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Materiality Navigator·Pharmaceuticals, Biotechnology and Life Sciences

Which topics should you investigate first?

Choose a business model to see the candidate sustainability topics most likely to need investigation, and why. Then refine the shortlist, work through each topic and record a preliminary screening decision.

This is an industry-informed hypothesis. Your task is to test it against the organisation's impacts, dependencies, risks, opportunities and stakeholder evidence. Industry relevance does not make a topic material.

Capsules and tablets scattered on a table.
Step 1 Choose the business model you are screening

Candidate topics — Pharmaceuticals, Biotechnology and Life Sciences

  • Environment
  • Industry baseline
  • Strong industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Safe segregation, storage, treatment, disposal and recovery of hazardous, biohazardous and pharmaceutical-specific waste streams from research, manufacturing, quality and packaging operations.

How it shows up in this industry

Laboratories, API plants, biologics facilities, sterile operations and quality control laboratories generate spent solvents, mother liquors, process residues, off-specification batches, cytotoxic residues, biohazardous waste, sharps, filters, gowns, rejected packaging and single-use bioprocess plastics requiring controlled storage and specialist off-site treatment.

Why it may be material

Waste streams are intrinsic to API synthesis, biologics processing, sterile fill-finish, quality testing and failed batch management. Poor segregation or treatment can expose workers and waste handlers to cytotoxic, infectious or solvent hazards and create liabilities through third-party disposal routes.

Impact pathway

  1. Potential effects may reach workers.
  2. Potential effects may reach contractors.
  3. Potential effects may reach supply-chain workers.
  4. Potential effects may reach water bodies.
  5. Potential effects may reach soil and groundwater.
  6. Potential effects may reach ecosystems.
  7. Potential effects may reach affected communities.
  8. Affected stakeholder groups identified in the source include Affected communities, Contractors, Employees, Suppliers.
  9. The source places the pathway in Own operations, Upstream, Downstream.

Financial pathway

  1. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  2. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  3. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  4. The topic may affect insurance availability, coverage terms, premiums or claims.
  5. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which upstream activities, suppliers or inputs create or concentrate the pathway?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • What is the scale, scope, likelihood and remediability of effects on workers?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Workforce, health and safety, engagement and grievance records
  • Contractor working-condition, incident and engagement records
  • Supplier workforce, audit, grievance and remediation records
  • Water withdrawal, discharge, quality and catchment-impact records
  • Soil and groundwater monitoring, incident and remediation records
  • Biodiversity, habitat and ecosystem-impact evidence
  • Community engagement, grievance and impact records
  • Operating-cost records and budgets linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Provision, claim, penalty, remediation and contingent-liability records
  • Insurance coverage, premium, exclusion and claims records
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): GMP small-molecule manufacturing plants with reactors, centrifuges, dryers, containment isolators and solvent recovery systems
  • Process-map item (assets): Biologics facilities with cell banks, seed trains, stainless-steel or single-use bioreactors, chromatography skids and viral clearance systems
  • Process-map item (assets): Specialised waste handling areas for cytotoxic, biohazardous, solvent and sharps waste before off-site treatment
  • Process-map item (emerging_pressures): Tighter scrutiny of antimicrobial manufacturing discharges and the contribution of pharmaceutical supply chains to antimicrobial resistance
  • Process-map item (emerging_pressures): Restrictions on PFAS, certain solvents, endocrine-active substances and persistent chemicals used in synthesis, packaging and laboratory operations

It may be less material when…

  • Organisation-specific evidence does not support significant scale, severity, likelihood or financial effect.
  • The organisation has no meaningful exposure to or influence over the relevant upstream or downstream pathway.

Affected stakeholders

  • Affected communities
  • Contractors
  • Employees
  • Suppliers

Users of the information

  • Investors / creditors
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Environment
  • Industry baseline
  • Strong industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Mitigation of greenhouse gas emissions and energy use from research laboratories, GMP manufacturing, biologics production, sterile facilities, cold-chain logistics and relevant product delivery formats.

How it shows up in this industry

The industry operates energy-intensive cleanrooms, chillers, boilers, ultra-low-temperature freezers, aseptic fill-finish lines, bioreactors, lyophilisers, validated warehouses and cold-chain networks. Biologics, vaccines, insulin, advanced therapies and some inhaler products create distinctive emissions hotspots from temperature control, refrigerants and propellants.

Why it may be material

Controlled environments and validated logistics create large energy and emissions profiles. Health systems, investors and procurement bodies increasingly ask for lower-carbon supply without compromising potency, sterility or regulatory validation, making transition planning relevant to OPEX, CAPEX, financing and revenue.

Impact pathway

  1. Potential effects may reach the atmosphere.
  2. Potential effects may reach future generations.
  3. Potential effects may reach affected communities.
  4. Potential effects may reach consumers.
  5. Affected stakeholder groups identified in the source include Business partners, Customers / end-users, Suppliers.
  6. The source places the pathway in Own operations, Upstream, Downstream, Cross value chain.

Financial pathway

  1. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  2. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  3. The topic may affect demand, pricing, market access or product and service revenue.
  4. The topic may affect access to finance, funding terms or the cost of capital.
  5. The topic may affect asset useful lives, impairment assumptions, valuations or stranded-asset exposure.
  6. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which upstream activities, suppliers or inputs create or concentrate the pathway?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • Where across the value chain is the pathway most significant?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Emissions, air-quality and atmospheric-impact records linked to the topic
  • Long-term scenario, cumulative-impact and intergenerational analysis
  • Community engagement, grievance and impact records
  • Consumer outcome, complaint and product-impact records
  • Operating-cost records and budgets linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Funding terms, lender or investor requirements and cost-of-capital analysis
  • Asset valuations, useful-life assumptions, impairment tests and stranded-asset analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): GMP small-molecule manufacturing plants with reactors, centrifuges, dryers, containment isolators and solvent recovery systems
  • Process-map item (assets): Biologics facilities with cell banks, seed trains, stainless-steel or single-use bioreactors, chromatography skids and viral clearance systems
  • Process-map item (assets): Sterile fill-finish facilities with aseptic lines, lyophilisers, cleanrooms, vial, syringe and cartridge filling equipment
  • Process-map item (assets): Cold-chain infrastructure including ultra-low-temperature freezers, validated warehouses, temperature loggers and insulated shippers
  • Process-map item (assets): Intellectual property portfolios covering compounds, biologic constructs, manufacturing processes, indications and delivery devices

It may be less material when…

  • Organisation-specific evidence does not support significant scale, severity, likelihood or financial effect.
  • The organisation has no meaningful exposure to or influence over the relevant upstream or downstream pathway.

Affected stakeholders

  • Business partners
  • Customers / end-users
  • Suppliers

Users of the information

  • Board / management
  • Investors / creditors
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Environment
  • Industry baseline
  • Strong industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Management of pharmaceutical residues, antibiotic discharges and bioactive intermediates entering wastewater from own manufacturing, laboratories and upstream API or intermediate suppliers.

How it shows up in this industry

API synthesis, biologics processing, cleaning, quality control laboratories and upstream chemical production can generate wastewater containing active ingredients, antibiotics, intermediates, solvents and transformation products. Antibiotic residues from own or supplier effluents can select for resistant organisms in receiving waters and sediments, attracting scrutiny from regulators, public health buyers and civil society.

Why it may be material

The pathway from API manufacture and supplier production to pharmaceutical residues in water is direct and sector-specific. Scrutiny is rising because antimicrobial discharge controls can influence treatment CAPEX, supplier qualification, public procurement and financing expectations for antibiotic portfolios.

Impact pathway

  1. Potential effects may reach water bodies.
  2. Potential effects may reach ecosystems.
  3. Potential effects may reach affected communities.
  4. Potential effects may reach future generations.
  5. Affected stakeholder groups identified in the source include Affected communities, Customers / end-users, Suppliers.
  6. The source places the pathway in Own operations, Upstream.

