Recommendations on the European Strategy to Pharmaceuticals in the Environment
By: Stichting Huize Aarde, Netherlands, March 29 2019
After years of research, consultation and participation, the European Strategy to Pharmaceuticals in the Environment has been published on 11 March 2019. The Huize Aarde Foundation was also able to respond to this strategy on earlier occasions (26 May 2017 and 21 February 2018). We believe the development of a European strategy to reduce the emission of human and veterinary medicines and multi-resistant micro-organisms is important, because it encourages governments, institutions and civil society organisations in countries inside and outside Europe to take action.
The general impression is that the European Commission has made an effort to serve all interests with this strategy. The strategy sets out the direction for future legislation. The aim is to establish a broad legal base in existing European legislation on medicines, water and soil. The EC also attaches the strategy to the United Nations’ sustainable development objective no. 6 (Clean water and sanitation), and to the European Action Plan against Antibiotic Resistance.
Existing knowledge and knowledge gaps have been traced, necessary actions are identified, research and development funding is envisaged, and a deadline for an evaluation of the strategy is set (2020). The implementation of the actions described will depend to a large extent on availabiliy of the right knowledge and on sufficient support among human and veterinary care professionals and users of medicines; as well as on the cooperation of stakeholders outside the European Union.
The EC stands for an approach in which all links in the human and veterinary medicine chain assume their responsibilities. The aim is to tackle the problem as much as possible at source in several ways: by raising awareness among medical professionals (in training), in medicine advertising, during prescription, during the development of more biodegradable medicines, and during the production phase. The aim is to increase the responsibility of producers, particularly during the development phase and waste phase.
Below are the three most important recommendations of Stichting Huize Aarde on the strategy:
1. Broader scope
Although the strategy indicates that medicines are found in drinking water, soil and plants; and that the existence of risks in and via the environment is recognised, the topic is generally still seen primarily as an environmental issue. To get the issue in people’s minds and on political and policy agendas, and in European and national legislation, more emphasis is needed on the environmental cycle of these pollutants: how do these chemical and biological contaminants return to humans and animals; to what extent are we exposed to them on a daily basis. For example, data requirements are projected by the EU only on the aquatic environment. The determination of total human exposure is not yet advocated #. This makes the strategy look too much like a “far-from-my-bed issue” that can more easily be denied and externalised as an inevitable effect of progress. Given the persistence and biological activity of conventional medicines, and from the perspective of a circular economy, policies should aim to ensure that human and veterinary medicines do not enter the environmental cycle (zero tolerance). A solution for this environmental cycle should be part of a health policy. Synergies should be sought with efforts to prevent medicalisation of society.
# Environmental monitoring of medicines and multi-resistance is a labour-intensive, long-term and costly issue. Moreover, analysis provides little decisive information because analytical techniques are not yet sufficiently sensitive and medicines and multi-resistance occur in many forms in the environmental cycle. A more model-based approach is recommended. Models, in turn, depend on independently conducted toxicological studies. More emphasis may therefore be placed on this.
2. Critical selection of sources
The fact that the concentrations of medicines in the environmental cycle are significantly lower than the therapeutic doses, is not an (eco)toxicologically valid argument for a low estimate of the chance of health effects. At low concentrations, medicines in tap water, swimming water, food and air can cause health effects other than those intended, including hormone disruption and cocktail effects. Policy on possible health risks should be based on sources from independently operating toxicologists, epidemiologists, biologists, etc. Water technologists, etc. are not the first group to be able to make a well-considered assessment. Sources from representatives of, or financed by, interest groups such as drinking water companies and pharmaceutical industry should be avoided here.
3. Embedding in more Sustainable Development Goals (SDGs)
Embedding the strategy in a global policy for a sustainable society, such as the United Nations Sustainable Development Goals (SDGs), is of strategic importance. Apart from SDG 6 (Clean water and sanitation), the subject also falls under SDG 3 (Good health and wellbeing), particularly the sub-targets on the misuse of substances and harmful chemicals. Target 9 (Industry, innovation and infrastructure) also provides a suitable framework, particularly sub-targets on sustainable industry and Research & Development. As well as SDG 11 (Sustainable cities and communities), especially its sub-target on waste management; and SDG 12 (Responsible consumption and production), with its sub-targets on environmentally conscious use of chemicals; waste management; sustainable methodologies in international companies; information and awareness.