The European Commission (EC) communicated its strategy on reducing the influence of pharmaceutical residue in water and soil across the European Union (EU), confirming that tackling the issue is of importance due to the ‘emerging evidence of risk’.
In the communication, the EC states that evidence of pharmaceutical contamination of surface and ground waters, soils, and animal tissues have been discovered across the EU, at varying degrees of concentration.
It suggests that largest source of the pharmaceutical residue is likely to come from human or veterinary use, due to formulations that are designed for metabolic stability, resulting in 90% of active ingredients being excreted or washed off.
However, the analysis notes that run-off from manufacturing plants is also a source of contamination, although it tempered this by suggesting it was a greater problem outside of the EU.
In terms of the impact the excess pharmaceutical product can have, the EC’s communication references the ability for active ingredients to have on local wildlife – citing an example where fish behaviour was found to be altered by exposure to low levels of antidepressants.
The EC mentions antimicrobial resistance as another emerging danger but states that there is, as yet, “no clear link established between pharmaceuticals present in the environment and direct impacts of human health.”
The communication does suggest that evidence of antimicrobial pharmaceuticals have been found in water and soil, furthering that this ‘may’ have some link to “accelerating the development, maintenance and spread of resistant bacteria and fungi.”
Vytenis Andriukaitis, EC’s Commissioner for Health and Food Safety, said: “It is essential that medicines are safe and effective for our health, however, we should be aware of the environmental impact they may have.”
He continued, “Drug-resistant bacteria is one of the major health threats worldwide, therefore in our fight against antimicrobial resistance, everyone benefits not only from the prudent use of medicines but also from a well thought-through production and disposing system.”
The EC outlined a five-point plan to tackle the issue – the most prominent of which was its move to encourage the ‘produce use of medicinal products’.
EC's five-point action plan:
- Promote the development of guidelines for healthcare professionals on the prudent use of pharmaceuticals posing a risk to or via the environment
- Explore, in cooperation with relevant stakeholders, how environmental aspects could become part of medical training and professional development programmes
- Aim to limit the preventive use of veterinary antimicrobials by ensuring correct implementation of the newly adopted Regulation on veterinary medicinal products
- Foster best-practice exchanges between Member States on how environmental considerations are taken into account in the advertising and prescription of medicinal products and the choice of therapy more generally, where appropriate
- Strengthen cooperation with the World Health Organisation and other key international organisations on activities to raise awareness of the issue and find solutions, including by the sharing of best practices
Industry reaction
European industry bodies released a joint press release on the communication that broadly welcomed the strategy announced by the EC.
The Association of European Self-Medication Industry, the European Federation of Pharmaceutical Industries and Associations, and Medicines for Europe released a joint statement that referred to the topic as a ‘critical issue’.
“We broadly support the policy areas that the European Commission puts forward in its strategic approach on pharmaceuticals in the environment, most of which are aligned with the actions that industry has identified to effectively reduce possible environmental risks,” the statement reads.
In addition, the joint statement confirms that the industry has been investing in ‘greener manufacturing methods’, but outlined that the safety and efficacy of the medicines produced are the organisations’ priority.
