Resolution on a strategic approach to pharmaceuticals in the environment

2019/2816(RSP)

The European Parliament adopted by 671 votes to 15, with 10 abstentions, a resolution on a strategic approach to pharmaceuticals in the environment.

The resolution was tabled by the Committee on the Environment, Public Health and Food Safety.

Improving pharmaceutical pollution control

Members pointed out that pharmaceuticals harm ecosystems when released into the environment and reduce the future effectiveness of medicines, in particular by causing antibiotic resistance. Pharmaceuticals and their residues are particularly present in waterbodies and are not completely removed by conventional treatment plants.

Parliament insisted on the need for a holistic approach, including all relevant stakeholders, to combat pharmaceutical pollution, taking into account the entire life cycle of drugs. It asked the Commission to consider the use of extended producer responsibility to reduce the adverse environmental impact of pharmaceuticals.

Raising awareness, prevention and rational use of pharmaceutical products

Parliament called on Member States to share best practices on the preventive use of antibiotics and to promote training for health professionals and awareness campaigns for patients on the prudent use of medicines, such as antimicrobials, antidepressants or contrast fluids. Patients and farmers shall be clearly informed about the negative environmental impacts that can result from medicines that are not disposed of properly.

Concerned about the steady growth in overall per capita consumption of medicines in the EU, Members suggested organising campaigns to raise public awareness of the dangers of over-consumption of non-prescription medicines. They drew attention to the growing number of supermarket and online sales without a medical recommendation and to the dangers of media advertising for such points of sale outside of pharmacies or suitably accredited establishments.

Promoting greener manufacturing

Members called for more ambitious measures to reduce the risks posed by pharmaceutical pollution. They stressed the need to support research and development of ‘greener pharmaceuticals’, while taking into account that greater biodegradability could potentially impair the efficacy.

According to Members, the environmental impact of pharmaceuticals shall be included in the risk-benefit assessment of human medicines, provided that marketing authorisations are not delayed nor refused solely on the grounds of adverse environmental impacts.

The Commission shall take all necessary measures to ensure that the production of imported medicinal products meets the same environmental standards as those applicable to medicinal products produced in the Union.

Reducing waste and improving waste management

Members considered it is necessary to reduce the overall consumption of medicines per person, without complicating access to medicines or reducing the effectiveness of treatments. Overall consumption of veterinary medicines per animal should also be reduced, without compromising animal health and welfare, and better solutions should be found.

The resolution supported the Commission's intention to reduce waste by allowing medicines to be dispensed in quantities better matching patients' needs and to explore the possibility of extending the expiry dates of medicines to prevent medicines so that they can still be used and are not unnecessarily discarded.

Members called on the Commission to present a proposal to review Directive 86/278/EEC by the end of 2021 at the latest, in order to update the quality standards in line with the latest scientific data to promote a real circular economy. Member States are invited to fully implement the provisions on take-back schemes for unused medicines.

Expand environmental monitoring

Concerned that the monitoring of pharmaceuticals in the environment, particularly in soils, remains very limited, Members stressed the need to strengthen post-market monitoring mechanisms, including environmental impacts.

The Commission is invited to: (i) add pharmaceuticals posing a high risk to the environment to the list of priority substances under the Water Framework Directive; (ii) develop a monitoring system for antibiotics for human use.

Improving environmental risk assessment and increasing transparency

Parliament stressed the importance of:

- setting out a clear roadmap for carrying out environmental risk assessments;

- filling knowledge gaps regarding the entry and persistence of pharmaceuticals in the environment, in particular in aquatic and marine ecosystems;

- supporting research on the direct impact of exposure to pharmaceuticals and their residues in the environment on human health and ecology;

- improving analytical methods to quantify the presence of pharmaceuticals in the environment;

- establishing a centralised and secure database enabling all relevant stakeholders to have access to the results of environmental risk assessments of products.