As a global company with a variety of highly innovative businesses, the Merck Group is exposed to potential risks and opportunities. The risk categories presented as well as the opportunities described in the Report on Risks and Opportunities of the Annual Report for 2013 remain valid for the Merck Group in the current reporting period. The only change related to the elimination of the risk of an import ban on products to the United States due to a warning letter from the United States Food and Drug Administration (FDA) in connection with inspections of production facilities in Tiburtina (Italy) as well as Aubonne and Vevey (Switzerland). The corrective actions taken by Merck are considered to be adequate by the FDA. The FDA has formally closed out the procedure.
At present, the company is not aware of any risks that could jeopardize the continued existence of the Merck Group. The company has a group-wide risk management system in place to identify and mitigate potential risks. Merck continuously monitors business risks such as issues regarding liquidity, defaults on payables and receivables, currency and interest rates, market pricing, pension obligations, assessment of independent rating agencies, human resources and information technology. Regarding legal risks, Merck monitors a host of potential issues such as litigation regarding product liability, antitrust law, pharmaceutical law, patent law and environmental protection.