Select Page

Antimicrobial resistance (AMR) is a multifaceted global health threat that requires orchestrated action on many fronts. In Europe, 25,000 people die every year as a result of drug-resistant infection. The estimated global figure of 10 million deaths annually by 2050 demonstrates the scale of the challenge to public health and health systems.

AMR is a global public health threat whose proliferation cannot be halted by national actions or sporadic stakeholder initiatives alone. International travel and migration, and the global trade in pharmaceuticals, food products and animals mean that ‘superbugs’ do not develop in isolation – the threat is global, immediate and cannot be contained within borders.

The pharmaceutical industry and regulators in particular need to develop, adopt and quickly implement enforceable international environmental standards to curb API pollution from antibiotics production and the AMR it contributes to.

Providing full transparency on the origin of products and the conditions under which they are manufactured is an urgently necessary first step for the pharmaceutical industry, which should support the development of binding international production and supply standards.

Regulation is needed, preferably internationally, beginning with the inclusion of environmental criteria into Good Manufacturing Practice (GMP), as called for by the Swedish government, and the extension of Environmental Risk Assessment as part of the marketing authorisation process, including post-authorisation evaluations which should also apply to old products that have never been tested before.

This should go hand in hand with the development of supporting legislation that is consistent across the relevant areas (environmental, chemical, etc.), an example being the need for binding limits for pharmaceuticals in groundwater and surface water.

Especially (but not exclusively) in animal husbandry and agriculture, antibiotics use must be reduced, and a ban on non-therapeutic uses should be introduced as a matter of urgency, Antibiotics used as reserve antibiotics for humans should not obtain market authorisation for use in animals as a matter of principle.

The EU and WHO should also join forces and engage all stakeholders in an urgent dialogue to create an innovation model that puts public health needs first and recognises that people’s lives, in Europe and globally, depend on the continued effectiveness antibiotics. The failure of today’s pharmaceutical R&D model to bring any new antibiotics to market since the 1980s illustrates the fundamental flaws of the system as a whole – genuinely innovative alternatives are needed.

This will need to be supported by other measures that can contribute to the reduction of the need to prescribe antibiotics in the first place, such as investments in the development of improved diagnostics and in potential of alternatives to antibiotics.

Finally, more accurate and comparable data is required in order to better gauge how many antibiotics are actually consumed, by whom, and for what purposes. Coupled with education about correct and prudent use – treating antibiotics as a valuable public good – and infection control measures, which should be aimed at all stakeholders (from patients to prescribers to farmers and industry), such a truly holistic approach might hopefully yield some concrete results.

Download the report here.