Sustainability Accounting Standards. Health care sector: health care distributors

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Sustainability Accounting Standards Health care sector: health care distributors

What you need to know about the Health Care Standards for the health care distribution industry by the Sustainability Accounting Standards Board (SASB) and how EY can help

This thought leadership piece provides key details about the recently released SASB Health Care Standards and describes the services that EY can provide to companies in the health care distribution industry to assist with identifying and reporting on the material sustainability topics affecting their business. Additional thought leadership pieces focus on the standards for other sectors in the health care industry. For the latest pieces, please visit ey.com/us/sustainability. The Health Care Standards identify the sustainability topics that are material to the health care distribution industry and also provide guidance on accounting metrics that can be utilized by these industries with an aim of achieving standardized reporting. Specifically, the Health Care Standards provide the following information: Disclosure guidance: the sustainability topics that SASB has identified as being material to the health care distribution industry Accounting standards: standardized metrics to account for the material sustainability topics specified in the disclosure guidance when reporting to the United States Securities and Exchange Commission (SEC) in annual Form 10-K filings (Form 20-F for international companies) and other relevant periodic filings (Form 10-Q, Form 8-K, Form S-1 and Form S-3), as applicable The development process for the standards involved vetting of the material sustainability topics and metrics by an industry working group (IWG), which, as stated by SASB, consisted of publicly traded companies with more than $800 billion market cap, and investment firms with more than $952 billion in assets under management. The standards are currently provisional in nature until ratification by an external consensus body, which is set to occur in 2015 after SASB releases all its standards that are currently in the pipeline (SASB plans on releasing nine additional sector standards). It is not mandatory for companies in the health care distribution industry to disclose information on the material sustainability topics affecting them in conformity with the SASB standards. The standards have been designed in alignment with the SEC s definition of materiality, and the SEC has been briefed about the standards during their development process. The following are the sustainability topics material to the health care distribution industry, as identified by SASB: Product safety Counterfeit drugs Fuel efficiency Product lifecycle management Corruption and bribery Health care distributors 1

Introduction to SASB SASB, a 501 (c) nonprofit organization established in 2011 and accredited for the production of sustainability accounting standards by the American National Standards Institute (ANSI) released its Health Care Standards on 31 July 2013. SASB s goal is to design common standards for sustainability disclosures that will ultimately be included in mandatory filings to the Securities and Exchange Commission. The Health Care Standards are the first set of standards released by SASB and the organization is in the process of developing an additional nine standards comprising over 80 industries. 1 Standards development process Stage 1 sector research: research is conducted on the environmental, social and governance (ESG) issues affecting the sector for which the standards are being developed. Information gathered from the research process is compiled into industry briefs. Stage 2 vetting process: initial set of issues/metrics compiled based on the research conducted in stage 1 undergo a vetting process by the Industry Working Group (IWG) 2, which according to SASB for the Health Care Standards consisted of publicly traded companies with more than $800 billion market cap and investment firms with more than $952 billion in assets under management. Stage 3 standards development: reviewed issues/ metrics are published as public notice of material issues and are reviewed by the Standards Council, 3 which also reviews the standards development process leading up to that stage. At this point, the United States Securities and Exchange Commission (SEC) is briefed about the standards under development. Stage 4 public comment: The standards are released for public comment after which it undergoes further review by the Standards Council and is then made publically available. 2 Sustainability Accounting Standards Reprinted with permission Source: SASB 1 In addition to the Health Care Sector Standards, the other standards being developed by SASB are for the following sectors: financials (the next standard being released), technology & communication, non-renewable resources, transportation, services, resource transformation, consumption, renewable resources & alternative energy and infrastructure. 2 For a full list of SASB s IWG working Group members for the Health Care standards please refer to the following link: http://www.sasb.org/sectors/health-care/. 3 For a full list of the members of SASB s Standards Council please refer to the following link: http://www.sasb.org/sasb/standards-council/.

Overview of the Health Care Standards The SASB Health Care Sector Standards provide the following information: Disclosure guidance: the material sustainability issues relevant to the industry under consideration Accounting standards: standardized metrics to account for the material sustainability issues specified in the disclosure guidance Please refer to the table on pages 6 7 for the disclosure guidance and accounting standards health care distribution industry. Within the Form 10-K, the standards recommend that companies disclose information on their material sustainability issues in the Management s Discussion and Analysis section under a separate subsection titled Sustainability Accounting Standards Disclosure. According to SASB, other sections of the Form 10-K that can be leveraged for disclosure include the sections on the company s description of business, legal proceedings, risk factors affecting investment in the company, and the sections containing additional information related to materiality as mandated by the Securities Act Rule 408 and Exchange Rule 12b-20. With respect to the scope of disclosure, SASB recommends that companies disclose information on material sustainability topics affecting itself and entities over which it has controlling interest. Further, SASB also recommends, that for consolidated entities, disclosures be made, and accounting metrics calculated, for the whole entity, regardless of the size of the minority interest and information from unconsolidated entities not be included in the computation of SASB accounting metrics. A registrant should disclose, however, information about unconsolidated entities to the extent that such registrant considers the information necessary for investors to understand its performance with respect to sustainability issues. A number of recommendations and mandatory requirements (to be followed for a company to claim alignment with the SASB standards) related to reporting and assurance are also provided in the SASB Health Care Standards. 4 4 SASB provides guidance on the normalization of accounting metrics, reporting in International System of Units (SI Units), disclosure on uncertainty, disclosure on the nature and basis of any estimates used, the timing of disclosure and the use of a high level of assurance, among other topics. Health care distributors 3

