WHO must increasingly see its role as one of harnessing support from among a variety of players to meet its health development agenda.

WHO needs to create sound partnerships with public bodies, civil society and commercial enterprises to make health everybody's business. In developing partnerships with the corporate sector, WHO's position as an impartial holder of health values must be ensured. Scientific validity must not be compromised. The general principles of partnership building should be established on the basis of mutual respect, trust, transparency, and shared benefit.

Partnerships should have specific aims and meet the following basic criteria:

• The partnership should contribute to clear health gains.
• The health gains should be worthy of the effort involved in establishing and maintaining the partnership.
• The partnership should enhance WHO's role and image as the leading international public health organization.

The objective of this document is to guide the relationship between commercial enterprises and WHO and to provide an innovative and positive approach to cooperation and partnership with the commercial sector.

 2. Principles of collaboration

WHO regularly collaborates with the private sector in a variety of ways, including:

• exchange of information during meetings, seminars, workshops and conferences;
• product research and development activities aimed at improving health; and
• generating cash and in-kind donations to WHO.

Commercial enterprises working with WHO would be expected to follow WHO public health policies in areas such as food safety, chemical safety, ethical promotion of medicinal drug products, and tobacco control.

In addition, evaluation criteria might be used which are similar to those already being applied by a range of public agencies in evaluating potential partnerships with the corporate sector. These factors include the occupational health conditions on which products or services are produced, the environmental commitment of the commercial enterprise, marketing and advertising practices, research and development policy and practices, regulatory compliance of the enterprise and past activities which might reflect poorly on the credibility of WHO.

Conflict of interest is of particular concern for WHO's work in developing public health guidance, in setting regulatory standards and in other activities which may affect product costs, market demand, or profitability of specific goods and services. Such activities include norms for quality, safety, efficacy, promotion practices, and information provision for pharmaceuticals; diagnostic and treatment guidelines or advice which may affect the market for individual products and product categories; chemical safety standards; and nutritional guidelines.

To avoid conflict of interest, real or perceived: (i) the concerned WHO Offices and Departments must establish procedures which ensure that the establishment of norms and standards is based on science and evidence and not on commercial interests; and (ii) any interaction with commercial enterprises must be audited and monitored.

The commercial enterprise must be a suitable partner for WHO. The following questions should be asked when developing a policy toward a specific industry:

• Are the major products or services of the industry beneficial to health?
• Does the industry engage on a large scale in practices which are negative to health?
• Does the likely public health benefit outweigh any possible harmful practices, products or services?

Funds are acceptable from commercial enterprises whose activities are unrelated to the work of WHO such as banks, insurance companies, airlines, etc., provided this would not adversely reflect on WHO.

Funds are not acceptable from commercial enterprises whose activities are incompatible with WHO's objectives, (for example, tobacco producers and arms manufacturers).

The acceptability of donations from commercial enterprises whose activities are related to the work of WHO should be determined in accordance with the present guidelines.

Any donations received by WHO and which are subsequently discovered to be outside the terms of these guidelines will be returned to the donor by WHO.

Funds should not be sought or accepted from enterprises which have a direct commercial interest in the outcome of the project toward which they would be contributing, unless approved pursuant to section 3.4 below on clinical trials or otherwise part of product development agreements as outlined in section 4.

Considerable caution should be exercised in accepting funding from enterprises that have an indirect interest in the outcome of the project (i.e. the activity is related to the enterprise's field of interest, without there being a conflict as referred to above). In such event, other commercial enterprises having a similar indirect interest should be invited to contribute. In addition, it is preferable that funds from other sources are secured. The larger the proportion of the donation from any one source, the more scrutiny should be applied in avoiding the possibility of a perceived conflict of interest.

The question of whether it is acceptable to receive cash contributions from a company for a trial arranged by WHO on that company's proprietary product, without there being an agreement as referred to in point 4.1 below, is addressed on a case-by-case basis and should always be referred to the Committee on Private Sector Collaboration, via the Legal Office (LEG). In this connection, the following should be ensured:

1. it is in the interest of public health that the research or development activity be undertaken; and

 

2. the research is being performed at WHO's initiative and, if WHO were not involved,

• It would not be performed, or
• It would not be performed in conformity with internationally accepted technical and ethical considerations.

