Appendix H: Declarations of interests and confidentiality by FAO/WHO experts

DECLARATION OF INTERESTS FOR FAO EXPERTS

Title of meeting or work to be performed, including description of subject-matter, substance (compounds and organisms), technology or process to be considered:

Public health considerations and protection of the environment are of primary importance in all FAO technical work. Measures need to be taken to ensure that the best possible assessment of scientific evidence is achieved in an independent atmosphere free of either direct or indirect pressures. Thus, to assure the technical integrity and impartiality of FAO’s work, it is necessary to avoid situations in which financial or other interests might affect the outcome of that work.

Each expert is therefore asked to declare any interests that could constitute a real, potential or apparent conflict of interest, with respect to his/her involvement in the meeting or work, between (1) commercial entities and the participant personally, and (2) commercial entities and the administrative unit with which the participant has an employment relationship. "Commercial entity" refers to any company, association (e.g., trade association), organization or any other entity of any nature whatsoever, with commercial interests.

What is a conflict of interest?

Conflict of interest means that the expert or his/her partner ("partner" includes a spouse or other person with whom s/he has a similar close personal relationship), or the administrative unit with which the expert has an employment relationship, has a financial or other interest that could unduly influence the expert’s position with respect to the subject-matter being considered. An apparent conflict of interest exists when an interest would not necessarily influence the expert but could result in the expert’s objectivity being questioned by others. A potential conflict of interest exists with an interest which any reasonable person could be uncertain whether or not should be reported.

Different types of financial or other interests, whether personal or with the administrative unit with which the expert has an employment relationship, can be envisaged and the following list, which is not exhaustive, is provided for your guidance. For example, the following types of situations should be declared:

1. a current proprietary interest in a substance, technology or process (e.g. ownership of a patent), to be considered in - or otherwise related to the subject matter of - the meeting or work;

2. a current financial interest, e.g. shares or bonds, in a commercial entity with an interest in the subject-matter of the meeting or work (except share holdings through general mutual funds or similar arrangements where the expert has no control over the selection of shares);

3. an employment, consultancy, directorship, or other position during the past 4 years, whether or not paid, in any commercial entity which has an interest in the subject-matter of the meeting/work, or an ongoing negotiation concerning prospective employment or other association with such commercial entity;

4. performance of any paid work or research during the past 4 years commissioned by a commercial entity with interests in the subject-matter of the meetings or work;

5. payment or other support covering a period within the past 4 years, or an expectation of support for the future, from a commercial entity with an interest in the subject-matter of the meetings or work, even if it does not convey any benefit to the expert personally but which benefits his/her position or administrative unit, e.g. a grant or fellowship or other payment, e.g. for the purpose of financing a post or consultancy.

With respect to the above, an interest in a competing substance, technology or process, or an interest in or association with, work for or support by a commercial entity having a direct competitive interest must similarly be disclosed.

How to complete this Declaration

Please complete this Declaration and submit it to the FAO Secretariat. Any financial or other interests that could constitute a real, potential or apparent conflict of interest should be declared (1) with respect to yourself or partner, as well as (2) with respect to the administrative unit with which you have an employment relationship. Only the name of the commercial entity and the nature of the interest is required to be disclosed, no amounts need to be specified (though they may be, if you consider this information to be relevant to assessing the interest). With respect to items 1 and 2 in the list above, the interest should only be declared if it is current. With respect to items 3, 4 and 5, any interest during the past 4 years should be declared. If the interest is no longer current, please state the year when it ceased. With respect to item 5, the interest ceases when a financed post or fellowship is no longer occupied, or when support for an activity ceases.

Assessment and outcome

The information submitted by you will be used to assess whether the declared interests constitute an appreciable real, potential or apparent conflict of interest. Such conflict of interest will, depending on the situation, result in (i) you being asked not to take part in the portion of the discussion or work affecting that interest, (ii) being asked not to take part in the meeting or work altogether, or (iii) if deemed by FAO to be appropriate to the particular circumstances, and with your agreement, you taking part in the meeting or work and your interest being publicly disclosed.

Information disclosed on this Form may be made available to persons outside of FAO only when the objectivity of the meeting or work has been questioned such that the Director-General considers disclosure to be in the best interests of the Organization, and then only after consultation with you.

Declaration

Have you or your partner any financial or other interest in the subject-matter of the meeting or work in which you will be involved, which may be considered as constituting a real, potential or apparent conflict of interest?

If yes, please give details in the box below.

Is there anything else that could affect your objectivity or independence in the meeting or work, or the perception by others of your objectivity and independence?

______________________________________________________
______________________________________________________

I hereby declare that the disclosed information is correct and that no other situation of real, potential or apparent conflict of interest is known to me. I undertake to inform FAO of any change in these circumstances, including if an issue arises during the course of the meeting or work itself.