SASB definition of materiality: SASB adheres to the U.S. Supreme Court definition of materiality, defined as presenting a substantial likelihood that the disclosure of the omitted fact would have been viewed by the reasonable investor as having significantly altered the total mix of information made available. [(U.S. Supreme Court definition, (TSC Indus. V. Northway, Inc., 426 U.S. 438 (1976) and Basic v. Levinson, 485 U.S. 224 (1988)] SASB definition of sustainability: In the context of SASB standards, sustainability refers to environmental, social and governance (ESG) factors that have the potential to affect corporations long-term value creation and are in the interest of investors and the public. 4 Sustainability Accounting Standards

Users of the Health Care Standards The Health Care Standards are mainly aimed to be utilized by publicly traded companies when filing their Form 10-K, or Form 20-F in the case of international companies. Health care companies can also utilize the Health Care Standards to guide disclosure on materiality in their Form 10-Q, Form 8-K, Form S-1 and Form S-3. Provisional and voluntary nature of the Health Care Standards It should be noted that the Health Care Standards are provisional in nature and according to SASB will remain provisional until the full set of standards (for 80+ industries) is reviewed and ratified by an external consensus body, such as that required by the American National Standards Institute (ANSI). The full set of standards is scheduled to be ratified in 2015. It is not mandatory for companies in the health care sector to disclose information on their material sustainability topics in alignment with the Health Care Standards, and the standards themselves have not been endorsed by the SEC. However, the Health Care Standards have been designed in alignment with the requirements specified by the SEC for the materiality content in its mandatory filings. Next steps SASB will be organizing a Corporate Roundtable for the Health Care Sector standards in the first quarter of 2014. Companies that volunteer to be a part of the Corporate Roundtable will have subject matter experts assisting them with the identification and reporting of material sustainability issues specific to their business. Health care distributors 5

Description and accounting metrics for material sustainability topics in the health care distribution industry SASB identifies the following sustainability topics as being material to the health care distribution industry: Material sustainability issues Description Accounting metrics Product Safety Counterfeit Drugs Health care distributors play an integral role in the delivery of health care products to consumers. The industry therefore has a shared responsibility with manufacturers to ensure safety, labeling, and quality. Health care distributors that limit the incidence of safety or other product claims will be better positioned to protect shareholder value. The World Health Organization estimates that the global market for counterfeit drugs has reached $431 billion, representing one percent of the U.S. s supply chain, and 10 15 percent of the world s pharmaceuticals market. The issue presents a significant health and safety risk to consumers with an estimated 100,000 annual deaths attributed to substandard or counterfeit drugs worldwide. Health care distributors could face added costs, as the federal government, states, and federal agencies seek to implement pedigree tracking regulations in an effort to prevent counterfeit or mislabeled drugs from entering the pharmaceutical distribution system. Description of legal and regulatory fines and settlements associated with product safety. Dollar amount of fines and settlements and a description of corrective actions implemented in response to events. Description of efforts to minimize health and safety risks of products sold, including those related to toxicity/chemical safety (e.g., REACH substances of very high concern), high abuse potential (e.g., Schedule II controlled substances), or delivery (e.g., incorrect dispensing, mislabeling, transmission of disease through reuse of vials, etc.). Description of methods and technologies used to maintain traceability of products throughout the distribution chain and prevent counterfeiting. Description of due diligence process to qualify suppliers of drug products and medical equipment and devices. Description of process for alerting customers and business partners of potential or known risks associated with counterfeit products 6 Sustainability Accounting Standards

Material sustainability issues Description Accounting metrics Fuel Efficiency Product Lifecycle Management Corruption and Bribery The distribution of health care products and supplies requires significant transportation networks. As concern over climate change and dwindling natural resources continues to impact fuel pricing, health care distributors will be exposed to fluctuations in costs. Firms that are able to improve transportation efficiencies are likely to enhance shareholder value. Health care distributors have a shared responsibility to reduce the environmental impact of the products that they distribute. Specific opportunities to address these impacts exist in product packaging and take-back programs. Health care distributors are subject to various state, federal, and international laws that pertain to their operations, including the False Claims Act and the U.S. Foreign Corrupt Practices Act. The ability of companies to ensure compliance with relevant regulations is likely to have material implications. *Table consolidated from SASB Health Care Standards for the health care distribution industry. Payload fuel economy = gallons per ton-miles. Description of involvement in efforts to reduce the environmental impact of logistics, including involvement in the EPA SmartWay program. Description of initiatives to reduce the environmental impact of packaging, such as use of recycled materials, reductions in the amount of packaging material (i.e., dematerialization), packaging for consolidated shipping, and reduction in packaging waste (e.g., recycling and reuse of packaging, etc.). Describe product stewardship initiatives to promote take-back (for reprocessing or recycling) of products at the end of their lifecycle. Amount (by weight) of products accepted for take-back. Description of efforts to minimize conflicts of interest and unethical business practices, including mechanisms to ensure compliance. Description of legal and regulatory fines and settlements associated with corruption or bribery, including Foreign Corrupt Practices Act and False Claims Act violations. Dollar amount of fines and settlements and a description of corrective actions implemented in response to events. Health care distributors 7

