•    HOME   
•    NEWS   
•    BUSINESS   
•    INTERNATIONAL   
•    TECH   
•    SPORTS   
•    LIFE & TIMES   
•    OPINION   
•    MY JAKARTA   
•    BLOGS   
•    EYEWITNESS   

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