[Already,
the Obama administration has been trying to stop an effort by poorer nations to
strike a new international bargain that would allow them to get around patent
rights and import cheaper Indian and Chinese knock-off drugs for cancer and
other diseases, as they did to fight AIDS. The debate turns on whether diseases
like cancer can be characterized as emergencies, or “epidemics.”]
Chinese
and Indian drug makers have taken over much of the global
trade in medicines and now manufacture more than 80 percent of the active
ingredients in drugs sold worldwide. But they had never been able to copy the
complex and expensive biotech medicines increasingly used to treat cancer, diabetes and other diseases in rich
nations like the United States — until now.
 |
| Herceptin, a drug used to treat breast cancer, is expensive. |
These generic drug companies say they are on the verge of
selling cheaper copies of such huge sellers as Herceptin for breast cancer, Avastin for colon cancer, Rituxan for non-Hodgkin’s lymphoma and Enbrel for rheumatoid arthritis. Their entry into the
market in the next year — made possible by hundreds of millions of dollars
invested in biotechnology plants — could not only transform the care of
patients in much of the world but also ignite a counterattack by major
pharmaceutical companies and diplomats from richer countries.
Already, the Obama administration has been trying to stop an
effort by poorer nations to strike a new international bargain that would allow
them to get around patent rights and import cheaper Indian and Chinese
knock-off drugs for cancer and other diseases, as they did to fight AIDS. The debate turns on whether diseases
like cancer can be characterized as emergencies, or “epidemics.”
Rich nations and the pharmaceutical industry agreed 10 years
ago to give up patent rights and the profits that come with them in the face of
an AIDS pandemic that threatened to depopulate much of Africa, but they see
deaths from cancer, diabetes and other noncommunicable diseases as less of an
emergency and, in some cases, the inevitable consequence of better and longer
living.
The debate has intensified in recent weeks, before world
leaders gather at the United Nations on Monday and Tuesday to confront surging
deaths from noncommunicable diseases, which cause two-thirds of all deaths. It
is only the second global health issue that the United Nations General Assembly
has deemed urgent enough to call a meeting to discuss.
Participants in the negotiations, which include
nongovernmental organizations, described the Obama administration’s position on
the issue and provided e-mails from European diplomats that laid out the
American stance, which has been adopted in the agreement’s working draft.
Although the draft agreement for this week’s meeting at the
United Nations offers no support for poor nations seeking freer patent rules to
fight cancer and other noncommunicable diseases, their advocates have vowed to
continue fighting to loosen those restrictions not only this week in New York
but in continuing international trade negotiations around the world as well.
United States officials repeatedly declined to explain the
American position, though Mark Toner, a State Department spokesman, said
Friday, “Regardless of what you call it, this is clearly such a pressing
challenge globally that world leaders are gathering in New York next week to
discuss ways to confront this threat.”
The United States government has a long history of pushing
for strong patent protections in international trade and other agreements to
protect important domestic industries like pharmaceuticals and ensure continued
incentives for further inventions.
The new biotech copycats are likely to stir sharp debate
among advocates for the poor. Already, some contend that the billions spent to
treat AIDS have crowded out cheap and simple solutions to other afflictions of
poverty, like childhood diarrhea.
The copycats will be less expensive than the originals, but
they will never be cheap. It is unlikely that many African nations will be able
to afford such a costly medicine for breast cancer, when far cheaper ones for
colon and testicular cancer are going wanting.
Dr. Yusuf K. Hamied, chairman of the Indian drug giant Cipla
Ltd., electrified the global health community a decade ago when he said he
could produce cocktails of AIDS medicines for $1 per day — a fraction of the
price charged by branded pharmaceutical companies. That price has since fallen
to 20 cents per day, and more than six million people in the developing world
now receive treatment, up from little more than 2,000 in 2001.
Dr. Hamied said in a telephone interview last week that he
and a Chinese partner, BioMab, had together invested $165 million to build
plants in India and China to produce at least a dozen biotech medicines. Other
Indian companies have also built such plants. Since these medicines are made
with genetically engineered bacteria, they must be tested extensively in
patients before sale.
Once those tests are complete, Dr. Hamied promised to sell
the drugs at a third of their usual prices, which typically cost tens of
thousands of dollars for a course of treatment.
“And once we recover our costs, our prices will fall
further,” he said. “A lot further.”
Dr. Peter Piot, a former director of U.N.AIDS,
the United Nations AIDS agency, said the parallels between the current dilemma
over cancer drugs and the one 10 years ago over AIDS medicines were striking.
“Without a major reduction in the prices of the essential oncology drugs,
there’s no way we can really improve survival from cancer,” said Dr. Piot,
currently the director of the London School of Hygiene and Tropical Medicine.
But he also said he was more cautious about the promise of
generics this time, because biotech medicines were not easy to copy. “I believe
these medicines will make a huge difference, but I would like to see the
evidence that the quality is good before giving it to my patients or taking it
myself,” he said.
Having suffered global opprobrium 10 years ago when they were
seen as blocking efforts to save the lives of millions of poor AIDS patients,
executives for branded drug makers are far more cautious this time about
insisting that high prices are necessary. Sara Radcliffe, a spokeswoman for the
Biotechnology Industry Organization, said companies supported copycat versions
of biotech medicines as long as “countries do not abuse the flexibilities in
international law with respect to compulsory licensing in true public health
emergencies.”
Patents generally provide inventors rights to 20 years of
exclusive sales, but international law allows countries to force companies to
share those rights with competitors under a variety of circumstances, including
to protect public health. Even then, countries are generally not allowed to
export the products that result from forced patent sharing except under dire
circumstances.
But the only way poor countries can get drugs that result
from shared patent rights is if another country exports those medicines to them
under emergency exceptions.
In retrospect, the battle 10 years ago over AIDS medicines
was a small skirmish compared with the one likely to erupt over cancer,
diabetes and heart medicines. The AIDS drug market was never a major moneymaker
for global drug giants, while cancer and diabetes drugs are central to the
companies’ very survival. Roche Holding Ltd. earns $19 billion annually, or
half its annual drug sales, selling Rituxan, Avastin and Herceptin. And sales
of Herceptin have been rising faster in the developing world than in richer
nations — making the developing world a crucial market. For middle-income
countries straining to provide the best medicine possible, the new copycat
biotechs will almost certainly be warmly received.
Mexico alone spends about $120 million buying Herceptin to
treat women with breast cancer, which is nearly one-half of 1 percent of all
government spending on health care, said Dr. Alejandro Mohar, general director
of the Mexican National Cancer Institute. In 2007, Mexico guaranteed access to
Herceptin for all women with breast cancer through a public insurance program.
“We would love to have better access to better drugs,” Dr.
Mohar said. “This debate is going to heat up.”
Hermillia Villegas, a 47-year-old mother of two in Jalisco,
Mexico, recently learned that she had a virulent form of breast cancer that
responded well to treatment with Herceptin. Her husband is a janitor, and her
doctor initially told her that each of 17 treatments with Herceptin would cost
her more than $3,000.
“I don’t have that kind of money,” she said in a telephone
interview. The new health insurance program, which pays for
the whole cost of the drug, has saved her life, she said.
@ The New York Times
@ The New York Times