Financial pathway

  1. The topic may affect demand, pricing, market access or product and service revenue.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  4. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  5. The topic may affect access to finance, funding terms or the cost of capital.
  6. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which upstream activities, suppliers or inputs create or concentrate the pathway?
  • What is the scale, scope, likelihood and remediability of effects on water bodies?
  • What is the scale, scope, likelihood and remediability of effects on ecosystems?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Water withdrawal, discharge, quality and catchment-impact records
  • Biodiversity, habitat and ecosystem-impact evidence
  • Community engagement, grievance and impact records
  • Long-term scenario, cumulative-impact and intergenerational analysis
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Operating-cost records and budgets linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Provision, claim, penalty, remediation and contingent-liability records
  • Funding terms, lender or investor requirements and cost-of-capital analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): GMP small-molecule manufacturing plants with reactors, centrifuges, dryers, containment isolators and solvent recovery systems
  • Process-map item (assets): Intellectual property portfolios covering compounds, biologic constructs, manufacturing processes, indications and delivery devices
  • Process-map item (customers): Patients receiving prescription medicines, vaccines, biologics, cell therapies and rare disease treatments
  • Process-map item (customers): Community and hospital pharmacies dispensing finished medicines and providing patient counselling
  • Process-map item (customers): Contract research organisations, contract development and manufacturing organisations and licensing partners in outsourced development chains

It may be less material when…

  • Organisation-specific evidence does not support significant scale, severity, likelihood or financial effect.
  • The organisation has no meaningful exposure to or influence over the relevant upstream pathway.
  • The emerging signal has not yet created a relevant exposure, impact or financial effect for the organisation.

Affected stakeholders

  • Affected communities
  • Customers / end-users
  • Suppliers

Users of the information

  • Investors / creditors
  • NGOs / civil society
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Environment
  • Industry baseline
  • Moderate industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Responsible use and treatment of water required for pharmaceutical formulation, sterile production, cleaning, cooling and bioprocessing, especially in water-stressed basins.

How it shows up in this industry

Pharmaceutical and biologics plants rely on purified water, water for injection, clean steam and process water for formulation, cleaning, cooling, sterile manufacturing and bioprocessing. High water demand can be material where facilities operate in stressed catchments or where expansion requires additional treatment and utility capacity.

Why it may be material

Water is embedded in sterile and biologics production, cleaning validation and utility systems. In stressed catchments, withdrawals and treated discharges affect local availability, receiving water quality, permits and community acceptance of manufacturing expansion.

Impact pathway

  1. Potential effects may reach water bodies.
  2. Potential effects may reach affected communities.
  3. Potential effects may reach ecosystems.
  4. Affected stakeholder groups identified in the source include Affected communities.
  5. The source places the pathway in Own operations, Upstream.

Financial pathway

  1. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  2. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  3. The topic may affect asset useful lives, impairment assumptions, valuations or stranded-asset exposure.
  4. The topic may affect access to finance, funding terms or the cost of capital.
  5. The topic may create provisions, penalties, remediation costs, claims or other liabilities.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which upstream activities, suppliers or inputs create or concentrate the pathway?
  • What is the scale, scope, likelihood and remediability of effects on water bodies?
  • What is the scale, scope, likelihood and remediability of effects on affected communities?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Water withdrawal, discharge, quality and catchment-impact records
  • Community engagement, grievance and impact records
  • Biodiversity, habitat and ecosystem-impact evidence
  • Operating-cost records and budgets linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Asset valuations, useful-life assumptions, impairment tests and stranded-asset analysis
  • Funding terms, lender or investor requirements and cost-of-capital analysis
  • Provision, claim, penalty, remediation and contingent-liability records
  • Process-map item (emerging_pressures): Tighter scrutiny of antimicrobial manufacturing discharges and the contribution of pharmaceutical supply chains to antimicrobial resistance
  • Process-map item (emerging_pressures): Rising demand for supply chain resilience and domestic or regional manufacturing capacity for essential medicines and vaccines
  • Process-map item (emerging_pressures): Investor and payer demand for transparent access strategies, responsible pricing and equitable availability of high-impact medicines
  • Process-map item (external_impacts): Discharge of active pharmaceutical ingredients, intermediates and transformation products to wastewater from manufacturing sites and suppliers
  • Process-map item (external_impacts): High water demand for purified water, water for injection, cleaning, cooling and bioprocessing in regions with stressed catchments

It may be less material when…

  • The organisation's scale, exposure or effects are below the threshold set for further assessment.
  • The organisation has no meaningful exposure to or influence over the relevant upstream pathway.

Affected stakeholders

  • Affected communities

Users of the information

  • Board / management
  • Investors / creditors
  • Local authorities
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Environment
  • Business-model dependent
  • Moderate industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Downstream stewardship of medicine and packaging end-of-life, including design-for-recyclability where safe, returns and take-back interfaces, sharps disposal, cold-chain shipper recovery and safe handling of expired or unused medicines.

How it shows up in this industry

Finished medicines are distributed in blister packs, glass vials, pre-filled syringes, cartridges, stoppers, aluminium seals, cold-chain shippers, sharps containers and patient information leaflets. Expired products, returned cold-chain shipments and used injectable materials create downstream disposal and recovery challenges while sterility, anti-tampering and patient safety constraints limit packaging redesign.

Why it may be material

Packaging and medicine end-of-life are material for companies with high-volume blister packs, injectable products, cold-chain biologics or home-administered therapies. Poor disposal can contribute to packaging waste, sharps injury and pharmaceutical residues, while circular designs must maintain sterility, stability and regulatory compliance.

Impact pathway

  1. Potential effects may reach consumers.
  2. Potential effects may reach downstream users.
  3. Potential effects may reach affected communities.
  4. Potential effects may reach water bodies.
  5. Potential effects may reach ecosystems.
  6. Potential effects may reach soil and groundwater.
  7. Potential effects may reach workers.
  8. Affected stakeholder groups identified in the source include Affected communities, Customers / end-users, Suppliers.
  9. The source places the pathway in Downstream, Cross value chain.

Financial pathway

  1. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  2. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  3. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  4. The topic may affect demand, pricing, market access or product and service revenue.
  5. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • Where across the value chain is the pathway most significant?
  • What is the scale, scope, likelihood and remediability of effects on consumers?
  • What is the scale, scope, likelihood and remediability of effects on downstream users?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Consumer outcome, complaint and product-impact records
  • Downstream-user outcome, complaint and product-use evidence
  • Community engagement, grievance and impact records
  • Water withdrawal, discharge, quality and catchment-impact records
  • Biodiversity, habitat and ecosystem-impact evidence
  • Soil and groundwater monitoring, incident and remediation records
  • Workforce, health and safety, engagement and grievance records
  • Operating-cost records and budgets linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Provision, claim, penalty, remediation and contingent-liability records
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): Cold-chain infrastructure including ultra-low-temperature freezers, validated warehouses, temperature loggers and insulated shippers
  • Process-map item (assets): Specialised waste handling areas for cytotoxic, biohazardous, solvent and sharps waste before off-site treatment
  • Process-map item (customers): Wholesalers, speciality distributors and third-party logistics providers supplying regulated medicine channels
  • Process-map item (customers): Physicians, pharmacists and other prescribers who influence product selection and safe use
  • Process-map item (emerging_pressures): Expanded medicine price negotiation, reference pricing and health technology assessment requirements affecting revenue certainty and launch sequencing

It may be less material when…

  • The organisation's scale, exposure or effects are below the threshold set for further assessment.
  • The relevant business model, activity, asset or product is not present or is not significant.
  • The organisation has no meaningful exposure to or influence over the relevant downstream pathway.

