On 10 December 2015, EPHA and Health Care Without Harm Europe organised an event that discussed the link between AMR and environmental pollution, focusing on antibiotics manufacturing and animal husbandry. The event established that all stakeholders – in particular industry and regulators – must push for enforceable standards and regulation. A new EPHA report further develops this theme.
Why is the environment neglected in AMR debates?
Despite a number of scandals and growing evidence that pollution in the environment from antibiotics is rising, this aspect of AMR has until now been little discussed. Even the guiding documents of the European Commission and WHO deal with it only peripherally.
The problem is that regulatory gaps result in serious drawbacks throughout the life cycle of antibiotics that translate into negative consequences for the environment, people and animals. Production shortcuts leading to pollution of water and soil by factories, overconsumption of cheap antibiotics in animal husbandry, and careless disposal of antibiotics all add up. International travel and trade do their bit to spread resistant bacteria around the globe.
While this is still an emerging issue, the global rise of multi-drug resistant superbugs forces us to consider all dimensions of the ‘One Health’ approach, including environmental.
The event
In opening the event ‘Pharma pollution: An ignored cause of AMR‘, co-host and organic farmer MEP Martin Haeusling (Greens, DE) explained that the problem of overconsumption in animal husbandry was close to his heart. Far more antibiotics were given to animals than to people and too often their uses were non-therapeutic and unnecessary, triggering the development of resistant bacteria.
In a video address Jim O’Neill, Chairman of the UK Review on AMR, stated that the AMR threat posed a huge economic challenge. Their final report with recommendations would be released in mid-2016 and used to persuade the United Nations to draft an international agreement. Their latest report, ‘AMR in Agriculture and the Environment’ calls for global limits of antibiotics use
Natasha Hurley of Changing Markets, co-authors of the ‘Bad Medicines’ report by SumOfUs, explained that their research had revealed a complex web of links between Western pharma companies, antibiotic-producing factories in China and Indian middlemen. She deplored that factories in these countries were able to pollute in impunity, with obvious consequences for local communities and the environment. There was a strong case for regulation as companies needed to know what is and what isn’t acceptable, and to create a level playing field. The threats emanating from AMR are so serious that there is no justification to deflect action.
Representing WHO, Roberto Bertollini presented the new Global Action Plan and underlined the need for alignment with the EU level. He stressed that AMR is not a ‘medical’, but a social and economic issue which called for intersectoral coordination, international standards and data sharing. On the Commission side, Helen Clayton (DG ENV)) talked about the Water Framework Directive and stated that the Commission looked at environmental protection and health holistically, in a collaborative effort. A report on Pharmaceuticals in the Environment would soon be released; it assessed the scale of the problem and presented options, accompanied by a public consultation. The Action Plan review would also take this into account.
The ensuring panel discussion encouraged the panelists to reflect on a cluster of questions, inter alia related to taking responsibility for environmental management, transparency of global supply chains, reducing excessive use and changing the innovation model for antibiotics.
Elizabeth Kuiper (EFPIA) reported on several industry initiatives to support sustainable supply chains and environmental management, including the Eco-Pharmaceutical Stewardship framework. She argued that it was equally important for local governments to introduce and enforce environmental legislation, and implement sustainable procurement practices. On transparency, Adrian Van Den Hoven (EGA) affirmed that supply chains were highly regulated, however safeguarding adequate site inspections remained problematic.
Kia Salin, Swedish Medical Agency argued that authorities would do well to apply a strict ‘carrot and stick’ approach:
– Environmental considerations should feature in public procurement and reimbursement decisions;
– Environmental labeling could encourage forerunners; and
– Legal tools can raise pharmaceutical performance as a whole.
Participants commented that it was difficult to rely on local and regional authorities to enforce regulations, which is why companies have a special responsibility to apply pressure and engage with global suppliers around clean production standards. They also proposed that the Commission should consider alternatives to antibiotics, such as complementary and alternative medicines, rather than focusing only on vaccination as a prevention measure. Moreover, better data is required about the amount of antibiotics actually consumed.
In closing, MEP Jasenko Selimovic (ALDE, SWE) referred to the negotiations over veterinary medicinal products which might help solve part of the problem. However, he lamented the ‘obvious lack of interest from regulators’, urging Member States, the Commission and the Council to do more, and more quickly.
The report
Following the event, EPHA has drafted a report on AMR and the Environment aimed at policymakers and other stakeholders to address the environmental dimension of AMR. Among the report’s recommendations feature the following points:
– including environmental criteria into Good Manufacturing Practices;
– extending Environmental Risk Assessment as part of the marketing authorisation process, including post-authorisation evaluations (also for old products never tested before);
– banning non-therapeutic uses of antibiotics in animal husbandry, and excluding reserve antibiotics for humans from marketing authorisation
– researching the potential of alternatives, including herbal, anthroposophic and homeopathic medicines
Next steps
As announced at the 2015 European Antibiotic Awareness Day, EPHA will continue to develop an AMR campaign in 2016, which will look at this serious global health threat from different angles.
EPHA will also collaborate with the European Commission, WHO and other partners to ensure that the environmental dimension of AMR is given due diligence in the review of the Action Plan on AMR, and that policies pertaining to antibiotics are coherent with relevant legislation on the environment and chemicals. Moreover, EPHA will reach out to industry to push for transparency of global supply chains and good environmental practices.
