Thursday, July 14, 2011

Poor countries set to benefit from patent agreement on Aids drugs



Medicines Patent Pool agreement with Gilead Sciences allows Indian generics companies to make cheap copies of some of the best Aids drugs
Anti-Retroviral AIDS Drugs
Effective drug treatment can dramatically lengthen the lifespan of HIV-positive individuals. Photograph: Krista Kennell/Krista Kennell/ZUMA/Corbis
People with HIV in poor countries have a real prospect of obtaining not just the basic, cheap drugs to keep the virus at bay, but some of the best medicines that are on offer anywhere in the world - at a price their governments can afford.
This remarkable turnaround is due to the Medicines Patent Pool, headed by the formidable Ellen 't Hoen, which has taken a concept many thought would never work and made it reality. On Tuesday, the patent pool announced its first licensing agreement with a pharmaceutical company, Gilead Sciences, a world leader in HIV medicines.
Gilead is the first pharma company to agree to put specific drug patents in the "pool". This will allow generic companies in India to make cheap copies of them for use in poor countries with major Aids epidemics. Even more importantly, the generics companies will also be allowed to make combinations of drugs from different companies (provided other companies follow Gilead's lead). In an ideal world, anybody with HIV who needed medication would be able to take a single pill once a day in which three or four medicines are combined.
Gilead is to be congratulated. It has agreed to let Indian manufacturers copy and combine not only two important licensed drugs, tenofovir and emtricitabine, but also two drugs that are still under clinical development and do not yet have a licence, cobicistat and elvitegravir. Gilead is itself developing a single pill called the "quad", which will combine all four drugs. Generics companies will also be allowed to start copying that too. With such a head start, it means that cheap generic versions can be ready for distribution as soon as Gilead gets its licences from the US Food and Drug Administration (FDA). This is what Ellen 't Hoen said to me:

It provides a very significant improvement over the current status quo. These pipeline products really show the importance of it [the patent pool]. It will shorten the delays. Countries used to have to wait for years to get access to new medicines.
There is more too. Tenofovir is a hugely important HIV drug, which has lately been considered as a possible tool for preventing infection. It was the drug used in a vaginal gel in the CAPRISA trial in South Africa. The trial found women who used it were 39% less likely to become infected with HIV. Gilead has allowed generic companies to make copies of this important product, but the agreement will ensure access for more countries. The company is also going to allow generic versions for treating hepatitis B, for which tenofovir is also licensed.
The real value of the patent pool starts to become clear in this deal. The big pharma companies with important and lucrative Aids drugs have been willing to allow generic copies to be made, but on the basis of a deal here in India and another there in South Africa. Now - as long as Gilead's move is just the start - there will conceivably be a "one stop shop". 't Hoen says she will be encouraging generics companies to apply as early as this week. Her vision is of a multitude of generics companies making drugs - and driving the prices down through competition. Now that it has been shown that putting people with HIV on treatment makes them less likely to infect others, there is all the more reason to get good treatment to as many people as possible as early as possible.
Unitaid, which works for low prices for Aids drugs and was the launchpad for the patent pool, is delighted with the announcement. "We are sure now that the savings and price reductions that we have been working for over the last five years will continue to happen in the future," said Philippe Duneton, deputy executive secretary.
Mohga Kamal-Yanni, Oxfam senior health policy adviser, urged other companies to follow Gilead into the pool. "Other pharmaceutical companies now have no excuse for refusing to licence their drugs to the pool. Companies such as ViiV and Merck who are already in discussions with the pool need to get on board as quickly as possible to ensure the best possible medicines are made available to poor people at affordable prices. Others, such as Abbott, which have so far failed to engage at all with the pool should be ashamed of themselves and should start negotiations as soon as possible."

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