SASB disclosure 2023
We included our Sustainability Accounting Standards Board (SASB) disclosures into our Sustainability Report 2023. In addition to our disclosures pursuant to the SASB standard “Biotechnology & Pharmaceuticals”, we voluntarily report information for the “Medical Equipment & Supplies” and “Semiconductors” industries. We thus cover our three business sectors. With our voluntary SASB disclosures, we want to meet the increasing demands of our investors and other stakeholders. The reported data provide transparent, financially material and meaningful information on sustainability of our company. To meet the evolving interests and requirements of our stakeholders in the future as well, we will continuously develop and expand our SASB reporting.
The SASB disclosures were not part of the limited assurance engagement conducted by an independent auditor for our 2023 Sustainability Report.
Biotechnology & Pharmaceuticals
Safety of Clinical Trial Participants
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HC-BP-210a.1 |
Discussion, by world region, of management process for ensuring quality and patient safety during clinical trials |
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HC-BP-210a.2 |
Number of FDA Sponsor Inspections related to clinical trial management and pharmacovigilance that resulted in: |
In 2023, there were no FDA Good Clinical Practice (GCP) sponsor inspections related to clinical trials. Accordingly, there are no VAI or OAI. |
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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 |
Not reported due to confidentiality constraints/legal prohibitions. |
Access to Medicines
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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 |
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HC-BP-240a.2 |
List of products on the WHO List of Prequalified Medicinal Products as part of its Prequalification of Medicines Programme (PQP) |
Currently there is no product on the list. |
Affordability & Pricing
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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 due to confidentiality constraints. |
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HC-BP-240b.2 |
Percentage change in: |
The following overview shows the percentage change (2023 vs. 2022) in the average list price (WAC) of our Healthcare US product portfolio compared to the previous year (numbers in brackets: 2022 vs. 2021):
See also: Prices of medicines We do not report any net price for confidentiality reasons. |
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HC-BP-240b.3 |
Percentage change in: |
We only report the percentage change in average list price across our U.S. product portfolio. The largest increase compared with the previous year amounted to 3.3% for Rebif®. |
Drug Safety
| Code | Metrics | Reference/Comment | ||
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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 |
See FDA website: |
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HC-BP-250a.2 |
Number of fatalities associated with products as reported in the FDA Adverse Event Reporting System |
See FDA website: |
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HC-BP-250a.3 |
Number of recalls issued, total units recalled |
In 2023, we had two drug product recalls in total. None of these recalls was global they affected individual countries only. None of the recalls was related to the USA. None of the recalls was related to serious injury or fatality, all were either Class II or III. According to our internal policies, any recall type is reported and discussed with the relevant national regulatory authority, including the U.S. FDA. All recall processes are managed under a Global Standard Procedure “Product Recall and Withdrawal Management” which is applied worldwide for medicinal products (pharmaceutical prescription, biological) and devices. |
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HC-BP-250a.4 |
Total amount of product accepted for take-back, reuse, or disposal |
We do not take back products for reuse. In line with legal requirements in each country we take back products for disposal. The take back for disposal is organized on a local level and not tracked at global level. |
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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 type |
We had no such FDA enforcement actions in 2023. |
Counterfeit Drugs
| Code | Metrics | Reference/Comment | ||
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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 |
We have implemented processes and procedures to ensure that all suspected counterfeit medicines are assessed by a team of experts. The scope of any notification that we provide is the outcome of strategic alignment between relevant functions (e.g. Medical, Procurement, Legal, Quality, Corporate Security, Regulatory Affairs, Communications). Levels of details and format of any notification, including the HA information and collaboration, dedicated patient communication, information/awareness communication to distributors, pharmacies, physicians etc. about the presence of counterfeit or diverted products in the market, is decided on a case-by-case basis in accordance with the identified risks and taking into account corporate, legal and regulatory responsibilities. See also: Product-related crime |
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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 |
We report the number of actions that lead to filed cases related to counterfeit products to the authorities. For our Group-wide approach to counterfeit products, please see: Product-related crime |
Ethical Marketing
| Code | Metrics | Reference/Comment | ||
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HC-BP-270a.1 |
Total amount of monetary losses as a result of legal proceedings associated with false marketing claims |
Not reported due to confidentiality constraints/legal prohibitions. |
