In the document, the European Public Health Alliance (EPHA) describes pollution by pharma manufacturers as an "ignored cause" of AMR, saying that "substantial quantities" of antibiotics released from factories are combining with runoff from farms and human waste to create a perfect breeding ground for drug-resistant bacteria.
The report focuses particularly on producers in China and India, which account for the bulk of the world's manufacturing of antibiotic active pharmaceutical ingredients (APIs) and intermediates but in some cases have revealed substantial shortcomings in drug manufacturing standards.
Name and shame
China is the world's top manufacturer of penicillin salts while India has a smaller but significant antibiotic API industry and also produces antibiotic dosage forms in massive quantities for international generic drug markets.
EPHA cites a number of recent incidents that it suggests "are not a one-off but rather part of a wider pattern of pharmaceutical pollution in the countries which supply our medicines." Companies mentioned in the report include North China Pharmaceutical Group (NCPC), CSPC Pharmaceutical, Aurobindo, Hetero Drugs and Mylan, amongst others.
The public health group wants pharma companies which are contributing to the spread of AMR through irresponsible manufacturing practices - citing Aurobindo specifically - to be blacklisted by purchasers of medicines such as the UK National Health Service (NHS).
It also demands that the pharma industry "clean up its supply chain and introduce greater transparency on the origin of antibiotic drugs" and also implement ethical procurement policies that with include environmental/AMR criteria as a contractual requirement for suppliers.
"Whilst health services and authorities are increasingly required to devote resources to stop the spread of AMR at home, their influential purchasing power could bring about a significant change in the way drugs are sourced and produced for European markets," said the EPHA.
"Taking measures at home without tackling causes further afield is akin to locking the front door while leaving the back door wide open."
Industry response
The report was welcomed by some antibiotics producers, who indicated it is in alignment with many of the practices already deployed in their companies.
Karl Rotthier, chief executive of antibiotics producer DSM Sinochem Pharmaceuticals (DSP), told in-PharmaTechnologist.com that the document "once again highlights the fact that antibiotic resistance is not exclusively caused by overuse by humans and agriculture, but are also driven by environmental factors such as antibiotic waste and inadequate waste management practices."
"I have emphasized that it is the industry’s responsibility to stop buying, making and selling irresponsibly made antibiotics at several occasions," Rotthier continued, adding: "all antibiotics manufacturers have an obligation to work together to produce these life-saving medicines at the highest quality and meet the strictest environmental standards."
DSP recently launched a Sustainable Antibiotics Program to help fighting antimicrobial resistance. The head of the programme - Lucas Wiarda - said the solution to slow down the emergence of drug-resistant bacteria can be summed up in one sentence: "take, use and make antibiotics responsibly."
To that end, DSP says it uses the best and cleanest technology available for manufacturing, operates 24-hour dedicated waste water treatment plants and applies antimicrobial activity testing to ensure returned waste water is truly clean.
Quality mark
On the issue of transparency, DSP is calling for the introduction of environmental criteria and antibiotic disposal standard either within existing legislation or via a voluntarily industry 'quality mark'.
The latter could be used for tender, purchasing and reimbursement purposes, whilst also allowing consumers and pharmacists to easily recognise responsibly made antibiotics, it suggested.
The company pointed out that similar measures have been recommended by the UK Review on Antimicrobial Resistance, which also made reference to growing evidence of API manufacturers not adequately treating waste and other supply chain problems within the pharmaceutical industry.
"The new EPHA briefing paper painfully substantiates these important focus points, which cannot be ignored," said DSP.