[Ip-health] Tina Rosenberg in the New York Times: Sharing Patents to Wipe Out AIDS
thiru at keionline.org
Thu Jul 21 22:30:48 PDT 2011
July 21, 2011, 8:35 pm
Sharing Patents to Wipe Out AIDS
By TINA ROSENBERG
Not since the announcement in 1996 that antiretroviral therapy could effectively control H.I.V. has there been a season of AIDS news as hopeful as this one. Trials of a new microbicide have brought positive results; ongoing studies of circumcision are showing that it gives strong, lasting, protection; a man has been cured of H.I.V. infection and new animal and clinical trials are raising hopes that he won’t be alone.
The research with the most immediate and dramatic impact, however, examines two novel ways to use those antiretroviral drugs. People with H.I.V. who start their antiretroviral therapy as soon as they are diagnosed, instead of waiting for their immune systems to degrade, have a near-zero chance of passing the virus on to their sexual partners. This is the AIDS vaccine we’ve been waiting for — a 96 percent drop in infection rates is far better protection than any actual AIDS vaccine could provide. It has also now been shown that giving one antiretroviral pill a day to people who don’t have H.I.V. but are at very high risk for catching it can reduce their risk by two-thirds or more.
Taken together, these two methods of using antiretroviral drugs not just to treat AIDS, but also to prevent its spread, offer real hope of ending the epidemic. But there’s a catch: they require providing these drugs to millions, perhaps tens of millions, more people than are getting them now. Someone has to pay for all this.
That’s why it matters that last week, Gilead Sciences, one of the most important manufacturers of AIDS drugs, became the first drug maker to join something called the Medicines Patent Pool, a two-year-old organization that was established by Unitaid, an international body dedicated to buying AIDS drugs. In joining the patent pool, Gilead agrees to let generic pharmaceutical companies copy four of its drugs for sale at very low prices in poor countries. Gilead will get a small royalty for every copy sold.
This development might seem like the most obscure of events. But it is an important step towards solving the problem of paying for AIDS drugs for vast numbers of people. Wealthy countries’ tolerance for spending money on medicine has already diminished to the point where we are not only denying drugs to people sick enough to be in desperate need of them, but also contemplating cutting off the supply to people already on them. This is happening even in the United States — for example the state of Florida, which already has nearly 4,000 people with AIDS on a waiting list to get antiretroviral drugs, has proposed cutting off funding for about 1,600 people who now rely on them. (A foolish plan: the cost of their emergency room visits will more than make up for any savings.)
As budgets shrink, the fate of the AIDS epidemic will increasingly depend on our success in lowering the price of antiretroviral drugs. In the past 10 years, as more and more poor countries have begun offering antiretroviral treatment, competition from generic drugs has brought down the price of AIDS medicines dramatically. A year of the gold-standard triple therapy is now available for only $143 in some poor countries.
Even that is far too expensive for most developing countries, so these drugs are largely paid for by the Global Fund to Fight AIDS, Tuberculosis and Malaria, and by the United States President’s Emergency Plan for AIDS Relief, or PEPFAR. When the Bush administration began PEPFAR, it resisted the use of generic drugs, at the behest of the pharmaceutical industry. But even under President Bush PEPFAR officials realized that the use of generics would allow the program to reach far more people — generics, one study showed, saved PEPFAR $323 million over four years.
The Medicines Patent Pool is modeled on a patent pool created by aircraft manufacturers in World War I. The idea of using it for AIDS drugs came from Jamie Love, a veteran campaigner for lower prices for essential medicines. Love, who now leads a group called Knowledge Ecology International, first proposed the idea at an AIDS conference in 2002, and it became a reality in 2009. Now the patent pool has left Unitaid and is a freestanding organization.
Last year, in a show of support from the Obama administration, the U.S. National Institutes of Health became the first entity to donate intellectual property to the patent pool. It gave the pool rights to an AIDS drug developed in N.I.H. labs. Gilead, the first pharmaceutical company to join, has granted the patent pool licenses to four medicines for use in the developing world, and will supply all the data and information needed to make them. The patent pool can then award sub-licenses to certain generic drug makers. Gilead will receive royalties for sales of the copies of its drugs.
