In the rapidly-moving world of today, a drug regulator must be at the forefront of change. Similarly, drug regulatory authorities must know how to deal appropriately with these changes, and an important instrument to accomplish this is a mission statement. This statement is a concise, challenging and inspiring declaration of what the authority wants to achieve and what it essentially stands for. It is the authority's "raison d'être".
For Walt Disney, this mission was simply "to make people happy". Drug regulatory authorities usually state their mission as "to protect public health". But is this sufficient? There are many examples to show that this may not be enough. In industrialized societies, HIV-infected patients are pressing governments to permit anti-HIV medicines to be allowed on the market, even though the side-effects and efficacy are as yet unknown. These patients want to decide for themselves which therapy to use and in their opinion it is not important to wait before a risk-benefit ratio is pronounced in favour of this therapy.
Equally, the antibiotic, chloramphenicol, is no longer used in developed countries because of possible myelotoxic effects, but in those countries with a high incidence of typhoid fever, it is a life-saving medicine. These examples illustrate the need to reconsider whether the protection of public health is our only goal. In general, a mission combines two elements: vision and beliefs. A vision is dynamic - it reflects what we want to achieve. Beliefs represent values and behaviour.
Some drug regulatory authorities have already stated their mission. But it would be particularly useful to have one mission statement which can be used by all drug regulatory authorities everywhere. Once this mission is made known, it directs the way the authority will react to the changes taking place and will determine to a large extent the structure and policy of the authority.
The objective of the present session is therefore to reach a consensus on a mission statement which will be useful for all drug regulatory authorities and to explore the consequences of this mission with regard to (1) independence, financing, and staffing; (2) implementation of regulation; and (3) control of drug information.
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