Biotechnology & Pharmaceuticals

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The Biotechnology & Pharmaceuticals industry develops, manufactures, and markets a range of brand-name and generic medications. A significant portion of the industry is driven by research and development, a high risk of product failure during clinical trials, and the need to obtain regulatory approval. Concerns over pricing practices and consolidation within the sector have created downward pricing pressures. Demand for the industry’s products is largely driving by population demographics, rates of insurance coverage, disease profiles, and economic conditions.

Relevant Issues (8 of 26)

Why are some issues greyed out? The SASB Standards vary by industry based on the different sustainability-related risks and opportunities within an industry. The issues in grey were not identified during the standard-setting process as the most likely to be useful to investors, so they are not included in the Standard. Over time, as the ISSB continues to receive market feedback, some issues may be added or removed from the Standard. Each company determines which sustainability-related risks and opportunities are relevant to its business. The Standard is designed for the typical company in an industry, but individual companies may choose to report on different sustainability-related risks and opportunities based on their unique business model.

Disclosure Topics

What is the relationship between General Issue Category and Disclosure Topics? The General Issue Category is an industry-agnostic version of the Disclosure Topics that appear in each SASB Standard. Disclosure topics represent the industry-specific impacts of General Issue Categories. The industry-specific Disclosure Topics ensure each SASB Standard is tailored to the industry, while the General Issue Categories enable comparability across industries. For example, Health & Nutrition is a disclosure topic in the Non-Alcoholic Beverages industry, representing an industry-specific measure of the general issue of Customer Welfare. The issue of Customer Welfare, however, manifests as the Counterfeit Drugs disclosure topic in the Biotechnology & Pharmaceuticals industry.
General Issue Category
(Industry agnostic)

Disclosure Topics (Industry specific) for: Biotechnology & Pharmaceuticals

Human Rights & Community Relations
  • Safety of Clinical Trial Participants

    Clinical trials are an essential part of the biotechnology and pharmaceutical products approval process. Clinical trial participant safety is a critical component of an entity’s ability to bring a product to market successfully. Oversight of these trials is an important factor in the industry because of the numerous clinical trials conducted by third-party contract research organisations. Biotechnology & Pharmaceuticals entities that manage clinical trials effectively may enhance shareholder value through the incremental revenue associated with new products.
Access & Affordability
  • Access to Medicines

    Biotechnology and pharmaceuticals entities play an important role in providing access to the industry’s products around the world. Entities may develop product pricing frameworks that account for varying levels of economic development and different health care needs across various countries. Strategies related to improving access to medicines may yield growth opportunities, innovation and unique partnerships, which may enhance shareholder value.
  • Affordability & Pricing

    Stakeholder emphasis on health care cost containment and increased access may continue to place downward pricing pressures on the Biotechnology & Pharmaceuticals industry. As a result, entities that have relied on raising drug prices, contractual advantages and reverse payments to protect profits may be challenged by efforts to reduce costs. Entities that effectively manage their global pricing practices and associated stakeholder scrutiny of pricing practices may limit their risk exposure to regulatory action or adverse reputational effects.
Product Quality & Safety
  • Drug Safety

    Important product safety information may be discovered after controlled clinical trials and regulatory approval. Subsequently, entities may be exposed to the financial implications of associate adverse events and product recalls. Product safety concerns, manufacturing defects or inadequate disclosure of product-related risks may result in significant product liability claims. Biotechnology & Pharmaceuticals entities that mitigate the incidence of product recalls, safety concerns and enforcement actions may better preserve shareholder value. In addition, concern over the abuse or resale of certain medications has resulted in the development of mandated take-back programmes. Entities that successfully engage in these programmes may limit future liabilities.
Customer Welfare
  • Counterfeit Drugs

    Fake or substandard medication presents a significant risk to consumers in all countries. Biotechnology & Pharmaceuticals entities may face added costs as jurisdictions implement drug supply chain regulations to prevent counterfeit, substandard or mislabelled drugs from entering the pharmaceutical distribution system. Entities that fail to manage this issue effectively may face material risks associated with the loss of public confidence and reduced revenue.
Selling Practices & Product Labeling
  • Ethical Marketing

    Biotechnology & Pharmaceuticals entities face challenges associated with the marketing of specific products. Direct-to-consumer advertisements for prescription drugs provide opportunities for increasing market share. However, marketing off-label uses may result in significant fines and settlements. Corporate disclosure of legal and regulatory fines and the codes of ethics that govern marketing activities may allow investors to better understand performance in this area.
Employee Engagement, Diversity & Inclusion
  • Employee Recruitment, Development & Retention

    Biotechnology & Pharmaceuticals entities face intense competition for recruiting and retaining employees. The industry relies on highly skilled employees to develop new products, conduct clinical trials, manage government regulations and commercialise new products. Entities that attract and retain employees despite a constrained talent pool may be better positioned to protect and enhance shareholder value.
Supply Chain Management
  • Supply Chain Management

    For the Biotechnology & Pharmaceuticals industry, managing supply chain quality is essential for protecting consumer health and corporate value. Biotechnology and pharmaceuticals entities that fail to ensure quality throughout their supply chains may be susceptible to lost revenue, supply disruptions and reputational damage. Disclosure of supply chain audit programmes may provide investors with an understanding of how entities in this industry are protecting shareholder value.
Business Ethics
  • Business Ethics

    Biotechnology & Pharmaceuticals entities are subject to various jurisdictional laws and regulations pertaining to bribery, corruption and health care fraud and abuse. The ability of entities to ensure compliance throughout their global and domestic operational footprint may have material implications. Corporate disclosure of legal and regulatory fines and the codes of ethics that govern their interactions with health care professionals may allow investors to monitor performance in this area.

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Biotechnology & Pharmaceuticals
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