Leaked Documents Reveal Discarded Proposals to Avoid Antibiotic Resistance Through More Detailed Analysis of Pharmaceutical Firms
The EU has scrapped plans for a crackdown on pharmaceutical contamination that contributes to the spread of deadly superbugs.
Plans to monitor agricultural and pharmaceutical companies, add environmental standards to EU medical product regulations and force an assessment of the environmental risk of drugs used by humans have been scrapped, according to documents released by The Guardian.
An estimated 700,000 people die each year from antimicrobial resistance, in part due to drug-resistant bacteria created by the overuse, misuse, and spillage of antibiotics.
UK Medical Director Dame Sally Davies has warned that failure to act could lead to a post-antibiotic apocalypse, spelling "the end of modern medicine" as routine infections defy effective treatment.
Some studies predict antimicrobial resistance could cost $ 100bn (£ 75bn) between now and 2050, with the annual death toll reaching 10 million in that period.
An EU strategy for pharmaceuticals in the environment was supposed to propose ways around the threat, but the leaked material shows that a number of ideas contained in an initial draft have since been watered down or deleted.
Proposals that have fallen by the wayside include an EU push to have environmental criteria for antibiotic use included in international agreements as "good manufacturing practice requirements." This would have allowed EU inspectors to visit factories in Asia or Africa, and sanctioning them was evidence of pharmaceutical contamination found.
In turn, this could have had an impact on trade negotiations between the EU and India, where pollution of inland waterways more than doubled in the first half of this decade, partly due to industrial effluents.
India is an outsourced center for global drug manufacturing and a study published last year in the scientific journal Infection said "excessively high" levels of antibiotic contamination were found in the waterways around Hyderabad.
Nusa Urbancic, a spokeswoman for the Changing Markets Foundation, said: “We are surprised that the European commission seems willing to ditch the option of including environmental criteria… so early in the process, given the overwhelming evidence presented about how pharmaceutical contamination contributes. to the proliferation of drug-resistant bacteria ".
A replacement passage in the new draft that suggests "the possibility of using a purchasing policy to encourage greener pharmaceutical design" was described as "completely lame" and "completely toothless" by Nina Renshaw, Secretary General of the Health Alliance European Public. "This approach will not work, as the worst offenders will still have the option to continue discharging antibiotics in their local environment," Renshaw said.
Another scrapped proposal would have ensured that pharmaceutical companies collect, monitor and share data on the discharge of their microbials in effluents from global hotspots, often caused by intensive cattle farms.
Scientists have noted a worrying lack of global research on such links, and the information gap can have commercial and public health repercussions.
Sasja Beslik, head of sustainable finance at Nordea Bank AB, which has 300 billion euros (£ 263 billion) in assets, said disclosing the data would "increase transparency and make investors more informed about risks." For us, timely and adequate information is key to assessing the materiality of risks. "
The inclusion of environmental criteria in good manufacturing practices would be "crucial" for drug manufacturers, he added.
The drift of the commission's strategy has been in the opposite direction, however. An initial goal to “reduce the non-essential use of pharmaceuticals” has been replaced by a more business-friendly goal, to “promote the prudent use of pharmaceuticals”.
An EU source, speaking on condition of anonymity, said: “That is not the wording that we would have chosen, or that we wrote for this. There have been some modifications and attenuation of the commitment level, because we cannot make those commitments without investigating more, so they have become more vague. "
Urbancic, however, was not convinced. "The commission's strategy has already been delayed for three years," he said. "The weakening of this draft has the fingerprints of the pharmaceutical industry everywhere."
The European Commission declines to comment on the leaked documents, but sources said there was "no particular pressure" on the officials who compiled the earlier draft.
The pharmaceutical industry spent nearly € 40 million lobbying the EU institutions in 2015, according to voluntary statements, and enjoys infamous access to officials.
Public records show that the European Federation of Pharmaceutical Industries and Associations had more than 50 meetings with the Juncker commission in its first four and a half months of office.
In the same period, GlaxoSmithKline had 15 meetings with the commission, Novartis had eight engagements, Sanofi and Johnson & Johnson had six sessions each, while Pfizer and Eli Lilly met with EU officials five times each.
Other measures ruled out in the EU strategy would have forced pharmaceutical companies to complete environmental risk assessments of human medicines before they could be authorized. Most pharmaceutical products currently lack details on their ecotoxicological properties.
The final version of the EU strategy on pharmaceuticals in the environment is expected to be published later this summer.
Source: (in English)