Pharmaceutical, biotechnology and medical device companies (Companies) are facing unprecedented compliance challenges, and the close regulatory scrutiny is unlikely to abate anytime soon. The scope of these challenges, like the industry itself, has grown global - and so have the attendant risks.
The level of scrutiny is significant. Companies cannot afford to ignore the corporate, reputational and personal risks attaching to their business activities, wherever in the world they operate. Sales and marketing practices, transparency of company spend on health care professionals and organisations, clinical trial activity, patient safety as well as issues of privacy of patient and customer information; especially have been under the regulatory microscope. Recent, highly visible investigations and aggressive prosecution have resulted in significant financial judgments against leading companies, and subsequent criminal convictions - not only in the United States but also in several other territories, including emerging markets. One should also underscore the significant reputational damage caused by these allegations and settlements, both in the courts of the land and the court of public opinion.
Squeezed on all sides by business, economic and regulatory pressures, Companies urgently need a new approach to meet the heightened challenges of integrating new governance, risk and compliance practices at global level.
PwC is a long-standing leader in providing governance, risk and compliance (GRC) advisory services to Companies. We help our clients develop cost-effective compliance programmes focused on delivering sustainable solutions, combining culture, processes and technology — which are fundamental to viable profitability.
These solutions address the key drivers in the new global competitive and regulatory environment: