Appendix
EU Legislation Data Points
EU List of datapoints in cross-cutting and topical standards that derive from other EU legislation
Disclosure requirement |
|
Data point |
|
Description |
|
Regulation |
|
Section (state if not material) |
---|---|---|---|---|---|---|---|---|
ESRS 2 GOV-1 |
|
21 (d) |
|
Board’s gender diversity |
|
SFDR, Benchmark regulation |
|
|
ESRS 2 GOV-1 |
|
21 (e) |
|
Percentage of board members who are independent |
|
Benchmark regulation |
|
|
ESRS 2 GOV-4 |
|
30 |
|
Statement on sustainability due diligence |
|
SFDR |
|
|
ESRS 2 SBM-1 |
|
40 (d) i |
|
Involvement in activities related to fossil fuel activities |
|
SFDR, Pillar 3, Benchmark regulation |
|
Not relevant |
ESRS 2 SBM-1 |
|
40 (d) ii |
|
Involvement in activities related to chemical production |
|
SFDR, Benchmark regulation |
|
Not relevant |
ESRS 2 SBM-1 |
|
40 (d) iii |
|
Involvement in activities related to controversial weapons |
|
SFDR, Benchmark regulation |
|
Not relevant |
ESRS 2 SBM-1 |
|
40 (d) iv |
|
Involvement in activities related to cultivation and production of tobacco |
|
Benchmark regulation |
|
Not relevant |
ESRS E1-1 |
|
14 |
|
Transition plan to reach climate neutrality by 2050 |
|
EU Climate Law |
|
|
ESRS E1-1 |
|
16 (g) |
|
Undertakings excluded from Paris-aligned Benchmarks |
|
Pillar 3, Benchmark regulation |
|
|
ESRS E1-4 |
|
34 |
|
GHG emission reduction targets |
|
SFDR, Pillar 3, Benchmark regulation |
|
|
ESRS E1-5 |
|
38 |
|
Energy consumption from fossil sources disaggregated by sources (only high climate impact sectors) |
|
SFDR |
|
|
ESRS E1-5 |
|
37 |
|
Energy consumption and mix |
|
SFDR |
|
|
ESRS E1-5 |
|
40-43 |
|
Energy intensity associated with activities in high climate impact sectors |
|
SFDR |
|
|
ESRS E1-6 |
|
44 |
|
Gross Scope 1, 2, 3 and Total GHG emissions |
|
SFDR, Pillar 3, Benchmark regulation |
|
|
ESRS E1-6 |
|
53-55 |
|
Gross GHG emissions intensity |
|
SFDR, Pillar 3, Benchmark regulation |
|
|
ESRS E1-7 |
|
56 |
|
GHG removals and carbon credits |
|
EU Climate Law |
|
Not stated (phase-in) |
ESRS E1-9 |
|
66 |
|
Exposure of the benchmark portfolio to climate-related physical risks |
|
Benchmark regulation |
|
|
ESRS E1-9 |
|
66 (a) |
|
Disaggregation of monetary amounts by acute and chronic physical risk |
|
Pillar 3 |
|
|
ESRS E1-9 |
|
66 (c) |
|
Location of significant assets at material physical risk |
|
Pillar 3 |
|
|
ESRS E1-9 |
|
67 (c) |
|
Breakdown of the carrying value of its real estate assets by energy-efficiency classes |
|
Pillar 3 |
|
|
ESRS E1-9 |
|
69 |
|
Degree of exposure of the portfolio to climate-related opportunities |
|
Benchmark regulation |
|
|
ESRS E2-4 |
|
28 |
|
Amount of each pollutant listed in Annex II of the E-PRTR Regulation emitted to air, water and soil |
|
SFDR |
|
|
ESRS E3-1 |
|
9 |
|
Water and marine resources |
|
SFDR |
|
Not material |
ESRS E3-1 |
|
13 |
|
Dedicated policy |
|
SFDR |
|
Not material |
ESRS E3-4 |
|
28 (c) |
|
Total water recycled and reused paragraph |
|
SFDR |
|
Not material |
ESRS E3-4 |
|
29 |
|
Total water consumption in m 3 per net revenue on own operations |
|
SFDR |
|
Not material |
ESRS 2 SBM-3 – E4 paragraph 16 (a) i |
|
16 (a) i |
|
|
|
SFDR |
|
Not material |
ESRS 2 SBM-3 – E4 paragraph 16 (b) |
|
16 (b) |
|
|
|
SFDR |
|
Not material |
ESRS 2 SBM-3 – E4 paragraph 16 (c) |
|
16 (c) |
|
|
|
SFDR |
|
Not material |
ESRS E4-2 |
|
24 (b) |
|
Sustainable land/agriculture practices or policies |
|
SFDR |
|
Not material |
ESRS E4-2 |
|
24 (c) |
|
Sustainable oceans/seas practices or policies |
|
SFDR |
|
Not material |
ESRS E4-2 |
|
24 (d) |
|
Policies to address deforestation |
|
SFDR |
|
Not material |
ESRS 2 SBM3 |
|
14 (g) |
|
Risk of incidents of child labour |
|
SFDR |
|
|
ESRS S1-1 |
|
20 |
|
Human rights policy commitments |
|
SFDR |
|
|
ESRS S1-1 21 |
|
21 |
|
Sustainability due diligence policies on issues addressed by the fundamental International Labor Organisation Conventions 1 to 8 |
|
Pillar 3 |
|
|
ESRS S1-1 |
|
22 |
|
Processes and measures for preventing trafficking in human beings |
|
SFDR |
|
|
ESRS S1-1 |
|
23 |
|
Workplace accident prevention policy or management system |
|
SFDR |
|
|
ESRS S1-3 |
|
32 (c) |
|
Grievance/complaints handling mechanisms |
