Dr Stewart Jessamine, New Zealand

Unexpected events that require major regulatory action include product failure, manufacturing error, media interest and overseas regulatory action. Advance planning for such crises is essential, to ensure that sufficient resources are available. Crisis management is multifactorial, and a team of people, each with designated activities, is needed. Advice should be based on the best evidence available; uncertainties and the limitations of information should be acknowledged if they exist, and risk should be placed in the appropriate context. If possible, advice should be sensible, practicable and implementable by health care professionals and consumers alike. Identify target audiences and deliver key messages that are clear, complete and action-oriented. Regulators should also assess the impact of actions and of the communication strategy.

WHO should finalize and distribute its crisis management plans to its Member States. Moreover, countries should develop crisis management plans and test them periodically. WHO should also provide technical assistance and resources in crisis management, communications and research to member countries to develop crisis management plans. Most crises arise from existing adverse reactions, and the seeds of future crises can often be found in the data provided for the premarketing evaluation. Regulators should therefore be encouraged to develop postmarketing risk management strategies for products identified at the time of initial evaluation as posing a significant risk. WHO (via the Uppsala Monitoring Centre) should help Member States to identify criteria that indicate a product is likely to pose a significant risk.