The European Green week this year focuses on the EU ‘zero pollution ambition´ to promote a toxic-free environment. PREMIER aligns and contributes to the main European actions under the EU green deal which provides a legal framework for regulatory risk assessment requirements of pharmaceuticals.
This year The European Green Week is held from the 31th of May to the 4th of June with Partner Events taking place between the 3rd of May and 13th of June. This annual event, organised by the European Commission´s Directorate-General for Environment, brings together policymakers, world leading environmental scientists, and other stakeholders from Europe and beyond to discuss European environmental policies. This year EU green week coincides with the World Environment Day, held on the 5th June, featuring the theme “Reimagine. Recreate. Restore”, calling for an urgent action to revive our damaged ecosystems.
The EU Green Week 2021, will be dedicated to the EU Action Plan ‘Towards a Zero Pollution Ambition for Air, Water and Soil’ and other related initiatives such as the European Green Deal, the upcoming Chemicals Strategy, as well as initiatives in the field of energy, industry, mobility, agriculture, fisheries, health and biodiversity. The EU is therefore taking actions to tackle biodiversity loss and the impact this could pose to our health and environment. The EU Zero Pollution vision for 2050 claims a healthy planet for all with the following statement “Air, water and soil pollution is reduced to levels no longer considered harmful to health and natural ecosystems and that respect the boundaries our planet can cope with, thus creating a toxic-free environment”. The EU Strategic Approach to Pharmaceuticals in the Environment (PiE), launched in March 2019 and the Pharmaceutical Strategy for Europe, launched in November 2020 also aim at providing a EU legal framework to ensure a cleaner and sustainable feature for all.
In line with these initiatives, the PREMIER project targets the risks that pharmaceuticals pose to the environment promoting a more sustainable future and protecting biodiversity and our ecosystems. There are currently more than 1,500 pharmaceuticals that were approved for use prior to the need to conduct an environmental risk assessment . This accounts for those pharmaceuticals marketed before 2006 and limited environmental data are available for many of the active ingredients in these medicinal products. PREMIER aims at tackling this gap, by developing a novel information and assessment system for identifying and addressing the risks that these medicines pose to our environment. PREMIER aims at creating a centralised user-friendly database which is transparent and accessible to all relevant stakeholders, from water managers to regulators to environmental scientists. The project will also develop detailed guidance and recommendations on how to steer the development of medicines in a more sustainable direction while identifying opportunities to minimise animal testing.
Thus, PREMIER explicitly contributes to the following actions defined in the EU Strategic Approach to PiE:
- Support the development of pharmaceuticals intrinsically less harmful for the environment,
- Improve environmental risk assessment and its review
- Expand environmental monitoring, and
- Fill other knowledge gaps, particularly those on ecotoxicity and fate in the environment.
PREMIER also aligns with the EU Pharmaceutical Strategy, which builds on and complements the EU Strategic approach to PiE and the other abovementioned initiatives, especially with regards to the review of pharmaceutical legislation, including reviewing the provisions on environmental risk assessment. The EU aims at promoting innovation for environmentally sustainable and climate-neutral pharmaceuticals and manufacturing to become a driver for the EU pharmaceuticals industry which should apply the best available techniques at manufacturing level to reduce emissions and contribute to the EU’s climate ambition along their supply chains. The Pharmaceutical Strategy therefore, interlinks with the PiE strategy but also with the EU´s Chemical Strategy for sustainability towards a toxic-free environment which is based on the Green Deal zero-pollution ambition.
Among the flagship initiatives of the EU Pharmaceutical Strategy, there is a proposal to revise the pharmaceutical legislation to strengthen the environmental risk assessment requirements and conditions of use for medicines, and take stock of the results of research under the innovative medicines initiative (2022).
Overall, this legal framework constitutes the regulatory foundation for PREMIER and to which we aim at contributing to further develop and expand in the future.
PREMIER is formed by a world-leading multidisciplinary consortium of public and private partners with expertise in (eco)toxicology, environmental chemistry, chemical risk assessment, environmental regulation of pharmaceuticals, drug design, software development, and many other essential specialties. This project is therefore, uniquely positioned to be able to work synergistically and collaborate with these European actions to ensure the products developed in PREMIER are useful to a range of key stakeholders, from policymakers, to regulators, to environmental scientists.
PREMIER is a great example of how the public and private sectors can join forces to fight for a toxic-free and more sustainable future and altogether support the establishment of a new European standard for environmental protection.