EMA consults on reformed medicine named controls
Companies could choose another name for an existing pharmaceutical if they failed to obtain trademark rights for their chosen branding
The European Medicines Agency (EMA) has released revised guidance for pharma companies on choosing invented names for their products.
The new guidance stresses that while European Union (EU) laws aim to ensure that each medicine has a unique name, it outlines how companies might pick another name for an existing pharmaceutical if they failed to obtain trademark rights for their chosen branding.
The guidance explains: ‘Where the proposed trademark has been cancelled, opposed or objected to under trademark law in a [EU] member state, the [European] Commission may accept the existence of more than one name for a single product, in order not to disadvantage patients and their access to the concerned medicinal product’.
To do this a pharma company has to provide the Commission with evidence of its failed efforts to obtain a trademark.
The guidance stresses that using an invented name is not mandatory under EU law, but where pharmaceutical firms do, the branding cannot cause ‘confusion with the common name [of a medicine], or a common name or scientific name accompanied by a trademark or the name of the marketing authorisation holder’.
Another EU law defines common names as being ‘the international non-proprietary name (INN) recommended by the World Health Organisation, or…the usual common name’.