MistraPharma policy brief 2015

Recommendations for Improving Environmental Risk Assessment of Pharmaceuticals

The MistraPharma research program proposes 10 recommendations for improving environmental risk assessment of human pharmaceuticals. The recommendations are based on up-to-date scientific knowledge concerning pharmaceuticals’ effects and presence in the environment, as well as experiences from the REACH-framework that regulates industrial chemicals.

Download the policy brief here or read abour our recommendations below.

Require environmental risk assessment also for products
put on the market before 2006

We recommend that environmental risk assessments are performed also on pharmaceutical products approved  before the European Medicines Agency’s guideline came into force. There is simply no scientific evidence that products put on the market before 2006 are of less environmental concern than new products.

Perform only one environmental risk assessment per pharmaceutical substance

We recommend that pharmaceutical companies that produce or import the same pharmaceutical substances submit a joint environmental risk assessment instead of submitting one per company. This would provide decision makers with coherent information, avoid duplication of work and reduce animal testing.

Perform mixture toxicity assessments on pharmaceutical substance with similar modes of action

We recommend that environmental risk assessments also consider the total exposure for groups of pharmaceutical  substances with similar modes of action. This would enable a more accurate assessment of the environmental risks.

Include environmental risks in the risk-benefit analysis

We recommend that environmental risks are included in the risk-benefit analysis when a product is considered for market authorization. This would make the assessment of risks associated with the use of pharmaceuticals more complete and hence more accurate.

Include data on emissions from production of pharmaceutical substances

We recommend that the risk associated with discharges from manufacturing sites is included in environmental risk assessments. This would enhance the relevance of the assessments by including the part of the product lifecycle responsible for the highest environmental concentrations detected.

Add requirements to assess the risk for development of antibiotic resistance

We recommend that information that enables assessment of the risk for increased antibiotic resistance development is included in the environmental risk assessment for antibiotic substances. This would provide a more accurate picture of the risks associated with environmental  occurrence of antibiotics.

Refine the tiered approach

We recommend that the test approach is refined to include pharmacological and toxicological data from the drug discovery process, as well as bioconcentration data. This would improve the prioritization process for further testing so that ecotoxicity testing is focused on the most problematic substances and the most relevant test organisms.

Mandate use of all available ecotoxicity studies

We recommend that research studies of sufficient reliability and relevance are used in the environmental risk  assessment. This would make better use of the available knowledge and could provide decision makers with important information.

Require review of the environmental risk assessments at regular intervals

We recommend that environmental risk assessments must be updated when significant new information is available. This would bring forward the regulatory use of new scientific data and may also increase collaboration between  stakeholders.

Increase transparency

We recommend that environmental risk assessments and  information about manufacturing sites are made publicly available. This would enable use of that information for  other purposes such as research and external evaluation,  and it would encourage companies to take more  environmental responsibility throughout their supply chains.