The patent pool is designed to solve several important problems. One is that poor countries — the countries where medicine is most desperately needed — usually have to wait a long time for affordable medicines. Under ordinary circumstances, medicines are not available in generic form until 20-year patents expire. But the patent pool can make drugs them available in generic form right away. Two of Gilead’s covered AIDS drugs and one combination pill are still in development, not even yet on the market. With the patent pool, they will likely be available in affordable form in poor countries the same time that people can get them in the United States and Europe.
Another advantage of the patent pool is that it can overcome the intellectual property obstacles in the way of creating combination pills. People are much more likely to take their medicines successfully when they are combined into a single pill, to be taken daily or twice-daily. It can’t happen if each medicine is under patent by a different company, but it can with the patent pool’s licenses. Generic manufacturers can also improve on the drugs in other ways — by inventing formulations that are heat-stable, for example, or made for children. (To encourage the development of pediatric formulations, which are in very short supply, Gilead says it will waive its royalties on these drugs.)
The Medicines Patent Pool is also designed to drive down the price of drugs. One way is by licensing various generic manufacturers to make them, creating competition. The other path is by selling these generic medicines in middle-income countries as well — the larger markets will bring down prices.
There are other ways to make medicines more affordable. Companies can choose to slash prices or license their drugs to generic manufacturers for sale in poor countries; most AIDS drug makers have done some of this. Or countries can legally make or buy the generics without the originator company’s consent, paying the originator company a royalty. These strategies, however, have been piecemeal, in many cases temporary, legally complicated, politically difficult and slow. Most countries don’t do them. They are afraid to — such moves are often punished by the United States and the European Union, where pharmaceutical companies exert a heavy influence over trade policy.
It’s obvious how people with AIDS can benefit from the patent pool, but what’s in it for the drug companies? Some royalties and economies of scale. A lot of goodwill. Over the past 10 years, drug companies have gradually moved from a “one planet, one price” dictum — or worse: they used to charge more in Kenya than in Britain — to acceptance of tiered pricing. They have never wanted to give up their intellectual property rights by licensing generics, but they have been pushed into it by the public relations catastrophe caused by their aggressive defense of high prices everywhere.
“A piece of their motivation is reputational benefits,” said Brook K. Baker, a professor at Northeastern University School of Law who has been a vocal supporter of increased access to medicines. “They’ve faced their fair share of protest over the years. And they are hoping it will take the pressure off for even more sweeping reform. They are betting that by giving access to more countries and earlier access, it will take the pressure off demands for middle-income-country access.”
This is a key point. It is the patent pool’s most important draw for pharmaceutical companies — and its most serious potential weakness. Gilead says its licensing agreements “focus on the countries with the greatest need and where the greatest number of people with H.I.V. live.” But the agreement Gilead negotiated only covers very poor countries. It leaves out Egypt, China, Brazil, plus dozens of other developing countries. Current AIDS drug prices in these countries are six or seven times the price of drugs in sub-Saharan Africa. Without help from the patent pool, these countries have little hope of expanding antiretroviral coverage.
The patent pool reports that seven other drug companies are currently in negotiations. They are likely to try to copy Gilead. “The big worry is what will happen with middle income countries,” said Tido von Schoen-Angerer, executive director of Medecins Sans Frontieres’ campaign for access to essential medicines. “What we have seen with Gilead should be the floor, not the ceiling.”
This attempt to draw a line between the Malawis and Afghanistans of the world and the slightly-better off Egypts and Indonesias is not limited to the patent pool alone. On Wednesday, I’ll respond to comments and look at how drug makers are now raising prices significantly in these lower-middle-income countries. And not just drug makers — for all its support of the patent pool and use of generic drugs in PEPFAR, the Obama administration is still negotiating trade deals that are likely to put lifesaving medicines out of reach for millions of people.
Tina Rosenberg won a Pulitzer Prize for her book “The Haunted Land: Facing Europe’s Ghosts After Communism.” She is a former editorial writer for The Times and now a contributing writer for the paper’s Sunday magazine. Her new book is “Join the Club: How Peer Pressure Can Transform the World.”
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