If the above-mentioned requirements are met, it is acceptable to receive a financial contribution from the company having a direct commercial interest in the trial in question.

Subject to the provisions of these Guidelines, commercial enterprises can make unearmarked donations to WHO. The receipt of such general support is encouraged, provided that:

I the donation is not to be used to fund activities which are related to the commercial interests of the donor; and

II. the amount of the overall funds to be raised is not expected to be so large that the programme would become substantially dependent on such support from a single company, or group of enterprises, for its continued operations. The dependency of the work of the Office or Department on the support will be evaluated at regular intervals.

For WHO meetings, contributions from commercial enterprises should not be accepted to support the participation of specified invitees (including such invitees' travel and accommodation), regardless of whether such contributions would be provided directly to the participants or be channelled through WHO. Contributions should rather be accepted to support the cost of a meeting in general, which includes the overall cost of the participants and subject to provisions relating to avoidance of conflict of interest.

For the purpose of these Guidelines, an outside meeting is a meeting held by another party than WHO and does not include a WHO co-sponsored meeting. No recommendations or other consensus emanating from an outside meeting can be considered as WHO recommendations or a position statement.

The question of whether it is acceptable to receive funds from commercial enterprises or trade associations to support travel of WHO staff to attend outside meetings or conferences falls into two categories:

• Meetings held by the company or trade association paying for travel: Travel support funds can be received if the company or trade association is also supporting the travel and other expenses of other participants at the meeting.
• Meetings held by a third party (i.e. a party other than the company or trade association proposing to pay for the travel): Travel support funds cannot be received.

In the particular case where a WHO activity is intended to produce guidelines or recommendations which are likely to be associated with WHO as WHO guidelines or recommendations, funds should not be accepted from commercial enterprises which have a direct commercial interest in the subject matter of the guidelines. With regard to commercial enterprises which do not have such a direct interest, funding must be secured from at least two sources and pooled. This is intended to try to minimize the risk that WHO guidelines or recommendations are identified with a particular company.

Except in the case of secondments under section 5 below, it is not acceptable to receive funds designated to support the salary of specific staff or posts (including short-term consultants) from commercial enterprises or other commercial sources where contributions could give rise to a real or perceived conflict of interest in relation to WHO. On the other hand, it may be permissible to receive funds for a project which has a staffing element. The acceptability of such contributions to projects should be reviewed in the light of other relevant guidance mentioned in this document.

Subject to paragraphs 3.1 and 3.3 above, funds may be accepted from commercial enterprises for meeting the cost of WHO publications. Such contributions will be acknowledged in accordance with paragraph 3.10 below. In no event should commercial advertisements be placed in WHO publications.

For reasons of transparency, contributions from commercial enterprises must be publicly acknowledged. The basic and most common approach to acknowledging contributions from commercial enterprises is to insert an acknowledgement in documentation relating to the activity concerned, including in any publication by WHO of the results of this activity. Acknowledgements should normally be worded along the following lines:

Contributors should not use the results of WHO's work for commercial purposes or seek promotion from the fact that they have made a donation. However, contributors are entitled to make reference to donations in their internal official documents, such as corporate annual reports. In order to ensure compliance with the above, fundraising letters to, and letters of acceptance of donations from, commercial enterprises should always be drafted in consultation with LEG.

Anonymous donations from the corporate sector may not be accepted under any circumstances.

4.1 WHO collaborates with commercial enterprises in the development of new health-related technology, i.e. either by conducting research and development work on their products, or by licensing certain intellectual property belonging to WHO to such enterprises. Collaborative research and development work should, as a general rule, only be undertaken if WHO and the company have concluded an agreement which ensures that the final product will ultimately be made widely available, including to the public sector and/or to developing countries at a preferential price. If such an agreement is concluded, it is acceptable to receive funds from the commercial enterprise for a trial arranged by WHO on the product in question. The reason for this is that the contractual commitments obtained from the company in the public interest outweigh any potential conflict of interest in accepting the financial contribution. These contributions should be distinguished from the acceptance of contributions for a trial arranged by WHO on a proprietary product, without there being an agreement as referred to above. The acceptability of these latter types of contribution is addressed in point 3.4 above.

