In recent years a trend has been observed whereby manufacturers applying for
an INN increasingly request the establishment of a new INN stem for substances
for which they claim a novel mode of action or a new therapeutic approach. This issue has been
extensively discussed among the INN Expert Group at various consultations and, at the 44th INN
Consultation held in May 2007, it has been decided to provide manufacturers and national nomenclature
authorities with a guidance paper concerning the establishment of new INN stems. The INN stem system is operating according to the WHO Executive Board resolution
EB15.R7 (as amended by the resolution EB115.R4), which requests that "a group
relationship of pharmacologically related substances should, if possible, be
shown in the name by using a common stem." A stem is a syllable (or 2-3
syllables) inserted to the new INN, in most cases as a suffix, to indicate the pharmacological relationship. The INN Programme
publishes every two years a document containing extensive information about the
INN stem system and the complete INN stem lists: "The use of stems in the
Selection of International Nonproprietary Names for Pharmaceutical Substances", which is complemented twice a year, after
each INN Consultation, by an Addendum listing newly selected pre-stems and
former pre-stems promoted to stems.
During the 44th INN Consultation, the INN Expert Group agreed that an
excessive number of new stems would limit considerably the ability of creating new
distinctive INNs, and thus endanger basic aims of any nomenclature system by
diminishing its usefulness to healthcare practitioners. Distinctive INNs contribute to the safety of drug prescription
and dispensation by excluding any confusion that may arise among INNs and with other
well-established drug names, especially T/M names. Moreover, as the World Health Assembly requested Member States in its resolution WHA 46.19 "to discourage the use of trade names derived from or including
established INN stems", an undue proliferation of INN stems would also impact
adversely on the ability to coin future T/Ms.
Therefore, the INN Programme confirms its present policy of using existing
stems whenever possible and of establishing new INN stems only in those cases
where a group of at least several new substances shows a confirmed novel mode of
action.