Affected stakeholders

  • Affected communities
  • Customers / end-users
  • Suppliers

Users of the information

  • Investors / creditors
  • Local authorities
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Environment
  • Emerging issue
  • Moderate industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Governance and investment in replacing persistent, restricted or high-concern chemicals in pharmaceutical R&D, API synthesis, packaging and laboratory operations while maintaining GMP validation, impurity control and regulatory approval status.

How it shows up in this industry

Pharmaceutical process development uses acetonitrile, methanol, dichloromethane, dimethylformamide, fluorinated materials, excipients, packaging components and laboratory reagents. Substitution must align with route selection, impurity profiling, GMP validation, change control and marketing authorisation requirements, which can slow transition away from high-concern inputs.

Why it may be material

Restrictions on PFAS, certain solvents, endocrine-active substances and persistent chemicals are moving faster than pharmaceutical route revalidation cycles. Marketed products, packaging systems and clinical-stage pipelines can face revalidation cost, supplier disruption, contamination liabilities and access delays where dependencies are hard to substitute.

Impact pathway

  1. Potential effects may reach workers.
  2. Potential effects may reach contractors.
  3. Potential effects may reach water bodies.
  4. Potential effects may reach ecosystems.
  5. Potential effects may reach soil and groundwater.
  6. Potential effects may reach downstream users.
  7. Affected stakeholder groups identified in the source include Customers / end-users, Employees, Suppliers.
  8. The source places the pathway in Own operations, Upstream, Downstream.

Financial pathway

  1. The topic may affect demand, pricing, market access or product and service revenue.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  4. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  5. The topic may affect asset useful lives, impairment assumptions, valuations or stranded-asset exposure.
  6. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which upstream activities, suppliers or inputs create or concentrate the pathway?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • What is the scale, scope, likelihood and remediability of effects on workers?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Workforce, health and safety, engagement and grievance records
  • Contractor working-condition, incident and engagement records
  • Water withdrawal, discharge, quality and catchment-impact records
  • Biodiversity, habitat and ecosystem-impact evidence
  • Soil and groundwater monitoring, incident and remediation records
  • Downstream-user outcome, complaint and product-use evidence
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Operating-cost records and budgets linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Provision, claim, penalty, remediation and contingent-liability records
  • Asset valuations, useful-life assumptions, impairment tests and stranded-asset analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): Discovery biology, medicinal chemistry and translational research laboratories with high-throughput screening equipment, mass spectrometry and bioassay platforms
  • Process-map item (assets): Pilot-scale API synthesis suites and process development plants for route selection, scale-up and impurity profiling
  • Process-map item (assets): GMP small-molecule manufacturing plants with reactors, centrifuges, dryers, containment isolators and solvent recovery systems
  • Process-map item (assets): Intellectual property portfolios covering compounds, biologic constructs, manufacturing processes, indications and delivery devices
  • Process-map item (assets): Specialised waste handling areas for cytotoxic, biohazardous, solvent and sharps waste before off-site treatment

It may be less material when…

  • The organisation's scale, exposure or effects are below the threshold set for further assessment.
  • The organisation has no meaningful exposure to or influence over the relevant upstream or downstream pathway.
  • The emerging signal has not yet created a relevant exposure, impact or financial effect for the organisation.

Affected stakeholders

  • Customers / end-users
  • Employees
  • Suppliers

Users of the information

  • Board / management
  • Investors / creditors
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Social
  • Industry baseline
  • Strong industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Ethical and scientifically robust conduct of clinical trials, including participant safety, informed consent, fair recruitment, diversity of evidence generation, trial transparency and oversight of contract research organisations and trial sites.

How it shows up in this industry

Clinical development spans Phase I to Phase IV studies, site selection, participant recruitment, monitoring, electronic data capture, genomic data, clinical records and real-world evidence. Regulators and payers increasingly expect trial populations to reflect real-world disease burden for biologics, oncology, vaccines, rare disease products and advanced therapies.

Why it may be material

Clinical research directly affects participants before products are approved and determines whether evidence supports safe and effective use across patient groups. Weak consent, monitoring, inclusion or data integrity can delay approvals, narrow labels, increase liability and reduce payer confidence.

Impact pathway

  1. Potential effects may reach consumers.
  2. Potential effects may reach affected communities.
  3. Potential effects may reach downstream users.
  4. Potential effects may reach supply-chain workers.
  5. Affected stakeholder groups identified in the source include Business partners, Customers / end-users.
  6. The source places the pathway in Own operations, Upstream, Downstream, Cross value chain.

Financial pathway

  1. The topic may affect demand, pricing, market access or product and service revenue.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  4. The topic may affect access to finance, funding terms or the cost of capital.
  5. The topic may affect asset useful lives, impairment assumptions, valuations or stranded-asset exposure.
  6. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which upstream activities, suppliers or inputs create or concentrate the pathway?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • Where across the value chain is the pathway most significant?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Consumer outcome, complaint and product-impact records
  • Community engagement, grievance and impact records
  • Downstream-user outcome, complaint and product-use evidence
  • Supplier workforce, audit, grievance and remediation records
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Operating-cost records and budgets linked to the topic
  • Provision, claim, penalty, remediation and contingent-liability records
  • Funding terms, lender or investor requirements and cost-of-capital analysis
  • Asset valuations, useful-life assumptions, impairment tests and stranded-asset analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): Clinical trial operating systems, electronic data capture platforms, pharmacovigilance databases and regulated cloud environments
  • Process-map item (emerging_pressures): Growing regulatory expectations for diversity in clinical trial recruitment and evidence generation across under-served populations
  • Process-map item (emerging_pressures): Increased cyber risk and data governance scrutiny as AI-enabled drug discovery, remote trials and connected manufacturing expand
  • Process-map item (emerging_pressures): More litigation and regulatory attention on opioid misuse, product safety disclosures, off-label promotion and patient assistance schemes
  • Process-map item (external_impacts): Hazardous waste generation including spent solvents, cytotoxic residues, contaminated single-use bioprocess plastics and failed batches

It may be less material when…

  • Organisation-specific evidence does not support significant scale, severity, likelihood or financial effect.
  • The organisation has no meaningful exposure to or influence over the relevant upstream or downstream pathway.

Affected stakeholders

  • Business partners
  • Customers / end-users

Users of the information

  • Board / management
  • Investors / creditors
  • NGOs / civil society
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Social
  • Industry baseline
  • Strong industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Safety, quality-in-use and post-market surveillance of medicines, vaccines, biologics and advanced therapies throughout distribution, administration, real-world use, complaint handling and safety signal management.

How it shows up in this industry

Biotechnology and pharmaceutical companies supply prescription medicines, vaccines, biologics, inhalers and advanced therapies through hospitals, pharmacies, wholesalers and specialist distributors. Pharmacovigilance databases, product complaint systems, medical information services, risk management plans, serialisation and post-authorisation study data are central to maintaining approvals and patient trust.

Why it may be material

Medicine safety failures can affect large treated populations and directly influence regulatory approval, label maintenance, formulary access, product liability, insurance cost and prescriber confidence. The issue is especially acute for biologics, vaccines, controlled medicines, sterile injectables and cell or gene therapies with complex safety profiles.

Impact pathway

  1. Potential effects may reach consumers.
  2. Potential effects may reach downstream users.
  3. Potential effects may reach affected communities.
  4. Potential effects may reach future generations.
  5. Affected stakeholder groups identified in the source include Business partners, Customers / end-users.
  6. The source places the pathway in Own operations, Downstream, Cross value chain.

