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ISPE 可持续发展实践社区 Scope 3 工作组开发制药行业 Scope 3 框架：现实还是愿景？

Scope 3 Sustainability in the Pharmaceutical Industry: Reality or Aspiration?

AI 导读

ISPE 可持续发展实践社区下的 Scope 3 工作组正在开发一套适用于制药与生物技术行业特点的 Scope 3 框架及统一指标，因现有 Ecovadis 等框架不针对生命科学行业。制药行业 Scope 3 排放占比为 Scope 1 与 2 合计的五至六倍，而美国无联邦层面 Scope 3 报告要求、欧盟已将要求放宽至营收超 4.5 亿欧元或员工超 1,000 人的企业。

正文

iSpeak Blog

22 September 2026

Scope 3 Sustainability is defined as indirect emissions from an organization's supply chain and operations. Data collection and reporting of Scope 3 emissions within the pharmaceutical manufacturing supply chain is complex and complicated by current regulations, GMP requirements and the diverse geography of suppliers within a global supply chain. The Scope 3 task force within ISPE's Sustainability Community of Practice is developing a Scope 3 framework that is relevant to the specifics and the complexities of the pharmaceutical industry.

Categories of emissions, as defined by the US Environmental Protection Agency (EPA) as Scope 1, 2 and 3, cover direct emissions from sources that the organization owns (Scope 1), emissions from purchased energy (Scope 2), and indirect emissions from an organization’s supply chain and operations (Scope 3).1

Within the ISPE Sustainability Community of Practice, the Scope 3 taskforce is focused on developing harmonized metrics that are appropriate for the pharmaceutical and biotech industries. While there are current frameworks, such as Ecovadis,2 they are industry agnostic and do not, generally, reflect the specifics of the Scope 3 challenges in the life sciences industry.

Research shows that the healthcare sector is responsible for 4 percent to 5 percent of global greenhouse gas (GHG) emissions and that Scope 3 emissions account for between 80 percent and 90 percent of that figure. The proportion of Scope 3 emissions in the pharmaceutical industry is between five to six times higher than Scope 1 and 2 combined.3, 4

The scale of the Scope 3 contribution to emissions within the pharmaceutical industry presents significant challenges in several areas:

  • Reporting: Given the scale and the numbers of suppliers, accurate recording and reporting of Scope 3 emissions requires close collaboration between the end user and the supplier. Additional reporting may also cause a financial burden on smaller suppliers, thereby increasing costs.
  • GMP regulations: Any change of supplier or product that has a potential impact of product quality or patient safety, requires a significant investment in requalification of both the supplier and the product before it can be introduced into the manufacturing process. This is both time consuming and costly.
  • Geography: Suppliers to the pharmaceutical industry are often in different countries with different regulations and opportunities to reduce their emissions. This is particularly true of active pharmaceutical ingredients (APIs) that, despite the recent onshoring efforts and investment in the US and Europe, are primarily sourced from India and China.

While it is relatively straightforward to tackle Scope 1 and 2 emissions within any industry –as they are under the manufacturers control and can be addressed with intentional design for new facilities and by upgrades for existing facilities, Scope 3 emissions require a very different approach, and require prioritization and commitment from the product manufacturer along with the same prioritization and commitment from both upstream suppliers and downstream distributors.

There are large discrepancies in Scope 3 reporting requirements between the US and the European Union (EU). While the US has no federal Scope 3 reporting requirements, there are potential requirements for individual states, including California. The EU has relaxed their requirements to cover only corporations with revenue in excess of €450 million or greater than 1,000 employees.5. It is also the case that US companies operating within the EU may be subject to Scope 3 reporting dependent on the value of the business conducted in the EU. Does this reporting inconsistency combined with the difficulty in obtaining complete and accurate data, drive the pharmaceutical industry to overlook the impact of Scope 3 emissions?

Other sustainability initiatives, such as those driven by the United Nations (UN),6 received early commitment from the industry, greater than 50 percent commitment, but less than 10 percent are on track. The World Health Organization also references the UN sustainability goals7 to emphasize not only the health components of the initiative but also its global impact.

The current competitive market situation for many pharmaceutical manufacturers presents a dilemma: Should the focus on Scope 3 attributes be suppliers and distributors or on ensuring that the supply chain is consistent and cost effective? Do the competing corporate initiatives to provide cost effective treatments for their patients clash with the effort to minimize Scope 3 emissions?

That said, corporations are looking at innovative means to reduce their overall emissions and Scope 3 specifically. The industry has seen manufacturers look to become less reliant on APIs that may be more environmentally damaging. Manufacturers are also exploring if product shelf life can be extended, reducing waste by improving circularity. Another area for potential is the switch to “green” propellants within respiratory portfolios. Transportation of goods could be shifted from GHG heavy air transport to sea and innovative vehicle solutions. These, and other innovations, will both directly and indirectly reduce Scope 3 emissions but require collaboration across multiple parties and a long-term outlook and goals.

This is a formidable challenge for the industry as a whole and will take a consistent approach from sustainability regulators and leaders to drive change through the industry.

Defining a set of measures that are pertinent to the pharmaceutical and biotech industries will provide the tools to drive a consistent approach to sustainability across the industry’s disparate range of suppliers and distributers. To develop a meaningful set of measures, the industry needs to understand the perspectives of manufacturers, suppliers and distributers. As the current climate changes are highlighting—from excessive heat to water shortages, the impact of sustainability efforts throughout the industry will have a profound impact on the world around us and we, as an industry, have a responsible not only to our patients but also to the communities that we serve globally.

GHG emissions as a whole and, in particular, Scope 3 emissions within the pharmaceutical industry present both challenges and opportunities. If Scope 3 challenges are of interest, please reach out to contribute to the efforts of the Scope 3 taskforce.

About the Author

Consultant

Independent

Mr. Robert Perks has over twenty years of experience in the design, development and implementation of pharmaceutical manufacturing automation and MES platforms. Robert has worked...

References

来源：ISPE iSpeak 专家博客 · ispe.org

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