Pharma services and solutions

Supply chain: Compliance

The challenge

During 2009, ethics loomed large on the regulatory landscape for pharmaceutical, life sciences, and medical-device companies. The Advanced Medical Technology Association (AdvaMed) and Pharmaceutical Research and Manufacturers of America (PhRMA) revised their codes of ethics to include stricter guidelines for sales and marketing practices. Congress reintroduced a Physician Payments Sunshine Act that would place tougher requirements on the industry to share information openly with the public about payments and gifts to healthcare professionals. These initiatives could result in sweeping operational and financial impact while simultaneously raising the bar for corporate compliance efforts.

The growth in outsourcing and off-shoring of clinical trials, manufacturing, and other processes in the industry has increased the difficulty of complying with ethical standards and laws governing bribery and corruption. The complexities of a distribution system involving wholesalers, hospitals, retail pharmacies and patients make product tracking and monitoring difficult.

Companies should use the emergence of stricter ethical guidelines and stronger anti-corruption laws as an impetus to establish a global, integrated, transparent compliance system that will deliver the associated benefits of risk mitigation, cost reduction, efficiency, effectiveness, corporate integrity and positive public perception. A strategically integrated system for transparency provides actionable insight for better business decision-making, resource allocation and avoidance of conflicts of interest.

How we can help you

A holistic supply chain risk management program continually identifies and assesses risks throughout the supply chain life cycle. PwC contributes broad experience in global strategic sourcing to risk program development. Our knowledge spans cultural practices, intellectual property protection policies, and political and economic pressures. PwC’s holistic approach to supply chain risk management provides corporate managers with higher-quality supply chain risk data, enabling smarter business decisions and creating sustained competitive advantage.

Common services include

• Risk assessments
• Supplier contract review
• Compliance program analysis and design
• Compliance training