Financial pathway

  1. The topic may affect demand, pricing, market access or product and service revenue.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  4. The topic may affect insurance availability, coverage terms, premiums or claims.
  5. The topic may affect asset useful lives, impairment assumptions, valuations or stranded-asset exposure.
  6. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • Where across the value chain is the pathway most significant?
  • What is the scale, scope, likelihood and remediability of effects on consumers?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Consumer outcome, complaint and product-impact records
  • Downstream-user outcome, complaint and product-use evidence
  • Community engagement, grievance and impact records
  • Long-term scenario, cumulative-impact and intergenerational analysis
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Operating-cost records and budgets linked to the topic
  • Provision, claim, penalty, remediation and contingent-liability records
  • Insurance coverage, premium, exclusion and claims records
  • Asset valuations, useful-life assumptions, impairment tests and stranded-asset analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): Clinical trial operating systems, electronic data capture platforms, pharmacovigilance databases and regulated cloud environments
  • Process-map item (customers): Patients receiving prescription medicines, vaccines, biologics, cell therapies and rare disease treatments
  • Process-map item (customers): Community and hospital pharmacies dispensing finished medicines and providing patient counselling
  • Process-map item (customers): Wholesalers, speciality distributors and third-party logistics providers supplying regulated medicine channels
  • Process-map item (customers): Physicians, pharmacists and other prescribers who influence product selection and safe use

It may be less material when…

  • Organisation-specific evidence does not support significant scale, severity, likelihood or financial effect.
  • The organisation has no meaningful exposure to or influence over the relevant downstream pathway.

Affected stakeholders

  • Business partners
  • Customers / end-users

Users of the information

  • Board / management
  • Investors / creditors
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Social
  • Industry baseline
  • Strong industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Protection of employees and contractors from routine chemical, biological, cytotoxic, sharps, cryogenic and ergonomic hazards in pharmaceutical research, development and GMP operations.

How it shows up in this industry

Discovery laboratories, pilot API suites, containment isolators, biologics facilities, sterile cleanrooms and quality control laboratories expose staff to potent compounds, cytotoxics, solvents, biological agents, viral vectors, sharps, cryogenic materials and shift work in controlled environments.

Why it may be material

The pathway from laboratory and GMP processes to worker harm is immediate and sector-specific. High-potency APIs, solvent handling, viral vectors, cell culture materials and aseptic operations require specialist containment, training, monitoring and occupational health systems.

Impact pathway

  1. Potential effects may reach workers.
  2. Potential effects may reach contractors.
  3. Affected stakeholder groups identified in the source include Contractors, Employees, Trade unions.
  4. The source places the pathway in Own operations.

Financial pathway

  1. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  2. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  3. The topic may affect insurance availability, coverage terms, premiums or claims.
  4. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • What is the scale, scope, likelihood and remediability of effects on workers?
  • What is the scale, scope, likelihood and remediability of effects on contractors?
  • Could this topic change operating costs or the cost of controls and remediation?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Workforce, health and safety, engagement and grievance records
  • Contractor working-condition, incident and engagement records
  • Operating-cost records and budgets linked to the topic
  • Provision, claim, penalty, remediation and contingent-liability records
  • Insurance coverage, premium, exclusion and claims records
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): Discovery biology, medicinal chemistry and translational research laboratories with high-throughput screening equipment, mass spectrometry and bioassay platforms
  • Process-map item (assets): GMP small-molecule manufacturing plants with reactors, centrifuges, dryers, containment isolators and solvent recovery systems
  • Process-map item (assets): Intellectual property portfolios covering compounds, biologic constructs, manufacturing processes, indications and delivery devices
  • Process-map item (customers): Public health systems, national procurement bodies and government vaccination or pandemic preparedness agencies
  • Process-map item (customers): Private health insurers, pharmacy benefit managers and reimbursement authorities determining formulary access

It may be less material when…

  • Organisation-specific evidence does not support significant scale, severity, likelihood or financial effect.

Affected stakeholders

  • Contractors
  • Employees
  • Trade unions

Users of the information

  • Board / management
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Social
  • Industry baseline
  • Strong industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Responsible management of medicine pricing, reimbursement, tender participation, patient support, value evidence and equitable availability across public systems, private payers and global health procurement channels.

How it shows up in this industry

Market access in this industry depends on health technology assessment, pricing submissions, reference pricing, formulary placement, public procurement, donor-funded schemes, private insurers and pharmacy benefit managers. Patent-protected medicines, rare disease therapies, oncology products, vaccines and advanced therapies are subject to intense scrutiny over value, affordability and equitable availability.

Why it may be material

Pricing and access decisions determine whether patients obtain effective therapy and whether companies realise expected revenue from long development cycles. Expanded price negotiation, public tender criteria and investor expectations make access strategy financially and socially material across most pharmaceutical portfolios.

Impact pathway

  1. Potential effects may reach consumers.
  2. Potential effects may reach downstream users.
  3. Potential effects may reach affected communities.
  4. Potential effects may reach future generations.
  5. Affected stakeholder groups identified in the source include Affected communities, Customers / end-users.
  6. The source places the pathway in Downstream, Cross value chain.

Financial pathway

  1. The topic may affect demand, pricing, market access or product and service revenue.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  4. The topic may affect access to finance, funding terms or the cost of capital.
  5. The topic may affect asset useful lives, impairment assumptions, valuations or stranded-asset exposure.
  6. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • Where across the value chain is the pathway most significant?
  • What is the scale, scope, likelihood and remediability of effects on consumers?
  • What is the scale, scope, likelihood and remediability of effects on downstream users?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Consumer outcome, complaint and product-impact records
  • Downstream-user outcome, complaint and product-use evidence
  • Community engagement, grievance and impact records
  • Long-term scenario, cumulative-impact and intergenerational analysis
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Operating-cost records and budgets linked to the topic
  • Provision, claim, penalty, remediation and contingent-liability records
  • Funding terms, lender or investor requirements and cost-of-capital analysis
  • Asset valuations, useful-life assumptions, impairment tests and stranded-asset analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (customers): Patients receiving prescription medicines, vaccines, biologics, cell therapies and rare disease treatments
  • Process-map item (customers): Community and hospital pharmacies dispensing finished medicines and providing patient counselling
  • Process-map item (customers): Wholesalers, speciality distributors and third-party logistics providers supplying regulated medicine channels
  • Process-map item (customers): Private health insurers, pharmacy benefit managers and reimbursement authorities determining formulary access
  • Process-map item (customers): Global health organisations and donor-funded procurement schemes purchasing medicines for low- and middle-income countries

It may be less material when…

  • Organisation-specific evidence does not support significant scale, severity, likelihood or financial effect.
  • The organisation has no meaningful exposure to or influence over the relevant downstream pathway.

Affected stakeholders

  • Affected communities
  • Customers / end-users

Users of the information

  • Board / management
  • Investors / creditors
  • NGOs / civil society
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Social
  • Business-model dependent
  • Moderate industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Ethical governance of animal use in pharmaceutical discovery, toxicology, potency testing and disease models, including welfare standards, study justification and adoption of validated non-animal approaches.

How it shows up in this industry

Drug discovery, preclinical pharmacology, toxicology, safety pharmacology, batch testing and disease models may involve animals where regulators or scientific validation do not yet accept alternatives. OECD Test Guidelines, animal welfare laws and 3Rs principles shape how companies design studies and justify animal use.

Why it may be material

Animal testing remains relevant for many development programmes but varies by modality, jurisdiction and availability of validated alternatives. Poor welfare practices can lead to study rejection, enforcement, reputational harm and delays, while credible alternatives can improve translation and reduce ethical concerns.

Impact pathway

  1. Potential effects may reach consumers.
  2. Affected stakeholder groups identified in the source include Business partners, Customers / end-users.
  3. The source places the pathway in Own operations, Upstream.

