=
The World Health Organization's Division on Drug Management and =
Policies (WHO/DMP) should like to take this opportunity to comment o=
n =
the suggested "Draft Substantive Guidelines for Administrative Domai=
n =
Name Challenge Panels" and would be grateful if the Policy Oversight=
=
Committee could explore the possibility of expanding these guideline=
s =
to International Nonproprietary Names (INN).
=
=
The World Health Organization (WHO) has the constitutional mandat=
e =
to "develop, establish and promote international standards with resp=
ect =
to biological, pharmaceutical and similar products". Pursuant to WH=
A =
resolution 3.11 on Nonproprietary Names for Pharmaceutical Substance=
s =
(adopted in May 1950 by the Third World Health Assembly), the =
Organization collaborates closely with national nomenclature committ=
ees =
to select a single, nonproprietary name of worldwide acceptability f=
or =
each active substance used in pharmaceutical preparations. In this =
regard, WHO has been made responsible for selecting and promoting th=
e =
protection of International Nonproprietary Names (INN) for =
Pharmaceutical Substances, in co-ordination with national authoritie=
s =
worldwide.
=
=
The underlying reason for ensuring that no party can claim any =
proprietary rights in INN is to protect the safety of patients by =
allowing them to identify a specific pharmaceutical substance under =
one single, globally available name. After their selection, INN are=
=
adopted by the national authorities of WHO Member States, which mean=
s =
that such INN may not, in principle, be registered as trade-marks. =
INN are published in the following official languages: English, =
French, Latin, Russian and Spanish.
=
=
For the Committee's information, WHO/DMP should like to refer to =
the =
following documents which are available via WHO homepage =
(http://www.who.ch): =
=
- Resolutions on Nonproprietary Names for Pharmaceutical =
=
Substances, adopted by the World Health Assembly and the =
=
Executive Board respectively:
- WHA3.11
- EB7.R79
- WHA46.19
=
=
- Procedure for the Selection of Recommended International =
=
Nonproprietary Names for Pharmaceutical Substances =
(http://www.who.ch/programmes/dmp/innmain.htm)
=
A hardcopy of these documents and two further documents referred =
to below will be sent to the Committee by mail, together with a =
printout of this letter:
=
=
- List 77 of proposed INN published in WHO Drug Information=
, =
Vol.11, No.2, 1997, and a copy of a Note Verbale (Ref. =
=
CL.16.1997) from the Director-General of WHO to relevant =
=
national authorities of WHO Member States and other =
=
interested bodies, as an example of the procedure followe=
d =
in selecting, proposing and recommending INN
=
- An article on INN published in the Bulletin of the World =
=
Health Organization, 1955, 73 (3): 275-279
=
=
To illustrate the protection of pharmaceutical substances under o=
ne =
single, globally available name, WHO/DMP should furthermore like to =
give the following examples of INN for antibacterial agents and =
tranquillizers, respectively: amoxicillin, ampicillin, flurithromyci=
n, =
temafloxacin, tetracycline (being antibacterial agents) and diazepam=
, =
lorazepam, meprobamate, domperidone, etc. (being tranquillizers).
=
=
Although - as opposed to trade-marks - INNs are in the public =
domain, WHO considers it important that their free availability is =
used exclusively for its intended purpose in the public interest, i.=
e. =
for the identification of a specific pharmaceutical substance. The =
Organization is therefore concerned to learn that - like trade-marks=
- =
INNs have been registered as domain names on INTERNET.
=
=
In view of the above, WHO/DMP considers that such domain names sh=
ould =
also be open to challenge by interested parties, i.e. for example by=
=
manufacturers of drugs, which contain pharmaceutical substances =
bearing an INN.
=
=
Thank you for your consideration of these comments. WHO/DMP =
remains at the Committee's disposal to provide further information =
and/or documentation on this issue, as and when required.
=
=
=
Dr J. Id=E4np=E4=E4n-Heikkil=E4
Director
Division of Drug Management and Policies=
=
World Health Organization