General
10 In-kind contributions (of goods) should be treated separately from financial contributions, as they are subject to different considerations and require specific agreements. Such donations must be treated in line with Standard Operating Procedures FIN.SOP.IV.013 In-Kind and In-Service Awards (https://emanual.who.int/eM_RelCont_Lib/FIN.SOP.IV.013_In-Kind_and_In-Service_Awards.pdf). For in-kind contributions of medicines, see paragraphs
40 -
60 below (Donations of pharmaceuticals).
WHO can accept in-kind contributions from non-State actors as long as such contributions fall within WHO’s General Programme of Work, do not create conflicts of interest, are managed in accordance with FENSA, and comply with other relevant regulations, rules and policies of WHO. In-kind contributions from non-State actors of medicines/ pharmaceuticals and other health technologies must meet the requirements of FENSA.
20 LEG should be consulted for all in-kind contributions with a view to negotiating and drafting an appropriate agreement with the donor, including to address issues such as purpose of use, directions for use, delivery, transfer of title, warranties and representations in respect of the donated goods, liability, indemnification of WHO, distribution to recipient countries, public statements and press releases, etc. In addition, FNM should be consulted with a view to determining the value at which the donation will be recorded in WHO’s financial records and the WHO Register of non-State actors (where relevant).
30 If a contribution in-kind can be accepted (see section IV.1.1 paragraph
20), departments are responsible for ensuring that adequate arrangements are made for storage (if necessary) and transportation and insurance during transportation to recipient countries (including importation and customs clearance). Departments (Head of WHO office) are also responsible for ensuring that the necessary funds are available to manage the contribution in-kind (including for example, to cover the cost of transportation and insurance, assistance to recipient countries, monitoring and evaluation, etc.). If no such funds are available, the funds should be secured in advance of the acceptance of the donation in-kind (i.e. either from the entity making the donation in-kind or from another source).
Donations of pharmaceuticals
40 In case of donations of pharmaceuticals, departments should also ensure that:
50 In determining the acceptability of large-scale donations of pharmaceuticals, the following criteria should be met:
sound evidence exists of the safety and efficacy of the pharmaceutical for the indication for which it is being donated. The pharmaceutical is approved by the recipient country for the indication for which it is being donated; it should preferably appear on the WHO model list of essential drugs for that indication;
objective and justifiable criteria for the selection of recipient countries, communities or patients have been determined (the donation should, in principle, be sufficient to meet the demand for the pharmaceutical in eligible recipient countries);
a supply system is in place and consideration is given to means of preventing waste, theft and misuse (including leakage back onto the market);
a training and supervision programme is in place for all personnel involved in the supply, storage, distribution and administration of the pharmaceutical at every point from the donor to the end-user;
a drug donation is not of a promotional nature, either with regard to the company itself, or by creating a demand for the pharmaceutical which is not sustainable once the donation has ended;
a phase-out plan for the donation has been agreed upon with recipient countries;
a system for monitoring adverse events has been set up with the participation of the donating company.
60 Additional issues to be addressed in the agreement for a donation of pharmaceuticals (in addition to those mentioned above for donations in-kind generally) are sustainability, packaging and labelling, shelf life, regulatory approval, prequalification, recommendations for proper administration, adverse events, etc. "Sustainability" means that the donation should not have the effect of creating a demand which is not sustainable in the long-term. Thus, WHO generally seeks the commitment from the donor to give favourable good faith consideration to continue making the pharmaceutical available to WHO free of charge once the donation has been fully utilized.
Clearance process and signature of agreements for in kind contributions
70 In-kind contributions (of goods, including but not limited to medical products) should be treated separately from financial contributions as they are subject to different considerations and require specific agreements. CRM, CRE/DAN (for donations from non-State actors, standard procedure only), LEG and FNM should be consulted for all in-kind contributions with a view to negotiating and drafting an appropriate agreement with the contributor. In addition, FNM should be consulted with a view to determining the value at which the donation will be recorded in WHO's financial records.
80 Agreements must be signed by the Director-General, an Assistant Director-General, or a Regional Director, unless signature authority has been delegated.
