EU seeks 'greener' pharmaceuticals

Out-Law News | 15 Mar 2019 | 2:22 pm | 2 min. read

Measures to reduce the impact pharmaceutical products have on the environment have been outlined by the European Commission, which has said medicines manufacturers, policy makers, regulators and health care professionals all having a role to play.

The plans are contained in a new communication published by the Commission (13-page / 580KB PDF) earlier this week. The Commission said the plans meet its legal obligation to propose an approach addressing the pollution of water by pharmaceuticals under Article 8(c) of the EU's Priority Substances Directive.

The communication highlights how residues from pharmaceutical products can make their way into surface and ground waters, soils and animal tissues through a variety of sources, including from sewage treatment plants, manufacturing centres and the spreading of animal manure. The products can then "persist in the environment and spread through water and soil or accumulate in plants or wildlife", it said.

The Commission said, though, that there are gaps in the knowledge of how individual pharmaceutical products impact the environment and the levels of risk they pose. It said there is a particular need to better understand the presence and impact of "antimicrobial resistant micro-organisms and antimicrobial resistance genes" on the environment.

Six broad areas of action have been set out by the Commission in its communication. They include measures to "promote prudent use of pharmaceuticals", support the development of "intrinsically less [environmentally] harmful" pharmaceuticals, and improve the way environmental risk is assessed and review. Further actions focus on reducing wastage of pharmaceuticals, improving the data available by expanding environmental monitoring, and filling other knowledge gaps. 

More specifically, the Commission said it would explore whether there is scope to safely extend the expiry dates on some medicines to ensure fewer are thrown away, as well as whether the size of pharmaceutical packages could be altered to ensure "medicines can be dispensed in quantities better matching needs". 

It also said it would encourage pharmaceutical companies to consider the environment more in the way they design and manufacture products, and that it could move to incentivise "the development of 'greener' pharmaceuticals that degrade more readily, to harmless substances, in waste water treatment plants and the environment" through EU funding schemes. The Commission said it would similarly discuss whether national procurement policy could be used to "encourage greener pharmaceutical design and manufacturing".

Other measures the Commission set out include its plans to promote the development of new guidelines for doctors and other health care professionals "on the prudent use of pharmaceuticals posing a risk to or via the environment", and said it would look into requiring trainee doctors in future to consider "environmental aspects" as part of their "medical training and professional development programmes". 

In addition to 'upstream' measures concerning the use of pharmaceuticals, the Commission's communication also envisages the potential for 'end-of-pipe' controls. Of relevance to the water industry, this includes improved waste water treatment to remove pharmaceuticals from waste water. The Commission intends to assess whether existing urban waste water treatment legislation sufficiently controls pharmaceutical emissions and investigate the feasibility of upgrading treatment plants to more advanced treatment technologies, although there is no mention as to who should bear this cost.

The Commission also said it would aim to "limit the preventive use of veterinary antimicrobials".

"The Commission’s communication sets out a strategic approach to the risks from pharmaceuticals in the environment," said environmental law expert James Nierinck of Pinsent Masons, the law firm behind Out-Law.com. "The EU considers that while treating disease relies on effective pharmaceuticals, there is sufficient evidence that action should be taken to reduce the risk from pharmaceuticals in the environment. Given the complex lifecycle of pharmaceuticals, there will be a diverse range of stakeholders, however these developments will be of most interest to the pharmaceutical industry, the water industry, farmers and medical professionals."