UNITAID, the international finance mechanism for drugs to treat HIV, tuberculosis and malaria, has given the go-ahead for a patent pool for antiretroviral drugs, a mechanism to promote wider licensing of patented drugs to generic manufacturers, in order to lower the cost of treatment.
The decision, taken by UNITAID's Executive Board, was announced on December 14. The pool, scheduled to start operating in mid-2010, aims to make newer medicines available at lower prices, for low- and middle-income countries.
UNITAID has committed to provide start-up funds of up to US$ 4 million over the next year.
Expected savings exceed one billion dollars a year, which will make more medicines available for more people.
“This is an historic day,” said Philippe Douste-Blazy, Chair of UNITAID's Executive Board. “UNITAID has now put in place a mechanism that will make medical advances work for the poor, while compensating companies for sharing their technology.”
The Patent Pool will allow generic companies to make lower cost versions of widely patented new medicines by creating a common space for patent holders to license their technology in exchange for royalties. This will spur competition and further bring down the price of vital new and effective medicines, says UNITAID.
It is hoped that the administrative efficiency of managing voluntary licenses through the patent pool will prove attractive to companies which must currently manage a proliferating number of licenses.
UNITAID says that it has already had consultations with several major manufacturers of antiretrovirals including Gilead, Tibotec, Merck, as well as Sequoia, a biotechnology company that is developing an agent that could replace ritonavir as a booster for protease inhibitors.
One of the chief merits of the patent pool proposal, say its advocates, is the opportunity it gives for the creation of novel fixed-dose drug combinations that will aid adherence and cut down on supply chain management problems.
Rather than waiting for 20 years for patents to expire, generic producers would be able to develop new products quickly to respond to emerging needs, says UNITAID.
The first three-drug fixed dose combinations were created by Indian generic manufacturers using products that were not patented in India. These products were critical in permitting rapid scale-up of antiretroviral treatment from 2003 onwards.
Patent pool advocates say that similar products will be needed in order to promote access to lower-cost second-line treatment, and to encourage adoption of safer, more potent drugs for first-line treatment.
Potential combinations of interest will include a wider selection of three-drug combinations that include tenofovir and efavirenz, in order to promote greater price competition in the first-line therapy market.
In second-line treatment there will be interest in creating fixed dose products that contain the protease inhibitor atazanavir and two nucleoside analogues, or the integrase inhibitor raltegravir in combination with a boosted protease inhibitor.
None of these second-line combinations are currently available as products created by the patent holders.
UNITAID has identified 19 products from nine companies for potential inclusion into the pool. The pool will facilitate the development of fixed-dose combinations (FDCs).
“FDCs are especially important in the treatment of children, who make up 10% of current treatment needs,” said Jorge Bermudez, UNITAID Executive Secretary. “The Patent Pool will greatly help us accomplish our mission of scaling up treatment access, particularly for specific target groups otherwise neglected by the market – that is, children and people who fail on older therapies.”
The idea of a Patent Pool has been in discussion for a number of years. In 2006, Knowledge Ecology International and Médecins Sans Frontières proposed it to UNITAID.
“Today is a good day for people living with HIV/AIDS in developing countries,” said Nelson Otwoma, the HIV/AIDS community representative on UNITAID's Executive Board. “When my son was a baby we had to break pieces of adult tablets for him - treating him was guess work. The Pool gives me hope that we'll have better medicines to treat children in the future.”
“We’ve had enormous interest from companies and political support from numerous constituencies around the globe,” said Ellen ‘t Hoen, in charge of the Patent Pool for UNITAID. “We're now ready to move to the next phase - reaching agreements with companies to get the drugs out.”
Further information
Adapted from a UNITAID press release and background materials available at www.unitaid.eu.