remain far from becoming common practice in the pharmaceutical industry [7, 8].
Furthermore, existing pharma-LCAs are quite inhomogeneous in multiple respects,
e.g. the choice of functional unit or of impact categories. This, in turn, reduces the
robustness of their results and their reproducibility and makes industry-wide
insights with respect to typical environmental ‘hotspots’ or possible strategies for
‘greener’ drug designs practically futile. Naturally, the distinct goals of
pharma-LCAs are partly responsible for the diversity of methodological choices
among the studies. However, given the high degree of flexibility provided by the
ISO 14040/14044 standards, it is fair to assume that even two studies of the same
drug done by two different LCA-practitioners would show considerable disparity. It
is exactly that realisation that has led over the last few years to the need—and
consequently the parallel rise—of so-called ‘product category rules’ (PCRs), i.e. a
set of harmonized rules on specific LCA modelling requirements for a given product category [9]. With the aim to develop PCRs for the pharma-sector, a three-year
project, entitled ‘Development of a sector-specific environmental sustainability
assessment approach for pharmaceutical products and processes’ (German abbreviation: SERUM), was launched last year at the Technische Universität Berlin.
The purpose of this paper is to present current gaps and challenges impeding a
full adoption of LCA into the sustainability practices and product development
processes of the pharma-sector and to provide preliminary recommendations on
how to tackle some of those challenges. Following a short review of existing LCAs
in the pharma-sector in Sect. 2, Sect. 3 will briefly describe the current state of Life
Cycle Impact Assessment (LCIA) in pharma-LCAs and introduce some of the
present constraints in modelling the toxicity of pharmaceutical compounds.
Section 4 addresses early considerations on the way to developing PCRs for the
pharmaceutical sector. Finally, a few concluding remarks and implications for
future research within the LCA community will be presented.
2 Review of LCAs in the Pharmaceutical Industry
A comprehensive review on the state of LCA-application in the pharmaceutical
industry, specifically human pharmaceuticals, was initially performed in order to
identify common LCA-practices within the sector (e.g. choice of functional unit),
regularly identified ‘Hotspots’ in the life cycle of drugs, as well as often encountered challenges and remaining gaps. Results of the review were meant to lay the
ground for harmonized sector-specific rules—in the form of PCRs—and reveal
thematic focal points for achieving greater LCA-application within the
pharma-sector. Given the unique characteristics of the pharmaceutical industry (e.g.
exceptionally high standards of cleanliness maintained during production) and the
relatively young age of ‘green pharmacy’-practices, the focus of the literature
review was on LCA case studies of human pharmaceutical products (i.e. APIs or
final drug, incl. packaging) or pharmaceutical processes, performed in or after the
year 2000. LCAs of precursor chemicals (e.g. enzymes) were only included if
80
Y. Emara et al.
Furthermore, existing pharma-LCAs are quite inhomogeneous in multiple respects,
e.g. the choice of functional unit or of impact categories. This, in turn, reduces the
robustness of their results and their reproducibility and makes industry-wide
insights with respect to typical environmental ‘hotspots’ or possible strategies for
‘greener’ drug designs practically futile. Naturally, the distinct goals of
pharma-LCAs are partly responsible for the diversity of methodological choices
among the studies. However, given the high degree of flexibility provided by the
ISO 14040/14044 standards, it is fair to assume that even two studies of the same
drug done by two different LCA-practitioners would show considerable disparity. It
is exactly that realisation that has led over the last few years to the need—and
consequently the parallel rise—of so-called ‘product category rules’ (PCRs), i.e. a
set of harmonized rules on specific LCA modelling requirements for a given product category [9]. With the aim to develop PCRs for the pharma-sector, a three-year
project, entitled ‘Development of a sector-specific environmental sustainability
assessment approach for pharmaceutical products and processes’ (German abbreviation: SERUM), was launched last year at the Technische Universität Berlin.
The purpose of this paper is to present current gaps and challenges impeding a
full adoption of LCA into the sustainability practices and product development
processes of the pharma-sector and to provide preliminary recommendations on
how to tackle some of those challenges. Following a short review of existing LCAs
in the pharma-sector in Sect. 2, Sect. 3 will briefly describe the current state of Life
Cycle Impact Assessment (LCIA) in pharma-LCAs and introduce some of the
present constraints in modelling the toxicity of pharmaceutical compounds.
Section 4 addresses early considerations on the way to developing PCRs for the
pharmaceutical sector. Finally, a few concluding remarks and implications for
future research within the LCA community will be presented.
2 Review of LCAs in the Pharmaceutical Industry
A comprehensive review on the state of LCA-application in the pharmaceutical
industry, specifically human pharmaceuticals, was initially performed in order to
identify common LCA-practices within the sector (e.g. choice of functional unit),
regularly identified ‘Hotspots’ in the life cycle of drugs, as well as often encountered challenges and remaining gaps. Results of the review were meant to lay the
ground for harmonized sector-specific rules—in the form of PCRs—and reveal
thematic focal points for achieving greater LCA-application within the
pharma-sector. Given the unique characteristics of the pharmaceutical industry (e.g.
exceptionally high standards of cleanliness maintained during production) and the
relatively young age of ‘green pharmacy’-practices, the focus of the literature
review was on LCA case studies of human pharmaceutical products (i.e. APIs or
final drug, incl. packaging) or pharmaceutical processes, performed in or after the
year 2000. LCAs of precursor chemicals (e.g. enzymes) were only included if
80
Y. Emara et al.