The Responsible Antibiotics Manufacturing Platform

Growing awareness points to that pharma manufacturing contributes to the spread of antimicrobial resistance (AMR), one of humanity’s greatest health threats. The Responsible Antibiotics Manufacturing Platform, RAMP, was launched in February 2020 to change the standards of the industry. Producing medication that is safe and sustainable, today and tomorrow, must be a competitive advantage.

Antimicrobial resistance is among the worst health threats the world needs to address. It is increasingly linked to antibiotics emitted from manufacturing. Close to production plants, the concentration of antibiotics in the water can be higher than levels found in the blood of patients undergoing treatment.

The World Health Organization warns that antimicrobial resistance, AMR, could wipe out many of the health gains made in the past century. It is estimated that antimicrobial resistance (AMR) could claim 10 million lives per year by 2050, if urgent action is not taken.

Over-subscription of antibiotics to humans and overuse in intensive animal farming and food supply chains are among main culprits behind the dramatic rise of AMR, but pharmaceutical production is increasingly seen as another important driver.

In 2007, researchers from the University of Gothenburg, Sweden, were the first to discover shockingly high levels of antibiotics in rivers downstream from a wastewater treatment plant in India’s pharmaceutical hub, Hyderabad. The concentration of antibiotics in the water was not only the highest ever recorded in the environment, it exceeded what can be found in the blood of patients undergoing treatment.

All antibiotics released into the environment drive antimicrobial resistance world-wide and must be addressed globally. At the same time, we must not forget the high human and environmental price paid locally, in the production areas. People living near pharmaceutical production hubs such as Hyderabad in India report skin diseases, fish dying and livestock becoming poisoned. A recent NGO investigation describes serious human rights impacts and environmental damage related to unregulated release of effluents. Scientific studies have shown high levels of pharmaceutical residues in surface and ground water systems near drug manufacturing facilities.

Compared to the risks of antimicrobial resistance caused by overconsumption of antibiotics, the role of wastewater emissions from pharmaceutical production is less understood and remains insufficiently addressed. But to stand a fighting chance against resistant bacteria, we need swift action to curb pollution from pharma production.

The Responsible Antibiotics Manufacturing Platform, RAMP, was launched in February 2020 to promote safer manufacturing of antibiotics. Through this pioneering network, stakeholders can work together to change the standards of the industry.

Awareness is growing that pharma production contributes to the deadly spread of antimicrobial resistance (AMR), one of humanity’s greatest health threats, but fragmented approaches limit the impact of the, so far relatively few, relevant initiatives. RAMP could break this stalemate through an innovative approach where the progressive part of the pharmaceutical industry joins forces with the most forward-thinking buyers and regulators to set new standards for more sustainable manufacturing.

What is special about RAMP is that it brings together pioneers from three fields: procurers, regulators, and companies. This is probably the only way to overcome the obstacles that have so far prevented progress in an industry that is infamous for its lack of transparency. As things stand, many companies refuse to disclose information about manufacturing practices, making it impossible for procurers and consumers to choose products that are sustainably produced. In turn, companies have few incentives to shift to more responsible practices, which may come with additional costs and no rewards. To reverse this trend, regulators have an important role to set standards for emissions as well as for information and transparency.

RAMP was first launched in India, one of the world’s major antibiotic producers and one of the countries most impacted by emissions from manufacturing facilities. This, in combination with excessive use of antibiotics, has led to extreme levels of antimicrobial resistance. In response to this, India in 2017 launched an ambitious National Action Plan on Antimicrobial Resistance and could now become the first country in the world to regulate industrial effluents of antibiotics. The country’s Ministry of Environment, Forest and Climate Change (MoEFCC) recently announced a draft notification on environmental standards for bulk drug and formulation (pharmaceutical) industry.

This is an encouraging example of a shift in thinking compared to when SIWI first started to promote safer antibiotic manufacturing. Other positive developments include how the progressive part of the pharmaceutical industry has formed the AMR Industry Alliance and started to develop voluntary standards for responsible antibiotics manufacturing, including a Common Antibiotics Manufacturing Framework. Countries like Sweden and Norway, as well as the UN Initiative on Sustainable Procurement in the Health Sector, have begun requesting information about how antibiotics are produced in their procurements.

The interest is there, but so far this has not been enough to drive the profound change that is needed to create a level playing field for responsible producers. RAMP therefore seeks to bring together partners to co-create a sustainable business case with incentives for companies, procurers, and regulators to set a new standard. Companies that join the platform are expected to provide information, including access to their factories, and all partners should contribute to mutual learning and improvements. Through this flow of information, it will be possible to regulate emissions and develop procurement criteria that give companies real incentives to shift to sustainable production methods.

RAMP is a collaboration platform with the vision that by 2030, the release of antibiotics to the environment from manufacturing is minimized, and broader sustainability gains have been achieved in partnership with industry, governments, international agencies, and other stakeholders. Through a collaboration of pioneers we want to trigger incentives and ensure access to antibiotics that are manufactured in a manner that does not cause antimicrobial resistance or harm the environment.

Quick facts about RAMP

Started: By SIWI as an inception phase during 2020. The project is expected to run 2021-23.

Partners and funders: Swiss Agency for Development and Cooperation (SDC), Centrient Pharmaceuticals, GlaxoSmithKline (GSK) and Shawview Consulting. The AMR Industry Alliance is a key advisor to the project.

Actions: Partners provide information, including access to their factories, and contribute to mutual learning and improvements. The aim is to contribute to higher standards in production, procurement, and regulations.

In the white-paper Reducing Emissions from Antibiotic Production, you can learn more about the results of SIWI’s previous project on reducing emissions from antibiotics production REAP, funded by the Swedish Postcode Foundation.

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The role of pharmaceutical production for the spread of antimicrobial resistance was the theme of several articles in Stockholm WaterFront magazine 3-4 2018, with interviews with leading actors.

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The project builds to a large extent on experiences from the previous Swedish cluster group on water and pharmaceuticals, hosted by Swedish Water House, summarized in a report, policy brief and study on sustainable procurement.
Cluster group report
Policy Brief
Procurement study

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