Standards Development

Scope

This PAS specifies requirements for the product category rules (PCR) to be applied when carrying out an environmental life cycle assessment (LCA) for pharmaceutical products and for reporting environmental LCA results.

This PAS covers:

•           pharmaceutical products intended for human use;

•           the pharmaceutical product life cycle, including the manufacture of the drug substance, drug product formulation, administration device (if applicable), packaging, distribution, patient use and end of product life. The life cycle includes both “cradle to gate” and “cradle to grave” analyses; and

•           most modalities/active pharmaceutical ingredients (API) currently commercially available.

This PAS also covers:

•           LCA goal/intent;

•           declared/functional units;

•           system boundaries and life cycle stages;

•           product categories and descriptions;

•           multiple environmental impact category indicators;

•           cut-off criteria and assumptions;

•           allocation rules;

•           data quality requirements;

•           key assumptions and modelling requirements;

•           primary data requirements;

•           secondary data selection;

•           expected outputs;

•           interpretation and communication of results; and

•           reporting and documentation.

This PAS is intended for use by those carrying out, assessing and reviewing environmental LCAs of pharmaceutical products, including the determination of related greenhouse gas emissions as well as other environmental impacts.

This PAS might be of interest to (but is not limited to) the following stakeholders and their representative associations:

•           manufacturers of pharmaceutical products and suppliers;

•           policymakers, regulators and legislators;

•           payors and procurement representatives;

•           environmental managers;

•           healthcare providers;

•           healthcare professionals;

•           medicines appraisers;

•           researchers; and

•           patients/public.

This PAS is intended to be applicable internationally.

This PAS does not cover:

•           the assessment of patient care pathways;

•           the provision of ready-to-use environmental product emission factors;

•           the assessment of research and development phases;

•           medical diagnosis products;

•           unlicensed pharmaceutical products/custom unlicensed medicinal products created or imported on the basis of specific medical advice, i.e. very bespoke and low volume;

•           the assessment of standalone medical devices as defined by the Medical Devices Regulations 2002 [1], which include devices neither containing drug products nor intended for drug product administration (e.g. software, monitoring devices, thermometers, lasers);

•           precise specifications broken down by pharmaceutical product sub-categories;

            NOTE Comprehensive specifications are not provided for precise sub-category specificities, such as cell therapies or vaccines. A distinction is only made between biological and synthetic API.

•           details on the modelling and assessment of packaging return schemes for patients and healthcare providers, including the return of primary (administration device or other) and secondary packaging for cleaning, repair and subsequent refilling; and

•           the assessment of unused products distributed or prescribed but not taken by the patient (i.e. not resulting from manufacturer action).