Financial pathway

  1. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  2. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  3. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  4. The topic may affect access to finance, funding terms or the cost of capital.
  5. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which upstream activities, suppliers or inputs create or concentrate the pathway?
  • What is the scale, scope, likelihood and remediability of effects on consumers?
  • Could this topic change operating costs or the cost of controls and remediation?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Consumer outcome, complaint and product-impact records
  • Operating-cost records and budgets linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Provision, claim, penalty, remediation and contingent-liability records
  • Funding terms, lender or investor requirements and cost-of-capital analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): Quality control laboratories for sterility testing, stability studies, release testing and analytical method validation
  • Process-map item (external_impacts): Animal welfare impacts from preclinical studies, batch testing and toxicology work where non-animal methods are not accepted
  • Process-map item (impact_channels): Animals used in discovery, toxicology, potency testing and disease models
  • Process-map item (processes): Preclinical pharmacology, toxicology, dose-ranging, safety pharmacology and animal or alternative model testing
  • Process-map item (processes): Quality assurance, batch release, stability testing, deviation management, validation and change control

It may be less material when…

  • The organisation's scale, exposure or effects are below the threshold set for further assessment.
  • The relevant business model, activity, asset or product is not present or is not significant.
  • The organisation has no meaningful exposure to or influence over the relevant upstream pathway.

Affected stakeholders

  • Business partners
  • Customers / end-users

Users of the information

  • Board / management
  • Investors / creditors
  • NGOs / civil society
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Social
  • Business-model dependent
  • Moderate industry signal
  • Double materiality
  • Cross-cutting

Workcard generated from the catalogue

What this topic covers

Safety and emergency controls for hazardous pharmaceutical logistics, including dangerous-goods classification, packaging, carrier qualification, loading and unloading, spill response and route management for chemical, biological, cryogenic and waste shipments.

How it shows up in this industry

Pharmaceutical logistics include hazardous goods transport for flammable solvents, cytotoxic compounds, dry ice, liquid nitrogen, biological samples and infectious substances, as well as bulk solvent and waste tanker movements between manufacturing plants, recovery facilities, incinerators and wastewater treatment sites. Validated temperature-controlled distribution and clinical trial depots add complexity to safe transport controls.

Why it may be material

Transport incidents can injure drivers, warehouse staff, responders and nearby communities while interrupting regulated medicine supply. Materiality is higher for companies with API synthesis, cytotoxic products, biologics, advanced therapies, cryogenic shipments or significant hazardous waste movements.

Impact pathway

  1. Potential effects may reach workers.
  2. Potential effects may reach contractors.
  3. Potential effects may reach affected communities.
  4. Potential effects may reach emergency responders.
  5. Potential effects may reach water bodies.
  6. Potential effects may reach soil and groundwater.
  7. Potential effects may reach ecosystems.
  8. Affected stakeholder groups identified in the source include Affected communities, Business partners, Contractors, Employees.
  9. The source places the pathway in Upstream, Own operations, Downstream, Cross value chain.

Financial pathway

  1. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  2. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  3. The topic may affect insurance availability, coverage terms, premiums or claims.
  4. The topic may affect demand, pricing, market access or product and service revenue.
  5. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which upstream activities, suppliers or inputs create or concentrate the pathway?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • Where across the value chain is the pathway most significant?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Workforce, health and safety, engagement and grievance records
  • Contractor working-condition, incident and engagement records
  • Community engagement, grievance and impact records
  • Emergency-response plans, incident logs and responder feedback
  • Water withdrawal, discharge, quality and catchment-impact records
  • Soil and groundwater monitoring, incident and remediation records
  • Biodiversity, habitat and ecosystem-impact evidence
  • Operating-cost records and budgets linked to the topic
  • Provision, claim, penalty, remediation and contingent-liability records
  • Insurance coverage, premium, exclusion and claims records
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): GMP small-molecule manufacturing plants with reactors, centrifuges, dryers, containment isolators and solvent recovery systems
  • Process-map item (assets): Specialised waste handling areas for cytotoxic, biohazardous, solvent and sharps waste before off-site treatment
  • Process-map item (customers): Wholesalers, speciality distributors and third-party logistics providers supplying regulated medicine channels
  • Process-map item (emerging_pressures): Tighter scrutiny of antimicrobial manufacturing discharges and the contribution of pharmaceutical supply chains to antimicrobial resistance
  • Process-map item (emerging_pressures): Pressure to decarbonise cold-chain logistics, energy-intensive biologics production and metered-dose inhaler propellants

It may be less material when…

  • The organisation's scale, exposure or effects are below the threshold set for further assessment.
  • The relevant business model, activity, asset or product is not present or is not significant.
  • The organisation has no meaningful exposure to or influence over the relevant upstream or downstream pathway.

Affected stakeholders

  • Affected communities
  • Business partners
  • Contractors
  • Employees

Users of the information

  • Investors / creditors
  • Local authorities
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Social
  • Business-model dependent
  • Moderate industry signal
  • Double materiality
  • Cross-cutting

Workcard generated from the catalogue

What this topic covers

Prevention of high-consequence fires, explosions, runaway reactions and toxic releases from pharmaceutical process development, API synthesis, solvent systems, high-potency manufacturing and associated emergency response arrangements.

How it shows up in this industry

Pilot-scale API suites and GMP small-molecule plants use reactors, centrifuges, dryers, flammable solvents, reactive chemicals and high-potency compounds. Serious site events can also occur at solvent recovery systems, containment areas and high-hazard interfaces with biologics, cytotoxic or cryogenic operations.

Why it may be material

The issue is most material for companies with API synthesis, pilot plants, solvent recovery and high-potency or cytotoxic compound handling. A major loss of containment can injure workers and responders, affect nearby communities, contaminate air, soil or water, and halt high-value production.

Impact pathway

  1. Potential effects may reach workers.
  2. Potential effects may reach contractors.
  3. Potential effects may reach affected communities.
  4. Potential effects may reach emergency responders.
  5. Potential effects may reach soil and groundwater.
  6. Potential effects may reach water bodies.
  7. Potential effects may reach the atmosphere.
  8. Affected stakeholder groups identified in the source include Affected communities, Contractors, Employees.
  9. The source places the pathway in Own operations.

Financial pathway

  1. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  4. The topic may affect insurance availability, coverage terms, premiums or claims.
  5. The topic may affect asset useful lives, impairment assumptions, valuations or stranded-asset exposure.
  6. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • What is the scale, scope, likelihood and remediability of effects on workers?
  • What is the scale, scope, likelihood and remediability of effects on contractors?
  • What is the scale, scope, likelihood and remediability of effects on affected communities?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Workforce, health and safety, engagement and grievance records
  • Contractor working-condition, incident and engagement records
  • Community engagement, grievance and impact records
  • Emergency-response plans, incident logs and responder feedback
  • Soil and groundwater monitoring, incident and remediation records
  • Water withdrawal, discharge, quality and catchment-impact records
  • Emissions, air-quality and atmospheric-impact records linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Operating-cost records and budgets linked to the topic
  • Provision, claim, penalty, remediation and contingent-liability records
  • Insurance coverage, premium, exclusion and claims records
  • Asset valuations, useful-life assumptions, impairment tests and stranded-asset analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): Discovery biology, medicinal chemistry and translational research laboratories with high-throughput screening equipment, mass spectrometry and bioassay platforms
  • Process-map item (assets): GMP small-molecule manufacturing plants with reactors, centrifuges, dryers, containment isolators and solvent recovery systems
  • Process-map item (assets): Quality control laboratories for sterility testing, stability studies, release testing and analytical method validation
  • Process-map item (assets): Specialised waste handling areas for cytotoxic, biohazardous, solvent and sharps waste before off-site treatment
  • Process-map item (emerging_pressures): Tighter scrutiny of antimicrobial manufacturing discharges and the contribution of pharmaceutical supply chains to antimicrobial resistance

It may be less material when…

  • The organisation's scale, exposure or effects are below the threshold set for further assessment.
  • The relevant business model, activity, asset or product is not present or is not significant.

