typically dwarfs impacts of the actual in-house synthetic processes [10, 11].
Furthermore, the use phase and end-of-life of a pharmaceutical product may as well
bear considerable environmental impacts, especially if eco- and
human-toxicological effects due to API-emissions into sewage systems (and
eventually into surface waters) are to be included in the analysis (for further details
see next section). Consequently, pharmaceutical corporations should strive towards
complete cradle-to-grave analyses.
A closer examination of the existing pharma-LCAs quickly revealed that the
individual studies are quite inhomogeneous in a number of respects: e.g. their
choice of functional unit (FU), system boundaries setting, use of background
databases and data quality, choice of impact assessment methods and the impact
categories they consider. For instance, while Brunet et al. [12] set the FU at
20,840,000 kg of penicillin V produced over a time horizon of 20 years, De Soete
et al. [13] chose 1 daily dosage of PREZISTA (anti-HIV medication) as their FU.
The majority of reviewed studies though opted for 1 kg of API as FU. Similarly,
while Wernet et al. [10] chose to assess sixteen impact categories (both at midpointand endpoint level) using 5 different impact assessment methods, Kim et al. [14]
considered 5 impact categories using one method only.
In light of the different goals and scopes of the reviewed studies and the inherent
uniqueness of individual APIs/drug formulations, a certain degree of methodological variation among pharma-LCAs is only logical, if not expedient.
Nevertheless, lack of sufficient experience and guidance has led to large discrepancies in the application of LCA in the pharma-sector, often jeopardizing the
coherence and reliability of pharma-LCAs. Consequently, there is an evident need
for PCRs for the pharmaceutical industry to guide and facilitate future
pharma-LCAs. Preliminary thoughts on pharma-PCRs are discussed in Sect. 4.
3 Life Cycle Impact Assessment (LCIA) in Pharma-LCAs
The LCIA phase of the reviewed pharma-LCAs was carried out using quite
divergent impact categories and impact assessment methods. A streamlined LCA
tool developed by the American Chemical Society Green Chemistry Institute
(ACS-GCI) Pharmaceutical Roundtable (hereinafter ‘the Roundtable’) sets forth
nine impact categories/indicators to be assessed in LCAs of drug synthesis routes
[11]. Table 1 lists these nine impact categories, next to the top five assessed impact
categories in the reviewed pharma-LCAs, as well as a preliminary selection of eight
categories recognized by the authors as the most relevant for pharma-LCAs. The
latter list was determined in consultation with the SERUM advisory committee,
which comprises experts from academia, politics and the pharmaceutical industry.
Quite notably, impacts—especially toxicity-related impacts—which have been
identified as relevant for the pharmaceutical industry within the SERUM project are
not often considered in LCA studies nor recommended in the Roundtable’s
streamlined tool. Given the desired functionality of pharmaceuticals—e.g. to kill
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Y. Emara et al.
Furthermore, the use phase and end-of-life of a pharmaceutical product may as well
bear considerable environmental impacts, especially if eco- and
human-toxicological effects due to API-emissions into sewage systems (and
eventually into surface waters) are to be included in the analysis (for further details
see next section). Consequently, pharmaceutical corporations should strive towards
complete cradle-to-grave analyses.
A closer examination of the existing pharma-LCAs quickly revealed that the
individual studies are quite inhomogeneous in a number of respects: e.g. their
choice of functional unit (FU), system boundaries setting, use of background
databases and data quality, choice of impact assessment methods and the impact
categories they consider. For instance, while Brunet et al. [12] set the FU at
20,840,000 kg of penicillin V produced over a time horizon of 20 years, De Soete
et al. [13] chose 1 daily dosage of PREZISTA (anti-HIV medication) as their FU.
The majority of reviewed studies though opted for 1 kg of API as FU. Similarly,
while Wernet et al. [10] chose to assess sixteen impact categories (both at midpointand endpoint level) using 5 different impact assessment methods, Kim et al. [14]
considered 5 impact categories using one method only.
In light of the different goals and scopes of the reviewed studies and the inherent
uniqueness of individual APIs/drug formulations, a certain degree of methodological variation among pharma-LCAs is only logical, if not expedient.
Nevertheless, lack of sufficient experience and guidance has led to large discrepancies in the application of LCA in the pharma-sector, often jeopardizing the
coherence and reliability of pharma-LCAs. Consequently, there is an evident need
for PCRs for the pharmaceutical industry to guide and facilitate future
pharma-LCAs. Preliminary thoughts on pharma-PCRs are discussed in Sect. 4.
3 Life Cycle Impact Assessment (LCIA) in Pharma-LCAs
The LCIA phase of the reviewed pharma-LCAs was carried out using quite
divergent impact categories and impact assessment methods. A streamlined LCA
tool developed by the American Chemical Society Green Chemistry Institute
(ACS-GCI) Pharmaceutical Roundtable (hereinafter ‘the Roundtable’) sets forth
nine impact categories/indicators to be assessed in LCAs of drug synthesis routes
[11]. Table 1 lists these nine impact categories, next to the top five assessed impact
categories in the reviewed pharma-LCAs, as well as a preliminary selection of eight
categories recognized by the authors as the most relevant for pharma-LCAs. The
latter list was determined in consultation with the SERUM advisory committee,
which comprises experts from academia, politics and the pharmaceutical industry.
Quite notably, impacts—especially toxicity-related impacts—which have been
identified as relevant for the pharmaceutical industry within the SERUM project are
not often considered in LCA studies nor recommended in the Roundtable’s
streamlined tool. Given the desired functionality of pharmaceuticals—e.g. to kill
82
Y. Emara et al.