Subject: Guidelines on Interaction with Commercial Enterprises

Dr. Denis Aitken

Senior Policy Advisor

Chairman, Committee on Private Sector Collaboration

CH-1211 Geneva 27, Switzerland

December 25, 1999

Dear Dr. Aitken:

This is an e-mail letter from YAKUGAI Ombudsperson Medwatcher Japan to WHO in order to make a comment to WHO's Draft Guidelines on Interaction with Commercial Enterprises, to which WHO are inviting public comments.

YAKUGAI Ombudsperson Medwatcher Japan is a NGO working nationwide in Japan as a pharmaco-vigilance organization monitoring the behavior of pharmaceutical companies and regulatory authorities in order to protect public health from irrational drug use.

We are interested in not only in domestic matters but also in the logistics of international drug use.

As a result, we have established a cooperative partnership with Health Action International as one of the focal points of these activities in Japan.

We are very much interested in the work of the World Health Organization and earnestly desire its guideline to be adequately revised. So we would like to comment on the draft Guidelines on Interaction with Commercial Enterprises, especially on item 3 regarding cash donations.

First of all, we regard any donation from any commercial enterprises whose interests are directly or even tangentially related to any WHO project to be inappropriate.

According to item 3.3 of this draft, judgments about whether funds can or can not be accepted from a company is to be determined by means of judging whether or not the company has a direct commercial interest in the outcome of the particular WHO project to which they are contributing.

However, we feel that even when the company doesn't have a direct commercial interest in the outcome of a particular project, if WHO accepts a donation from the company for that particular project, then the possibility exists that such donations may influence decision making by the staff of WHO concerning other projects in which the contributor company has some direct commercial interest.

In line with this point of view, we, YAKUGAI Ombudsperson Medwatcher Japan, established our rules so as to prohibit the acceptance of any kind of donation from pharmaceutical companies.

Therefore, it is our firm belief that any attempt to consider the circumstances or occasions under which a donation could be accepted from entities such as pharmaceutical companies should not be considered or entertained in this guideline, and that any kind of donation from any commercial enterprise whose activities have some commercial bearing or relevance to the work of WHO should be prohibited.

If the need for such donation becomes necessary and inevitable because the WHO is facing financial difficulties, then WHO should attempt to obtain such funds from some independent organization that has some form of external monitoring system. We believe that such an organization might be able to redistribute funds contributed by pharmaceutical companies, thus avoiding the formation of close ties between industries and the WHO.

We hope that you formulate these guideline based on policy ideals of the highest standards, and that as a result of this independence, the WHO will come to be respected and relied upon by the public.

YAKUGAI Ombudsperson Medwatcher Japan

Address: 3F Ito Bldg. 1-2 Yotsuya, Shinjuku-ku, Tokyo 160-0004 Japan

Fax: Fax:+81-3-5363-7080

E-mail: yakugai@t3.rim.or.jp