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 2022 corporate reporting suite (Novartis in Society Integrated Report and Annual Report/Form 20-F), our corporate website, and Novartis public policies and positions.
SASB indicator |
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Reference |
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HC-BP-210a.1 |
Discussion, by world region, of management process for ensuring quality and patient safety during clinical trials |
Our approach to clinical trials |
HC-BP-210a.2 |
Number of FDA Sponsor Inspections related to clinical trial management and pharmacovigilance that resulted in: |
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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 (F-48). |
SASB indicator |
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Reference |
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HC-BP-240a.1 |
Description of actions and initiatives to promote access to health care products for priority diseases and in priority countries as defined by the Access to Medicine Index |
Affordability and availability |
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. |
SASB indicator |
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Reference |
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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: |
not reported |
HC-BP-240b.3 |
Percentage change in: |
not reported |
SASB indicator |
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Reference |
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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 |
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HC-BP-250a.4 |
Total amount of product accepted for takeback, reuse, or disposal |
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HC-BP-250a.5 |
Number of FDA enforcement actions taken in response to violations of current Good Manufacturing Practices (cGMP), by type3 |
SASB indicator |
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Reference |
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HC-BP-260a.1 |
Description of methods and technologies used to maintain traceability of products throughout the supply chain and prevent counterfeiting |
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HC-BP-260a.2 |
Discussion of process for alerting customers and business partners of potential or known risks associated with counterfeit products |
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HC-BP-260a.3 |
Number of actions that led to raids, seizure, arrests, and/or filing of criminal charges related to counterfeit products |
SASB indicator |
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Reference |
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HC-BP-270a.1 |
Total amount of monetary losses as a result of legal proceedings associated with false marketing claims |
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HC-BP-270a.2 |
Description of code of ethics governing promotion of off-label use of products |
Professional Practices Policy |
SASB indicator |
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Reference |
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HC-BP-330a.1 |
Discussion of talent recruitment and retention efforts for scientists and research and development personnel |
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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 |
SASB indicator |
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Reference |
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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 thirdparty audit programs for integrity of supply chain and ingredients |
Protecting patient health and safety |
SASB indicator |
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Reference |
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HC-BP-510a.1 |
Total amount of monetary losses as a result of legal proceedings associated with corruption and bribery |
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HC-BP-510a.2 |
Description of code of ethics governing interactions with health care professionals |
SASB indicator |
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Reference |
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HC-BP-000.A |
Number of patients treated |
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HC-BP-000.B |
Number of drugs |
1) Novartis Global Product Portfolio |