Guest article Jean-Yves Stenuick, Pharmaceuticals Policy & Projects Officer, Health Care Without Harm (HCWH) Europe
The MEP Interest Group on AMR organised an online discussion on the environmental aspects of antimicrobial resistance on 13 November 2020 as part of a webinar series hold in the run-up to European Antibiotic Awareness Day and World Antimicrobial Awareness Week. It was kindly hosted by Nicolae Ștefănuță MEP and Vice-Chair of the Interest Group.
The discussion featured as speakers Yayoi Lagerqvist of the Swedish NGO Swedwatch, Caroline Moermond with the Dutch National Institute for Public Health and the Environment (RIVM), Nicolai Schaaf with the Stockholm International Water Institute (SIWI), and Hans Stielstra who represented the European Commission’s DG Environment.
UN Environment has identified growing antimicrobial resistance (AMR) linked to the discharge of drugs and particular chemicals into the environment as one of the most worrying health threats today. As wastewater treatment plants have limited capacities to remove antimicrobial residues, the role of the environment as a reservoir for AMR is particularly concerning.
As the pharmaceutical industry has outsourced antibiotic production to Asia, 80-90% of antibiotic active pharmaceutical ingredients are now being manufactured in China while India leads the production of ‘finished dose’ antibiotic products. Due to weak oversight and regulation, pharmaceutical residues are discharged into the environment during the manufacturing process.
Local populations are particularly affected as pharmaceutical pollution contaminates their water and food sources. Antibiotic residues discharged into the environment also contribute to the development of antibiotic-resistant bacteria that can easily spread around the world through trade and travel and drive resistance globally.
In 2019, the European Commission adopted a Strategic Approach to address the issue of pharmaceuticals in the environment. Whilst this communication highlighted that this problem could no longer be ignored, it largely failed to propose concrete measures to mitigate the devastating impact of pharmaceutical pollution on human, animal, and environmental health.
Last month the European Commission released its Pharmaceutical Strategy for Europe with a whole section on high-quality, safe and environmentally sustainable medicines. It acknowledges the need to strengthen oversight of the global manufacturing chain and ensure more transparency across the pharmaceutical supply chain.
It notably paves to the way to a welcomed revision of the pharmaceutical legislation to strengthen the environmental risk assessment requirements and a review of the framework on good manufacturing practice that should assess the extent to which AMR can be addressed. The scope and ambition of these initiatives remain however to be evaluated.
During the session, Yayoi Lagerqvist outlined the results of a study carried out by Swedwatch on the widespread environmental pollution from manufacturing facilities in India. Her main message was that affordable medicines in Europe should not violate fundamental rights to a safe, clean and sustainable environment.
Following up on this, Hans Stielstra gave an overview of the EU regulatory framework and particularly talked about the possible addition of antibiotics to the List of Priority Substances – a list of pollutants that Member States need to phase out or reduce in water. The angle taken is direct toxicity to animal and plant life but he said that this was not incompatible with AMR.
The floor was then given to Nicolai Schaaf who presented the Responsible Antibiotics Manufacturing Platform (RAMP), which aims to improve the flow of information among stakeholders in order to help incentivise the improvements that needs to happen at the manufacturing level to reduce manufacturing emissions.
The last speaker, Caroline Moermond, spoke about the lack of environmental risk limits for pharmaceuticals in the environment. She presented the PREMIER project funded by the Innovative Medicines Initiative, which seeks to bridge this gap by developing a large database with environmental information on pharmaceuticals and an assessment system for water companies.
The session was closed by Nicolae Ștefănuță MEP who reminded participants of the need for comprehensive actions within a ‘One Health’ approach to efficiently tackle AMR. He highlighted the importance of the EU4Health budget in this area and advocated for a dedicated fund on AMR to support actions that bring results.