RIVM has drawn up criteria for the development of sustainable new medicines in an international study. These GREENER criteria are an important first step to develop medicines that have no harmful effects if they end up in the environment after use. According to RIVM, it is important that environmental experts and drug developers develop the methods required for this together. This research is funded by the European Commission. The results have been published in the international journal Environmental Science & Technology Letters.
RIVM 23 augustus 2022
What are the GREENER criteria?
Drug developers focus on efficacy and safety for the patient. At the same time, more and more is known about the harmful effects that residues of medicines can have on water quality after use by the patient. These effects affect our living environment, which in turn is vital for our health.
The GREENER criteria bring these perspectives together. A drug must work well for the patient. That remains the most important criterion. At the same time, when developing active substances, attention can be paid to, for example, the degradability in the environment, undesired harmful effects for plants and animals or the reduction of the amount that enters our living environment via urine after use. Sustainable development (“safe and sustainable by design”) of new active substances can thus prevent environmental problems. The GREENER criteria drawn up in English help with this.
The GREENER criteria stand for:
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G
Good practice for patients / Medicines that work well for patients
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E
Exposure reduction via less emissions/ Less discharge to the environment
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E
Environmental (bio)degradability / Degradability in the environment
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N
No PBTPersistent, Bioaccumulative and Toxic (persistent, bioaccumulative as well as toxic) properties /No substances that are PBT (persistent, bioaccumulative, toxic)
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E
Effects reduction: avoid undesirable moieties / Avoidance of effects by undesirable molecular groups
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N
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R
Risk and hazard mitigation / Measures to reduce risks after use
Collaboration and follow-up
The development of new medicines is a complex process that takes years. It is important that the environmental sector and R&DResearch and Development departments of drug developers know how to find each other. The joint development of the GREENER criteria is an important first step in this.
These criteria need to be further elaborated. Attention must be paid to the way in which sustainability and safety of active substances can be tested in the R&D process. Global procurement criteria that include sustainability can accelerate this process.
This research was carried out by the PREMIER consortium, which consists of a collaboration between scientific institutes and universities, the European Medicines Agency, and researchers at drug developers and manufacturers. RIVM is part of this collaboration. The GREENER criteria and a number of required methods will be further developed by this consortium.
RIVM’s contribution is financed by the European Commission. All research results are made public.