Are stricter requirements for pharmacovigilance a positive development for the industry?
The reality is that all stakeholders in PV, not just regulatory authorities, are taking a tougher stance on safety and have become increasingly intolerant of excuses for system failure and unethical behaviour. The fundamental premise that increased regulation improves safety is flawed. Experience from other industries have clearly shown that making complex systems more complicated increases the risk of system failure which may further undermine confidence in safety. Q. Could frameworks governing drug safety be improved further? Yes, there is great room for improvement within the pharmaceutical sector. In 2000, the US Institute of Medicine produced a report, “To Err is Human”, which analysed how organisations involved in high-risk activities mitigated risk. This report provided evidence-based principles about how any organisation, such as a pharmaceutical company or regulatory authority, could implement a system that enhanced safety. Thus, vigilance refers to those processes for monitor
