News Briefs

July 2005

China 

The Chinese government has taken several very public steps to focus attention on HIV/AIDS in the country, including the decision of Premier Wen Jiabao to spend the Lunar New Year, February 8, with HIV-positive people in Henan province, where many farmers contracted the virus in the mid-1990s because of unsafe blood collection. President Hu Jintao also appeared on state-run television in November shaking hands and conversing with AIDS patients. Less than a week earlier, Premier Wen acknowledged that China is facing a “worsening crisis” and called for “strenuous efforts to curb the spread of HIV/AIDS.” (Agence France-Presse, 2/9/05; Ang, AP/Long Island Newsday, 11/30/04; Agence France-Presse, 11/30/04)

The Chinese government has begun to promote condoms to prevent the spread of HIV. In Beijing, HIV prevention advertisements were posted publicly around World AIDS Day in December, including some that promoted condom use. Ordinarily ads for family planning products are banned, but condom ads are considered acceptable if they focus on prevention of HIV/AIDS. Agence France-Presse, 11/24/04) Despite a growing public emphasis on condoms to reduce HIV infection, a recent survey in the South China town of Shenzhen revealed that only 20 percent of men who have sex with men use condoms each time, and 33 percent say that they “never or seldom” do. (South China Morning Post, 5/23/05)

India 

Following weeks of competing pressures from international aid groups and multinational pharmaceutical companies, the Indian Parliament passed a new patent law on March 23 that will bring the country in line with World Trade Organization requirements on patents, including those on ARVs. Because India has not protected product patents for the last 35 years, its drug companies have been able to develop an extensive list of generics. In the case of HIV/AIDS, the lower prices of the Indian generics have made it possible for hundreds of thousands to be treated, and many predict that changes in the patents will diminish the supply of affordable AIDS medicines.

The patent bill introduced by the Indian government was amended as it made its way through Parliament, and the law that resulted appears to be less restrictive than many had expected. According to the final language, generics that are already approved can still be manufactured and sold, albeit with the payment of new licensing fees. Local drug companies can make generic versions of new drugs if the drug is determined to be urgently needed. The new patent law was also amended to prevent the practice of “evergreening” a drug—which companies attempt to do when their 20-year monopolies have run their course, typically by patenting a variant of the same molecule. (The Hindu, 3/22/05; The New York Times, 3/24/05.)

The U.S. Food and Drug Administration (FDA) has tentatively approved a generic ARV manufactured by New Delhi-based Ranbaxy—a move that will allow the Ranbaxy medication to be purchased with funds from the President’s Emergency Plan for AIDS Relief (PEPFAR). Ranbaxy’s version of lamivudine is only the second FDA-approved generic medication to be covered by the US$15 billion PEPFAR program, which provides HIV/AIDS prevention and care in 15 target nations. In January, the US announced a plan to fast-track approvals for low-cost generic ARVs in order to allow their inclusion under PEPFAR. Ranbaxy has applied for FDA approval for four other generics. (Reuters, 5/31/05)

WHO has reinstated two Indian-manufactured generic ARV drugs from Cipla to its list of approved medications for HIV/AIDS patients, even as a growing number of generic AIDS treatments have been withdrawn from the list while they undergo further testing to determine if they are the bioequivalents of brand-name drugs.

Concerns over low-priced generic ARVs arose last summer when WHO removed Cipla’s drugs, followed by three generic anti-AIDS drugs produced by Ranbaxy, and in November four more from Ranbaxy and six from Hetero Drugs. Generic antiretrovirals are relied on widely in Africa and Asia, and the removal of these medications from WHO’s list could threaten efforts to make cheaper drugs more widely available. (Reuters, 11/9/04, 11/30/04)