Affected stakeholders

  • Affected communities
  • Contractors
  • Employees

Users of the information

  • Board / management
  • Investors / creditors
  • Local authorities
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Social
  • Emerging issue
  • Moderate industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Resilience of manufacturing networks and critical input supply for essential medicines and vaccines, including dual sourcing, technology transfer, regional capacity, stockholding under validated conditions and continuity plans for shortage-prone products.

How it shows up in this industry

Pharmaceutical supply depends on specialised global suppliers for fine chemicals, biologic media, vials, stoppers, resins, single-use systems, contract manufacturers, qualified persons, customs approvals, import licences and batch release documentation. Governments and health systems increasingly favour resilient regional supply for vaccines, antibiotics, sterile injectables and other essential medicines.

Why it may be material

Pandemic preparedness, geopolitical tension, export controls and medicine shortages are changing procurement and manufacturing network decisions. Supply continuity directly affects patients and can determine eligibility for public preparedness contracts, tenders and strategic partnerships.

Impact pathway

  1. Potential effects may reach consumers.
  2. Potential effects may reach downstream users.
  3. Potential effects may reach affected communities.
  4. Potential effects may reach future generations.
  5. Potential effects may reach supply-chain workers.
  6. Affected stakeholder groups identified in the source include Business partners, Customers / end-users, Suppliers.
  7. The source places the pathway in Upstream, Own operations, Downstream, Cross value chain.

Financial pathway

  1. The topic may affect demand, pricing, market access or product and service revenue.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  4. The topic may affect access to finance, funding terms or the cost of capital.
  5. The topic may affect reputation, licences to operate, intellectual property or other intangible value.
  6. The topic may affect asset useful lives, impairment assumptions, valuations or stranded-asset exposure.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which upstream activities, suppliers or inputs create or concentrate the pathway?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • Where across the value chain is the pathway most significant?
  • What geopolitical developments could change the topic's relevance?

Evidence to collect

  • Consumer outcome, complaint and product-impact records
  • Downstream-user outcome, complaint and product-use evidence
  • Community engagement, grievance and impact records
  • Long-term scenario, cumulative-impact and intergenerational analysis
  • Supplier workforce, audit, grievance and remediation records
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Operating-cost records and budgets linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Funding terms, lender or investor requirements and cost-of-capital analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Asset valuations, useful-life assumptions, impairment tests and stranded-asset analysis
  • Process-map item (assets): GMP small-molecule manufacturing plants with reactors, centrifuges, dryers, containment isolators and solvent recovery systems
  • Process-map item (assets): Intellectual property portfolios covering compounds, biologic constructs, manufacturing processes, indications and delivery devices
  • Process-map item (customers): Wholesalers, speciality distributors and third-party logistics providers supplying regulated medicine channels
  • Process-map item (customers): Contract research organisations, contract development and manufacturing organisations and licensing partners in outsourced development chains
  • Process-map item (emerging_pressures): Expanded medicine price negotiation, reference pricing and health technology assessment requirements affecting revenue certainty and launch sequencing

It may be less material when…

  • The organisation's scale, exposure or effects are below the threshold set for further assessment.
  • The organisation has no meaningful exposure to or influence over the relevant upstream or downstream pathway.
  • The emerging signal has not yet created a relevant exposure, impact or financial effect for the organisation.

Affected stakeholders

  • Business partners
  • Customers / end-users
  • Suppliers

Users of the information

  • Investors / creditors
  • Local authorities
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Social
  • Emerging issue
  • Entity-specific validation required
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Patient-specific traceability, custody and logistics controls for cell and gene therapies from sample collection through manufacturing, release, cryogenic transport and reinfusion, including treatment scheduling and site qualification.

How it shows up in this industry

Advanced therapies use patient-derived samples, viral vectors, cell banks, aseptic processing, cryogenic storage, liquid nitrogen, direct-to-site clinical depots and reinfusion at specialist treatment units. Autologous products require exact patient-product matching and rapid vein-to-vein logistics from collection through manufacture, release and administration.

Why it may be material

Cell and gene therapies are growing into more complex commercial networks, where a custody error, temperature excursion or delayed manufacturing slot can directly affect an individual patient and create high-value product loss. Materiality depends on whether a company develops or commercialises personalised advanced therapies.

Impact pathway

  1. Potential effects may reach consumers.
  2. Potential effects may reach downstream users.
  3. Potential effects may reach workers.
  4. Potential effects may reach contractors.
  5. Affected stakeholder groups identified in the source include Business partners, Customers / end-users, Suppliers.
  6. The source places the pathway in Own operations, Downstream, Cross value chain.

Financial pathway

  1. The topic may affect demand, pricing, market access or product and service revenue.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  4. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  5. The topic may affect insurance availability, coverage terms, premiums or claims.
  6. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • Where across the value chain is the pathway most significant?
  • What is the scale, scope, likelihood and remediability of effects on consumers?
  • What technology changes could alter the topic's impacts or financial effects?

Evidence to collect

  • Consumer outcome, complaint and product-impact records
  • Downstream-user outcome, complaint and product-use evidence
  • Workforce, health and safety, engagement and grievance records
  • Contractor working-condition, incident and engagement records
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Operating-cost records and budgets linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Provision, claim, penalty, remediation and contingent-liability records
  • Insurance coverage, premium, exclusion and claims records
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): Biologics facilities with cell banks, seed trains, stainless-steel or single-use bioreactors, chromatography skids and viral clearance systems
  • Process-map item (assets): Cold-chain infrastructure including ultra-low-temperature freezers, validated warehouses, temperature loggers and insulated shippers
  • Process-map item (customers): Patients receiving prescription medicines, vaccines, biologics, cell therapies and rare disease treatments
  • Process-map item (customers): Hospitals, oncology centres, infusion clinics and specialist treatment units administering complex therapies
  • Process-map item (customers): Wholesalers, speciality distributors and third-party logistics providers supplying regulated medicine channels

It may be less material when…

  • Entity-specific evidence does not show meaningful scale, exposure or effects.
  • The organisation has no meaningful exposure to or influence over the relevant downstream pathway.
  • The emerging signal has not yet created a relevant exposure, impact or financial effect for the organisation.

Affected stakeholders

  • Business partners
  • Customers / end-users
  • Suppliers

Users of the information

  • Board / management
  • Investors / creditors
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Governance
  • Industry baseline
  • Strong industry signal
  • Double materiality
  • Cross-cutting

Workcard generated from the catalogue

What this topic covers

Governance and resilience of AI models, cybersecurity, data privacy and operational technology controls protecting clinical evidence, pharmacovigilance records, GMP systems, serialisation and temperature-controlled or chain-of-identity logistics.

How it shows up in this industry

Biotechnology and pharmaceutical operations rely on electronic data capture, remote trial platforms, clinical trial operating systems, pharmacovigilance databases, AI-enabled discovery, regulated cloud environments, connected manufacturing, serialisation, temperature loggers and chain-of-identity systems. These systems handle genomic data, clinical records, batch records, release data and product complaint information.

Why it may be material

Cyber compromise or weak model governance can interrupt clinical trials, corrupt GMP records, delay batch release, expose sensitive health or genomic data, disrupt cold-chain and chain-of-identity logistics, increase insurance costs and undermine regulatory confidence in data integrity.

Impact pathway

  1. Potential effects may reach consumers.
  2. Potential effects may reach workers.
  3. Potential effects may reach contractors.
  4. Potential effects may reach downstream users.
  5. Potential effects may reach affected communities.
  6. Potential effects may reach supply-chain workers.
  7. Affected stakeholder groups identified in the source include Business partners, Customers / end-users, Employees, Suppliers.
  8. The source places the pathway in Own operations, Upstream, Downstream, Cross value chain.

Financial pathway

  1. The topic may affect demand, pricing, market access or product and service revenue.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  4. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  5. The topic may affect insurance availability, coverage terms, premiums or claims.
  6. The topic may affect asset useful lives, impairment assumptions, valuations or stranded-asset exposure.
  7. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which upstream activities, suppliers or inputs create or concentrate the pathway?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • Where across the value chain is the pathway most significant?
  • What technology changes could alter the topic's impacts or financial effects?