Collaborative research and development agreements as referred to in this paragraph 4.1 should always be drafted and negotiated in consultation with LEG.

4.2 If WHO has developed official specifications for a product (e.g. cold chain refrigerators), it is acceptable to provide technical advisory assistance to manufacturers to develop their product in accordance with these specifications provided that all enterprises known to have an interest in such a product have been invited to collaborate with WHO in the same way.

5.1 Secondments from commercial enterprises to WHO are acceptable under the following conditions:

• There is no conflict of interest between the person's proposed activities for WHO and his/her activities for the company. Particular care should be taken in this regard when it is proposed to second persons from pharmaceutical and other health-related enterprises. Such secondment should therefore only be considered in consultation with LEG and may need to be referred to the Committee on Private Sector Collaboration.
• The person being proposed for secondment should have the skills, experience and language abilities to carry out the proposed tasks. The aforesaid skills and experience provided by the secondment should be for time-limited needs.
• The terms of reference of the seconded person should be designed to ensure that this person will not, during the secondment, participate in activities in which the employer company is involved or which could promote the interests of this company. The seconded person should furthermore be subject to clear obligations of confidentiality (both during and subsequent to the secondment) and undertake not to seek or accept any instructions from, and not to report to, any authority or entity external to WHO, including specifically the company.
• Generally, the seconded person will be subject to the same rules of the Organization as other staff members and will report only to WHO.
• The secondment should be time-limited for a period to be agreed in advance by mutual agreement.

5.2 Secondment agreements with commercial enterprises have to be negotiated in consultation with LEG and PER. The employment contract with the seconded person should be cleared with LEG to ensure that it includes all the above-mentioned safeguards and accurately reflects the terms of WHO's agreement with the company.

In cases where an official WHO evaluation scheme is in place, i.e. to evaluate certain products, processes or services against official WHO guidelines, WHO may charge enterprises for the evaluation of their products on a non-profit basis. For example, pesticide manufacturers pay for having their product tested in the WHO Pesticide Evaluation Scheme (WHOPES). N.B: The purpose of official WHO evaluation schemes is always to provide advice to governments and/or organizations, such as UNICEF for procurement. Evaluation does not constitute endorsement by WHO of the product(s) in question.

7.1 The acceptability of donations in kind is covered by paragraphs VI.3.10-110 in the WHO Manual. In summary, these paragraphs provide that such contributions may be accepted "if they can be utilized and if any condition attached to them is consistent with the objectives and policies of the Organization". However, pursuant to WHO Manual VI.3.30, LEG should be consulted in the case of contributions in kind from commercial enterprises.

7.2 In determining the acceptability of large-scale donations of pharmaceuticals, the following criteria should be met:

There should be sound evidence of the safety and efficacy of any drug in the indication for which it is being donated. The drug should be officially recommended by WHO for use in this indication and be approved in the recipient country for use in the indication for which it is being donated. It should preferably be on the WHO model list of essential drugs for that indication.

• Objective and justifiable criteria for the selection of recipient countries, communities or patients should be developed.
• A supply system should be in place and consideration should be given to means of preventing waste, theft and leakage into the private sector.
• A training and supervision programme should be in place for all personnel involved in the efficient administration of supply, storage and distribution at every point from the donor to the end-user.
• A drug donation should not be promotional character, whether of the company itself, or of a demand for the drug which is not sustainable after the donation has ended.
• A phase-out plan of the donation should be agreed with the recipient countries.
• A system for monitoring adverse events should be in place.
• Programmes should consult LEG with a view to negotiating and drafting an appropriate agreement with the donor. Programmes should consult the Department of Financial Services (FNS) with a view to determining the value at which the donation will be recorded in WHO's financial records.

