November 24, 2008
Thailand 2004 © Joanne Wong/MSF
A patent-sharing scheme that helped the United States build planes during World War I now could help drug manufacturers create new, urgently needed medicines.
When legal wrangling between patent holders of various aircraft components looked like it would permanently ground US planes by bringing manufacturing to a halt, just as the United States was preparing to enter the war, Congress pushed through the creation of a patent pool. The pool worked by placing all aircraft patents under the control of a new association, and manufacturers licensed the patents for a fee, which was paid to the original patent holders. The United States got its planes. Now UNITAID1, the international drug purchase facility, is taking up the same concept as a way to break down barriers to medical innovation and deliver the treatments that MSF patients and others in developing countries urgently need.
One example of how a patent pool for medicines could make a huge difference is in treating children living with HIV. Ann, a 15-year-old MSF patient in Thailand, tells her story:
“I was 10 years old when I started taking antiretrovirals (ARVs). I weighed just 11 kilograms (39 pounds). I had to take medication for TB and HIV at the same time. There were so many pills around 18 tablets a day that it was almost impossible to swallow them all. I was so sick I couldn’t move, I couldn’t eat, and my lips were stuck together. My mother used to sit with me for ages, getting me to swallow the pills one by one with glasses of water. Fortunately, I need to swallow far fewer pills now, but I still don’t like it. If I could talk to someone who makes the medicine I would ask if it could be just one tablet, twice a day.”
Since she first started taking ARVs, part of Ann’s wish has come true: there is now one pill for children that combines three anti-AIDS drugs in one tablet in a fixed-dose combination, which is used by many MSF projects. But children living with HIV have different needs and require different formulations, and this single option is not a solution. The vast majority of HIV-infected children are still left without proper treatment. Instead, their caregivers have to split up adult tablets or grind them into powder to try to roughly approximate a child’s dosage of ARVs—clearly a risky business.
The problem is that making fixed-dose combination ARVs for children has not been a priority for most pharmaceutical companies. They make their money in industrialized countries where there are barely any children living with HIV anymore so there’s no market argument to develop the products. As well, to come up with a pill combining two or three component drugs, a manufacturer would have to negotiate with all the separate patent holders a potentially horrendously lengthy legal process even if the parties were willing to negotiate.
So that’s why the simplicity of the UNITAID proposal has been causing some excitement in the public health community. This is how it works: under a voluntary agreement, the holders of individual drug patents put their patents into a ‘pool.’ Then, the administrators of the pool license the use of the patents to any interested producers on payment of a royalty, which goes back to the original patent holder. There’s still work to be done on the terms of the licenses for instance, where the products can be sold and which diseases can be treated, but since the negotiations with patent holders, license-issuing, and royalty payments are all carried out under one roof, the hope is that this streamlined process will encourage multiple drug developers to take the plunge.
Another advantage will be the reduction in the cost of medicines, as Ellen t’Hoen, director of policy and advocacy at MSF’s Campaign for Access to Essential Medicines, explains:
“Today, when you’re faced with a patent in a country, as a generic producer you have to wait 20 years until the patent term runs out. With a patent pool you can speed that up because as soon as the patent is in the pool, the generic company can go to the pool, pay the royalties, and develop a generic version of the product so you will get competition much earlier, and competition is the single most important force that drives drug prices down.”
The benefits of this scheme aren’t restricted to helping develop new medicines for children. It could also generate affordable, newer fixed-dose combination drugs for adults who need them. At the moment, the prices of new drugs are just too high. For instance, MSF pays between $613 and $1,022 for the newer World Health Organization (WHO)– recommended regimen for first-line AIDS treatment—a 7- to 12-fold increase compared to older first-line treatments, which are now available for $87 per patient per year.
But if the patents for these new drugs were put into the patent pool, the situation could be transformed as generic and other manufacturers come forward to develop new products. That’s why many donors and public health experts are behind the idea of the patent pool; they recognize that long-term treatment for HIV/AIDS cannot be supplied without major changes in the way we access medicines.
As a voluntary initiative, the buy-in from pharmaceutical companies is critical. So far, reaction from the industry has been cautiously positive. The main body, the International Federation of Pharmaceutical Manufacturers and Associations, has called the idea “very interesting,” and individual companies have also said they would be willing to consider licensing patents to the pool depending on the nature of the licensing terms.
T’Hoen is optimistic about the future of the patent pool. She says it’s also very important that generic drug producing companies come forward to show their support for the idea. If it takes off, she says, the pool could bring huge benefi ts to both MSF patients and millions of other people in developing countries in need of new and affordable treatments.
“I think if the UNITAID patent pool succeeds, the effects could be really phenomenal, both in the area of access, namely bringing prices down, and in the area of developing desperately needed combinations and pediatric formulations. But success will depend on everybody collaborating.”
© 2013 Doctors Without Borders/Médecins Sans Frontières (MSF)