26 June 2015: promotion of an unlicensed medicine
Published 20 July 2015
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This publication is available at https://www.gov.uk/government/publications/advertising-investigations-june-2015/26-june-2015-promotion-of-an-unlicensed-medicine
A legal firm complained about a planned symposium sponsored by Keryx Biopharmaceuticals, which they anticipated would promote an unlicensed medicine.
MHRA wrote to the company responsible for the symposium, The Med Ed Group, reminding them of the regulations in this area and provided guidance on the content of the symposium and to Keryx. The Med Ed Group provided assurances that Keryx had no involvement in the development of the content (confirmed by Keryx) and agreed to amend the material to ensure it did not promote an unlicensed medicine.
MHRA guidance
The promotion of unlicensed medicines is prohibited. This doesn’t prevent companies from exchanging clinical and other scientific information during the development of a medicine in the scientific programme at conferences and other similar events. Conference organisers and companies considering sponsoring sessions should take care to ensure their decisions are based on scientific considerations and not on attracting or providing funding for favourable coverage of unlicensed uses of medicines.
The advertising restrictions apply to any person who promotes a medicine, not just the manufacturer.