On 28 April 2017, the European Commission (the EC) published a “roadmap” on the strategic approach to pharmaceuticals in the environment, particularly in the aquatic environment.

Concurrently, the EC launched a 12-week open public consultation to address the environmental pollution caused by human and veterinarian pharmaceutical substances.

Under the title “Strategic approach to pharmaceuticals in the environment”, the EC aims to implement Article 8c of Directive 2008/105/EC, as amended by Directive 2013/39/EU, according to which the strategic approach shall include proposals to improve the procedure for placing medicinal products on the market more effectively to reduce the environmental impacts of medicines. In addition, by September 2017, the EC shall propose measures at the EU and/or Member State level recommending the reduction of discharges, emissions, and losses of such substances into the aquatic environment.

This initiative aims to:

  • Identify remaining knowledge gaps and uncertainties, and present possible solutions for filling them
  • Explore how to address the challenge of protecting the environment (and human health via the environment), while safeguarding access to effective and appropriate pharmaceutical treatments for human patients and animals, considering inter alia opportunities for innovation

The initiative responds to a number of problems resulting from the interaction of active pharmaceuticals ingredients (APIs) with the environment. Such problems include the fact that APIs, at certain concentrations, may affect wildlife; that the presence of antibiotics in the environment may contribute to the development and spread of antibiotic-resistant strains of bacteria; and that risk assessment approaches need to be improved, as most urban wastewater treatment plants are not able to remove all of each API.

The consultation will be open for 12 weeks, and some academic institutions and NGOs have already provided feedback about the strategic approach to pharmaceuticals. For example, the Leuphana University of Lüneburg in Germany proposes that “risk assessment should include products of incomplete degradation/mineralisation in the environment and/or sewage treatment as it has been found that some may be even more toxic than parent compounds”. Likewise, the Centre for Antibiotic Resistance Research (CARe) of the University of Gothenburg, in Sweden, has also commented in support of including “risks concerning discharges from manufacturing and antibiotic resistance development” because “the antibiotic resistance development” is one of the “largest recognized human health risk associated with pharmaceuticals in the environment”. However, the NGO European Sustainable Phosphorus Platform suggested that the strategic approach should address pharmaceuticals not only in water, but also in the environment more generally, and particularly in soils.

From the pharma sector, the European Federation of Pharmaceuticals Industries and Associations (EFPIA) has already referred to this issue in its Eco-Pharmaco-Stewardship initiative, which identified the following three key areas of focus for the pharmaceutical industry:

  1. Identifying the potential environmental risks of existing and new API through intelligent and targeted assessment strategies
  2. Compiling industry best practices, enabling manufacturers to minimize risks to the environment
  3. Refining the existing environmental risk assessment process for medicinal products to ensure the processes remain up-to-date and relevant

The pharmaceutical industry should closely follow this “Strategic approach to pharmaceuticals in the environment” and the relevant pending implementing regulations as they develop.

Industry stakeholders should send comments on the roadmap to the EC by 20 July 2017. Latham & Watkins can provide comprehensive advice on both the pharmaceutical and environmental aspects of this initiative.