Key elements of the EU’s strategic approach to Pharmaceuticals in the Environment have been “diluted or deleted”

Proposals such as including environmental criteria for antibiotic use in international agreements, known as “good manufacturing practice” (GMP), have been removed from recent drafts of the Strategic Approach as reported by The Guardian.

The Strategic Approach to Pharmaceuticals in the Environment currently being developed by the European Commission (EC) was due in September 2015 according to Article 8c of Directive 2013/39/EU but has been significantly delayed, and is now expected to be released this year.

The core purpose of the Strategic Approach should be to present measures aimed at protecting the health of EU citizens and the environment from pharmaceutical pollution. As previously announced within the European One Health Action Plan against Antimicrobial Resistance, another key aim of this strategic approach is to also tackle antimicrobial resistance (AMR) – a global threat that challenges the sustainability of European health systems.

Seemingly, according to the leaked draft, the EC has ignored responses to their consultation, which sought “views on possible actions to address the risks from pharmaceuticals in the environment […] in support of the development of the strategic approach to pharmaceuticals in the environment”.

In response to this consultation, not only did HCWH Europe call for environmental criteria to be included in the GMP, but we also called on the EC to:

  • Support research and monitoring of the active pharmaceutical substances (including antibiotics) in different environmental compartments
  • Support development and use of “green” pharmaceuticals that are benign by design
  • Support awareness raising about non-essential use of pharmaceuticals
  • Consider environmental risk assessments for all pharmaceutical products of human-use during the authorisation procedure.

It is very concerning to discover that a Strategic Approach to pharmaceutical pollution has become political. It is no longer about the results of the consultation, and it’s not even about precautionary measures to protect the health of citizens and the environment – it’s about vested interests, expressed by the industry who spend vast amounts of money lobbying the EC, money that could have otherwise been invested in improving our health and protecting our environment.

The silence of the EC on this matter is also cause for concern, considering that the World Health Organization (WHO) calls for a precautionary approach in tackling the possible effects of long-term exposure to pharmaceuticals on vulnerable populations. Whilst some industry figures are reluctant for a precautionary approach because of knowledge gaps, products such as paracetamol continue to be sold for patient consumption despite some knowledge gaps surrounding how the drug takes effect , known as the mechanism of action.

We don’t see any reason for the EC not to present a Strategic Approach that includes high-level protective measures on pharmaceutical pollution and AMR; in spite of the knowledge gaps, a precautionary approach should be the priority to safeguard human and environmental health.