• endocrine disruption mediated by exposure to endocrine disrupting chemicals
(EDCs) (reviewed in [21]),
• the development of antibiotic resistance [22] or
• behavioural alterations such as change in feeding behaviour or predator
avoidance due to wildlife-exposure to antidepressants (reviewed in [23]).
Such examples of more subtle and sub-lethal toxic effects with possibly significant repercussions on species’ ecological fitness and population-relevant endpoints are often not captured by endpoints that are typically assessed in regulatory
ecotoxicology. Consequently, using toxicity data on traditional endpoints (e.g.
mortality, growth and reproduction) as recommended by USEtox to calculate CFs
for pharmaceutical compounds fails to reflect certain impact pathways of individual
pharmaceuticals with specific toxic modes of action such as EDCs or antibiotics
[24].
In an attempt to tackle the second methodological constraint, Larsen et al. [24]
sought to integrate endocrine disruption into LCA by suggesting to use test results
from fish laboratory tests with the endpoint sex ratio as effect data when estimating
eco-toxicity characterization factors for estrogenic compounds [24]. Considering
the complexity of the endocrine system—whether in humans or in wildlife—and
the variety of EDCs’ mechanisms of action (e.g. (anti)estrogenic/(anti)androgenic
or interference with thyroid hormone pathways) more endpoints will have to be
eventually included to capture and map the ‘full’ array of EDCs and their potential
toxic effects.
When seeking to include other missing pharma-specific impact pathways such as
the development of antibiotic resistance, it is less likely that the same approach, i.e.
to broaden the endpoints used to calculate effect factors, would suffice to reflect the
specific mechanisms in which bacteria develop or transfer antibiotic resistant genes.
Consequently, a new indicator and characterization model for the inclusion of
antibiotic resistance into LCIA may need to be developed.
4 Product Category Rules (PCRs) for the Pharmaceutical
Industry
PCRs are usually defined for a group of products which have an equivalent or
similar function, making them largely comparable. Despite the compelling case for
a harmonized framework in the form of PCRs to guide LCAs of pharmaceutical
products, so far there has only been one PCR developed for vaccines [25]. On the
basis of this PCR, Pfizer conducted and published an Environmental Product
Declaration (EPD) for IMPROVAC, an immunological product used as alternative
to physical castration in pig management [26]. However the EPD for IMPROVAC
is no longer valid since 2015.
To develop new PCRs, there are no rules on how ‘narrow’ or ‘broad’ a product
category should be defined. In other words, the ‘granularity’ of PCRs is entirely up
84
Y. Emara et al.
(EDCs) (reviewed in [21]),
• the development of antibiotic resistance [22] or
• behavioural alterations such as change in feeding behaviour or predator
avoidance due to wildlife-exposure to antidepressants (reviewed in [23]).
Such examples of more subtle and sub-lethal toxic effects with possibly significant repercussions on species’ ecological fitness and population-relevant endpoints are often not captured by endpoints that are typically assessed in regulatory
ecotoxicology. Consequently, using toxicity data on traditional endpoints (e.g.
mortality, growth and reproduction) as recommended by USEtox to calculate CFs
for pharmaceutical compounds fails to reflect certain impact pathways of individual
pharmaceuticals with specific toxic modes of action such as EDCs or antibiotics
[24].
In an attempt to tackle the second methodological constraint, Larsen et al. [24]
sought to integrate endocrine disruption into LCA by suggesting to use test results
from fish laboratory tests with the endpoint sex ratio as effect data when estimating
eco-toxicity characterization factors for estrogenic compounds [24]. Considering
the complexity of the endocrine system—whether in humans or in wildlife—and
the variety of EDCs’ mechanisms of action (e.g. (anti)estrogenic/(anti)androgenic
or interference with thyroid hormone pathways) more endpoints will have to be
eventually included to capture and map the ‘full’ array of EDCs and their potential
toxic effects.
When seeking to include other missing pharma-specific impact pathways such as
the development of antibiotic resistance, it is less likely that the same approach, i.e.
to broaden the endpoints used to calculate effect factors, would suffice to reflect the
specific mechanisms in which bacteria develop or transfer antibiotic resistant genes.
Consequently, a new indicator and characterization model for the inclusion of
antibiotic resistance into LCIA may need to be developed.
4 Product Category Rules (PCRs) for the Pharmaceutical
Industry
PCRs are usually defined for a group of products which have an equivalent or
similar function, making them largely comparable. Despite the compelling case for
a harmonized framework in the form of PCRs to guide LCAs of pharmaceutical
products, so far there has only been one PCR developed for vaccines [25]. On the
basis of this PCR, Pfizer conducted and published an Environmental Product
Declaration (EPD) for IMPROVAC, an immunological product used as alternative
to physical castration in pig management [26]. However the EPD for IMPROVAC
is no longer valid since 2015.
To develop new PCRs, there are no rules on how ‘narrow’ or ‘broad’ a product
category should be defined. In other words, the ‘granularity’ of PCRs is entirely up
84
Y. Emara et al.