Studies show that today many pharmaceutical companies are still discharging antibiotics into the environment on a mass scale via wastewater from their production plants. Over the last years pharmaceutical companies made commitments for change, and curbing antibiotic waste has been voiced as one of their top priorities in for instance the Industry Roadmap presented at the Davos Forum in 2016.
Last year at World Water Day ReAct wrote a piece on the Environmental Effects of Antibiotics in Sewage. This year we grab the opportunity of World Water Day to look at where we are now: Have pharmaceutical companies taken action on their own commitments? And how are governments tackling this issue?
Antibiotics in wastewater from pharmaceutical companies: an example
Hyderabad is a city in India with a lot of pharmaceutical industry. When researchers analyzed water in villages surrounding Hyderabad’s industrial suburb Pattancheru, antibiotics were found in every village where samples were taken. More than 10 years ago it was reported that effluent from drug manufactures that are released into the water contain extremely high levels of antibiotics. In some places concentrations of antibiotics were found to reach up into the mg/L range, higher than the concentration you find in the blood of patients taking antibiotics.
Researchers found that ‘the industrially polluted sites stand out as extreme when it comes to harboring antibiotic resistance genes’. It has also been shown that the resistant environmental bacteria are efficient in sharing their resistance genes with for instance E. coli. The probability that resistance genes in environmental bacteria are transferred to and maintained by pathogenic bacteria may be low. However, as the types and abundance of antibiotic resistance genes in the environment increases, so does the risk that it will happen.
Learn More in the ReAct Toolbox about Antibiotics in the environment.
Commitments by pharmaceutical companies
One of the main commitments made by pharmaceutical companies is the Antibiotic Manufacturing Framework that has been created by the AMR Industry Alliance. The AMR Industry Alliance is hosted by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), and brings together pharmaceutical companies, as well as generics, diagnostics, and biotech companies to work on antimicrobial resistance. It follows in the path of the Industry Declaration on AMR at the World Economic Forum in Davos in 2016, and a roadmap adopted by a number of pharmaceutical companies at the United Nations High-Level Meeting on AMR, also in 2016.
In the Roadmap, reduction of the environmental impact from production of antibiotics by pharmaceutical companies was set as a top priority by industry itself. The Antibiotic Manufacturing Framework is the outcome after two years of work.
Lacks focus on limiting antibiotic resistance
While the framework acknowledges the specific problems of antibiotics compared to other pharmaceuticals in the environment, it focuses on the production process and pharmaceuticals as a whole, and as a result is lacking in specific focus on limiting antibiotic resistance. The Framework for instance relies heavily on compliance with ‘local laws and regulations’ and ‘environmental permits’. These are empty commitments. That manufacturers around the world are required to follow local environmental regulations is not questionable. Besides that, restrictions on release of antibiotics can theoretically be implemented by local authorities, but to date it appears extremely rare that specific regulations on such emissions have been implemented. Laws specifically aimed at curtailing antibiotics in wastewater in order to limit antibiotic resistance do not exist in Europe, the U.S.A. or India. India notably is one of the few countries that has already voiced an intent to regulate antibiotic discharges in its National Action Plan 2017-2021.
Conflict of interest and lack of expertise
Roadmap companies plan to implement science-based discharge limits once they establish a method for determining resistance-based limits, which they estimate to be in 2020.
Pharmaceutical companies are however not the right actors to set their own standards. First because they have an obvious conflict of interest, second, because they lack expertise both in antibiotic resistance and in the environmental impact of pharmaceuticals. Furthermore, currently the Framework does not seem to incorporate tests for such future standards as part of its audit reports.
Independence and transperancy?
There are also question marks over how independent and transparent the ‘Common Antibiotic Manufacturing Framework’ is. While audit reports might be shared with other companies and the supplier or manufacturing site, it is not clear whether such documents will also be open to governments or the public for scrutiny. A lack of openness effectively prevents prescribers and consumers to make active choices based on the potential environmental impact of the production.
A main cause of antibiotics in the environment is the production of the active pharmaceutical ingredient (API), the working element of a medicine, which is often produced in a separate facility. Plans for transparency in the further supply chain proposed by pharmaceutical companies are varied and rather vague. One-quarter of responding companies anticipate doing so by 2018, with some expecting this to take until 2025. So far only four companies applied limits to their suppliers’ sites: GSK, Johnson & Johnson, Pfizer and Roche. No company has committed to publish its environmental audit results, or its discharge levels. As long as there is no transparency to countries, let alone to consumers, both are prevented from making an informed decision.
Limited company support
Despite the described limitations and concerns, the Common Antibiotic Manufacturing Framework should be acknowledged as a step forward. The willingness amongst pharmaceutical companies to sign up for it, however, has so far been limited. It is estimated that the AMR Industry Alliance represents about 40% of global manufacturing capacity and of the Alliance only 36% actively participated in the last Progress Report indicating underwhelming support and engagement amongst pharmaceutical companies in the Alliance.
In absence of company support the effectiveness of self-regulation is small and complementing government action on standard-setting and regulation needs to be considered.
The role of procurement
An alternative way to improve antibiotic production is through including criteria in procurement. In many countries companies when registering a new pharmaceutical product on the market are required to report to a government agency where and by whom the active pharmaceutical ingredient (API) is produced. While countries are thus often aware of where medicines and their active pharmaceutical ingredients are produced, they are not fully aware of the environmental impact of the release of active pharmaceutical ingredients.
Sweden started looking into revising the criteria for procurement of antibiotics some years ago. It is proposed to revise the procurement practices not only to give weight to lowest price for generic medicines, but also to the level of pollution they create. Presenting these plans in January in Brussels at the European Parliament’s event “Joining the Dots”, it was noted that this needed to be reinforced by trade policy, meaning that the directorate for trade of the European Commission would also need to be involved in discussions to advance such a proposal. It was also noted in these discussions that Nordic countries combined market share remained very small (about 2% of global medicines) and that a European-wide change would be needed in order to have a real impact.
Professor Joakim Larsson in TEDx talk: Why pharmaceuticals in wastewater are our problem too.