How the Medicines Patent Pool expands access to live-saving HIV treatment

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The Medicines Patent Pool licensing process.

At last week’s Global Aids Policy Partnership meeting, representatives from the Medicines Patent Pool gave a presentation on their organization, which works to expand access to life-saving antiretroviral (ARV) medicines in the developing world by working with patent holders to negotiate licenses for key HIV medicines patents.  This allows generic drug companies to produce high quality, low cost HIV drugs in developing countries.

Greg Perry, Executive Director of the Medicines Patent Pool, explained that the Pool has three main objectives: to enable the development of new fixed dose drug combinations that address treatment needs, to promote the development of adapted drug formulations for children or for specific developing countries, and accelerate the availability of more affordable versions of new antiretroviral drugs in developing countries.

The Pool invites patent holders – whether they are pharmaceutical companies, research institutes, governments, etc. – to voluntarily share their patents for HIV drugs with the Pool by entering negotiations to license their drugs.  The Pool’s Expert Advisory Group reviews each license before signing an agreement.  The Pool then identifies qualified manufacturers who can use the patents to produce needed generic medicines.  Once generic manufacturers obtain a license, Pool staff works with them on product development and regulatory approval.  Robust generic competition will in turn reduce prices so more people can afford drugs.

Perry explained that the Pool simplifies interactions between patent holders and generic manufacturers by acting as a repository for all patents needed to make medicines, which is particularly useful for producing fixed-dose combination HIV drugs.  Fixed-dose combination drugs simplify treatment for people living with HIV and facilitate treatment scale-up in developing countries.  Without participating in the Pool, generic manufacturers must negotiate with the patent holding company for every patent needed for producing a fixed-dose combination drug – an expensive, lengthy, and uncertain process.

Perry noted that license are negotiated from a public health, pro-access perspective, and are transparent, as every licensing agreement is published on their website.  He explained that at least 12 developing countries have already benefitted from Pool licenses, with five licenses already signed and four in negotiations on priority ARVs identified by the Pool.

One of the Pool’s key priorities right now is to open up the market for greater access to second-line drugs.  They’re currently in negotiations with Bristol-Meyers Squibb on atazanavir, a once-daily ARV with reduced adverse side effects.  Another key priority is to improve pediatric formulations – the Pool is currently working to get AbbVie to license LPV/r for pediatric use.

The Pool is also working to license promising new drugs, such as TAF, a tenofovir formulation being developed by Gilead Sciences, which Perry said could revolutionize first-line HIV treatment.  The new version of tenofovir will be 10-30 mg instead of 300 mg, will have a much lower toxicity, and will be cheaper to produce.

The Pool has been endorsed by the UN General Assembly, the World Health Organization, and the G8 as a mechanism for enhancing access to treatment, and the Pool’s Patent Status Database is considered “an invaluable step towards furthering access to treatment of HIV/AIDS” by UN agencies and major organizations that procure ARVs.

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