Section 7 defines the obligations that arise after an inappropriate sales information activity has occurred. Detecting a problem and handling it properly once detected are distinct challenges. This section focuses on the latter, setting out a sequential response flow: fact-finding, correction, recurrence prevention, progress monitoring, and action against the individuals involved.
01Fact-Finding, Correction, and Recurrence Prevention
Upon becoming aware of an inappropriate sales information activity, the company must promptly investigate the facts, implement corrections, and take measures to prevent recurrence. "Promptly" allows no interval between identifying the issue and commencing a response. Investigation must be grounded in established facts rather than inference, and correction means not only stopping the problematic conduct but also identifying the scope of its impact and, where necessary, recalling affected materials.
So what: From the moment an inappropriate activity comes to light, a three-stage obligatory response is triggered: fact verification → correction → recurrence prevention. Handling the matter informally through an internal verbal reprimand or within-department processing is unlikely to satisfy the guideline's requirements.
So why: The longer it takes to act after an inappropriate information provision is discovered, the harder it becomes to recover or correct whatever influence the information may have had on healthcare professionals' prescribing decisions. The prompt-response obligation functions as a time constraint that minimises the risk of inaccurate information spreading further through clinical settings.
02Monitoring Progress and Directing Additional Action as Necessary
Even after a response has been initiated, companies must actively monitor progress themselves and, where necessary, direct additional action. The phrase "actively monitor themselves" signals that waiting passively for updates from personnel is not sufficient. The oversight department or senior management must proactively track whether corrective measures are taking effect, and must issue further instructions if the initial measures prove inadequate.
So what: Issuing instructions and then stepping back is not enough. Companies must actively track whether initial measures are working and take further steps when they are not. A corrective response is evaluated by its completion, not its initiation.
So why: In practice, there have been cases where superficially instituted corrective measures became hollow formalities while problems continued. Explicitly requiring progress monitoring ensures that corrections produce genuine effect rather than remaining procedural. The explicit authority to direct additional action institutionally underpins the supervisor's continued involvement.
03Strict Measures Against Personnel Who Engaged in Inappropriate Activities
Companies must take strict measures against those who engaged in inappropriate sales information activities. The guidelines do not specify the precise form of measures, but personnel actions such as formal warnings, demotion, or disciplinary action are within scope. The modifier "strict" indicates that nominal or token punishment does not satisfy the requirement.
So what: The organisation has an obligation to assign clear accountability to the individuals involved and to impose commensurate disciplinary action. Responding only verbally—"we provided guidance" or "we gave a caution"—is unlikely to meet the "strict measures" standard.
So why: Light consequences for inappropriate conduct send an implicit organisational message that violations carry little cost. Requiring strict measures demonstrates the organisation's genuine commitment to rule compliance and raises the deterrent effect against similar violations. The weight of disciplinary action shapes organisational culture over a longer timeframe than any individual recurrence-prevention measure.