Development of List of Health Products

Once the selection, quantification and supply planning of health products is completed and documented, UNDP requires all Country Offices (COs), implementing Global Fund grants and other health programmes, to have a detailed approved list of health products, with quantities and costs, including any and all related procurement and supply management costs before any funds are spent on health products.

For Global Fund grants, the list of health products, quantities and costs must be prepared in the Global Fund Health Product Management Template (HPMT), which is aligned with the grant Performance Framework and the grant Detailed Budget. The Global Fund Principal Recipient (PR), when submitting the HPMT for approval to the Global Fund, should also attach supporting documentation with the relevant quantification, hypotheses and assumptions used to calculate the quantities listed.

For interim Principal Recipients (PR) of Global Fund grants, the HPMT must be approved by the Global Fund during the grant-making process or, in the case of Financing Agreements, the list of health products planned for procurement must be approved by the relevant government authority before initiating procurement.

The List of Health Products should include the following information:

• Complete product specifications:
  • For pharmaceuticals: INN, strength, dosage form, packaging, specific formulation, etc.
  • For diagnostics: product characteristics (e.g., intended use, performance characteristics, operational characteristics) for all items required to complete a test (i.e., all reagents and related consumables), packaging, installation and training, warranties, guarantees, services, and maintenance requirements, etc.
  • For health equipment: also include whether the contracting modality is for “purchasing the equipment”, “leasing the equipment”, or a “reagent rental agreement”.

Practice Pointer

To support UNDP COs with developing robust technical specifications for tendering, procurement and purchasing of the health products that ensure compliance with UNDP’s expectations regarding the safety, quality and performance, the GHPC QAS Team has developed templates for writing the technical specifications of items not included in Global Fund QA lists (i) medical devices including medical Personal Protective Equipment, medical equipment etc (ii) Rapid kits for diagnostic use (iii) General Lab Use products (iv) IVD Equipment (v) Reagents for IVD uses, and (vi) Finished Pharmaceutical Products. The technical specification details essential criteria that must be provided by the end-user to enable suppliers to meet these requirements when submitting their offer.

• Required quantities together with expected delivery dates and incoterm
  • This is especially important for items with a very short shelf-life requiring multiple staggered deliveries.
• UNDP budgeted (reference) price
• Consignee details
• Delivery address and contact details
• Registration Status
• Regulatory requirements
  • For most health products this will relate to the legislative requirements established by the NRA
  • There may also be specific regulatory requirements for importation of narcotics, precursors, and/or psychotropic medicines into the country
  • For pesticides the requirements might be linked to the Ministry of Agriculture
• Marking or labelling requirements
• WHO Shelf life requirements, the remaining shelf life at time of arrival in-country should be in accordance with the NRA’s regulations, or as agreed with the NRA in case of deviations
• Language requirements
• Any other requirements

National Regulatory Authority (NRA) authorization

According to the UNDP QA policy, medicines and other health products (as appropriate) should be authorized by the NRA in the recipient country. “Authorization” includes formal registration, temporary import authorization, waiver for non-commercial use or any other exceptional procedure. It is the responsibility of the suppliers to provide appropriate product information as required by the NRA.

Patent Issues

A product’s patent provides its inventor with property rights that prevent competitors from making, using, or selling the item, typically for around 20 years. Each country, or region, has its own patent laws, which determine the duration of the patent. It can be challenging to determine the intellectual property status of a health product in a country, and obtain information that is correct and up-to-date.

Most of the medicines on the WHO List of Essential Medicines are off-patent. Some more recent medicines, however, such as anti-retroviral (especially second line and third line), newer cancer, tuberculosis and hepatitis C medicines may be still patent-protected in many LMICs and UMICs countries, leading to high prices.

UNDP is committed to applying national laws and applicable international obligations in the field of intellectual property. This includes applying the flexibilities provided in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and interpreted in the Doha Declaration, in a manner that achieves the lowest possible price for products of assured quality.

In July 2018, UNDP developed a Standard Operating Procedure (SOP) on Addressing intellectual property matters in procurement of medicines by UNDP which serves as a framework to:

• Ensure UNDP does not infringe upon patent during health procurement activities;
• Determine whether UNDP can procure an originator or a generic/biosimilar medicine (More information can be found in the UNDP **Methodology for Patent Searches)**;
• Determine if a country can utilize any of the flexibilities in the TRIPS Agreement to legally purchase generic versions of the health product.

For support related to intellectual property, please contact the UNDP GFPHST HPM Specialist, who serves as a focal point for Country Offices implementing health procurement activities and who liaises with intellectual property specialists in UNDP’s HIV and Health Group and with external partners.

Additional guidance to support this area of work are also available through resources listed below:

• SOP on Addressing intellectual property matters in procurement of medicines by UNDP
• Methodology for Patent Searches on Essential Medicines in Developing Countries