The specific design of the CSRD disclosure requirements—i.e., what and how your company must report on sustainability—is not defined by the German implementation act, but by the European Sustainability Reporting Standards (ESRS), which, as EU Delegated Regulation 2023/2772, have been applicable since 1 January 2024 for companies within the scope of the CSRD and thus also for many pharmaceutical companies.
With a total of 10 topical standards and two cross-cutting standards, the ESRS cover environmental, social and governance aspects as well as general reporting requirements and disclosures, and thus comprise a total of 84 disclosure requirements, such as strategies, targets, action plans and metrics. These disclosure requirements in turn include a total of 1,178 data points (!).
But don’t worry: as a company, it is important for you to know that you do not have to report on all standards, but only on those that are material to you. This is where the cross-cutting standards ESRS 1 and 2 come into play, as they set the framework for reporting.
The starting point of the CSRD process is carrying out a due diligence analysis as well as a double materiality assessment to identify the sustainability topics that are material for your company. Both processes interlock and are regulated as important components of CSRD reporting in ESRS 1. In addition, EFRAG provides you with a comprehensive guidance document for implementing the materiality assessment .
The due diligence analysis serves to identify, prevent, mitigate and account for actual and potential adverse impacts on the environment and people that your company causes or contributes to through its business activities, products or services. Due diligence is an ongoing process that, among other things, aims at sustainability-related changes to strategy, the business model and business relationships, and also represents an important first step with regard to carrying out the double materiality assessment.
In comparison with other sectors, the pharmaceutical industry faces particularly complex challenges. Global supply chains and the production of life-saving medicines have significant impacts on people and the environment—both in the countries of production and in those where the medicines are used.
A study from 2019 shows, for example, that CO2 emissions from the pharmaceutical industry are significantly higher than those of the automotive industry. Another major problem is the burden on ecosystems caused by pharmaceutical residues that enter bodies of water and can cause considerable damage there.
Packaging waste and the emergence of antibiotic resistance are also major challenges arising from the production and use of medicines. In addition, raw material sourcing is a critical area, particularly dependence on a small number of producing countries, where problematic environmental and labour standards often prevail.
The CSRD forces companies to identify and document all these potential and actual adverse environmental and social impacts and to develop strategies to minimise them. And this is where the double materiality assessment comes in. Building on the findings of due diligence, it identifies the sustainability aspects that are material for your company and determines which sustainability topics and sub-topics your company will have to report on in future. It also considers the opportunities for your company that arise from a sustainability perspective.
Two dimensions of sustainability must be distinguished:
Impact materiality reflects the actual and potential positive and negative impacts of your company on the environment and society, e.g., air pollution or the positive significance of being a manufacturer of important medicines.
Financial materiality reflects the financial opportunities and risks of sustainability aspects for your company, e.g., liability risks as a result of environmental pollution or human rights violations, but also profitability gains through improved and sustainable processes and innovations.
The ESRS stipulate that, as a reporting company, you must assess all impacts, risks and opportunities for the topics listed in the so-called application requirement AR16 (Annex A ESRS 1) in the value chain for materiality.
These include the three areas of Environment, Social and Governance with their topics (e.g., water and marine resources), sub-topics (e.g., water) and sub-sub-topics (e.g., water withdrawal). Materiality can be determined at all three topic levels and thus oblige your company to report accordingly.
To this end, you must define assessment criteria for the materiality assessment yourself and can define qualitative and quantitative thresholds that determine whether sustainability aspects are material or not. The use of scales is common, e.g., from 1 to 10.
For assessing the individual sustainability topics, the involvement of relevant internal and external stakeholders—e.g., staff, NGOs, supervisory authorities, etc.—is essential, as these processes are later also reviewed as part of the assurance by the auditor and therefore must be well documented.