9th Workshop, Paris: “Significant Benefit of Orphan Drugs:Impact on Clinical Development and Assessment”
Further to the revision of the EMEA Recommendation on significant benefit and the increasing discussions on added-value of orphan drugs at European level, this meeting provided a good forum to discuss how significant benefit can be linked to the post-marketing assessment of Orphan Medicinal Products in the Member States.
Among the meeting outcomes, we can highlight the consensus on the need to communicate to the public on significant benefit. Greater transparency on the benefit provided by each new orphan drug authorised in Europe will certainly have an impact on the use of orphan drugs by physicians and patients, and, in general, on the recognition of the value of these products by national authorities and society at large.
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