7.3Arrangements involving the provision of expertise for a WHO project or activity by a commercial enterprise should always be referred to the Committee on Private Sector Collaboration via LEG, at an early stage of development.

 8. Meetings (see also section 3 for funding of meetings)

Exhibitions by commercial enterprises are permissible at WHO co-sponsored meetings. The exhibition should be held in a room other than the meeting room. In this latter respect, it should be noted that WHO does not co-sponsor commercial exhibits, either as part of co-sponsored meetings or as events on their own. If WHO involvement in an exhibition is considered important (e.g., to permit a certain audience to become acquainted with products and/or services), this should (subject to clearance by LEG) be achieved in another way than through co-sponsorship and use of the WHO name in relation to the event

There should be no commercial exhibits at WHO meetings (i.e., regardless of whether this is a meeting of WHO's governing bodies or a WHO technical meeting and regardless of whether the meeting is held on WHO premises or elsewhere). The reason for this is that such exhibits would change the dynamics of the meetings and could give rise to a conflict of interest.

It is acceptable to co-sponsor or jointly organize a meeting with trade associations if a conflict of interest is not created.

It is not acceptable to co-sponsor, or to jointly organize, a meeting with specific commercial enterprises. However, this does not preclude WHO co-sponsorship of a meeting where the scientific initiators have hired a commercial conference organizer to deal with the purely logistical aspects of the meeting, and this conference organizer has no input in the scientific content of the meeting.

No commercial company shall be authorized to use the WHO name or logo for the marketing of its products.

WHO receptions and similar functions cannot be paid for by commercial enterprises or trade associations.

WHO must maintain full control over the activity to which a cash, human and/or material contribution relates, including over the contents of any report of the activity and over whether or not this report is published or disseminated in any form (e.g. electronically), and if so when.

The application and impact of these Guidelines will be periodically reviewed. Such review will include input from Member States, the WHO departments and projects most involved in interactions with commercial enterprises, bodies collaborating with WHO, commercial enterprises with which WHO collaborates and public interest organizations.

Contact between a commercial enterprise and WHO may be initiated by either party. At first contact with a commercial enterprise, the Office, Cluster or Department should review the above Guidelines and decide whether or not the proposed arrangement is acceptable. The public health goal underlying the collaboration should be clearly stated If it is not clear whether the arrangement is acceptable, the issue should be referred to LEG in a form similar to that of a Cabinet Paper. The Regional Director or Executive Director will be responsible for these decisions.

LEG will review the proposal and if, in LEG's opinion, there is no conflict of interest, the proposed arrangement will be cleared for action.

If, in the opinion of LEG, there could be a conflict of interest, LEG will, in consultation with the Office or Cluster, submit the proposed arrangement to the Committee on Private Sector Collaboration.

In the case of apparently unacceptable proposals, the Office, Cluster or Department concerned is invited to work with LEG to develop a mutually acceptable arrangement.

The Committee on Private Sector Collaboration will meet once a month to review any proposals. In the case of urgent proposals, the document will be copied to the members of the Committee for a rapid decision, or in exceptional cases, an ad hoc meeting will be convened. If this is not possible, the Chair of the Committee may take an executive decision, consistent with prior Committee jurisprudence. If it is felt desirable, the Office, Cluster or Department may present additional information on its case at the meeting of the Committee on Private Sector Collaboration.

The Committee on Private Sector Collaboration will record its decisions and the reasons for such decisions. In the event that a consensus is not achieved, the different points taken will be recorded. All decisions of the Committee will be submitted for endorsement by the Director-General. If appropriate, this document will be updated (i.e. in cases of a change in policy or in unprecedented cases).

A routine application with a referral to the Committee on Private Sector Collaboration and a decision will normally take four weeks.

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(1) It is anticipated to expand the first section of these guidelines to deal in more detail with the evolution of collaboration with elements of civil society in the context of the United Nations system in general; and to expand the second section to deal in more detail with ethical issues arising in the establishment of collaborative arrangments with commercial enterprises.