Chinese and
Indian drugmakers 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.
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 dire and, in some cases,
the inevitable consequence of better and longer living.
The debate
has intensified in recent weeks, before world leaders gathered at the United
Nations for a two-day meeting ending today to confront surging deaths from
noncommunicable diseases, which cause two-thirds of all deaths. It is only the
second global health issue that the UN 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 emails 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.
US
officials repeatedly declined to explain the US position, though Mark Toner, a
State Department spokesman, said on 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
US 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, such as childhood diarrhea.
The new
biotech 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 lacking.
Dr. Yusuf
K. Hamied, chairman of the Indian drug giant Cipla, electrified the global
health community a decade ago when he said he could produce cocktails of AIDS
medicines for $1 per day — a small fraction of the price charged by branded
pharmaceutical companies.
That price
has since fallen to 20 cents per day, and more than 6 million people in the
developing world now receive treatment, up from little more than 2,000 in 2001.
Hamied said
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.
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.
The New York Times
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