Sustainability Accounting Standards Board (SASB) Index

Healthcare sector

Biotechnology and pharmaceutical industry

The Novartis Sustainability Accounting Standards Board (SASB) Index aligns with the biotechnology and pharmaceutical industry guidelines. Data and information disclosed are sourced from the Novartis 2021 corporate reporting suite (Novartis in Society Integrated Report and Annual Report/Form 20-F), our corporate website,  and Novartis public policies and positions.

SAFETY OF CLINICAL TRIAL PARTICIPANTS

SASB indicator

 

Novartis references

HC-BP-210a.1

Discussion, by world region, of management process for ensuring quality and patient safety during clinical trials

We have mechanisms in place to protect all trial participants when consenting to the research, during the conduct of the trial, and after completion. We have additional processes in place to protect vulnerable patients. We ensure voluntary informed consent to the research, including the right to withdraw from the trial at any time and the right to withdraw consent for the collection and use of their personal data.
Novartis Position on Responsible Clinical Trials
Novartis Commitment to Patients and Caregivers
Information for patients and caregivers Human Rights Commitment Statement (p. 7)

HC-BP-210a.2

Number of FDA Sponsor Inspections related to clinical trial management and pharmacovigilance that resulted in: (1) Voluntary Action Indicated (VAI) and (2) Official Action Indicated (OAI)

Ensuring patient Health and Safety

HC-BP-210a.3

Total amount of monetary losses as a result of legal proceedings associated with clinical trials in developing countries

All material legal proceedings are disclosed within the Annual Report and accounts (p. F-48).

ACCESS TO MEDICINES

SASB indicator

 

Novartis references

HC-BP-240a.1

Description of actions and initiatives to promote access to healthcare products for priority diseases and in priority countries as defined by the Access to Medicine Index

Leading the way on access and global health
Novartis Access

HC-BP-240a.2

List of products on the WHO List of Prequalified Medicinal Products as part of its Prequalification of Medicines Programme (PQP)

Novartis has tuberculosis and malaria products on the WHO List of Prequalified Medicinal Products.
Novartis products
Sandoz products

AFFORDABILITY & PRICING

SASB indicator

 

Novartis references

HC-BP-240b.1

Number of settlements of Abbreviated New Drug Application (ANDA) litigation that involved payments and/or provisions to delay bringing an authorized generic product to market for a defined time period

Not reported

HC-BP-240b.2

Percentage change in: (1) average list price and (2) average net price across US product portfolio compared to previous year

We report these changes annually within our Novartis in Society US Report.

HC-BP-240b.3

Percentage change in: (1) list price and (2) net price of product with largest increase compared to previous year

Not reported

DRUG SAFETY

SASB indicator

 

Novartis references

HC-BP-250a.1

List of products listed in the Food and Drug Administration’s (FDA) MedWatch Safety Alerts for Human Medical Products database

Available via FDA Adverse Event Reporting website

HC-BP-250a.2

Number of fatalities associated with products as reported in the FDA Adverse Event Reporting System

Available via FDA Adverse Event Reporting website

HC-BP-250a.3

Number of recalls issued, total units recalled

Ensuring patient Health and Safety

HC-BP-250a.4

Total amount of product accepted for takeback, reuse, or disposal

Ensuring patient Health and Safety

HC-BP-250a.5

Number of FDA enforcement actions taken in response to violations of current Good Manufacturing Practices (cGMP), by type

Ensuring patient Health and Safety

COUNTERFEIT DRUGS

SASB indicator

 

Novartis references

HC-BP-260a.1

Description of methods and technologies used to maintain traceability of products throughout the supply chain and prevent counterfeiting

Falsified medicines
Novartis Position on Falsified and Counterfeit Medical Products

HC-BP-260a.2

Discussion of process for alerting customers and business partners of potential or known risks associated with counterfeit products

Falsified medicines

HC-BP-260a.3

Number of actions that led to raids, seizure, arrests, and/or filing of criminal charges related to counterfeit products

Falsified medicines

ETHICAL MARKETING

SASB indicator

 

Novartis references

HC-BP-270a.1

Total amount of monetary losses as a result of legal proceedings associated with false marketing claims

All material legal proceedings are disclosed within the Annual Report and accounts (p. F-48).

HC-BP-270a.2

Description of code of ethics governing promotion of off-label use of products

Procedures for off-label requests outlined; further information on ethical marketing contained in Professional Practices Policy (p. 6) on Promotional and Non-Promotional Materials

EMPLOYEE RECRUITMENT, DEVELOPMENT & RETENTION

SASB indicator

 

Novartis references

HC-BP-330a.1

Discussion of talent recruitment and retention efforts for scientists and research and development personnel

Learning and development

HC-BP-330a.2

(1) Voluntary and (2) involuntary turnover rate for:
(a) executives/senior managers,
(b) midlevel managers,
(c) professionals, and
(d) all others

People performance indicators table

SUPPLY CHAIN MANAGEMENT

SASB indicator

 

Novartis references

HC-BP-430a.1

Percentage of (1) entity’s facilities and (2) Tier I suppliers’ facilities participating in the Rx-360 International Pharmaceutical Supply Chain Consortium audit program or equivalent third-party audit programs for integrity of supply chain and ingredients

Ensuring patient Health and Safety
Novartis Quality Management System (QMS)

BUSINESS ETHICS

SASB indicator

 

Novartis references

HC-BP-510a.1

Total amount of monetary losses as a result of legal proceedings associated with corruption and bribery

All material legal proceedings are disclosed within the Annual Report and accounts (p. F-48).

HC-BP-510a.2

Description of code of ethics governing interactions with healthcare professionals

Professional Practices Policy
Payments to Healthcare Professionals

ACTIVITY METRICS

SASB indicator

 

Novartis references

HC-BP-000.A

Number of patients treated

Access to healthcare performance indicators table

HC-BP-000.B

Number of drugs (1) in portfolio and (2) in research and development (Phases I-III)

(1) Novartis Global Product Portfolio (Novartis Innovative Medicines)
Sandoz
Advanced Accelerator Applications
(2) 160+
Our approach to R&D