Governance, risk and compliance: Delivering sustainable solutions
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.
How PwC's consultants can help you
PricewaterhouseCoopers 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:
Across our value chain, and all areas of your operation, PwC can help you address these pressures, manage these drivers, and come out ahead. We offer a full set of solutions, including:
Research and development:
Sales and marketing:
Across the value chain:
- Dynamic enterprise risk management. Finding ways to enhance shareholder value, increase efficiency, contain costs and manage risk according to the organisation’s control environment, risk appetite and risk tolerance.
- Anti-bribery, anti-corruption, and other legal standards. Balancing the various anti-bribery, fraud and abuse, reporting and accounting requirements (enforced by the US Foreign Corrupt Practices Act (FCPA) amongst others) with standard commercial practices and regulations in the US, Europe, Asia, and Latin America — which, in recent years, have become more and more strenuously enforced.
- Aggregate spend reporting. States have been pushing for stricter and tougher requirements on the industry to openly share with the public the relationships with and financial investments made to Healthcare Professionals (HCPs). Several states have enacted state marketing and disclosure laws setting limits on industry payments to physicians and/or requiring the disclosure of these payments and associated marketing and advertising costs. The information disclosure requirements disparity between states makes it very difficult for companies to comply, as accurate spend reporting requires an understanding and management of the interrelationships between business processes, compliance policies/procedures and data capture and integration.
- Compliance Monitoring Programmes. As compliance programmes evolve along the continuum and continue to mature, the one consistent challenge for companies is developing and sustaining effective, real-time, informative compliance monitoring programmes that cut across the value chain while simultaneously driving value to both the Compliance Organisations and the businesses.
- Supply chain harmonisation and globalisation. In an increasingly interrelated supply chain — the traditional validation response is no longer sustainable — requesting cost-effective, scalable, risk-based approaches and robust IT support processes.
- IT governance. Creating a solid and agile IT foundation to address the new risks and compliance requirements that will emerge as companies increase their reliance on technology — transforming commercial and R&D processes, extending the walls of the virtual organisation, automating business processes, outsourcing IT operations, or sharing increasing amounts of sensitive information on a global basis.
- Enterprise-wide Risk Management (ERM) services
- Pharmaceutical licensing management and alliances advisory
- Internal audit
- Business continuity and disaster recovery