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Last year, I taught a short course at Gilead Sciences in California and was impressed by not only the high quality of their scientific research but their efforts to increase access of their HIV medications to developing countries. Now Gilead has joined a group of pharmaceutical companies to try something bold and innovative – to share patents to both support basic research and to make their medicines more accessible.

The mission of the Medicines Patent Pool is:

…to improve access to affordable and appropriate HIV medicines in developing countries. We are working to bring down the prices of HIV drugs and encourage the development of desperately needed new treatments, such as medicines for children. We do this through voluntary licensing of critical intellectual property – making patents work for public health, while giving pharmaceutical companies fair compensation for their work.

How does it work?

1. First, the Pool negotiates with the patent holder of a given medicine – a pharmaceutical company, research institute, government, university, etc. – to voluntarily share their patents with the Pool. This means that the patent holder is willing to let another producer manufacture and sell generic versions of the medicine in developing countries, or develop adapted formulations in exchange for a royalty payment on any sales of the drug.

2. Next, interested manufacturers and other entities, such as product development initiatives, can obtain a licence through the Pool to develop and/or produce the drug in question. The manufacturer is then free to develop, produce and sell the medicine in the agreed countries under strict quality assurance. The Pool will particularly ease the development and production of fixed-dose combination drugs (FDCs) that have proven to simplify treatment for patients and facilitate treatment scale-up in developing countries. The Pool’s ‘one-stop shop’ service streamlines and facilitates negotiations that may be required to combine two or three medicines into one pill. While FDCs for older HIV medicines exist, ones that include newer medicines, which are patented in many developing countries, are urgently needed.

3. Finally, once the licences are agreed and production has begun, robust market competition ensures lower sustainable prices are achieved. This means more people can be treated with the same amount of money, which is crucial in a climate of increasing needs and funding challenges.

The Pool is a win-win-win model, whereby patent holders are compensated for sharing their patents, generic manufacturers gain access to markets, and patients benefit more swiftly from appropriate and adapted medicines at more affordable prices. It is estimated that the Pool could lead to ARV cost savings of up to US$ 1 billion per year.

Some might be skeptical as to whether major pharmaceutical companies would be willing to share patent rights and work as a team with their competitors. But they are willing to do so, shown by the current list of partners in this effort: Note that some companies are actively in negotiations while others are considering the Medicines Patent Pool’s proposal.

Abbott Laboratories

Boehringer-Ingelheim

Bristol-Myers Squibb

F. Hoffman-La Roche {In negotiations.}

Gilead Sciences {In negotiations.}

Merck & Co.

Sequoia Pharmaceuticals {In negotiations.}

Tibotec/Johnson & Johnson

US National Institutes of Health {In negotiations.}

ViiV Healthcare {In negotiations.}

Partners:

UNITAID – the innovative financing mechanism dedicated to scaling up the treatment of AIDS, tuberculosis and malaria – decided to explore the possibility of establishing a patent pool for medicines in July 2008. It then decided in December 2009 to create and fund a patent pool for medicines. The Medicines Patent Pool was established in July 2010, and is being funded by UNITAID under a five-year Memorandum of Understanding [pdf].

UNITAID was established in 2006 by the governments of Brazil, Chile, France, Norway and the United Kingdom to provide additional funding for the fight against HIV/AIDS, malaria and tuberculosis (TB). UNITAID is hosted by the World Health Organization. Roughly 70% of UNITAID’s funds come from a solidarity levy on airline tickets. Today, UNITAID is supported by 29 countries and the Bill and Melinda Gates Foundation.

Through implementing partners, UNITAID funds the purchase of quality-assured drugs and diagnostics for use in developing countries, using its market power to expand supply, promote development of new and better products, cut delivery lead times and reduce prices. UNITAID’s partners for HIV/AIDS are CHAI (Clinton Health Access Initiative), UNICEF (United Nations Children’s Fund), the World Health Organization (WHO), the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM), ESTHER (Ensemble pour une Solidarité Thérapeutique Hospitalière en Reseau) and the Medicines Patent Pool.

Pro Bono Legal Services

The Medicines Patent Pool recognises and appreciates the pro bono legal services provided by Dechert LLP, Katten Muchin Rosenman LLP and Rajeshwari & Associates.

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