Copycats or life-savers?

Indian,Chinese generic drug makers could transform healthcare,but rich nations are not happy.

Chinese and Indian drug makers have taken over much of the global trade in medicines and now manufacture more than 80 per cent 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 Statesuntil 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-Hodgkins lymphoma and Enbrel for rheumatoid arthritis. Their entry into the market in the next yearmade possible by hundreds of millions of dollars invested in biotechnology plantscould 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.

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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.

The debate has intensified in recent weeks,before world leaders gather at the United Nations this week,to confront surging deaths from noncommunicable diseases,which cause two-thirds of all deaths.

Although the draft agreement for this weeks meeting at the UN 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.

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.

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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 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 daya 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.

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,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.

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And once we recover our costs,our prices will fall further, he said. A lot further.

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 Organisation,said companies supported copycat versions of biotech medicines as long as countries do not abuse the flexibilities in international law with respect to compulsory licencing 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.

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.

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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. 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 nationsmaking 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. GARDINER HARRIS