New Working Paper as of November 2012:
ARV Priority List for the Medicines Patent Pool [pdf]
Comments welcome and encouraged. Please mail input to gro.looptnetapsenicidemnull@eciffo with subject line “Comments on ARV Priority List Working Paper”

The Medicines Patent Pool focuses on increasing access to HIV medicines. Target medicines include those that exist but are either too expensive because of a lack of competition or are not adapted to the specific needs of resource-limited settings (e.g. medicines for children). They also include those that exist, but for which fixed-dose combinations have not yet been developed, drugs that are not yet available on the market, or those that are still under development.

The HIV medicines currently targeted for inclusion in the Pool are chosen based on ongoing consultation with a wide variety of HIV experts. A working paper explaining the rationale for choosing these medicines is available here [pdf]. The working paper is a living document currently in its second edition. Comments are both welcome and encouraged. The first edition was released September 2011 and is available here [pdf].

Work is constantly on-going to revise the list of priority products for inclusion in the Patent Pool, as the field for HIV medicines changes constantly and new products are being developed and as more information is gathered about what is patented and where. The priority list will be updated on the basis of the latest scientific knowledge.

Current target products and formulations:

The Pool decides on target medicines based on two criteria: the medicine’s clinical importance (determined with the aid of medical and public health experts) and the existence of market and/or patent barriers that might prevent access to it. Each drug gets a ranking within each criterion of high, medium, or low.

The drug is then assigned a priority level of 1, 2 or 3. Level one priorities were ranked “medium” or “high” for both criteria. Level 2 priorities were ranked “medium” or “high” for clinical and “low” for market/patent barriers. Level 3 priorities were ranked “low” for clinical and “medium” or “high” for market/patent barriers.

The Pool has concluded licence agreements for compounds in dark green.

The Pool is in negotiations for compounds in light green.

**The Pool has signed a licensing agreement covering darunavir patents with the US National Institutes of Health. However, in order to allow for the manufacture of darunavir, patents are still needed from Johnson & Johnson/Tibotec.

* Compounds in late stages of clinical trials (Phase III)

The table above is based on the Pool’s ARV Priority List [pdf]. Earlier proposed lists of priority essential medicines for HIV as developed by UNITAID and the WHO are listed in “The Selection and Use of Essential Medicines.” More information on the list of priority missing essential medicines for HIV developed by UNITAID and the WHO, please read “UNITAID and WHO Secretariat proposal: the priority missing essential medicines for HIV.”

The Medicines Patent Pool on 18 February 2011 submitted a joint document with UNITAID and the WHO HIV/AIDS Department to the WHO Expert Committee on the Selection and Use of Essential Medicines. This document, available here [pdf], revises the list of missing antiretroviral formulations needed to treat adults and children living with HIV. It was reviewed at the 21-25 March meeting of the Expert Committee, and the evidence was incorporated into the ARV Priority List released in September 2011.