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Pharmaceuticals in the Environment workshop

The European Commission and the Dutch ministry of infrastructure and environment co-organised a workshop on Pharmaceuticals in the Environment on 13 May 2019. The workshop follows the adoption of the long awaited Commission Communication on the Strategic approach on Pharmaceuticals in the Environment in March this year.

In June 2018 POLITICO had already published a leaked draft of the Strategy which differs significantly from the final adopted document.

The workshop was web-streamed and featured a mixed line-up of speakers from the European Commission, the Member States’ ministries and stakeholders.

Hans Stielstra (DG Environment) and Marc de Rooy (Netherlands Ministry of Infrastructure and Environment) chaired the meeting and introduced the topic by reminding that the main source of pharmaceuticals in the environment is the human consumption and excretion. Furthermore studies have confirmed the negative effect of pharmaceuticals on beetles, vultures and fish.      

Mr Stielstra presented briefly the strategy that revolves around 6 areas of action encompassing the whole life-cycle of pharmaceuticals:

  1. Increasing the awareness and the prudent use of pharmaceuticals
  2. Developing of greener pharma and greener manufacturing
  3. Improvement of the Environment Risk Assessment (ERA) within the authorisation process and exploring the links between REACH and pharmaceuticals legislation
  4. Improving the packaging, the to-be-used date, take-back schemes and collection systems, as well as evaluating the possibilities of treatment and the waste water treatment plants.
  5. Expanding the environmental monitoring with tools like the watch list
  6. Addressing the knowledge gaps around chronic exposure and the Anti-Microbial Resistance (AMR) from slurry, manure and sewage sludge.    

Mr Aurelien Perez and Ms Marilena Lungu from DG SANTE gave account, respectively, of the European Union One Health Action Plan against AMR and the architecture of the European pharmaceuticals legislation (namely Directive 2001/83/EC on the Community code relating to medicinal products for human use and Regulation 726/2004 on laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency).

Reference was made to the ongoing European Medicine Agency’s public consultation on the update of the ERA guideline that is available here and is running till the 30 June.     

The pharmaceuticals sector presented what they are already doing to address the issue from the treatment of their plants’ effluents to awareness raising for collecting the unused drugs, from the ERA for all new medicinal products to the IMI iPiE Project that tries to identify potential environmental risks of pharmaceutical substances while prioritising ‘legacy APIs’.

From the NGOs side, Health Care Without Harm, reminded that most of the PiE detected were authorised before 2006, which means that they have not been covered by the today-compulsory ERA in the authorisation. HCWH spoke in favour of using the numerous legal instruments already in place (such as the EQS Directive) to take action all along the life-cycle of medical drugs for human use.

A representative from the Dutch Health ministry showed how the health authorities have worked towards a sustainable healthcare system, a Green Deal, taking a chain-approach and focusing a lot on prevention and healthy life-styles rather than cure and treatments. This has also contributed to the economic sustainability of the healthcare sector.

Michael Bentvelsen spoke on behalf of EurEau, giving the views of water services. He stressed the need for control-at-source measures and the life-cycle approach while conceding that end-of-pipe treatment of pharmaceuticals may play a role within the strategic approach. He spoke about the current knowledge gaps, promising technologies and the cost-estimates from EU countries and affordability of the water bill for EU citizens.

EurEau’s message was similar to the views of the International Commission for the Protection of the Rhine expressed by Tabea Stötter: the source control strategy should be preferred and the waste water treatment plants that need to be upgraded will have to be prioritised.

Representatives of Switzerland, Germany, Sweden and The Netherlands gave an overview of the national approaches to limit the release of pharmaceuticals in the environment, with the Swiss focusing on the treatment at specifically identified waste water treatment plants.

The OECD presented their current work on pharmaceuticals and microplastics: they announced that an OECD report on Pharmaceuticals in the Environment will be published at the Stockholm Water Week 2019. In the next two years the OECD will also conduct a study on take-back schemes and the recycling of pharmaceuticals.

In 2019-2020 they will also conduct a study on secondary microplastics.

In conclusion the European Commission confirmed that they are willing to continue working on this issue and that there may be additional similar events in the future. They also expressed their intention to consider the issue of PiE within the ongoing legislative reviews that could lead to the revision of the legislation (read the UWWTD!). They would also welcome ideas from both the European Parliament (an INI-report for instance) and from the Council of the EU in the form of Council Conclusions.


Water matters. EU matters. 


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