As heightened regulatory scrutiny of the pharmaceutical industry grows increasingly global, sales and marketing practices, as well as privacy of patient and customer information, have emerged as targets for the most intense focus. Recent highly visible investigations and aggressive prosecutions regarding global compliance violations have resulted in significant financial judgments against leading pharmaceutical companies and subsequent criminal convictions, not only in the United States but also in Indonesia, China and Poland.
Other countries, including Germany, Italy and the United Kingdom, are investigating the activities of pharmaceutical companies or negotiating settlements for compliance violations. Such compliance missteps could lead consumers to question whether the pharmaceutical industry has lost track of its original vision to advance and improve the human condition.
These expanding regulatory forces are driving an urgent need for pharmaceutical companies to develop practical and effective solutions for meeting the challenges of integrating governance, risk and compliance on a global level. Such an integrated approach must properly synergise culture, process and technology to address current and emerging requirements and performance expectations, including:
- Foreign Corrupt Practices Act (FCPA): Pharmaceutical companies must balance the anti-bribery and accounting requirements of this act with standard sales and marketing practices in foreign countries, which often are in direct conflict.
- Legal and regulatory standards in each country: Foreign countries are increasingly enforcing their own laws and regulations, imposing fines and penalties for violations. Some countries don’t allow direct-to-consumer marketing, and some even regulate how much a company can spend on a pen or pad of paper.
- Deficit Reduction Act of 2005 (DFA): This act added another layer of complexity to the already multifarious process of government price reporting. Until final regulations are published, the issues are unclear, but the passage of this act demonstrates Congress's ongoing intense interest in continued enforcement and scrutiny of government pricing practices and reporting.
How PricewaterhouseCoopers can help you
PricewaterhouseCoopers offers a wide array of industry-focused compliance management and performance improvement services that address regulatory compliance for pharmaceutical and healthcare products companies. Services include:
- Compliance programme development and assessment
- Compliance risk assessment
- Strategic reputation management
- Enterprise-wide Risk Management (ERM) services
- Political risk management
- Corporate Integrity Agreement (CIA)/Independent Review organisation (IRO) services
- Pharmaceutical pricing compliance
- Pharmaceutical samples management compliance
- Sales and marketing compliance
- Patient Assistance Programmes (PAP) review
- Chargeback compliance
- Privacy and data protection
- Pharmacy benefit management rebate compliance
- Clinical trial vendor review
- Integrated operations and business planning services for R&D organisations
- Good clinical practice and performance improvement advisory services
- Pharmaceutical licensing management and alliances
