A new proposal that will bring down the cost of HIV/AIDS drugs requires patent holders to voluntarily offer their intellectual property to a “patent pool” for use by manufacturers of generic drugs, under a licensing arrangement
The high cost of HIV/AIDS drugs has always been a contentious issue. Companies that manufacture generic versions of drugs have to wait for the patent to expire before they can make cheaper versions.
Now, global healthcare aid agencies such as UNITAID and Medicines Sans Frontieres (MSF) are lobbying for a “patent pool” of HIV/AIDS drugs. The aim is to get patent holders to voluntarily offer their intellectual property to the pool. Any company that wants to use the intellectual property to produce drugs will have to get a licence from the pool, against payment of a royalty. UNITAID is to present the concept before the World Health Assembly in Geneva in May, say sources.
A licensing agency will manage the licences, negotiate and handle royalties, thus simplifying a process that usually requires complex negotiations and litigation over patent rights before cheaper medicines become available. Without having to wait for patents to expire, which usually takes up to 20 years, producers will be able to make generic versions under predetermined licensing conditions.
Indian generic companies manufacture drugs at a fraction of the cost of patent-protected drugs, and are the largest suppliers of cheap HIV/AIDS drugs globally, treating 220,000 patients every year. Of the 20-plus common antiretrovirals, which include fixed-dose combinations of second-line and new-generation drugs, many are patent-protected and Indian companies cannot legally make these under the Trade-Related Intellectual Property Rights (TRIPS) regime of the WTO that India entered in 2005. The only way round this obstacle is for the Indian government to grant a compulsory licence.
New-generation drugs for treating HIV/AIDS manufactured by innovator companies cost between $600 and $1,000 per patient, per year. Indian companies have the ability to supply reverse-engineered or copycat versions at $150-$300 per patient, per year. If the patent pool idea fructifies, makers of generic drugs will benefit, as will the public, as costs will come down.
“The concept has to evolve and requires support from crucial countries such as India, which has the largest number of generic drug makers,” says Leena Menghaney, project manager, India, Campaign for Access to Essential Medicines of MSF.
Source: Business Standard, May 15, 2009