Sustainability Accounting Standards Board (SASB) index

Health Care Sector

Biotechnology and Pharmaceuticals 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 2020 Corporate Reporting suite (Annual Review; Annual Report/Form 20-F; Novartis in Society ESG Report), 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
Ethics in Clinical Trials
Human Rights Guideline (p.6) – Procedure to obtain participants’ free, prior and informed consent

HC-BP-210a.2

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

Novartis received six FDA inspections for which one resulted in a Form 483. In each case, corrective and preventative actions were taken.
Helping ensure 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-49).

ACCESS TO MEDICINES

SASB indicator

 

Novartis references

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

Being part of the solution on pricing and access
Addressing global health challenges

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 U.S. 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

In 2020, Novartis initiated 27 recalls (vs. 29 in 2019 and 42 in 2018).
There were no global recalls.
Helping ensure patient health and safety

HC-BP-250a.4

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

Enhancing environmental sustainability

HC-BP-250a.5

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

Helping ensure 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

Helping ensure patient health and safety

HC-BP-260a.2

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

Helping ensure patient health and safety

HC-BP-260a.3

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

We investigated 247 incidents of suspected falsified medicines, which led to 60 successful enforcement actions and the seizure of 1.7 million medicines unit dosage forms) by law enforcement and health authorities.
Helping ensure patient health and safety

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-49).

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.5) 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

Strengthening health systems
Unleashing the power of our people

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

Voluntary/overall turnover rate: 5.2%/10.1%; high performers voluntary turnover rate: 4.2%
Performance indicators 2020

SUPPLY CHAIN MANAGEMENT

SASB indicator

 

Novartis references

HC-BP-430a.1

Percentage of (1) entity’s facilities and (2) Tier 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

(1) For the manufacture of medical devices, we hold the relevant certifications from ISO and other notified bodies. For all manufacturing, supply and distribution of Novartis pharmaceutical products, we hold the relevant manufacturing licenses and GMP/GxP certificates issued by the appropriate health authorities (FDA, EMEA, WHO, SwissMedic), that confirm after inspection that our duties, including our quality management systems, comply with their regulatory requirements.

All Novartis employees in Manufacturing and Quality Assurance are continuously trained to maintain the skills and knowledge needed to manufacture medicine safely, compliantly and effectively. These trainings include Aseptic Operator, Enhanced Third-party Oversight, Investigation Certification Program and Quality Management Systems.
Being a responsible citizen
Helping ensure patient health and safety
Novartis Quality Management System (QMS)
Product and patient safety training
(2) Not reported

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-49).

HC-BP-510a.2

Description of code of ethics governing interactions with health care professionals

Professional Practices Policy (p.5)
Payments to Healthcare Professionals

ACTIVITY METRICS

SASB indicator

 

Novartis references

HC-BP-000.A

Number of patients treated

769 million
How we create value

HC-BP-000.B

Number of drugs (1) in portfolio and (2) in research and development (Phases 1-3)

(1) Novartis Global Product Portfolio (Novartis Innovative Medicines)
Sandoz
Advanced Accelerator Applications
(2) 160+
Selected products in development