to their developers. Based on feedback obtained in consultation with
pharma-experts, developing PCRs at two different levels/granularities would prove
practical for the pharmaceutical industry (see Fig. 2). First, a generic PCR for the
pharmaceutical sector (‘horizontal rules’) should be developed, determining broad
LCA-modelling provisions which capture some of the industry-wide characteristics
(e.g. the importance of including treatment processes of solvent waste within the
system boundaries). Such a generic “frame-PCR” is subject to a considerable
degree of uncertainty/inaccuracy, as it intends to provide common modelling rules
for quite distinct products of a given sector, while having to rely on numerous
assumptions and a significantly simplified representation of the industry as a whole.
Therefore, in a second step and in close alignment with the frame-PCR, specific
PCRs (‘vertical rules’) should be cumulatively developed for:
(1) pharmaceutical products categorized into different drug classes according to the
international Anatomical Therapeutic Chemical (ATC) Classification System
(product-PCRs) and
(2) drug manufacturing processes (process-PCRs).
The product-PCRs are to be developed for the different drug classes available at
the third level of the ATC-code, i.e. the different therapeutic/pharmacological
subgroups of APIs, and would serve the objective of assessing drug alternatives
according to the same harmonized scheme on the basis of their common functionality (therapeutic purpose) and pharmacological properties. Process-PCRs
would guide LCAs which are primarily focused on process optimization. The
existence of a generic ‘frame-PCR’ encircling product- and process-PCRs will
prove particularly valuable at the early stages when PCRs have not yet been
developed for all therapeutic/pharmacological subgroups of APIs.
A harmonized LCA reference framework for the pharmaceutical industry will
inevitably guarantee better (qualitative) comparability of the results (especially
Fig. 2 Proposal for categorization (‘granularity’) of product category rules for pharmaceutical
products and processes
Life Cycle Management in the Pharmaceutical Industry …
85
pharma-experts, developing PCRs at two different levels/granularities would prove
practical for the pharmaceutical industry (see Fig. 2). First, a generic PCR for the
pharmaceutical sector (‘horizontal rules’) should be developed, determining broad
LCA-modelling provisions which capture some of the industry-wide characteristics
(e.g. the importance of including treatment processes of solvent waste within the
system boundaries). Such a generic “frame-PCR” is subject to a considerable
degree of uncertainty/inaccuracy, as it intends to provide common modelling rules
for quite distinct products of a given sector, while having to rely on numerous
assumptions and a significantly simplified representation of the industry as a whole.
Therefore, in a second step and in close alignment with the frame-PCR, specific
PCRs (‘vertical rules’) should be cumulatively developed for:
(1) pharmaceutical products categorized into different drug classes according to the
international Anatomical Therapeutic Chemical (ATC) Classification System
(product-PCRs) and
(2) drug manufacturing processes (process-PCRs).
The product-PCRs are to be developed for the different drug classes available at
the third level of the ATC-code, i.e. the different therapeutic/pharmacological
subgroups of APIs, and would serve the objective of assessing drug alternatives
according to the same harmonized scheme on the basis of their common functionality (therapeutic purpose) and pharmacological properties. Process-PCRs
would guide LCAs which are primarily focused on process optimization. The
existence of a generic ‘frame-PCR’ encircling product- and process-PCRs will
prove particularly valuable at the early stages when PCRs have not yet been
developed for all therapeutic/pharmacological subgroups of APIs.
A harmonized LCA reference framework for the pharmaceutical industry will
inevitably guarantee better (qualitative) comparability of the results (especially
Fig. 2 Proposal for categorization (‘granularity’) of product category rules for pharmaceutical
products and processes
Life Cycle Management in the Pharmaceutical Industry …
85