|
SFDR |
|
|
ESRS S1-14 |
|
88 (b), (c) |
|
Number of fatalities and number and rate of work-related accidents |
|
SFDR, Pillar 3 |
|
|
ESRS S1-14 |
|
88 (e) |
|
Number of days lost to injuries, accidents, fatalities or illness |
|
SFDR |
|
|
ESRS S1-16 |
|
97 (a) |
|
Unadjusted gender pay gap |
|
SFDR, Pillar 3 |
|
|
ESRS S1-16 |
|
97 (b) |
|
Excessive CEO pay ratio |
|
SFDR |
|
|
ESRS S1-17 |
|
103 (a) |
|
Incidents of discrimination |
|
SFDR |
|
|
ESRS S1-17 |
|
104 (a) |
|
Non-respect of UNGPs on Business and Human Rights and OECD Guidelines |
|
SFDR, Benchmark regulation |
|
|
ESRS 2 SBM-3 – S2 |
|
11 (b) |
|
Significant risk of child labour or forced labour in the value chain |
|
SFDR |
|
Not material |
ESRS S2-1 |
|
17 |
|
Human rights policy commitments |
|
SFDR |
|
Not material |
ESRS S2-1 |
|
18 |
|
Policies related to value chain workers |
|
SFDR |
|
Not material |
ESRS S2-1 Non-respect of UNGPs on Business and Human Rights principles and OECD guidelines paragraph 19 |
|
19 |
|
Non-respect of UNGPs on Business and Human Rights principles and OECD guidelines |
|
SFDR, Benchmark regulation |
|
Not material |
ESRS S2-1 |
|
19 |
|
Due diligence policies on issues addressed by the fundamental International Labor Organisation Conventions 1 to 8 |
|
Benchmark regulation |
|
Not material |
ESRS S2-4 |
|
36 |
|
Human rights issues and incidents connected to its upstream and downstream value chain |
|
SFDR |
|
Not material |
ESRS S3-1 |
|
16 |
|
Human rights policy commitments |
|
SFDR |
|
Not material |
ESRS S3-1 |
|
17 |
|
Non-respect of UNGPs on Business and Human Rights, ILO principles or OECD guidelines |
|
SFDR, Benchmark regulation |
|
Not material |
ESRS S3-4 |
|
36 |
|
Human rights issues and incidents |
|
SFDR |
|
Not material |
ESRS S4-1 |
|
16 |
|
Policies related to consumers and end-users |
|
SFDR |
|
|
ESRS S4-1 |
|
17 |
|
Non-respect of UNGPs on Business and Human Rights and OECD guidelines |
|
SFDR, Benchmark regulation |
|
|
ESRS S4-4 |
|
35 |
|
Human rights issues and incidents |
|
SFDR |
|
|
ESRS G1-1 |
|
10 (b) |
|
United Nations Convention against Corruption |
|
SFDR |
|
|
ESRS G1-1 |
|
10 (d) |
|
Protection of whistleblowers |
|
SFDR |
|
|
ESRS G1-4 |
|
24 (a) |
|
Fines for violation of anti-corruption and anti-bribery laws |
|
SFDR, Benchmark regulation |
|
|
ESRS G1-4 |
|
24 (b) |
|
Standards of anti-corruption and anti-bribery |
|
SFDR |
|
|
SASB
SASB Table
SASB Reference |
|
Metric description |
|
argenx response |
---|---|---|---|---|
HC-BP-000.A |
|
Number of clinical trial patients treated. |
|
1,052 |
HC-BP-000.B |
|
Number of drugs in research and development (Phase 1-3). |
|
3 |
HC-BP-000.B |
|
Number of drugs in portfolio. |
|
7 |
HC-BP-210a.1 |
|
Discussion, by region, of management process for ensuring quality and patient safety during clinical trials. |
|
We ensured the continuous monitoring of the safety profile of our investigational products and ensured compliance with adverse event reporting to health authorities worldwide. We also ensured supply to patients on clinical trials and have had no supply disruption. |
HC-BP-210a.2 |
|
Number of inspections related to clinical trial management and pharmacovigilance that resulted in (2) regulatory or administrative actions taken against the entity. |
|
0 |
HC-BP-210a.2 |
|
Number of inspections related to clinical trial management and pharmacovigilance that resulted in (1) entity voluntary remediation. |
|
0 |
HC-BP-240a.2 |
|
List of products on the WHO List of Prequalified Medicinal Products as part of its Prequalification of Medicines Programme (PQP). |
|
0 |
HC-BP-250a.1 |
|
Products listed in public medical product safety or adverse event alert databases. |
|
Vyvgart is listed in the European Medicines Agency’s list of medicinal products under additional monitoring |
HC-BP-250a.2 |
|
Number of fatalities associated with products. |
|
0 |
HC-BP-250a.3 |
|
(2) Total units recalled. |
|
0 |
HC-BP-250a.3 |
|
(1) Number of recalls issued. |
|
0 |
HC-BP-250a.4 |
|
Total amount of product accepted for takeback, reuse, or disposal. |
|
0.051 |
HC-BP-250a.5 |
|
Number of enforcement actions taken in response to violations of good manufacturing practices (GMP) or equivalent standards, by type. |
|
0 |