______________________________________________________

DECLARATION OF INTERESTS FOR WHO EXPERTS

Title of meeting or work to be performed, including description of subject-matter, substance (compounds and organisms), technology or process to be considered:

Public health considerations have a primary importance in all WHO technical work. Measures need to be taken to ensure that the best possible assessment of scientific evidence is achieved in an independent atmosphere free of either direct or indirect pressures. Thus, to assure the technical integrity and impartiality of WHO’s work, it is necessary to avoid situations in which financial or other interests might affect the outcome of that work.

Each expert is therefore asked to declare any interests that could constitute a real, potential or apparent conflict of interest, with respect to his/her involvement in the meeting or work, between (1) commercial entities and the participant personally, and (2) commercial entities and the administrative unit with which the participant has an employment relationship. "Commercial entity" refers to any company, association (e.g., trade association), organization or any other entity of any nature whatsoever, with commercial interests.

In addition, as a result of WHO’s strong stance against tobacco use, it is considered relevant for the Organization to know whether experts working with it have, or have had, any relationship with any part of what may be called "the tobacco industry". Nevertheless, declaration of such an interest would not necessarily be considered a reason to disqualify an expert.

What is a conflict of interest?

Conflict of interest means that the expert or his/her partner ("partner" includes a spouse or other person with whom s/he has a similar close personal relationship), or the administrative unit with which the expert has an employment relationship, has a financial or other interest that could unduly influence the expert’s position with respect to the subject-matter being considered. An apparent conflict of interest exists when an interest would not necessarily influence the expert but could result in the expert’s objectivity being questioned by others. A potential conflict of interest exists with an interest which any reasonable person could be uncertain whether or not should be reported.

Different types of financial or other interests, whether personal or with the administrative unit with which the expert has an employment relationship, can be envisaged and the following list, which is not exhaustive, is provided for your guidance. For example, the following types of situations should be declared:

1. a current proprietary interest in a substance, technology or process (e.g. ownership of a patent), to be considered in - or otherwise related to the subject matter of - the meeting or work;

2. a current financial interest, e.g. shares or bonds, in a commercial entity with an interest in the subject-matter of the meeting or work (except share holdings through general mutual funds or similar arrangements where the expert has no control over the selection of shares);

3. an employment, consultancy, directorship, or other position during the past 4 years, whether or not paid, in any commercial entity which has an interest in the subject-matter of the meeting/work, or an ongoing negotiation concerning prospective employment or other association with such commercial entity;

4. performance of any paid work or research during the past 4 years commissioned by a commercial entity with interests in the subject-matter of the meetings or work;

5. payment or other support covering a period within the past 4 years, or an expectation of support for the future, from a commercial entity with an interest in the subject-matter of the meetings or work, even if it does not convey any benefit to the expert personally but which benefits his/her position or administrative unit, e.g. a grant or fellowship or other payment, e.g. for the purpose of financing a post or consultancy.

With respect to the above, an interest in a competing substance, technology or process, or an interest in or association with, work for or support by a commercial entity having a direct competitive interest must similarly be disclosed.

How to complete this Declaration

Please complete this Declaration and submit it to the Secretariat. Any financial or other interests that could constitute a real, potential or apparent conflict of interest should be declared (1) with respect to yourself or partner, as well as (2) with respect to the administrative unit with which you have an employment relationship. Only the name of the commercial entity and the nature of the interest is required to be disclosed, no amounts need to be specified (though they may be, if you consider this information to be relevant to assessing the interest). With respect to items 1 and 2 in the list above, the interest should only be declared if it is current. With respect to items 3, 4 and 5, any interest during the past 4 years should be declared. If the interest is no longer current, please state the year when it ceased. With respect to item 5, the interest ceases when a financed post or fellowship is no longer occupied, or when support for an activity ceases.

Assessment and outcome

The information submitted by you will be used to assess whether the declared interests constitute an appreciable real, potential or apparent conflict of interest. Such conflict of interest will, depending on the situation, result in (i) you being asked not to take part in the portion of the discussion or work affecting that interest, (ii) being asked not to take part in the meeting or work altogether, or (iii) if deemed by WHO to be appropriate to the particular circumstances, and with your agreement, you taking part in the meeting or work and your interest being publicly disclosed.

Information disclosed on this Form may be made available to persons outside of WHO only when the objectivity of the meeting or work has been questioned such that the Director-General considers disclosure to be in the best interests of the Organization, and then only after consultation with you.

Declaration: Have you or your partner any financial or other interest in the subject-matter of the meeting or work in which you will be involved, which may be considered as constituting a real, potential or apparent conflict of interest?

If yes, please give details in the box below.

Do you have, or have you had during the past 4 years, an employment or other professional relationship with any entity directly involved in the production, manufacture, distribution or sale of tobacco or any tobacco products, or directly representing the interests of any such entity?

If yes, please give details in the box below.