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HC-BP-270a.2 |
Description of code of ethics governing promotion of off-label use of products |
Employee Recruitment, Development & Retention
| Code | Metrics | Reference/Comment | ||
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HC-BP-330a.1 |
Discussion of talent recruitment and retention efforts for scientists and research and development personnel |
Merck KGaA, Darmstadt, Germany is a diverse company with three business sectors. Our Group approach to talent recruitment and retention efforts applies to everyone and does not differentiate between non-scientist and scientist employees. |
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HC-BP-330a.2 |
(1) Voluntary and |
We report the overall turnover rate (including voluntary as well as involuntary fluctuation) by gender, age and region. |
Supply Chain Management
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HC-BP-430a.1 |
Percentage of |
Our Healthcare business sector does not participate in the Rx-360 International Pharmaceutical Supply Chain Consortium. However, our facilities are frequently audited by the respective health authorities of the countries in which we distribute our healthcare products. As a major supplier to the pharmaceutical industry, our Life Science business sector participates in the Rx-360 audit program . Regarding our supplier base, we have access to sustainability audits and assessments of our suppliers through our membership in the industry initiatives Together for Sustainability and Pharmaceutical Supply Chain Initiative . See also: Supply chain management |
Business Ethics
| Code | Metrics | Reference/Comment | ||
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HC-BP-510a.1 |
Total amount of monetary losses as a result of legal proceedings associated with corruption and bribery |
Not reported due to confidentiality constraints/legal prohibitions. |
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HC-BP-510a.2 |
Description of code of ethics governing interactions with health care professionals |
Activity metrics
| Code | Metrics | Reference/Comment | ||
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HC-BP-000.A |
Number of patients treated |
In 2023, our Healthcare products were used to treat around 93 million patients, thereof more than 57 million patients in low- and middle-income countries. See also: Global Health |
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HC-BP-000.B |
Number of drugs |
We disclose our drug portfolio and R&D pipeline in the Annual Report and our website: |
Medical Equipment & Supplies
Affordability & Pricing
| Code | Metrics | Reference/Comment | ||
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HC-MS-240a.1 |
Ratio of weighted average rate of net price increases (for all products) to the annual increase in the U.S. Consumer Price Index |
Not reported due to confidentiality constraints. |
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HC-MS-240a.2 |
Description of how price information for each product is disclosed to customers or to their agents |
We disclose price information for our products via our website (excluding custom requests): Life Science portfolio . |
Product Safety
| Code | Metrics | Reference/Comment | ||
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HC-MS-250a.1 |
Number of recalls issued, total units recalled |
We conduct monthly reviews of key performance quality indicators which include a review of multiple quality metrics including number of recalls. Quarterly trends are evaluated and reported through management reviews. |
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HC-MS-250a.2 |
List of products listed in the FDA’s MedWatch Safety Alerts for Human Medical Products database |
In 2023, there were no Life Science products listed in the FDA’s MedWatch Safety Alerts for Human Medical Products database . |
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HC-MS-250a.3 |
Number of fatalities related to products as reported in the FDA Manufacturer and User Facility Device Experience database |
In 2023, there were no fatalities related to our Life Science products reported to the FDA’s Manufacturer and User Facility Device Experience database . |
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HC-MS-250a.4 |
Number of FDA enforcement actions taken in response to violations of current Good Manufacturing Practices (cGMP), by type |
Life Science received three U.S. FDA 483 forms in 2023. |
Ethical Marketing
| Code | Metrics | Reference/Comment | ||
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HC-MS-270a.1 |
Total amount of monetary losses as a result of legal proceedings associated with false marketing claims |
Not reported due to confidentiality constraints/legal prohibitions. |
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HC-MS-270a.2 |
Description of code of ethics governing promotion of off-label use of products |
Before any products can be purchased from our Life Science platform, we use a customer screening process to guard against the purchase of our products for illegal purposes. Core steps of this process cover data sourcing, hazard assessment, safe-use/risk assessment and labels/safety data sheets. Besides our own process, we cooperate with responsible authorities in the U.S. (FBI and the Bureau of Alcohol, Tobacco, Firearms and Explosives, ATF), as well as international authorities (Interpol). See also: Patient safety |
Product Design & Lifecycle Management
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HC-MS-410a.1 |
Discussion of process to assess and manage environmental and human health considerations associated with chemicals in products, and meet demand for sustainable products |
We assess environmental, human health, and further sustainability aspects of chemical products that we are sourcing and/or producing and selling. |
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HC-MS-410a.2 |
Total amount of products accepted for take-back and reused, recycled, or donated, broken down by: |