HC-BP-260a.1 |
|
Description of methods and technologies used to maintain traceability of products throughout the supply chain and prevent counterfeiting. |
|
To the extent this is required by national legislation (e.g. DSCSA in U.S. and FMD in EU), all commercial argenx products are serialized at unit, case and pallet (aggregated level). On each sellable unit a unique random serial number is printed as well as a product code, lot number and expiration date, both in human readable format and encoded in a 2D data matrix barcode. All products are tamper-evident sealed and shipping systems and trucks are sealed with numbered seals during transit to prevent product tampering. During batch manufacturing (outsourced to CMOs), all processing steps are documented to have a full processing history and lot genealogy of consumed raw materials, which is also maintained in the CMO’s quality system. An ERP system is used to provide full lot genealogy and traceability of intermediates and finished products owned by argenx, located at its CMOs, third party warehouses and 3PL. For downstream distribution, the entity can rely on the distributors and wholesaler’s systems to trace product to the end customer. |
HC-BP-260a.2 |
|
Discussion of process for alerting customers and business partners to potential or known risks associated with counterfeit products. |
|
argenx has a procedure in place to ensure that all suspicions of falsified or counterfeit medicine are reported in a consistent manner. When a case is reported, the impacted batches will be separated and quarantined, an investigation will be performed and the impacted stakeholders in the supply chain will be informed, as well as the relevant competent authorities in case of confirmed counterfeit product. Market actions will be taken in consultation with the competent authority. |
HC-BP-260a.3 |
|
Number of actions that led to raids, seizure, arrests, or filing of criminal charges related to counterfeit products. |
|
0 |
HC-BP-270a.1 |
|
Total amount of monetary losses as a result of legal proceedings associated with false marketing claims. |
|
No monetary losses as a result of legal proceedings. No documentation to provide as there were no losses. |
HC-BP-270a.2 |
|
Description of code of ethics governing promotion of off-label use of products. |
|
argenx’s Code of Ethics and related policies strictly govern the promotion of its products, ensuring compliance with all applicable laws, regulations, and ethical standards. It explicitly prohibits the promotion of off-label use of products. All marketing and promotional activities must align with approved product indications and regulatory guidelines. |
HC-BP-330a.1 |
|
Discussion of talent recruitment and retention efforts for scientists and research and development staff. |
|
Talent Attraction |
HC-BP-510a.1 |
|
Total amount of monetary losses as a result of legal proceedings associated with corruption and bribery. |
|
0 |
HC-BP-510a.2 |
|
Description of code of ethics governing interactions with health care professionals. |
|
argenx’s Code of Ethics governs interactions with healthcare professionals (HCPs) to ensure compliance with all applicable laws, regulations, and ethical standards. The code requires that all engagements with HCPs are conducted with transparency, integrity, and respect for their independence. It prohibits any improper influence or incentives, ensuring that decisions regarding patient care remain unbiased and in the best interest of patients. Interactions are guided by policies such as the Interactions with HCC Policy, which includes provisions on fair market value compensation for services, appropriate documentation, and adherence to anti-bribery and anti-corruption laws. Training programs, regular monitoring, and internal audits reinforce these standards. |
HC-BP-240b.3 |
|
Percentage change in: (1) list price and (2) net price of product with largest increase compared to previous reporting period |
|
(1) Percentage change in list price: 2% |
HC-BP-240b.2 |
|
Percentage change in: (1) weighted average list price and (2) weighted average net price across product portfolio compared to previous reporting period |
|
(1) Percentage change in weighted average list price: -1% |