Is there anything else that could affect your objectivity or independence in the meeting or work, or the perception by others of your objectivity and independence?

I hereby declare that the disclosed information is correct and that no other situation of real, potential or apparent conflict of interest is known to me. I undertake to inform you of any change in these circumstances, including if an issue arises during the course of the meeting or work itself.
_______________________________________________
_______________________________________________

FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS

WORLD HEALTH ORGANIZATION

CONFIDENTALITY UNDERTAKING

1) The Food and Agriculture Organization of the United Nations ("FAO"), acting through its Plant Production and Protection Division, and the World Health Organization ("WHO"), acting through its Department of Communicable Disease Control, Prevention and Eradication, have access to certain information relating to pesticides, including but not limited to pesticide specifications, which information FAO and WHO consider to be proprietary to themselves or to parties collaborating with them, including but not limited to the manufacturers of such pesticides (hereinafter referred to as "the Information").

2) The Undersigned, as a [participant in] [temporary adviser to] the FAO/WHO Joint Meeting on Pesticide Specifications ("JMPS"), may have access to the Information in the course of his/her participation in and/or contributions to the meetings of the JMPS.

3) FAO and WHO are willing to provide, or to arrange for the provision of, the Information to the Undersigned for the sole purpose of performing his/her responsibilities in connection with the activities of the JMPS, provided that the Undersigned undertakes to treat the Information as confidential and to disclose it only to persons who have a need to know in connection with the activities of the JMPS and are bound by like obligations of confidentiality and non-use as are contained in this Undertaking.

4) The Undersigned undertakes to regard the Information as confidential and proprietary to FAO and/or WHO, and/or to parties collaborating with FAO and/or WHO (including but not limited to pesticide manufacturers) and agrees to take all reasonable measures to ensure that the Information is not used, disclosed or copied, in whole or in part, other than as provided in this Undertaking, except that the Undersigned shall not be bound by any such obligations if he/she is clearly able to demonstrate that the Information:

a) was known to him/her prior to any disclosure by or on behalf of FAO and/or WHO to the Undersigned; or

b) was in the public domain at the time of disclosure by or on behalf of FAO and/or WHO to the Undersigned; or

c) becomes part of the public domain through no fault of the Undersigned; or

d) becomes available to the Undersigned from a third party not in breach of any legal obligations of confidentiality.

5) The Undersigned also undertakes not to communicate the deliberations and decisions of the meetings of the JMPS to persons outside these meetings except as agreed by FAO and WHO.

6) The obligations of the Undersigned shall survive the termination of his/her responsibilities in connection with the JMPS.

7) The Undersigned agrees to return any and all copies of any Information to FAO and/or WHO (dependent on by whom or on whose behalf the Information was provided to the Undersigned), promptly following the completion of the review thereof by the JMPS.

8) Nothing in this Undertaking, or in any document relating thereto, shall be construed as constituting a waiver of privileges and immunities of FAO and/or WHO..[Note: temporary advisers/experts on mission enjoy certain privileges and immunities.]

9) Any dispute relating to the interpretation or application of this Undertaking shall, unless amicably settled, be subject to conciliation in accordance with the Conciliation Rules of the United Nations Commission on International Trade Law (UNICITRAL) as at present in force. In the event of failure of the latter, the dispute shall be settled by arbitration. The arbitration shall be conducted in accordance with the Arbitration Rules of UNCITRAL, as at present in force. The parties shall accept the arbitral award as final adjudication of any such dispute.

LETTER OF ACCESS TO CONFIDENTIAL DATA

[Addressed to the evaluator and the registration authority]

Within the process of the development of FAO/WHO pesticide specifications, it is necessary to assess whether or not the confidential data on manufacturing process, purity and impurities, provided in support of the technical material for which an FAO/WHO specification is proposed, are similar to those assessed by a competent authority for the purposes of registering the pesticide.

The purpose of this letter of access, provided by ...... [company name and address] in support of the development of pesticide specifications for ...... [name of active ingredient], is to provide the evaluator, ...... [name of evaluator], appointed by ...... [WHO or FAO or both] and the registration authority with the following:

[The company should choose one of the following two options. The option which is most appropriate for the circumstances of the evaluator should be preferred. The option which is not used should be deleted. If the pesticide is registered for both agricultural and public health use, by separate authorities (whether in one country or two), the company should identify both authorities.]

i) Authorisation to access the registration data submitted by ...... [company name] for ...... [name of active ingredient] held by ...... [name of registration authority], in its function as the national registration authority for pesticides in ...... [name of country].; OR

ii) Authorisation to send the data provided by ...... [company name] for [active ingredient] to ...... [contact name and full address of registration authority] for their assessment of the similarity and subsequent communication with the evaluator, ...... [name of evaluator].

This authorization relates only to the above mentioned substance manufactured by ...... [name of the Company] for the intended purpose as described above.

...... [signed by company representative]