8 Sustainability Accounting Standards

How EY can help The following are a list of services that EY can provide to companies in the health care distribution industry to guide them through the process of identifying sustainability topics material to their business, reporting on these topics and addressing the potential risks faced by their business: Industry benchmarking: EY s Climate Change and Sustainability Services (CCaSS) team can provide key insights on sustainability best practices in the health care distribution industry based on research and industry experience including benchmarking the five material topics in the SASB standard. Gap assessment and recommendations: CCaSS can provide a gap assessment against industry best practices and current sustainability initiatives in place, with an aim to identify gaps for improvement and provide recommendations on addressing these gaps. Identification of material sustainability topics in alignment with the requirements specified in the SASB Health Care Standards: CCaSS can assist companies in the health care distribution industry seeking to identify the material sustainability topics specific to their company. We can assist companies with evaluating whether reporting in their annual or periodic filings to the SEC in alignment with the guidance provided in the SASB standards is right for them. Employhee, health and safety (EHS) assessments: we can assist clients with managing EHS and sustainability risks; identifying and generating cost savings; and implementing process improvements. Assurance readiness: SASB s hope is that registrants will report on sustainability metrics with the same rigor, accuracy and responsibility as all other information in the SEC filings. SASB is recommending that registrants use a higher level of assurance (attestation), such as the American Institute of Certified Public Accountants AT Section 701. We can assist clients on their assurance journey by first providing assurance readiness over individual material sustainability topics identified by companies in the health care distribution industry to evaluate the associated processes and controls and in doing so increase internal confidence and reduce the risk of misstatement. Assurance: when clients are ready for independent assurance, we can also provide assurance over individual material sustainability topics identified by companies in the health care distribution industry to add an additional level of credibility to reports that resonate with investors, non-governmental organizations (NGOs) and other stakeholders. Health care distributors 9

EY Assurance Tax Transactions Advisory About EY EY is a global leader in assurance, tax, transaction and advisory services. The insights and quality services we deliver help build trust and confidence in the capital markets and in economies the world over. We develop outstanding leaders who team to deliver on our promises to all of our stakeholders. In so doing, we play a critical role in building a better working world for our people, for our clients and for our communities. EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. For more information about our organization, please visit ey.com. Ernst & Young LLP is a client-serving member firm of Ernst & Young Global Limited operating in the US. About EY s Climate Change and Sustainability Services Climate change and sustainability continue to rise on the agendas of governments and organizations around the world with rapidly evolving drivers and expectations. Your business faces regulatory requirements and the need to meet stakeholder expectations as well as respond to the opportunities presented for revenue generation and cost reduction. This means a fundamental and complex transformation for many organizations and the embedding of climate change and sustainability into core business activities to achieve short term objectives and create long-term shareholder value. The industry and countries in which you operate as well as your extended business relationships introduce additional complexity, challenges, responsibilities and opportunities. Our global, multidisciplinary team combines our core experience in assurance, tax, transactions and advisory with climate change and sustainability skills and deep industry knowledge. You ll receive a tailored service supported by global methodologies to address issues relating to your specific needs. Wherever you are in the world, EY can provide the right professionals to support you in achieving your potential. It s how we make a difference. 2014 EYGM Limited. All Rights Reserved. EYG no. FQ0064 1401-1180563 ED 0115 This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting, tax, or other professional advice. Please refer to your advisors for specific advice. Our point of view Some of our published insights include: Let s talk: sustainability Let s talk: sustainability a new point of view for business leaders. Conflict minerals What you need to know about the new disclosure and reporting requirements and how EY can help Contacts Brendan LeBlanc Executive Director Climate Change and Sustainability Services Ernst & Young LLP +1 617 585 1819 brendan.leblanc@ey.com John J. DeRose Executive Director Climate Change and Sustainability Services Ernst & Young LLP +1 720 931 4306 john.derose@ey.com Six growing trends in corporate sustainability As shareholders speak up and companies begin connecting risk management and corporate sustainability, environmental issues become more prominent on company agendas. How today s investors are framing conversations on corporate sustainability Investors with long-standing interests in environmental and social (E+S) topics are having an increasing impact on how companies address corporate sustainability. Carol A. Casazza Senior Manager Climate Change and Sustainability Services Ernst & Young LLP +1 212 773 5490 carol.casazza@ey.com