Evidence to collect

  • Consumer outcome, complaint and product-impact records
  • Workforce, health and safety, engagement and grievance records
  • Contractor working-condition, incident and engagement records
  • Downstream-user outcome, complaint and product-use evidence
  • Community engagement, grievance and impact records
  • Supplier workforce, audit, grievance and remediation records
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Operating-cost records and budgets linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Provision, claim, penalty, remediation and contingent-liability records
  • Insurance coverage, premium, exclusion and claims records
  • Asset valuations, useful-life assumptions, impairment tests and stranded-asset analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): Pilot-scale API synthesis suites and process development plants for route selection, scale-up and impurity profiling
  • Process-map item (assets): GMP small-molecule manufacturing plants with reactors, centrifuges, dryers, containment isolators and solvent recovery systems
  • Process-map item (assets): Clinical trial operating systems, electronic data capture platforms, pharmacovigilance databases and regulated cloud environments
  • Process-map item (assets): Intellectual property portfolios covering compounds, biologic constructs, manufacturing processes, indications and delivery devices
  • Process-map item (customers): Wholesalers, speciality distributors and third-party logistics providers supplying regulated medicine channels

It may be less material when…

  • Organisation-specific evidence does not support significant scale, severity, likelihood or financial effect.
  • The organisation has no meaningful exposure to or influence over the relevant upstream or downstream pathway.
  • The emerging signal has not yet created a relevant exposure, impact or financial effect for the organisation.

Affected stakeholders

  • Business partners
  • Customers / end-users
  • Employees
  • Suppliers

Users of the information

  • Board / management
  • Investors / creditors
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Governance
  • Industry baseline
  • Strong industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Governance of pharmaceutical GMP quality systems and manufacturing compliance across API synthesis, biologics processing, sterile fill-finish, packaging, testing, batch certification and outsourced manufacturing, with emphasis on preventing quality-control and release failures in approved medicine production.

How it shows up in this industry

Small-molecule API plants, biologics facilities, sterile fill-finish lines, quality control laboratories and validated warehouses operate under GMP, quality risk management, batch release, stability testing, validation and change control. Warning letters, import alerts, recalls, consent decrees and batch failures can stop release of approved medicines when manufacturing controls do not meet required quality standards.

Why it may be material

Manufacturing and release deficiencies can expose patients to contaminated, sub-potent or incorrectly released medicines, destroy high-value batches, require remediation CAPEX, suspend imports and delay launches. The topic is central for sterile products, biologics, vaccines and advanced therapies with tightly controlled production processes, while remaining distinct from broader medicine access, shortage planning and pharmacovigilance issues.

Impact pathway

  1. Potential effects may reach consumers.
  2. Potential effects may reach downstream users.
  3. Potential effects may reach workers.
  4. Affected stakeholder groups identified in the source include Business partners, Customers / end-users, Suppliers.
  5. The source places the pathway in Own operations, Upstream, Downstream.

Financial pathway

  1. The topic may affect demand, pricing, market access or product and service revenue.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  4. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  5. The topic may affect asset useful lives, impairment assumptions, valuations or stranded-asset exposure.
  6. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which upstream activities, suppliers or inputs create or concentrate the pathway?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • What is the scale, scope, likelihood and remediability of effects on consumers?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Consumer outcome, complaint and product-impact records
  • Downstream-user outcome, complaint and product-use evidence
  • Workforce, health and safety, engagement and grievance records
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Operating-cost records and budgets linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Provision, claim, penalty, remediation and contingent-liability records
  • Asset valuations, useful-life assumptions, impairment tests and stranded-asset analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): GMP small-molecule manufacturing plants with reactors, centrifuges, dryers, containment isolators and solvent recovery systems
  • Process-map item (assets): Sterile fill-finish facilities with aseptic lines, lyophilisers, cleanrooms, vial, syringe and cartridge filling equipment
  • Process-map item (assets): Quality control laboratories for sterility testing, stability studies, release testing and analytical method validation
  • Process-map item (assets): Intellectual property portfolios covering compounds, biologic constructs, manufacturing processes, indications and delivery devices
  • Process-map item (customers): Contract research organisations, contract development and manufacturing organisations and licensing partners in outsourced development chains

It may be less material when…

  • Organisation-specific evidence does not support significant scale, severity, likelihood or financial effect.
  • The organisation has no meaningful exposure to or influence over the relevant upstream or downstream pathway.

Affected stakeholders

  • Business partners
  • Customers / end-users
  • Suppliers

Users of the information

  • Board / management
  • Investors / creditors
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Governance
  • Industry baseline
  • Strong industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Governance of supplier and partner due diligence across pharmaceutical research, development, manufacturing, packaging, logistics and waste networks, including labour rights, modern slavery, environmental controls, anti-bribery, sanctions screening and corrective action management.

How it shows up in this industry

The industry relies on specialised global suppliers for fine chemicals, intermediates, biologic media, vials, stoppers, resins, single-use systems, contract research, contract manufacturing, sterilisation, qualified person services, temperature-controlled logistics and licensed distribution. Supplier failures can affect patient safety, worker conditions, environmental discharges, data integrity and continuity of regulated medicine supply.

Why it may be material

Complex outsourcing creates third-party exposure across clinical trials, API manufacture, CDMO production, packaging, cold-chain logistics and waste treatment. Regulatory expectations, procurement rules and investor scrutiny increasingly require evidence that supplier labour, environmental, quality and integrity controls are effective.

Impact pathway

  1. Potential effects may reach supply-chain workers.
  2. Potential effects may reach workers.
  3. Potential effects may reach contractors.
  4. Potential effects may reach affected communities.
  5. Potential effects may reach water bodies.
  6. Potential effects may reach ecosystems.
  7. Affected stakeholder groups identified in the source include Business partners, Customers / end-users, Suppliers, Value chain workers.
  8. The source places the pathway in Upstream, Downstream, Cross value chain.

Financial pathway

  1. The topic may affect demand, pricing, market access or product and service revenue.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may require capital expenditure to adapt assets, processes or infrastructure.
  4. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  5. The topic may affect access to finance, funding terms or the cost of capital.
  6. The topic may affect asset useful lives, impairment assumptions, valuations or stranded-asset exposure.
  7. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which upstream activities, suppliers or inputs create or concentrate the pathway?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • Where across the value chain is the pathway most significant?
  • What is the scale, scope, likelihood and remediability of effects on supply-chain workers?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Supplier workforce, audit, grievance and remediation records
  • Workforce, health and safety, engagement and grievance records
  • Contractor working-condition, incident and engagement records
  • Community engagement, grievance and impact records
  • Water withdrawal, discharge, quality and catchment-impact records
  • Biodiversity, habitat and ecosystem-impact evidence
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Operating-cost records and budgets linked to the topic
  • Capital plans, asset adaptation budgets and investment approvals
  • Provision, claim, penalty, remediation and contingent-liability records
  • Funding terms, lender or investor requirements and cost-of-capital analysis
  • Asset valuations, useful-life assumptions, impairment tests and stranded-asset analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): Quality control laboratories for sterility testing, stability studies, release testing and analytical method validation
  • Process-map item (assets): Cold-chain infrastructure including ultra-low-temperature freezers, validated warehouses, temperature loggers and insulated shippers
  • Process-map item (assets): Clinical trial operating systems, electronic data capture platforms, pharmacovigilance databases and regulated cloud environments
  • Process-map item (emerging_pressures): Tighter scrutiny of antimicrobial manufacturing discharges and the contribution of pharmaceutical supply chains to antimicrobial resistance
  • Process-map item (emerging_pressures): Growing regulatory expectations for diversity in clinical trial recruitment and evidence generation across under-served populations

It may be less material when…

  • Organisation-specific evidence does not support significant scale, severity, likelihood or financial effect.
  • The organisation has no meaningful exposure to or influence over the relevant upstream or downstream pathway.

