a large nuclear power station. It’s the amount the International Monetary Fund paid out in March 2015 to bail out Ukraine’s banks. It’s what member states of the UN Framework Convention on Climate Change collectively put every year into the Green Climate Fund.

Ten billion dollars is also the approximate cost of combating antibiotic resistance across the globe over the next decade, according to Kevin Outterson, who researches health law at the University of Boston, United States. Outterson joined with colleagues in February to call for the creation of an international legal framework to address the problem of increasing antimicrobial resistance. [1] According to their proposal, published in the Bulletin of the World Health Organization, this money would be enough to perform three vital steps to solve the problem: provide universal access to antimicrobial drugs, better administrate drug dispensing to reduce the misuse of antibiotics, and ramp up research across the world on finding better drugs.

International health bodies are pushing for action on the matter. On 25 May the WHO launched a set of resolutions to tackle antimicrobial resistance. These include strengthening surveillance and research, develop better medicine and alert those at the highest level of government to the problem.

Yet there is little awareness among policymakers and the general public of the scale of antimicrobial resistance ­— and that’s why the proposed US$10 billion is incredibly hard to find.
But the scale of the problem is frightening — antimicrobial resistance already kills around 700,000 people a year all over the world, according to medical research charity the Wellcome Trust. By 2050, this could hit ten million, the charity says, as resistance is rising rapidly, especially in the developed world.

While they are no less urgent, other global health crises such as Ebola and cholera look minor in comparison. Yet, as Outterson says: “You don’t see people in orange jumpsuits helping people who are dying [of antibiotic resistance]. Why did Ebola provoke this amazing response, but the potential destruction of the most important drug class in human history doesn’t? Why are we scraping for dollars?”

Three-pronged response

Part of the answer is that antimicrobial resistance is a multipronged problem. The drugs are vital to tackle bacterial infections, such as tuberculosis, pneumonia and typhus. But the problem is not just about drugs. A combination of ignorance around the world, even among doctors, and lax controls over medicine distribution mean antibiotics are often used to treat parasites, such as malaria, and viruses. Antibiotics are ineffective against these and deploying them wrongly allows bacteria to build resistance to them, rendering them useless. This problem is magnified by the difficulty of developing new antibiotics, as research leads are becoming scarcer and funding dries up.

Therefore restricting the inappropriate use of antibiotics everywhere — in animal farming as well as human medicine — is an important first step. There are fears, however, that this could devastate many poorer countries where access to these life-saving drugs is still a problem, and many die because antibiotics fail to reach those who need them in the first place. And according to Iruka Okeke, a biologist at Haverford College in the United States who studies antimicrobial resistance, improving access to antibiotics would actually address some of the issues around maladministration and treatment disruption.

“One of the reasons why people hoard antibiotics, for example from a previous prescription, is because they do not have assurance that they will be able to get them when they need them,” she says.

india-drugs
But controlling drug administration while improving access is only two-thirds of the battle — the last, and perhaps most important, part of the offensive is increasing research and innovation to find new drugs.

This is crucial, as the present spending pattern on antibiotics research looks alarming, even in rich countries. Over the last year, many health, scientific and government associations — including the WHO, the European Union, the UK’s Royal Society of Chemistry and the US National Institutes of Health — have urged policymakers to force drugs firms to step up antibiotic development. According to a UK government-commissioned review led by economist Jim O’Neill, the United States spent just US$1.7 billion on this in combined public and private funding between 2010 and 2014, compared with US$14.5 billion on HIV/AIDS and US$26.5 billion on cancer. [2] Only two new systemic antibiotics (drugs that affect the whole body) were approved in the United States between 2008 and 2012.

Incidentally, antimicrobial resistance costs the US health system almost exactly US$10 billion a year. So with new drugs, the United States alone could save every year the proposed entire ten-year cost of tackling antimicrobial resistance worldwide.

Unfortunately, spending on research into cheaper and more varied antibiotics is almost zero in the developing world. The framework proposal in the Bulletin of the World Health Organization calls for increased collaboration between rich countries and those without the money for drug development to make them cheaper and more accessible.
The framework adds that funding for antimicrobial drugs research should be pooled and better coordinated. O’Neill’s review also proposes creating a US$2 billion fund to increase global research into antimicrobial resistance.

