Changes in regulation, alongside the introduction of stringent anti-corruption legislation, are forcing pharmaceutical companies to renew their focus on compliance. Globally, pharma organizations have to embrace a holistic approach. This involves aligning complex and disparate risks and regulatory compliance activities to the overall corporate strategy.
The Increased Risks in Regulatory Compliance
The pharmaceutical industry is coming under increased scrutiny across the value chain from drug discovery to post-marketing surveillance. Pharma organizations are understandably keen to avoid the negative publicity, fines and possible court cases associated with bribery and corruption. They are also mindful of patient safety issues where failures can jeopardize the future of entire enterprises.
In 2012, GlaxoSmithKline was fined $3 billion for wrongly branding the antidepressant drugs Paxil and Wellbutrin and failing to report required safety data on Avandia, a diabetes drug.¹ Enforcement agencies are increasing pressure and there are more regulatory action letters to pharmaceutical and biotech companies regarding social media communication. The FDA issued an enforcement letter to Novartis for its use of a Facebook widget that promoted its drug Tasinga without communicating any relevant risk information.⁴ The Prescription Medicines Code of Practice Authority (PMCPA) reprimanded Bayer for promoting its prescription medication on Twitter.⁵
Organizations should understand that these benefits of integrated compliance management will be fully realized only when a systematic and coherent approach is applied. That includes proper training of staff, effective communication and the visible support of senior management. Strict disciplinary actions for violations, regular review and revisions, as well as the use of KPIs and benchmarking will also contribute greatly to the chances of sustainable success.
This paper examines some of the legislation and proposes an approach built around people, processes and technology that can help companies manage compliance more effectively. The proposed approach links core elements of risk management, assurance structures, and governance with the foundation elements of organizational culture, change management, and data and knowledge management. It identifies the main risk influences – corporate strategy, organization values and business model, statutory changes, new laws, industry standards, new business risks – and how pharmaceutical organizations can mitigate the risks by creating a systematic approach and a culture conducive to compliance.
Tata Consultancy Services is the Platinum Sponsor at HNC’s World Drug Safety Europe Congress being held on the 8-9th September 2015, in Berlin