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What is PAS 2090:2025 Pharmaceutical products – Product category rules (PCR) for environmental lifecycle assessments – Specification about?
PAS 2090 specifies requirements for the product category rules (PCR) to be applied when carrying out an environmental lifecycle assessment (LCA) for pharmaceutical products and for reporting environmental LCA results.
Who is PAS 2090:2025 Pharmaceutical products – Product category rules (PCR) for environmental lifecycle assessments – Specification for?
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;
- Payors and procurement representatives;
- Environmental managers;
- Policy setters;
- Regulators;
- Healthcare providers;
- Healthcare professionals;
- Patients/public;
- Medicines appraisers; and
- Researchers and legislators.
NOTE: This PAS is intended to be applicable internationally.
What does PAS 2090:2025 Pharmaceutical products – Product category rules (PCR) for environmental lifecycle assessments – Specification cover?
This PAS covers pharmaceutical products intended for human use and the pharmaceutical product life cycle, including the drug substance, formulation, device (if applicable), packaging, distribution, patient use and end of product life. The life cycle includes both “cradle to gate” and “cradle to grave” stages.
This PAS also covers:
- LCA goal/intent;
- Declared/functional units;
- System boundaries and lifecycle 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 does not cover:
- Assessment of patient care pathways;
- Environmental product inventory factors;
- Assessment of development;
- Medical diagnosis products;
- Unlicensed pharmaceutical products/custom, unlicensed medicinal products created or imported on the basis of specific medical advice
- Standalone medical devices, as defined by the Medical Device Regulations 2002.
Why should you use PAS 2090:2025 Pharmaceutical products – Product category rules (PCR) for environmental lifecycle assessments – Specification?
PAS 2090 provides manufacturers with a pharmaceutical-specific product category rule for conducting LCAs that is:
- Clear and consistent: Creates a shared technical language across the industry and provides a clear methodology so that LCAs are carried out in line with recognised international standards but adapted for pharma.
- Flexible: Allows organisations at different levels of data maturity (from data-rich innovators to virtual-only generics) to comply without disproportionate burden.
- Transparent: Establishes clear rules for documenting assumptions, boundaries, and data sources, so results are credible even if not strictly comparable.
- Voluntary and enabling: Acts as a reference point manufacturers can use to prepare for growing external expectations, without imposing new regulatory obligations.
- Credibility-enhancing: Helps manufacturers demonstrate environmental responsibility in a way that stakeholders (including payors like the NHS) will recognise as robust and standards-based.
- Efficient: Reduces duplication by harmonising methods across the sector.
What has changed?
PAS 2090:2025 is a new publication.