Compliance is a powerful term with seemingly paradoxical implications; it can keep businesses awake at night and, as compliance training and administration reach overload, send employees to sleep during the day. But pharmaceutical executives that fail to understand the full extent of their compliance obligations could be sleepwalking their way towards major reputational damage.
Compliance in all its guises (see table 1), and the reputation concerns that drive it, is now fi rmly established as one of pharmaʼs biggest business-critical issues. However, as the industry strives to build public trust, compliance now extends much further than promotional codes of practice, self-regulation and statutory legislation. The strengthening of international regulations around anti-bribery – and renewed vigour in their enforcement – has placed pharmaceutical companies under unparalleled scrutiny. Moreover, that scrutiny does not end at pharmaʼs security-controlled gates – it extends to third-party suppliers and agencies. Crucially, pharmaceutical managers that commission work to third parties must treat service providers as an extension of their business – making them accountable for the conduct of their chosen suppliers. The stakes are high.
Industry outsourcing shows no sign of abating, with companies increasingly contracting out key disciplines to drive growth. But choosing the right partner is no longer simply a calculation based on cost, expertise and ROI. Itʼs about ensuring that suppliers have the infrastructure, systems and processes required to meet the same rigid regulations by which the industry itself is measured. This leads to a dichotomy. Pharma companies want lean, agile and cost-effective agencies to deliver innovative, responsive and effi cient programmes, but these objectives appear at odds with the growing expectation for agencies to have the appropriate resources and corporate support frameworks to manage variable compliance requirements. Furthermore, such operational pressures risk compromising creativity and innovation. The demands, however, are understandable and unlikely to disappear.
Compliance has always been a strategic imperative for pharma. However, while governance determining how industry communicates with healthcare stakeholders is well-established, a sharper focus on ethics and corporate responsibility has emerged. Further, in a global marketplace enabled by online communication, legislative controls increasingly cross national borders. The most prominent regulations around business ethics are now enshrined in law. In the past five years, antibribery legislation across much of Europe, as well as the Foreign Corrupt Practices Act (FCPA) in the US, have enforced strict rules around benefi ts that health professionals might receive from their relationships with healthcare companies. This is leading to previously unimagined resources being dedicated to transparency and disclosure of the details of those ʻtransfers of valueʼ. The penalties for violation have been severe. With authorities able to impose unlimited fines for corporate malpractice, pharma has been hit by a number of high-profile penalties for fraud and corruption. In 2013 alone pharma forked out almost $3.75bn in settlement fees, with the cumulative five-year total extending beyond $10bn. …
Read: The heart of the matter: The only way is ethics produced in association with McCann Complete Medical
