World Intellectual Property Organization

Second WIPO Internet Domain Name Process

The Recognition of Rights and the Use of Names in the Internet Domain Name System

ANNEX III
World Health Assembly Resolutions on Nonproprietary Names for Pharmaceutical Substances

 

WHA3.11 - Non Proprietary Names for Drugs

The Third World Health Assembly,

Recognizing the desirability that a system of non proprietary names be established internationally for such new pharmaceutical products as might be contemplated for later insertion in the Pharmacopoea Internationalis,

1. APPROVES the general principles enumerated by the Expert Committee on the Unification of Pharmacopoeias at its fifth session, and

2. RESOLVES as follows

(1) the Expert Committee on the Unification of Pharmacopoeias should undertake the selection and approval of non proprietary names for drugs which might be described in later editions of the Pharmacopoea Internationalis ;

(2) such names as are from time to time selected and approved by the expert committee should be communicated by the Director-General to national pharmacopoeial authorities, together with a recommendation that these names be officially recognized and approved, and, if the substances are eventually included in the national pharmacopoeia, adopted as pharmacopoeial names ;

(3) such recommendations shall further include a request that such measures asmay be deemed appropriate by Member States be taken with a view to preventing the use of the names selected for unauthorized purposes, and in particular to prevent the granting of exclusive proprietary rights in these names to the manufacturer.

 

WHA46.19 - Nonproprietary Names for Pharmaceutical Substances

The Forty-sixth World Health Assembly,

Recalling resolution WHA31.32 on the importance of using nonproprietary names in establishing national drug formularies;

Noting the fundamental contribution of the WHO programme on international nonproprietary names (INN) to effective communication in medicine, and the challenge inherent in maintaining the nomenclature as new substances are introduced into clinical use;

Acknowledging with satisfaction the increasing contribution of generic products to national drug markets in both developed and developing countries;

Noting the current trend to market products with the same active ingredient as, and intended to be clinically interchangeable with, a product currently on the market (multisource products) under trade-marks or brandnames derived from stems or other descriptors used in international nonproprietary names;

Recognizing that such a practice, particularly in respect of single-ingredient prescription drugs, may compromise the safety of patients by creating confusion in prescribing and dispensing medicines and by interfering with the orderly development of the nomenclature for international nonproprietary names;

Aware of the concern expressed by the Sixth International Conference of Drug Regulatory Authorities (1991) about the increasing use of pharmaceutical brandnames that are very similar to or derived from international nonproprietary names;

Noting the recommendation made by the WHO Expert Committee on the Use of Essential Drugs, in its fifth report, on the need to discourage, as a matter of urgency, the use of trade-marks that are derived from international nonproprietary names,

1. REQUESTS 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 the 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;

2. CALLS ON the Director-General to intensify his consultations with governments and representatives of the pharmaceutical industry on ways of reducing to a minimum the problems arising from drug nomenclatures that may create confusion and jeopardize the safety of patients.

 

[Annex IV follows]

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