12. Nomenclature

The need to identify each pharmaceutical substance by a unique, globally recognized generic name is of critical importance in facilitating communication as well as in the labelling and advertising of medicinal products in international commerce.

This is the objective of the WHO programme on the selection of international nonproprietary names (INNs), whose activities have led to the publication of names for roughly 6900 new pharmaceutical products since 1950. Its role is to coordinate and harmonize the activities of existing national drug nomenclature commissions, which now follow a common set of conventions for devising generic names. Officially assigned generic names now rarely differ from the INNs, and some countries have disestablished their national commissions and automatically accept all recommended INNs.

The procedure for selecting INNs allows manufacturers to contest names that are either identical or similar to their licensed trade marks. In contrast, trade-mark applications are disallowed, in accordance with the present procedure, only when they are identical to an INN. A case for increased protection of INNs is now apparent as a result of competitive promotion of products no longer protected by patents. Rather than marketing these products under the generic name, many companies apply for a trade mark derived from an INN and, in particular, including the INN common stem. This practice endangers the principle that INNs are public property; it can frustrate the rational selection of further INNs for related substances, and it will ultimately compromise the safety of patients by promoting confusion in drug nomenclature.

On the basis of the Committee’s previous recommendations concerning trade marks derived from INNs, a resolution on nonproprietary names for pharmaceuticals (WHA46.19) was adopted by the World Health Assembly in 1993 (38). The resolution requested Member States:

(1) to enact rules or regulations, as necessary, to ensure that international nonproprietary names (or the equivalent nationally approved generic names) used in the labelling and advertising of pharmaceutical products are always displayed prominently;

(2) to encourage manufacturers to rely on their corporate name and the international nonproprietary names, rather than on trade marks, to promote and market multisource products introduced after expiry of a patent;

(3) to develop policy guidelines on the use and protection of international nonproprietary names, and to discourage the use of names derived from them, and particularly names including established stems, as trade marks.

The resolution called upon the Director-General to intensify his consultations with governments and representatives of the pharmaceutical industry on ways of minimizing the problems arising from drug nomenclatures that may create confusion and jeopardize the safety of patients.

While INNs are widely used in reference books and journals, they are not always identified as such, or even accorded preference, particularly in the case of older substances that may have several different generic names. Editors are urged to give preference to INNs in reference works, journals and data banks and to allow the use of a code for a new substance (pending the assignment of an INN) rather than an unofficial name.