The recent joint declaration on pharmaceuticals in the environment, led by The European Federation of Pharmaceutical Industries and Associations (EFPIA), comes not long after the European Commission’s consultation views on possible actions to address the risks from pharmaceuticals in the environment. Representing 40 pharmaceutical companies and 33 national associations, EFPIA opened their recent joint declaration on pharmaceuticals in the environment with the following:
“We confirm our commitment to take actions in the areas where we can make a difference in order to reduce the presence of pharmaceuticals in the environment”
Whilst declaring they will take action where they can make a difference, they only make reference to disposal - shifting the responsibility to patients.
The continuous growth of the EU market for both human and veterinary medicine highlights the region’s heavy reliance on pharmaceuticals (Eurostat, 2013). At the EU level, however, pharmaceuticals in the environment are mainly addressed in legislation on veterinary medicinal products and are not fully tackled in legislation on medicinal products for human use. The European Commission’s long awaited Strategic Approach on pharmaceuticals in the environment is meant to cover this legislative gap.
Two reports published by Deloitte for the European Commission (2013 and 2016) clearly provide evidence that even low concentrations of pharmaceuticals can pose environmental risks e.g. antimicrobial agents, pharmaceuticals with endocrine-disrupting effects, some anti-parasitic and anti-inflammatory drugs.
Although several studies report very low risks for human health at the concentrations measured in the environment, long-term effects on humans as a result of chronic exposure to pharmaceuticals have not been yet explored. There is also no scientific evidence on the impact that pharmaceuticals in the environment have on children, who are documented to respond to lower doses of medicines compared to adults.
The 2016 Deloitte report clearly states the three main pathways through which Active Pharmaceutical Ingredients (APIs) enter the environment are:
- Emissions from the API manufacturing facilities – no longer negligible anymore, but a clearly observed fact.
- Human and animal excretion (30-90% of an oral dose can be excreted as an active substance both by humans and animals).
- Improper disposal practices by consumers
This industry-led declaration is a smokescreen that unfairly puts the onus on patients by only focusing on one pathway: disposal. This moves focus away from the fact that pharmaceutical companies should be cleaning up their own production and supply chains and investing in biodegradable pharmaceuticals for safer excretions (two pathways that they should take responsibility for). Solely focusing on one pathway as the EFPIA declaration suggests, will not ensure long-term protection of the environment - it will not sufficiently reduce the amount of pharmaceuticals entering the environment.
Promoting sustainable use of pharmaceuticals is a better alternative to campaigning on medicine disposal - both industry and health professionals are well aware that consumption patterns depend on factors beyond the therapeutic needs of a patient. Consumption is affected by prescription practices, patients interrupting their treatment due to intolerance/voluntary choice, or by patients’ increased ability to self-medicate without professional advice.
Only strong legislation will reduce pharmaceutical pollution throughout the life-cycle of pharmaceuticals. The 2016 Deloitte report prepared for the European Commission already provides enough evidence for legislators to act and tackle pharmaceuticals in the environment.