Author byline as per print journal: Shivani Mittra, MPharm, PhD; Shylashree Baraskar; Elena Wolff-Holz2, MD; Sandeep N Athalye, MBBS, MD

Submitted: 17 April 2024; Revised: 16 July 2024; Accepted: 17 July 2024; Published online first: 30 July 2024

Introduction

While previously, the focus was mostly on environmental issues, the current wave of the earth’s sustainability consciousness is now unprecedented [1], and commitment towards environmental, social, and governance (ESG) goals has started impacting how business operations are conducted globally. ESG goals are the non-financial metrics that companies, including pharma, have started working on to assess their governance standards, social responsibility, and environmental influence. With clients, consumers, and potential employees all gravitating towards businesses that prioritize ESG initiatives, these have become a biomarker of business purpose and success, as with a commitment towards ESG, businesses can differentiate themselves and gain competitive advantage. As the needle moves, we find that a large majority (83%) of consumers think companies should be actively shaping ESG best practices, and 86% of employees prefer to work for companies that care about these issues [2]. Science Based Targets initiatives (SBTi) guide organizations on how much and how quickly they need to reduce their greenhouse gas (GHG) emissions to prevent further climate change. This will entail more target-based actions beyond greenwashing [3]. Pharma companies are encouraged to take the climate pledge to reach net-zero carbon emissions by 2040. Many companies have committed to reducing emissions but have yet to set a target for SBTi net zero [1].

This article discusses the three principles of ESG and how drug development can be aligned to these principles. It also discusses the potential global challenges and solutions to applying these principles, considering different regulatory environments. The Low Carbon Clinical Trials Working Group has developed guidance for trialists to determine the clinical trials’ carbon footprints [4, 5]. The environment is but one of the ESG pillars, and companies need to excel in all three pillars of ESG. Inadequate performance in environmental and social issues leads to inadequate governance. Artificial intelligence (AI) and machine learning (ML) can build efficiency and enhance the governance of the trial by de-centralizing them [7, 8]. Table 1 provides the ESG values that guide companies, including the pharmaceutical industry, toward creating measurable goals [1, 4, 6-12].

It is also pertinent to add here that policymakers and regulators are equally responsible for driving the ESG goals, as this needs to be a collective initiative. This article also discusses the recent guidelines proposed by the UK National Institute for Health Research (NIHR), US Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO) for sustainable drug development, keeping the ESG goals in focus [7-13].

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.