Since 2013, we have been partnering with Seeding Labs, a non-profit organization dedicated to equipping scientists in resource-limited countries with scientific equipment and support. In 2023, we donated 153 items of scientific equipment valued at more than $243,102. |
Supply Chain Management
| Code | Metrics | Reference/Comment | ||
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HC-MS-430a.1 |
Percentage of (1) entity's facilities and (2) Tier I suppliers' facilities participating in third-party audit programs for manufacturing and product quality |
As a major supplier to the pharmaceutical industry, our Life Science business participates in the Rx-360 audit program. The Life Science facilities are regularly audited by customers and respective health authorities for regulated products. |
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HC-MS-430a.2 |
Description of efforts to maintain traceability within the distribution chain |
Quality & regulatory management (Life Science) For our Group-wide approach see also: |
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HC-MS-430a.3 |
Description of the management of risks associated with the use of critical materials |
Business Ethics
| Code | Metrics | Reference/Comment | ||
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HC-MS-510a.1 |
Total amount of monetary losses as a result of legal proceedings associated with bribery or corruption |
Not reported due to confidentiality constraints/legal prohibitions. |
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HC-MS-510a.2 |
Description of code of ethics governing interactions with health care professionals |
Activity metrics
| Code | Metrics | Reference/Comment | ||
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HC-MS-000.A |
Number of units sold by product category |
Not reported |
Semiconductors
Greenhouse Gas Emissions
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TC-SC-110a.1 |
(1) Gross global Scope 1 emissions |
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(2) amount of total emissions from perfluorinated compounds |
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TC-SC-110a.2 |
Discussion of long-term and short-term strategy or plan to manage Scope 1 emissions, emissions reduction targets, and an analysis of performance against those targets |
Energy Management in Manufacturing
| Code | Metrics | Reference/Comment | ||
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TC-SC-130a.1 |
(1) Total energy consumed |
We report our total energy consumed in terajoule (TJ) and gigawatt hours. |
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(2) percentage grid electricity |
42% (2022: 40%) See also: Indicators: Environment |
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(3) percentage renewable |
Water Management
| Code | Metrics | Reference/Comment | ||
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TC-SC-140a.1 |
(1) Total water withdrawn |
We report our total water withdrawn in millions of cubic metres. |
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(2) total water consumed, percentage of each in regions with High or Extremely High Baseline Water Stress |
Waste Management
| Code | Metrics | Reference/Comment | ||
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TC-SC-150a.1 |
Amount of hazardous waste from manufacturing, percentage recycled |
We report our waste figures in metric kilotons. |
Employee Health & Safety
| Code | Metrics | Reference/Comment | ||
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TC-SC-320a.1 |
Description of efforts to assess, monitor, and reduce exposure of employees to human health hazards |
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TC-SC-320a.2 |
Total amount of monetary losses as a result of legal proceedings associated with employee health and safety violations |
Not reported due to confidentiality constraints/legal prohibitions. |
Recruiting & Managing a Global & Skilled Workforce
| Code | Metrics | Reference/Comment | ||
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TC-SC-330a.1 |
Percentage of employees that are |
We recruit, hire, train and promote our employees based on diversity, equity and inclusion. We report the number of employees by region, the number of nationalities and the percentage of non-Germans in management positions on Group level. |
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(2) located offshore |
We recruit, hire, train and promote our employees based on diversity, equity and inclusion. We report the number of employees by region, the number of nationalities and the percentage of non-Germans in management positions on Group level. |
Product Lifecycle Management
| Code | Metrics | Reference/Comment | ||
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TC-SC-410a.1 |
Percentage of products by revenue that contain IEC 62474 declarable substances |
Not reported |
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TC-SC-410a.2 |
Processor energy efficiency at a system-level for: |
Not applicable |
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(2) desktops, |
Not applicable |
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(3) laptops |
Not applicable |
Materials Sourcing
| Code | Metrics | Reference/Comment | ||
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TC-SC-440a.1 |
Description of the management of risks associated with the use of critical materials |
Intellectual Property Protection & Competitive Behavior
| Code | Metrics | Reference/Comment | ||
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TC-SC-520a.1 |
Total amount of monetary losses as a result of legal proceedings associated with anti-competitive behavior regulations |
Not reported due to confidentiality constraints/legal prohibitions. |
Activity metrics
| Code | Metrics | Reference/Comment | ||
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TC-SC-000.A |
Total production |
Not reported |
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TC-SC-000.B |
Percentage of production from owned facilities |
Not reported |