The narrow definition of unmet medical need used in the General Pharmaceutical Legislation may hinder rather than help efforts to find new treatments.

In the world of medicine development, innovation is closely associated with unmet needs. When we as a pharmaceutical company advance innovative science into development, we take a holistic perspective on the unmet need – for instance, new biology, patient and caregiver preferences, a gap in current treatment options, better safety profile and value to society.

One of the requests from some EU member states in the ongoing revision of the General Pharmaceutical Legislation is to establish clear criteria for unmet medical needs. While it may not seem an unreasonable request, the practical task is nearly impossible: establishing criteria that will give an equal, non-biased consideration for all disease areas. Any arbitrary prioritization between diseases inevitably means that some patients – and likely some therapy areas – will be neglected.

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