E-DRUG: Resolution Internet Promotion

E-DRUG: Resolution Internet Promotion (cont)
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Dear e-druggers,

The WHA-resolution (number 50.4) on 'Cross-border advertising,
promotion and sale of medical products through the Internet' from
May, 12, 1997, can be found at:

http://who_hq_policy.who.ch/cgi-bin/folioisa.dll/wha50/
query=3D[jump!3A!27resolutions!27]/doc/{@31256}

The WHO will organize a conference on this subject of Internet
advertising in September this year.

Here's the full text of the resolution:

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FIFTIETH WORLD HEALTH ASSEMBLY WHA50.4

Agenda item 1912 May 1997

                 Cross-border advertising, promotion and sale
                   of medical products through the Internet

   The Fiftieth World Health Assembly,

   Aware of the increasing use of electronic communication means
by the general public for shopping and gathering information;

   Aware of the fact that the efficacy, safety and quality of
medical products require careful assessment, and that in many
Member States such products require authorization prior to
marketing, and are available only on medical prescription;

   Aware that the proper and safe use of medical products may
require review of the medical history, medical examination,
diagnosis of the condition and subsequent counselling and
follow-up by the health care professional;

   Recognizing that regulations and regulatory control vary among
countries regarding prescription/non- prescription
(over-the-counter) status of medical products, resulting in
national differences in their availability;

   Aware that advertising, promotion and legal sale of medical
products in one country may be violative in other countries;

   Recognizing that in some situations provision of medical
products by an authorized health professional on the basis of an
electronically communicated request may contribute to more
rational and better health care, and to the easier availability
of necessary medical products and information about them;

   Recognizing that such mail order service may in some countries
include prescription-only products, and that in such situations
national law may specify additional requirements to authorize the
order;

   Noting the continued need for vigilance in the maintenance of
legal and ethical standards in the advertising, promotion and
sale of medical products;

   Concerned, however, that uncontrolled advertising, promotion
and sales of medical products by electronic communication may
present a hazard for public health as well as a risk for the
individual patient, particularly with regard to misleading or
fraudulent product information and lack of individual
counselling;

   Particularly concerned that advertising, promotion and sales
through the Internet may lead to uncontrolled across-the-border
trade of medical products or fraudulent imitations that may be
unevaluated, unapproved, unsafe or ineffective, or used
inappropriately,

1.URGES all Member States to collaborate with WHO in order to
facilitate collection of information on the Internet regarding
the points listed above;

2.REQUESTS the Director-General:

   (1)to collect information on the various aspects and
consequences of advertising, promotion, and sale of medical
products through the Internet;

   (2)to collaborate with the drug regulatory authorities and
national and international enforcement agencies, consumer groups,
professional associations, the pharmaceutical industry and other
relevant parties, to collect all necessary information on the
subject;

   (3)to convene a WHO ad hoc working group consisting of
representatives of the parties mentioned above, and, in addition,
experts in ethics, legal matters, marketing and communication,
and other experts as required, to consider and review the above
and related issues in the advertising, promotion and sale of
medical products through the Internet, and to formulate
recommendations for action to the Director- General;

   (4)to report on progress to the Executive Board at its 101st
session in January 1998, and to the Fifty- first World Health
Assembly in May 1998;

   (5)to mobilize extrabudgetary resources for this activity.

   Eighth plenary meeting, 12 May 1997

   A50/VR/8 =

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The European Commission directives forbid direct-to-the-public
sale of prescription medicines (92/28/EEC and 92/26/EEC). The
problem with Internet advertising however is it cross-border
character and difficulties in tracing owners of home-pages, hence
in this case drug-providers. In the European Union the agenda of
the pharmaceutical committee already has an item on Internet
advertising: It is considered that Internet Providers should be
made responsible for the information they provide. Strict
surveillance of distribution channels of medicines
is seen as the best way to tackle this problem. =

Can anyone comment this? I'm also interested in case-material
(Internet-addresses where medicines can be ordered).

Regards,

Mark Raijmakers

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