Inside job

While such outside help is welcome, some developing countries have made their own strides in tackling antimicrobial resistance. Take India, which has been working on a system that fixes the price of drugs, including antibiotics, to help widen access and control of distribution.

The country’s Drug Price Control Order (DPCO) was set up in 2013 to make life-saving drugs more affordable for poor people (see chart). Research done ahead of the law’s introduction showed that Indians living in rural areas would have to spend about a quarter of their monthly food budget on one treatment course of antibiotics for pneumonia. The DPCO was meant to work in conjunction with the National policy for containment of antimicrobial resistance: India, launched in 2011, which aims to curtail the use of antibiotics in animal farming and tackle inappropriate prescriptions. [3]

However, the system is currently in limbo after India’s prime minister withdrew his support last September over concerns that the system would discourage multinational pharmaceutical companies from selling drugs in India. Even before it was put on hold, its price-limiting approach came under fire for covering only brands with more than one per cent market share, thereby excluding a large number of less-common antibiotics and important combination drugs, which treat several ailments at once. Monitoring and reducing poor administration of drugs also remains a problem, as no legal framework has yet been created to address this.

“In India, regulating medical practitioners is a big challenge,” says Madhavi Yennapu, a scientist at the National Institute of Science, Technology and Development Studies in New Delhi. Yennapu believes that [any global efforts to create a legal basis for antimicrobial resistance work could trickle down to national governments. “Certainly an international legal framework may directly put pressure on enacting law at national level,” she says.

Together now

Despite the teething problems, India’s efforts to address antimicrobial resistance have made the country’s policymakers aware of the problem, and started a national conversation about addressing it. As a result, funding for research into new drugs is increasing in the country, and India is also reaching out to international partners to work on cheaper, better antibiotics. In February, for example, India’s science and technology ministry signed a funding deal to create two research centres in collaboration with UK universities that will tackle antimicrobial-resistant tuberculosis and minimise the indiscriminate use of antibiotics.

Such a joint approach is exactly what Outterson and his colleagues propose in their framework. If they work together, richer countries can fund the development of innovative drugs, as well as supporting poorer countries in their efforts to monitor antimicrobial resistance and educate their medical professionals about the problem. If all countries worldwide pooled their existing funding, the framework’s target spend of US$10 billion over a decade should be easy to achieve.

Another difficult part is to get poor countries to invest into better surveillance and control of these medicines, Outterson says. “In exchange, they would get access to more powerful drugs, but at a price that their populations can afford.” The framework states that each country should contribute “according to their means”.

But to do so would require more attention at the highest policy level, and more dedication from pharmaceutical companies, which are deterred by price controls and the idea of reducing the amount of antibiotics in use. This is the flaw in India’s stalled plan: while the idea of cheaper medicines and better controls on sale and administration address antimicrobial resistance quite well, they reduce the incentives for private companies to produce better and more innovative drugs.

In the end, it will be down to richer countries to fund innovation, as Outterson and Okeke acknowledge. But for this to happen, they must be alerted to a growing health crisis of their own making. Aníbal Sosa, a medical microbiologist and an advisory board member of the US-based Alliance for the Prudent Use of Antibiotics, says most policymakers in rich countries do not see or understand the problem, even when confronted with data on shocking antibiotic misuse in the West. “How can we explain that 50 per cent of the antibiotics prescribed in the United States are unjustified,” he says.

The complexity of antimicrobial resistance, the variety of its causes and the multipronged approach needed to tackle it complicate the policymaking response. Yet researchers remain dedicated to lobbying for action on antibiotics, whether it’s about spurring innovation in the West or getting life-saving drugs to patients in India. And the legal framework jointly proposed by Outterson has caught the attention of national leaders across the world, he says — including those in the European Union, United Kingdom and United States — whose concerns mirror the framework’s three-pronged approach.

“The policy people want to focus on stewardship and the Western doctors want new drugs and innovation,” Outterson says. “But doctors in Sub-Saharan Africa, for example, say they would just be fine with better diagnostics and access to simple antibiotics. So we are telling leaders that these three things are interdependent, and must be tackled together.”

References

[1] Steven J. Hoffman and others An international legal framework to address antimicrobial resistance (Bulletin of the World Health Organization, 2015)
[2] Tackling a global health crisis: initial steps (Review on Antimicrobial Resistance, February 2015)
[3] National policy for containment of antimicrobial resistance: India (Indian government, 2011)

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