Affected stakeholders

  • Business partners
  • Customers / end-users
  • Suppliers
  • Value chain workers

Users of the information

  • Board / management
  • Investors / creditors
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Governance
  • Industry baseline
  • Strong industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Governance of pharmaceutical marketing, medical information, patient assistance, prescriber interactions and controlled-medicine stewardship to prevent inappropriate use, diversion, improper inducements and misleading product claims.

How it shows up in this industry

Commercialisation involves physicians, pharmacists, hospitals, speciality treatment units, reimbursement authorities, pharmacy benefit managers, patient support services and medical information teams. Opioids, sedatives, stimulants, complex biologics and high-cost therapies require strong controls over claims, inducements, patient assistance and diversion.

Why it may be material

Improper promotion, bribery, misleading safety disclosures or weak controls over controlled medicines can distort prescribing, harm patients and communities, trigger enforcement actions, lead to large settlements, restrict procurement eligibility and damage prescriber and payer confidence.

Impact pathway

  1. Potential effects may reach consumers.
  2. Potential effects may reach downstream users.
  3. Potential effects may reach affected communities.
  4. Potential effects may reach future generations.
  5. Affected stakeholder groups identified in the source include Business partners, Customers / end-users.
  6. The source places the pathway in Own operations, Downstream, Cross value chain.

Financial pathway

  1. The topic may affect demand, pricing, market access or product and service revenue.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  4. The topic may affect access to finance, funding terms or the cost of capital.
  5. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Which products, services, customers or end uses create or concentrate the pathway?
  • Where across the value chain is the pathway most significant?
  • What is the scale, scope, likelihood and remediability of effects on consumers?
  • What litigation or claims could change the topic's relevance?

Evidence to collect

  • Consumer outcome, complaint and product-impact records
  • Downstream-user outcome, complaint and product-use evidence
  • Community engagement, grievance and impact records
  • Long-term scenario, cumulative-impact and intergenerational analysis
  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Operating-cost records and budgets linked to the topic
  • Provision, claim, penalty, remediation and contingent-liability records
  • Funding terms, lender or investor requirements and cost-of-capital analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (assets): Quality control laboratories for sterility testing, stability studies, release testing and analytical method validation
  • Process-map item (customers): Patients receiving prescription medicines, vaccines, biologics, cell therapies and rare disease treatments
  • Process-map item (customers): Community and hospital pharmacies dispensing finished medicines and providing patient counselling
  • Process-map item (customers): Wholesalers, speciality distributors and third-party logistics providers supplying regulated medicine channels
  • Process-map item (customers): Physicians, pharmacists and other prescribers who influence product selection and safe use

It may be less material when…

  • Organisation-specific evidence does not support significant scale, severity, likelihood or financial effect.
  • The organisation has no meaningful exposure to or influence over the relevant downstream pathway.

Affected stakeholders

  • Business partners
  • Customers / end-users

Users of the information

  • Board / management
  • Investors / creditors
  • Media
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

  • Governance
  • Business-model dependent
  • Moderate industry signal
  • Double materiality

Workcard generated from the catalogue

What this topic covers

Governance, transparency and alignment of lobbying, trade association activity, political contributions and public policy positions on pharmaceutical regulation, pricing, access, patents, clinical trials, manufacturing quality and environmental controls.

How it shows up in this industry

Biotechnology and pharmaceutical companies engage with regulators, payers, health technology assessment bodies and legislators on approval pathways, pricing and reimbursement, patent exclusivity, clinical trial regulation, pharmacovigilance, GMP inspections, antimicrobial discharge expectations and public procurement. Policy influence can affect access, affordability, innovation incentives and environmental safeguards.

Why it may be material

The industry is heavily regulated and often participates in policy debates that directly shape medicine prices, market exclusivity, approval requirements, procurement, environmental controls and supply resilience. Misaligned or opaque engagement can damage trust with patients, health systems, investors and regulators.

Impact pathway

  1. Affected stakeholder groups identified in the source include Customers / end-users.
  2. The source places the pathway in Own operations, Cross value chain.

Financial pathway

  1. The topic may affect demand, pricing, market access or product and service revenue.
  2. The topic may change operating costs through resource use, controls, remediation or ongoing management.
  3. The topic may create provisions, penalties, remediation costs, claims or other liabilities.
  4. The topic may affect access to finance, funding terms or the cost of capital.
  5. The topic may affect reputation, licences to operate, intellectual property or other intangible value.

Questions to test

  • What evidence supports both the impact and financial materiality pathways?
  • Which own operations, assets or decisions create or concentrate the pathway?
  • Where across the value chain is the pathway most significant?
  • Could this topic affect demand, pricing, market access or revenue?
  • Could this topic change operating costs or the cost of controls and remediation?
  • What current or proposed regulation could change the topic's relevance?

Evidence to collect

  • Revenue, demand, pricing and market-access analysis linked to the topic
  • Operating-cost records and budgets linked to the topic
  • Provision, claim, penalty, remediation and contingent-liability records
  • Funding terms, lender or investor requirements and cost-of-capital analysis
  • Reputation, licence-to-operate, intellectual-property and other intangible-value evidence
  • Process-map item (customers): Public health systems, national procurement bodies and government vaccination or pandemic preparedness agencies
  • Process-map item (customers): Private health insurers, pharmacy benefit managers and reimbursement authorities determining formulary access
  • Process-map item (customers): Global health organisations and donor-funded procurement schemes purchasing medicines for low- and middle-income countries
  • Process-map item (emerging_pressures): Expanded medicine price negotiation, reference pricing and health technology assessment requirements affecting revenue certainty and launch sequencing
  • Process-map item (emerging_pressures): Tighter scrutiny of antimicrobial manufacturing discharges and the contribution of pharmaceutical supply chains to antimicrobial resistance

It may be less material when…

  • The organisation's scale, exposure or effects are below the threshold set for further assessment.
  • The relevant business model, activity, asset or product is not present or is not significant.

Affected stakeholders

  • Customers / end-users

Users of the information

  • Board / management
  • Investors / creditors
  • Local authorities
  • Media
  • NGOs / civil society
  • Regulators

Standards to check

See how companies report it →

Your preliminary screening decision

Saved in this browser. Your notes leave it only when you export the screening.

An initial screening — not a materiality assessment

To turn a shortlist into a defensible result, you still need to:

  • engage affected stakeholders
  • assess severity and likelihood
  • evaluate financial effects
  • define thresholds
  • document governance and approval
  • keep an audit trail
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How this screening is built, and what it is not

Candidate topics come from the LRA materiality topic catalogue (20 topics for this industry that passed quality checks), aligned to GRI sector numbering and the SASB SICS classification.

Topics, rationales, impact and financial channels, stakeholders and standard hints come from the reviewed catalogue. Workcards and activity matches are generated from it by fixed rules; where LRA has written a workcard or a disclosure mapping by hand, it is labelled as curated.

Your selections, decisions and notes stay in this browser. They are sent to LRA only to build an Excel file when you choose to export, and are not stored.

This is an educational screening aid. It is not issued or endorsed by GRI, the IFRS Foundation, EFRAG or SASB, and it is not a materiality assessment of any organisation.

Initial screening summary

Pharmaceuticals, Biotechnology and Life Sciences

Organisation profile

    Include for further assessment

      More evidence required

        Provisionally lower priority

          Important limitation. These are screening decisions only. They have not been validated through stakeholder engagement, severity assessment, financial-effect analysis or formal approval.

          The link carries only the sub-industry and the activities you ticked — never your decisions or notes.

          An .xlsx file with your screening, the workcards and the sources for the chosen sub-industry.